[Senate Hearing 107-916]
[From the U.S. Government Publishing Office]
S. Hrg. 107-916
FOOD SAFETY RECALL PROCEDURES
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HEARING
before a
SUBCOMMITTEE OF THE
COMMITTEE ON APPROPRIATIONS
UNITED STATES SENATE
ONE HUNDRED SEVENTH CONGRