[Senate Hearing 109-741]
[From the U.S. Government Publishing Office]
S. Hrg. 109-741
S. 3128: THE NATIONAL UNIFORMITY
FOR FOOD ACT
=======================================================================
HEARING
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED NINTH CONGRESS
SECOND SESSION
ON
EXAMINING S. 3128, TO AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT TO
PROVIDE FOR UNIFORM FOOD SAFETY WARNING NOTIFICATION REQUIREMENTS
__________
JULY 27, 2006
__________
Printed for the use of the Committee on Health, Education, Labor, and
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COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
MICHAEL B. ENZI, Wyoming, Chairman
JUDD GREGG, New Hampshire EDWARD M. KENNEDY, Massachusetts
BILL FRIST, Tennessee CHRISTOPHER J. DODD, Connecticut
LAMAR ALEXANDER, Tennessee TOM HARKIN, Iowa
RICHARD BURR, North Carolina BARBARA A. MIKULSKI, Maryland
JOHNNY ISAKSON, Georgia JAMES M. JEFFORDS (I), Vermont
MIKE DeWINE, Ohio JEFF BINGAMAN, New Mexico
JOHN ENSIGN, Nevada PATTY MURRAY, Washington
ORRIN G. HATCH, Utah JACK REED, Rhode Island
JEFF SESSIONS, Alabama HILLARY RODHAM CLINTON, New York
PAT ROBERTS, Kansas
Katherine Brunett McGuire, Staff Director
J. Michael Myers, Minority Staff Director and Chief Counsel
(ii)
C O N T E N T S
__________
STATEMENTS
THURSDAY, JULY 27, 2006
Page
Enzi, Hon. Michael B., Chairman, Committee on Health, Education,
Labor, and Pensions, opening statement......................... 1
Burr, Hon. Richard, a U.S. Senator from the State of North
Carolina, opening statement.................................... 2
Prepared statement........................................... 4
Feinstein, Hon. Dianne, a U.S. Senator from the State of
California, opening statement.................................. 6
Prepared statement........................................... 7
Boxer, Hon. Barbara, a U.S. Senator from the State of California,
opening statement.............................................. 9
Prepared statement........................................... 10
Chambliss, Hon. Saxby, a U.S. Senator from the State of Georgia,
opening statement.............................................. 13
Prepared statement........................................... 14
Roberts, Hon. Pat, a U.S. Senator from the State of Kansas,
opening statement.............................................. 15
Stadtlander, William, Owner, Homestat Foods, Dublin, Ohio........ 19
Prepared statement........................................... 21
Hutt, Peter Barton, Senior Counsel, Covington and Burling,
Washington, DC................................................. 23
Prepared statement........................................... 24
Murano, Elsa A., Dean, College of Agriculture and Life Sciences,
Texas A&M University, College Station, TX...................... 30
Prepared statement........................................... 32
Hubbard, William K., Former Associate Commissioner for Policy,
Food and Drug Administration, Chapel Hill, NC.................. 36
Prepared statement........................................... 38
ADDITIONAL MATERIAL
Statements, articles, publications, letters, etc.:
Senator Kennedy.............................................. 52
Senator Hatch................................................ 53
Senator Jeffords............................................. 54
Senator Nelson............................................... 54
Leslie G. Sarasin............................................ 55
Thomas R. Frieden............................................ 56
Benjamin Cohen............................................... 59
Response to Questions of Senator Jeffords by Panel II........ 86
Response to Questions of Senators Enzi, Kennedy, and Reed by
William Stadtlander........................................ 87
Response to Questions of Senators Enzi, Kennedy, Harkin,
Reed, and
Clinton by:
Peter Barton Hutt........................................ 90
Elsa A. Murano........................................... 109
Response to Questions of Senators Enzi, Kennedy, Harkin, and
Reed by William K. Hubbard................................. 111
Letters of Support........................................... 116
Letters of Opposition........................................ 123
(iii)
S. 3128: THE NATIONAL UNIFORMITY
FOR FOOD ACT
----------
THURSDAY, JULY 27, 2006
U.S. Senate,
Committee on Health, Education, Labor, and Pensions,
Washington, DC.
The committee met, pursuant to notice, at 10:00 a.m. in
Room SD-430, Dirksen Senate Office Building, Washington, DC.,
Hon. Michael B. Enzi, chairman of the committee, presiding.
Present: Senators Enzi, Burr, Isakson, Feinstein, Boxer,
Chambliss, and Roberts.
Opening Statement of Senator Enzi
The Chairman. Good morning and welcome to this hearing on
food safety standards and warning requirements. Today's hearing
will help the committee understand how the National Uniformity
for Food Act might affect food safety across our Nation. In
looking at foods, we see that nutrition labeling is nationally
uniform, health claims are nationally uniform, and allergen
labeling is nationally uniform. As a result, consumers have
consistent science-based information about these products. Yet
warning labels and other notifications vary from State to
State. How do I as a consumer use these different warnings to
make good decisions in food choices? What do I do if benefit
information is always the same but the risk information is
different, depending on where I live? Can a loaf of bread be
more dangerous in California than the same loaf in Wyoming or
Massachusetts? The bill before us today, the National
Uniformity for Food Act, would create a uniform, national
system of food safety standards and warning requirements. The
bill would create this system by preempting State laws
regarding food warning labels and tolerances. The bill provides
that where FDA has acted by setting a safety standard for a
food ingredient, the States would adopt and enforce the same
standard. If FDA has not set a safety standard for a particular
substance in food, the States would remain free to set and
enforce their own standards. The bill would also provide for
national uniformity in product warnings. States would not be
permitted to require a warning in labeling, advertising, or any
other form of public communication if that warning differs from
that imposed under Federal law. States would remain free to
issue their own public warnings under State laws. Under the
bill, a State with the requirement that differs from a related
Federal requirement could petition the FDA either to adopt the
requirement as a national requirement or exempt it from the
requirement of uniformity. FDA's decisions on State petitions
would occur only after public input. The bill before us seeks
consistency in substantive standards between State and Federal
requirements. It does not address how requirements are
enforced. The State requirements and authorities for handling
potentially hazardous foods, sanitation, date marking and
related issues would not be effected by the legislation. The
bill also would preserve the authority of the States to act if
a food presents an imminent hazard. Today the States inspect
most food manufacturing establishments. This bill would not
change the partnership between FDA and State authorities in
food safety. In fact, just last week, FDA announced a program
to create uniform standards for the multi-level inspection
program. FDA worked with State food regulators to create the
draft uniform standards. This is exactly the sort of thing that
should be happening. When it comes to drugs, we've been talking
a lot lately about how important it is to weigh risks and
benefits together. Senator Kennedy and I agree on this, yet
while half of all Americans take at least one prescription drug
daily, every one of us eats daily. So we're all affected by the
actions that our Federal and State Governments take in
regulating food safety standards. The bill before us raises
important questions and here are just a few: Why should we
weigh risks and benefits together when it comes to drugs but
separately by State when it comes to food? Why should we charge
the FDA with regulating the positive information about foods
but leave decisions about warnings and tolerances to the
States? And do consumers really benefit from the 50-state
hodge-podge of different warnings and labelings on these
products? I hope this hearing will help us answer these
questions as we consider the National Uniformity for Food Act
and I appreciate our colleagues who are here to testify today.
I have to apologize, I have to go to a mark-up of the Small
Business Committee. We've got a couple of small business issues
in Wyoming since that is all we have in Wyoming--small
businesses.
So I'll turn the gavel over to Chairman Burr.
Opening Statement of Senator Burr
Senator Burr [presiding]. Thank you, Mr. Chairman. I want
to thank you before you leave for holding this hearing on
uniformity and I want to welcome our colleagues. This is the
way it is supposed to work. I sponsored this legislation in the
105th Congress. I never dreamed that I would be in this
institution, the U.S. Senate, but I also never dreamed that it
would take this long to bring what I thought was common sense
legislation to this country.
I believe consumers should be able to make informed
decisions about foods they purchase. As a Nation, we have
uniform nutrition labeling and with S. 3128, we would have
uniform warning labels as well. This legislation provides for a
national, uniform and scientific approach to food safety
regulation and it provides for consideration of State Food
Safety requirements as national requirements.
This food uniformity legislation has been carefully crafted
over many years to help ensure our system of food regulation
remains the gold standard of the world. Currently, the Food and
Drug Administration is widely recognized as the preeminent food
regulatory agency. This bill we discuss today will build on
that strength and help make our food regulatory system even
stronger.
The intention behind this uniformity legislation is quite
simple. It is to provide strong and consistent national
regulations to ensure the quality of our country's food supply.
Right now, our system of food regulation involves actions not
just by the FDA but States and localities as well. Each of
those entities has an important role to play in ensuring the
quality and the safety of our food supply.
Historically, the FDA has established standards to
determine when food is safe and has established national
requirements for food labeling. The FDA conducts some
inspections of food facilities and participates in standard
setting that occurs at a multinational level. State and local
governments have historically inspected food facilities, in
fact, often under a contract with the FDA and they play an
important role in shellfish and dairy product safety, in
retail, local restaurants and food service safety.
This uniformity legislation preserves and protects these
important roles. Let me be clear. S. 3128 does not change any
of these roles and functions, but I believe inconsistent, often
conflicting and often nonscience-based requirements and
warnings imposed at the State or local level--those also not
supported by the FDA--create confusion for consumers and
unnecessarily increase production costs for thousands of food
manufacturers across the country.
In order to simplify the process, the bill provides for a
single national standard on food adulteration and a system of
determining whether food labels should bear particular warning
labels. Clearly, we should rely on the FDA to make the final
determination as to when food is adulterated and when food
should bear a warning statement.
When a warning about food is supported by science and it is
necessary to help consumers make informed decisions about the
foods they purchase and consume--that warning should be applied
to the food items sold in all 50 States. This bill achieves
that result. I would respectfully suggest that if food is safe
to be sold in one State or 20 States or 30 States, it should be
safe in all 50 States. Likewise, if a warning is needed, surely
that warning should be shared with consumers in all 50 States.
The concept of a national system for food adulteration,
including warnings, is not new. In fact, the absence of
uniformity between Federal and State food systems is an
exception. For example, current law provides for uniformity in
the regulation of meat and poultry products, pesticide
residues, nutrition labeling, health claims and standards of
identity. The uniformity bill before us is built on many years
of uniform food regulation experience.
As I've said before, States play an important role in
enforcing food safety requirements. States do this through
inspection of food facilities and embargoing contaminated
products. Under this legislation, States will continue to be in
charge of inspections to enhance basic sanitation requirements
in places such as restaurants, retail food stores, shellfish
processors, and dairy farms. Recognizing this important role,
unlike other uniformity bills considered by Congress, S. 3128
enables States to petition the FDA to consider potential
Federal requirements of any food adulteration requirements
under the State law that, on the date of enactment, does not
have a Federal counterpart and in this proposed process the
State requirement remains in effect. Let me repeat that.
Remains in effect until the FDA takes action on the State
petition. Not only does the legislation provide for uniformity
but it also includes a predictable process by which all
existing State Food Adulteration requirements can be considered
for adoption at the Federal level by the FDA.
I believe S. 3128 will ensure that food sold in this
country is subject to a single contemporary standard that will
benefit consumers. Again, I thank our colleagues for their
willingness to come and at this time, the Chair recognizes the
Senator from Kansas, for any statement you might like to make.
[The prepared statement of Senator Burr follows:]
Prepared Statement of Senator Burr
Thank you, Chairman Enzi and Senator Kennedy, for holding a
hearing on S. 3128, the National Uniformity for Food Act. I am
proud to be the lead sponsor of S. 3128. I have sponsored
legislation on this issue since the 105th Congress. I can
assure you that back then I did not know I would be a member of
the Senate HELP Committee participating in a hearing on this
bill in the 109th Congress!
I believe consumers should be able to make informed
decisions about the foods they purchase. As a Nation, we have
uniform nutrition labeling, and with S. 3128 we would have
uniform warning labeling as well. This legislation provides for
a national, uniform, and scientific approach to food safety
regulation and it provides for consideration of State food
safety requirements as national requirements as well.
This food uniformity legislation has been carefully crafted
over many years to help ensure our system of food regulation
remains the gold standard of the world. Currently, the Food and
Drug Administration is widely recognized as the pre-eminent
food regulatory agency. The bill we are discussing today will
build on that strength and help make our food regulatory system
even stronger.
The intention behind this uniformity legislation is simple.
It is to provide for strong and consistent national regulations
to ensure the quality of our country's food supply. Right now
our system of food regulation involves actions not just by the
FDA, but States and localities as well. Each of those entities
has an important role to play in ensuring the quality and
safety of our food supply.
Historically, the FDA has established standards to
determine when food is safe and has established national
requirements for food labeling. The FDA conducts some
inspections of food facilities and participates in standard
setting that occurs at a multinational level. State and local
governments have historically inspected food facilities (in
fact, often under contract with the FDA), and play an important
role in shellfish and dairy product safety, and retail, local
restaurant and food service safety.
This uniformity legislation certainly preserves and
protects these important roles. Let me be very clear--S. 3128
does not change any of these roles and functions. But I believe
inconsistent, often conflicting, and nonscience-based
requirements and warnings imposed at the State or local level--
those also not supported by the FDA--create confusion for
consumers and unnecessarily increase production costs for
thousands of food manufacturers across our country.
In order to simplify the process, the bill provides for a
single national standard on food adulteration and a system of
determining whether food labels should bear particular warning
statements. Clearly, we should rely on the FDA to make the
final determination as to when food is adulterated and when
food should bear a warning statement.
When a warning about food is supported by science and is
necessary to help consumers make informed decisions about the
foods they purchase and consume, that warning should be applied
to that food item sold in all 50 States. This bill achieves
that result. I would respectfully suggest that if food is safe
to be sold in one State, or 20 States, or 30 States, it should
be safe in all 50 States. Likewise, if a warning is needed,
surely that warning should be shared with consumers in all 50
States.
The concept of a national system for food adulteration,
including warnings, is not new. In fact, the absence of
uniformity between the Federal and State food systems is an
exception. For example, current law provides for uniformity in
the regulation of meat and poultry products, pesticide
residues, nutrition labeling, health claims, and standards of
identity. The uniformity bill before us is built on many years
of uniform food regulation experience.
As I have said before, States play an important role in
enforcing food safety requirements. States do this through
inspections of food facilities and embargoing contaminated
products. Under this legislation, States will continue to be in
charge of inspections to enforce basic sanitation requirements
in places such as restaurants, retail food stores, shellfish
processors, and dairy farms. Recognizing this important role,
unlike other uniformity bills considered by Congress, S. 3128
enables States to petition the FDA to consider potential
Federal requirements of any food adulteration-related
requirement under State law that, on the date of enactment,
does not have a Federal counterpart. And, in this proposed
process, the State requirement remains in effect until FDA
takes action on the State petition. Not only does the
legislation provide for uniformity, but it also includes a
predictable process by which all existing State food
adulteration requirements can be considered for adoption at the
Federal level by the FDA.
I believe S. 3128 will ensure that food sold in this
country is subject to a single contemporary standard that will
benefit consumers. Again, I thank the Chairman for having this
hearing today. Thank you and I look forward to the witnesses'
testimony.
Senator Roberts. Mr. Chairman, I know that there are
Senators on the panel who have time schedules as I do and I'm
going to reserve my statement. I want to thank you for yours
and I want to thank you for your leadership in this regard but
I hope I can be recognized after the panelists make their
statements. I know they are eager to go on to their other
duties so I will yield at this time.
Senator Burr. Does the Senator from Georgia have----
Senator Isakson. I would like to publicly acknowledge the
hard work over four Congresses, by the Senator from North
Carolina on this issue. I appreciate his dedication to it and
appreciate the members of the Senate being here to testify
today.
Senator Burr. I'd like to welcome our three distinguished
colleagues to the committee today, Senator Saxby Chambliss of
Georgia, Senator Barbara Boxer from California, and Senator
Diane Feinstein from California. I appreciate all of your
longstanding interest in food uniformity, your willingness to
appear before the committee and as would be a southern custom,
we would start with our Senator from California, Senator
Feinstein.
Opening Statement of Senator Feinstein
Senator Feinstein. Thank you very much, Mr. Chairman. I
appreciate the committee holding this hearing. I appreciate my
colleague from California being here. Mr. Chairman, I must say
that both of us are strongly opposed to this bill as is our
Governor, Governor Schwarzenegger and others. I believe this
bill would have a very deleterious effect on the people that we
represent and that's 37.2 million Californians. I think it has
to be looked at, that California is as big in population as 21
States and the District of Columbia put together. It is a huge
consumer market and 17 years ago, the State passed an
initiative known as Proposition 65. It passed with 63 percent
of the vote and the product of 65 was to impose separate and
distinct warning requirements for known carcinogens in consumer
products. I must say that since that time, having been in
public life, I have never had a single complaint from anybody
about Proposition 65 and I very much doubt that my colleagues
has either. There is strong bipartisan opposition to these
proposed measures. Not only our Governor but the Governors of
seven other States, the attorneys general of 39 States, the
Association of Food and Drug Officials, the State Departments
of Agriculture, Consumers Union and Rumors National Consumer
and Environmental groups oppose pre-empting State and local
Food Safety requirements. This legislation would pre-empt over
200 of these Food Safety State laws and regulations nationwide
and they would impede States and localities from enacting and
implementing food safety regulations stronger than those
required by the Federal Government, even if that authority is
needed to respond quickly to an incident, such as an act of
bioterrorism. This bill is a major assault on California's
initiative and it would cancel out major benefits under the law
that protects California consumers from cancer-causing
chemicals to lead and arsenic poisoning.
Let me give you a few examples. This year, the State used
Proposition 65 to stop Pepsi from selling soda bottles with
leaded labels, which can cause birth defects and cancer. With
respect to lead in ceramic tableware, California required clear
warnings for lead that leeches from ceramic tableware into food
and beverages. The marketplace has responded. Now these
ceramics have disappeared from shelves. Lead and calcium
supplements--makers of calcium supplements such as Tums and
Rolaids, agreed to reduce levels of lead contamination in their
products. This result was reached without posting warnings that
might have discouraged women from taking calcium. Leaded
crystal, fully leaded crystal, especially when used for storage
of beverages, leeches substantial amounts of lead. California
requires point of sale signs while FDA has provided a consumer
advisory. Mercury in fish--California requires that information
be posted in stores where fresh fish is sold, warning pregnant
women about the high levels of mercury in seafood and it would
no longer be able to do so. As you can see, this bill, in just
these ways that I've elucidated, undermines California's
Proposition 65 and this is not the first assault on California
law. Earlier, similar efforts to overturn Proposition 65 and
pre-empt State and local food safety laws, have been opposed by
people on both sides of the isle. For example, the Reagan
administration conducted an economic analysis of the impact of
Proposition 65 in 1988, which the first President Bush
concurred with and that found that industry's claims that
Proposition 65's financial burden ``vast overstate the
potential impact on producers.'' Mr. Chairman, I think what I
want to say is that on behalf of my colleague, Senator Boxer
and I, if this bill were to come to the floor, we would use
every parliamentary device available to us to stop it. We both
strongly oppose this bill. Thank you very much.
[The prepared statement of Senator Feinstein follows:]
Prepared Statement of Senator Feinstein
Mr. Chairman, thank you very much for holding this hearing
today.
I hope that this hearing--the first to be held on this
issue--will clarify the major negative impact of establishing
uniform requirements for food safety warning labels nationwide.
This legislation effectively cancels strong food safety
laws approved by State and local governments, such as
California's Proposition 65 (``Safe Drinking Water and Toxic
Enforcement Act'') enacted into law 17 years ago by 63 percent
of Californians.
This Senate bill (S. 3128), like the house-passed bill,
undermines hundreds of important food safety laws across the
country. And it sets a dangerous precedent undermining States'
rights.
There is strong bipartisan opposition to these proposed
measures. Governors of eight States, including Governor
Schwarzenegger, Attorneys General of 39 States, the Association
of Food and Drug Officials, State Departments of Agriculture,
Consumers Union and numerous national consumer and
environmental groups oppose preempting State and local food
safety requirements.
This Senate bill would:
Preempt over 200 food safety State laws and
regulations nationwide.
Impede States and localities from enacting and
implementing food safety regulations stronger than those
required by the Federal Government, even if that authority is
needed to respond quickly to an incident such as an act of
bioterrorism.
Threaten laws passed by California and at least
eight other States limiting the sale of sodas and junk food in
public schools aimed to promote healthy eating habits for
children.
In September 2005, Governor Schwarzenegger signed two bills
(one bill which takes effect in July 2007) restricting certain
foods and beverages from being sold in California's public
schools so that children are not exposed, for example, to such
high levels of sugar in their food and beverages that
contribute to the major issue of child obesity.
Prohibit States, like California, to issue their
own mercury warnings to pregnant women about the significant
risks from high levels of mercury in seafood such as swordfish
and shark. California requires that signs be posted in grocery
stores where fresh fish is sold warning pregnant women about
the high levels of mercury in seafood and would not be able to
continue to post these warning signs that protect consumers.
Force States to petition the FDA to maintain
important food safety laws, imposing major financial burdens on
the financially-strapped FDA and States. The Center for Science
in the Public Interest estimates it will cost FDA at least $120
million to process the expected 300 waiver requests just for
Proposition 65 (i.e. waivers for lead in calcium supplements
and arsenic in bottle water).
This bill is a major assault on California's Proposition 65
and would cancel out major benefits under the law that protect
California consumers from cancer causing chemicals to lead and
arsenic poisoning.
Here are just a few examples:
This year, the State used Proposition 65 to stop
Pepsi from selling soda bottles with leaded labels which can
cause birth defects and cancer.
Lead in ceramic tableware: California required
clear warnings for lead that leaches from ceramic tableware
into food and beverages.
The marketplace responded. Now these ceramics have
disappeared from shelves.
Lead in Calcium Supplements: Makers of calcium
supplements, such as Tums and Rolaids, agreed to reduce levels
of lead contamination in their products. This result was
reached without posting warnings that might have discouraged
women from taking calcium.
Leaded crystal: Fully leaded crystal, especially
when used for storage of beverages, leaches substantial amounts
of lead. California requires point-of-sale signs, while FDA has
provided a consumer advisory.
Mercury in fish: California requires that
information be posted in stores where fresh fish is sold
warning pregnant women about the high levels of mercury in
seafood and it would no longer be able to do so.
As you can see, this bill significantly undermines
California's Proposition 65. This is not the first assault on
the California law.
Earlier similar efforts to overturn Proposition 65 and
preempt State and local food safety laws have been opposed by
people on both sides of the aisle.
For example, the Reagan administration conducted an
economic analysis of the impact of Prop 65 in 1988--which the
first President Bush administration later concurred with--that
found industries claims of Prop 65's financial burden to
``vastly overstate the potential impact on producers.''
State and local governments should have the right to
protect their citizens. Consumers deserve to know if the
product they are purchasing may cause them harm.
The bottom line is this: Congress should NOT approve
legislation that threatens hundreds of critical food safety
laws across the country and puts at risk the health and safety
of all Americans.
Thank you Mr. Chairman.
Senator Burr. Thank you for your willingness to speak.
Senator Feinstein. I might be excused and I thank my
colleague for allowing me to go earlier. I have a judiciary
mark-up.
Senator Burr. We understand.
Senator Boxer.
Opening Statement of Senator Boxer
Senator Boxer. Thanks so much, Mr. Chairman and I have a
hearing in Foreign Relations with Ambassador Bolton and so I
will also have to bolt after my statement. Thank you so much
for allowing us to speak here. I know it is not a happy time
for you to hear two colleagues lead off in opposition to a bill
you really care about so in advance, let me say that I respect
your view but we are in strong disagreement because, as Senator
Feinstein has said, we view this legislation as a direct threat
to California's Food Safety and Consumer Rights and their
protections. Our people were heard at the ballot box. This
isn't our opinion, this is the opinion--Republicans, Democrats,
Independent voters, our Republican Governor--we're all united
against this bill and that is why we are so, just letting you
know right now, today, that I know you've fought long and hard
for this but the fight is not over because we think this bill
will roll back essential food safety laws and in essence,
prevent State and local authorities from enacting food safety
regulations. Our State is a national leader in ensuring food
safety. We have more people than any other State by far, as was
pointed out. We've got more kids, we've got more sick people,
we've got more vulnerable populations and therefore, we have
stepped out in our State, again Californians passing Prop 65
with 63 percent of the vote, one of the most popular
initiatives we've ever had on our ballot in terms of pulling
people together. It is interesting because really, the act of--
it doesn't force anything. It just says to the manufacturer,
let us know what is in your product and then people will decide
and if you have high levels of arsenic in your bottled water,
then people have a right to know and guess what? They're not
going to buy that product and that's why this has been so
successful, because we believe in the people's right to know
and if the people know, they'll buy the safest products and it
has worked really, really well. We don't want to go back to the
days when our consumers were in the dark about dangerous
contaminants in their food. Now, I know your response is,
``Well the Federal Government will do just as good a job.''
That hasn't been proven to be the case and I want to talk about
lead in candy. Senator Chambliss leaned over and said, ``Wow!
That looks awful good.'' And it does look awful good. This is
candy with lead in it, dangerous lead and I want to show you a
picture.
It just shows you how much I love you! Here we go. This is
a photograph of lead-tainted candy being given to little
children and they are having such a wonderful time eating this
dangerous candy and in our State, we outlawed this. The Federal
Government has no such law. It could have had. It doesn't have
it and I want to tell you about what this does to children.
Lead is a dangerous toxin. It attacks the nervous system
causing behavior problems, learning disabilities, seizures and
even death. Children are at the greatest risk. The State of
California, as I said, has a law to reduce lead in candy along
with the State of Illinois and we know New York City has it. We
believe if this bill becomes law, these important protections
will be threatened and we could have kids eating bowls of this
candy and unfortunately ingesting lead. Parents won't know any
better. They trust their government would act but the fact is,
we haven't acted here in the Federal Government, to ban this.
We also in California have addressed other issues of arsenic,
mercury in fish, lead in places Senator Feinstein mentioned, in
gold and glassware and PCBs in salmon. We've also passed
innovative State protections to combat childhood obesity by
ensuring that public schools provide our children with healthy
food: juice, milk and water rather than soda and it was a big
fight in California but we did this and all of you know now
that childhood obesity is likely to lead to an epidemic of
diabetes later in life. So we are out there moving forward and
we think this legislation will set us way back. Now, what I
want to show you then, is another chart that gives you a sense
of this bill and you know this better than I do, but if a State
wants to be able to get around this bill, they have quite a
maze to go through in order to get around this bill. We're
going to use this to show our colleagues on the floor, it is
just a bureaucratic nightmare. It is a petition process that
just is not going to work for our State.
Mr. Chairman, I'd ask that the rest of my statement be
placed in the record and since this is my sum-up time.
[The prepared statement of Senator Boxer follows:]
Prepared Statement of Senator Boxer
Thank you, Mr. Chairman for allowing me to speak today on
an issue of great importance to people in my State of
California, and to people in every State across the Nation.
I am here today to voice my strong opposition to S. 3128,
the National Uniformity for Food Act.
This legislation poses a direct threat to California's food
safety and consumer right-to-know protections, including
Proposition 65.
The bill would roll back essential food safety laws and
prevent State and local authorities from enacting food safety
regulations that act as a safety net and fill in critical gaps
in Federal law.
And for a State like California, which is a national leader
in ensuring food safety, this legislation is particularly
harmful, threatening laws that protect the most vulnerable
among us, including pregnant women and children.
Californians passed Proposition 65 in 1986 with 63 percent
of the vote because they wanted to know if dangerous
contaminants were in their food and drinking water, and they
knew such a law would encourage food manufacturers to provide a
safer product--because who wants to buy bottled water with an
arsenic warning label?
For more than 20 years, this simple combination of consumer
education and market forces has reduced exposure to dangerous
substances in food throughout California.
But now, California's State food safety laws are under
attack from special interests, who would keep consumers in the
dark about dangerous contaminants in their food and water.
Why? Because of claims that food safety regulations may cut
into profits.
Rather than looking at a picture like this (Chart--photo of
children eating lead candy), and being disgusted at the sight
of innocent children eating candy contaminated with lead, these
special interests see dollars signs.
Lead is a dangerous toxin that attacks the nervous system,
causing behavioral problems, learning disabilities, seizures
and death, with children at greatest risk.
If this legislation becomes law, the Food and Drug
Administration could do away with State laws prohibiting lead-
infested candy from being sold in our supermarkets, and
uninformed consumers will be the worse for it.
The State of California already has a law to reduce lead in
candy, along with the State of Illinois and New York City. If
this bill becomes law, these important State and local
protections will be threatened.
Once again in convenience stores and at family picnics,
children could see bowls like this full of enticing treats, and
reach for them as a child would reach for a snickers bar or
Hershey's kiss.
And unfortunately most parents won't know any better,
because they trust that their government would not allow
children to eat candy with high levels of lead. Unfortunately,
the Federal Government does not have a requirement in place
that would ensure children are protected from dangerous levels
of lead in candy. This simple fact alone answers the question
of why we need a State safety net.
In addition to addressing the issue of lead in candy,
Californians have acted to reduce arsenic in bottled water,
mercury in fish, lead in plates, bowls, and glassware, and
polychlorinated biphenyls (''PCBs'') in salmon.
Californians have also passed innovative State protections
to combat childhood obesity by ensuring that public schools
provide our children with healthy foods, juice, milk and water
rather than soda.
The dangerous and bureaucratic process in S. 3128 that
would in theory allow the Federal Government to consider
allowing State protections to continue not only wastes scarce
resources, but provides little hope of success. [Chart on S.
3128's Petition Process]
There is widespread opposition to efforts to eliminate
State food safety and consumer right-to-know protections.
Numerous State, public health, scientific, labor, environmental
and other public interest groups have objected to the H.R.
4167, the House version of S. 3128, as well as the bill at
issue in this hearing. I would like to place these letters into
the record to accompany my statement.
[Editor's Note: The letters of opposition may be found in
Additional Material.]
Don't let the nice title, ``National Uniformity for Foods
Act'', fool you. This legislation poses a threat to the health
of Americans in every State in the Union.
Senator Boxer. I'm going to just read a few of the groups
that oppose this legislation: the National Association of State
Departments of Agriculture, the National Association of Food
and Drug Officials, Consumer Federation of America, United
Steel Workers, Consumers Union, Center for Science in the
Public Interest, National Environmental Trust, Physicians for
Social Responsibility, Attorneys General in 39 States and
territories, including California, New York, Hawaii, Alaska,
Arizona, Connecticut, Delaware, Idaho--it goes on and on and
interestingly, the North Carolina Consumers Union opposes this
as well. The bottom line is, Mr. Chairman, I know that your
aims and that of my colleagues are good. I have no question
that your aims are good and your intentions are good but it is
the practical impact of this. Coming from a State that is way
out in front on food safety, we don't want to go back and our
people don't want us to go back. This is not partisan and
that's why Senator Feinstein and I are here. We so appreciate
the chance to speak with you very directly. You're direct,
we're direct. We know we have disagreements and honorably, we
will debate those differences. Thank you very much.
Senator Burr. Senator Boxer, thank you. Your full statement
will be a part of the record.
Senator Boxer. Thank you.
Senator Burr. I'll take this opportunity as I introduce my
colleague from Georgia, to also put up a chart.
That chart is a chart of Prop 65.
Senator Boxer. Sure.
Senator Burr. If you will, it's over here.
Senator Boxer. Well, ours is prettier. Ours is in better
color.
Senator Burr. We didn't have the money, you know, too----
[Laughter]
Senator Boxer. I know you spent the entire Federal surplus.
Senator Burr. Small thing here. We just had a copy machine.
That's the only thing we had.
Senator from Georgia.
Opening Statement of Senator Chambliss
Senator Chambliss. Well, as usual, I hate to follow my
friend from Kansas. Thank you Mr. Chairman, Senator Isakson,
Senator Roberts, I appreciate the opportunity to share my views
with you on S. 3128, the National Uniformity for Food Act. As
Chairman of the Senate Committee on Agriculture, Nutrition and
Forestry, I engage in this debate from a unique perspective.
The Senate Agriculture Committee oversees a significant portion
of America's food safety system and the Federal food safety
functions over which the committee has jurisdiction, have long
employed uniform standards to protect public health.
The U.S. Department of Agriculture's Food, Safety and
Inspection service is responsible for the safety of meat,
poultry and egg products, both domestic and imported. It
enforces uniform standards through the authority granted to the
USDA by the Federal Meat Inspection Act, the Poultry Products
Inspection Act, and the Egg Products Inspection Act.
USDA isn't the only agency charged with enforcing national
uniformity. There are many other areas where Congress has
decided that national uniform standards are warranted. These
areas include nutrition labeling, allergens, pharmaceuticals,
and medical devices, just to name a few. For example, the Food
Quality Protection Act, a State may not set tolerance levels
for pesticide residues that differ from national levels unless
the State petitions the Environmental Protection Agency for an
exception.
I support the National Uniformity for Food Act because it
will not only remove unnecessary and costly impediments to
interstate commerce but even more importantly, it will provide
consumers with clear and useful information.
The bill that you have drafted will ensure that consumers
have access to the same accurate, science-based information
regardless of where they live. It will eliminate consumer
confusion and bolster confidence in the safety of our food
supply by placing our Nation's food safety in the hands of the
U.S. Food and Drug Administration, the world's leading food
safety agency. In addition, this bill will streamline the
regulatory process by creating a single process for
establishing food safety standards and warning labels for
packaged foods under the authority of the FDA.
States traditionally have played a strong role in the
formulation of our Nation's food safety policy and that will
not change under this bill. Under this legislation, States will
continue to have authority for enforcements, sanitation
inspections at local restaurants, licensing and the protection
of public health in the event of a food emergency or a
terrorist attack.
States will also be able to continue their constant
communication and information sharing with the FDA when it
comes to food safety. A unique provision in the bill allows any
State to petition the FDA to keep its existing State law or
elevate that standard to the National level, following a
thorough review of the entire body of scientific evidence. In
fact, no State law would disappear upon the enactment of this
bill. States would have 180 days to petition the FDA under the
provision I just outlined. If the FDA fails to act on a State
petition, then that State law would remain in effect.
With the world's safest food supply, every American
benefits from uniform food safety standards. The National
Uniformity for Food Act builds on that record of success by
extending the same approach used by the USDA and other
regulatory agencies to the FDA. This is not only a common sense
approach but it assures every American that the food they enjoy
is regulated by strict, national standards meant to ensure
their health and well-being.
I would like to commend Chairman Enzi and you, Senator Burr
and the other members of this committee, for holding this
hearing today. It is important to debate this issue in a public
forum so that American consumers understand our goal is to
strengthen and harmonize food safety efforts in this country.
It is rather ironic that at the international level, we
actively pursue the goal of harmonizing food safety standards
yet we still debate this issue at home. The National Uniformity
for Food Act provides us with an opportunity to bring a long-
needed, common sense approach to the regulation of packaged
foods. I urge the members of this committee as well as the rest
of our Senate colleagues, to support this bill and I thank you
very much for letting me share these thoughts with you.
[The prepared statement of Senator Chambliss follows:]
Prepared Statement of Senator Chambliss
Thank you Mr. Chairman. I appreciate the opportunity to
share my views on S. 3128, the National Uniformity for Food
Act. As Chairman of the Senate Committee on Agriculture,
Nutrition and Forestry, I engage in this debate from a unique
perspective. The Senate Agriculture Committee oversees a
significant portion of America's food safety system, and the
Federal food safety functions over which the committee has
jurisdiction have long employed uniform standards to protect
public health.
The U.S. Department of Agriculture's Food Safety and
Inspection Service is responsible for the safety of meat,
poultry, and egg products, both domestic and imported. It
enforces uniform standards through the authority granted to the
USDA by the Federal Meat Inspection Act, the Poultry Products
Inspection Act and the Egg Products Inspection Act.
USDA isn't the only agency charged with enforcing national
uniformity; there are many other areas where Congress has
decided that nationally uniform standards are warranted. These
areas include nutrition labeling, allergens, pharmaceuticals,
and medical devices to name a few. For example, under the Food
Quality Protection Act, a State may not set tolerance levels
for pesticide residues that differ from national levels unless
the State petitions the Environmental Protection Agency for an
exception.
I support the National Uniformity for Food Act because it
will not only remove unnecessary and costly impediments to
interstate commerce but even more importantly it will provide
consumers with clear and useful information.
The bill will ensure that consumers have access to the same
accurate, science-based information regardless of where they
live. It will eliminate consumer confusion and bolster
confidence in the safety of our food supply by placing our
Nation's food safety in the hands of the U.S. Food and Drug
Administration, the world's leading food safety agency. In
addition, this bill will streamline the regulatory process by
creating a single process for establishing food safety
standards and warning labels for packaged foods under the
authority of the FDA.
States traditionally have played a strong role in the
formulation of our Nation's food safety policy, and that will
not change under this bill. Under the legislation, States will
continue to have authority for enforcement, sanitation
inspections at local restaurants, licensing, and the protection
of public health in the event of a food emergency or a
terrorist incident.
States will also be able to continue their constant
communication and information-sharing with the FDA when it
comes to food safety. A unique provision in the bill allows any
State to petition the FDA to keep its existing State law or
elevate that standard to the national level following a
thorough review of the entire body of scientific evidence. In
fact, no State law would disappear upon the enactment of this
bill. States would have 180 days to petition the FDA under the
provision I just outlined. If the FDA fails to act on a State
petition, then that State law would remain in effect.
With the world's safest food supply, every American
benefits from uniform food safety standards. The National
Uniformity for Food Act builds on that record of success by
extending the same approach used by the USDA and other
regulatory agencies to the FDA. This is not only a common sense
approach, but assures every American that the food they enjoy
is regulated by strict, national standards meant to ensure
their health and well-being.
I would like to commend Chairman Enzi and the members of
this committee for holding this hearing today. It is important
to debate this issue in a public forum so that American
consumers understand our goal is to strengthen and harmonize
food safety efforts in this country. It is rather ironic that
at the international level we actively pursue the goal of
harmonizing food safety standards, yet we still debate this
issue at home.
The National Uniformity for Food Act provides us with an
opportunity to bring a long-needed, common sense approach to
the regulation of packaged foods.
I urge the members of the committee, as well as the rest of
my Senate colleagues to support this bill. Thank you very much.
Senator Burr. Mr. Roberts.
Opening Statement of Senator Roberts
Senator Roberts. Well, I would never dismiss the Senator
from Georgia. I'd let him ride off into the sunset if he
wishes.
Mr. Chairman, thank you for holding this hearing today on
the National Uniformity Food Act. This bill, as others have
said, is an important piece of legislation. Quite frankly, we
should have passed this a long time ago. I'm very pleased to
have been a lead sponsor of this bill in the past. I'm pleased
to be joining Senator Burr and I am his shotgun rider or wing
man, as of this time around and I think we ought to dispel some
concerns and some news, as the Chairman has indicated, about
this bill. We discussed this for a long time but recent events,
Mr. Chairman, in the food industry and the courts show us that
the time for debate has passed. It is time for us to do our
jobs and bring uniformity to the food safety tolerances and the
warning label systems for consumers nationwide. I just don't
understand why you have--you don't have food safety concerns in
49 States but you do in one. I guess that means the consumers
in the other States are undergoing a real problem or a real
concern. I want to emphasize that facts can be stubborn things.
The thing that occurred to me about--whoop! Put that candy back
up there.
Audience Member. OK.
Senator Roberts. Let me have that candy!
Audience Member. Only if you promise not to eat it.
[Laughter]
Senator Roberts. All right. This has been tested in the lab
and it contains high levels of lead. Can you tell what the
tolerance is in regards to how much food a young child would
have to eat in terms of candy before it would become a real
problem? That's the thing, it seems to me, that is important
because that would be important for every State and every
consumer and every parent.
Audience Member. One piece.
Senator Roberts. One piece of this particular candy?
Audience Member. A child would exceed the daily limit based
on----
Senator Roberts. On California standards?
Audience Member. That's correct, but they are not----
Senator Roberts. Well, the thing that I remember so well is
when we were talking about this--is this candy for sale in all
49 States? So it's unsafe in all 49 States? No, it's unsafe in
California but it's not unsafe in all 49 States, is that right?
Audience Member. I'm sorry. Essentially, the Federal
Government, the FDA has a tolerance proposed but they don't
have an enforceable standard and have not actually fulfilled a
gap----
Senator Roberts. So it is an enforcement issue with the
FDA, not the tolerance?
Audience Member. They don't have enforceable requirements.
Senator Roberts. No enforceable requirements? Well, if this
is being sold in 49 States, let me go back to my one example I
at least know something about because on the floor of the
House, when we were considering this 15 years ago and I was
asking people why pancake flour in Pennsylvania was okay but
pancake flour in California wasn't and even had a demonstration
of flipping pancakes but that's another whole story.
We got the example of domenicide which was used to control
pests in regards to the production of peanuts and the argument
was that obviously domenicide was a carcinogen in certain
amounts and if you raised it to certain levels, it is a real
problem. So I ask about the tolerance level on how many peanuts
a person would have to eat every day to reach the tolerance
level set by the critics of the FDA and it turned out to be 600
pounds of peanuts a day. That's a lot of peanuts. Now, I knew
several members in the Congress at that time that I would have
liked to have fed 600 pounds of peanuts a day but that was not
an option. So I think we ought to at least use some common
sense.
I am distressed to learn about the enforcement thing in
terms of an enforcement mechanism but I think we have to look
at this in this world of parts per trillion. There is a little
bit of something in everything and you have to have a cost-
benefit risk and you have to have a sound science risk and 49
States do, with the FDA. Not California.
The fact of the matter is, this legislation does not
propose taking some unprecedented step in food and consumer
safety; rather as many of our witnesses will testify today, the
legislation simply intends to add national uniform standards
for food safety tolerances and warning labels. Now what am I
talking about? We've already got uniform requirements for meat
and poultry products, nutrition labeling, allergen labeling,
pesticide tolerances and medical devices.
Your bill, sir. Passed the Ag Committee in 2000. Now it's
here where obviously you'd have jurisdiction and this debate
should take place, don't misunderstand me. I just don't think
it should be to one committee and then we go to the floor. Why
shouldn't we also have them on the tolerance and warning label
front, I just don't understand that. I think the FDA can do the
job. This issue has always been focused largely on the
tolerance and warning discrepancies between the rest of the
United States and California. Not unusual and largely as a
result of Proposition 65, as has been referred to by my friends
and colleagues. But let me just state that there are a lot of
people in California, if I can find my list, who are for this
bill, Senator. The California Chamber of Commerce, the
California Farm Bureau Federation, California Grocer's
Association, California League of Food Processors, California
Manufacturers and Technology Association, California/Nevada
Soft Drink Association and the California Restaurant
Association. I do not think these people are interested in the
business of poisoning any family or any youngster or for that
matter, anybody.
We found on the California Attorney General's Web site that
if you take a look at Proposition 65 settlement dollars paid in
private cases, including attorney fees, you'll see that the
total amount for 2000 to 2005 was about $57 million. About $40
million of it, 70 percent, went to attorney fees. More
significantly, the total civil penalties only averaged about
$885,000 over a 6-year period.
So I think you can see that there are other factors in
regards to opposition to this legislation. I don't think we
need to look any further to understand the need for this
legislation than the prepared testimony of Mr. Bill Stadtlander
today. Bill, if I've mispronounced your last name, I apologize.
Here is a man who has produced a product that the FDA has
determined can be labeled, and I'm quoting, ``heart healthy,
bone healthy, may reduce the risk of certain types of cancer.''
May reduce the risk of certain types of cancer but the State of
California says, in that regard that the product that Bill
would like to sell, is that naturally occurring Acrylamide
may--may cause cancer. He is now being subjected to a multi-
million dollar lawsuit because his product does not contain a
label saying that the State of California believes his product
could--could, may cause cancer. Forty-nine other States, Bill--
why don't you bring your company to Kansas? Where are you?
[Laughter]
You know, Dodge City will give you a special deal. We'll
make you Marshall. We'll give you the land--well, I'm maybe a
little out of line there but at any rate, think about it. But
at any rate, I think it is time to bring common sense to our
food safety tolerance and warning label policies. Mr. Chairman,
I thank you again for holding this hearing. Pardon my sort of
wanderings here or being rather irascible in regards to this
but 15 years we've tried to get uniform and we've done it on so
many other different things, as I've said. Pesticides,
allergens, nutritional labeling, pesticides in 1996,
nutritional labeling in 1990, allergens 2004. As science has
progressed in this parts per trillion, or even more than that
in terms of technology. I think we can do the job. I think the
FDA can do the job and I certainly would support funding in
regards to enforcement practices. So I thank you again for
holding the hearing. I urge my colleagues to help us move
forward in ensuring this legislation is enacted as of this year
if possible. I yield whatever time I have remaining, which is
probably none.
Senator Burr. All right, I thank the Senator from Kansas
for his work in the past and his work today. The Chairman also
said that it is his understanding that the FDA is in the
process of issuing, probably before the end of the year, a
regulation as it relates to lead in candy. Were this to be the
law today, California, in this particular case, because there
was no Federal standard, would petition the FDA as it related
to lead in candy. Until the FDA acted on that petition, this
would be the letter of the law in California. We would not
alter California's regulation of lead in candy and clearly,
there is the opportunity that California may object with what
the FDA came out with or in fact, California's experience might
guide the FDA as to what that regulation should look like. But
I think clearly, the point needs to be made that passing this
bill would not in any way, shape or form, affect what
California has done as it relates to lead in candy. The Chair
would recognize Senator Reed if he has any opening remarks. He
does not, then the Chair would call up the second panel. On our
second panel is William Stadtlander, who has been president and
CEO, owner of Homestat Farms, Limited since creating the
company in 2001. The company is based in Dublin, Ohio and makes
the hot cereals Maypo, Wheatena and Maltax as well as G.
Washington Seasoning and Broth. Prior to creating Homestat
Farms, Mr. Stadtlander worked at Abbott Laboratories for 21
years and served for 9 years as Vice President, Corporate
Officer for the Ross Division of Abbott Labs. Mr. Stadtlander
will discuss the impact of nonuniform food safety laws on his
small business. In addition, Mr. Peter Barton Hutt is a Senior
Counsel in the Washington, D.C. law firm of Covington and
Burling, specializing in food and drug law. He began his law
career practicing with the firm in 1960 and except for his 4
years in the Government, has continued at the firm ever since.
From 1971 to 1975, he was the Chief Counsel for the Food and
Drug Administration. Mr. Hutt will discuss the history of food
regulation and why establishing uniformity in food adulteration
regulations and warning notifications is an important step
forward. Welcome, Mr. Hutt.
Senator Roberts. Mr. Chairman, could I make a point?
Senator Burr. Yes.
Senator Roberts. I'm the candy man here again. You folks
have to get a better example here, more up to date because this
is pretty old stuff and it is hard to read the label but this
candy is from Mexico and I think maybe this is a trade issue or
certainly an inspection issue for products coming in from
Mexico to California. And I would agree, I wouldn't eat this
stuff. This looks like it is about 2 or 3 years old.
Senator Burr. I'm confident our second panel might be able
to share some insight on that candy as well. In addition, Dr.
Elsa Murano----
Senator Roberts. Jack, do you want some candy?
[Laughter]
Senator Burr. Dr. Elsa Murano is the former Undersecretary
of the USDA. She is currently the Vice Chancellor and Dean of
Agriculture and Life Science at Texas A&M University and
Director of the Texas Agricultural Experiment Station. Prior to
being appointed Undersecretary for Agriculture for Food Safety
by President George Bush in 2001, Dr. Murano was a Professor in
the Department of Animal Science at Texas A&M and holder of the
Sadie Hatfield Professorship in Agriculture. Dr. Murano will
discuss why food adulteration regulations need to be based on
sound science. And before his recent retirement, Mr. William
Hubbard advised the Commissioner of Food and Drugs on agency
policy, coordinated the development of the agency rulemaking,
directed the agency's congressional relations and legislative
activities and oversaw the planning and evaluation functions of
the Food and Drug Administration. He was also a principal
representative of the agency with the Secretary of Health and
Human Services, other members of the Cabinet, Governors and
other senior officials of several States and with the White
House. Mr. Hubbard will discuss the FDA's activities on food
safety and the agency's interaction with States and I might
also add--I understand you are now a resident of North
Carolina. We're delighted to have you there.
Mr. Hubbard. Thank you, Mr. Chairman. I'm a native of the
State and while those others down east are not as sophisticated
or probably intelligent as those of you up in the Piedmont, we
do appreciate your concerns, Mr. Burr.
Senator Burr. Thank you, Mr. Hubbard. We will start with
Mr. Stadtlander.
STATEMENT OF WILLIAM STADTLANDER, OWNER,
HOMESTAT FOODS, DUBLIN, OH
Mr. Stadtlander. Thank you, Mr. Chairman.
Senator Burr. And I would ask all of you to make sure the
mics are on and that you pull them close enough so everybody
can hear.
Mr. Stadtlander. Thank you, Mr. Chairman. My name is Bill
Stadtlander. I own a small company, Homestat Farm, which makes
Maypo, Wheatena and Maltex hot cereals. Homestat Farm was
formed in October 2001, when I purchased these brands as well
as G. Washington Seasoning and Broth, from ConAgra Grocery
Products. My company is located in Dublin, Ohio and we have a
manufacturing facility in Highspire, Pennsylvania, where our
cereals are manufactured. We work with BCTGM Local 464.
Homestat Farm is a small company. Our annual sales are $4.5
million. We employ about 20 people. Although I am a small
company, I pay good wages to my employees. I pay 85 percent of
their health insurance, have a pension plan for union employees
related to their years of service. I spent more than 25 years
working for food and consumer products companies, many of those
years making nutritious foods. I created Homestat Farm because
I wanted to continue to offer, as my slogan says, healthy
nutrition for those you love.
The Wheatena story, which is the subject of a lawsuit right
now in California, is what I am here for. The Wheatena story
goes back a long way to 1879, when a small bakery owner on
Mulberry Street in lower New York City, roasted whole wheat,
ground it, sold it in packages branded Wheatena. That is pretty
much what Wheatena remains today: a toasted wheat product with
a unique taste and lots of healthy fiber, 25 percent more than
the leading brand. Health experts now recognize that fiber is
essential to a healthy diet. The FDA food pyramid and
nutritionists across the world recommend eating high fiber
diets and whole grains to maintain good health and to reduce
both the risk of heart disease and some types of cancers. A
healthy way for a person to start the day is to have a high-
fiber breakfast. Wheatena provides that. People may disagree
about what foods are healthy and which are not but I've never
heard anyone dispute that Wheatena is a high-fiber, healthy
food. Nevertheless, I have been sued by a trial lawyer in
California who claims that because Wheatena--like hundreds of
other cooked or heated foods--contains a naturally occurring
by-product of the cooking process, I should have provided a
Prop 65 cancer warning to Wheatena customers. What is this by-
product? It is Acrylamide, a substance produced whenever foods
that have starch are browned.
It's not just Wheatena that Acrylamide is found in, it's in
whole grain breads and cereals such as Cheerios, Corn Flakes,
Raisin Bran, Granola, Rice Krispies, and Shredded Wheat. It is
found in crackers and cookies, toast and pastries. It is found
in roasted nuts, prunes, grilled asparagus, to just name a few.
Coffee also has Acrylamide. I'm told about 40 percent of the
food people consume today have Acrylamide in it.
I am in compliance with all Federal laws, including NLEA
labeling and health claims and I know now that the FDA actually
says there should not be warnings on foods just because they
contain Acrylamide but this lawyer claims that California law
is otherwise. It is extremely difficult as a small businessman,
to keep up with potentially 50 different State laws regarding
ingredients and warnings.
Although I sell approximately $70,000 worth of Wheatena in
California each year, California's Prop 65 allows this trial
lawyer to sue me for millions of dollars. Food safety agencies
around the world have been studying the Acrylamide issue
intensively since the substance was first discovered in food 4
years ago and none of them found any significant health risks
or recommended any Acrylamide warnings. But that does not stop
the lawsuit against me, which I have to spend thousands of
dollars to defend.
I understand that those who oppose the National Uniformity
for Food Act claim it will gut the Nation's food safety laws. I
do not believe that is true but I do know they will prevent a
State from trying to dictate food policy to the rest of the
country and giving bounty hunter lawyers a financial plug to
make me think twice about selling Wheatena in that State. As a
result of the California lawsuit, I have a real dilemma in that
State. I am selling a product that reduces the risk of cancer
but the lawyers claim I have to either remove the product from
the market or put a cancer warning on it. A cancer warning on a
product that nutritionists agree reduces cancer risk all
because Acrylamide in Wheatena, even though the same Acrylamide
is in lots of other foods with a lot fewer health attributes.
Wheatena is a healthy, all-natural, toasted wheat hot
cereal that has been on the market since 1879. The Federal
Government has very rigorous procedures for determining health
claims a food product can make and Wheatena is in the minority
of foods that are allowed three different health claims: heart
healthy, bone healthy and may reduce the risk of certain types
of cancer. Even though the FDA specifically determined that
Wheatena may reduce the risk of cancer, California wants foods
that contain Acrylamide, including whole grain breads and
cereals, to have a warning that the product may cause cancer,
even when no other regulatory party in the world believes
warnings are required for Acrylamide at this time. Are you
confused? I am and consumers are sure to be confused if Federal
guidelines say a product may reduce the risk of certain cancers
followed by a California warning that it may cause cancer.
The combination of the litigation costs and potentially
pulling out of the State of California is enough to jeopardize
my small business when I believe I am selling a very healthy
cereal. Because of the real risk to my business, I am fully
supportive of the National Uniformity for Food Act that
provides for national uniform food safety standards and warning
requirements. The basic rationale is for one, uniform,
scientifically sound food safety standard rather than a
patchwork of 50 different State laws. I want to thank the
committee for allowing me to speak here today and I urge you to
quickly pass this bill.
[The prepared statement of Mr. Stadtlander follows:]
Prepared Statement of William Stadtlander
My name is Bill Stadtlander and I own a small company, Homestat
Farm, which makes Maypo, Wheatena and Maltex--hot cereals which, as
many mothers have said to their children, are good and good for you.
Homestat Farm was formed in October 2001 when I purchased these brands,
as well as G. Washington's Seasoning and Broth, from ConAgra Grocery
Products. My company is located in Dublin, Ohio and we have a
manufacturing facility in Highspire, PA. where our cereals are
manufactured. We work with BCTGM Local 464.
Homestat Farm is a small company. Our annual sales are $4,500,000--
all in the United States--with sales of $70,000 of Wheatena in
California.
We have 3 full-time employees and 3 part-time consultants in our
Dublin office which are new jobs that were created when I bought the
business. In our manufacturing facility, we have 2 full-time employees
in administration and 10 full-time union employees.
Although I am a small company, I pay good wages to my employees, I
pay 85 percent of their health insurance, and I have a pension plan for
the union employees related to their years of service.
I spent more than 25 years working for food and consumer product
companies, many of those years making nutritious foods. I created
Homestat Farm because I wanted to continue to offer (as my slogan says)
``Healthy Nutrition for Those You Love.''
I do not know how many on this committee had Wheatena growing up,
but I did, and I did not want to see Wheatena disappear. The Wheatena
story goes back a long way--to 1879, when a small bakery owner on
Mulberry Street in lower New York City roasted whole wheat, ground it
and sold it in packages branded Wheatena. That's pretty much what
Wheatena remains today: a toasted wheat product, with unique taste, and
lots of healthy fiber--25 percent more than the leading brand.
Health experts now recognize that fiber is essential to a healthy
diet. The FDA food pyramid and nutritionists across the world recommend
eating high fiber diets and whole grains to maintain good health and to
reduce both the risk of heart disease and some types of cancers. A
healthy way for a person to start the day is to have a high fiber
breakfast--Wheatena provides it.
And Wheatena promotes health in other ways:
It is Calcium fortified to help keep bones strong.
It has, as I said, 25 percent more fiber than the leading
brand of hot cereal.
It is 100 percent natural, toasted whole wheat, rich in
bran, protein and wheat germ.
It is cholesterol free, low in fat, low in sugar, low in
sodium and fortified Kosher by the Orthodox Union.
People may disagree about what foods are healthy and which are not.
But I have never heard anyone dispute that Wheatena is a high fiber,
healthy food. In fact, one of the most vocal consumer activist groups
engaged in advocating for good nutrition, the Center for Science in the
Public Interest (CSPI), lists Wheatena as a good source of whole grains
in ``Nine Weeks to a Perfect Diet'' on its Web site.
Nevertheless, I have been sued by a trial lawyer in California who
claims that because Wheatena--like hundreds of other cooked or heated
foods, contains a naturally occurring by-product of the cooking
process, I should have provided a Proposition 65 cancer warning to
Wheatena customers. What is this by-product? It is acrylamide--a
substance produced whenever foods that have starch are browned. It is
not just Wheatena. Acrylamide is found in whole grain breads and
cereals such as Cheerio's, Corn Flakes, Raisin Bran, Granola, Rice
Krispies, and Shredded Wheat; it is found in crackers and cookies,
toast and pastries; and it is found in roasted nuts, prunes, and
grilled asparagus to name just a few. I am told that about 40 percent
of the food people consume has acrylamide in it.
Apparently, acrylamide is one of the chemicals California has
listed as requiring a cancer warning under its law. I am told that this
requirement was adopted when people thought acrylamide existed only in
synthetic form and was used in large quantities in industrial settings.
I make food products and I try my best to keep up with food
regulations. But nobody thought of this Prop 65 listing as applying to
food. So I wasn't even aware of Prop 65 until I received notice of the
lawsuit. I am in compliance with all Federal laws including NLEA
labeling and health claims. And I know now that FDA actually says there
should not be warnings on foods just because they contain acrylamide.
But this lawyer claims that California law is otherwise. It is
extremely difficult as a small businessman to keep up with potentially
50 different State laws regarding ingredients and warnings.
Although I sell only approximately $70,000 worth of Wheatena in
California each year, California's Proposition 65 allows this trial
lawyer to sue me for millions of dollars. Food safety agencies around
the world have been studying the acrylamide issue intensively since the
substance was first discovered in food 4 years ago, and none of them
have found any significant health risk or recommended any acrylamide
warnings. But that does not stop the lawsuit against me, which I have
to spend thousands of dollars defending.
In the meantime, I understand that the same CSPI that love
Wheatena, is leading the charge against the National Uniformity for
Food Act, claiming it will ``gut'' the Nation's food safety laws. I do
not believe that is true, but I do know that it will prevent a State
from trying to dictate food policy to the rest of the country, and
giving ``bounty hunter'' lawyers a financial club to make me think
twice about selling Wheatena in the State.
As a result of the California lawsuit, I have a real dilemma in
that State. I am selling a product that reduces the risk of cancer. But
to limit the lawyer's claims, I have to either remove the product from
the market or put a cancer warning on it--a cancer warning on a product
that nutritionists agree reduces cancer risk--all because of acrylamide
in Wheatena, even though that same acrylamide is in lots of other foods
with a lot fewer health attributes.
Wheatena is a healthy all natural toasted wheat hot cereal that has
been on the market since 1879. The Federal Government has very rigorous
procedures for determining the health claims a food product can make
and Wheatena is in the minority of foods that are allowed three
different health claims: (1) Heart Healthy; (2) Bone Healthy; and (3)
May reduce the risk of certain types of cancer.
Even though FDA specifically determined that Wheatena may reduce
the risk of cancer, California wants foods that contain acrylamide--
including whole grain breads and cereals--to have a warning that the
product may cause cancer, even when no other regulatory body in the
world believes warnings are required for acrylamide at this time. Are
you confused? I am. And consumers are sure to be confused if Federal
guidelines say a product may reduce the risk of certain cancers
followed by a California warning that it may cause cancer.
The alternative of a different label for one State than for the
remaining 49 States is virtually impossible to implement because food
chains and wholesalers pull from the same warehouse for different
States and diverters move products around the country. Another
possibility is to have a separate label with a different UPC code and
carry duplicate inventory to conform to individual State requirements
which is expensive and potentially confusing.
The combination of the litigation costs and potentially pulling out
of the State of California are enough to jeopardize my small business
when I believe I am selling a very healthy cereal that has been on the
market for more than a century and is widely recommended by
nutritionists.
Because of the real risk to my business, I am fully supportive of
The National Uniformity for Food Act that provides for national,
uniform food safety standards and warning requirements. The basic
rationale is for one uniform, scientifically sound food safety standard
rather than a patchwork of 50 different State laws. I understand that
uniformity already exists for nutrition labels and for meat, poultry
and eggs, and I believe that system works very well.
I want to thank the committee for allowing me to speak here today,
and I urge you to quickly pass this bill.
Senator Burr. Thank you, Mr. Stadtlander.
Mr. Hutt. Welcome.
STATEMENT OF PETER BARTON HUTT, SENIOR COUNSEL,
COVINGTON AND BURLING, WASHINGTON, D.C.
Mr. Hutt. Mr. Chairman and members of the committee, I am
Peter Barton Hutt, Senior Counsel at the Washington, D.C. law
firm of Covington and Burling. I have practiced and taught food
and drug law for my entire professional career. From 1971 to
1975, I served as Chief Counsel for the Food and Drug
Administration. I am the co-author of the casebook used to
teach food and drug law throughout the country and since 1994,
I have taught a full course on this subject each year at
Harvard Law School. Mr. Chairman, I'm not from North Carolina
but my younger daughter does teach at Duke Law School and
enjoys it greatly. S. 3128 balances the need for a strong
national law to assure safe food for all our citizens, wherever
they may live, with the right and duty of each State to protect
its own citizens from harm. It recognizes the primary
jurisdiction of FDA to provide uniform requirements for safe
and properly labeled food throughout the country, enforced by
both Federal and--and I emphasize--State officials as well. It
would be impossible to maintain a national food market of each
of the 50 States who are free to impose their own separate food
safety and food warning requirements. But at the same time, the
States must be given the right to collaborate with FDA in
assuring that appropriate national requirements are imposed and
the States should take the predominant role in public
protection where uniquely local matters are involved. This
legislation accomplishes both of these objectives. Let me hit
just the highlights of this legislation. There is no impact on
State administrative procedures in this bill. There is no
impact on State enforcement power and there is no impact on
State inspections of food manufacturers. States can fully
enforce any State food law that is the same as the Federal food
law. Nothing in the bill, nothing at all, disrupts the
longstanding Federal/State partnership in food safety. No
existing food safety program is weakened. Traditional local
food sanitation matters are not subject to national uniformity
under the bill. Thus, regulation of milk production, shellfish
and restaurants is not under the bill. Economic adulteration is
also excluded, thus the illegal addition of water or other
adulterates to milk, juice, honey, cider vinegar or maple
syrup, in order to deceive the public, are not included within
the legislation. Now, in contrast, there are inherently
national matters for which uniformity is essential to an
orderly and free national marketplace. Regulation of the safety
of food ingredients, color additives and packaging components
must be consistent in every jurisdiction in the country in
order to permit our free market economy to thrive. But even
then, as S. 3128 explicitly confirms the authority of the
States to enforce their identical State laws regardless whether
FDA does or does not take action itself. But provisions of S.
3128 that relate to food warnings are narrowly limited to
actual warnings and not to a large number of their types of
statements relating to food. Thus, the legislation does not
apply to directions for use such as keep refrigerated or to
descriptions of the origin of a food such as farm-raised fish.
Now, the Center for Science in the Public Interest erroneously
asserts that more than 200 State laws will be affected by S.
3128. In fact, all but a handful of the State laws cited by
CSPI are not affected by the legislation in any manner
whatsoever. The most notable State law that would be affected
by S. 3128 is, of course, California's notorious Proposition 65
that Bill has just described. This law has resulted in a
veritable torrid of warnings as well as major litigation about
the applicability to various food products in spite of numerous
FDA letters opposing the warnings that California has required.
For those nonuniform State laws and regulations that have
already been enacted and are currently in effect, the State may
petition for an exemption from uniformity or for a national
standard. These existing State laws stay in place, as everyone
recognizes, as long as it takes the FDA to rule on the
petitions. Finally, there will be no flood of State petitions.
Only six State exemption petitions have ever been submitted to
FDA under the National Uniformity provisions of the Nutrition
Labeling and Education Act of 1990. Not one exemption petition
has been submitted by a State in the last 13 years. I'll be
happy to answer any questions, Mr. Chairman.
[The prepared statement of Mr. Hutt follows:]
Prepared Statement of Peter Barton Hutt
Mr. Chairman and members of the committee, I am Peter Barton Hutt,
senior counsel at the Washington, D.C. law firm of Covington & Burling.
I have practiced and taught food and drug law for my entire
professional career. From 1971 to 1975, I served as chief counsel for
the Food and Drug Administration. I am the coauthor of the casebook
used to teach food and drug law throughout the country and since 1994 I
have taught a full course on this subject each Winter Term at Harvard
Law School. My curriculum vita is attached to this testimony.
I appear today in support of S. 3128, the National Uniformity for
Food Act. This legislation balances the need for a strong national law
to assure safe food for all our citizens, wherever they may live, with
the right and duty of each State to protect its citizens from harm. It
recognizes the primary jurisdiction of FDA to provide consistent and
uniform requirements for safe and properly labeled food throughout the
country, enforced by both Federal and State officials. It would be
impossible to maintain the national food market that we have come to
demand if each of the 50 States imposed its own separate food safety
and warning requirements. At the same time, the States must be given
the right to collaborate with FDA in assuring that appropriate food
safety and warning requirements are imposed and, where uniquely local
matters are involved, to assume the predominant role in public
protection. This legislation accomplishes these dual objectives.
It is fitting that, on this the 100th anniversary of our first
national food and drug law, the Congress is considering legislation
that strengthens the authority and responsibility of FDA to regulate
the safety and labeling of the entire food supply. Our country has
moved well beyond the day when most food was locally produced and
consumed. Now, food that has been grown, produced, and packed all over
the world is sold in every State. Different standards and warnings
imposed on food in one State but not in others impedes commerce,
confuses consumers, and increases the cost of food without commensurate
benefit.
Consumers are entitled to assurance that the food they purchase and
consume, whether for themselves or for their families, is safe. Whether
it be a container of milk, a box of cereal, or a bottle of juice, the
decision whether that food is safe ought to be applied consistently
from State to State. Disparate standards and warnings--the current
circumstance which S. 3128 addresses--does not facilitate informed
decisionmaking by consumers about the foods that they choose to
consume.
Let me provide an example of this point. There has been
considerable recent discussion and controversy about regulation
regarding mercury in fish. No one seriously questions that pregnant and
nursing women and young children should limit their consumption of fish
known to be relatively high in mercury. At the same time, the health
benefits of eating fish (low fat, high protein, and an abundant source
of omega-three fatty acids) are also well known. The challenge for
health and safety regulators is thus to provide advice to consumers
that properly balances the risks and benefits of fish consumption.
In 2004, the Food and Drug Administration and the Environmental
Protection Agency did just that. The two agencies issued a
comprehensive advisory to consumers that is scientifically based and
carefully drawn to encourage consumption of fish while also permitting
consumers--especially those most at risk--to avoid fish with relatively
high levels of mercury. Nevertheless, one State, California, has taken
a contrary position that focuses on the risk of mercury while
minimizing or ignoring the benefits of eating fish.
The position California has taken is contrary to the public health.
Several months ago, the highly regarded Tufts Health and Nutrition
Letter reported on a study done at the Harvard School of Public Health.
That study concluded that government warnings about mercury in fish did
more harm than good because they caused consumers to avoid fish and
thus to deprive themselves of the health benefits of fish in return for
a negligible reduction in risk due to avoidance of mercury. Several
studies have compared the risk of exposure to mercury with the benefits
of omega-three fatty acids in terms of the risk of stroke and coronary
heart disease and relative to prenatal development. The conclusion of
those studies is clear: the health benefits to the pubic of consuming
fish outweigh the risks from mercury.
The mercury in fish matter demonstrates the need for regulators to
speak with one voice and to apply sound science to reach a conclusion
that gives consumers a basis to make informed and sound choices about
the food they consume. We do consumers a disservice when we perpetuate
a system that allows inconsistent, indeed contradictory, standards to
be applied and warnings to be issued in some places in the country
which are at odds with the science-based conclusions that regulators
with national responsibility have reached after thorough and careful
consideration of the available scientific data and information.
S. 3128 would properly and effectively ensure that the standards to
be applied and the warnings to be issued are based on sound science and
consistent throughout the country.
The Congress has repeatedly exercised its Constitutional authority
to regulate interstate commerce in the food and drug arena by enacting
legislation that provides for uniformity in food and drug regulation.
The legislation before the committee today is not novel, unique, or
unprecedented. National Uniformity exists for meat and poultry products
under the Federal Meat Inspection Act and the Poultry Products
Inspection Act, both of which are administered by the U.S. Department
of Agriculture. When the Congress enacted the Nutrition Labeling and
Education Act in 1994, it provided for national uniformity for
nutrition labeling, health claims, nutrient content claims, ingredient
labeling, standards of identity and numerous other aspects of food
labeling. Congress has also provided national uniformity for pesticide
regulation, medical devices, and cosmetic and over-the-counter drug
product labeling.
In 1990, Congress enacted the Nutrition Labeling and Education Act
(NLEA) which amended the Federal Food, Drug, and Cosmetic Act (FD&C
Act) to modernize food labeling. As part of that legislation, Congress
included Section 403B of the FD&C Act, 21 U.S.C. 343-1, to require
national uniformity for most aspects of food labeling. Two areas of
food regulation were not included under the 1990 national uniformity
provisions: (1) the food safety provisions of the FD&C Act and (2) food
warnings. The National Uniformity for Food Act is intended to address
these two important areas, in order to assure that food is safe
throughout the Nation and that, whenever some form of warning is
appropriate, it will be provided in every part of the country.
It is a conspicuous anomaly that a statutory requirement for
national uniformity does not currently exist for food safety and food
warnings for products regulated by FDA. The absence of uniformity in
these areas is an historic accident that cannot be explained by
fundamental differences between food safety and all of the other areas
in which the Congress has provided for consistent and uniform
regulation. Under the food safety related provisions of the FD&C Act,
FDA has extensive statutory authority to establish standards for the
adulteration of foods, establish tolerances or other limits for
environmental contaminants in food, determine whether food additives,
color additives and other categories of food ingredients are safe, and
establish standards for the safe processing and packaging of foods. One
cannot explain the absence of national uniformity for food safety and
food warnings by claiming that the authority of the States to regulate
food is more extensive than the authority that the Congress has given
to FDA.
SUMMARY OF MAIN FEATURES OF S. 3128
The legislation divides food safety into two categories: (1)
traditional local matters that have long been the subject of city,
county, and State regulation and (2) inherently national matters for
which a consistent policy throughout the country is essential to a
nationwide market.
The pending legislation does not include traditional local food
safety matters within the requirement for national uniformity. For
example, there are three areas of local food sanitation that have long
been handled by cooperative Federal/State/industry/academia programs:
milk production (a program begun in 1923), seafood (begun in 1925), and
regulation of restaurants, vending machines, and retail food stores
(begun in 1935). All three of these areas largely involve food
sanitation and administrative procedures that are excluded from
national uniformity. Similarly, the economic adulteration provisions of
the law that have long been handled at the local level are also
excluded from national uniformity. For example, the illegal addition of
water or other adulterants to milk, juice, honey, or maple syrup in
order to deceive the public are not included within this legislation.
Because each uniquely takes place in a local jurisdiction and
regulation has no impact upon a nationwide market, there is no need for
national uniformity in order to preserve the ability of the food
industry to serve the entire country. As a practical matter, moreover,
the cooperative programs that have long been used in these areas assure
widespread uniformity in food sanitation and economic adulteration
requirements that has served the public so well for decades.
In contrast, there are inherently national matters for which
national uniformity is essential to an orderly and free national
marketplace. Regulation of the safety of natural and synthetic food
ingredients, color additives, and packaging components must be
consistent in every jurisdiction in the country in order to permit our
free market economy to thrive. If differing standards and requirements
were adopted in each State, and specific ingredients were regarded as
safe in some States but not in others, there would be economic chaos.
Thus, national uniformity is applied under this legislation to all of
these inherently national aspects of food regulation, with three
exceptions which are addressed later in this testimony.
I now turn to the provisions of S. 3128 and describe briefly how
these provisions would operate if enacted. Because there has been so
much misinformation circulated about S. 3128 (and H.R. 4167, the
version of the legislation that passed the House of Representatives), I
also address the major criticisms of the legislation that I conclude
are without merit.
S. 3128 contains four main features:
Uniformity for food safety regulation
Uniformity for food safety warnings
Implementation of the legislation and the process for
consideration of State requirements
Specific exemptions
I will address each of these features in turn.
Uniformity for Food Safety Regulation
Section 2(a) of S. 3128 provides for uniformity in food safety
regulation. The bill would do this by amending the existing uniformity
provision in Section 403A of the FD&C Act (21 U.S.C. 343-1). The bill
sets forth 10 sections of Federal food safety law under which the vast
majority of Federal food safety regulation arises and provides that
State requirements that are the counterpart to these 10 sections must
be identical. The 10 sections of Federal law that are included in the
bill relate to adulteration of food, food and color additive
regulation, regulation of contaminants in food, emergency permits for
low acid canned food, and animal drugs used in food producing animals.
The bill defines ``identical'' broadly to encompass many State
requirements that are not literally identical. As defined in Section
2(a)(4)(c)(1), ``identical'' means that the language of the State law
is ``substantially the same'' as the Federal provision and that any
differences in language do not ``result in the imposition of materially
different requirements.'' This definition is unique. Ordinarily when
the Congress enacts legislation to create uniformity it merely requires
that State law be identical to Federal law. The language in S. 3128,
however, accommodates differences in the wording of State and Federal
requirements that do not affect the meaning of the respective
provisions.
The premise of this provision of S. 3128 strikes me as
straightforward: the basic provisions of law--whether Federal or
State--under which the safety of the food supply is regulated, ought to
be the same. If a State were to apply different standards to
determining, for example, whether a food was adulterated, than other
States or the Federal Government, interstate commerce in food would be
chaotic.
The notion that underlying food and drug law at the Federal and
State levels should be the same is not new. The food and drug laws of
virtually every State are patterned after the Model State Food and Drug
Bill which was developed to foster uniformity. The Model State Bill
was, in turn, patterned after Federal law. For example, Section
402(a)(1) of the FD&C Act, 21 U.S.C. 342(a)(1), has contained the basic
food safety standard for 100 years. It provides that a food is
adulterated if it contains any added poisonous or deleterious substance
which may render the food injurious to health. This very same provision
is found in the laws of all 50 States.
In point of fact, there are very few differences between Federal
and State food safety laws, which is why I am puzzled that this
provision of S. 3128 has generated so much discussion. With some
exceptions, including notably Proposition 65 in California, existing
differences between Federal and State food safety law are few and
generally of a minor nature.
Section 2 of S. 3128 also contains provisions to clarify the
ability of the States to enforce their identical State laws even in
circumstances in which FDA has not or does not take enforcement action.
Thus, under Section 2(a)(4)(c)(2) and (3), a State may enforce its
identical State food safety law as it deems appropriate if FDA has not
by regulation or final guidance applied Federal law to the matter in
question. If there is an FDA regulation or final guidance, however, the
State may still enforce its identical law, but it must conform that
enforcement to the FDA regulation or final guidance. Finally, if FDA
has formally considered a regulation or guidance and affirmatively
concluded not to adopt one (where, for example, there is insufficient
scientific evidence to support the adoption of a tolerance by
regulation), then the State must abide by that FDA decision.
In my experience, State and local officials routinely consult with
the FDA when they encounter a food safety problem and they will
continue to do so under S. 3128. S. 3128 carefully preserves the
ability of State officials to use the various enforcement tools
available to them under State law to remove potentially dangerous food
from the marketplace. It imposes no additional requirement to consult
with FDA or to obtain the concurrence of FDA to take action. S. 3128
will help to ensure that, regardless whether it is a State or a Federal
official deciding whether a food is safe, the standard applied to that
food will be the same.
Uniformity for Food Safety Warnings
The provisions of the national uniformity legislation that relate
to food warnings are narrowly limited to warnings, and do not apply to
a large number of other types of statements relating to food. For
example, the legislation does not apply to directions for use such as
``keep refrigerated,'' or to descriptions of the origin of a food such
as ``free-range-chicken'' or ``farm-raised fish.'' It does not cover
specialized laws found in many States that require that the term
``honey'' can only be used for a food that consists solely of honey, or
that the term ``maple syrup'' can only be used if the product is made
solely from the sap of the maple tree, or that ``cider vinegar'' must
be made solely from apple cider. None of these is in the nature of a
warning. Finally, the legislation itself excludes non-warning statutes
and regulations relating to freshness dating, open date labeling, grade
labeling, a State inspection stamp, religious dietary labeling, organic
or natural designation, returnable bottle labeling, unit pricing, a
statement of geographical origin, and dietary supplement regulation.
None of these involve safety warnings and thus are explicitly excluded
from the statute. One type of safety warning--a consumer advisory under
the FDA Food Code relating to the risk of eating raw or undercooked
food--has also been explicitly excluded from the legislation because it
is already recommended on a national basis by FDA.
Thus, there are dozens of State statutes and regulations that are
excluded from the legislation because they are essentially local in
nature and do not in any way relate to food safety.
The national uniformity legislation focuses exclusively on food
safety warnings. It prohibits a State from imposing any such warning
that is in addition to or different from a warning imposed by FDA, in
order to assure that the same information on food safety is provided to
citizens in every part of the country.
Section 2(b) of S. 3128 provides for uniformity in food warnings.
Under that section, States would not be permitted to impose on the food
industry a requirement to communicate a ``notification requirement for
a food that provides for a warning'' unless there is a Federal warning
and the State warning is identical. States would remain free, however,
to issue their own warnings to citizens of their States, even if there
is no Federal label warning or if the State-issued warning contradicts
a Federal warning.
In order for the warning uniformity language to apply, the State
requirement must be (1) a notification requirement (2) that contains a
warning and (3) is imposed on the food industry.
I am familiar with a report issued by the Center for Science in the
Public Interest that asserts that nearly 200 State laws will be
affected by S. 3128 (or the House counterpart). I have examined this
report and conclude, as have others who have studied it in detail, that
the CSPI report is incorrect. The CSPI report is incorrect because,
while it collects numerous examples of State food laws or regulations,
it assumes erroneously that the uniformity legislation will affect them
without examining the language of the legislation to determine if that
is so. For example, there are numerous State laws listed in the CSPI
report that contain notification requirements for such things as ``keep
refrigerated,'' or ``farm-raised,'' or that restrict the use of certain
terms on food products unless certain conditions are met (Massachusetts
law on halibut and Connecticut law on honey). None of these State laws
are affected by the uniformity legislation because they are
notification requirements but not warnings. S. 3128 makes it perfectly
clear that it reaches only notification requirements that contain food-
related warnings.
The most notable State law that would be affected by S. 3128 is
California's Proposition 65. Proposition 65 was adopted in California
in 1986 under the State's initiative process. It was promoted as a law
to ensure the safety of the State's drinking water. As we have come to
know, Proposition 65 is considerably broader. Under Proposition 65, the
State maintains a list of chemicals ``known to the State of California
to cause cancer or reproductive toxicity'' and makes it illegal to
``expose'' anyone to a listed chemical without providing a warning.
California has listed more than 750 chemicals under Proposition 65. The
law has resulted in a veritable flood of warnings in restaurants, bars,
grocery stores, hotel lobbies, and elsewhere, as well as major
litigation about its applicability to various food products.
Proposition 65 provides for substantial monetary penalties for
violations ($2,500 per violation per day). In addition to the Attorney
General, Proposition 65 may be enforced by private persons, which has
given rise to lawyers who bring private Proposition 65 suits because,
if successful, they receive not just attorneys fees, but a portion of
the penalty imposed.
These suits are expensive to defend and risky to litigate because
of the financial exposure involved. Many companies, faced with a
Proposition 65 lawsuit, have elected to reformulate their products to
remove or reduce the substance in the food that creates the legal
exposure, rather than engage in protracted litigation.
Some have characterized these reformulations as ``success stories''
and as demonstrating that, under Proposition 65, action has been taken
at the State level to make food safer in situations where the FDA has
not acted. This argument cannot be sustained.
Under Proposition 65, chemicals in food are determined to present a
significant risk by using a vastly different approach to risk
assessment than that used by FDA and EPA. When assessing the potential
risk to human health from a chemical shown to cause cancer in animal
studies, for example, FDA and EPA calculate an upper limit on the risk
as one potential additional cancer per 1 million persons. California,
however, used a standard of one additional cancer per 100,000 persons.
Further, in estimating the potential exposure of a person to a
chemical, California assumes exposure 24/7 for 70 years. FDA and EPA,
estimate exposure conservatively, but not constantly throughout one's
lifetime, as is done under Proposition 65.
The result of the approach to assessing risk under Proposition 65
is that significant risk is asserted where it does not exist. Thus, the
claims that Proposition 65 has resulted in safer food are often not
correct. If a food contains a chemical in a small quantity such that
the risk from exposure to it is negligible, forcing the manufacturer
either to lower the level of the chemical in the food or to face costly
and uncertain litigation and adverse publicity does not make the food
less risky. Proposition 65 creates the illusion of safer food while
simultaneously creating a proliferation of warnings that can only cause
consumers to believe that ``everything is unsafe.''
Implementation of the Legislation and Process For Consideration of
State Requirements
For both food safety requirements and safety warning requirements,
the national uniformity legislation divides State laws and regulations
into two categories: (1) those already existing as of the date of
enactment of the legislation and (2) those that are the subject of
State action after the legislation goes into effect.
For those State laws and regulations that have already been enacted
and are currently in effect, the legislation provides for a 2-year
process for FDA consideration as to whether the requirements can be
justified on the basis of sound science or whether they cannot
withstand close scrutiny. If a State wishes to abandon a requirement,
it need do nothing further. If the State desires to continue enforcing
the requirement, it can petition FDA either for an exemption from
national uniformity or to adopt the State requirement throughout the
country. Following a 2-year public process, FDA will make a decision
based on sound science. That decision may also be appealed to the
courts. At every stage of this process, the States will be intimately
involved. If FDA fails to take action as required by the legislation,
provisions authorize the courts to force the agency to do so. State
requirements that are the subject of State petitions to FDA remain in
effect until FDA takes action on the petition, however long that may
take.
For future State safety requirements and warnings, there are three
mechanisms by which a State may adopt provisions that do not conform to
national uniformity. First, a State may petition FDA for an exemption
from national uniformity in order to address a local problem. Second,
the State may petition for a national standard that would impose a
requirement throughout the country, in order to address a nationwide
problem. Third, the State may act immediately in order to address an
imminent hazard to health, for example, an issue of bioterrorism.
For all three of these areas, the legislation explicitly provides
that FDA must expedite consideration of any requirement relating to a
cancer risk or to the safety of pregnant women and children. Again the
courts are empowered to force FDA to take action if the agency fails to
do so.
Some have suggested that FDA will be overwhelmed with petitions
under the petition process set forth in the legislation for existing
State requirements. I will be very surprised if this were the case.
First, as noted earlier in this testimony, there are likely to be very
few State requirements in effect on enactment that will be affected by
the legislation. Of the 196 State requirements in the CSPI report, in
reality only 11 would be affected. Second, to the extent that States
submit petitions to FDA out of caution, FDA will be able to address
this summarily and without substantial expenditure of resources.
Finally, to the extent that FDA is not able to resolve petitions in the
time periods set forth in the legislation, State requirements will
remain in effect.
Food Bioterrorism
The national uniformity legislation fully recognizes valid concern
about the potential for bioterrorism through intentional poisoning of
the food supply. First, States retain all of the enforcement
authorities that exist under State law. Second, as already noted, any
State can act immediately under the imminent hazard provision of the
legislation in the event of food bioterrorism. Third, the entire bill
will not go into effect unless and until the Secretary of HHS certifies
to Congress, after consultation with the Department of Homeland
Security, that implementation will pose no additional risk to the
public health or safety from terrorism attacks.
CONCLUSION
The national uniformity legislation explicitly reinforces the
unique and important role of State officials in enforcing food safety
requirements. The legislation provides, for example, that it does not
affect State administrative procedures or enforcement powers. The
legislation explicitly confirms that States can enforce, at any time,
local laws and regulations that are the same as the requirements of the
FD&C Act. And States can at any time issue their own food safety
warnings to their citizens, even if the State warnings do not conform
to FDA policy. Thus, States retain substantial authority to protect
their citizens. In this way, national uniformity is reconciled with the
fundamental right and duty of a State to protect the public from unsafe
food.
The national uniformity legislation represents a balanced approach,
incorporating both the need for a consistent and coordinated approach
to food safety and food warnings throughout the country, while
retaining the authority of States to take the lead on local issues, to
collaborate with FDA to assure appropriate national regulatory
requirements, and to cooperate in a comprehensive enforcement system
that will protect the public in every jurisdiction throughout the
country.
Senator Burr. Thank you, Mr. Hutt.
Dr. Murano.
STATEMENT OF ELSA A. MURANO, DEAN, COLLEGE OF AGRICULTURE AND
LIFE SCIENCES, TEXAS A&M UNIVERSITY, COLLEGE STATION, TX
Dr. Murano. Thank you. My name is Dr. Elsa Murano. I am the
Dean of the College of Agriculture and Life Sciences at Texas
A&M University, Director of the Texas Agricultural Experiment
Station and Vice Chancellor of Agriculture for the Texas A&M
University system. Mr. Chairman, I am a food microbiologist by
training, holding a Master's and Ph.D. degrees from Virginia
Tech in Anaerobic Microbiology and Food Science and Technology.
In the 1990s, I was Professor of Food Microbiology at Iowa
State University and then at Texas A&M University.
From 2001 to 2004, I served as Undersecretary for Food
Safety at the U.S. Department of Agriculture, where I was
responsible for developing the policies and programs
implemented by the Food Safety and Inspection Service or FSIS.
This public health agency is believed to be the premier public
health agency in the world, with FDA as a close second. This
public health agency is charged with ensuring that the Nation's
commercial suppliers of meat, poultry and egg products is safe,
wholesome and correctly labeled and packaged. While
Undersecretary, I was also responsible for representing the
U.S. Government on the Codex Alimentarius Commission, which is
an international organization that develops food standards
guidelines and codes of practice to protect the health of
consumers, ensure fair trade practices and promote coordination
of all food standards at the international level.
Mr. Chairman, S. 3128 would provide a national approach for
establishing food safety tolerances and inserting warning
information on the label and related materials for packaged
foods. The bill would assure a consistent approach to labeling
information for all 50 States. The proposed law is not a new
concept as we have heard already this morning. National
uniformity already exists for most of the U.S. food supply and
many other products. The laws under which I operated as
Undersecretary for Food Safety at the USDA are a good example.
Besides my representing a new concept, S. 3128 is designed to
ensure that the public is protected and well informed without
impacting the fundamental food safety laws at the Federal or
State level or affecting any enforcement authority at the State
or Federal level. It is through cooperation that exists between
Federal and State agencies that these activities are carried
out. A good example of this cooperation is the Food Code. The
FDA, the Center for Disease Control and Prevention and FSIS all
contribute to the Food Code to make sure it addresses control
for risk factors that the Government has identified as causing
outbreaks of food borne illness. The Code provides food control
authority at all levels of government, a scientifically sound
technical and legal basis for regulating the retail and food
service segment of the industry. In fact, according to the FDA,
local, State, tribal and Federal regulators use the FDA Food
Code as a model to develop or update their own food safety
rules and to be consistent with national food regulatory
policy. As a trained researcher, as a scientist, I understand
how science can be used to determine the true risk posed by
food-borne hazards. As Undersecretary, I put this back on to
use, applying the scientific principle of hazard analysis,
epidemiology, risk assessment and statistical sampling in order
to develop policies that would reduce the risk of illnesses
such as those caused by E. coli or 157H7, Listeria
monocytogenes, among others. As a result, the number of
illnesses caused by these pathogens was reduced by 42 percent
and 40 percent respectively, as reported last year by the CDC.
At the USDA, our scientific experts work very hard to develop
the underlying data used in risk assessments, incorporating
research also from the entire scientific community, which
resulted in these public health improvements. Establishing a
uniform national system will put food safety in the hands of
the Nation's top food scientists and food safety experts, such
as those at the USDA and just like USDA, the FDA is best
positioned to assure that these scientists and experts are
brought together, whether they come from Federal Government,
State government or academia. There are few issues that are
important to point out when applying science. First, science
sometimes can be misinterpreted by people without sufficient
expertise. In the area of food safety, a range of different
interpretations leading to different advice or warnings in
different States would be obviously problematic. The benefit of
a national uniformity approach is that it will bring the best
scientists together to address issues of public health
significance, thereby helping to determine how best to
communicate to consumers in all 50 States. Second, sometimes
obtaining results via the scientific process can take time and
all the answers to our questions may not be available as
quickly as we want them to be. In these cases, the Federal
agencies, as well as the States, have the authority and the
capability to step in and protect the American public. The
proposed law includes an eminent hazard authority that would
retain the authority of the State's health regulators to take
protective actions on a local basis. Third, sometimes a safety
issue appears locally, not nationally but because we have a
national food supply, an action taken locally may not help all
consumers. If there is a true safety issue, State authorities
should bring it to the attention of the Federal agencies so
that it can be confirmed and together, they can take a national
approach to protect all U.S. consumers. The proposed law
provides a process to establish national standards in order to
protect all consumers, not just some. Fourth, on occasion, the
data will show that a safety issue could truly be local and
advice or warnings should be provided to consumers in that
area. The proposed law recognizes this and allows for an
exemption from national uniformity when a safety issue is
demonstrated to be unique to a specific State.
So Mr. Chairman, S. 3128 would provide a national approach
for establishing food safety tolerances and warning label
requirements that are consistent in all 50 States.
Incidentally, this objective is also consistent with activities
the U.S. Government has been engaged in for international food
standards. As I mentioned in my opening statements, while at
USDA, one of my responsibilities was to represent the United
States as a member Nation of the Codex Alimentarius Commission.
Allow me to quote very briefly from a Codex document on the
harmonization of food standards internationally to emphasize
the value of national uniformity here in the United States,
``With respect to the ever-increasing global market, in
particular, the advantages of having universally uniform food
standards for the protection of consumers are self evident.''
It is not surprising, therefore, that the agreement on the
application of sanitary and pseudo sanitary measures and the
agreement on technical barriers to trade both encourage the
international harmonization of food standards. As I think
Senator Roberts said, it would be ironic for us to be
supporting harmonization internationally and then here at home,
allow and even encourage individual States to impose their own
labeling requirements. In closing, it is incumbent upon those
who are charged with protecting public health to avail
themselves with the best data, obtained with the best
scientific methodology and analyze using sound scientific
principles in order to provide consumers with the most accurate
information that can effectively reduce, if not eliminate,
risks. Federal agencies like the FDA are charged with such a
mandate and are best equipped to implement it on a nationwide
basis in order to protect the health of Americans and every one
over 50 States. In a world in which confusion and
misinformation can provide either a false sense of security or
create unwarranted fears in consumers, uniform tolerances and
labeling requirements as provided by the proposed bill simply
makes sense. Thank you, Mr. Chairman.
[The prepared statement of Dr. Murano follows:]
Prepared Statement of Elsa A. Murano
My name is Dr. Elsa Murano, and I am the Dean of the College of
Agriculture and Life Sciences at Texas A&M University, the Director of
the Texas Agricultural Experiment Station, which is the agency in the
State of Texas charged with conducting research in agriculture and the
life sciences, and the Vice Chancellor of Agriculture for the Texas A&M
University System. I am a food microbiologist by training, and hold a
Masters and Ph.D. degree from Virginia Tech in Anaerobic Microbiology
and Food Science & Technology. During the 1990s, I was professor of
food microbiology at Iowa State University and then at Texas A&M
University, where I taught and conducted research in food safety. I am
very familiar with the scientific process of arriving at solutions to
problems in food safety, having published dozens of peer-reviewed
scientific papers, book chapters, and monographs. At Texas A&M, I also
served as Director of the Center for Food Safety, in charge of research
in this important area.
From 2001 to 2004, I served as Undersecretary for Food Safety at
the U.S. Department of Agriculture (USDA), where I was responsible for
developing the policies and programs implemented by the Food Safety and
Inspection Service, or FSIS. This public health Agency is charged with
ensuring that the Nation's commercial supply of meat, poultry, and egg
products is safe, wholesome, and correctly labeled and packaged. This
duty is not limited to domestically produced products, but it also
extends to ensuring the same for products that are imported from other
countries. As Undersecretary for Food Safety, I was also responsible
for representing the U.S. Government at the Codex Alimentarius
Commission, an international organization created in 1963 by FAO and
WHO which develops food standards, guidelines and codes of practice to
protect the health of consumers, ensure fair trade practices, and
promote coordination of all food standards at the international level.
As I mentioned, my experience in government was principally with
USDA-regulated products. However, having worked very closely with my
counterpart, the Commissioner of the Food and Drug Administration
(FDA), I can assure you that the same principles we applied at USDA to
ensure that the products we regulated were safe, wholesome, and
appropriately labeled, are also employed by FDA for the foods they
regulate.
S. 3128 would provide a national approach for establishing food
safety tolerances and inserting warning information on the labels and
related materials for packaged foods. The bill would thus assure a
consistent approach to labeling information for all 50 States. As
others have pointed out, the proposed law is not a new concept--
national uniformity already exists for most of the U.S. food supply and
many other products. In fact, Congress has repeatedly established
uniform requirements for nutrition labeling, allergen labeling,
standards and labeling of meat and poultry products, prescription
drugs, medical devices and pesticide tolerances. The laws under which I
operated as Undersecretary for Food Safety at USDA are a good example.
The Federal Meat Inspection Act states that:
``Marking, labeling, packaging, or ingredient requirements in
addition to, or different than, those made under this chapter
may not be imposed by any State or Territory or the District of
Columbia with respect to articles prepared at any establishment
under inspection.'' [21 U.S.C. 678]
Similarly, in the Poultry Products Inspection Act the Congress
established uniformity in labeling:
``Marking, labeling, packaging, or ingredient requirements
(or storage or handling requirements found by the Secretary to
unduly interfere with the free flow of poultry products in
commerce) in addition to, or different than, those made under
this chapter may not be imposed by any State or Territory or
the District of Columbia with respect to articles prepared at
any official establishment in accordance with the requirements
under this chapter . . .''[21 U.S.C. 467e]
As I mentioned before, Congress has on these and many previous
occasions established nationally uniform requirements for labeling, and
with good reason. Uniformity in labeling would provide a consistent
national approach to addressing food safety issues and communicating
effectively with American consumers important information to safeguard
their health.
As mentioned previously, S. 3128 focuses on food safety tolerances
and warning statements for packaged foods. The bill is designed to
ensure that the public is protected and well-informed, without
impacting the fundamental food safety laws at the Federal or State
level, or affecting any enforcement authority at the State or Federal
level. In fact, it is impressive to note just how much actual or de
facto uniformity already exists between the FDA and the USDA and the
State authorities responsible for food safety. The proposed bill does
not impact such uniformity at all. For example, the FDA and the State
Public Health Officials cooperate through the National Conference on
Interstate Milk Shipments to establish milk sanitation standards and
procedures for testing and evaluation, thus assuring the safety of the
Nation's milk supply. FDA and the States cooperate similarly on seafood
safety. Similarly, FSIS cooperates with States that like to conduct
their own inspections so that the food safety systems they use are
equivalent to those used by the Federal agency.
Another area of cooperation between Federal agencies and their
cooperation with State and local food safety authorities is the Food
Code. The FDA, the Centers for Disease Control and Prevention (CDC) and
the USDA's Food Safety and Inspection Service (FSIS) have all
contributed to the Food Code to make sure it addresses controls for
risk factors that the Government has identified as contributors to
outbreaks of food-borne illnesses, and includes actions designed to
strengthen the inspection process and improve food safety as product
moves from the plant to the consumer. The Food Code is updated
regularly taking into account current science, emerging food safety
issues, and imminent health hazards related to food safety.
The Code provides food control authorities at all levels of
government, a
``. . . scientifically sound technical and legal basis for
regulating the retail and food service segment of the industry
(restaurants and grocery stores and institutions such as
nursing homes). Local, State, tribal, and Federal regulators
use the FDA Food Code as a model to develop or update their own
food safety rules and to be consistent with national food
regulatory policy.'' [http://www.cfsan.fda.gov/dms/
foodcode.html#get05, accessed July 24, 2006.]
The Association of Food and Drug Officials (AFDO) has reported that
48 of the 56 States and territories--or 86 percent representing 79
percent of the U.S. population--have adopted their own food codes
modeled on the Food Code.
In fact, the Food Code was, and continues to be, very useful to
USDA and its efforts with State food safety authorities to assure a
safe food supply, as it no doubt is for FDA. In my opinion there is
nothing in proposed S. 3128 that would limit, restrict or compromise
the Food Code or the State or territorial codes modeled on it. Nor can
I see anything that would impact FDA's or USDA's other cooperative food
safety programs with the States.
As a trained researcher, I understand how science can be used to
determine the true risk posed by food-borne hazards. As Undersecretary,
I put this to use, applying the scientific principles of hazard
analysis, epidemiology, risk assessment, and statistical sampling in
order to develop policies that would reduce the risk of illnesses such
as those caused by E. coli O157:H7, Listeria monocytogenes, among
others. As a result, the number of illnesses caused by these pathogens
was reduced by 42 percent and 40 percent, respectively, as reported
last year by the CDC.
In 2003, application of the scientific principle of risk assessment
provided me with the information I needed to develop science-based
regulations that would virtually eliminate the risk of exposure to the
mad cow disease agent. This assessment, conducted by Harvard
University, showed that banning brain and spinal cord from animals
older than 30 months from the food supply would present the greatest
protection to human health. We quickly developed regulations that
banned such materials. A follow-up analysis conducted to determine the
effect of our policies showed that indeed, actions we took in 2003
virtually eliminated the risk of exposure to this agent.
At USDA, our scientific experts worked very hard to develop both
the underlying data used in risk assessments, incorporating research
from the entire scientific community, and the scientific models on
which they are based. At the same time, they continue to pursue
measures designed to reduce acute and chronic risks to public health.
Establishing a uniform national system will put food safety in the
hands of the Nation's top food scientists and food safety experts. Just
like USDA, the FDA is best positioned to assure that these scientists
and experts are brought together, whether they come from Federal
Government, State Government, or academia.
As you have no doubt seen, science is not always absolutely certain
or complete, and as a result it can be interpreted differently by
different people. In the area of food safety a range of different
interpretations, leading to different advice or warnings in different
States, is obviously problematic. The benefit of a national uniformity
approach is that it will bring the best scientists together to address
issues of public health significance, thereby helping to determine how
best to communicate to consumers in all 50 States.
It is important to point out that simple warning statements may not
always be appropriate. Sometimes the science is complex and different
population groups may be affected differently than others, and
sometimes an ineptly worded warning statement could cause people to
avoid certain foods and miss real benefits. This is another reason why
it is better to have safety issues thoroughly evaluated on a national
basis before warning statements are considered.
Sometimes, obtaining results via the scientific process can take
time and all the answers to our questions may not be available as
quickly as we want them to be. In these cases, the Federal agencies as
well as the States have the authority and the capability to step in and
protect the American public. The proposed law includes an Imminent
Hazard Authority that would retain the authority of the States' health
regulators to take the same protective actions on a local basis.
In other instances, there may be preliminary results that may seem
to contradict existing data. In these cases, Federal agencies like FDA
and USDA are best positioned to protect all consumers, given their
significant resources, experience, and expertise that can be brought to
bear in reviewing the entire body of scientific evidence in order to
issue food safety regulations that will actually protect public health.
Sometimes a safety issue appears locally, not nationally. But
because we have a national food supply, an action taken locally may not
help all consumers. If there is a true safety issue, State authorities
should bring it to the attention of the Federal agencies so that it can
be confirmed and together they can take a national approach to protect
all U.S. consumers. The proposed law provides a process to establish
national standards in order to protect all consumers, not just some.
Similarly, on occasion, the data will show that a safety issue
could truly be local, and advice or a warning should be provided to
consumers in that area. The proposed law recognizes this and allows for
an exemption from national uniformity when a safety issue is
demonstrated to be unique to a specific State.
Again, S. 3128 would provide a national approach for establishing
food safety tolerances and warning label requirements that are
consistent in all 50 States. This objective is also consistent with
activities the U.S. Government has been engaged in for international
food standards. As I mentioned in my opening statements, while at USDA
one of my responsibilities was to represent the United States as a
member Nation of the Codex Alimentarius Commission. In establishing
this international organization, the Food and Agriculture Organization,
the World Health Organization, and the member countries felt that
``. . . if all countries harmonized their food laws and adopted
internationally agreed standards, such issues would be dealt
with naturally. Through harmonization, they envisaged fewer
barriers to trade and fewer barriers to trade and freer
movement of food products among countries, which would be to
the benefit of farmers and their families and would also help
to reduce hunger and poverty. [Understanding the Codex
Alimentarius, Rome, 2005 edition, p. 29]
The Codex, through the agreement of the participating countries,
sets standards with the dual purpose to assure consumer safety and to
facilitate international trade in food. These standards cover, among
other topics, specific foods, food ingredients and additives, food
hygiene procedures, and food labeling.
Allow me to quote from a Codex document on the harmonization of
food standards internationally to emphasize the value of national
uniformity here in the United States:
With respect to the ever-increasing global market, in
particular, the advantages of having universally uniform food
standards for the protection of consumers are self-evident. It
is not surprising, therefore, that the agreement on the
Application of Sanitary and Phytosanitary Measures (SPS
Agreement) and the Agreement on Technical Barriers to Trade
(TBT Agreement) both encourage the international harmonization
of food Standards. [Understanding the Codex Alimentarius, Rome,
2005 edition, Preface]
Codex has also commented on the potentially significant problems
that may occur if countries went their separate ways in setting
standards and tolerances:
A principal concern of national governments is that food
imported from other countries should be safe and not jeopardize
the health of consumers or pose a threat to the health and
safety of their animal and plant populations. Consequently,
governments of importing countries have introduced mandatory
laws and regulations to eliminate or minimize such threats. In
the area of food, animal and plant control, these measures
could be conducive to the creation of barriers to intercountry
food trade. [Understanding the Codex Alimentarius, Rome, 2005
edition, p. 29]
It would be ironic for us to be supporting harmonization
internationally and then here at home allowing, or even encouraging,
individual States to impose their own labeling requirements.
In closing, it is incumbent upon those who are charged with
protecting public health to avail themselves of the best data, obtained
with the best scientific methodology, and analyzed using sound
scientific principles, in order to provide consumers with the most
accurate information that can effectively reduce, if not eliminate,
risks. Federal agencies like FDA are charged with such a mandate, and
are best equipped to implement it on a nationwide basis, in order to
protect the health of Americans in every one of our 50 States. In a
world in which confusion and misinformation can provide either a false
sense of security, or create unwarranted fears in consumers, uniform
tolerances and labeling requirements, as provided by the proposed bill,
simply make sense.
Senator Burr. Thank you, Dr. Murano.
Mr. Hubbard.
STATEMENT OF WILLIAM K. HUBBARD, FORMER ASSOCIATE COMMISSIONER
FOR POLICY, FOOD AND DRUG ADMINISTRATION, CHAPEL HILL, NC
Mr. Hubbard. Thank you, Mr. Chairman.
Senator Burr. Push the button, Bill.
Mr. Hubbard. Thank you, Mr. Chairman. I have submitted
written testimony, which I will not, in the interest of time,
read. I'll just make a few brief remarks, if I may. I cannot
speak formally for the FDA, as you know I have been retired,
but I think I can give you some of the viewpoints from the
point of view of the FDA. If I slip up and say we in talking
about the FDA, please forgive me as old habits die hard.
Uniformity is a word to go and I would like to say more
about that. Let me divide my comments up into three points. The
premise behind the bill, interpretation of the bill and the
effects of the bill and various implementation by the FDA of
the bill. First of all, the premise, as you know, is that
uniformity does not exist and the conflicts are rampant. The
States and the FDA are very good partners and they've worked
closely together over the years to develop a relatively
seamless food safety enforcement system that I believe works
very well. There, in fact, is great consistency now and
inconsistencies--they have arisen, I think, have been
relatively minor and generally get resolved by scientists
working out the issues. In fact, in my 20 years of working on
this issue, I've never had a consumer tell me he was confused
by State labels that differ from Federal or I've never gotten a
letter. The industry has often said that and I think that there
are specific examples of where particular companies have had a
problem and we heard one today but there has been very little
evidence of a negative impact, is my view. I served on the
Regan panel that looked extensively at this. I think they, in
fact, weren't assigned the kind of inconsistency the industry
alleged and after a very lengthy study, concluded that there
just wasn't the sort of impact that was being alleged. That was
repeated again in the Bush administration, repeated again in
the Clinton administration. There has just been no adverse
impact at the level that I think people often say. And the
conclusion of all of these public officials over the years is
that there has not been an adverse effect, impact and the
action should be taken only if a serious problem does emerge.
So to some extent, Mr. Chairman, I feel that this is a bill
with a solution in search of a problem.
Only--pushed the bill into effect so I will not at all go
into the provisions of the bill. There is voluminous
documentation that I hope you've not attempted to read about
all of these points that have been made today, between the
industry and the opposing groups. They are obviously opposed. I
think the fact that you have a consensus among State Attorneys
General, Food and Drug officials in the States, consumer
interest groups, that this will have very negative impacts. I
think it is something to listen to. But I am particularly
concerned that there are vast differences of opinion about what
the language even does or what it means and that--intent of
Congress before this bill proceeds. Please don't raise this
ambiguity that clearly exists between the competing parties.
Nail all of the FDA scientists or the courts. I would beg you
to look very closely at the differences of opinion and try to
get those resolved because they are diametrically opposed and
someone is right or someone is wrong or there is truth in the
middle and I don't know which is which.
Last, I don't believe the FDA can implement this bill, Mr.
Chairman. The food program of the FDA has undergone tremendous
budget cuts in recent years. They've gone from being able to do
35,000 inspections of food facilities in 1972 to perhaps 5,000
today. When Proposition 65 was enacted, there were perhaps
100,000 imports of food coming to the United States. There will
soon be 10 million coming into the United States. You took the
lead on a very important bioterrorism bill that included a
registration provision. FDA now has 200,000 registrants
domestically and perhaps another 100,000 foreign. That's
300,000 food firms that they should be looking at and they can
look at 5,000 a year. So to put on that system an additional
burden of taking on State responsibilities, I am very concerned
about. The FDA headquarters' staff that want to do this work,
if this bill passes, has been reduced by 10 percent in just the
last 2 years and is going down further. Overall, the food
program at FDA, which includes--has lost hundreds of people
since 1903 alone, at a time in which the Congress is saying
worry more about bioterrorism. Be more active. I am very
concerned about that. The program is weaker than at any time
since the 1960s and the President's budget commands FDA to
further reduce the food safety effort and put it over into
terrorism, a worthy goal. But Dr. Murano mentions that the meat
program has preemption. I think if the FDA got nine times more
staff, as USDA does, including stackers, I think they would be
very willing to say to you, we can do it now. But I don't think
that's in the cards. When you've got an agency that has such
pervasive regulatory influence over a problem such as the meat
program or when you take a food label in the FDA, preemption, I
believe, is appropriate because you have an area where the
States will not inflate and the Federal Government came in to
no votes and took control and I think that is a good idea. In
the case of food safety, the States were doing this long before
the FDA was created.
Last, I'll point out this petition process. Mr. Hutt may be
right but certainly the Congressional Budget Office says there
will be many petitions. I must tell you that the call petition
process of the FDA is broken. They have a backlog of over 200
petitions now. Last year, they were able to get nine done. The
backlog actually grows every year. If S. 3128 passes, the FDA
can't implement it, Mr. Chairman. They cannot do it. If the CEO
is correct and they'll get 200 petitions, virtually the entire
food headquarters staff will drop everything else and do
nothing but review these petitions. If the food industry is
right, that there will be 300 of these petitions, they will
drop everything and do nothing but this and still fail and of
course, this is not a subjective determination. I can tell you
objectively, they will fail massively in implementing a bill
like this or they will be forced to simply tell you no, we
can't do it and to stand there and do nothing.
Either way, that is a very bad outcome for the public
health and for the agency. So, in sum, Mr. Chairman, while
consistency is a worthy goal, I think the bill appears to be
unjustified by the current circumstances. It is lacking clarity
about its extent and effects as we see from these differing
opinions and I truly believe, Mr. Chairman, that it is
impossible to regionally implement by the FDA under current
circumstances and current resource levels. Thank you for your
attention.
[The prepared statement of Mr. Hubbard follows:]
Prepared Statement of William K. Hubbard
Thank you, Mr. Chairman, for inviting me to present views today on
S. 3128, The National Uniformity for Food Act of 2006. I am William K.
Hubbard, and until recently was an official of the Food and Drug
Administration. I retired in 2005 after 33 years of Federal service,
the last 14 of which were as an Associate Commissioner at the FDA. The
issue of national uniformity for food safety laws was one in which I
was involved repeatedly over the years, as successive Presidential
Administrations sought FDA advice when they examined this issue.
Let me begin by observing that protecting citizens from unsafe food
is a quintessential governmental function. Even before the creation of
the United States, individual States (then colonies) were establishing
laws protecting the public from hazards that could be intentionally or
mistakenly placed in food sold in the marketplace. That role grew as
commerce in food expanded, until, a century ago, in 1906, Congress
determined that a Federal food safety role should be established as
well, in the forms we know today as the Food and Drug Administration
and the Agriculture Department's meat inspection program. With this
addition of a Federal food safety structure, State and Federal food
safety officials have become closely allied partners in protecting our
citizens from unsafe food--sharing scientific data about potential
risks to foods, cooperating on inspecting food manufacturing
facilities, responding to outbreaks of foodborne illness, removing
hazardous food from the market, and devising similar regulatory
structures for overseeing the safety of the food supply.
Together, State and Federal health officials have developed a
modern, science-based infrastructure that, along with the hard work and
dedication to high standards of food producers, has given Americans a
food supply of unparalleled abundance, affordability, quality,
nutritional variety, and safety. There is no doubt that this system has
served the Nation well, and that State and Federal food safety programs
have not only co-existed, but have evolved to protect our citizens
using essentially the same scientific standards, regulatory mechanisms
and statutory constructs. Indeed, most States, in an effort to
harmonize with the judgment of Congress, have enacted food and drug
laws identical or quite similar to the provisions of the Food, Drug and
Cosmetic Act (the principal source of FDA's food safety authority).
There have, over the years, been occasional instances in which FDA and
State determination about product safety (and their concomitant public
warnings) have differed. But those instances have been relatively rare,
and generally have been worked out amicably among the scientists
involved. There certainly has not been the sort of mass conflict and
confusion that would warrant a fundamental undermining of the strong
Federal/State partnership that currently exists. And the States have
served the valuable function at times of being the first to identify a
health risk and, through their actions to protect their own citizens,
have alerted the FDA, so that it could extend such protections
nationally.
The issue before the committee today, of course, is whether
Congress should preempt the laws of the States, in deference to the
regulatory role of the FDA. There are certainly examples where Congress
has done so. For example, USDA has meat inspectors in every
slaughterhouse while that facility is processing meat, and a separate
State function would be redundant. When Congress required all foods to
bear nutrition labeling in 1990, it judged that a single Federal
standard was appropriate, as the States had no separate nutritional
labeling requirements at that time and FDA was authorized to create a
strong, enforceable national standard. Most recently, Congress
established standards for labeling the 8 major food allergens, and gave
those preemptive effect.
However, in the case of contaminants in the food supply, Congress
has never done so, and the circumstances are much different. The
States' role in protecting against adulterated foods long pre-dates the
creation of the FDA, and the FDA's ability to adequately oversee such
potential threats to the food supply is inadequate today and growing
weaker each year. So it is ironic that at this time Congress would be
considering legislation that would remove a valuable food safety tool,
and perhaps provide incentives to further weaken FDA. Let me explain
the basis for those conclusions.
In 1972, FDA's food program constituted approximately one-half of
the FDA's efforts, in terms of the agency's resource allocation. Today,
it is about one-quarter, even though FDA has little more staff than it
had in the 1970s. Likewise, 34 years ago, FDA conducted 35,000
inspections of food manufacturing facilities. This year, they will do
perhaps 5,000. The volume of food imports from overseas is approaching
10 million per year, and the number that FDA inspectors physically
examine is in the single digit thousands--making it virtually certain
that any given food shipment will enter the United States with no FDA
inspection. I could provide many more similar statistics, all of which
paint a picture of an FDA regulatory structure that is under-resourced,
under-staffed, and essentially incapable of meeting the growing demands
to oversee food production, food additives, cosmetics, dietary
supplements, nutrition labeling, foods produced from biotechnology,
foodborne disease outbreaks, dangerous new pathogens that infect food,
pesticides, and the many other responsibilities of that program. And,
most recently, the President has proposed diverting traditional food
safety resources toward protecting the Nation against terrorism threats
to the food supply--a worthy effort, but one that will force FDA to
rely even more on State food safety efforts.
Yet S. 3128, in the name of ``uniformity,'' would remove FDA's
partner in protecting against food adulteration, and throw even more
responsibilities at the agency--in effect, moving problem solving from
a source that has proven to be an effective complement to Federal
authorities to one that cannot accept more responsibility and will thus
be ineffective. Further, because the States' ability to deter
adulterated foods would be weakened, and with FDA the only alternative,
producers of food about which safety concerns have been raised would
have incentives to maintain a weak FDA.
FDA's resource shortfalls beg for a focus on the mechanism embodied
in S. 3128 to permit the States to act against adulterated food. The
bill would create a petition process whereby a State wishing to
maintain an existing standard, or create a new one, would petition FDA
either for an exemption from preemption or to create a uniform,
national standard. This provision is simply impracticable. First, FDA
has shown demonstrably that resource constraints prevent it from
processing the flow of citizen petitions that it currently receives. In
fact, the agency slips further behind each year in its handling of
citizen petitions; there is now a backlog of over 200 citizen petitions
in the queue for response in the food program alone, many dating back
several years; and that program managed to respond to only 9 petitions
in all of 2005. Adding yet another flood of petitions to this already-
overwhelmed system would merely build in additional failure.
But I can describe an even more dismal prospect regarding FDA's
ability to respond to the petitions envisioned by S. 3128. The
Congressional Budget Office assumes that FDA will receive at least 200
State petitions during the first year after the bill's enactment, and
that it will cost $400,000 to review each petition. So FDA would be
required to spend $80 million to answer those petitions--for no
discernible public health gain. Mr. Chairman, the entire budget for
salaries and expenses of the scientists in FDA's headquarters food
program is under $100 million, so this bill, if enacted, would
essentially mean that the food program would need to cease all other
functions except for the review of State petitions, if it were to make
a sincere effort to comply with Congress's charge. If the industry's
prediction, that FDA would receive over 300 petitions from California
alone, is correct, the effort to address the petitions would require
more resources than the agency's food program possesses, meaning that
FDA could not accomplish the goal even if ALL food headquarters staff
were assigned only to petition review. Or, if FDA chose not to engage
in this decimation of the agency's food safety programs, it could be
forced to basically ignore the statute, thus setting the stage for
great confusion, potentially endless lawsuits, and a vacuum in both
State and Federal protection against food adulterants.
I would add that it is very unclear what the bill preempts. The
dispute between the food industry and others--whether the State
Attorneys General, State food safety officials, or the Center for
Science in the Public Interest--about the number of laws preempted is a
good indicator of that ambiguity. There is a very real question whether
most State enforcement actions will be met with a rejoinder that the
action is preempted by this bill. Resolving such disputes through the
courts will add significantly to State enforcement costs and inevitably
reduce the volume of enforcement the States can undertake. Obviously,
FDA will not have resources to take up any slack.
The bill does not give preemptive effect only to requirements
imposed by FDA by regulation. Instead, it appears to completely
eliminate State safety notifications, whether the FDA has acted or not.
In terms of enforcing State safety standards themselves, the bill
starts at the top, broadly preempting State safety requirements unless
they are identical to Federal requirements. It then allows States to
enforce only those State requirements that are identical to existing
FDA requirements, or even guidances, which are non-binding FDA
advisories to industry. Localities, such as New York City, are
apparently preempted from enforcing their own requirements. While
preemption focused on circumstances when FDA has made a well-
reasoned determination can make sense, it is difficult to see a problem
that supports such a broad preemption. Further, the bill would not
require that FDA step in (even if it had the resources) and replace
State and local laws that might be necessary, further exacerbating the
vacuum in safety oversight that the bill would create.
In conclusion, Mr. Chairman, when a well resourced FDA has been
able to examine a potential health risk in food, bringing to bear the
best scientific data and analytical ability, and resulting in the
establishment of a reasoned determination--whether to bless a
substance's safety, to require safety warnings to consumers, or to ban
the substance--it would be reasonable to consider whether that
determination should be dispositive for the entire Nation, and whether
States should second guess such a carefully reasoned disposition.
However, until and unless FDA is given the resources and ability to
deal with any and all questions about the safety of food constituents,
I believe that the existing Federal/State cooperative relationship has
passed the test of time in its effectiveness and ability to work
together to protect our citizenry. Not only does the current system
work well, but there is little evidence of a problem now that would
justify the broad preemption envisioned by the bill, and no reason to
believe that there will be a problem in the future. The vast majority
of State attorneys general agree with that conclusion, as do the
States' food and drug officials, and virtually all consumer interest
groups. That practical consensus of opposition to S. 3128 should be
seen as a significant cautionary message about this bill. Adding in
FDA's absolute inability to implement this bill in any reasonable
fashion should raise those caution flags even higher.
Thank you for giving me the opportunity to comment on this
important matter.
Senator Burr. Bill, thank you. It is the intent of the
Chair to recognize the Senator from Georgia first for questions
but let me say, from 1995 to 1997, the FDA, as we worked on FDA
modernization, said we can't absorb that type of change. Well,
we did it and we went from, I believe, eight applications
approved in 1997 to 81 in 1998. What we found was that
sometimes when you find a system that is broken, our
responsibility is to fix it. I don't think that is a suggestion
that we didn't take on FDA modernization or that the FDA
shouldn't exercise what is their mission and their
responsibility as it relates to food safety. I think that if
there is one individual and certainly we have one today, it's
probably fairly easy for Mr. Stadtlander to say, ``You know,
it's not worth selling cereal in California. I'm just going to
pull the damn thing off the shelf.'' But it's not just losing
$70,000-$80,000 worth of revenue. In his case, it is a multi-
million dollar lawsuit that he has to defend, so to suggest
that there is not an impact, I think, is to ignore what's going
on. We've got ample time with the few members that are here to
explore a number of different areas and I'll take the
opportunity to do that with all of you. But I do want to
recognize the Senator from Georgia first, for a line of
questions.
Senator Isakson. Well, thank you, Senator Burr and I
apologize to the panelists for missing your live testimony but
I had to go cast a vote in the Small Business committee. My
experience in the private sector is not with the processing of
food. I was in the construction and housing industry. By
California standards, caused problematic issues even in that
because California would have a standard, for example, in terms
of suspended particles in the air and you'd get a lawsuit going
and somebody would go find the California standard and you'd
get sued in Georgia for not meeting a California standard even
though it didn't apply because it was by that State. So it cost
me and I got involved in one of those one time, it caused me to
think of a few things and Mr. Hutt, again I apologize. I didn't
hear your testimony but you're an attorney and I'm assuming
that when you have a variety of different standards or an
inconsistency of standards nationwide, that the practical
effect of those inconsistencies for the mass producer of almost
any product ends up being a lot of litigation. Is that correct
or am I wrong?
Mr. Hutt. You have only two options. Either you meet the
toughest standard in the entire Nation or yes, you are subject
to numerous lawsuits.
Senator Isakson. Mr. Stadtlander, I read part of your
testimony with regard to the product, Wheatena?
Mr. Stadtlander. Yes, right.
Senator Isakson. OK. And you produce your product
uniformly, I guess, at a production facility, is that correct?
Mr. Stadtlander. Yes, sir.
Senator Isakson. So, in the case of this product, because
of the Acrylamide or whatever that element was, you then,
because of the California standard, just not sell in
California? Or do you have to go into a separate processing
facility or labeling facility? Tell me how you deal with that.
Mr. Stadtlander. Wheatena, as well as 40 percent of the
food that people in this room consume, would have Acrylamide as
a byproduct, so it is impossible to sell these products without
having Acrylamide because it is a byproduct of toasting.
Otherwise, you'd be eating raw wheat or oats. As soon as you
cook them--and it can be cooked at home, it doesn't need to be
done by a manufacturer--you end up with Acrylamide. So the
first answer to your question, it is impossible for the vast
majority, 40 percent of what you're eating, to remove
Acrylamide. That's the first thing. So the options are warning
people on 40 percent of the food supply, that it may cause
cancer, negating or confusing consumers when the Federal
Government is saying I may reduce the risk of cancer because of
high fiber content. So this package, to conform to California
law, would say, may reduce the risk of cancer, Federal law and
may cause cancer, California law. That's what I would be
selling on the marketplace. It doesn't work that way. The other
thing is, in terms of California saying this works, the 40
percent of the food supply that so-called may cause cancer
because of Acrylamide, which is strictly California--the rest
of the world has reviewed this and no one is coming to that
conclusion of warning people on food supply. You end up with
suits. So the suit I'm involved in right now, is the law firm
says, we're suing because you didn't warn consumers. If you
give me $250,000, I'll go away. I'm saying I'm not doing it.
I'm selling a healthy product so California is still to be
resolved because the 40 percent of the food supply that has
Acrylamide is not warning consumers today that it may cause
cancer. That's why the court is backed up with suits because
manufacturers are saying, I can't remove it and I'm not going
to label it or I can't label it strictly for the State of
California and 49 other States are going to have a cancer
warning on my product. Manufacturers are not going to do that.
Senator Isakson. So Acrylamide is a natural occurring
element we cannot control?
Mr. Stadtlander. Exactly right, including if you toasted
something at home. So it's not just manufacturers. I'm saying
what you'd be doing is not selling ovens any more because you
create Acrylamide anytime you'd put a starch product in your
cooking facility.
Mr. Hutt. And that's not the only instance of naturally
occurring substances that the California Proposition 65 applies
to. There are suits on mercury in fish, which is naturally
occurring, the lead in calcium, which is naturally occurring,
the cancer-causing substances every time you grill a steak,
charcoal broiled steak, every one in the country produces
carcinogens and there are lawsuits on that. There is no end to
this type of litigation in California.
Senator Isakson. Well, that was the reason. And again, I'm
sorry I missed both of your testimony but the reason I brought
the question up was because in my private life, my experience
is that when you have a lack of uniformity, all you do is open
up people who are doing good things in honorable businesses to
be in court all the time, spending their money trying to defend
something. But in the case of this, you couldn't have had any
control over it anyway. Dr. Murano, I'm sorry I missed your
testimony but which side do you come down on as the
distinguished Head of the College of Agriculture, I think that
is correct.
Dr. Murano. Yes, sir. Well, as a scientist I have to tell
you that you've got to use science in order to make the best
decisions possible when it comes to food safety, for sure and
to simply say that because there is a certain substance or
ingredient in a food that may cause adverse effects, that that
warrants a label, is irresponsible because as I think the
gentleman at the other table said, there are so many foods that
contain naturally occurring substances that, given enough of a
dose, perhaps will make an adverse effect but yet the doses
that we're exposed to, science has not shown to cause any
adverse effect. It makes absolutely no sense and frankly
affects the credibility of whatever agency requires such a
label to be put on there because consumers will soon realize
that if there is a warning on everything, because everything
basically has a component that potentially could be harmful if
consumed in high enough levels, then it ceases to have an
impact. The credibility of the agency is compromised and
frankly, as I was mentioning in my testimony, on the
international arena, we have to abide by good, sound science
because if we don't, we're surely prone to be accused by other
countries of setting up false trade barriers because we're not
basing them on science.
Senator Isakson. Thank you and I know my time is up but I
did want to ask one question, Mr. Hubbard. Mr. Hubbard, do you
think the FDA does a good job with the drug industry?
Mr. Hubbard. Actually I do. I think it is a very good job.
Congress has given the FDA pervasive regulatory authority over
drugs to oversee their testing, their approval and the
manufacturing and marketing. In fact, when California has
attempted to step into the drug area, the FDA has been
assertive in saying, ``Do not put a warning label on these
products because we know these products better than you do.''
And we have tangled with them and we have prevailed. The
problem here is that on the third side, you have a much less
pervasive authority, much weaker program, much less information
and the FDA has relied traditionally upon the States to be a
strong partner in protecting the public against unsafe foods.
Senator Isakson. But I would assume that if the FDA had the
authority over food like it has over drugs, they could do a
good job.
Mr. Hubbard. Whenever we have made a sound determination
based on good science, about the safety of a product, whether
to leave it on the market, take it off the market or label it,
we have stood by that and we have told States, do not come up
with a different answer. We have brought the science to bear
and made the decisions and I said, we've tangle with California
on this and I think we've prevailed. Generally we work it out
in a scientist to scientist fashion. A few times we literally
had to threaten them but those are occasions when FDA had the
scientific leadership on the issue. That was not necessarily
the case here. If I could comment on the Acrylamide, if I may.
Acrylamide is really an example of both points of view.
Acrylamide came as a surprise to the whole world for its safety
risk in 2002. People have been screaming to understand what it
means and the fact that the consensus said high levels of
Acrylamide might cause cancer. However, it is in many, many of
our foods and FDA has been trying to say to the industry, let's
get it out but give them time. Let's don't scare people that
there is an immediate risk. California has done a similar
thing. They have stayed their rulemaking to give folks the time
to understand that. Mr. Stadtlander is a victim of thing called
a bounty hunter, which is a human provision they have in
California which a trial lawyer can go to court on its own. I
certainly hope personally that a judge will say, to the various
food safety authorities who are looking at this, Mr.
Stadtlander should not be punished because it is in many, many
foods and you should not be singled out because his product has
Acrylamide when so many others do. I will say, however,
California put Acrylamide on their cancer warning list in the
late 1980s so they kind of got there first and he, I think,
started marketing his product many years later. But again, I
don't want to defend the bounty hunter provision. There are
some potential issues there that I think would be fair for you
to look at.
Senator Isakson. You ought to send that testimony to your
lawyer. I think it will help. Thank you, Mr. Chairman.
Senator Burr. I'm not so sure anything will help short of
the amount of money you're going to have to pay your lawyer to
hopefully get to a reasonable judge on the bench that makes a
determination this shouldn't go forward. Unfortunately at the
end of the day, it's going to cost you a lot of money. Without
objection, I would ask that the entire testimonies of all of
our witnesses be put into the record. It is my intent to share
whatever time with my colleague from Georgia and if we're
joined by any other member, to also include them. And I'm going
to attempt to work my way down the line, if I can, and try to
help enlighten us on not only what the current law is, what the
language in this bill says, and how it affects current law, be
it Proposition 65 or anything else. Let me ask you, Mr.
Stadtlander, has any other State raised an issue, other than
California, on Wheatena?
Mr. Stadtlander. No.
Senator Burr. Would it be possible to make a Wheatena box
with a warning label just for California sales or does that,
over and above the fact that you'd be saying contradictory
things--lessen the chance of cancer and contributes to cancer--
what does that challenge you to do in your distribution
process?
Mr. Stadtlander. From a commercial standpoint, it is
virtually impossible if you're selling--basically, I'm selling
in 50 different States. For me to have a separate label
specifically for California, the chains that I sell through,
people like Kroger, et cetera, have warehouses where they pull
from for different States. They have diverters that buy product
and move it across the country, so to have a label specifically
for California would be, I don't want to say impossible, but
extremely difficult, in the same way that chains, like the
Krogers of the world, who normally would take a product in and
distribute to all Krogers, so that would be one challenge. If
you had a separate product for the State of California, and
they ordered that separately, you would then still have
confusion because what you would need is, the chains that
specifically say this store is getting this product and that
store is not going to get this product. So from a practical
standpoint, it is impractical to virtually impossible to
control that.
Senator Burr. You actually described a process though,
where a stock person in a chain grocery store could, in fact,
have two boxes, one marked for California and one marked for
the other 49. A minimum wage worker may make a mistake and put
on the shelves in California through a distribution truck, a
box not labeled for California and you as a company would then
be liable not by a bounty hunter but by the State, once the
State promulgated those rules, even if you were well-
intentioned to do that, that could happen to you?
Mr. Stadtlander. Yes.
Senator Burr. Mr. Hutt, is Mr. Stadtlander alone?
Mr. Hutt. He is not alone.
Senator Burr. The only one in the country that has got this
problem?
Mr. Hutt. The entire food industry is endangered here
because as he pointed out, you can't eliminate, based on
current science, Acrylamide from food and unfortunately, if
Bill Hubbard were running California, we would have no problem
but he's not. And the people who he deals--or used to deal with
in the California government agency, are not the people who are
running this show. It's the attorney general who has political
ambitions to go higher and it's the bounty hunters who have an
enormous economic stake here. They've been earning millions of
dollars based on this litigation. If you take a look at all the
food products involved, let's talk about mercury in fish, which
as I already pointed out, is naturally occurring.
Senator Burr. Could you also, as you talk about mercury in
fish, take us through the most current court case that
manufacturers challenged and won?
Mr. Hutt. I'd be happy to do that. The court in California
turned back the case that was brought again by the State--not
by a bounty hunter but by the State of California. It was
masterminded by the office of the Attorney General and the
court said on three separate grounds, that the State of
California's mercury level for fish was wrong. First they said
it was not backed up by sound science. Second, they said--and
in fact, what they said was that the State scientific witnesses
had no scientific credibility. It was a remarkable opinion in
that respect. Second, they said that deference should be given,
under the Doctrine of Primary Jurisdiction, to the views of the
FDA because the FDA thoroughly opposed the way that California
was trying to bring that case. And finally, they said that the
mercury was naturally occurring. It wasn't put in there by
humans. Mercury is prevalent throughout the environment and
thus, for those three reasons, the court threw out the
California case. Now, the same might happen with Acrylamide.
But Bill is going to have to pay millions of dollars if he
wants to litigate that case in California. The same, presumably
I hope would happen, with regard to benzthanrozine and other
carcinogens in steak, in chicken and in any other cooked meat,
we don't need a warning on every piece of meat in California.
That is not--I'm sure Dr. Murano, you would agree with that,
from your experience at USDA. So we're talking about the entire
food industry being at risk here. If Bill Hubbard could
negotiate with the State officials on a science basis, none of
this would have occurred.
Senator Burr. Do you think the lawsuits that truly do come
out of Prop 65 have peaked or are we going to see a
continuation of a climb in lawsuits?
Mr. Hutt. Well, I'm afraid that my profession, other
members of my profession--I'm not a trial lawyer--have found a
gold mine in California and I don't think they will stop.
Senator Burr. Senator Feinstein, in her comments, talked
about bioterrorism. Would S. 3128 impair the ability of a State
to take action in the case of food bioterrorism, in your
estimation, or any other food safety emergency?
Mr. Hutt. There are two provisions in the law that make it
clear that it would not, in any way, impede the State. The
first provision says that the bill cannot go into effect at all
unless the Department of Homeland Security certifies to the
Department of Health and Human Services, that there would be no
impairment of bioterrorism protection. That's the first
provision. The second one authorizes any State to act in the
event of an emergency, an imminent hazard to health so that
bioterrorism is covered fully in this legislation.
Senator Burr. One additional question, if I could. The
Center for Science in the Public Interest released a study that
concluded that nearly 200 State laws would be affected by the
National Uniformity legislation. Do you agree with their
conclusions?
Mr. Hutt. Well, their conclusions, as I testified earlier,
are just dead wrong. They do not read the legislation. For
example, the sanitation--I'll just give one example--the
sanitation provisions of the Federal Food, Drug and Cosmetic
Act under which restaurants and shellfish and milk--those three
are regulated. Those are not covered by national uniformity but
CSPI keeps saying, knowing that it is untrue, that they are
covered. Even if you take a look, for example, at the history
of these three types of regulatory programs, the Milk Program
that was begun 1923 by the Public Health Service, the National
Shellfish Program that started in 1925 and the third one, the
restaurants, in 1935. They are authorized under the Public
Health Service Act. They are not even conducted under the
Federal Food, Drug and Cosmetic Act and they are not subject in
any way, shape or manner, to any form of national uniformity,
under this legislation. The legislative history is clear and
indeed, the statute or the bill, is clear. I agree with Bill
Hubbard. The legislation should be clear. I don't know how it
could be made any clearer.
Senator Burr. Thank you. Thank you for that and I think we
all agree that we should require more people to actually read
the legislation before they comment on the contents and the
effects of the legislation. Dr. Murano, has uniform regulation
of products under the USDA been a good thing?
Dr. Murano. It has been a great thing. It's been great when
we were faced with outbreaks of food-borne illness, the E. coli
in undercooked hamburger meat, for example, because we were
able to very, very quickly, as we developed policies that could
be enacted nationwide without any obstacles to really getting
that implemented as quickly as one could. When we, for example,
implemented some new policies regarding ways to avoid exposure
to the Mad Cow Disease agent and we put policy that removed
certain high-risk materials from the food supply, again having
that authority to do it nationwide by virtue of one piece of
regulation, gave us a tremendous advantage because we were able
to not only protect the public's health, which is uppermost in
our consideration but also had the credibility worldwide that
what we were doing was going to be implemented nationwide and
was going to be backed up and it was backed up by scientific
studies, risk assessments that were conducted by Harvard
University that had been shown, now most recently by a further
study of the impact of our regulation to have been the most
significant thing we could have done to prevent exposure to the
Mad Cow Disease agent and protect the public's health.
Senator Burr. Do you feel that there is enough evidence-
based science behind the food-related activities in
California's Proposition 65?
Dr. Murano. If we take, for example, the Acrylamide
question, since that is the one that affects the discussion
here this morning as a good example, there is evidence
certainly that Acrylamide may cause cancer. It has been shown
to do so in laboratory animals. But the levels at which
Acrylamide is naturally found in all the many foods that have
been mentioned already, including good coffee by the way, so if
you had coffee this morning, you consumed a little bit of
Acrylamide but what is a little bit? A little bit, we're
talking about microgram amounts and even less than that and the
scientific evidence is just not there to support any claim of
that being a hazard to human health at all whatsoever. So the
question here is, if you have a substance in a food, naturally
occurring or otherwise--what science does for us is it permits
us to figure out what is the dose, the exposure level that will
cause a detrimental effect and if that exposure level is not
met because the amounts are so well below that tolerance level,
then it is not a hazard to human health and it is
misinformation to put a warning on a product simply because
there is the presence of a certain amount. If it is below a
tolerance level, if it is below a level that has been shown to
cause deleterious effects, then it is not a hazard, by
definition, by scientific definition.
Mr. Chairman, I just wanted to add something somewhat
unrelated to your question--and I feel compelled to do so
because my colleague is formally from FDA as I am formally with
the USDA--I wanted to point out when I was Undersecretary, I
worked very closely with the Commissioner of FDA to make sure
that if the FDA needed help or assistance--for example, in
conducting inspections or any other function that our
inspection force could help them with--they could deputize our
inspectors to do so. There are Federal agencies that work for
the good of public health and we work together and we have a
Memorandum of Understanding and other agreements in order to be
able to maximize the resources that we are both given. So I
feel certain that if this legislation becomes law that the
resources of the Federal Government would be put to use and in
fact, if FDA needed assistance from other agencies, those
agencies would certainly assist them.
Mr. Hubbard. Mr. Chairman, if it is not tomorrow, in fact,
Mr. Burr's bioterrorism bill of a couple years ago did in fact
do that. It gave FDA the authority to deputize and that is
working very well and I think everyone is appreciative of your
leadership on that.
Senator Burr. Thank you for that. I'm curious and I should
know the answer to this but all of the products that might
resemble yours, from the standpoint of makeup and crackers and
other things, do they all have to have that warning or is there
a threshold that you hit from the standpoint of what California
set as a tolerance, that they haven't?
Mr. Stadtlander. There is no threshold in California at
this point in time. So any amount.
Senator Burr. So technically--and I trust you--you are a
microbiologist. You've got Acrylamide in coffee. Does coffee
have to have a label in California that says may cause cancer?
Mr. Hutt. Yes.
Senator Burr. All coffee does?
Mr. Hutt. Yes.
Senator Burr. Does wine have any in it?
[Laughter]
Mr. Hutt. No, but I will--I'm glad you brought up that
issue because of the concern expressed by the two Senators from
California about lead in candy and various other--pottery,
etcetera. What they failed to point out is that California is
the only State that has a law that explicitly allows lead foil
for closures of wine.
Senator Burr. Interesting. At this time, I ask unanimous
consent. I'm going to enter into the record a chart that shows
for 2005, the Prop 65 settlement dollars paid in private cases,
a total of $56 million and the breakout of the attorney fees
from that, which is $38 million. I think it is only appropriate
to have that in the record, matched with civil penalties,
$5,300,000.
[The previously referred to information follows:]
Proposition 65 Benefits Private Attorneys, Not the Public
----------------------------------------------------------------------------------------------------------------
Prop. 65
settlement Percent of
dollars paid settlement
Year in private Attorneys' going to Civil
cases (incl. fees attorneys' penalties
attorneys' fees* [In
fees) percent]
----------------------------------------------------------------------------------------------------------------
2000............................................ $9,030,974 $5,675,457 63% $590,712
2001............................................ 7,584,034 4,704,800 62 559,875
2002............................................ 6,443,808 3,676,455 57 325,015
2003............................................ 8,090,248 5,290,940 65 566,300
2004............................................ 15,385,638 12,656,669 82 1,857,508
2005............................................ 9,892,989 6,145,768 62 1,414,800
---------------------------------------------------------------
6-year Total................................ $56,427,691 $38,150,089 $5,314,210
---------------------------------------------------------------
6-year Average.............................. $9,404,615 $6,358,348 65% $885,702
----------------------------------------------------------------------------------------------------------------
* In addition to attorneys' fees, ``Prop. 65 settlement dollars paid'' includes additional payments that go
directly to the plaintiffs or are steered to organizations that work in conjunction with plaintiffs.
SOURCE: Office of The California Attorney General, data available at http://ag.ca.gov/prop65/index.htm.
Senator Burr. Bill, I sort of feel like you're holding up
the whole end of the table.
Mr. Hubbard. Thank you.
Senator Burr. I should say thank you for your long service
and I think over the last decade, there has been a partnership
between Congress and the FDA to move forward and to make
advances. You and I probably still have a long way to go and
just under the mission of the FDA, the challenge is huge. I'm
not sure that we all fully understand and appreciate what this
global economy is going to produce to us and we had it first on
drugs as we talked about harmonization with the EU and when we
looked at the EU, which walked out and said, ``We'll just
accept everybody's standard.'' When we went to harmonize with
the EU and we saw that they accepted the Italian standard. We
looked at it and said there is no way that we can operate
within that system--we found that there is a great need for us
to uphold that solid foot-in-the-ground gold standard that we
had. I understand your concerns about staffing and I understand
your concerns about budgets. Were the FDA to be charged with
this and we addressed those staffing and budgetary issues, any
question in your mind as to whether the FDA could do this job?
Mr. Hubbard. Well, as I said, Mr. Chairman, I believe this
is a reasonable approach and that had the FDA had the
scientific wherewithal to make a judgment on food or drug or
anything else and could bring the best science to bear, they
would make a reasonable decision. I believe it is appropriate
for the FDA to then say to the States, don't do anything
different. You can require the same label that FDA or warning
or whatever the FDA has decided and then you get the compliment
of the States acting and I think that's your goal. I think the
problem is that in some areas of regulation, FDA had that but,
in this area, it does not and it is unlikely to get it anytime
soon and the States have been able to fill the back in many
ways and do some important things. Certainly the California
experience has been challenging, shall I say, for industry and
the FDA. But, I surely would hope that you wouldn't necessarily
take a nationwide approach to one particular problem that
perhaps has some particular eccentricities about it in
California.
Senator Burr. I think you stated it very clearly in the
beginning of your written statement when you said, and I quote,
``Most States have enacted food and drug laws identical or
quite similar to the provisions of the Food, Drug, and Cosmetic
Act.'' Later you said that the bill is unclear in what it
creates. Now, I'm sort of with you, Mr. Hutt and its not
because I'm the author. It's because I've had an opportunity to
read it and read it and read it. And when I do, I see that in
the bill, if State food laws are identical in language or
meaning to Federal food laws, the State food law remains in
effect. I don't see how it could be any clearer than that. You
acknowledged in your written testimony, you know, States are
out doing this. Then, there is patchwork, there is a lack of
consistency, some do, some don't. The real basis that this bill
came from was not to penalize States that have actually been
out there doing this but if the Federal standard was the same
in language or in meaning, the State could feel confident that
their language, in fact, stayed in effect.
Mr. Hubbard. May I comment?
Senator Burr. Sure.
Mr. Hubbard. I would never question Mr. Hutt's legal
opinions. It is rumored at the FDA that he was there to change
the diapers of the first FDA Commissioner and so I would not
question what he is telling you at all, but the fact that the
majority of attorneys general, the Food and Drug officials in
the States and so many consumer groups have also looked at this
with their legal expertise, their statutory and legislative
expertise, and disagreed. I guess I'm simply saying to you that
there needs to be some effort to understand whether they are
right or wrong and then perhaps amend your bill accordingly
because someone is right or wrong here and I will not pretend
to tell you who that someone is.
Senator Burr. I can only share with you that as the author,
it is my intent that it be applied exactly like I read it. I
have no reason to dislike lawyers but they go through extensive
training to look at a sentence and figure out if it really
means something different and then lie. I think Mr. Hutt has
had a long experience dealing with FDA, you're exactly right.
He will outlive both of us from a standpoint of his tenure.
Mr. Hutt. Could I, Mr. Chairman, give two examples of the
misinterpretation and of this legislation?
Senator Burr. Sure.
Mr. Hutt. Recently CSPI has added two more types of State
laws that they saw would be drastically changed and indeed, in
effect, repealed. The first deals with State laws that require
messages to put at bars, warning pregnant women not to consume
alcoholic beverages. In 1976, the U.S. District Court held that
FDA has no authority whatsoever with regard to the labeling and
advertising of alcoholic beverages. So FDA--that all occurs
under the Federal Alcohol Act. It does not occur under the
Federal Food, Drug and Cosmetic Act and thus, this legislation
has absolutely no impact at all. The FDA has no jurisdiction in
this area. The second set of laws that they say would be
affected deal with State and local laws that govern when food
can be sold, particularly snacks and soft drinks, can be sold
in schools. Those laws are, as Dr. Murano knows, solely the
jurisdiction of USDA and they are not in any way affected by
the Federal Food, Drug and Cosmetic Act. So all of this
misinformation is being put out there. People are becoming
States--are therefore doing what Bill Hubbard said, ``they're
expressing concern for absolutely false reasons.''
Senator Burr. Trust me when I tell you, some of us have
been the subject of media accounts that would--the basis for
being against the bill was because of what we did to Meat and
Poultry. Again, as you referenced earlier, Meat and Poultry is
not included in this and I would say this for all of you. What
we've found is that as we've been contacted by AGs, as we've
been contacted by State Ag Commissioners who expressed
concerns, we said go back and read the bill and then call us
back and tell us if you've got a problem and in many cases, not
all--but in many cases, individuals have changed their opinion
of the legislation because in fact, the consumer groups
basically put out a notice that said, ``this is a bad bill.''
Those that were being kind just said it was a bad bill. They
didn't use the host of things that were inaccurate and I think
as reasonable people have gone back and read it, they found
that to be the case. I'm going to ask you one more question,
Mr. Hubbard. You mentioned that State enforcement actions may
be pre-empted in this bill. I wanted to point out page 5, lines
15-23 of the bill, affirm that the State enforcement actions
are not impacted by the bill, including notification,
disclosure, inspection, mandatory recall, embargo, and
detention orders. This is for my own good. Tell me where I am
unclear.
Mr. Hubbard. Well, I think I was reflecting the predominant
opinion by the Attorneys General so if I'm wrong, let's go back
and look at what their concerns are.
Senator Burr. I appreciate your candor on that because I
think, at the root of this, I really do, I think many of the
concerns come from individuals who have not read the
legislation, who have been handed, in some cases, not by their
staffs, a Talking Point sheet that contains many things that
are inaccurate but it has forced me to go back through the
legislation and read it with staff to make sure that the
clarity that existed when I read it the first few times, was in
fact, there and that it was a misinterpretation. I would turn
to my colleague from Georgia to see if he has any additional
questions.
Senator Isakson. One question. Mr. Hutt's comment about the
wine closures in California and the exemption to the lead
standards probably is a pretty good example of the economic
interests of the State having an effect on the regulatory power
of the State, which begs a question to Dr. Murano because I
think in your answer to me, Doctor, you referred to exports of
agricultural products. I remember the Japanese used key MOs
basically as scare tactics to try and limit importing of
American food products. It would seem like to me the uniformity
of labeling would be of benefit to us from the standpoint of
our international exports, is that correct?
Dr. Murano. That is correct, sir and frankly, it is the TTO
that is the world body, where you are supposed to settle
disputes when there are disagreements of a nature and it is the
standards that are agreed to by countries in food safety,
through the Codex Alimentarius Commission that are used as the
evidence and actually were the reason why the European Union
could no longer not allow GMO products to be sold there from
the United States and it is because it has to be based on
science. It cannot be just an arbitrary regulation or warning
label without basis for science because then if everyone does
that, we'll have a chaotic situation and trade certainly can
come to a screeching halt.
Senator Isakson. Thank you and that's all the questions I
have, Mr. Chairman.
Senator Burr. Last thing, Mr. Stadtlander. Senator
Feinstein testified to something that I have no reason to
question the accuracy. She said that she had never heard a
complaint from her constituents about Prop 65. If you are
forced to pull Wheatena from the marketplace, do you think
there is at least one person out there that likes that product
well enough that they may complain about this?
Mr. Stadtlander. I can make sure they complain.
[Laughter]
Senator Burr. I thank you for that and I will warn her
exactly how I set her up. I would like to thank all of you for
your willingness to be here, to share your experience, your
knowledge and your concerns as it relates to your livelihood
but more importantly, the safety of food and labeling for the
American people. I think the hearing has been a great
contribution to the debate and I think one would have to say
that the top bullet that people should leave here with is, go
read the bill again. Even if you think you know everything that
is in it, go read it one more time. I am told we have no
further questions. I ask unanimous consent that all members'
statements be included in the record of the hearing and I also
ask unanimous consent that the Letters of Support for S. 3128
be included. Without objection, so ordered. Members of this
committee may submit questions in writing for any of the
witnesses and I would ask you to make yourself available, as we
would appreciate a timely response to any questions. The record
will remain open for 10 days for these questions and for
further statements from my colleagues. Again, thank you for
your time commitment to us and for instilling in us the
knowledge on this issue.
The hearing is adjourned.
[Additional material follows.]
ADDITIONAL MATERIAL
Prepared Statement of Senator Kennedy
Thank you, Mr. Chairman, for calling this hearing on the
National Uniformity for Food Act, which would prohibit States
from applying food safety laws unless they are identical to
provisions of the Federal Food, Drug, and Cosmetic Act.
This extreme bill is a giveaway to the food industry, and
all Americans will pay for it with their health. Everyone
agrees that the bill would preempt Proposition 65, the
California law that requires warning labels on products that
contain ingredients known to the State to cause cancer, birth
defects, or reproductive problems. But there is little
agreement after that.
The food industry claims that only about a dozen State laws
would be preempted, but the Center for Science in the Public
Interest, with the support of many State officials, has
identified about 200 such laws.
For example, according to the Center, the bill would
preempt statutes regulating the quality of milk and food served
in restaurants in all 50 States. It would preempt laws on
unsafe food and color additives and laws on shellfish in more
than a dozen States. It would preempt warnings required by at
least 18 States about the effect of alcohol consumption by
pregnant women on their unborn children.
In Massachusetts, the sale of dead lobster is banned,
because it decomposes so rapidly. We can now set more stringent
bacterial standards for milk than under FDA guidelines, and ban
or require warnings about food or color additives that are
considered safe under Federal law. These and potentially other
food safety laws in Massachusetts would be preempted by S.
3128.
In fact, the bill is so vaguely written that we don't know
how broad the preemption of State and local health laws would
be. There will certainly be costly litigation on the issue.
Otherwise, States will have to assume their laws are preempted
and resort to the costly process in the bill to petition the
FDA for exemptions. The Congressional Budget Office estimated
costs of $100 million to FDA and $64 million to the States for
these petitions over 5 years. But the estimate assumes that
California will file one petition for Proposition 65, instead
of one for each compound for which that law now requires a
warning. Because determinations for each compound are obviously
highly fact-specific, there will need to be individualized
petitions for each one, and the CBO estimate is obviously too
low.
State officials across the Nation argue that their laws
would be unfairly preempted and their efforts to improve the
safety of food would be crippled. The legislation obviously is
intended to benefit the food industry, regardless of its impact
on the right of States to protect the health of their citizens.
Even identical State laws would be limited under this bill.
Every State enforcement action would potentially be subject to
a Federal preemption defense, on the ground that the State is
imposing a ``materially different'' requirement than under
Federal law. The cases could even be removed to Federal court,
and this is especially true when neither the FDA nor the State
has issued a regulation setting a tolerance for a harmful
substance in food.
The bill would, however, allow a State to enforce when FDA
has issued a regulation setting a tolerance level for a harmful
substance or, if the FDA hasn't issued a regulation, when the
State has a policy on the harmful substance, either through
regulation or administrative decision.
But the bill blocks the State from enforcing a policy
rejected by the FDA. This prohibition is true even when the FDA
rejected the policy 20 years ago and there is new science
validating the policy.
The bill also implies that a State may not enforce its laws
when there is neither an FDA nor a State regulation or policy.
In such cases, the State should be permitted to allege that a
food contains a substance, that the substance is poisonous, and
that it may be injurious to health. The bill implies that local
food safety laws--such as those in New York City--may never be
enforced, even when they are identical to Federal laws.
The uncertainty surrounding enforcement and the hugely
increased cost to the States of each enforcement action would
drastically reduce the number of those actions, and could deter
the States from even bringing them at all. We can't expect an
under-funded FDA--which conducts only about 20 percent of
domestic inspections and is able to inspect, at most, 2-3
percent of imported food--to fill this gap.
Congress shouldn't even be considering such a step,
especially when we've all focused on strengthening the Nation's
ability to respond to bioterrorism. Do we really want to
prevent a State from doing more to protect its citizens from
bioterrorism than the Federal Government does? Why disarm our
State food safety officials--who will be our first responders
if terrorists put anthrax in our food supply? The certification
by the Secretary of Health and Human Services is hollow
reassurance that this won't happen--all it indicates is that
the authors of the bill know this is a real possibility.
If we ever mark this bill up, the first amendment should be
to rename it the ``Make Way for Terrorism with Foods Act.''
Cal Dooley, the President of the Food Products Association,
could not cite a single case in which manufacturers had to put
two different labels on a food, let alone 50 labels. Label
uniformity is obviously not the issue here. Yet the food
industry wants us to cripple State efforts to enforce the
safety of our food.
In fact, as we all know, the industry wants to be able to
add ingredients to food that some States feel may cause serious
health risks, or even cancer or birth defects. Which of the
Proposition 65 ingredients, for example, does the food industry
want to put in our food? I hope these hearings will help us get
to the bottom of issues like this.
I thank the Chairman and I look forward to today's
testimony.
Prepared Statement of Senator Hatch
Mr. Chairman, I regret that a prior commitment precludes my
attendance at this hearing today, because I am very interested
in this legislation.
I commend Senator Burr for his work on this important
issue.
Mr. Chairman, I am very sympathetic to the goals of this
legislation. Indeed, I appreciate that differing food safety
tolerances and warning labels among the various States can be
disruptive to interstate commerce.
That being said, I look forward to examining this
legislation and its impact in more detail as the committee
process moves forward. For example, I would like to understand
more fully how the bill defines food, if the bill is
significantly flexible to allow State and local authorities the
ability to respond to emerging public health problems
associated with foods, and if the Food and Drug Administration
will be able to meet the timeframes established for the
petition process.
Thank you for holding this hearing today and for
considering my concerns.
Prepared Statement of Senator Jeffords
Mr. Chairman, thank you for this hearing and for giving
those of us with strong reservations about S. 3128, the
National Uniformity for Food Act of 2005, a chance to ask
questions and receive testimony. To our witnesses, thank you
for appearing today before this committee.
In May, I joined 20 of my Senate colleagues in writing to
the Senate leadership asking for, at least, some committee
consideration of this legislation. As a former chairman of this
committee, I appreciate, Mr. Chairman, your willingness to hold
this hearing and proceed under regular order.
I have heard from many Vermonters who are genuinely
concerned with S. 3128 and its counterpart H.R. 4167. To these
constituents, the enactment and enforcement of strong food
safety laws are legitimate functions of State governments. As a
former Attorney General, I agree.
This hearing will also bring to light the growing gap
between the many responsibilities given to the Food and Drug
Administration (FDA) and the funding levels that fall short of
being adequate to carry out those responsibilities. If S. 3128
were to be enacted into law, it would exacerbate the FDA's lack
of funding and possibly cause more problems than it is intended
to fix.
Again, thank you, and I look forward to the testimony of
our witnesses.
Prepared Statement of Senator Nelson
Mr. Chairman, I would like to express my support for S.
3128 and national uniformity for our Nation's food products. I
am proud to be an original cosponsor of this bill seeking to
set a national standard for food safety, food safety labeling
and put food safety in the hands of the Nation's top food
scientists and food safety experts.
My commitment to a safe food supply is second to none, but
I also understand the reality that our food supply is national,
and indeed global, in scope. Effective regulation of this
national food supply and assurance of safe, wholesome and
affordable food requires uniformity in food safety regulation,
especially warnings. Because our food supply is truly national
in scope with products made in one facility distributed and
sold throughout the Nation, both consumers and food
manufacturers should be able to rely on national,
scientifically-based standards for food safety.
I think this legislation reflects a commonsense
understanding that consumers should have the same confidence
about the food they consume regardless of the State they live
in or the State in which the food is sold. Food cannot be safe
in one State and unsafe in another and food that is safe should
be freely sold in all States and food that is not safe should
not be sold anywhere.
I believe that States have an important role in making sure
that the food supply is safe and sanitary. I think the States
should actively cooperate with FDA to develop sensible,
science-based requirements and to assist in the enforcement of
these uniform, national requirements. I am convinced that S.
3128 will facilitate the development and enforcement of uniform
food safety and food warning requirements, while preserving the
ability of the States to use their enforcement authorities to
prevent the sale of unsafe foods and to remove such foods from
the marketplace. This bill will improve the safety of the food
supply, remove unnecessary burdens on the food industry and
help to ensure that our food supply is as safe, wholesome and
affordable in the future as it has been in the past.
The National Uniformity for Food Act provides the mechanism
for a national, uniform, and scientific approach to food safety
regulation. The bill also provides a mechanism for considering
State food safety requirements as national requirements. To the
extent that there are State requirements that are stricter than
Federal requirements, the bill ensures that all of those State
requirements will be considered for adoption by Federal
regulators. State authority to take action against adulterated
food is preserved and they will still be in charge of
inspections to enforce basic sanitation requirements in places
such as restaurants, retail food stores, shellfish processors
and dairy farms.
Uniformity in food regulation is not unprecedented and
already exists for all meat and poultry products regulated by
the U.S. Department of Agriculture; health claims, standards of
identity, pesticide residue tolerance, medical devices, and
drugs regulated by the U.S. Food and Drug Administration are
all regulated at the Federal level.
I would like to reiterate that when a warning about food is
supported by science and is necessary to help consumers make
informed decisions about the foods they purchase, then the
warning should be applied to food sold in all 50 States. Food
cannot be safe in one State and unsafe in another, and that is
why I am an original cosponsor of S. 3128 and I urge my
colleagues to support this bill.
Prepared Statement of Leslie G. Sarasin
The American Frozen Food Institute (AFFI) supports S. 3128,
the National Uniformity for Food Act of 2006. S. 3128 would set
uniform national food safety standards that will provide all
Americans with the same high level of confidence in and
protection with the Nation's food supply.
On March 8, 2006, the House passed the bill (H.R. 4167)
with a strong bipartisan vote of 283-139. Support from
committee members during the Senate HELP Committee hearing is
absolutely critical to this legislation becoming law this
session.
AFFI is the national trade association that promotes and
represents the interests of all segments of the frozen food
industry. The approximately 500 members of the Institute are
engaged in the processing of frozen foods, as well as other
functions in the frozen food supply chain. These functions
include ingredient supply, cold storage, transportation,
packaging, marketing and scientific research. The Institute
fosters industry development and growth, advocates on behalf of
the industry before legislative and regulatory entities, and
provides additional value-added services for its members and
for the benefit of consumers.
AFFI has consistently endorsed policy initiatives that
facilitate the needs of its members while maintaining core
consumer interests. The National Uniformity for Food Act of
2006 is not only vital to frozen food manufacturers who engage
in interstate commerce, but ensures the promotion of accurate
and consistent food safety information for consumers.
The legislation provides for science-based uniform food
safety standards and warning requirements so that Americans in
every State are protected equally. It is common-sense
legislation that will help consumers make educated decisions
for themselves and their families in an ever-changing and
confusing food labeling environment. Consumers deserve a single
standard when it comes to food safety, and this bill will allow
States and the Food and Drug Administration to work
collaboratively in establishing sound food safety policies that
benefit, rather than confuse, consumers.
The National Uniformity for Food Act is a top priority for
the frozen food industry. In advocating this policy, AFFI is
mindful of concerns that States should have the opportunity to
establish policies according to their discretion based on local
or regional issues. However, it is important to note that the
legislation contains provisions that give States the ability to
petition the Federal Government to seek variances from the
Federal standard should there be a belief that a different
requirement is necessary or appropriate. Furthermore, issues of
interstate commerce are appropriate topics for Federal
policymaking.
AFFI is enthusiastic that the National Uniformity for Food
Act is advancing and appreciates the committee's consideration
of this legislation, which clearly constitutes good public
policy. AFFI urges its enactment.
Prepared Statement of Thomas R. Frieden, M.D., M.P.H.
The legislation being considered by this Senate Committee, S. 3128,
represents dangerous public policy and would, if enacted, seriously
jeopardize public safety by compromising the ability of State and local
officials to protect their citizens from unsafe foods.
Similar legislation was passed by the House of Representatives in
March 2006 without public hearings, despite the strenuous opposition of
39 State attorneys general, the National Association of State
Departments of Agriculture, the National Conference of State
Legislatures, the Association of Food and Drug Officials, and many
other State and local elected and appointed officials representing
diverse geographic and political views. I commend the Senate HELP
Committee for holding hearings and I strongly urge that you not pass
this legislation, noting the strong objections of national, State and
local food safety experts who work on the front lines to ensure food
safety. These are the individuals and institutions responsible for
assuring the public that the food in their own neighborhoods--their
markets, restaurants, school cafeterias and corner delis--is safe and
unadulterated.
As the chief health officer of the Nation's largest city, I urge
the committee to prevent this significant nationwide diminution of food
safety protection. Not only would it compromise traditional and
fundamental State and local responsibilities regarding food safety, it
would also likely prevent cities and States from taking timely action
to protect the public in the event of a terrorist attack involving
contaminated food. This is especially important in light of the
increased risk of terrorism, especially in large urban areas such as
New York City.
S. 3128 is often described as a food-labeling bill, but it goes far
beyond legislating uniformity of food labels. It preempts State and
local laws and regulations that are not identical to Federal laws or
regulations regarding adulterated food or food that ``bears or contains
any poisonous or deleterious substance which may render it injurious to
health.'' Thus, the act prevents State and local governments from
enacting or enforcing their own laws and regulations bearing upon
contaminated, adulterated or poisoned food--even when particular
regional or local circumstances warrant, justify or require State and
local laws, regulations and enforcement, or when State or local action
is needed to cover areas and circumstances not addressed by Federal
law.
Furthermore, S. 3128 would prevent enforcement of local laws even
when they are identical to Federal law. For New York City, whose
population is greater and whose health department is correspondingly
larger than that of many States, and for other large cities with
marketplaces that serve large diverse and increasingly international
populations, this would create extremely dangerous enforcement gaps.
Any expectation that State or Federal Government, or any other entity,
would or could fill these gaps is completely unrealistic. According to
S. 3128, the States, but not local governments, could petition the
Federal Government for an exemption, or for establishment of a national
standard. These are not acceptable options when lives and health are
threatened by adulterated or contaminated food in the marketplace and
when preventing deaths or illness may depend on enforcement action
within hours--rather than the weeks or months required for a
bureaucratic petitioning process.
For more than a century, assuring food safety has been a
fundamental State and local responsibility. The highest Federal court
in New York recognized that ``States have traditionally acted to
protect consumers by regulating foods produced and/or marketed within
their borders.'' [Grocery Manufacturers of America v. Gerace, 755 F.2d
993, 1003 (1985)]. State and local agencies conduct more than 80
percent of the food safety and enforcement activities in the country's
marketplaces and food service establishments.
This proposal is an unwarranted intrusion on traditional State and
local governments' inherent police powers and responsibilities to act
to protect the public health. If enacted, it will create endless
confusion and costly litigation around what constitute ``identical
laws,'' causing delays in removing contaminated food from circulation.
It will prevent cities such as New York from acting when the Federal
Government has not addressed, or has not adequately regulated, a
dangerous food contaminant. Furthermore, it can be interpreted as
preempting State action even when the Federal Government has not
established a standard. This would be a particular problem for cities
such as New York, where each day potentially dangerous food products
from all over the world find their way into the local food supply.
The bill's language and its sponsors suggest that there exists a
comprehensive body of Federal laws and standards that should be applied
uniformly across States, such that State and local responsibilities are
unneeded or duplicative. New York City's experience informs us that the
reality is far different, and in fact often quite the opposite of what
is being suggested. Time and time again, we have sought clear Federal
standards to address adulterated food products that have been directly
linked to illnesses, but have found either no standards, or
unenforceable guidelines. A recent example is the discovery of lead in
certain imported candy in New York City. The lack of adequate or
enforceable Federal standards led to enactment of a local law banning
the sale of lead-containing candy in New York City. This law could be
preempted and unenforceable if S. 3128 were enacted.
The bill is dangerously ambiguous. Although the bill's proponents
have stated that under the proposed law, States would be free to
regulate ``in the void''--that is, to regulate when the Federal
Government has no existing standards--they have also stated the
following:
``Where States have existing requirements without a Federal
counterpart and those State requirements `protect an important
public interest that would otherwise be unprotected,' the
State's petition will be found by FDA to be well taken. Where
States have requirements without Federal counterpart and those
State requirements cannot be justified as contributing to the
safety of the food supply, the State requirements will
ultimately not be sustained.''
These statements seem completely inconsistent with authorizing
States to regulate in the void. Further, it appears that what would be
contemplated is for the State to submit a petition in order for the
necessary determinations to be made.
The longstanding authority of States and localities to regulate the
safety of the food provided to their own citizens, particularly in
areas such as food preparation in food service establishments, must be
preserved. For example, this law would preempt various State statutes
such as those that require food establishments that sell alcoholic
beverages to post a sign warning pregnant women about the risk of birth
defects. This is just one example of the very type of activities that
must continue to remain within the purview of State and local
government regulation.
In the event of a terrorist attack involving deliberate poisoning
or contamination of food, the proposed law could cause serious delays
while public health officials consult, deliberate and debate to
determine whether a relevant ``identical'' State and Federal law and
standard exists. If no relevant Federal standard were found to exist,
would a State be expected to petition the Federal Government for a
determination of imminent hazard authority before action could be
taken? This petitioning process is not only cumbersome and time-
consuming, but, as discussed previously, only a State, and not a
locality, is an eligible petitioner. These are not acceptable
scenarios, particularly in view of the heightened threat of terrorism
in New York City.
Enactment of S. 3128 would have serious consequences for the
enforcement of New York City's Health Code, which has historically
regulated food safety in more than 20,000 local restaurants and food
service establishments and which provides the authority to seize and
embargo any unsafe food. With Federal support and encouragement, the
city has developed a state-of-the-art disease surveillance system
capable of detecting food-borne and other illnesses early on. Yet S.
3128 could prevent the city from using its authority under its Health
Code to act on critical information gathered from this system, because
it would eliminate local authority to remove adulterated food from
stores or restaurants. Accompanying this testimony is an attachment
entitled New York City's position on S. 3128, The National Uniformity
for Food Act of 2005, which contains additional examples of important
enforcement actions the New York City Department of Health and Mental
Hygiene has taken over past decades that would have been preempted, had
S. 3128 been in effect.
The effect of S. 3128 would be to prevent States and localities
from legislating on health-related matters affecting their citizens, a
result that more than 100 years ago the U.S. Supreme Court recognized
was not intended in the conferring upon Congress the regulation of
commerce. [See Sherlock v. Alling, 93 U.S., 99, 103 (1876).]
I believe that if members of this committee consider carefully the
opinions of the many national, State and local organizations who
collectively represent substantial expertise in food and safety and the
law and who have raised fundamental concerns about the serious
consequences of this legislation, you will reach the conclusion that
this bill should not be enacted into law.
I appreciate the opportunity to provide these comments and thank
the committee members for your attention to these concerns. I would be
happy to discuss my comments in person or provide any additional
information you might request.
______
Attachment
New York City's Department of Health and Mental Hygiene (NYC DOHMH)
is responsible for supervising and regulating the food supply in New
York City. [New York City Charter 556(x)(9)] Food service
establishments in New York City are licensed and regulated by the
Department in accordance with Article 81 of the New York City Health
Code. The Department is also authorized by existing local law to seize,
embargo or condemn food that is adulterated or otherwise constitutes a
danger to public health. [New York City Health Code 3.03(a) and
71.22] These authorities are essential public health tools that the
city has used for many decades to protect its citizens. City health
officers must be able to continue this critical public health activity,
especially in light of New York City's disproportionate risk for future
acts of terrorism, including the threat of deliberate contamination of
food. Following are examples of actions the city has taken and that
could be preempted by S. 3128 or be subject to legal challenges,
creating dangerous delays and costly litigation. The law in such
critical areas of public health should not be left unsettled and
unclear. The authority to act needs to be unequivocal.
NYC DOHMH issued a warning to city residents to avoid
eating certain candies and food products made in Mexico that had been
found to contain lead. Based on its authority under the Health Code and
in cooperation with New York State authorities, NYC DOHMH inspected and
tested these products. These actions, along with actions by other
States and localities, resulted in a voluntary recall by a candy
manufacturer. However, under this bill, if the manufacturer had not
voluntarily taken this action, the city would have been preempted from
taking enforcement action to remove candy from the market because there
were no enforceable FDA safety standards regarding lead in candy.
Because any increase in lead exposure to New York City's
children is a serious public health concern, the New York City Council
subsequently adopted a law banning sale of candy products containing
lead. This action was prompted by concerns about the inadequacy of
Federal regulatory efforts to set allowable safety limits for lead in
food products and stop contaminated products from entering the country.
NYC DOHMH linked certain imported cheeses to infection by
Mycobacterium bovis, a form of tuberculosis found in cattle; 35 cases,
including the death of an infant, were attributed to M bovis
tuberculosis. The city monitored certain markets to assure that no
contaminated cheese was sold, and would have relied upon its local
Health Code authority to seize or embargo such products had they been
discovered
NYC DOHMH used its powers under the city's Health Code to
embargo certain herbal products after several cases of adult lead
poisoning were confirmed among residents who used these products.
Although there were National Academy of Science recommendations about
tolerance levels, there were--and continue to be--no specific Federal
standards. In previous years, NYC DOHMH had also ordered the cessation
of sale of an herbal tea that contained high concentrations of lead and
arsenic. While an amendment in the House-passed version of S. 3128
exempts regulation of dietary supplements, it is unclear whether food
products containing dietary supplements would be similarly exempted.
Following a sewage back-up in a manufacturing
establishment in which specialty desserts and candies were made, NYC
DOHMH used its powers under the city's Health Code to order the owner
to cease production and thoroughly clean the processing area. NYC DOHMH
embargoed and ultimately destroyed the contaminated products.
NYC DOHMH, under the authority in the City Charter and the
Health Code, ordered the surrender of shellfish that had been
identified as the source of several cases of cholera.
Recent New York City Health and Nutrition Examination
Survey (HANES) data revealed that mercury levels are elevated in the
Asian population. NYC DOHMH is currently examining reasons behind these
elevated levels. The investigation may reveal certain food staple
products or traditional remedies commonly used by Asians to be the
source. However, if the act becomes law, NYC DOHMH will be unable to
remove these products from the market.
Prepared Statement of Benjamin Cohen
``In all that we do, our purpose will be to strengthen the family by .
. . promoting decisionmaking at the level closest to the people--our
communities, counties, schools districts and, most importantly, our
homes.'' (emphasis added) (Mission Statement of Senator Michael B. Enzi
for Senate Committee on Health, Education, Labor, and Pensions (on wall
of Room 835 Hart Senate Office Building))
On behalf of its 800,000 members in the United States, the Center
for Science in the Public Interest \1\ is pleased to submit this
testimony in strong opposition to the National Uniformity for Food Act,
S. 3128, which was introduced by Senator Richard Burr on May 25, 2006.
The fallout from this thermonuclear attack on California's
Proposition 65 could be the destruction of hundreds of other State and
local food safety and labeling laws in every State (including six from
North Carolina) (see attached table).\2\ This destruction would occur
even though Cal Dooley, President of the Food Products Association,
admitted in March 2006 (according to a USA Today editorial opposing the
bill) that he could not ``cite a single instance in which manufacturers
have to put two different labels on a [food] product, let alone 50.''
\3\ (emphasis in original)
INTRODUCTION
S. 3128 does not mention Proposition 65. Instead, it preempts any
State or local food safety or labeling law--with the exception of
returnable bottle labeling and 10 other specific categories \4\--that
is not ``identical'' to a requirement of the Food and Drug
Administration (``FDA''). S. 3128 (but not its companion bill, H.R.
4167) would allow any State ``policy such as a State regulation or an
administrative decision, that is based on a State law that contains a
requirement that is identical to'' the adulteration requirement in
section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act \5\
(``FFDCA'') if the FDA has not issued ``a regulation or adopted final
guidance'' on this matter. S. 3128 does not, however, identify which
State laws, if any, are protected by this vague provision.\6\ Moreover,
it certainly does not shield local government laws and may only protect
State regulations--rather than State statutes.
A State can ask the FDA to waive this preemption by filing a
petition. For State or local laws passed after the legislation is
enacted, the State or local law--with the exception of one dealing with
an ``imminent hazard''--cannot take effect until the FDA grants the
waiver; for State or local laws in effect on the day the legislation is
enacted, the law remains in effect until the FDA denies the request for
a waiver (which must be submitted within 180 days after enactment). The
FDA may grant the waiver if the FDA determines that the State or local
law ``protects an important public interest that would otherwise be
unprotected'' and ``would not unduly burden interstate commerce.'' \7\
In its February 2006 analysis of the companion House bill, H.R.
4167, the Congressional Budget Office (``CBO'') estimated that roughly
200 petitions for existing laws and an additional 40 petitions for
future laws could be filed with the FDA and that--at a cost of about
$400,000 per petition--it would cost the FDA about $100 million (over 5
years) to process these petitions.\8\ This new burden on the FDA comes
at a time when the number of FDA employees devoted to food issues has
fallen steadily by 10 percent over the last 4 years (from 3,167 in
fiscal year 2003 to 2,843 in fiscal year 2006).\9\
There has been a rising tide of bipartisan opposition to this
legislation. Attorneys General of 37 States, Governors of 8 States
(California, Delaware, Illinois, Iowa, Michigan, New Jersey, New
Mexico, and Oklahoma), food safety officials in 7 States (Colorado,
Florida, Georgia, Michigan, New York, Washington, and Wisconsin), and
food safety officials in New York City and Baltimore have told Congress
they oppose H.R. 4167.\10\ The Association of Food and Drug Officials,
the National Association of State Departments of Agriculture, numerous
consumers groups and environmental organizations, the Humane Society of
the United States, and labor unions also oppose the legislation.\11\ As
the Attorneys General put it, ``under this bill, States would be
forbidden from adopting their own policies, even if the Federal
Government had not acted in a particular area or adopted a particular
warning . . . this bill would strip State governments of the ability to
protect their residents through State laws and regulations relating to
the safety of food and food packaging.'' \12\
I. The Ambiguity of the National Uniformity for Food Act Would Lead to
Much Litigation About Its Scopes As Even the Food Industry is
Uncertain As to Which State Laws It Threatens
The CBO said ``the scope of the State and local regulations that
would be affected by the legislation is ambiguous.'' \13\
On April 24, 2006 Cal Dooley, the President and CEO of the Food
Products Association, and C. Manly Molpus, the President and CEO of the
Grocery Manufacturers of America, held a press conference; they were
joined by Stuart M. Pape, an attorney with the Washington law firm of
Patton Boggs, and John W. Bode, an attorney with the Washington law
firm of Olsson, Frank and Weeda. In their summary statement they claim
that H.R. 4167 affects only 11 State laws,\14\ but in their
accompanying (unsigned) detailed table they concede that at least 26
laws are preempted.\15\ Five of these are food labeling laws:
California's Proposition 65, laws in Connecticut and Michigan requiring
warning of a possible allergic reaction to bulk foods containing
sulfites, a Maine law requiring a warning on the risks of eating smoked
alewives, and a Nevada law requiring a warning in restaurants and other
food establishments that sell alcoholic beverages of the risks, to
pregnant women of drinking alcoholic beverages. The others are food
safety laws: food additive laws in 16 States; milk safety laws in
Massachusetts, Michigan, and Nebraska; and laws in Michigan and
Virginia banning the use of sulfites in restaurants and other food
service establishments.
We, however, have identified at least 220 State and local laws that
are threatened by S. 3128 (see attached table). We have also identified
at least 240 State and local laws that are threatened by H.R. 4167 (see
attached table). Our estimates are conservative, as--with a few
exceptions--they ignore both State regulations (as distinct from State
statutes) and food safety and labeling requirements of the more than
87,000 local governments.
This uncertainty about the scope of the legislation will, of
course, lead to litigation in both State and Federal courts.
II. The Food Industry Concedes That California Would Have to File About
300 Petitions With the FDA to Preserve the Requirements of
Proposition 65 if Congress Were to Pass the National Uniformity
for Food Act, Thereby Forcing the FDA to Spend About $120
million Just on These Petitions
The food industry concedes that California's Proposition 65 would
be preempted by this legislation.\16\ Proposition 65--passed by
referendum in 1986--requires a warning when a product contains a
chemical that may cause cancer or birth defects if the amount of the
chemical is above a certain threshold. California has established
``safe harbor'' ceilings for about 270 carcinogens and about 25
chemicals causing reproductive toxicity.\17\ Some--such as lead--have
long been known to be present in some foods. Others--such as acrylamide
and benzene--have only recently been discovered to be in foods.
The food industry admitted at its April press conference that in
order to preserve these ``safe harbors'' California would have to file
a separate petition for each chemical that may be in a food--as the
science for each chemical and the impact of the required warning on
interstate commerce would differ for each chemical. Thus, California
would likely have to file about 300 waiver petitions in order to
preserve its ability to enforce these Proposition 65 safe harbors.
Using CBO's estimate of $400,000 per petition, the FDA would have to
spend $120 million to handle these Proposition 65 petitions.
III. The Food Industry Concedes that at Least 17 States Would Have to
File Petitions With the FDA to Preserve Their Law That Allows
the State to Establish a Ceiling for a Food Additive That is
More Protective of Public Health Than One Established by the
FDA
At least 17 States--Alabama, California, Colorado, Florida, Hawaii,
Illinois, Indiana, Kansas, Maryland, Massachusetts,\18\ Montana, New
Hampshire, North Dakota, Oregon, South Carolina, Texas, and Utah--have
a law that authorizes the State to adopt standards for unsafe food and
color additives that are more protective of human health than those the
FDA has set.
The food industry concedes that these laws would be preempted by
this legislation, but asserts this preemption would be of no
``practical effect'' because the State has never used this
authority.\19\ Even if this assertion were true, there may come a time
when the State may want to use its authority because the FDA has not
acted, and so each State would have to ask the FDA for a waiver in
order to preserve the option of using these laws in the future.
IV. The Food Industry Has Not Refuted the Argument of State Food Safety
Officials That at Least 100 State Laws Governing the Safety of
Milk, Restaurant Food, and Shellfish or Fish Are Threatened by
S. 3128
S. 3128 (at page 2, lines 7-21) amends the FFDCA to preempt any
State or local requirement that is not ``identical'' to 10 sections of
the FFDCA. Of particular relevance here, the State or local law must be
identical to subsection 402(a)(1) and section 406 of the FFDCA.
Subsection 402(a)(1) provides, in pertinent part, that a food is
adulterated if it ``contains any poisonous or deleterious substance
which may render it injurious to health,'' and in order ``to protect
the public health'' section 406 directs the FDA to set a ceiling for
the amount of any poisonous or deleterious substance that can be added
to a food if such substance is required to produce the food.
The Wisconsin Secretary of Agriculture, Trade and Consumer
Protection told Congress that his lawyers had examined H.R. 4167 and
concluded that it ``would severely hinder Wisconsin's ability to
protect citizens from contaminated foods.'' \20\ He went on to point
out that ``there are no Federal laws governing the inspection and
regulation of grade A milk production for interstate commerce,
shellfish harvester and processors, or regulation of retail food
establishments like grocery stores and restaurants.'' (emphasis in
original) \21\ The Florida Commissioner of Agriculture and Consumer
Services told Congress, after having H.R. 4167 examined by his lawyers,
that H.R. 4167 would ``place at risk our . . . programs for milk, dairy
and shellfish.'' \22\ New York's Commissioner of Agriculture and
Markets told Congress that ``food inspection enforcement laws relating
to grade A milk, grocery stores and shellfish would be preempted'' by
H.R. 4167.\23\
In order to fill the gaps in the FDA's regulations,\24\ every State
has a law to ensure the safety of milk and a law to ensure the safety
of food served in restaurants, cafeterias, nursing homes, and other
food service establishments. At least 16 States have a law to ensure
the safety of shellfish, and Arizona has a law to ensure the safety of
farm-raised fish. About 88 percent (100 of these 116 laws) are clearly
threatened by S. 3128 (see attached table).\25\
The food industry claims that these laws--with the exception of
milk safety laws in Massachusetts, Michigan, and Nebraska--are not
affected by this legislation because they deal with food ``sanitation''
rather than with food adulteration.\26\
The Association of Food and Drug Officials rejects this argument.
It told Congress ``Proponents of this bill emphasize that H.R. 4167
does not impact State sanitation laws, and thus, will not impact State
programs. Nothing could be further from the truth. States perform
sanitation inspections in an effort to assist food businesses in
preventing contamination or adulteration of products, but one of the
States' critical complementary functions is to take action when these
preventive measures fail . . . If enacted, H.R. 4167 would
significantly impede resolution of the unsafe conditions and removal of
contaminated foods from the human food supply. Sanitation and
adulteration are not identical, but rather complementary. . . . While
proponents [of H.R. 4167] argue that programs such as the cooperative
milk and shellfish programs are not at risk our attorney, along with 11
other State attorneys, read the bill quite differently.'' \27\
(emphases added)
V. S. 3128 Threatens at Least Ten Other Food Safety Laws (Including
Bans on Lead in Candy) of at Least Nine States and New York
City That Fill Gaps in the FDA's Regulations
There are at least 10 State and local government food safety laws
(in addition to the milk, restaurant, and shellfish laws discussed
above) that fill gaps in the FDA's current requirements and are not
part of a State's general food safety law. California has a law
limiting the amount of lead in candy and a law dealing with the
adulteration of wine. Illinois has a law limiting the amount of lead in
food. Maine, Mississippi, and Utah have laws governing the safety of
honeybees.\28\ New York has a law prohibiting the combined amount of
lead, cadmium, mercury, and hexavalent chromium in any package from
exceeding 100 parts per million. New York City has a law banning lead
in candy. Texas has a regulation setting a minimum chlorine residual
level in water that is being hauled. Virginia has a law banning
sulfites in foods served in restaurants and other food service
establishments.
Consider, for example, lead in candy. In 1995 the FDA told the
candy industry--via an unenforceable guidance document \29\ rather than
through a regulation--that the FDA would consider enforcement action
against candy with lead levels exceeding 0.5 parts per million
(``ppm''). In May 2005 the New York City Council determined that ``lead
poisoning is linked to many adverse health effects among children . . .
[and] that certain candy products have been discovered to contain
dangerously high levels of lead.'' \30\ So New York City banned the
sale of candy products containing lead. In October 2005 Governor
Schwarzenegger signed a California law limiting the amount of lead in
candy to the amount that cannot be avoided by good agricultural,
manufacturing, and procurement practices. Perhaps in reaction to these
two bans, in December 2005 the FDA urged the candy industry to reduce
the maximum amount of lead from 0.5 ppm to 0.1 ppm; the FDA explained
that this new guidance ``describes the Agency's current thinking on a
topic and should be viewed only as recommendations.'' \31\ In June 2006
Illinois's Governor signed a law banning the sale of food (and other
items) containing lead in excess of 0.06 percent of the weight of the
food. The National Uniformity for Food Act threatens these laws of New
York City, California, and Illinois and, if enacted, would leave
children and other consumers of candy protected only by the FDA's
``recommendation'' to the candy industry.
VI. The Food Industry Concedes that the Legislation Threatens the Laws
of at Least 17 States Requiring That Establishments Selling
Alcoholic Beverages Post A Sign Warning Pregnant Women About
the Risks of Birth Defects from Drinking Such Beverages
The FDA shares jurisdiction over alcoholic beverages with the
Alcohol and Tobacco Tax and Trade Bureau of the Department of the
Treasury.\32\
The food industry concedes that the legislation would preempt
Nevada's law requiring that establishments selling alcoholic beverages
post a sign warning pregnant women of the risks of drinking such
beverages.\33\ At least 16 other States--Alaska, Arizona, Delaware,
Georgia, Kentucky, Minnesota, Missouri, Nebraska, New Hampshire, New
Jersey, New Mexico, New York, South Dakota, Tennessee, Washington, and
West Virginia--have similar laws. (These State laws complement the
Congressional requirement that bottles of alcoholic beverages carry
such a warning.)
VII. The National Uniformity for Food Act Threatens at Least 32 Other
Food Labeling Laws in at Least 26 States and a County
The legislation provides that a State or local government may not
require any ``notification'' for ``a food that provides for a warning
concerning the safety of the food'' unless it is ``identical'' to a
notification requirement of the FDA.\34\ The legislation goes on to say
that ``the term `warning' . . . means any statement, vignette, or other
representation that indicates, directly or by implication, the food
presents or may present a hazard to health or safety.'' (emphasis
added).\35\
There are at least 31 State food labeling laws in 26 States \36\
that the food industry claims are not affected by the legislation.\37\
However, it is clear that these laws are ``warnings'' within the broad
meaning of H.R. 4167 and S. 3128 because ``directly or by
implication,'' as the bills state, they may be about health or safety--
and so they are threatened by S. 3128 and H.R. 4167. For example,
Alaska requires the labeling of genetically modified fish
or fish products. Many consumers believe that such fish would be less
safe than fish that has not been genetically modified.
At least four States require disclosure on whether fish
are farm raised: Alaska (salmon), Arkansas (catfish), Louisiana
(catfish), and Mississippi (catfish). Certain farm-raised fish may
contain elevated levels of PCBs or other contaminants.
At least three States--New Hampshire, New York, and
Vermont--have statutes that require that a food labeled as ``maple
syrup'' consist only of maple syrup. By contrast, the FDA permits a
product labeled as ``maple syrup'' also to contain salt, chemical
preservatives, and defoaming agents.\38\ Consumers may believe that
such an additive-containing product is less healthy than pure maple
syrup.
At least 10 States--Connecticut, Georgia, Iowa, Minnesota,
Montana, Nevada, New York, Ohio, Pennsylvania, and Washington--have
laws requiring that a food labeled as ``honey'' be only honey. Such
honey labels may be challenged as preempted by the legislation under
the guise that these restrictions are an implied warning to consumers
who believe that natural food is healthier than foods that contain
artificial sweeteners and flavorings, or highly refined sugar.
Los Angeles County requires restaurants to display letter
grade reports on what the county's inspectors found about the safety of
the food in the restaurant.
VIII. The Legislation Threatens Laws Passed by at Least Nine States
That Restrict the Sale of Sodas and Certain Foods and Beverages
in Schools in Order to Promote the Health of Children
In September 2005 Governor Schwarzenegger signed two bills
restricting what foods can be sold in California's schools. SB 12
requires local school districts to prohibit, beginning July 2007, the
sale of certain foods and beverages. SB 965 requires local school
districts to prohibit the sale of certain beverages during various
times, depending on whether it is an elementary school or a middle or
junior high school. The California legislature determined in section 1
of SB 12 that the ingredients in certain foods, including added sugar
in soft drinks, contribute to the ``growing epidemic of overweight
children,'' which is ``putting growing numbers of California children
at risk for type 2 diabetes, hypertension, heart disease, and cancer.''
Laws in at least eight other States--Arizona, Arkansas,
Connecticut, Indiana, Kentucky, Louisiana; North Carolina,\39\ and West
Virginia--also restrict the sale of sodas and other foods and beverages
in public schools.\40\
The FDA has broad power to restrict the sale of any food that, in
the words of section 402(a)(1) of the FFDCA, contains a ``deleterious
substance which may render it injurious to health.'' Section 406 of the
FFDCA authorizes the FDA to issue regulations to limit the amount of a
deleterious substance as the FDA ``finds necessary for the protection
of public health.'' Section 409(a) of the FFDCA directs the FDA to
establish conditions under which a food additive may be safely used. As
discussed above, S. 3128 amends the FFDCA and provides, in pertinent
part, that ``any requirement [of any State or political subdivision of
a State] for a food described in section 402(a)(1), . . . 406, [and]
409'' is preempted unless the State or local government's requirement
is identical to a requirement of the FDA.\41\
As the FDA has not used its broad legal powers to issue any
regulations restricting the sale of foods, including soft drinks
containing added sugar or artificial sweeteners, to children, the laws
of these nine States restricting sales in schools could be preempted by
S. 3128 and H.R. 4167.\42\
conclusion: congress should not tamper with the federal-state food
safety partnership that the food industry admits is not now broken
More than 70 years ago Supreme Court Justice Louis D. Brandeis said
``It is one of the happy incidents of the Federal system that a single
courageous State may, if its citizens choose, serve as a laboratory;
and try novel social and economic experiments without risk to the rest
of the country.'' \43\ For decades the food safety partnership among
the FDA, the States, and local governments has worked well. As
discussed above, Cal Dooley, President of the Food Products
Association, admitted to USA Today in March 2006 that he could not
``cite a single instance in which manufacturers have to put two
different labels on a [food] product, let alone 50.'' \44\ (emphasis in
original) Congress should not tamper with this partnership merely
because the food industry thinks there may be an unspecified problem in
the future.
Attachment: Examples of State and local food safety and labeling laws
and regulations threatened by either H.R. 4167 (as passed by the House
of Representatives on March 8, 2006) or S. 3128, the National
Uniformity for Food Act.
Notes
1. The Center for Science in the Public Interest, a nonprofit
organization based in Washington, DC., is supported by about 900,000
members in the United States and Canada who subscribe to its Nutrition
Action Healthletter. CSPI has been working to improve the Nation's
health through better nutrition and safer food since 1971.
2. This July 2006 table reflects criticisms by the food industry of
a March 2006 table. My CSPI colleagues Hilary Kennedy and Samantha
Williams were of great help in the preparation of these tables.
3. USA Today (March 27, 2006) at 12A.
4. The other exempt categories are ``freshness dating, open date
labeling, grade labeling, a State inspection stamp, religious dietary
labeling, organic or natural designation, . . . unit pricing, a
statement of geographic origin, dietary supplements, or a consumer
advisory relating to food sanitation that is imposed on a food
establishment, or that is recommended by the Secretary, under part 3-6
of the [Model] Food Code issued by the Food and Drug Administration,''
the Centers for Disease Control, and the U.S. Department of
Agriculture. H.R. 4167, page 14, lines 9-25 and S. 3128, page 14, lines
12-23. The Model Food Code is published periodically and deals with
more than consumer advisories; it can be used by State and local
governments in establishing their own regulations to ensure the safety
of food served in restaurants, schools, hospitals, nursing homes, and
other food service establishments.
5. This exception also applies to nine other enumerated parts of
the FFDCA that deal with any poisonous or added deleterious substance
added to food (subsection 402(a)(2)), a food container that contains a
poisonous or deleterious substance (subsection 402(a)(6)), irradiated
food (subsection 402(a)(7)), the safety of color additives in foods
(subsection 402(a)(c)), emergency permits (section 404), tolerances for
poisonous ingredients in foods (section 406), the safety of food
additives (section 409), the safety of new animal drugs (section 512),
and the safety of color additives in foods, drugs, devices, or
cosmetics (subsection 721(a)). See S. 3128 at page 3, lines 5-12.
6. For example, in North Carolina it might refer to regulations
adopted pursuant to the North Carolina Food, Drug, and Cosmetic Act
(``NCFDCA''). North Carolina General Statutes, Chapter 106, Article 12,
sections 106-120-106-145. However, other important North Carolina food
safety laws--such as those dealing with the safety of milk, food eaten
in restaurants and other food service establishments, and shellfish,
are not part of the NCFDCA and so are threatened by S. 3128.
7. H.R. 4176 at page 10, lines 1-13 and S. 3128 at page 10, lines
1-10. The courts will, of course, strike down any State or local food
safety or labeling law that unduly burdens interstate commerce. For
example, more than 60 years ago the U.S. Supreme Court held that a
Madison, Wisconsin ordinance requiring that all pasteurized milk be
bottled at an approved pasteurization plant located within a five mile
radius of the center of Madison violated the Commerce Clause of the
U.S. constitution. Dean Milk Co. v. City of Madison, 340 U.S. 349
(1951). See also Granholm v. Heald, 544 U.S. 460 (2005) (Michigan and
New York laws banning out-of-state wineries from selling directly to
consumers violate the Commerce Clause).
8. H.R. Rept. 109-379, 109th Cong. 2d Sess. (February 28, 2006) at
11.
9. FDA, Office of Management and Budget Formulation and
Presentation, ``Foods'' www.fda.gov/oc/oms/ofin/budget/2007/pdf/
3consolidatednarrative.pdf (visited May 1, 2006).
10. March 1, 2006 letter of National Association of Attorneys
General; April 18, 2006 letter of Governor Arnold Schwarzenegger; March
2, 2006 letter of Governor Rod R. Blagojevich; March 7, 2006 letter of
Governor Ruth Ann Minner, Governor Tom Vilsack, Governor Jennifer M.
Granhohn, Governor Jon S. Corzine, Governor Bill Richardson, and
Governor Brad Henry; January 30, 2006 letter of Colorado Commissioner
of Agriculture; February 14, 2006 letter of Florida Commissioner of
Agriculture and Consumer Services; March 24, 2006 letter of Georgia
Commissioner of Agriculture; February 17, 2006 letter of Michigan
Director of Agriculture;
March 1, 2006 letter of New York Commissioner of Agriculture and
Markets; February 27, 2006 letter of Washington Assistant Director of
Agriculture; December 12, 2005 letter of Wisconsin Secretary of
Agriculture, Trade and Consumer Protection; April 21, 2006 letter of
Baltimore Commissioner of Health; July 10, 2006 letter of New York City
Commissioner of Health and Mental Hygiene. Many of these letters are
available at http://www.house.gov/waxman/issues/health/food_safety_hr
4167.htm and http://www.house.gov/waxman/issues/health/food_safety_hr_
4167_letters_oppostion.htm.
11. See, e.g., January 16, 2006 letter of Association of Food and
Drug Officials; June 1, 2006 letter of National Association of State
Departments of Agriculture. These and other letters opposing H.R. 4167
are available at http://www.house.gov/waxman/issues/health/
food_safety_hr_4167.htm and http://www.house.gov/waxman/issues/health/
food_safety_hr_4167_letters
_opposition.htm.
12. March 1, 2006 letter of National Association of Attorneys
General at 1.
13. H.R. Rept. 109-379, 109th Cong. 2d Sess. (February 28, 2006) at
11.
14. National Uniformity for Food Coalition press release (April 24,
2006) www.uniformityforfood.com/coalitionrelease042406pressconf.pdf.
15. Analysis of State Laws Cited in CSPI Report Shredding the Food
Safety Net (hereafter cited as Pape-Bode paper).
www.uniformityforfood.org/statelawanalysis
summarydetails.pdf. The Pape-Bode paper deletes the first six pages of
our March 2006 report, thereby making it appear that we were presenting
the maximum number of laws--rather than examples of laws--that are
threatened by H.R. 4167. The full text of our report--Shredding the
Food Safety Net, A Partial Review of 200 State Food Safety and Labeling
Laws Congress is Poised to Effectively Kill with H.R. 4167 (Center for
Science in the Public Interest and Natural Resources Defense Council
March 2006)--is available at www.cspinet.org/new/pdf/shredding.pdf.
16. Pape-Bode paper at 4.
17. www.oehha.ca.gov/prop65/pdf/Augt2005statusreport.pdf (visited
May 1, 2006). California has identified about 770 chemicals that cause
cancer or reproductive toxicity. www.oehha.ca.gov/prop65/prop65_list/
files/060906p65single.pdf (visited July 19, 2006).
18. In 1988 the Massachusetts Supreme Court rejected a challenge by
the food industry to the Massachusetts statute whereby the
Massachusetts Department of Public Health had set a ceiling for
daminozide residue in processed apple products that was lower than what
the FDA had established. Processed Apples Institute, Inc. v. Department
of Public Health, 402 Mass. 392 (1988).
19. See, e.g., Pape-Bode paper at 4.
20. December 12, 2005 letter of the Wisconsin Secretary of
Agriculture, Trade and Consumer Protection at 1.
21. Id. at 2.
22. February 14, 2006 letter from Florida Commissioner of
Agriculture and Consumer Services at 2.
23. March 1, 2006 letter of New York Commissioner of Agriculture
and Markets at 2.
24. The FDA prohibits the interstate shipment of both contaminated
shellfish and unpasteurized milk. 21 CFR 1240.60 and 1240.61. However,
its regulations do not deal with ensuring the safety of milk or
shellfish within a State. The FDA has no regulations governing the
safety of food in restaurants and other food service establishments.
25. Sixteen milk safety, restaurant safety, and shellfish safety
laws in Alaska, Kentucky, Massachusetts, Michigan, Missouri, Nebraska,
Ohio, Wisconsin, and Wyoming may not be threatened by S. 3128 because
in these States these laws are part of the State law that resembles the
FFDCA.
26. See, e.g., Pape-Bode paper at 1.
27. January 16, 2006 letter from Association of Food and Drug
Officials at 1, 2.
28. At a press conference on March 7, 2006 the Attorney General of
Utah said he opposed the legislation, in part because, in his opinion,
it threatened Utah's honeybee safety law.
29. James T.O. Reilly, Food and Drug Administration, 2nd ed. (2005)
volume 1 at 4-71-4-72 (``Guidelines have the legal status of advisory
opinions, which are merely an indication of policy directions . . .
guidelines are legally unenforceable--rather a list of desires than of
mandates . . .'') (footnotes omitted). See 21 CFR 10.90(c).
30. New York City Law No. 49 (May 19, 2005).
31. www.fda.gov/bbs/topics/NEWS/2005/NEW01284.html. (visited March
1, 2006).
32. See, www.fda.gov/ora/compliance_ref/cpg/cpgfod/cpg510-450.html.
(visited July 6, 2006)
33. Pape-Bode paper at 21.
34. H.R. 4167 at page 4, lines 11-22 and S. 3128 at page 4, lines
8-19.
35. H.R. 4167 at page 5, lines 9-13 and S. 3128 at page 5, lines 5-
9.
36. Alaska requires both the labeling of farm-raised salmon
products and the labeling of genetically modified fish or fish
products. Arkansas requires a label that catfish be labeled as ``farm-
raised,'' ``river or lake,'' ``imported,'' or ``ocean.'' California
requires labels to disclose both if the food contains more than \1/2\
percent alcohol and if a food is perishable when not refrigerated.
Connecticut, Georgia, Iowa, Minnesota, Montana, Nevada, New York, Ohio,
Pennsylvania, and Washington each have a law governing when ``honey''
can be on the label of a food. Delaware requires that carbonated
beverages containing artificial sweeteners be labeled as dietetic. Iowa
also has a law governing when a food can have on the label the word
``sorghum.'' Louisiana has a law requiring that any catfish product be
labeled as farm-raised or naturally produced. Maine has laws requiring
disclosure of whether fresh produce has had a post-harvest treatment
and whether apples have been exposed to controlled atmosphere. Maryland
has a law requiring disclosure of whether a ``fresh'' food has been
previously frozen. Massachusetts has a law governing the labeling of
halibut. Minnesota also has a law governing the labeling of various
types of wild rice. Mississippi requires any catfish product to be
labeled as ``farm-raised,'' ``river or lake,'' or ``ocean.'' New
Hampshire, New York, and Vermont have laws requiring that maple syrup
be made solely from the sap of the maple tree. New York also requires a
label to disclose whether a frozen food has previously been offered for
sale in unfrozen form. North Carolina has a law governing the labeling
of milk used in summer camps. Oregon has a law requiring that food that
has been ``salvaged'' have a label stating that fact. Rhode Island has
a law requiring disclosure of whether uncooked fish or shellfish have
ever been frozen and a law governing the labeling of closed packages of
apples. South Dakota requires a food label to disclose whether the food
contains chloroform and various narcotics. Wisconsin has a labeling law
governing the age of cheese made in Wisconsin.
37. See, e.g., Pape-Bode paper at 2. Depending on the particular
State labeling law, the food industry gives one of three reasons why it
is not affected by H.R. 4167: (1) the label is not a ``warning'' as
defined in the bill, (2) the label deals with what the industry calls
``economic adulteration'' (a term that does not appear either in the
National Uniformity for Food Act or the FFDCA), or (3) there is no
comparable FDA requirement (even though for other State labeling
requirements--such as Proposition 65--the industry says the law is
preempted although there is no comparable FDA requirement).
38. 21 CFR 168.140(b).
39. The North Carolina law also bans the sale of foods containing
trans fatty acids from partially hydrogenated vegetable oils.
40. For further discussion of State efforts to restrict the sale of
certain foods and beverages in schools, see School Foods Report Card
(CSPI June 20, 2006) available at http://cspinet.org/new/pdf/
school_foods_report_card.pdf.
41. S. 3128 at page 2, lines 7-21.
42. These State laws are not part of the State law resembling the
FFDCA.
43. New State Ice Co. v. Liebmann, 285 U.S. 262, 311 (1932)
(dissenting opinion).
44. USA Today (March 27, 2006) at 12A.
______
Questions of Senator Jeffords to Panel II
Question 1. I am concerned that S. 3128 would undermine Vermont's
food labeling laws, particularly those that control what may or may not
be labeled as maple syrup. Some testimony states that S. 3128 would
only affect State warnings that address the safety of food. On most
containers of Vermont maple syrup, the word ``pure'' is used, and is
widely understood, to indicate an absence of impurities or pollutants.
According to S. 3128, a ``warning'' is a direct or implied indication
of a food's risk to health or safety. Would S. 3128, should it become
law, prohibit Vermont from regulating what is considered ``pure?''
Answer 1. Response not available.
Question 2. In Vermont, maple syrup must be ``100 percent maple
syrup which is entirely produced within the State of Vermont.''
According to the FDA, however, maple syrup may contain one or more
``optional ingredients,'' including salt or chemical preservatives, as
long as the optional ingredient is ``safe and suitable.'' Since the FDA
allows other ingredients to be present in maple syrup, and since this
bill prohibits State food laws that result in ``materially different
requirements,'' would S. 3128 override Vermont's higher standards?
Answer 2. Response not available.
Question 3. When the FDA uses ``safe and suitable'' to describe a
food ingredient, as it does with optional ingredients allowed for maple
syrup, it seems that a judgment on that ingredient's healthfulness has
been made. If S. 3128 prohibits States from issuing warnings about food
safety, would this judgment by the FDA on an optional ingredient's
healthfulness affect Vermont's ability to regulate the labeling of
maple syrup or other maple products?
Answer 3. Response not available.
Response to Questions of Senator Enzi, Senator Kennedy, and Senator
Reed by William Stadtlander
QUESTIONS OF SENATOR ENZI
Question 1. Your product, Wheatena, bears an FDA-approved health
claim to the effect that Wheatena may help reduce the risk of cancer.
At the same time, if I understand the situation correctly, you are
being sued in California for failure to warn that your product contains
a substance that causes cancer. Do I have that right?
Answer 1. Exactly right. The health benefits of whole grain cereals
like Wheatena are well established. Indeed, the reason that Wheatena
can make these claims is that FDA has rigorously reviewed the data and
determined that fiber-rich whole grain foods like Wheatena may help
reduce the risk of cancer.
Question 2. What would happen to your company and your employees if
you had to pay out the $250,000 to settle the California Prop 65 law
suit? What are your other options? Couldn't you just decide not to sell
your product in California?
Answer 2. Homestat Farm is a small company. Having to pay that kind
of money to settle a lawsuit would have a huge impact on my ability to
continue offering healthy products to consumers and jobs to my
employees.
As I understand them, my options in this litigation are to pay to
settle these claims or to pay my attorneys to defend me in court. Since
Proposition 65 puts the burden on defendants, winning this case (and
I'm confident that I will win) will cost a tremendous amount of money
that will be lost to my company forever because I can't get it back
from the people who are bringing these claims against me.
These costs won't necessarily go away even if I agreed to put a
cancer warning on my product or to pull the products off California
shelves. In fact, I'm told that some plaintiffs (even the California
Attorney General) could sue me if someone sold the product in
California without my authorization, even if I tried my best to prevent
that from happening.
Therefore, I could be forced to put a warning on the product,
regardless of where it is sold. Aside from the injury to my business,
that warning could discourage consumers in all 50 States from eating
these products and deprive them of these well established benefits, all
in order to give warnings about miniscule amounts of a naturally
created chemical that poses little or no risk to people.
Question 3. In your testimony, you stated that Wheatena has been
sold since 1879. Have you changed the way you make Wheatena since it
was first marketed? If you have not, doesn't that suggest there has
been acrylamide in Wheatena for over 100 years?
Answer 3. Wheatena is and always has been a pure and simple
product--toasted wheat. Of course, people have been eating roasted,
toasted, and baked wheat- and grain-based products for hundreds if not
thousands of years. Since these basic cooking methods create
acrylamide, you're right that it's been part of the human diet all of
that time.
In addition, calcium has been added for building strong bones.
QUESTIONS OF SENATOR KENNEDY
Question 1. Wheatena.--You state on page 3 of your testimony that
``FDA specifically determined that Wheatena may reduce the risk of
cancer.'' This statement surprises me, because FDA health claims don't
typically identify a specific food product, but instead talk about food
types, or foods that contain certain substances, usually as part of a
certain diet, as reducing the risk of a disease.
For example, a health claim under 21 CFR 101.76 relates the risk of
cancer to low fat diets rich in fiber-containing grain products,
fruits, and vegetables. The health claim under 21 CFR 101.77 is
similar: it relates the risk of heart disease to diets low in saturated
fat and cholesterol and rich in fruits, vegetables, and grain products
that contain some types of dietary fiber, particularly dietary fiber.
Could you please provide the committee with a copy of, or citation
to, the document in which FDA ``specifically determined that Wheatena
may reduce the risk of cancer?''
Answer 1. FDA has specifically determined that fiber-rich grain
products are components of a healthy diet associated with a reduced
risk of cancer. 21 CFR 101.76(a)(2). Wheatena is a fiber-rich grain
product.
There are many other cereals as components of a healthy diet that
reduce the risk of cancer.
Question 2. Status of Acrylamide.--The following are some
statements from the FDA Action Plan for Acrylamide in Food, March 2004
(http://www.cfsan.fda.gov/dms/acrypla3.html):
``[A]crylamide is a potential human carcinogen and
genotoxicant, based on high-dose animal studies, and a known
human neurotoxicant.''
``Acrylamide causes cancer in laboratory animals in high
doses. As a result, acrylamide is considered a potential human
carcinogen. However, it is not clear whether acrylamide causes
cancer in humans at the much lower levels found in food.
Scientists have conducted epidemiological studies of people
exposed to acrylamide in the workplace and through the diet.
The studies did not show increased cancer risk with acrylamide
exposure. However, these studies do not rule out the
possibility that acrylamide in food can cause cancer because
they have limited power to detect this effect. Also, we do not
have enough information to rule out the possibility that subtle
effects can occur on the developing nervous system at
acrylamide doses lower than those that have been studied so far
in animals and humans.''
``In June 2002, the World Health Organization (WHO) and the
Food and Agriculture Organization (FAO) convened an expert
consultation on acrylamide. The consultation, in which three
FDA experts participated, concluded that the presence of
acrylamide in food is a major concern, and recommended more
research on mechanisms of formation and toxicity. Both the WHO/
FAO consultation and the FDA have recommended that people
continue to eat a balanced diet rich in fruits and vegetables.
The WHO/FAO consultation advised that food should not be cooked
excessively, i.e., for too long a time or at too high a
temperature, but also advised that it is important to cook all
food thoroughly--particularly meat and meat products--to
destroy foodborne pathogens (bacteria, viruses, etc.) that
might be present.''
The FDA Web site (http://www.cfsan.fda.gov/dms/acrydata.html) also
includes reports on its sampling of foods with acrylamide, and FDA
tested Wheatena three different times as having 1057, 689, and 467 ppb
acrylamide. Although some foods had higher levels than these--some
considerably higher--most foods tested had much lower levels.
Considering these statements and assuming there were foods that
provided the nutritional benefits of Wheatena that contain less
acrylamide than does Wheatena, do you believe that a consumer could
reasonably choose to eat the other foods and not eat Wheatena? How do
you think a consumer who might consider these statements relevant to a
decision to eat Wheatena or not should be informed of such statements?
Answer 2. As FDA has pointed out, people who are frightened away
from eating certain foods because of an acrylamide warning will not
necessarily substitute foods that are more wholesome or healthful. In
the case of Wheatena, they almost certainly would not (since there
aren't many more healthful foods around).
Wheatena offers the following nutritional benefits:
All Natural, High Fiber (25 percent more fiber than the
leading brand), Low fat, Cholesterol free, Sodium Free, Calcium
fortified;
Wheatena is Heart Healthy, Bone Healthy and May reduce the
risk of cancer;
Healthy whole grain cereals, breads and bagels contain acrylamide.
More importantly, the numbers you mention are expressed in parts
per billion--these amounts are extremely small. FDA has said that the
levels of acrylamide present in foods as the result of cooking do not
warrant a change in diet. Differences between the levels present in my
products and others on the market are therefore so insignificant that
they simply do not provide any meaningful information regarding
differences in actual risk. These warnings don't help consumers choose
one product over another based on a comparison of such small numbers,
they do the opposite--they mislead.
The levels of acrylamide in Wheatena are smaller than the FDA
reports based on our testing through an independent lab. In addition,
Wheatena was tested in raw form versus mixed with a liquid to make hot
cereal and Wheatena's serving size is 24 percent greater than other hot
cereals.
Question 3. Acrylamide Labeling.--In your testimony on page 2, you
say, ``I know now that FDA actually says there should not be warnings
on foods just because they contain acrylamide.'' I'm not aware of any
statement to that effect from the agency--certainly not a formal
advisory opinion. Would you please submit for the record any
information that you have suggesting the FDA took a formal position on
the issue, including any written statement from FDA?
Answer 3. Representatives of FDA have twice written to government
agencies in California indicating that Proposition 65 warnings on foods
based on acrylamide are unwarranted and may confuse consumers or
conflict with Federal policy. The first was a July 14, 2003 letter from
acting director Lester Crawford to the director of the California
Environmental Health Hazard Assessment. This view was recently
reiterated in a March 21, 2006 letter from the FDA's Dr. Terry Troxell
to the California Deputy Attorney General Ed Weil.
Question 4. Regulations adopted under Proposition 65 provide that a
warning need not be given for a chemical that causes cancer where
``sound considerations of public health'' support using a standard more
favorable to businesses.
1. Were you aware of this provision prior to your testimony?
2. Have you done anything to raise this issue in your case?
3. Do you plan to follow-up on this provision and potentially use
it in the future?
Answer 4. I am aware of this provision, and it is among the
defenses that make me confident that the claims in the lawsuit against
my company are without merit. However, proving it will require me to
hire expert witnesses to develop a risk assessment and to engage in a
``battle of experts'' with the plaintiff if my case goes to trial.
These things are enormously expensive, particularly for a small
business such as mine.
QUESTIONS OF SENATOR REED
Question 1. Food Manufacturing Facility Inspections.--As a food
manufacturer, you are inspected regularly by a variety of different
State and Federal agencies. How often are you inspected by State
entities and how often does the FDA come to inspect your manufacturing
sites presently?
Answer 1. I can not speak to either State or Federal inspections
prior to my ownership of Homestat Farm, however, in the nearly 5 years
of ownership the FDA has conducted one inspection resulting in the FDA
inspector stating the facility ``looked good.'' While I am in
compliance with State requirements, no State inspection has taken place
since I have owned the company.
Question 2. Acrylamide.--I understand that acrylamide is a
naturally occurring substance contained in Wheatena as well as numerous
other products consumed by millions of Americans. Does the amount of
acrylamide contained in Wheatena differ from similar products? Does the
California law or its regulations specify a particular threshold for
consumption of acrylamide, and if so, how does Wheatena measure up to
that standard?
Answer 2. As I've stated, there are differences between the
concentrations found in one food product or another (and between one
sample and another of the same food product). However, because the
numbers are so small, the differences between them are immaterial and
do not provide a sound basis for choosing between one product and
another.
The appropriate warning threshold for acrylamide in foods is one
that is supported by sound considerations of public health. For all of
the reasons I've discussed here and in my testimony before the
committee, I am confident that sound considerations of public health
support a warning threshold that does not require warnings that could
scare people away from foods that they have been eating for hundreds of
years without ill effect.
Acrylamide is a naturally occurring substance and is in
approximately 40 percent of the food people consume. Many of these
products are considered healthy by the FDA and nutritionists. Toasters,
microwaves and ovens all create acrylamide when starches and
carbohydrates are cooked. In addition, coffee contains acrylamide. As a
result of small quantities of naturally occurring acrylamide in food,
and the total percent of foods with acrylamide I do not believe there
should be any acrylamide warning.
Response to Questions of Senator Enzi, Senator Kennedy, Senator Harkin,
Senator Reed, and Senator Clinton by Peter Barton Hutt
QUESTIONS OF SENATOR ENZI
Question 1. How do you respond to the charges that suggest State
officials have the primary responsibility for protecting the food
supply and that this legislation would impair their ability to ensure
the safety of the food supply?
Answer 1. Under the Federal Food and Drugs Act of 1906 and then the
Federal Food, Drug, and Cosmetic Act (FD&C Act) of 1938, Congress has
entrusted to FDA the primary responsibility for protecting the
nationwide food supply for the past 100 years. Under State and local
food and drug laws, State and local officials are given the primary
responsibility for protecting the food supply within their own local
jurisdictions. Thus, regulation of the food supply necessarily requires
a cooperative and collaborate approach between Federal and State
officials. In order to have a nationwide food supply, one nationwide
policy must be established to govern both the labeling and the safety
of our food. That policy can then be implemented at both the Federal
and State levels. Permitting every State and local jurisdiction to have
their own conflicting and inconsistent rules would destroy interstate
commerce in food and directly violate the intent of Congress in
establishing FDA with primary jurisdiction over nationwide food issues.
As the National Uniformity for Food Act recognizes, however, there
are food issues that are essentially local in nature. These include, as
examples, regulation of milk, shellfish, and restaurants. That is the
reason why the National Uniformity for Food Act excludes these type of
local activities from the requirement of national uniformity. The
cooperative Federal/State/industry/academic programs that cover these
local issues will not in any way be affected. It is only nationwide
issues that are subject to the requirement of national uniformity, and
the legislation makes it clear that every State and local jurisdiction
will retain full authority to enforce compliance with nationwide policy
on a local level.
Question 2. Your testimony mentioned that there were only six
petitions for an exemption under NLEA. What process did NLEA use for
petitions? It has been suggested that the Citizen Petition process
would be used under the National Uniformity for Food Act, but I don't
see that requirement anywhere in the legislation. Could FDA use a
different process?
Answer 2. As enacted by the Nutrition Labeling and Education Act
(NLEA) of 1990, Section 403A(b) of the FD&C Act provides that a State
or political subdivision may petition FDA for an exemption from
national uniformity. FDA has by regulation established a form in 21 CFR
10.30(b) for all citizen petitions, regardless of the subject matter.
Because the NLEA did not specify any particular form to be used for an
exemption petition, the form established by FDA in 21 CFR 10.30(b) was
used for the six submitted petitions. It is reasonable to anticipate
that FDA would use the same form for exemption petitions under the
National Uniformity for Food Act. The process that FDA uses in
considering such petitions is also established by FDA in its
administrative regulations set forth in 21 CFR Subpart B. FDA could
lawfully adopt a different process if it chose to do so, but it is
standard FDA practice to use the forms and procedures set forth in 21
CFR Part 10 except in unusual circumstances where a more detailed or
targeted petition may be appropriate.
Question 3. There has been considerable disagreement about the
number of State laws that would or would not be preempted by this
proposed legislation. I have heard numbers ranging from 11 to 240.
While I have heard a lot of back and forth about which number is right,
and whether a particular law would or would not be preempted, I have
not heard anything definitive about the sources of the confusion. For
example, some have suggested the definition of ``identical'' is
unclear. Others have indicated that the problem lies with
distinguishing between a State law and a State regulation. Please
discuss what you believe to be the sources of disagreement and
confusion in this debate, and any suggestions or recommendations to
clarify the proposed language.
Answer 3. There are a number of reasons for the disagreement
regarding the number of State laws that would be affected by the
National Uniformity for Food Act.
First, the people who oppose the legislation argue that it would
affect a very large number of State laws, hoping that this will give
strength to their argument. They contend that the bill is ambiguous and
thus could have a very broad impact on State laws. On not one occasion,
however, have these critics ever suggested ways that the language could
be improved and clarified. Their strategy, instead, is simply to repeat
vague allegations and not to respond to requests for specific details.
Second, an analysis of the list of 240 State laws that would
supposedly be affected by the legislation demonstrates in detail why in
fact only 11 State laws would be affected. The proof of the validity of
this analysis lies in the fact that the critics who have put forth the
list of 240 State laws have been unable to respond substantively to the
analysis which shows their list to be inaccurate. If their list was
accurate, they would have responded.
Third, the definition of the word ``identical'' is a good example.
In response to criticism that this word was not defined, Senator Burr
added a specific definition in order to make clear that it requires
only that the State law be substantially the same as the Federal law
and that any differences in language do not result in the imposition of
materially different requirements. Nonetheless, the critics continue to
say the provision is ambiguous--but, importantly, offer no clarifying
language. The purpose of the critics is simply to oppose the
legislation, not to offer meaningful clarifying language.
Fourth, the problem does not lie with distinguishing between a
State law and a State regulation. A State regulation cannot exceed the
authority granted by a State law. Because a State regulation only
implements a State law, the National Uniformity for Food Act refers
only to the State laws themselves and not to the various regulations
promulgated to implement them.
Fifth, the only suggestion I have to clarify the proposed language
would be for the committee to request all of the critics of the
legislation for their suggestions to clarify the language of the bill
in order to implement--not change--the stated purpose of the
legislation. I believe this would quickly reveal that the purpose of
the critics is to defeat the legislation, not to clarify it.
Sixth, part of the confusion is also caused by the fact that
critics either do not read or do not wish to understand the clear words
of the bill. For example, William Hubbard, who appeared before the
committee and initially criticized the legislation, later admitted that
he had not read the bill at all. He relied upon the March 1, 2006
letter from the National Association of Attorneys General raising
concerns about 10 specific examples of State laws that would be
affected. I am attaching an analysis of those 10 examples which
demonstrates that none of them is valid. NAAG simply failed to conduct
the research and analysis necessary to understand the provisions of the
legislation.
National Uniformity for Food Act
ANALYSIS OF CONCERNS RAISED BY THE NATIONAL ASSOCIATION OF ATTORNEYS
GENERAL LETTER OF MARCH 1, 2006
In a letter dated March 1, 2006, the National Association of
Attorneys General (NAAG) raised 10 specific concerns about H.R. 4167,
the National Uniformity for Food Act, which would amend the current
national uniformity provisions of the Federal Food, Drug, and Cosmetic
Act (FD&C Act). A close review of these 10 concerns, however, reveals a
serious misunderstanding of the impact of the National Uniformity for
Food Act on the authority of States to regulate the food supply. The
following analysis corrects the record and demonstrates that the
National Uniformity for Food Act would have none of the consequences
that were erroneously alleged in the NAAG letter.
1. Mercury in fish.--The NAAG letter states in two places that the
national uniformity legislation would prevent a State from requiring a
consumer warning with respect to the mercury content in tuna fish. The
letter fails to point out that FDA has determined--and sent a letter to
California explicitly stating its determination--that there is no valid
scientific or public policy basis for such a warning. On April 7, 2006,
the San Francisco Superior Court issued an opinion in California v.
Tri-Union Seafoods, LLC concluding that mercury is naturally occurring
throughout the environment, that it does not present a significant
human risk at the levels involved, that the FDA determination to handle
the matter through consumer advisories rather than safety warnings must
be given deference in California, and therefore that there is no legal
basis for the consumer warnings proposed by the State. Accordingly, the
example of mercury in fish simply reinforces the legal and factual
basis for the National Uniformity for Food Act.
2. Arsenic in drinking water.--The NAAG letter states that the
national uniformity legislation would remove the authority of a State
to require a warning about the level of arsenic in drinking water. This
is incorrect, because the national uniformity legislation does not
involve the regulation of drinking water in any way. The legislation
only covers food regulated by FDA. Regulation of drinking water is
handled by EPA, not FDA. Accordingly, consumer warnings about arsenic
in drinking water are not affected by the national uniformity
legislation. Research has uncovered no State law requiring a consumer
warning about arsenic in drinking water.
3. Lead in cans used to package food.--The NAAG letter states that
the national uniformity legislation would prevent a State from
requiring consumer warnings about the lead content in cans used to
package food. This is incorrect, because FDA banned lead soldered food
cans more than a decade ago. 21 CFR 189.240. FDA also banned lead foil
for wine bottles a year later. 21 CFR 189.301. California is the only
State that has an explicit law permitting the continued use of lead
foil for wine bottle closures.
4. Arsenic in bottled water.--NAAG argues that the National
Uniformity for Food Act takes away from the States the authority to
require consumer warnings about arsenic in bottled water. This is
incorrect, because FDA regulates the amount of arsenic permitted in
bottled water under a standard of identity promulgated by the agency.
21 CFR 165.110(4)(i)(A). Under the national uniformity provisions of
the Nutrition Labeling and Education Act of 1990, this FDA standard of
identity is already subject to national uniformity. 21 U.S.C. 343-
1(a)(1).
5. Lead in ceramic tableware.--The NAAG letter contends that the
national uniformity legislation would prevent a State from requiring
consumer warnings about lead in ceramic tableware. Following a landmark
court decision holding that FDA has jurisdiction over lead in ceramic
tableware, the agency has established and enforced stringent
regulations and action levels governing the migration of lead from food
utensils and ceramic ware, 21 CFR 109.16, and has determined that the
trace amounts of lead that do migrate are safe and should not be the
subject of consumer warnings.
6. Alcohol in candy.--The NAAG letter contends that a State will be
precluded from consumer warnings about the alcohol content of candy
within its jurisdiction. This is incorrect, for two separate reasons.
First, the provisions regarding the regulation of alcohol in candy,
under Section 402(d) of the FD&C Act, 21 U.S.C. 342(d), explicitly
state that each State is permitted either to ban or permit the use of
alcohol in candy. Second, the national uniformity legislation does not
cover this provision of the FD&C Act. Thus, the pending legislation
would not change current law with respect to the authority of a State
to require a consumer warning about the alcohol content of candy within
its own borders. Research has uncovered no State law that requires such
a warning.
7. The fat and oil content of a food.--The NAAG letter states that
the national uniformity legislation would take away the right of a
State to require a consumer warning about the fat and oil content of
food. This is also incorrect, for three reasons. First, to the extent
that the NAAG letter relates to the labeling of the content of fat and
oil in food, the national uniformity legislation does not cover this
subject. The labeling of food ingredients and nutrients is subject to
national uniformity that was enacted by Congress in the Nutrition
Labeling and Education Act of 1990, 21 U.S.C. 343-1(a). Second, to the
extent that the NAAG letter relates to regulating the safety of the
content of fat and oil in food, because FDA has no specific regulation
governing these matters States would be free to impose safety
limitations under their own State statutes in compliance with new
section 403A(c)(3) unless and until FDA issued its own contrary
determination. Third, to the extent that the NAAG letter relates to
consumer safety warnings about the safety of fat and oil in food, new
section 403B(a)(3) explicitly preserves the right of any State to issue
any consumer warning that it determines appropriate although it cannot
require the food industry to disseminate such warnings unless it
obtains FDA approval of a local exemption or a new national standard.
Research has uncovered no State law governing the safety or consumer
warnings relating to the fat and oil content of food.
8. Post-harvest pesticide application to fruits and vegetables.--
The NAAG letter argues that the national uniformity legislation would
take away the authority of a State to require consumer warnings about
post-harvest pesticide applications to fruits and vegetables. This is
incorrect, because FDA has no statutory authority to establish
pesticide tolerances or require consumer warnings about pesticide
residues. EPA has sole jurisdiction over pesticides, under Section 408
of the FD&C Act, 21 U.S.C. 346a, and this provision is not covered by
the National Uniformity for Food Act. National uniformity has already
been established for pesticides under the Food Quality Protection Act
of 1996, 21 U.S.C. 346a(n). Accordingly, the national uniformity
legislation has no impact on the authority of a State to require
warnings about post-harvest pesticide applications to food.
9. False claims of health benefits.--The NAAG letter states that
the national uniformity legislation would eliminate the ability of a
State to regulate false claims relating to the health benefits of food.
This is incorrect, because the national uniformity legislation only
covers safety warnings, and does not in any way relate to claims for
the health benefits of food. Congress enacted national uniformity
governing claims for the health benefits of food as part of the
Nutrition Labeling and Education Act of 1990, 21 U.S.C. 343-1(a)(5).
Accordingly, the current legislation has no impact on this matter.
10. Inadequate warnings for children.--Finally, the NAAG letter
argues that the national uniformity legislation will prevent a State
from imposing adequate warnings for children with respect to food
products. The letter gives no specific examples of appropriate warnings
that are not already required by FDA, and cites no State law or
regulation that imposes such warnings. The NAAG letter also fails to
recognize that new section 403B(c)(3)(C) of the legislation would grant
expedited consideration by FDA to any State petition for a local
exemption or a national standard governing warnings that could affect
the health of children. Thus, the pending legislation fully recognizes
the importance of any appropriate warnings to protect the health of
children.
QUESTIONS OF SENATOR KENNEDY
Question 1. Implied Warnings.--Under the bill, a warning includes a
statement ``that indicates, directly or by implication,'' that the food
presents or may present a hazard to health or safety.
In a notice published in the Federal Register in February 1994, FDA
stated:
``[T]he concept would better be formulated as `from cows not
treated with rbST' or in other similar ways. However, even such
a statement, which asserts that rbST has not been used in the
production of the subject milk, has the potential to be
misunderstood by consumers. Without proper context, such
statements could be misleading. Such unqualified statements may
imply that milk from untreated cows is safer or of higher
quality than milk from treated cows. Such an implication would
be false and misleading.''
Farm-raised salmon has more PCBs than wild salmon. Therefore, by
the reasoning FDA applied to statements about mild from rbST treated
cows, a statement that salmon is farm-raised implies that the fish may
be less safe than wild salmon, and is a warning under this bill. Do you
agree? If not, why not? Please explain what ``by implication'' means?
Why won't a food industry lawyer at least be able to argue that ``farm-
raised'' is an implied statement about safety?
Answer 1. Under the National Uniformity for Food Act, not all
statements regarding the origin or composition of food are subject to
national uniformity. Simple statements that provide information to
consumers without in any way stating or implying that the food presents
or may present a hazard to health or safety are not included within
this legislation. Thus, a statement that is not in the nature of a
warning is not covered by the legislation.
Your question raises two examples: ``From cows not treated with
rbST'' and ``farm-raised salmon.'' Taken by themselves, without a
negative context, neither of these statements is in the nature of a
warning. For the same reason, ``contains no caffeine'' on a soft drink
or any other of a large number of other ``avoidance''statements do not,
by themselves, inherently imply a warning. An avoidance statement is
intended to appeal to people who, for whatever reason, do not wish to
ingest a given type of substance or product. People have widely
variable reasons for preferring substances or food products, wholly
apart from safety reasons. Providing truthful, accurate, and
nonmisleading information about food is therefore useful to consumers
who wish to be able to make informed decisions in the marketplace.
Any of these types of avoidance statements can, on the other hand,
quickly be turned into safety warnings if the context is different. If
the statement about rbST were conjoined with safety concerns or if the
issue of PCBs were directly raised with regard to farm-raised salmon--
or if the safety of caffeine is questioned in conjunction with a
statement that a soft drink contains no caffeine--the result would be a
warning. Thus, this legislation unequivocally preserves the right of a
consumer to obtain accurate and nonmisleading information about the
composition of the food supply without confusing consumers about
warnings that are not imposed on a national basis.
Question 2. Preemption Defense.--Under the proposed section
403A(c)(1) in the Federal Food, Drug, and Cosmetic Act (page 2 of the
bill), every time language in a State requirement does not use exactly
the ``same language'' as the comparable provision under the Federal
Food, Drug, and Cosmetic Act, a food company lawyer will be able to
argue that the State provision is not ``substantially the same
language'' or that the ``differences in language . . . result in the
imposition of materially different requirements,'' especially when
there is no FDA standard for the substance at issue.
In fact, a food company lawyer would likely be committing
malpractice not to use a preemption defense in such a State enforcement
action following passage of S. 3128 if his or her client wanted him or
her to do so. Food company lawyers would even potentially try to remove
the cases to Federal court. How do you respond?
Answer 2. The FD&C Act is filled with broad and general terminology
that is designed to achieve the statutory purpose. Indeed, there is no
regulatory statute in American history for which this is not true. For
example, Section 402(a)(1) of the FD&C Act states that a food is deemed
adulterated if it bears or contains ``any poisonous or deleterious
substance which may render it injurious to health.'' Section 403(a)(1)
of the FD&C Act states that a food is deemed to be misbranded if its
labeling is ``false or misleading in any particular.'' The language in
these two provisions is far broader and less clear in its scope and
impact than is the definition of ``identical'' in the National
Uniformity for Food Act. In fact, the statutory terms for adulteration
and misbranding are not defined at all, whereas the statutory term
``identical'' is defined in a very clear and precise way. A State
statute will be deemed identical if it uses substantially the same
language and there is no materially different requirement. Compared to
other provisions in the FD&C Act, the intent is extremely clear and the
courts should have no difficulty whatever in implementing it.
Question 3. Guidance Documents.--Section 701(h) of the Federal
Food, Drug, and Cosmetic Act states that guidance documents are ``not
binding on the Secretary'' and requires that guidance documents
indicate their ``nonbinding nature.''
S. 3128 doesn't change that guidance documents aren't binding on
FDA or the industry. But it says that guidance documents are binding on
States and localities, because they may only enforce a State
requirement when it ``conforms'' to an FDA guidance.
Under this bill, a company is not required to comply with a
guidance document but a State can only act if it is alleging that the
company hasn't complied with the guidance. Could you please explain why
a State or locality should be bound by a guidance document that binds
neither the FDA nor a food company?
Answer 3. There are two answers to your question.
First, if there is no FDA regulation or guidance, a State is
entirely free to implement a statutory provision that is identical to
the same provision in the FD&C Act in any way that it believes is
justified. Thus, a State requirement imposed under a State statute
identical to the Federal statute is completely lawful unless FDA has
taken a contrary position in a regulation or guidance.
Second, Section 701(h) of the FD&C Act explicitly states that
guidance documents ``present the views'' of FDA on matters under its
jurisdiction. It requires FDA to ensure that agency employees do not
deviate from such guidances without appropriate justification and
supervisory concurrence. Thus, as FDA has often said, guidance
documents represent the enforcement position of the agency. The agency
deviates from them only on rare occasions and under unusual
circumstances.
FDA guidance documents therefore represent national policy. They
establish tolerances for food contaminants that the agency intends to
enforce in court and related food safety and labeling positions that
represent national policy established by the agency designated by
Congress as the primary regulatory agency for our nationwide food
supply.
Although a guidance is not legally binding in the way that a
statute or regulation is binding, it nonetheless represents FDA
enforcement policy. It is rare that a company would willfully violate
such a guidance. It is an informal substitute for a formal regulation.
FDA uses guidances rather than regulations in situations where the
formal procedures now required for promulgating regulations make that
form of policy statement infeasible. A guidance represents FDA
nationwide policy, however, and thus States should follow it or should
petition FDA to change it. If States were permitted to ignore FDA
guidance, FDA would be required to promulgate many more regulations in
order to assure national uniformity, thus making regulation far more
costly and difficult.
Question 4. Seafood HACCP.--In 1995, the FDA issued final
regulations under both section 402(a)(1) and 402(a)(4) of the Federal
Food, Drug, and Cosmetic Act to ensure the safe and sanitary processing
of fish and fishery products, known as Seafood HACCP, for Hazard
Analysis and Critical Control Point.
S. 3128 gives preemptive effect to section 402(a)(1) and it gives
no preemptive effect to section 402(a)(4). So what is the effect of the
HACCP regulations, which were issued under both of these statutory
requirements? It seems that any State that has a safety standard of any
sort related to fish, including shellfish, is preempted by this FDA
regulation, because those State standards are obviously not identical
to the FDA HACCP regulation. In any case, there is some real ambiguity
here that a food industry lawyer could exploit, isn't there?
Answer 4. The seafood HACCP regulations codified in 21 CFR Part 123
are unquestionably directed at the safety of seafood, to implement
Section 402(a)(1) of the FD&C Act. As often occurs, FDA included the
sanitation provisions of section 402(a)(4) as additional statutory
justification for these regulations. Even if FDA had not cited section
402(a)(4), however, all of the regulatory requirements in part 123
would be fully justified. Accordingly, to the extent that any State
enacts a competing or different seafood HACCP regulation, it could not
lawfully be enforced. This would be true whether the State law sought
to increase or reduce the seafood HACCP requirements. Thus, consumers
throughout the country are assured of a comprehensive, nationally-
applicable HACCP regulation protecting the safety of seafood products.
You ask whether any State that has a safety standard of any sort
related to fish is preempted by this regulation. The answer is that in
some circumstances it would be and in some circumstances it would not.
Such a State law would be subject to national uniformity if it
attempted to reduce or increase safety requirements addressed by part
123. If it addressed other issues relating to fish, however, national
uniformity would not apply. For example, the National Shellfish
Sanitation Program (NSSP) is not subject to national uniformity. The
NSSP program has been implemented for years under the authority of the
Public Health Service Act, not the FD&C Act. And the National
Uniformity for Food Act explicitly provides that shellfish warnings
established under the Food Code are not subject to national uniformity.
Thus, there is no ambiguity on what aspects of FDA regulations
governing seafood are and are not subject to the pending legislation.
Question 5. Preemption of Proposition 65.--Mr. Hutt, on page 6 of
your written testimony, you say that it is a ``conspicuous anomaly''
and an ``historic accident'' that there is not uniformity for foods, as
there is for other products, such as nonprescription drugs, cosmetics,
nutrition labeling, and pesticides. You seem to think the main point of
this bill is to pre-empt California's Proposition 65. It is therefore
interesting to note that both the Reagan and Bush I administrations
opposed preemption of Proposition 65. It is therefore not an
``accident'' that Proposition 65 is not preempted.
Nor is it an anomaly, as consideration of the preemptive actions of
Congress makes clear. When Congress gave preemptive effect to FDA's
regulation of over-the-counter drugs, cosmetic packaging and labeling,
pesticides, and nutrition labeling, it always protected Proposition 65.
Sections 751 and 752 of the Federal Food, Drug, and Cosmetic Act,
as added in 1997, include the following provision:
``This section shall not apply to a State requirement adopted
by a State public initiative or referendum enacted prior to
September 1, 1997.''
In fact, Congress added this provision to protect California's
Proposition 65 from preemption.
Similarly, paragraph (8) of the pesticide preemption provision,
section 408(n) of the Federal Food, Drug, and Cosmetic Act, says:
``Nothing in this Act preempts the authority of any State or
political subdivision to require that a food containing a
pesticide chemical residue bear or be the subject of a warning
or other statement relating to the presence of the pesticide
residue in or on such food.''
Again, Congress protected Proposition 65 from preemption.
Finally, section 6(c)(2) of the Nutrition Labeling and Education
Act states:
``The amendment made by subsection (a) and the provisions of
subsection (b) [both of which provided for preemption of
certain State laws] shall not be construed to apply to any
requirement respecting a statement in the labeling of food that
provides for a warning concerning the safety of the food or
component of the food.''
Once again, Congress protected Proposition 65.
With respect to prescription drugs, Congress has never given
preemptive effect to FDA regulation. It is true that Congress gave
preemptive effect to FDA regulation of medical devices in section 521
of the Federal Food, Drug, and Cosmetic Act, but the effect of this
provision is still being debated, and besides, it was passed in 1976,
before the citizens of California adopted Proposition 65 by referendum
in 1986. It cannot be argued that Congress explicitly intended section
520 to preempt a proposition that California had not yet adopted.
Certainly, as the Senate author of the 1976 medical device legislation,
it was not my intent to preempt Proposition 65 (nor any State product
liability claims, for that matter).
You argue that Congress should preempt Proposition 65 because you
suggest it has done so in the past, when in fact Congress has not.
Please comment.
Answer 5. I have not stated, and I do not believe, that the ``main
point'' of this legislation is to preempt California Proposition 65.
The purpose of the legislation is to establish national policy
regarding food safety in general and food warnings in particular. It is
intended to make certain that every citizen of our country, wherever
located, has access to the same safe and wholesome food that is clearly
and conspicuously labeled with whatever warnings are appropriate.
Uniformity in food warnings is uniquely important because of the
consumer confusion that would result if each State imposed its own
separate and different system of warnings.
The lack of uniformity in regulating food under the FD&C Act is
indeed an anomaly. When the Association of Official Agricultural (now
Analytical) Chemists (AOAC) was formed in 1884, its constitution stated
that the objectives were ``to secure, as far as possible, uniformity in
legislation . . . and uniformity and accuracy in the methods and
results'' of analysis. When the Association of Food and Drug Officials
(AFDO) was formed in 1897, the constitution of the new organization
stated that its purpose was ``to promote uniformity in legislation and
rulings.'' In 1898, the Chief of the USDA Food Laboratory (which later
became part of FDA) stated that national legislation was needed
because, ``By no other means can we hope to secure laws uniform in
their scope, requirements and penalties.'' The Director of the Bureau
of Chemistry of the New York State Department of Health stated in 1903
that ``uniformity in our food laws is much to be desired.'' Indeed, the
House Report on the Food and Drugs Act of 1906 stated that:
``The laws and regulations of the different States are
diverse, confusing, and often contradictory. . . . One of the
hoped-for good results of a national law on the subject of pure
foods is the bringing about of a uniformity of laws and
regulations on the part of the States within their own several
boundaries.''
Similarly, the 1935 Senate Report on the legislation that
ultimately became the FD&C Act of 1938 expressly recognized the
importance of enacting legislation that would result in greater
uniformity between Federal and State requirements.
Your question does not reflect the fact that numerous laws have
been enacted by Congress to achieve national uniformity in the
regulation of food products as well as in the regulation of other
products subject to FDA jurisdiction. These laws include the statutes
that govern meat, poultry, and eggs, the packaging and labeling
requirements for all food, and the misbranding provisions for food
enacted under the Nutrition Labeling and Education Act of 1990. It also
includes such other areas as medical devices. Most recently national
uniformity was included in the Food Allergy Labeling and Consumer
Protection Act of 2004, which you supported.
As you point out, California Proposition 65 was excluded from three
other provisions of law. These provisions were the result of political
compromise in order to expedite pending legislation. They represent
extremely unwise public policy. In effect, they permit one State to
dictate food safety requirements for the rest of the country. The
mistakes made in that prior legislation should not be repeated.
Question 6. Local Requirements.--I'd like you to explain why the
bill completely preempts localities from enforcing local requirements,
even those that are identical to Federal requirements.
Paragraphs (2), (3), and (4) of the proposed section 403A(c) (pages
2 and 3 of the bill) say when a State or political subdivision of a
State may or may not enforce a State law, but they don't say when the
law of a political subdivision may be enforced. Similarly, the proposed
section 403B(a)(3) (page 5) permits States to act under certain State
authorities, but it doesn't say that a locality may act under its own,
comparable authorities.
Proposed section 403B(b) (pages 6-9) provides for the review of
preempted State requirements, but not preempted local requirements.
Proposed section 403B(c) (pages 9-12) allows States to petition for
exemptions and national standards, but not localities. Proposed section
403B(d) (pages 12-14) gives States a so-called imminent hazard
authority, but not localities.
S. 3128 completely preempts local laws that are not identical to
Federal requirements, and it blocks localities from enforcing local
laws that are identical. Why?
Answer 6. The National Uniformity for Food Act does not completely
preempt localities from enforcing local requirements that are identical
to Federal requirements.
Section 403B(a)(1) explicitly provides that any political
subdivision of a State may enforce a local food safety warning that is
identical to a Federal warning. Section 403A(c) also explicitly
provides that a political subdivision of a State may enforce a State
law that contains a requirement that is identical to a Federal
requirement. I am unaware of any situation where a local jurisdiction
within a State has enacted a law governing food safety that is
identical to the Federal law but for which there is no comparable State
law. Your question does not identify any such situation, nor has AFDO
or other interested organizations stated that this has ever occurred.
Perhaps that is the reason why Senator Burr has not covered this
hypothetical situation in the legislation.
Nonetheless, there is a simple answer to this hypothetical
question. If the local jurisdiction has identified a provision of
Federal law governing food safety that has no State counterpart and has
enacted its own identical provision on a local level, it will be quite
simple for that local jurisdiction to persuade the State to enact it
into State law. Once that is done, it may be enforced by both State and
local officials.
Finally, the National Uniformity for Food Act funnels all State
issues relating to FDA review, petitions for exemption, national
standards, and imminent hazard action, through the appropriate State
officials rather than through each individual local jurisdiction, for
several reasons. First, as already stated, no one has thus far
identified the type of local laws that you hypothesize in this
question. Second, it is sound public policy to require each State to
coordinate whatever petitions may be appropriate within its own
jurisdiction, rather than to have a variety of viewpoints expressed by
different local authorities. For the same reasons that uniformity is
appropriate at the Federal level on nationwide issues, it is equally
justified at the State level on statewide issues. Assuming that there
are local laws governing food safety that are not applicable on a
statewide basis, the State has an interest in assuring both that those
laws are appropriate and that they should be advanced either as an
exemption or as a national standard.
Question 7. The Effect of Proposition 65.--On pages 14-15 of your
testimony, Mr. Hutt, you state that California's Proposition 65 ``has
resulted in a veritable flood of warnings in restaurants, bars, grocery
stores, hotel lobbies, and elsewhere, as well as major litigation about
its applicability to various food products.''
The implication of this statement is that Proposition 65 has
resulted in warnings on signs or placards in various places of business
in California, but not actual warnings on food labels. A bit later on
page 15, you concede that many companies have reformulated their foods,
rather than engage in litigation (or, implicitly, place a warning on
their food products).
First, there is obviously no burden on food manufacturers of a
requirement that signs be posted at points of sale in California.
Please respond.
Second, you obviously think that certain substances reduced as
ingredients or reformulated out of foods because of Proposition 65
should be reintroduced or increased in levels in foods. Please list
each substance for which a warning is required under Proposition 65
that is in your view improperly excluded from food or reduced in levels
in food. Provide all substantiating science for your views.
Third, you state on page 16 of your testimony that ``the claims
that Proposition 65 has resulted in safer food are often not correct.''
By implication, sometimes such claims are correct. Please list each
substance that Proposition 65 has properly reduced in, or excluded
from, foods, making them safer.
Answer 7. As you point out, I have testified that California
Proposition 65 ``has resulted in a variable flood of warnings in
restaurants, bars, grocery stores, hotel lobbies, and elsewhere, as
well as major litigation about its applicability to various food
products.'' Your question implicitly agrees with that statement. I also
testified that FDA has disagreed both with Proposition 65 itself and
with its applicability to several food products. Your question does not
disagree with that testimony. Thus, the real issue is whether this
``flood of warnings''--which has occurred in only 1 of 50 States in our
country and has not occurred anywhere else in the rest of the world--
represents sound public policy.
Your question implies that, because warnings have not been placed
on food labels and companies have simply reformulated in order to avoid
litigation rather than because of any concern about the safety of their
products, there is no impact on the food industry or on consumers. This
is wrong. There has been a major impact on the food industry and on
consumers. Forcing industry to promulgate warnings in California, even
if not on food labels, has a large impact on the food industry as well
as on consumers. First, it undermines the credibility and authority of
one of our most important Federal agencies, the Food and Drug
Administration. Second, it leads to enormous public concern about
issues that FDA and the rest of the world have determined do not
represent a significant health hazard. Third, it undermines our
nationwide food distribution system. Fourth, it forces food companies
either to engage in protracted expensive litigation in California (like
the recent tuna fish litigation) or else cave in to private bounty
hunters who have no interest in food safety but rather are focused on
extorting fines from food companies.
The recent tuna fish litigation responds to all three of your
specific questions. In California v. Tri-Union Seafoods, LLC (April 7,
2006), the San Francisco Superior Court issued an opinion concluding
that mercury is naturally occurring throughout the environment, that it
does not present a significant risk at the levels involved, that the
FDA determination to handle the matter through consumer advisories
rather than safety warnings must be given deference in California, and
therefore that there is no legal or policy basis for the consumer
warnings sought by the State. That decision illustrates the burden on
food manufacturers involved under signs posted at points of sale in
California, the existence of substances in food for which California
would require a warning even when FDA determines that no warning is
appropriate, and the false illusion that is created that any reduction
in substances like mercury will necessarily make the food safer. The
California court decision details the scientific evidence demonstrating
the lack of harm from existing mercury levels in fish. The court
determined that the testimony offered by the State was not credible.
Yet manufacturers were forced to spend millions upon millions of
dollars in defense of a case that should never have been brought. This
is but one example where FDA has opposed a warning that would be
required under Proposition 65, but it is the only one that has thus far
been litigated with respect to food products.
Question 8. Status of State Requirements Subject To a Petition.--On
page 17 of your testimony, you state: ``State requirement that are the
subject of State petitions to FDA remain in effect until FDA takes
action on the petition, however long that takes.'' The proposed section
403B(b)(2), on page 6 of the bill, says that if a State submits a
petition within 180 days after the date of enactment of the bill, ``the
notification of food safety requirement shall remain in effect in
accordance with subparagraph (C) of paragraph (3).'' Paragraph (3)(C)
of the proposed section 403B(b) says in clause (I) that the State
requirement stays in effect until FDA denies the petition, which makes
sense. Clause (II) says the State requirement stays in effect until FDA
approves the petition, which makes no sense: Shouldn't the State
requirement remain in effect after the petition is granted?
Answer 8. Sections 403B(b)(3)(C)(i)(I) & (II) provide that a State
requirement that is the subject of a petition submitted to FDA within
180 days after the date of enactment shall remain in effect until
either FDA denies the petition or, if the petition is approved, the
effective date of the final rule promulgating an exemption or national
standard, except that there is no applicable ending date if the final
rule does not establish any condition regarding the State law
provision. The State requirement remains in affect after the petition
is granted, except to the extent that the FDA determination modifies
the State requirement in some respect. Accordingly, there is no need to
revise this provision of the National Uniformity for Food Act.
Question 9. Number of Petitions for Proposition 65.--On page 18,
you suggest that the number of State petitions will be small. Everyone
agrees that the bill would preempt Proposition 65 and presumably also
every warning with respect to a substance in food required under it.
California could of course petition FDA to create an exemption for
Proposition 65 itself.
Do you believe that FDA could grant an exemption from preemption
for Proposition 65? If it could, would each of the current food warning
requirements under Proposition 65 be preserved from preemption, or not?
If FDA weren't to grant an exemption for Proposition 65, or if such
an exemption wouldn't preserve each of the Proposition 65 food
warnings, isn't it reasonable to assume that California would pursue a
petition for each such food warning? How many such warnings are there?
Please list each one. Would you agree that each such petition would
require FDA scientists to review an extensive scientific record, and
that FDA action on such petitions could not be addressed ``summarily?''
Answer 9. Sections 403B(b)(1) & (2) provide that the State may
petition within 180 days after the date of enactment with respect to
any State food safety warning ``that expressly applies to a specified
food or food component'' and ``that does not meet the uniformity
requirement.'' A petition by California to create an exemption for all
of Proposition 65 would therefore violate this provision and could not
lawfully be granted. California could, of course, file separate
petitions regarding safety warning requirements that are imposed under
Proposition 65 for each specified food or food component. Any such
petition would be required to demonstrate the scientific basis for the
warning. As I have already noted above, FDA has opposed Proposition 65
generally and the specific warnings for food products that have been
the subject of potential or actual litigation thus far. It is highly
doubtful that responsible toxicologists in California would conclude
that the types of warnings that FDA has opposed can be justified on a
scientific basis. Indeed, it is unclear that responsible scientists
would be able to mount a persuasive argument that cancer and
reproductive toxicity warnings under Proposition 65 should be applied
to any significant items in the food supply. Once the rules of science
are imposed, rather than the arbitrary political determinations set
forth in Proposition 65, the number of petitions is likely to be
extremely small. In fact, it is not clear that even a single petition,
backed by a strong scientific rationale, could be prepared for any
Proposition 65 food safety warning.
I fully agree that any California petition relating to a food
safety warning that is backed by substantial scientific data would be,
and should be, treated very seriously by FDA. Under no circumstances
could it be summarily dismissed. The length and depth of any scientific
analysis by FDA will, of course, depend upon the length and depth of
the scientific analysis presented in a State petition.
Question 10. Alcohol-Pregnancy Warnings.--At the food industry's
April 24, 2006, press conference, the industry conceded that H.R. 4167
threatened Nevada's law requiring that food establishments selling
alcoholic beverages post a sign warning pregnant women of the risk of
drinking such beverages (Analysis of State Laws Cited in CSPI Report
Shredding the Food Safety Net, www.uniformityforfood.org/
statelawanalysissummarydetails.pdf at 21). I believe at least 18 States
have such requirements. How do you explain this discrepancy with your
testimony that such warnings would not be preempted?
Answer 10. It is clear that State laws requiring food
establishments selling alcoholic beverages to post a sign warning
pregnant women of the risk of drinking alcoholic beverages is not
subject to the National Uniformity for Food Act. The National
Uniformity for Food Act only applies to food that is subject to the
jurisdiction of FDA under the FD&C Act. In Brown-Forman Distillers
Corp. v. Mathews, 435 F. Supp. 5 (W.D.Ky. 1976), the District Court
held that alcoholic beverages are exempt from the labeling requirements
of the FD&C Act. Alcoholic beverage labeling is instead subject to the
sole jurisdiction of the Federal Alcohol Administration Act, which is
administered by the Alcohol and Tobacco Tax and Trade Bureau (ATTTB,
formerly BATF). ATTTB also has exclusive jurisdiction over the
advertising of alcoholic beverages, and FDA does not have jurisdiction
over the advertising of any food that is subject to the National
Uniformity for Food Act. Accordingly, the State laws referenced in your
question are not covered by the National Uniformity for Food Act and
are not in any way affected by this legislation. I did not attend the
press conference that you reference and have no information about what
was said at that time.
Question 11. Number of Laws Preempted.--The same document
identified 26 State laws that would be threatened by the House bill,
whereas you state on page 18 of your testimony that only 11 would be
affected. Please explain the discrepancy.
Answer 11. I base the statement in my testimony that only 11 State
laws would be potentially affected by the National Uniformity for Food
Act on the April 24, 2006 analysis of State laws cited in the CSPI
Report ``Shredding the Food Safety Net.'' That analysis explicitly
identifies the 11 State laws that would be affected. My own review of
that analysis confirms that conclusion. Perhaps the discrepancy occurs
because a number of State statutes authorize the State to adopt
tolerances for food additives and color additives that are more
protective of human health than the applicable FDA tolerances. I do not
include those statutes in my analysis because no State has ever taken
action under one of these provisions in the 48 years that they have
been in existence.
Question 12. Meaning of ``Requirement''.--I would like you to
clarify what a ``requirement'' is under the bill. You seem to suggest
that individual phrases can be preempted, leaving the remaining
provisions of a State requirement that is ``identical'' to a Federal
Requirement in effect. Yet there is nothing in the bill language to
suggest that this is what ``requirement'' means.
Consider two examples. First is Chapter 94, Section 13 of the
General Laws of Massachusetts, which provides for rules for milk and
raw milk products. It consists of three sentences. The first of these
gives the State the authority to issue rules and regulations with
respect to milk and milk products. The second sentence requires that
these rules be consistent with FDA's Grade ``A'' Pasteurized Milk
Ordinance, and adds a proviso that the State may impose more stringent
bacterial and temperature standards. The third sentence provides for
fines for violations of the regulations.
So what is the State requirement here? The food industry seems to
argue that these provisions should be spliced up into various phrases
and that only the proviso in the second sentence would be preempted,
yet I see nothing in S. 3128 that compels this result. Indeed, it would
seem that S. 3128 would allow the requirement at issue to be the entire
section. The entire provision is by no means identical to anything in
the Federal Food, Drug, and Cosmetic Act, and would therefore be
preempted. At a minimum, it would seem that the entire second sentence
must be preempted. The bottom line is that there is at least a
reasonable argument that all of section 13 is preempted by S. 3128,
which would leave Massachusetts with no authority to enforce safe
standards for milk products.
There is a similarly troubling ambiguity with respect to
Massachusetts laws governing the safety of pesticides, food additives,
and color additives. The relevant provisions are found in Chapter 94,
Section 186. The second Paragraph relating to foods includes
subparagraphs (2) (pesticides), (3) (food additives), and (4) (color
additives) that say a substance adulterates a food if it is unsafe
under the corresponding provisions of the Federal Food, Drug, and
Cosmetic Act, with a proviso clause that the State may, by regulation,
prohibit pesticides, food additives, and color additives deemed safe
under Federal law. So is just the proviso preempted, or are all three
provisions preempted entirely? There appears to be nothing in the
language of S. 3128 to clarify the issue, which is arguable either way.
Please comment.
Answer 12. The term ``requirement'' is explicitly defined in
Section 403B(g)(1) of the National Uniformity for Food Act. It is
defined to mean a mandatory action or prohibition established under the
FD&C Act or the Fair Packaging and Labeling Act or by a regulation or a
court order. Thus, you are correct that the part of a State statute
that is identical to a Federal statute would remain in effect, but the
part that is not identical would no longer be effective (assuming that
it is not the subject of a State petition and FDA acceptance).
Your example of the Massachusetts law relating to milk and raw milk
products is not applicable. Beginning in 1923, the Pasteurized Milk
Ordinance (PMO) and Code were developed by the Public Health Service
under the Public Health Service Act, not the FD&C Act. FDA at one time
contemplated codifying the PMO in regulations under the FD&C Act, but
abandoned this approach at the request of State officials. Thus, the
PMO continues to be implemented under the Public Health Service Act,
which is not subject to the provisions of the National Uniformity for
Food Act. If at some point in the future FDA were to implement the PMO
under the FD&C Act, rather than the Public Health Service Act, the
following analysis would result. The State would continue to have full
authority to issue rules and regulations with respect to milk and milk
products that are identical with the PMO. The State would no longer
have authority to impose more stringent bacterial and temperature
standards than those required by FDA, but could petition FDA for an
exemption or a national standard adopting the Massachusetts
requirements. Because nothing in the National Uniformity for Food Act
affects enforcement mechanisms, Massachusetts would continue to be able
to impose fines for violations. This analysis is completely consistent
with the statutory definition of the term ``requirement,'' which
unambiguously refers to a mandatory action or prohibition and not to an
entire statutory provision. Your analysis is incorrect because it does
not refer to the statutory definition of ``requirement'' in the
National Uniformity for Food Act.
The second part of your question refers to Massachusetts laws
governing the safety of pesticides, food additives, and color
additives. First, the National Uniformity for Food Act does not cover
pesticides. Section 408 of the FD&C Act, which governs pesticides, is
not one of the provisions that is made subject to this legislation. The
Food Quality Protection Act of 1996 governs national uniformity for
pesticides. Accordingly, the rules governing national uniformity for
pesticides were enacted by Congress 10 years ago.
With respect to food additives and color additives, as I have
pointed out above, neither Massachusetts nor any other State has ever
utilized the authority to promulgate regulations for food additives or
color additives differing from the FDA regulations, in the past 48
years. Indeed, States do not bother to promulgate specific food
additive or color additive regulations identical to those adopted by
FDA. This is an area where States appropriately have deferred to FDA
for the past 5 decades. Nonetheless, in light of the statutory
definition of the term ``requirement,'' it is clear that States would
retain their authority to issue food additive and color additive
regulations identical to those promulgated by FDA, and to enforce those
requirements, under the National Uniformity for Food Act. It is only
the proviso in the State laws authorizing different regulatory
requirements that would be subject to national uniformity.
Question 13. Conforms.--Please explain the meaning of the word
``conforms'' in the proposed section 403A(c)(2) of the bill (page 3),
especially in light of Processed Apples Institute v. Department of
Public Health, 522 N.E.2d 965 (1988). Why doesn't that case compel the
preemption of both the second paragraph on foods of Chapter 94, Section
186 and Section 192?
Answer 13. Section 403A(c) contains provisions that confirm the
authority of both a State and a political subdivision to enforce any
requirement in a State or local law that is identical to a requirement
in the Federal law. If FDA has promulgated a regulation or guidance
relating to that requirement, the State or local government must
conform its requirement to the Federal requirement. If FDA has not
promulgated a regulation or guidance, the State or local government may
implement the identical provision in any way that it believes
appropriate.
The term ``conforms'' in Section 403A(c)(2) has its customary
English meaning, i.e., the State requirement must be in accord or
agreement with the Federal requirement. Once again, because of the
statutory definition of the term ``requirement,'' which makes it clear
that it refers to a specific action or prohibition and not to a
sentence or entire section, the meaning of ``conforms'' is very clear.
If the Federal and State statutes are identical, it is the specific
State requirement and not the entire statutory provision that must
conform to the Federal regulation or guidance.
Nothing in the Processed Apples Institute decision indicates a
contrary interpretation of the National Uniformity for Food Act. That
decision arose in a context where the court concluded that the State
had the authority to ban the pesticide completely. That situation could
not arise under the National Uniformity for Food Act. The court in that
case reasoned that, if the State could impose a complete ban, it could
also take the lesser action of imposing a more stringent tolerance.
Because the National Uniformity for Food Act expressly prohibits a
complete ban, that court's reasoning could not be applicable, and
conformity would be given its common and clear meaning.
Question 14. No FDA or State Regulation.--The proposed section
403A(c) allows a State or locality to enforce a State (but not a local)
requirement identical to a Federal requirement when FDA has issued a
regulation or guidance and the State or locality enforce the Federal
regulation or guidance (paragraph (2)), and when FDA has not issued a
final regulation or guidance and the State has its own ``policy'' such
as a regulation or ``administrative decision'' (paragraph (3)). S. 3128
doesn't say what a State or locality can do when neither the FDA nor
the State have a regulation, guidance, or ``policy'' in place.
It seems to me the better reading is that a State or locality may
not enforce in that instance, and, at a minimum, it is clear that a
food industry lawyer will be able to argue that the enforcement action
is not permitted under the bill. This seems to me a particular concern
when neither FDA nor a State may have anticipated a substance that
terrorists have put in food. Please respond.
Answer 14. Section 403A(c)(3) governs when a State and the FDA are
operating under an identical statute, FDA has taken no action in the
form of a regulation or guidance on a particular issue, and the State
wishes to enforce its State law in a particular way. For example, let
us assume that the State determines that a contaminant in the food
supply violates the ``poisonous or deleterious substance'' provision in
both the Federal and the State law, and FDA has expressed no opinion on
the matter. Under those circumstances, the State is completely free to
take action unless and until FDA takes its own action in the form of a
regulation or guidance and makes a different determination. The State's
``policy,'' under this hypothetical, consists of the determination that
the contaminant represents a ``poisonous or deleterious substance'' at
the level involved. Indeed, it would be impossible for the State to
take any form of action until it had reached the policy position that
the particular level of the contaminant that is involved constitutes a
``poisonous or deleterious substance.'' If, as you suggest, the
contaminant has been placed in the food by terrorists, it is
unquestionable that both FDA and the State would act, and in fact the
State would act under the imminent hazard provisions of the National
Uniformity for Food Act.
Question 15. Aborted FDA Action.--The proposed section 403A(c)(4)
blocks a State or locality from enforcing a policy rejected by FDA. If
FDA has rejected a tolerance of X for substance Y, it seems clear that
the State may not enforce the tolerance of X. What about twice X? X
plus a tenth X? X plus a hundredth X? It is entirely unclear what this
provision means. Suppose FDA rejected the policy 10 years ago, and
since that time new science supports the tolerance of X for substance
Y. Why should a State be prohibited from enforcing it? What if the new
science supports a tolerance of one tenth or one hundredth X? Why
should the State be blocked from acting until FDA has acted?
Answer 15. FDA is constantly reviewing contaminants and ingredients
in the U.S. food supply, and adopting formal and informal
determinations regarding the level at which a given contaminant is and
is not a hazard to public health. The hypothetical posed in your
question is not realistic. FDA does not determine that a particular
level of a contaminant or ingredient is safe and therefore all levels
are safe. In almost all instances, it determines the upper limit of
safety, so that anything above that limit would not be regarded as
safe. Thus your examples of contamination at levels in excess of the
FDA tolerance are easily answered. If FDA has said that X level is
safe, the simple answer is that in virtually all instances FDA has
determined either that this level is the upper limit of safety or that
some higher level is the upper limit and that this level falls within
it. It would be extremely unusual for FDA to make a safety
determination about a particular level and to stop at that point
without further analysis. If a State believes that FDA has in fact done
this, it is a simple matter for the State to discuss it with FDA in
order to obtain clarification, or to submit a petition for an exemption
or a national standard.
Without doubt, all regulatory standards are worthy of review and
reconsideration as time progresses. You ask what should be done if FDA
rejected a tolerance for a contaminant 10 years ago and new science now
supports such a tolerance. The National Uniformity for Food Act
anticipates exactly this type of circumstance. The State should then
discuss the matter with FDA and submit a petition for exemption or,
undoubtedly more appropriate, a new national standard. If the science
demonstrating the toxicity of the contaminant is compelling, and the
hazard is very serious, the State may utilize the imminent hazard
provision as well.
You ask why a State should be prohibited from simply adopting
whatever contaminant level it wishes, without regard to the FDA
determination. The answer to this is very clear and compelling.
Tolerances for food contaminants must be established on a national
level, not a local level, if we are to maintain a nationwide market in
food. If every State were to adopt its own tolerances in the light of
new scientific data, there would be chaos in the marketplace. It is
precisely for this reason that Congress delegated to FDA primary
authority to deal with nationwide food safety problems. This
legislation simply permits that delegation to have its intended
purpose.
QUESTIONS OF SENATOR HARKIN
Question 1. Exemption From Preemption.--The proposed section
403B(f) exempts from preemption certain types of State required
notifications such as open date labeling, religious dietary labeling,
organic or natural designation, and statements of geographic origin,
among others. Please explain why such exemption is needed for each of
the particular exemptions contained in this subsection. What provisions
in the bill imply that these sorts of provisions are preempted absent
the exemption? Does the clear exemption for these specific State-
required notifications create the implication that all other State-
required notifications are preempted?
Answer 1. The State laws you identify in Section 403B(f)(1)--open
date labeling and so forth--are not food safety provisions, are not
food warnings, and would not be covered by the legislation even without
the specific statutory exemption. I am told that Senator Burr included
them in the legislation because critics persisted in using each one of
these types of State required notifications as an example of State laws
that would be preempted by this legislation. Even though that was a
demonstrably incorrect interpretation of the bill, Senator Burr
apparently felt that it was easier to put in a specific exemption in
order to cut off this erroneous criticism. There would be no way to
interpret the legislation to imply that these sorts of provisions are
preempted absent the exemption. Thus, this specific exemption for these
types of non-warning statements does not create an implication that
other similar non-safety statements are subject to national uniformity.
Question 2. Scope of the Bill.--Mr. Hutt, you state in your
testimony that Proposition 65 is the overarching problem that
necessitates this uniformity legislation. But you also state that
``existing differences between Federal and State food safety law are
few and generally of a minor nature.'' Can you please explain how you
reconcile your opinions on this matter, which seem somewhat at odds
with one another?
In addition, if Proposition 65 is the problem that needs to be
addressed, can you tell me if there are there alternative and more
circumscribed means by which to address these matters? Is it possible
to create a mechanism by which to avoid the kind of situation in which
Mr. Stadtlander finds himself without such broad preemption?
Answer 2. As I have stated in response to a question from Senator
Kennedy, the main purpose of this legislation is to assure a cohesive
national approach to food safety. It is not directed primarily or
exclusively at Proposition 65.
In 1997, Congress directed USDA to fund a study by the National
Academy of Sciences to evaluate our current food safety system in the
United States. The Institute of Medicine undertook this study and
produced its report in 1998. The report found that ``Federal activities
are not well integrated with State and local activities'' and called
for a ``national food safety plan'' that would ``integrate Federal,
State, and local food safety activities.'' As the report recognized,
``officials at all levels of government must work together in support
of common goals of a science-based system.'' The report emphasized the
need for statutory authority ``to integrate State and local activities
regarding food safety into an effective national system.'' The
President's Council on Food Safety, which President Clinton established
in August 1998 in response to the Institute of Medicine report,
strongly endorsed this approach. President Clinton's Council issued its
own report in March 1999 stating that Federal and State food safety
agencies ``have expertise and resources that, when combined in an
integrated program, would significantly enhance the impact of food
safety programs.'' The Council's report concluded that there needs to
be ``public assurance that State and local activities are integrated
with, and an extension of, the Federal responsibility in order to
assure consistency, accountability, and above all, enhanced consumer
protection.'' This legislation provides the critical element to assure
an integrated national food safety program.
As I said in my testimony, existing differences between Federal and
State food safety laws are few and generally of a minor nature. This
means that there will be no wholesale revocation of existing food
safety laws. Most are presently identical to the Federal law, and thus
may continue to be enforced under the provisions of this legislation.
It is only the few that differ substantially from Federal law that will
no longer be enforceable.
Merely addressing California Proposition 65 would not meet the
mandate of President Clinton's Food Safety Council. A comprehensive
national food safety system is needed in order to assure maximum
consumer protection, and this legislation provides for just such a
system.
Question 3. Multiple Labels.--With regard to warning labels and
notification requirements, supporters of this bill, have complained
about a patchwork quilt of food safety warnings required by different
States. Yet I have not yet seen a specific food product that contains
multiple labels--one required by Federal law and another required by
State law. Can you provide me with such an example or multiple
examples?
Answer 3. I did not testify that food safety warnings have appeared
in food labeling. Rather, I said that they appear ``in restaurants,
bars, grocery stores, hotel lobbies, and elsewhere.'' None of these
warnings are required in any other State or by FDA or by any other
country in the world. Obviously, the ingredients required to be the
subject of a warning in California are not unsafe in California and
safe in 49 other States. There is a strong need to rationalize safety
decisions in order not to confound the public.
For example, a law suit was brought under Proposition 65 to require
a warning regarding the natural lead content of calcium in dietary
supplement products. The industry had only two options. Either it could
spend millions of dollars litigating the issue, with the always
uncertain result in a California court, or it could cave in and find a
way to use only low lead calcium in California. At no time did FDA
suggest that the lead content in calcium deserved a warning.
Nonetheless, the industry concluded that it was less expensive to find
a low-lead source of calcium for California than it was to litigate the
matter. In the view of FDA, this entire process did not in any way
advance the health and safety of consumers. It disrupted the dietary
supplement industry and cost them millions of dollars, for no public
health reason.
Question 4. Warning vs. Notification.--On the issue of what
constitutes a warning, there is some disagreement. The Center for
Science in the Public Interest asserts that nearly 200 State laws would
be affected by this legislation. Mr. Hutt, you have reviewed the CSPI
report on this matter and believe that the CSPI report is incorrect
because it doesn't distinguish between ``warnings'' and
``notification.'' You state that if one looks only at warnings and not
at notifications more broadly, that the number of State laws affected
would be significantly less. You also state that S. 3128 clearly
pertains only to notification requirements that contain food-related
warnings and not notification more broadly.
However, I am unclear as to whether the term ``warning,'' as
defined by the bill, is nearly as clear as has been asserted. The bill
says that ``warning,'' used with respect to a food, means any
statement, vignette, or other representation that indicates, directly
or by implication, that the food presents or may present a hazard to
health or safety.
Do you see any uncertainly under this definition, especially the
``by implication'' portion? Can you explain to me more precisely the
legal import and effect of this ``by implication'' language? Why it is
important to have the ``by implication'' language included in the bill
at all?
By way of example, what if a State adopts a requirement that grass-
fed beef be labeled as such? Directly, this may be only a notification.
But what if research definitively shows that grass-fed has health
benefits relative to grain-fed beef. By implication, wouldn't a grass-
fed beef notification then become a warning regarding grain-fed beef?
Perhaps this isn't the best illustration. My point is not to comment on
grass-fed beef or the state of science pertaining to it, but to ask
whether the definition of warning in the legislation is altogether
clear.
Answer 4. As I have said in response to your first question above,
the National Uniformity for Food Act covers only notifications that are
in the nature of a warning, and does not cover notifications that do
not state or imply a safety problem.
You have asked why it is necessary to impose national uniformity
both for direct warnings and for implied warnings. The answer is clear.
If only direct warnings were subject to national uniformity, it would
be very simple to convert them into implied warnings and thus escape
national uniformity. Let us take the example of farm-raised fish. State
laws that require farm-raised fish to be so labeled are not subject to
national uniformity because, as I have pointed out in response to
question No. 1 from Senator Kennedy, this type of statement is merely
an ``avoidance'' claim. Some people prefer wild fish to farm-raised
fish because they prefer ``natural'' food. Companies are entitled to
give this type of information on the source of the fish so that
consumers can satisfy their own personal eating preferences.
If a State were to decide that it wanted to discourage the sale of
farm-raised fish (because it could be in an ocean State's interest to
encourage the sale of wild fish), it could easily devise a statement
such as ``farm-raised fish contain PCBs.'' It would not include the
required use of the term ``warning'' and would not allege the lack of
safety of the product. It would, however, clearly imply that there was
a significant safety issue. Accordingly, it is important to harmonize
implied as well as direct food safety warnings throughout the country.
Question 5. Cost-Benefit Analysis.--Issues like food safety often
involve cost-benefit analyses. Are you aware of any cost-benefit
analysis showing the costs and benefits of a single national regulatory
scheme as envisioned under S. 3128 compared to the costs and benefits
under the current relationship?
Answer 5. Both the Report of the Institute of Medicine and the
Report of President Clinton's Food Safety Council strongly recommended
a nationally integrated food safety system. They argued that a
coordinated national regulatory scheme such as that envisioned under
the National Uniformity for Food Act would increase efficiency and
maximize consumer benefit. I am not aware whether they conducted formal
cost-benefit analyses in reaching their conclusions, but it seems very
clear that a single national food standard, enforced uniformly by every
Federal, State, county, and city regulatory agency, will be far more
efficient than a patchwork of requirements of the type that now exist.
Question 6. National Response to Local Issues.--Right now, State
and local officials are not preempted from taking action when food-
related health concerns arise that are limited to their jurisdictions.
How can we be sure that a national regulatory regime will: (a) be able
to respond in a timely fashion to what is a local concern; and (b) be
willing to respond to localized issues, when other matters will compete
for limited Federal resources?
Answer 6. The National Uniformity for Food Act balances the need of
the Federal Government to assert primary jurisdiction over national
issues and the right of State and local governments to take primary
responsibility for local issues. The legislation explicitly excludes
such food sanitation matters as regulation of milk, seafood, and
restaurants, which are quintessential local issues. Moreover, local
food safety officials will always be authorized under the National
Uniformity for Food Act to take immediate enforcement action under
their own State provisions that are identical to Federal law in order
to address local concerns promptly. And if those localized issues
present a serious health hazard, the State may act immediately under
the imminent hazard authority in this legislation. Thus, the National
Uniformity for Food Act explicitly provides for several ways in which
State and local officials can immediately respond to localized food
safety problems.
Question 7. Imminent Hazard Authority.--Could you please explain
the imminent hazard authority to me more fully? First, explain to me
the legal definition and standing of the term ``imminent hazard'' as
well as the term ``adverse health consequences.'' Are these terms
defined in statute, regulations, or guidance or, alternatively, have
they been further explicated in existing case law?
If a State determines that there is an imminent hazard, why is it
necessary for them to notify FDA and to determine if FDA has or has not
initiated enforcement action on the matter? And how do you envision
that this process would operate? Would a State have to receive word
from the FDA that they are not initiating enforcement? How long would a
State have to wait to determine whether or not the FDA has initiated or
plans to initiate enforcement action? And if there is truly an imminent
hazard that requires immediate action by State authorities, is this
process of notification, waiting, and clarification truly the best
process, in terms of expediency and therefore, in terms of human
health?
Answer 7. The imminent hazard provision in section 403B(d) is
patterned on two other provisions in the FD&C Act: (1) the imminent
hazard provision for new drugs in Section 505(e) of the FD&C Act and
(2) the standard of ``serious adverse health consequences'' that is
used in Sections 515(e)(3), 518(e)(1), and 522(a) of the FD&C Act and
in a number of FDA regulations. Thus, both of these statutory terms
have substantial FDA precedent.
For example, the term ``imminent hazard'' is defined in 21 CFR 2.5
and has been the subject of judicial interpretation in the decision in
Forsham v. Califano, 442 F. Supp. 203 (D.C.D.C. 1997). The term
``serious adverse health consequences or death'' has similarly been
defined by FDA in 21 CFR 810.2(1) & 814.3(1). Thus, these are not new
or undefined terms.
Under the imminent hazard provision in the legislation, once the
State notifies FDA and determines that FDA has not already initiated
enforcement action, it may immediately take its own action. It need not
wait another minute. No clarification by FDA is needed. The State must
later submit a petition to FDA relating to the matter, but in the
meanwhile it can take whatever action is necessary in order to address
the imminent hazard. Thus, the type of delay and confusion that you
envision is explicitly avoided under the legislative provisions.
As you know, the imminent hazard provision applies only where the
State action conflicts with the uniformity provisions of the
legislation. If the State wishes to take emergency action under a State
law that is identical to the Federal law and there is no contrary FDA
regulation or guidance, the State may proceed immediately without
consulting FDA.
Question 8. Restaurant Labeling.--This country has now required
food manufacturers to provide nutrition information on packaged foods
for about 15 years. I think most people agree that the nutrition
information provided on packaged foods has been successful. Americans
appreciate the information and rely on it to make informed choices
about what they eat.
However, more and more, Americans spend their food dollars away
from home, mostly in restaurants. As a result, individuals who have
good nutrition information when cooking at home are totally in the dark
when they go out to a restaurant. That's why I've proposed a bill that
would require chain restaurants to provide basic nutrition information
(calories, salt, fat, trans fat) on standard menu items at the point of
sale.
I'm hopeful that Congress will take up and pass my bill for
restaurant nutrition labeling. But if it doesn't happen, there is
always the possibility of a State or a municipality passing a similar
law on restaurant labeling. If a State were to pass a law that required
chain restaurants to provide nutrition information on calories, salt,
fat, and trans fat at the point of sale, would such a law, in your
view, be preempted by passage of the proposed National Uniformity
legislation?
Alternatively, what if, in addition to the required information on
calories, salt, fat, and trans fat, a State or municipality required
restaurants to also post the following notice, ``The National Academy
of Sciences has concluded that trans fats provide no known benefit to
human health and recommends that consumption of trans fats be as low as
possible.'' Would such a notification be preempted by passage of S.
3128?
Answer 8. Congress established the current statutory provisions
regarding national uniformity for nutrition labeling in the Nutrition
Labeling and Education Act of 1990. The National Uniformity for Food
Act does not in any way deal with nutrition labeling, whether on food
packages or in restaurants.
You ask whether a State requirement that a restaurant post a notice
that ``the National Academy of Sciences has concluded that trans fats
provide no known benefit to human health and recommends that
consumption of trans fats be as low as possible'' would be subject to
national uniformity under this legislation. In my opinion, such a
notice would be an implied safety warning. In contrast, a simple
restaurant statement that a food ``contains trans fats'' without an
implication that they are unsafe, like the ``avoidance'' claim that a
product ``contains no trans fats,'' would not be subject to uniformity.
I believe that this is consistent with my response above to your
question number 4 and illustrates why implied as well as direct food
warnings are properly covered by the National Uniformity for Food Act.
Question 9. School Nutrition Standards.--In testimony before the
committee, you raised the issue of State and local laws regarding
school food sales. In particular, these are laws that govern what and
when food can be sold at schools, especially unhealthy foods such as
soft drinks and snack foods. Your assertion, which I hope is correct,
is that because school nutrition issues are typically governed by USDA
rather than the FDA, then these State and local laws would not be
preempted by S. 3128.
But other than the simple argument that school nutrition is
traditionally the purview of USDA, are there other substantive reasons
why S. 3128 wouldn't or couldn't be applicable to State and local
school nutrition laws? Is there, for instance, any case law that you
can cite that would further support this assertion? Wouldn't it still
be possible that someone could challenge such laws by arguing that S.
3128, if passed, has preempted them?
Furthermore, if areas that are traditionally the jurisdiction of
USDA wouldn't be affected by this bill, why is it that organic
designations, which are the purview of USDA, are specifically preempted
by the proposed section 403B(f) of S. 3128? Does the clear exemption of
organic, even though it is traditionally governed and regulated by the
Department of Agriculture, create the implication that all other
requirements are therefore affected, even those that are under the
purview of USDA? Is it possible that someone could cite this language
in an action challenging State school nutrition laws following passage
of S. 3128?
Answer 9. State and local laws regarding school food sales are not
subject to national uniformity under this legislation. The FD&C Act has
no provision authorizing FDA to permit or prohibit the type of food
sold in schools. The laws that govern such programs--the National
School Lunch Act and the Child Nutrition Act of 1966--are under the
jurisdiction of USDA, not FDA, and are not in any way included under
the FD&C Act. Accordingly, it is absolutely clear that the National
Uniformity for Food Act has no impact of any kind on these laws.
It is not just a matter that school nutrition is ``traditionally''
the purview of USDA. It is the clear legal situation that school
nutrition matters do not fall within the FD&C Act. Rather, they fall
within the two specific statutes referred to above that are separate
and distinct from the FD&C Act and that are not included in the list of
statutory provisions to which the National Uniformity for Food Act
applies. Thus, the fact that State and local laws regarding school food
sales are not affected by the National Uniformity for Food Act is a
matter of statutory law, not a matter of simple tradition. It would be
impossible for anyone seriously to suggest that the National Uniformity
for Food Act applies to State and local laws regarding school food
sales, because the laws administered by USDA are not listed as subject
to uniformity under Section 403A or Section 403B as they are written
under the pending legislation.
The matter of organic labeling, however, is an entirely different
matter. As I have noted in response to your question No. 1, Section
403B(f)(1) included nonsafety food statements as a specific exemption
only because critics of the legislation persisted in erroneously
contending that otherwise they would be subjected to national
uniformity. In short, the provision was included for absolute clarity
in order to avoid giving critics yet another erroneous reason for
attacking the legislation.
You are correct that it was USDA who was given the statutory
authority to develop an organic food certification program under the
Farm bill of 1990. Because FDA has jurisdiction under the FD&C Act over
all food labeling statements, however, FDA is charged with enforcing
the USDA requirements for organic food labeling, even though it is USDA
who promulgates the implementing regulations. Thus, this is quite
different from the school nutrition programs. Quite simply, FDA has no
jurisdiction over school nutrition programs, has not been delegated by
Congress with any authority with respect to school nutrition, and has
never in its entire history taken any action with respect to school
nutrition. FDA has jurisdiction over the safety and labeling of the
entire food supply, but does not have authority to determine which safe
and properly labeled food may be sold in local school systems.
QUESTIONS OF SENATOR REED
Question 1. FDA Guidance Documents Versus State Food Safety Laws.--
The Federal Food, Drug, and Cosmetic Act (Section 701(h)) states that
guidance documents are ``not binding on the Secretary'' and requires
that guidance documents indicate their ``nonbinding nature.'' This bill
doesn't change the fact that guidance documents aren't binding on FDA
or the industry. But it says that guidance documents are binding on the
States and localities, because they may only bring an enforcement
action when it ``conforms'' to the guidance. As a practical matter, a
company is not required to comply with a guidance document but the
State can only act if it is alleging that the company hasn't complied
with the guidance. Would any of you care to comment on whether this
makes any sense?
Answer 1. Senator Kennedy has raised the identical question. My
response follows.
There are two answers to your question. First, if there is no FDA
regulation or guidance, a State is entirely free to implement a
statutory provision that is identical to the same provision in the FD&C
Act in any way that it believes is justified. Thus, a State requirement
imposed under a State statute identical to the Federal statute is
completely lawful unless FDA has taken a contrary position in a
regulation or guidance.
Second, Section 701(h) of the FD&C Act explicitly states that
guidance documents ``present the views'' of FDA on matters under its
jurisdiction. It requires FDA to ensure that agency employees do not
deviate from such guidances without appropriate justification and
supervisory concurrence. Thus, as FDA has often said, guidance
documents represent the enforcement position of the agency. The agency
deviates from them only on rare occasions and under unusual
circumstances.
FDA guidance documents therefore represent national policy. They
establish tolerances for food contaminants that the agency intends to
enforce in court and related food safety and labeling positions that
represent national policy established by the agency designated by
Congress as the primary regulatory agency for our nationwide food
supply.
Although a guidance is not legally binding in the way that a
statute or regulation is binding, it nonetheless represents FDA
enforcement policy. It is rare that a company would willfully violate
such a guidance. It is an informal substitute for a formal regulation.
FDA uses guidances rather than regulations in situations where the
formal procedures now required for promulgating regulations make that
form of policy statement infeasible. A guidance represents FDA
nationwide policy, however, and thus States should follow it or should
petition FDA to change it. If States were permitted to ignore FDA
guidance, FDA would be required to promulgate many more regulations in
order to assure national uniformity, thus making regulation far more
costly and difficult.
Question 2. Definition of ``identical'' in S. 3128.--Mr. Hutt, you
contend that most State laws will not be preempted by S. 3128 because
they will not have to exactly mirror the FDA standard. It is estimated,
however, that anywhere between 11 and 200 State and local laws would be
preempted by S. 3128. Won't the fact that identical means something
other than identical under this bill just result in a battle in the
courts to define what ``identical'' actually means?
Answer 2. It is extremely unlikely that there will be any
significant litigation regarding the scope of the term ``identical'' as
set forth in new section 403A(c)(1) of the National Uniformity for Food
Act, for several reasons. First, the definition is much clearer than
most definitions in the FD&C Act. It unambiguously states that it does
not require identical language, just the imposition of identical
requirements. It also explicitly excludes procedural requirements, and
section 403B(a)(3) explicitly excludes enforcement requirements.
Second, the 11 State laws that will be impacted by the National
Uniformity for Food Act are unlikely to be the subject of State
petitions. A review of these State statutes shows that most are
obsolete or represent minor deviations from existing FDA requirements
and are unlikely to survive rigorous scientific analysis.
QUESTIONS OF SENATOR CLINTON
Question 1. Local Agencies and Food Safety.--As you state in your
testimony,
``States must be given the right to collaborate with FDA in
assuring that appropriate food safety and warning requirements
are imposed and, where uniquely local matters are involved, to
assume the predominant role in public protection.''
However, S. 3128 only allows States, not local governments, to
petition the Federal Government for exemptions or to establish a
national standard. Furthermore, State governments are allowed to act
when the Federal Government has not set a standard, but local
governments are not allowed to take such action.
In New York City, a proactive local government, has identified and
addressed hazards for which Federal regulation does not exist. For
example, when imported candies contaminated with lead were found in New
York City, a city law was enacted banning the sale of such products.
In addition, New York City recently embargoed certain imported
herbal products that contained lead after several cases of adult lead
poisoning were confirmed among residents who used these products. This
action was taken despite the fact that there were--and continue to be--
no specific Federal standards about adult tolerance levels for adult
lead poisoning.
Given these facts, how can we ensure that food uniformity will not
constrain this important local role? Under the restrictions of S. 3128,
how can localities respond rapidly to products that pose an imminent
hazard to their population and do not affect the entire State?
Answer 1. Senator Kennedy has raised the identical question. My
response follows. The National Uniformity for Food Act does not
completely preempt localities from enforcing local requirements that
are identical to Federal requirements.
Section 403B(a)(1) explicitly provides that any political
subdivision of a State may enforce a local food safety warning that is
identical to a Federal warning. Section 403A(c) also explicitly
provides that a political subdivision of a State may enforce a State
law that contains a requirement that is identical to a Federal
requirement. I am unaware of any situation where a local jurisdiction
within a State has enacted a law governing food safety that is
identical to the Federal law but for which there is no comparable State
law. Your question does not identify any such situation, nor has AFDO
or other interested organizations stated that this has ever occurred.
Perhaps that is the reason why Senator Burr has not covered this
hypothetical situation in the legislation.
Nonetheless, there is a simple answer to this hypothetical
question. If the local jurisdiction has identified a provision of
Federal law governing food safety that has no State counterpart and has
enacted its own identical provision on a local level, it will be quite
simple for that local jurisdiction to persuade the State to enact it
into State law. Once that is done, it may be enforced by both State and
local officials.
Finally, the National Uniformity for Food Act funnels all State
issues relating to FDA review, petitions for exemption, national
standards, and imminent hazard action, through the appropriate State
officials rather than through each individual local jurisdiction, for
several reasons. First, as already stated, no one has thus far
identified the type of local laws that you hypothesize in this
question. Second, it is sound public policy to require each State to
coordinate whatever petitions may be appropriate within its own
jurisdiction, rather than to have a variety of viewpoints expressed by
different local authorities. For the same reasons that uniformity is
appropriate at the Federal level on nationwide issues, it is equally
justified at the State level on statewide issues. Assuming that there
are local laws governing food safety that are not applicable on a
statewide basis, the State has an interest in assuring both that those
laws are appropriate and that they should be advanced either as an
exemption or as a national standard.
You specifically refer to a New York City law banning the sale of
imported candies contaminated with high levels of lead. In that
instance, FDA also took enforcement action directly to prevent
importation of lead-contaminated candies under the prohibition of
poisonous or deleterious substances in Section 402(a)(1) of the FD&C
Act. New York State law contains an identical prohibition. Accordingly,
under the provisions of new Section 403A(c)(3) of the National
Uniformity for Food Act New York City would be fully authorized to
enforce the State law provisions banning these lead-contaminated
candies. The same is true in the situation of imported herbal products
with high levels of lead. Where there is no specific Federal standard,
New York City may enforce the State law prohibiting poisonous or
deleterious substances because that law is identical to the Federal
law. Thus, this is an excellent example of the collaboration and
cooperation among Federal, State, and local food regulatory agencies
that I emphasized in my testimony before the committee.
Question 2. Compensation for Testimony.--Did you or your law firm
receive compensation for the testimony you gave to the HELP Committee
on Thursday July 27, 2006? Please outline the amount of your
compensation together with the details of what companies, groups,
associations, or other parties provided that compensation.
Answer 2. I am told that the staff of the HELP Committee asked the
Grocery Manufacturers Association to suggest the names of experts in
the area of FDA regulation of food safety. GMA suggested me because I
have spent the past 45 years practicing food and drug law both as Chief
Counsel for FDA and in private practice, I teach food safety law at
Harvard Law School each Winter Term, and I am the co-author of the
casebook used to teach this subject at law schools throughout the
country. It was the HELP Committee that extended an invitation for me
to testify. I will be paid by GMA for the amount of time I spent
preparing for the hearing, testifying before the committee, and
responding to these questions, at my standard billable rate. At this
moment I do not know the amount of compensation that will be involved.
Response to Questions of Senator Enzi, Senator Kennedy, Senator Harkin,
Senator Reed, and Senator Clinton by Elsa A. Murano
QUESTIONS OF SENATOR ENZI
Question 1. I am told that under this legislation, States and
localities retain their enforcement authorities and the ability to set
food safety standards where FDA hasn't. Furthermore, States would
continue to conduct inspections, use their embargo and other
enforcement authorities. Do you see anything in the bill that will
prevent the States from doing the things they now do in terms of food
safety?
Answer 1. It is extremely important that the States retain their
inspection, embargo, and other enforcement authorities. The National
Uniformity for Food Act does not cover procedural authority states that
it does not cover inspection, recall, civil orders, embargo, detention,
or court proceedings. I support these provisions. I can find nothing in
the bill that will prevent the States from doing the things they do now
in terms of food safety.
Question 2. In your testimony, you discussed how when you were
Undersecretary, USDA worked with FDA on inspections and could be
deputized under Memoranda of Understanding to help FDA. This sounds
sensible to me. Do you think it makes sense to expand this approach?
Answer 2. Both USDA and the States have at times been deputized to
assist FDA, by conducting inspections, analyzing products, and
undertaking other related regulatory work. This has been going on for
decades, and I support continuing it and expanding it in the future.
QUESTIONS OF SENATOR KENNEDY
Question 1. Proposition 65.--Which of the ingredients requiring a
warning under Proposition 65 do you think should be put back into food,
or added to food at higher levels? On which ingredients did California
get it right? Please provide a complete list of each class of
substances.
Answer 1. To my knowledge, only one food warning case has been
litigated under Proposition 65. That case would have required a warning
for mercury levels where FDA has determined that a warning is not
appropriate. This is, I believe, a sufficient answer to your question.
I do not have a complete list of all substances for which warnings have
been sought, nor am I familiar with the negotiations that have taken
place. I am aware that FDA has opposed warnings that have been sought
under Proposition 65. In my opinion, California should follow the lead
of FDA in food safety matters, and should not try to set the rules for
the entire country.
Question 2. USDA-FDA.--How does Federal preemption on meat
inspections justify preemption on the FDA side of things, when USDA is
in the plant inspecting basically 24/7 and FDA gets to a food plant to
inspect perhaps every 5-10 years?
Answer 2. The justification for continuous factory inspection for
meat does not exist when it comes to the kind of processed food that
FDA regulates. USDA oversees the slaughter of live animals. FDA does
not. Instead, FDA focuses on issues of food toxicology in determining
whether safety warnings are appropriate. Accordingly, national
uniformity makes as much sense for FDA safety decisions as it does for
USDA safety decisions.
QUESTIONS OF SENATOR HARKIN
Question 1. Exemption From Preemption.--The proposed section
403B(f) exempts from preemption certain types of State required
notifications such as open date labeling, religious dietary labeling,
organic or natural designation, and statements of geographic origin,
among others. Please explain why such exemption is needed for each of
the particular exemptions contained in this subsection. What provisions
in the bill imply that these sorts of provisions are preempted absent
the exemption? Does the clear exemption for these specific State-
required notifications create the implication that all other State-
required notifications are preempted?
Answer 1. I agree with you that these particular exemptions are not
needed. I asked why they are there and was told that they were put
there to appease critics who insisted that otherwise the types of State
laws identified in that provision could possibly be included within
national uniformity. Since none of these State laws involves a safety
warning, they clearly would not be included under the bill even if this
section were not a part of the legislation. I do not believe there is
any implication that other non-safety State-required notifications are
subject to national uniformity.
Question 2. Multiple Labels.--With regards to warning labels and
notification requirements, supporters of this bill, have complained
about a patchwork quilt of food safety warnings required by different
States. Yet I have not yet seen a specific food product that contains
multiple labels--one required by Federal law and another required by
State law. Can you provide me with such an example or multiple
examples?
Answer 2. I have asked the same question, and I have been told that
the food industry prefers to put any required food safety warnings on
store posters rather than on labels. We are therefore unlikely to see
any food labels that contain a safety warning imposed by State law but
not required by Federal law.
Question 3. Cost-Benefit Analysis.--Issues like food safety often
involve cost-benefit analyses. Are you aware of any cost-benefit
analysis showing the costs and benefits of a single national regulatory
scheme as envisioned under S. 3128 compared to the costs and benefits
under the current relationship?
Answer 3. I have undertaken no research to determine whether cost-
benefit analyses of a single national regulatory scheme have been
performed. It is common sense, however, that one national safety
standard, as contrasted with numerous State standards, will be far more
effective and efficient. We do not need a study to understand that. It
is instructive that the European Union has adopted a common market in
food, and has abandoned its centuries-old balkanized approach of
individual country regulations, precisely in order to obtain the
benefits of a single standard that the National Uniformity for Food Act
would confirm.
QUESTION OF SENATOR REED
Question. USDA Meat Inspections Versus FDA Inspections.--How many
inspectors does the USDA have to conduct meat inspections? How many
inspectors does the FDA have for the thousands of food products under
its jurisdiction? How does Federal preemption on meat inspections
justify preemption on the FDA side of things, when USDA is in the plant
inspecting basically 24/7 and FDA gets to a food plant to inspect every
5-10 years?
Answer. USDA has about 9,000 meat inspectors, because of the
Federal statutory requirement of continuous factory inspection over the
slaughter of live animals. Comparing USDA inspection of the slaughter
of live animals with FDA inspection of processed food is like comparing
apples and oranges. The two have nothing in common. USDA must be
concerned with the safety of each individual animal. FDA is concerned
with the safety of ingredients, which can be used in thousands of
different types of products. Thus, while USDA focuses on one animal at
a time, FDA can cover thousands of food products by reviewing just a
single ingredient. For this reason, the two agencies properly conduct
their statutory responsibilities in extremely different ways.
QUESTION OF SENATOR CLINTON
Question. AFDO and the Food Code.--As you stated in your testimony,
48 of the 56 States and territories have adopted their own food codes
from the Food Code. You draw parallels between this code and the
National Uniformity for Food Act.
According to your testimony,
``there is nothing in proposed S. 3128 that would limit,
restrict or compromise the Food Code or the State or
territorial codes modeled on it . . . [nor] anything that would
impact FDA's or USDA's other cooperative food safety programs
with the States.''
It stands to reason that if this statement were true, the National
Uniformity for Food would enjoy the support of the organizations that
support the Food Code.
However, the Association of Food and Drug Officials (AFDO), the
non-profit organization whose mission is to foster ``uniformity in the
adoption and enforcement of food, drug, medical devices, cosmetics and
product safety laws and regulations,'' is opposed to H.R. 4167, the
House companion of S. 3128. In a letter to the House of Representatives
last January the AFDO addresses ``serious concerns'' regarding H.R.
4167 and its impact on State sanction laws and programs. The AFDO calls
the bill ``a disastrous step backwards in ensuring the safety of our
Nation's food supply.''
Considering the AFDO fully supports the Food Code but stands in
opposition to the National Uniformity for Food Act, how do you justify
your argument that the two are somehow equal? What differences exist
between the Food Code and the food uniformity legislation?
Answer. The Food Code began with a cooperative program undertaken
in 1935 by the Public Health Service in cooperation with State health
officials. It encompasses food service, vending, and retail food store
sanitation. It is a cooperative program with the States, and it is not
affected in any way by the National Uniformity for Food Act. In fact,
over the past 70 years the Food Code and its predecessor programs have
fostered uniformity in these areas that are uniquely the responsibility
of local health officials, and I expect that this will continue. I
regret that AFDO has seen fit to oppose the National Uniformity for
Food Act. This opposition seems to go against the stated mission of
this important organization. I see no difference between the Food Code
approach and the National Uniformity for Food Act. Both are consistent
with the mission of AFDO.
Response to Questions of Senator Enzi, Senator Kennedy, Senator Harkin,
and Senator Reed by William K. Hubbard
QUESTIONS FROM SENATOR ENZI
Question 1. On what basis do you conclude that such a large number
of petitions would be submitted? Mr. Hutt testified that many of the
State laws that were listed as vulnerable to preemption were not even
under the FDA's jurisdiction. How do you respond to this?
Answer 1. I based my conclusion on the assumptions made by the
Congressional Budget Office, which I understand is charged with guiding
legislators in gauging the impact of proposed legislation. The food
industry is on record as saying that there will be more petitions
coming to FDA than the CBO estimated. Whomever is correct, it appears
that there will likely be many petitions addressed to the FDA under the
bill, and even a much smaller number than estimated will result in
significant budgetary problems for the FDA.
Question 2. The Congressional Budget Office scored a similar House
bill, H.R. 4167 at $100 million over 5 years, using an estimated cost
of $400,000 per petition, 240 petitions and associated regulatory costs
of about 4.2 percent. You have suggested that FDA could not accommodate
such responsibilities in its current budgetary state. I, too, am
concerned about FDA's budget. However, if we stipulate to CBO's model
for the cost per petition and the add-on for any regulatory actions,
but take the lower number of 11 laws preempted, we would come up with a
cost estimate for this bill of a little under $5 million. Could FDA
handle that?
Answer 2. A $5 million estimate would assume that only about 20
petitions would be received by FDA in the first year. It is difficult
to conceive of so small a number of petitions, given the large number
of contaminants that California alone has listed under Proposition 65.
It might be useful to ask that State how many petitions it would expect
to submit. Further, even if California submitted just one petition to
cover the hundreds of contaminants it has regulated under Proposition
65, FDA would be forced to undertake the same expensive process for
assessing those contaminants as it would if the State had submitted a
separate petition for each hazardous substance.
Given FDA's precarious budget situation in its foods program, even
a $5M reallocation would be difficult for the agency to accommodate. In
essence, it would mean the assignment of perhaps 40 to 50 scientists
away from their public health mission to the review of petitions, for
no discernible public health gain.
Question 3. Dr. Murano's testimony discussed how when she was
Undersecretary, USDA worked with FDA on inspections and USDA staff
could be deputized under agreements between the two agencies to help
FDA. You indicated that deputization worked in combating bioterrorism.
Why wouldn't it work here?
Answer 3. The Bioterrorism Act authorized FDA to ``commission''
officials from other regulatory agencies with like missions to assist
FDA in its food safety oversight role--in essence, to empower those
agencies, where FDA determined it appropriate, to share FDA's
regulatory authority. For example, FDA has already commissioned Customs
officials who can assist in inspecting imported foods. However, the act
also required FDA to reimburse agencies for such commissioning efforts
where necessary, so there would need to be funding to allow USDA staff
to review petitions, if the purpose of this question is to inquire
about USDA doing petition review under the uniformity legislation.
Moreover, the meat inspectors that were under Dr. Murano's supervision,
while highly trained in their particular field, would not likely have
the scientific expertise to review the safety of contaminants that
would be the subject of uniformity petitions. Indeed, Congress
recognized that fact by assigning to FDA the principal authority to
approve new food additives, including those used in meat production. If
the question is aimed more at suggesting that USDA inspectors would
pick up any slack caused by FDA's inspection reduction due to their
having to reallocate inspectors to petition review, such reallocations
would not likely occur. Petition review would need to be done by the
scientists in FDA's headquarters food program, who would be best
qualified to conduct petition review.
QUESTIONS OF SENATOR KENNEDY
Question 1. FDA Inspections.--State officials, from attorneys
general to public health and agriculture officials, have expressed
concern that S. 3128 will disrupt their authority to inspect and
enforce the safety of food. States presently conduct 80 percent of all
domestic food inspections. Does it unsettle you that S. 3128 might
disrupt these inspections? What resources could FDA bring to bear to
replace lost State inspections?
Answer 1. FDA would have no resources to make up for lost State
efforts. Indeed, States do far more now than FDA does to enforce food
safety laws, and much of that enforcement is directly on FDA's behalf.
If States are allowed to continue their inspections, as S. 3128
contemplates, but not enforce the standards that those inspections are
intended to enforce, as S. 3128 appears to intend, it would be logical
to assume that States would simply stop inspecting altogether in many
instances. The result would be a significant diminution of food safety
protection nationwide.
Question 2. Petitions.--How do you think the FDA will be able to
afford the hundreds of millions of dollars it will take to implement S.
3128 over the next 5 years, when its budget is currently being cut?
Answer 2. The agency will not be able to afford to implement S.
3128. If enacted, and if FDA were to make a sincere effort to implement
it, I believe S. 3128 would force FDA to reallocate most of the efforts
of its headquarters scientists to petition review, for no discernible
public health gain. FDA's food budget needs to be doubled, not
drastically cut, as is already happening (and which would be
exacerbated by S. 3128).
Question 3. Implied Warnings.--Under the bill (page 5, paragraph
(B)), a warning includes a statement ``that indicates, directly or by
implication,'' that the food presents or may present a hazard to health
or safety. Because farm-raised salmon has more PCBs than wild salmon,
isn't a statement that salmon is farm-raised a warning under this bill?
Answer 3. FDA has interpreted similar circumstances in the past as
implied warnings. For example, when some States expressed their
intention to require that milk resulting from the use of the hormone
BST in milk cows bear a notification of that fact, FDA concluded that
consumers would view that notification as a warning. A farm-raised
salmon notification could easily be assumed to refer to fish that
contained higher levels of PCBs or a wild salmon notification could
refer to fish that contained higher levels of mercury. So viewed, these
notifications would be preempted by S. 3128.
Question 4. State Embargoes.--Given what you know about how State
embargo is used, including in coordination with FDA, what is your view
of the restrictions on such embargo authority under the proposed
section 403B(a)(3)?
Answer 4. Currently, State health officials can detain or
``embargo'' a food that they believe posed a health risk, by
essentially demanding that the food be held pending sampling or other
examination to affirm its safety. The Bioterrorism Act of 2002
attempted to give FDA detention authority as well, but so many
procedural requirements were imposed that the authority is essentially
unused and impractical. S. 3128 preserves various State authorities--
including embargo and detention authorities--but only when they
``involve food adulteration under a State statutory requirement
identical to a food adulteration requirement under this Act.'' So the
bill seems to result in diminution of States' current detention
authority, an authority that States have often used to deal with
critical food safety threats. If the intention is to retain current
State embargo authority, any ambiguity on this point should be
explicitly removed.
Question 5. Imminent Hazard.--What is your reaction to how the
imminent hazard provision in proposed section 403B(d)? Is it at all
realistic to think that a State can use this provision to respond
quickly to a food emergency?
Answer 5. The very term ``imminent hazard'' implies a public health
threat that must be addressed with alacrity. Under S. 3128, a State
wishing to use its imminent hazard authority would first be expected to
ask the FDA to deal with the issue (and perhaps engage in the
development of a scientific standard). Such a process would not allow
expeditious solution of an imminent hazard, and thus would be a
negative public health provision.
QUESTIONS OF SENATOR HARKIN
Question 1. Exemption From Preemption.--The proposed section
403B(f) exempts from preemption certain types of State required
notifications such as open date labeling, religious dietary labeling,
organic or natural designation, and statements of geographic origin,
among others. Please explain why such exemption is needed for each of
the particular exemptions contained in this subsection. What provisions
in the bill imply that these sorts of provisions are preempted absent
the exemption? Does the clear exemption for these specific State-
required notifications create the implication that all other State-
required notifications are preempted?
Answer 1. I am not a lawyer, but it appears to me that by clearly
listing certain things that are not preempted, one is left with the
impression that everything else is not exempted from preemption. So,
yes, I agree with you that the clear exemption for these specific
State-required notifications create the implication that all other
State-required notifications are preempted.
Question 2. Scope of the Bill.--Can you comment on the scope of the
bill compared to the scope of the problem? Most importantly, are there
alternative and more circumscribed means by which to address these
matters? Is it possible to create a mechanism by which to avoid the
kind of situation in which Mr. Stadtlander finds himself without such
broad preemption?
Answer 2. The bill's scope certainly implies that there is a major,
nationwide problem with consumer confusion and excessive costs to the
food industry. Such a problem has not, to my knowledge, been shown. Mr.
Stadtlander, however, certainly finds himself in a bind, due to the so-
called ``bounty hunter'' provision embodied in Proposition 65, which
allows private parties to sue if the State has not taken action. On the
one hand, Mr. Stadtlander's cereal is alleged to contain much higher
levels of acrylamide than other cereals, and public health officials at
international, national, and State levels are trying to lower
acrylamide levels in food across the board; so some would argue that
Mr. Stadtlander needs whatever urging possible to change his production
processes so as to lower acrylamide levels in his food. On the other
hand, California is engaged in a process to address acrylamide in all
foods, and, as I testified at the hearing, I would hope that the judge
in Mr. Stadtlander's case would defer further action on his case until
his product can be brought under the auspices of the State (and
Federal) actions that will be taken more broadly to lower acrylamide
levels.
Question 3. Multiple Labels.--With regards to warning labels and
notification requirements, supporters of this bill, have complained
about a patchwork quilt of food safety warnings required by different
States. Yet I have not yet seen a specific food product that contains
multiple labels--one required by Federal law and another required by
State law. Can you provide me with such an example or multiple
examples?
Answer 3. The food industry has long feared that individual State
actions will result in differing State labeling requirements that will
impose massive costs on them with regard to the distribution and
labeling of their products. In theory, their fears are legitimate.
However, States have acted responsibly on such matters, such
conflicting and confusing labels on foods have generally not appeared,
and thus the substantial consumer confusion and production costs have
not been seen. The Reagan administration conducted a lengthy study
looking for such adverse effects, and did not find them (and those
conclusions were affirmed by the first Bush and Clinton
administrations. If Congress believes those examinations are no longer
up to date, perhaps a better course than pursuing this legislation at
this time would be to sponsor another, independent, examination to
determine if such costs are being incurred.
Question 4. Warning vs. Notification.--On the issue of what
constitutes a warning, there is some disagreement. The Center for
Science in the Public Interest asserts that nearly 200 State laws would
be affected by this legislation. Mr. Hutt has reviewed the CSPI report
on this matter and states that the CSPI report is incorrect because it
doesn't distinguish between ``warnings'' and ``notification.'' He
argues that if one looks only at warnings and not at notifications more
broadly, that the number of State laws affected would be significantly
less and also asserts that S. 3128 clearly pertains only to
notification requirements that contain food-related warnings and not
notification more broadly.
However, I am unclear as to whether the term ``warning,'' as
defined by the bill, is as clear as has been asserted. The bill says
that ``warning,'' used with respect to a food, means any statement,
vignette, or other representation that indicates, directly or by
implication, that the food presents or may present a hazard to health
or safety.
Do you see any uncertainty under this definition, especially the
``by implication'' portion? Can you explain to me more precisely the
legal import and effect of this ``by implication'' language? Why is it
important to have the ``by implication'' language included in the bill
at all?
By way of example, what if a State adopts a requirement that grass-
fed beef be labeled as such? Directly, this may be only a notification.
But what if research definitively shows that grass-fed has health
benefits relative to grain-fed beef. By implication, wouldn't a grass-
fed beef notification then become a warning regarding grain-fed beef?
Perhaps this isn't the best illustration. My point is not to comment on
grass-fed beef or the State of science pertaining to it, but to ask
whether the definition of warning in the legislation is altogether
clear.
Answer 4. It appears that there is indeed ambiguity in whether a
notification is a safety warning. FDA concluded years ago that the
proposed ``notification'' by some States that some milk might contain
the animal hormone BST was, in fact, a ``warning,'' as it implied that
such milk might pose a safety risk (if the milk cow had been given BST
to promote milk production). Similarly, a ``grass-fed'' beef
notification would/could be felt to imply that the beef cattle were
free of beef hormones commonly used in beef cattle husbandry. Thus,
under that view, the term ``grass-fed'' would be an implied warning and
covered by S. 3128.
Question 5. Cost-Benefit Analysis.--Issues like food safety often
involve cost-benefit analyses. Are you aware of any cost-benefit
analysis showing the costs and benefits of a single national regulatory
scheme as envisioned under S. 3128 compared to the costs and benefits
under the current relationship?
Answer 5. I served on a Reagan administration task force, led by
the President's Council of Economic Advisors that was charged in the
late 1980s with carefully examining the costs of Proposition 65 and
similar State initiatives. Despite a long and detailed search for
excessive costs imposed on the food industry resulting from consumer
confusion and conflicting State labeling and warning requirements, that
analysis concluded that the costs were only theoretical and that
preemptive action to address State food safety warnings should be
considered only if substantial costs were to actually occur. The
Administrations of G.H.W. Bush and Bill Clinton also studied the issue
and reached the same conclusions as the original Reagan study--that
preemption was not warranted absent clear, proven negative effects on
the food production system.
Question 6. State Innovation.--States and local regulatory efforts
have often put State and local actors out ahead of Federal agencies in
discovering more efficient and effective means to accomplish the goal
of public protection. Enacting a single, national regulatory scheme may
mean the loss of these resources and of State and local innovation. How
can we be sure that a single Federal system will lead to the most
effective and efficient approaches to ensuring better public health?
Answer 6. As I said in my formal testimony at the committee's
recent hearing on this matter, the States have been a valuable
complement to Federal food safety protections, and have often taken the
lead in identifying public health threats that they have brought to the
attention of Federal officials. That synergistic system should be
protected and nurtured, and I fear that S. 3128 will have the opposite
effect, by weakening the ability of States to protect their citizens
(and thus to some extent remove the ``canary in the coal mine'').
Preemption can be quite appropriate where the States have not taken
action in the past, such as with allergen and nutrition labeling for
processed foods. But States have a long, distinguished, and effective
history in food safety, which should not be undermined.
Question 7. Imminent Hazard Authority.--Could you please explain
the imminent hazard authority to me more fully? First, explain to me
the legal definition and standing of the term ``imminent hazard'' as
well as the term ``adverse health consequences?'' Are these terms
defined in statute, regulations, or guidance or, alternatively, have
they been further explicated in existing case law?
If a State determines that there is an imminent hazard, why is it
necessary for them to notify FDA and to determine if FDA has or has not
initiated enforcement action on the matter? How do you envision that
this process would operate? Would a State have to receive word from the
FDA that they are not initiating enforcement? How long would a State
have to wait to determine whether or not the FDA has initiated or plans
to initiate enforcement action? If there is truly an imminent hazard
that requires immediate action by State authorities, is this process of
notification, waiting, and clarification truly the best process, in
terms of expediency and therefore, in terms of human health?
Answer 7. S. 3128 appears to require a State to come to the FDA
before it can act upon an identified ``imminent hazard,'' which is
generally meant to refer to a public health threat that needs prompt
and decisive action. Forcing a State to present its evidence to the
FDA, then perhaps await FDA's procedural efforts to regulate the
``hazard,'' would deprive the State of its ability to promptly protect
its citizens. Thus, it is difficult to see how the ``imminent hazard''
authority would, in fact, be what it claims to be.
Question 8. Restaurant Labeling.--This country has now required
food manufacturers to provide nutrition information on packaged foods
for about 15 years. I think most people agree that the nutrition
information provided on packaged foods has been successful. Americans
appreciate the information and rely on it to make informed choices
about what they eat.
However, more and more, Americans spend their food dollars away
from home, mostly in restaurants. As a result, individuals who have
good nutrition information when cooking at home are totally in the dark
when they go out to a restaurant. That's why I've proposed a bill that
would require chain restaurants to provide basic nutrition information
(calories, salt, fat, trans fat) on standard menu items at the point of
sale.
I'm hopeful that Congress will take up and pass my bill for
restaurant nutrition labeling. But, if it doesn't happen, there is
always the possibility of a State or a municipality passing a similar
law on restaurant labeling. If a State were to pass a law that required
chain restaurants to provide nutrition information on calories, salt,
fat, and trans fat at the point of sale, would such a law, in your
view, be preempted by passage of the proposed National Uniformity
legislation?
Alternatively, what if, in addition to the required information on
calories, salt, fat, and trans fat, a State or municipality required
restaurants to also post the following notice, ``The National Academy
of Sciences has concluded that trans fats provide no known benefit to
human health and recommends that consumption of trans fats be as low as
possible.'' Would such a notification be preempted by passage of S.
3128?
Answer 8. When the Nutrition Labeling and Education Act was enacted
by Congress in 1990, it preempted States from imposing separate
nutrition labeling requirements on packaged foods (correctly, in my
judgment, as States had not been active in that area and national
standards were appropriate). But the act also exempted restaurants,
including so-called ``fast food'' and other chain restaurants, from
nutritional labeling. Thus, States presumably have the authority to
require nutrition labeling for restaurants, and there is a public
health justification for doing so for restaurants with standard menu
items (and, indeed, most fast food chain restaurants do so voluntarily
now, with varying degrees of public display). However, if notification
of such food constituents as trans fats were required by States, and
considered ``warnings,'' then it would be logical to assume that the
States would be preempted from requiring such notifications.
Question 9. School Nutrition Standards.--Mr. Hutt, in his testimony
before the committee, raised the issue of State and local laws
regarding school food sales. In particular, these are laws that govern
what and when food can be sold at schools, especially unhealthy foods
such as soft drinks and snack foods. Mr. Hutt's assertion, which I hope
is correct, is that because school nutrition issues are typically
governed by USDA rather than the FDA, then these State and local laws
would not be preempted by S. 3128.
But other than the simple argument that school nutrition is
traditionally the purview of USDA, are there other substantive reasons
why S. 3128 wouldn't or couldn't be applicable to State and local
school nutrition laws? Is there, for instance, any case law that you
can cite that would further support this assertion? Wouldn't it still
be possible that someone could challenge such laws by arguing that S.
3128, if passed, has preempted them?
Furthermore, if areas that are traditionally the jurisdiction of
USDA wouldn't be affected by this bill, why is it that organic
designations, which are the purview of USDA, are specifically preempted
by the proposed section 403B(f) of S. 3128? Does the clear exemption of
organic, even though it is traditionally governed and regulated by the
Department of Agriculture, create the implication that all other
requirements are therefore affected, even those that are under the
purview of USDA? Is it possible that someone could cite this language
in an action challenging State school nutrition laws following passage
of S. 3128?
Answer 9. I am not a lawyer, and am certainly not familiar with
case law on this issue. But I would agree with you that the exemption
for organic descriptors creates the impression that other USDA-related
items may be covered by S. 3128, including State school lunch
requirements.
QUESTIONS OF SENATOR REED
Question 1. Previous Administrations have rejected Food
Uniformity.--Is it true that previous Administrations have considered
the issue of Federal standards for food uniformity and rejected it?
Could you please elaborate on which Administrations contemplated food
uniformity and their reasons for maintaining the current State food
safety framework?
Answer 1. The administrations of Presidents Reagan, G.H.W. Bush,
and Clinton explicitly examined this issue and rejected it, concluding
that preemption of State food safety standards was not warranted absent
a showing of significant adverse economic effects caused by conflicting
State requirements (which they concluded did not exist).
Question 2. Disruption of State Efforts.--States presently conduct
80 percent of all domestic food inspections. State inspection
authorities generally understand the intricacies of the local food
industries. For instance, seafood and shellfish in particular are big
business in my little State. Under this bill, responsibility for
inspection and oversight of these local manufacturers would fall under
the authority of FDA officials. Does it unsettle you that S. 3128 might
disrupt these inspections, especially as the Federal Government will
not be able to step in?
Answer 2. I would not read S. 3128 as specifically preempting a
State's ability to inspect food processors. However, if a State could
not set or enforce its food safety standards, as contemplated by S.
3128, why would they continue to inspect? Accordingly, the only
inspection system would be the FDA's. Let me give you an example of
what that would mean. FDA now has over 200,000 registrants of food
producers, each and every one of which should be inspected with some
regularity (even if only every year or two). This year, FDA will
conduct about 5,000 inspections. This means that a food producer in a
given State would be inspected only once every 40 years by the FDA. So,
the practical effect of removing State inspections would be eliminating
the likelihood that a given food processor would ever be inspected.
______
Letters of Support
National Black Chamber of Commerce,
Washington, DC 20036,
July 3, 2006.
Hon. Bill Frist,
Senate Majority Leader,
Washington, DC 20510.
Re: S. 3128, National Uniformity for Food Act of 2006
Dear Majority Leader Frist: The National Black Chamber of Commerce
joins the U.S. Chamber of Commerce, the Grocery Manufacturers
Association and many other organizations in support of the National
Uniformity for Food Act of 2006, S. 3128. This bill is to amend the
Federal Food, Drug and Cosmetic Act to provide for uniform food safety
warning notification requirements, and for other purposes. This is
consistent with the NBCC philosophy that mainstreaming regulation
avoids needless costs and bureaucracy. This will benefit American
citizens as well as businesses.
Under the current system, food regulations are composed of
different and sometimes contradictory requirements. This imposes
unnecessary complexity and cost on makers of food throughout the United
States. By bringing a uniform code to our industry, the legislation
represents a major step forward in assuring consumer confidence in the
food they buy for their families.
As you know, the House of Representatives overwhelmingly supported
their version of this bill by a vote of 283 to 139. Your support of
this bill when it hits the floor will be very appreciated by the 1.4
million Black-owned businesses which we represent.
Sincerely,
Harry C. Alford,
President and CEO.
______
U.S. Hispanic Chamber of Commerce,
Washington, DC 20037,
June 19, 2006.
U.S. Senate,
Washington, DC 20510.
Dear Members of the U.S. Senate: On behalf of the 2 million
Hispanic-owned businesses in the country, we are writing to you to vote
YES on S. 3128, the ``National Uniformity for Food Act of 2006.'' This
important piece of legislation will establish a single standard for
food safety, helping consumers, families and businesses in an ever-
changing and currently confusing food labeling environment.
Under the current system, food regulation is composed of a variety
of different and sometimes inconsistent requirements. This
``patchwork'' of different State laws adopting different regulatory
requirements on identical food products is confusing to consumers and
burdensome for businesses that distribute products across State lines.
This imposes unnecessary complexity and cost on food producers and
distributors throughout the United States. By bringing a uniform code
to our industry, the National Uniformity for Food Act represents a
major step forward in assuring that there are rational, scientifically-
based and consistent standards in all 50 States.
The National Uniformity for Food Act also takes a measured approach
to national uniformity for food labeling by providing a mechanism for a
thorough, orderly review of existing State regulations that may differ
from Federal regulations. By granting States the ability to have the
Federal Government adopt their State standard, this bill carefully
balances the need for uniformity while respecting the important role
State and local governments have in ensuring the safety of the food
supply.
Once again, the United States Hispanic Chamber of Commerce strongly
urges you to support S. 3128, the National Uniformity for Food Act of
2006, if you have any questions, please feel free to contact me at
(202) 842-1212.
Sincerely,
Michael L. Barrera,
President and CEO.
______
Wyoming Retail Merchants Association (wrma),
Cheyenne, WY 82003.
Hon. Michael B. Enzi,
U.S. Senate,
Washington, DC 20510.
Dear Senator Enzi: On behalf of the Wyoming Retail Merchants
Association, I am writing to urge you to cosponsor and support S. 3128,
the ``National Uniformity for Food Act of 2006.'' Senators Richard Burr
(R-NC), Pat Roberts (R-KA), and Ben Nelson (D-NE) introduced the
legislation on May 25, 2006. On March 8, the House passed the
legislation (H.R. 4167) with a strong bipartisan vote of 283-139. I
urge you to cosponsor this critical piece of legislation.
The legislation provides for science-based uniform food safety
standards and warning requirements so that Americans in every State are
protected equally. It is common-sense legislation that will help
consumers make educated decisions for themselves and their families in
an ever-changing and confusing food labeling environment. Consumers
deserve a single standard when it comes to food safety, and this bill
will allow States and the FDA to work collaboratively in establishing
sound food safety policies that benefit--not confuse--consumers.
The ``National Uniformity for Food Act'' is top priority for
Wyoming Retailers. It recognizes that it makes no sense to have
different States adopting different regulatory requirements for
identical food products. This legislation will instead provide
consumers with a single set of consistent, science-based food safety
regulations for food products sold in all 50 States.
Successful passage of the ``National Uniformity for Food Act'' is
absolutely critical. We urge you to make its passage a top priority.
Sincerely,
Lynn Birleffi,
Executive Director.
______
State of Nebraska,
Office of the Attorney General,
Lincoln, NE 68509,
April 19, 2006.
Hon. Ben Nelson,
U.S. Senate,
Washington, DC 20510.
Re: H.R. 4167--Food Labeling Legislation
Dear Senator Nelson: I am writing to urge you to support The
National Uniformity for Food Act when it is introduced in the Senate.
Last month, 39 Attorneys General signed a NAAG letter to Congress
urging you to oppose the House bill, H.R. 4167, which passed in the
House by a large and bipartisan margin on March 8. I respectfully
disagree with my colleagues regarding the effect of the bill and
believe it would establish a consistent, science-based framework to
ensure the security and safety of our food supply.
I am satisfied that H.R. 4167 in its current form will not
compromise the ability of State and local officials to act decisively
when faced with a food safety threat of any kind. Rather, the bill
fosters consistency in the regulation of our food supply and ensures a
framework in which State Attorneys General and our State agriculture
and health officials will remain unencumbered and effective in
protecting consumers.
Attorneys General across the country are generally protective of
States' rights. However, food label warnings seem to be one area in
which it makes sense to have a national standard. I do not believe that
food manufacturers that ship their food all around the world should be
required to potentially develop a different label for each State in the
union. H.R. 4167 recognizes and preserves the essential role that
States play in the day-to-day business of ensuring a safe food supply.
For example, the bill would keep all existing State warning
requirements in place while States petition the U.S. Food and Drug
Administration (FDA) and both a public comment period and transparent
review process are completed.
A similar petition procedure is also established for warnings
requirements that are not currently the subject of State law. Expedited
review is specifically required for petitions involving notifications
relating to cancer, reproductive or birth defects, or that furnish
information to parents that allows them to limit a child's exposure to
cancer-causing agents, or reproductive or developmental toxins.
It is noteworthy that the bill specifically applies only to
mandated warning statements. Nothing in H.R. 4167 infringes upon the
right of any State agency or official to share food safety concerns
(e.g., public education campaign) with their citizens. The sum of the
parts of H.R. 4167 that address warning statements ensures that States
participate in, and the Federal Government ultimately sets, national
food safety policy. A close reading of the proposed legislation
confirms that this balance would be achieved by H.R. 4167.
Certain food safety and adulteration provisions of the Federal
Food, Drug, and Cosmetic Act are also subject to national uniformity
under the bill, with several important limitations. is my understanding
that nearly all States have food statutes comparable to the food safety
and adulteration provisions of Federal law that are covered by the
bill. The bill is not likely to have any practical impact on the
content or application of such State food laws. Separately, I would
note that H.R. 4167 completely excludes--and thus would not affect the
Federal and corresponding State provisions that are most often relied
upon by State and local inspectors to seize, embargo or otherwise take
immediate action against unsafe food (e.g., food held under unsanitary
conditions, product unfit for food).
Where State food safety and adulteration law is the same as the
Federal, States are only restricted in adopting adulteration-related
requirements that are already the subject of an FDA regulation or
``final guidance'' as that term is defined by Federal regulation. If
there is no FDA regulation or ``final guidance,'' States would be free
to apply their food safety laws to a circumstance as they see fit.
Finally, the bill, once enacted, cannot become effective until the
U.S. Department of Health and Human Services, in consultation with the
U.S. Department of Homeland Security certifies to Congress that
implementation of the new law would pose no additional risk to public
health or safety from terrorist attacks on the food supply. State and
local officials remain on the front-line in protecting our food supply
and their rapid response is left intact under H.R. 4167. Accordingly,
this office does not foresee any significant changes in how State and
local officials protect consumers.
I urge your support for the Senate version of H.R. 4167, when
introduced. The plain language of the bill suggests that a proper
balance between uniform, consistent Federal food safety policies and
requirements can be achieved without compromising the critical role
States play day-in and day-out in the marketplace.
Sincerely,
Jon Bruning,
Attorney General.
______
Bimbo Bakeries USA, Inc.,
Fort Worth, TX 76155-2861,
June 28, 2006.
Hon. Michael B. Enzi,
U.S. Senate,
Washington, DC 20510.
Dear Senator Enzi: On behalf of Bimbo Bakeries USA, Inc., I am
writing to urge you to support S. 3128, the ``National Uniformity for
Food Act of 2006.'' Senators Richard Burr (R-NC), Pat Roberts (R-KS),
and Ben Nelson (D-NE) introduced the legislation on May 25, 2006. On
March 8, the House passed their version of this legislation (H.R. 4167)
with a strong bipartisan vote of 283-139. I urge you to support this
critical piece of legislation.
S. 3128 provides for science-based uniform food safety standards
and warning requirements so that Americans in every State are protected
equally. It is common-sense legislation that will help consumers make
educated decisions for themselves and their families in an ever-
changing and confusing food labeling environment. Consumers deserve a
single standard when it comes to food safety, and this bill will allow
States and the FDA to work collaboratively in establishing sound food
safety policies that will benefit--not confuse--consumers.
The ``National Uniformity for Food Act'' is a top priority for the
baking industry. This critical legislation recognizes that it makes no
sense to have different States adopting various regulatory requirements
for identical food products. S. 3128 will instead provide consumers
with a single set of consistent, science-based food safety regulations
for food products sold in all 50 States.
Successful passage of the ``National Uniformity for Food Act'' is
absolutely critical to Bimbo Bakeries USA, Inc. and our employees. I
urge you to make its passage a top priority.
Thank you in advance for your consideration of my request to
support S. 3128.
Sincerely,
Joe T. Dangelmaier,
Senior Vice President of Operations,
Bimbo Bakeries USA, Inc.
______
National Association of Manufacturers (NAM),
Washington, DC 20004-1790,
July 13, 2006.
Hon. Michael B. Enzi,
U.S. Senate,
Washington, DC 20510.
Dear Senator Enzi: On behalf of the National Association of
Manufacturers (NAM), I urge you to cosponsor and strongly support S.
3128, the National Uniformity for Food Act.
The National Uniformity for Food Act will create national, uniform
standards for food safety labeling. Under current policy, there could
be 50 or more labeling standards, causing logistical and distribution
inefficiencies and, potentially, drawing concerns from our
international trading partners about labeling being used as a non-
tariff barrier to trade. Thus, S. 3128 is an appropriate congressional
exercise of the Constitution's Interstate Commerce Clause.
Some State officials have wrongly argued that their citizens will
lose protections if S. 3128 becomes law. Actually, States will retain
their ability to contribute to food safety information by petitioning
to have their current and new standards approved by the FDA. If a
petitioned standard is warranted, all consumers nationwide would
benefit rather than just the citizens of certain States.
Your cosponsorship of and support for S. 3128 would be appreciated.
Please let me or Larry Fineran, the NAM's vice president for legal and
regulatory reform, know if you have any questions or need additional
information. Mr. Fineran can be reached at (202) 637-3174 or
[email protected].
Sincerely,
John Engler,
President and CEO.
______
State of Arkansas,
State Capitol Building,
Little Rock, AR, 72201,
April 17, 2006.
Hon. Mark Pryor,
Hon. Blanche Lincoln,
U.S. Senate,
Washington, DC 20510.
Dear Senator Pryor and Senator Lincoln: I am contacting you to ask
for your support for legislation that has been introduced in the Senate
that would provide national, uniform food safety standards and warning
requirements for food. The National Uniformity for Food Act passed the
U.S. House of Representatives on March 8th by a vote of 283-139 with
bipartisan support.
If approved by the Senate, States could petition the U.S. Food and
Drug Administration (FDA) to adopt their food safety standards and
warning requirements nationally. If approved by the FDA, food
manufacturers would incorporate the requirements, thus providing all
consumers nationwide with the same information.
This is an opportunity for Congress to embrace a measure that would
ensure critical safety information about food products delivered to
consumers nationwide in a simplified fashion. Arkansas consumers
deserve more than a mixed message when it comes to important
information regarding food safety.
I have spent a great deal of time in recent years looking at
wellness and obesity issues in America. Maintaining a consistent
labeling system is important to all our citizens. This policy will also
protect Arkansas-based food manufacturers from having to deal with the
logistical nightmare of 50 labels for each product sold in the United
States.
Maintaining consumer confidence in food safety is an important
goal. The National Uniformity for Food Act is a step in the right
direction. For this reason, I respectfully ask for your support on this
measure.
Sincerely yours,
Mike Huckabee,
Governor.
______
Chamber of Commerce of the United States of
America,
Washington, DC 20062-2000,
June 13, 2006.
To the Members of the United States Senate: The U.S. Chamber of
Commerce, the world's largest business federation representing more
than 3 million businesses and organizations of every size, sector, and
region, strongly urges you to consider cosponsoring S. 3128, the
National Uniformity for Food Act, a similar version of which recently
passed the House with strong bi-partisan support. This legislation
would amend the Federal Food, Drug, and Cosmetic Act by extending
national uniformity to food safety and warning label laws.
With the enactment of this legislation, national uniformity would
be extended to one of the very few areas where it has been lacking:
food safety and warning labeling. Meat and poultry regulations,
nutritional labeling, and pesticide tolerance standards are all
regulated at the Federal level. Food safety and warning label
requirements, on the other hand, have been governed by a ``patchwork
quilt'' of State and local regulations. This collection of inconsistent
requirements is burdensome for food businesses and confusing for
consumers.
The National Uniformity for Food Act takes a commonsense, measured
approach to achieving national uniformity for food safety and warning
label requirements, striking an appropriate balance between national
and State interests. The legislation provides ample time for review and
harmonization of preexisting State rules, and establishes procedures
under which States can opt out of uniformity requirements. Furthermore,
this legislation does not impact the States' inspection and enforcement
authority over food safety and warning label requirements.
With the increase in new food sources from overseas, thousands of
new products introduced each year by domestic manufacturers, and faster
communications and transportation, the need for a national food safety
system is greater today than it was even 10 years ago. Consumers should
not have to endure conflicting standards that declare an identical food
product safe in one State, but hazardous in another.
The Chamber strongly urges you to consider cosponsoring S. 3128,
the National Uniformity for Food Act, and looks forward to a hearing on
this bill in the near future.
Sincerely,
R. Bruce Josten,
Execitive Vice President,
Government Affairs.
______
International Dairy Foods Association (IDFA),
July 25, 2006.
Hon. Michael Enzi,
Chairman,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, DC 20510.
Hon. Edward Kennedy,
Ranking Member,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, DC 20510.
Dear Chairman Enzi and Ranking Member Kennedy: On behalf of the
International Dairy Foods Association, I am writing to ask for your
support of the National Uniformity for Food Act, S. 3128, which was
referred to the Senate Health, Education, Labor, and Pensions Committee
(HELP) in March. This important bill would create a uniform, national
system that recognizes the role of State and local governments in the
regulation of food products and integrates them into the national
system.
The International Dairy Foods Association (IDFA) represents the
Nation's dairy manufacturing and marketing industries and their
suppliers, with a membership of 530 companies representing a $90-
billion a year industry. IDFA is composed of three constituent
organizations: the Milk Industry Foundation (MIF), the National Cheese
Institute (NCI) and the International Ice Cream Association (IICA).
IDFA's 220 dairy processing members run more than 600 plant operations,
and range from large multi-national organizations to single-plant
companies. Together they represent more than 85 percent of the milk,
cultured products, cheese and frozen desserts produced and marketed in
the United States.
We ask you to consider the following points when the HELP Committee
hears S. 3128 on Thursday, July 27. Current individual State
regulations create an unwieldy national patchwork of standards, which
oftentimes confuse consumers about the food they eat and the beverages
they drink. Under the current system, food regulation is composed of a
variety of different and sometimes inconsistent requirements. S. 3128
seeks to harmonize these differences to achieve a more uniform and
national system. Consistency in labeling is vital to dairy processors
that sell their products in multiple States and want to provide the
clearest information to American consumers.
This legislation provides for science-based uniform food safety
standards and warning requirements so that Americans in every State are
protected equally. Under the bill, the Federal requirements would take
effect gradually and provide for thorough review of existing State
regulations. The bill allows for the States to petition the Food and
Drug Administration to adopt their regulations as national requirements
or exempt them from national uniformity. This legislation would not
undo current safety regulations, as opponents have claimed, for
products such as milk.
Congress has repeatedly recognized the importance of uniformity in
food regulation. The Nutrition Labeling and Education Act (1990), the
Food Quality Protection Act (1996), the Poultry Products Inspection Act
and the Meat Inspection Act are examples of policies containing
uniformity provisions. The House has already acted on this important
legislation and passed the bill with a strong bipartisan vote of 283-
139.
I urge you to join the list of cosponsors of S. 3128, the National
Uniformity for Food Act, and ultimately vote ``yes'' on this critical
legislation. Feel free to contact me directly for more information at
(202) 737-4332.
Sincerely,
Chip Kunde,
Senior Vice President,
Legislative and Economic Affairs.
______
Hispanic Association on Corporate Responsibility
(HACR),
Washington, DC 20005,
June 22, 2006.
Hon. Bill Frist,
Majority Leader,
U.S. Senate,
Washington, DC 20510.
Dear Senator Frist: On behalf of the Hispanic Association on
Corporate Responsibility (HACR), one of the most influential advocacy
organizations in the Nation representing 14 national Hispanic
organizations, I am writing to urge you to support S. 3128, the
``National Uniformity for Food Act of 2006.'' Senators Richard Burr (R-
NC), Pat Roberts (R-RA), and Ben Nelson (D-NE) introduced the
legislation on May 25, 2006. On March 8, the House passed the
legislation (H.R. 4167) with a strong bipartisan vote of 283-139.
This legislation recognizes that it makes no sense to have
different States adopting different regulatory requirements on
identical food products. S. 3128 will instead provide consumers with a
single set of consistent, science-based food safety regulations for
food products sold in all 50 States.
Under the current system, food regulations are composed of
different and sometimes contradictory requirements. This imposes
unnecessary complexity and cost on makers of food throughout the United
States. These costs are most often passed on to consumers. By bringing
a uniform code, the legislation represents a major step towards
ensuring consumer confidence in the food they buy for their families.
S. 3128 takes a measured approach to national uniformity for food
by providing a mechanism for a thorough, orderly review of existing
State regulations that may differ from Federal regulations. By granting
States the ability to have the Federal Government adopt their standard,
this bill carefully balances the need for uniformity while respecting
the important role State and local governments have in ensuring the
safety of the food supply.
Founded in 1986, HACR is one of the most influential advocacy
organizations in the Nation representing 14 national Hispanic
organizations in the United States and Puerto Rico. Our mission is to
advance the inclusion of Hispanics in corporate America at a level
commensurate with our economic contributions. To that end, HACR focuses
on four areas of corporate responsibility and community reciprocity:
employment, procurement, philanthropy, and governance.
Once again, we urge you to support this legislation. Thank you for
your time and consideration.
Sincerely,
Carlos F. Orta,
President and CEO.
______
Council for Citizens Against Government Waste,
Washington, DC 20036,
June 19, 2006.
U.S. Senate,
Washington, DC 20510.
Dear Senator: On behalf of the more than 1.2 million members and
supporters of the Council for Citizens Against Government Waste
(CCAGW), I urge you to support S. 3128, the ``National Uniformity for
Food Act of 2005.'' S. 3128 would harmonize inconsistent State
requirements by providing national, uniform food safety standards and
warning requirements.
Under the current system, States may impose different, and
sometimes contradictory, regulations. This imposes unnecessary
complexity and cost on food processors and manufacturers throughout the
United States. These costs are most often passed on to consumers. In
addition, taxpayers in the various States bear the burden for
administration of these unnecessary and duplicative regulations.
It does not make sense to have States adopting different regulatory
requirements on identical food products. S. 3128 will provide consumers
with a single set of consistent, science-based safety regulations for
food products in the entire country. The legislation provides that
where the Food and Drug Administration (FDA) has established a safety
standard, the States would adopt and enforce the same standard. If the
FDA has not set a safety standard for a particular food ingredient, the
States would remain free to set and enforce their own standards.
The National Uniformity for Food Act takes a measured approach by
providing a mechanism for a thorough, orderly review of existing State
regulations that may differ from Federal regulations. By providing
States with the ability to petition for adoption at the Federal level
any existing State food safety or warning requirements, the legislation
carefully balances the need for uniformity while at the same time
recognizing the role that State and local governments have in ensuring
the safety of the Nation's food supply.
Any votes on S. 3128 will be among those considered in CCAGW's 2006
Congressional Ratings.
Sincerely,
Thomas A. Schatz,
President.
______
Letters of Opposition
California League of Conservation Voters, California League for
Environmental Enforcement Now, CALPIRG, Center for Food Safety, Center
of Science in the Public Interest, Coalition for Clean Air, Consumer
Action, Consumer Federation of California, Consumers Union, Environment
California, Environment Law Foundation, Environmental Working Group &
EWG Action Fund, Friends of the Earth, GotMercury.Org, Greenpeace,
Healthy Children Organizing Project, National Environmental Trust,
Natural Resources Defense Council, Oceana, Physicians for Social
Responsibility, Sierra Club, Union of Concerned Scientists, U.S. Public
Interest Research Group, United Steelworkers
June 7, 2006.
U.S. Senate,
Washington, D.C. 20510.
Dear Senator: On behalf of our millions of members and supporters,
we strongly urge you to support the safety of America's food supply by
opposing and refusing to cosponsor the so-called ``National Uniformity
for Food Act of 2005,'' S. 3128. This legislation, more appropriately
labeled the ``State Food Safety Preemption Act,'' tinkers with--but in
some respects is actually worse than--the hastily-passed House food
safety preemption bill, H.R. 4167.
For example, the Senate bill explicitly deletes the House's
provision--adopted on the floor as the Wasserman-Shultz amendment by a
vote of 253-168--allowing States to retain warnings to pregnant women
and parents about the significant risks to the brains of fetuses and
young children from high levels of mercury in certain kinds of fish.
Consumer Reports (published by Consumers Union) just published an
article on the risk of mercury in tuna, which we have attached to this
letter. The U.S. Food and Drug Administration (FDA) warns on its Web
site that pregnant women and young children should avoid certain fish
due to high mercury levels, but under S. 3128 State-required warnings
about these risks--even one identical to the Federal FDA warning--would
be preempted.
In this and many other ways, S. 3128 undermines public health
protection. The Senate bill makes other minor changes to the House
legislation, but none alter the fundamental thrust of the bill, which
is to stop States from protecting their citizens from dangers in the
food supply when the Federal Government is not doing so. This bill has
been introduced repeatedly for many years, yet no public hearings have
been held on it, and we are confident it cannot withstand public
scrutiny.
The vast majority of editorial writers, State officials,
environmental, consumer, health, labor and other groups strongly oppose
this problematic legislation (see attached). For example, State and
local food safety officials and 39 Attorneys General have weighed in
against the House bill because it would nullify critically-important
consumer and health protections and right-to-know requirements.
Similarly, at least eight governors, including Governor Schwarzenegger,
oppose the bill. The preempted State and local rules protect consumers
by filling the gaps left by the understaffed and underfunded FDA.
States would no longer have the authority to provide important
protections for the public, such as shellfish, milk, and egg safety
standards--unless the FDA grants a State waiver. This seriously
undermines food safety and offends longstanding principles of
federalism. Preemption of State food safety laws is opposed by the
National Association of State Departments of Agriculture and the
Association of Food and Drug Officials (AFDO). AFDO points out that
this bill, if enacted, ``will effectively eliminate our Nation's
biosecurity shield, and will undermine our whole food safety and
biosurveillance capability.''
The waiver process of the legislation would impose huge financial
burdens on the financially-strapped FDA and States. The CBO estimated
that this legislation would require the FDA to spend $100 million (over
5 years) reviewing over 240 waiver requests. Moreover, States would
incur substantial legal and technical expenses in seeking an FDA
waiver. These Federal and State resources could be better used in
promoting food safety.
We urge you to oppose this rollback of State and local food safety
programs.
Sincerely,
Susan Smartt, Executive Director, California League of Conservation
Voters; Joseph H. Guth, J.D., Ph.D., Executive Director, California
League for Environmental Enforcement Now; Emily Clayton, Public Health
Advocate, CALPIRG; Will Rostov, Senior Attorney, Center for Food
Safety; Benjamin Cohen, Senior Staff Attorney, Center of Science in the
Public Interest; Tim Carmichael, President and CEO, Coalition for Clean
Air; Linda Sherry, Director of National Priorities, Consumer Action;
Richard Holober, Consumer Federation of California; Susanna
Montezemolo, Policy Analyst, Consumers Union; Rachel L. Gibson,
Environmental Health Advocate & Staff Attorney, Environment California;
James R. Wheaton, Esq., President, Environment Law Foundation; Bill
Walker, Vice President/West Coast, Environmental Working Group & EWG
Action Fund; Sara Zdeb, Legislative Director, Friends of the Earth; Eli
Saddler, JD, MPH, MA, Public Health Analyst, GotMercury.Org; Rick Hind,
Legislative Director, Greenpeace; Neil Gendel, Project Director,
Healthy Children Organizing Project; Karen Steuer, Vice President,
National Environmental Trust; Erik Olson, Advocacy Center Director,
Natural Resources Defense Council; Ted Morton, Legislative Director,
Oceana; Will Callaway, Legislative Director, Physicians for Social
Responsibility; Ed Hopkins, Director of the Environmental Quality
Program, Sierra Club; Susan Prolman, J.D., Washington Representative,
Union of Concerned Scientists; Anna Aurillio, Legislative Director,
U.S. Public Interest Research Group; Roxanne D. Brown, Legislative
Representative, United Steelworkers.
[Editor's Note: Due to the high cost of printing, previously
published materials submitted by witnesses are not reproduced. The
article, ``Mercury in Tuna'' may be found at ConsumerReport.org.]
______
U.S. Public Interest Research Group,
Washington, DC 20003,
May 4, 2006.
Dear Senator: On behalf of the 30 State Public Interest Research
Groups (PIRGs) across the country, we are writing to urge you to oppose
the National Uniformity for Food Act, which passed the House on March
8. This bill, as passed by the House, would nullify at least 200
effective State and local food safety and right-to-know requirements,
leaving a critical gap in the food safety net that protects public
health and consumer choice.
This bill does not establish uniform food safety and labeling
requirements; instead, it simply eliminates proven food safety and
labeling standards that are more protective than Federal standards,
even when the Federal Government has done nothing. In effect, the bill
asks American consumers to trust that an increasingly unresponsive and
under-funded Federal bureaucracy will enact adequate food safety and
labeling standards that fully inform and protect them. Unfortunately,
this often is not the case.
In the absence of adequate Federal regulations, numerous State and
local governments have passed strong laws designed to safeguard public
health, ensure a safe supply of food, and give consumers the
information they need and deserve. Laws at risk of preemption include
milk safety and restaurant sanitation standards in all 50 States;
shellfish safety standards in 16 States; laws in 17 States requiring
bars and liquor stores to post signs warning pregnant women of the
effects of drinking alcohol; laws in 15 States allowing the States to
enact stricter standards for food additives; and scores of laws that
require food manufacturers to truthfully label their products.
In addition to nullifying proven food safety laws already on the
books, this bill would forever tie the hands of States and
municipalities on a range of emerging food safety issues, whether or
not the Federal Government has addressed public health concerns.
Federal legislation preempting State law would affect dozens of
States, but the law that started the food industry's crusade is
California's Proposition 65. In 1986, California voters approved
Proposition 65, which requires warning labels on products containing
chemicals known to cause cancer or birth defects. Consumers have the
right to know if their food contains dangerous chemicals, and States
and localities have the right to provide this information in the
absence of strong Federal standards. Although critics of Proposition 65
say varying State standards pose a burden to food manufacturers, past
administrations have dismissed this claim. When asked by the food
industry to preempt California's law, President George H.W. Bush's
administration concluded in 1989 that ``no Federal preemptive action--
either by regulation or otherwise--is warranted.'' The Reagan-Bush
administration came to the same conclusion, and this is why Governor
Arnold Schwarzenegger of California has opposed this bill.
Although the bill provides States with a limited opportunity to
petition the Food and Drug Administration (FDA) to keep State laws on
the books, the petition process is slow, uncertain, and expensive. In
fact, the Congressional Budget Office estimates that this bill would
cost FDA at least $100 million over a 5-year period. FDA does not have
the staff or financial resources to absorb these costs. In fact, the
number of full-time FDA employees dealing with food safety has fallen
steadily from 3,167 in fiscal year 2003 to 2,843 in fiscal year 2006;
the president's proposed fiscal year 2007 budget for FDA would further
reduce that number to 2,757.
Eight Governors, 39 Attorneys General, the National Conference of
State Legislatures, National Association of State Departments of
Agriculture, Association of Food and Drug Officials, and others from
both political parties have come out in sharp opposition to this bill,
as it would usurp power from those best-positioned to serve as the
first line of defense against threats to our food supply: States and
localities. Oppose the National Uniformity for Food Act to preserve the
State and local laws so critical to the safety of our food supply.
Sincerely,
Anna Aurilio,
Legislative Director.
______
State of New York,
Department of Agriculture and Markets,
March 1, 2006.
Dear Member of New York State Delegation: I am writing to express
my concern for H.R. 4167, the National Uniformity for Food Act, as
currently written. This bill could make it more difficult for States
like New York with strict food safety regulations to protect our food
supply.
As you know, the current food safety regulatory system in the
United States is the shared responsibility of local, State and Federal
partners. Local and State agencies currently perform approximately 80
percent of the food safety work across the Nation and Federal agencies
often seek assistance from local/state partners in dealing with
imminent health hazards. Therefore, it is imperative that States have
the right to act quickly to enact laws and issue rules that address
local and statewide public health concerns that cannot be anticipated
or are not adequately addressed nationally.
In addition to preempting State laws relating to food safety
warnings, H.R. 4167 would require States to change their laws to be
identical to the Federal Food, Drug, and Cosmetic Act (FDCA).
If this proposed legislation is enacted, the Association of Food
and Drug Officials anticipates the following:
State enforcement action related to adulterated food or misbranding
would be open to challenge. Variations in language currently exist
between many of New York's food laws, relating to adulterated food and
additives, and the respective Federal counterpart. Under this proposed
legislation, States will be required to seek clarity to determine if
New York laws are ``identical'' to Federal law through an appeals
process with the U.S. Food and Drug Administration (FDA). During this
process, the States' enforcement attempts to ensure food safety and
security will be open to legal challenge by anyone who violates State
food safety provisions. This fact is problematic at a time when the
Nation is forced to address current problems such as ``mad cow''
disease (State food safety laws cover adulterated animal feed), unsafe
food or food ingredients, and possible terrorist threats to the
Nation's food supply. If passed into law, H.R. 4167 has the potential
to deregulate food safety requirements at a time when quick food safety
action could prove crucial to protecting the public. In the past, FDA
has typically acted months after a food safety concern has occurred
where New York State has taken action quickly to protect our consumers.
New York State's ability to enforce food safety laws would be
hampered. Currently, there is very limited food inspection and
corrective action taken in New York by Federal authorities. The New
York State Department of Agriculture and Markets has coordinated over
1,000 food recalls in the past 3 years. If H.R. 4167 is passed, the New
York law authorizing the quarantine or seizure of misbranded or
adulterated food could be unenforceable. Due to the broad wording
relating to the ``construction'' provision in this proposed Federal
law, New York could be left without any means to keep contaminated food
from entering the Nation's food supply.
Food inspection enforcement laws relating to grade A milk, grocery
stores and shellfish would be preempted. Currently there are no Federal
laws governing the inspection and regulation of grade A milk production
for interstate commerce, shellfish harvesters and processors, or
regulation of retail food establishments like grocery stores and
restaurants. By failing to specifically reference these code sections
in the bill, States are left to assume that State regulations, relating
to inspection and enforcement of these programs, may be preempted
because there are no Federal laws governing these program areas. These
food safety areas would then be left unregulated.
For the above reasons, I ask you to work with us to amend H.R. 4167
to ensure that New York's strong food safety programs remain intact so
that our food supply remains as safe as possible. Please let me know if
we can provide any additional information or assistance.
Sincerely,
Patrick H. Brennan,
Commissioner.
______
The National Association of State Departments of
Agriculture,
Washington, DC 20005,
June 1, 2006.
Members of the U.S. Senate.
Dear Senators: The National Association of State Departments of
Agriculture (NASDA) is writing to express our strong opposition to S.
3128, the National Uniformity for Food Act. NASDA represents the
commissioners, secretaries and directors of agriculture in the 50
States and four territories, and we are partners in the Nation's food
safety system.
The State Departments of Agriculture are very concerned that this
legislation goes far beyond its stated purpose of providing uniform
food safety warning notification requirements and greatly expands
Federal preemption under the Food, Drug and Cosmetics Act. This
preemption would seriously compromise our ability to enact laws and
issue rules in numerous areas of food safety. Specifically, we believe
the bill as currently written threatens existing State food safety
programs and jeopardizes State/Federal food safety cooperative programs
such as those related to Grade A milk, retail food protection, and
shellfish sanitation. We simply disagree with recent analyses which
claim that State laws and regulations will not be undermined by this
legislation.
Our current food safety regulatory system is the shared
responsibility of local, State and Federal partners. Approximately 80
percent of food safety inspections in the United States are completed
at the State and local level. It is imperative that States retain their
traditional right to address local and statewide public health concerns
that cannot be anticipated or are not adequately addressed nationally.
The preemption embodied in this legislation is broad, vague and
sweeping. It calls into question the authorities of State and local
laws that address adulterated foods, animal feed, and antiterrorism and
other food defense programs. It will leave a critical gap in the safety
net that protects consumers.
We are dismayed that Congress has not held any hearings on these
important issues, especially since the legislation would radically
change the traditional allocation of power between States and the
Federal Government. NASDA urged the House of Representatives to hold
hearings on similar legislation, and we were extremely disappointed
when this did not happen. We call on the Senate to hold hearings before
taking further action on S. 3128 and to seek full input from State and
local partners in our food safety system.
NASDA would welcome the opportunity to discuss ways the legislation
could be amended to achieve its intent without dismantling critical
food safety regulatory programs at the State and local level. We
respectfully request that you oppose S. 3128 until these critical
issues are fully addressed.
Sincerely,
J. Carlton Courter III,
President, NASDA,
Commissioner, Virginia Department of Agriculture
& Consumer Services.
______
The City of New York,
Department of Health and Mental Hygiene,
Office of the Commissioner,
New York, NY 10013,
April 11, 2006.
Hon. Hillary Clinton,
U.S. Senate,
Washington, DC 20510.
Dear Senator Clinton: I am writing to advise you of the very
serious impact that enactment of H.R. 4167, the ``National Uniformity
for Food Act,'' would have on public health and safety in New York
City. We join a broad spectrum of groups, including attorneys general
and State agriculture commissioners, who strongly oppose this bill.
This act would encroach upon State and local governments' inherent
power to act to protect the public health of their citizens. Moreover,
by preempting local authority to seize, embargo and condemn adulterated
food, it would seriously undermine the ability of New York City and
other localities to respond immediately to the threat of terrorist
activity affecting the food supply. Enactment of this bill, which
passed the House of Representatives without public hearings, would have
serious consequences that may not be intended or clearly understood by
some of its proponents. I urge you to request that the appropriate
Senate committees hold hearings and carefully review its impact. The
bill, in its present form, should not be adopted by the Senate.
This legislation would go far beyond regulation of food labeling.
It preempts State and local governments from enforcing laws regarding
adulterated food that are not ``identical'' to Federal laws, creating a
serious obstacle to our ability to protect the public from dangerous
conditions that the Federal Government has not yet regulated. The power
to act on local authority is of particular importance to New York City
and other localities with multicultural populations that create a
market for imported specialty foods and products. These products may be
rare and unique to certain nationalities and cultures, and often
present hazards that have not been anticipated or adequately addressed
either by State or national governments. For example, when imported
candies contaminated with lead were found in the city, a city law was
enacted banning the sale of such products, because Federal regulatory
efforts had been inadequate to stop these contaminated products from
entering the country.
In addition, the bill may prevent local governments from enacting
and enforcing even laws ``identical'' to Federal law. The definition of
``identical'' in section 403A refers to a law ``of a State or a
political subdivision'' that uses ``substantially the same language as
the comparable provision'' under H.R. 4167, and where ``any differences
in language do not result in the imposition of materially different
requirements.'' This language by itself would create endless
challenges, confusion, and litigation as to whether any given law meets
the ``identical'' standard. Moreover, while the definition refers to
local as well as State laws, the operative provision states only that a
``State or political subdivision of a State may enforce a State law''
meeting the ``identical'' standard; there is no provision for enforcing
a local law which meets that standard. This inconsistency in the
drafting of the statute creates serious doubt about the ability of
local governments to enforce a wide range of laws concerning food
safety. New York City, which has had a longstanding and critical role
in protecting its residents from adulterated food, is particularly
impacted by this legislation.
New York City has a comprehensive body of law regarding food
safety, and the city's Department of Health and Mental Hygiene has the
primary responsibility for these matters in the city. These activities
are at the very core of the mission of local health departments and
must be preserved, especially in view of New York city's
disproportionate risk for future terrorist attacks, including the
threat of deliberate contamination of our food supply.
As the Supreme Court stated more than 125 years ago in Sherlock v.
Ailing, 93 U.S. 99, 103 (1876),
``In conferring upon Congress the regulation of commerce, it
was never intended to cut the States off from legislating on
all subjects relating to the health, life and safety of their
citizens, though the legislation might indirectly affect the
commerce of the country.''
As recent events have proven, local governments are ultimately
responsible for the safety of their citizens, and must continue to have
the necessary tools to fulfill this responsibility.
Enclosed is an analysis of the impact of this bill on New York
City, as well as news articles and letters from other public officials
and experts expressing concerns about this legislation. I appreciate
your continued interest in this critical issue.
Sincerely,
Thomas R. Frieden, M.D., M.P.H.,
Commissioner.
______
New York City Position on H.R. 4167, The National Uniformity
for Food Act of 2005
New York City strongly opposes this legislation. If enacted, H.R.
4167, by preempting local authority to seize, embargo and condemn
adulterated food, would seriously undermine the ability of New York
City and other localities to protect citizens from unsafe food and to
respond immediately to the threat of terrorist activity affecting the
food supply.
New York City's Department of Health and Mental Hygiene (DOHMH) is
responsible for supervising and regulating the food supply in New York
City. [New York City Charter 556(a)(9)]. Food establishments in New
York City are licensed and regulated by DOHMH in accordance with
Article 81 of the New York City Health Code.
DOHMH is also authorized by existing local law to seize, embargo or
condemn food that is adulterated or otherwise constitutes a danger to
public health [New York City Health Code 3.03(a) and 71.11]. These
authorities are essential public health tools that DOHMH has used for
many decades to protect the citizens of New York City. DOHMH must be
able to continue this critical public health activity, especially in
light of New York City's disproportionate risk for future terrorist
attacks, including the threat of deliberate contamination of our food
supply.
The following are examples of actions that New York City's DOHMH
has taken and that would be preempted by H.R. 4167 or be subject to
legal challenges that would result in dangerous delays and costly
litigation. Law in such critical areas of public health should not be
left unsettled and unclear. The authority to act needs to be
unequivocal.
In March 2005, DOHMH linked certain imported cheeses to
infection by Mycobacterium bovis, a form of tuberculosis found in
cattle; 35 cases, including the death of an infant, were attributed to
M. bovis tuberculosis. The city monitored certain markets to assure
that no contaminated cheese was sold.
In December 2005, DOHMH used its powers under the city's
Health Code to embargo certain imported herbal products that contained
lead or mercury after several cases of adult lead poisoning were
confirmed among residents who used these products. Although there were
National Academy of Science recommendations about tolerance levels,
there were--and continue to be--no specific Federal standards. In
previous years, DOHMH had also ordered the cessation of sale of an
herbal tea that contained high concentrations of lead and arsenic.
While an amendment in the House-passed version of H.R. 4617 exempts
regulation of dietary supplements from preemption, it is unclear
whether food products containing dietary supplements would be similarly
exempted.
In October 2005, following a sewage backup in a
manufacturing establishment in which specialty desserts and candies
were made, DOHMH used its powers under the city's Health Code to order
the owner to cease production and thoroughly clean the processing area.
DOHMH embargoed and ultimately destroyed the contaminated products.
In August 2004, DOHMH issued a warning to city residents
to avoid eating certain candies and food products made in Mexico that
had been found to contain lead. DOHMH, based on its authority under the
Health Code, and in cooperation with New York State authorities,
inspected and tested these products. These actions, along with actions
by other States and localities, resulted in a voluntary recall by a
candy manufacturer. Because any increase in lead exposure to New York
City's children is a serious public health concern, the New York City
Council subsequently adopted a law banning sale of candy products
containing lead. This action was prompted by concerns about the
inadequacy of Federal regulatory efforts to set allowable safety limits
for lead in food products and stop contaminated products from entering
the country.
In 1999, reports of food-related illnesses were traced to
salmonella bacteria in cheese blintzes prepared and sold by a local
retail food manufacturer. DOHMH used the power of the Health Code to
order the retailer to cease production of the blintzes and to destroy
all contaminated products.
In 1991, DOHMH, under the authority of the City Charter
and the Health Code, ordered the surrender of shellfish that had been
identified as the source of several cases of cholera.
______
KEY PROVISIONS OF H.R. 4167 THAT WOULD IMPACT NEW YORK CITY'S FOOD
SAFETY PROGRAM
The bill amends 21 USCA 343-I, the National Uniform Nutrition
Labeling Act. The proposed amendments, however, go well beyond
regulation of labeling. The bill would prevent a State or locality from
enforcing requirements for adulterated foods that are also regulated by
Federal law when the State or local requirement is not ``identical'' to
a Federal requirement. This invites litigation about whether a State or
local requirement meets the ``identical' standard and will thereby
seriously undermine the ability of State and local governments to
enforce laws of great importance to public safety.
It is unclear whether a State or locality would continue to have
any authority to act regarding adulterated food in the absence of a
Federal requirement addressing the relevant type of adulteration. An
amendment to section 2 of the bill seemingly authorizes States and
localities to act in some such cases, but the amendment is made to a
section that still refers to enforcement of a State law that is
``identical'' to a requirement in Federal law, thereby creating
confusion about whether an ``identical'' Federal requirement is a
prerequisite to State or local action. Denying State and local
governments the ability to protect their citizens from threats in the
food supply that the Federal Government has not addressed is clearly
not in the public interest.
Section 403A(c)(2) of H.R. 4167 establishes circumstances under
which a State or political subdivision of a State may enforce a State
law regarding adulteration, and says nothing about enforcement of a
local law, even though the definition of ``identical'' laws does refer
to laws of a political subdivision as well as to laws of a State. New
York City has a comprehensive body of city law regarding food safety.
Given New York City's population, which includes citizens from every
part of the world, the unique cultural and ethnic foods that are
imported and consumed by these populations, and New York City's
disproportionate risk for future attacks or deliberate contamination of
food, enforcement of local law must be recognized. Many imported
specialty foods may present public health hazards that have not been
anticipated or adequately addressed either by State or national
governments. Local governments, as first responders, would be in the
best position to quickly identify, investigate and remove harmful
products from the local food supply.
Section 403B(a)(3) of the bill is also of great concern to DOHMH.
This provision states that section 403B should not be construed to
prevent a State from embargoing adulterated food pursuant to a State
requirement identical to a Federal food adulteration requirement, but
again fails to recognize the need of a locality to take such action, or
to act pursuant to a local law. These activities (i.e., seizure,
embargo of adulterated food) are at the very core of the mission of
local health departments and must be preserved, not preempted.
H.R. 4167 attempts to address the threat of an imminent hazard by
explicitly allowing States--but again, not localities--to impose
requirements for adulterated foods or take action that would otherwise
violate the proposed uniformity requirement in 403B(a), but only upon
satisfying various conditions (for example, submission of a petition).
This process would be unduly burdensome and is unreasonable in
situations involving an imminent threat to public health, when
immediate action is necessary. New York City's health authority must be
able to protect its citizens without having to comply with additional
layers of bureaucracy.
Immediately after 9/11, DOHMH intensified its surveillance for
food-related illnesses because of concern about the potential for
terrorist activity involving the food supply. If the provisions of H.R.
4167 had been in effect at that time, the city would likely have been
powerless to embargo potentially harmful food, even if our surveillance
system had detected a serious threat. We have strengthened and enhanced
that system, and it is now a model for the Nation. However, this
legislation, if enacted, would compromise our ability to use our model
system to respond quickly and preserve the public health.
Enactment of H.R. 41671, which passed the House of Representatives
without public hearings, will have serious consequences that may not be
intended or clearly understood by some of its proponents. I urge you to
request that the appropriate Senate committees hold hearings and
carefully review its impact. The bill, in its present form, should not
be adopted by the Senate.
______
State of Connecticut, Department of Agriculture,
Office of the Commissioner,
Hartford, CT 06106,
August 4, 2006.
Hon. Christopher Dodd,
Putnam Park,
100 Wethersfield, CT 06109.
Dear Senator Dodd: I am writing to you on behalf of Governor Roll
to urge your rejection of S. 3128 ``National Uniformity for Food Act of
2006.''
The Connecticut Department of Agriculture (CT DOA) has the
following concerns regarding S. 3128, known as the ``National
Uniformity for Food Act of 2006'':
Potential preemption of State and local food safety
authority particularly in the area of dairy products including yogurt
and cheese, more specifically locally produced product, and locally
grown and harvested shellfish, all of which CT DOA regulates.
CT DOA has concerns about the economic impact the passage
of this bill may have on its local producers of dairy product and
shellfish in terms of new or additional labeling requirements and also
Connecticut Grown promotional labeling.
CT DOA is uncertain about the impact of the bill on intra-
state commerce for example labeling of Connecticut grown/produced food
products at Connecticut farmers' markets.
At this point in time, we are not convinced that this bill is in
the best interests of, primarily Connecticut's agricultural industry,
and secondarily, the citizens of the State of Connecticut.
It is my understanding that the Connecticut Department of Consumer
Protection also has concerns and you may be hearing from them in a
separate communication.
It is for these reasons I urge your careful consideration and
rejection of S. 3128. Thank you for the opportunity to comment.
Sincerely,
F. Philip Prelli,
Commissioner.
______
National Association of Attorneys General,
Washington, DC 20002,
March 2, 2006.
Dear Members of Congress: On March 1, 2006, we sent to you a sign-
on letter by 37 Attorneys General in opposition to H.R. 4167, the
``National Uniformity for Food Act.'' Attorneys General Wayne Stenehjem
of North Dakota and Malaetasi M. Togafau of American Samoa would like
to join their colleagues in supporting this issue, so attached is the
revised letter which includes their signatures. Thus, a total of 39
Attorneys General have signed on to the March 1 letter.
Sincerely,
Lynne Ross,
Executive Director.
______
National Association of Attorneys General,
Washington, DC 20002,
March 1, 2006.
Dear Members of Congress: We write to urge you to oppose the
``National Uniformity for Food Act,'' H.R. 4167, 109th Cong. (2005)
which undercuts States' rights and consumer protection. This bill,
which the House Energy and Commerce Committee approved on December 15,
2005, would preempt all existing and future State and local food
labeling requirements that expressly or indirectly imply that a
particular food or its packaging ``presents or may present a hazard to
health or safety'' unless identical to Food and Drug Administration
requirements. Indeed, under this bill, States would be forbidden from
adopting their own policies, even if the Federal Government had not
acted in a particular area or adopted a particular warning. Important
consumer warnings dealing with mercury in fish, arsenic in drinking
water, and lead in cans are just a few examples of States food labeling
requirements that would be eviscerated by this bill.
Food safety has been largely a matter of State law and oversight
for well more than a century. State and local agencies perform more
than 80 percent of food safety work, with Federal agencies often
seeking their assistance. There is nothing in the public record showing
that Federal uniformity in this area provides a greater level of
protection to consumers or is in the public interest. Indeed, although
this bill would radically change the traditional allocation of power
between the States and the Federal Government, it has never been the
subject of public hearings.
This bill would strip State Governments of the ability to protect
their residents through State laws and regulations relating to the
safety of food and food packaging. Some of the more obvious state-level
warnings that almost certainly would be challenged include consumer
warnings about mercury contamination of fish, arsenic in bottled water,
lead in ceramic tableware, the alcohol content in candies, the content
of fats and oils in foods, and post-harvest pesticide application to
fruits and vegetables. Unscrupulous merchants could contend that this
bill immunized their false claims of health benefits ascribed to their
products from State prohibitions or remedies such as laws barring
deceptive advertising of food. The same could occur with regard to
inadequate warnings regarding a child's use of a product.
While H.R. 4167 provides States with a limited opportunity to
petition the Federal Government for authorization to take action in a
particular area, the petition process is slow, expensive and uncertain,
and certainly is no substitute for allowing States their traditional
role of taking action on their own to protect consumers. The bill would
create a new Federal bureaucracy dedicated to evaluating, judging and
even invalidating proposed State and local laws, a startling change in
State-Federal relations in the food safety area.
Without question, the target of this bill is California's
Proposition 65, which was approved by California voters by initiative
in 1986 and provides consumers with health and safety information
concerning foods they may purchase and eat. There is no evidence that
this popular initiative has harmed consumers or merchants.
The Association of Food and Drug Officials, an organization
comprised of State regulators with responsibility for ensuring food
safety since 1896, strongly opposes this bill and, on January 16, 2006
wrote:
passage of this bill would undermine proven consumer protection
programs . . . [t]he preemption provisions are broad, vague and
sweeping and will likely dismantle the authority of State and
local laws that address adulterated foods--which include food
laws, dairy laws, animal feed laws, other agricultural
commodity laws, anti-tampering laws, anti-terrorism laws, etc.:
Letter from Association of Food and Drug Officials regarding H.R.
4167 to the Honorable Mike Rogers, January 16, 2006 (copy attached).
We need all levels of government to work together to protect food
safety. State and local governments are often the first line of defense
when problems emerge. Prohibiting State and local leadership and action
in this area is a serious mistake. We respectfully request that you
oppose H.R. 4167.
Sincerely,
Eliot Spitzer, Attorney General, New York; Mark J. Bennett,
Attorney General, Hawaii; David W. Marquez, Attorney General, Alaska;
Malaetasi M. Togafau, Attorney General, American Samoa; Terry Goddard,
Attorney General, Arizona; Bill Lockyer, Attorney General, California;
Richard Blumenthal, Attorney General, Connecticut; Carl C. Danberg,
Attorney General, Delaware; Robert Spagnoletti, Attorney General,
District of Columbia; Lawrence Wasden, Attorney General, Idaho; Lisa
Madigan, Attorney General, Illinois; Tom Miller, Attorney General,
Iowa; Greg Stumbo, Attorney General, Kentucky; Charles Foti, Attorney
General, Louisiana; G. Steven Rowe, Attorney General, Maine; J. Joseph
Curran, Jr. Attorney General, Maryland; Tom Reilly, Attorney General,
Massachusetts; Mike Cox, Attorney General, Michigan; Mike Hatch,
Attorney General, Minnesota; Jim Hood, Attorney General, Mississippi;
Jeremiah W. Nixon Attorney General, Missouri; Mike McGrath, Attorney
General, Mississippi; George J. Chanos; Attorney General, Nevada; Kelly
Ayotte, Attorney General, New Hampshire; Zulima V. Farber, Attorney
General, New Jersey; Patricia A. Madrid, Attorney General, New Mexico;
Wayne Stenehjem, Attorney General, North Dakota; W.A. Drew Edmondson,
Attorney General, Oklahoma; Hardy Myers, Attorney General, Oregon;
Patrick Lynch, Attorney General, Rhode Island; Henry McMaster, Attorney
General, South Carolina; Larry Long, Attorney General, South Dakota;
Paul G. Summers, Attorney General, Tennessee; Greg Abbott, Attorney
General, Texas; Mark Shurtleff, Attorney General, Utah; William H.
Sorrell, Attorney General, Vermont; Darrell V. McGraw, Jr. Attorney
General, West Virginia; Peg Lautenschlager, Attorney General,
Wisconsin; Pat Crank, Attorney General, Wyoming.
______
Association of Food and Drug Officials (AFDO),
York, PA 17402,
January 16, 2006.
U.S. House of Representatives,
Washington, DC 20515.
Dear Representative: I am writing on behalf of the Association of
Food and Drug Officials (AFDO) to express serious concerns regarding
H.R. 4167, ``The National Uniformity for Foods Act of 2005'' introduced
by Congressman Mike Rogers (MI-8). Originally introduced in the 108th
Congress as H.R. 2699, the bill's stated purpose is to amend the
Federal Food, Drug and Cosmetic Act (FFDCA) to provide for uniform food
safety warning notification requirements--and for other purposes. It is
the phrase ``for other purposes'' that alarms members of AFDO. The
legislation has been reviewed by attorneys for 11 State food safety
programs, and unfortunately, all of the reviews are unanimous in their
conclusion that the bill will preempt States and local food safety and
defense programs from performing their functions to protect citizens.
You may have already received some information concerning this
bill's impact from its proponents. This information claims that State
regulators, and organizations such as AFDO, are erroneous in their
legal evaluation of the bill. However, in addition to AFDO's attorney,
attorneys in 11 States, after careful review of this bill (as H.R.
2699), have reached similar conclusions regarding its severe negative
impacts to State programs. While it is not uncommon for legal
authorities to differently interpret the meaning of a given law,
because this disagreement is so profound and has such far-reaching
implications, it is imperative to amend this bill and clearly specify
Congress' intent to address solely food labeling. I urge you to oppose
this bill until these differences can be resolved in Congress, and not
leave it to the courts to decide while public health is put at risk.
Proponents of this bill emphasize that H.R. 4167 does not impact
State sanitation laws, and thus, will not impact State programs.
Nothing could be further from the truth. States perform sanitation
inspections in an effort to assist food businesses in preventing
contamination or adulteration of products, but one of the States'
critical complementary functions is to take action when these
preventive measures fail. Whether food becomes contaminated by
accident, intent, or act of nature, it is critical that States retain
their authorities to contain and remove food from the marketplace.
Because we believe that H.R. 4167 compromises these authorities, it is
our belief that the impact of this legislation is huge. If enacted,
H.R. 4167 would significantly impede resolution of the unsafe
conditions and removal of contaminated foods from the human food
supply. Sanitation and adulteration are not identical, but rather
complementary, and if public health is to be protected, States must
retain their authority to respond to contaminated (adulterated)
products--without seeking Federal permission.
Please take note that FDA has adopted few adulteration standards
for microbial contamination. While some guidance has been issued in the
form of Action Levels, adulteration is frequently determined on a case-
by-case basis. With States' rulemaking authority in question under H.R.
4167, States cannot take action unless they first confer with FDA and a
determination is made, or unless the State concurrently petitions FDA.
In 2001 alone, States took action in over 45,000 separate instances to
embargo or remove adulterated foods from the market place. No
additional resources have been provided to FDA to undertake such review
of these petitions, and again--this is an issue that extends well
beyond uniform labeling.
A vote in support of H.R. 4167 puts at risk the health and
wellbeing of all our citizens. While proponents argue that programs
such as the cooperative milk and shellfish programs are not at risk,
our attorney, along with 11 other State attorneys, read the bill quite
differently. These are cooperative programs. The milk program, based on
the Pasteurized Milk Ordinance (PMO), is written under the auspices of
the Public Health Service Act. In order to participate in either
program, a State must first demonstrate clear authority in adulterated
foods--and this authority is lost under H.R. 4167. Under this bill, a
State cannot have ANY law, not just a food law, which is not identical
to the FFDCA.
Please note the differences in language between this ``uniformity
bill'' and Section 11 of S. 3, the ``National Biodefense Act of 2005'',
which specifically states its intended uniformity applies to the
labeling of drugs. AFDO does not oppose uniform food labeling; however,
H.R. 4167 extends its reach well beyond this, and because of its
ambiguity, it would be a disastrous step backwards in ensuring the
safety of our Nation's food supply.
Again, with so much at risk, I urge you to oppose this bill and to
call for hearings to better delineate the impact and issues that are
clouded by the broad, vague, sweeping language that comprises H.R.
4167. AFDO representatives would appreciate and welcome an opportunity
to discuss our concerns with you and your staff.
Thank you in advance for your thoughtful consideration of our
concerns. Should you or your staff have any questions, please do not
hesitate to contact me at (850) 488-0295 or Mr. Cameron Smoak,
Assistant Commissioner, GA Department of Agriculture at (404) 656-3627.
Sincerely,
Marion F. Aller, DVM, DABT,
President.
[Whereupon, at 12:08 p.m., the hearing was adjourned.]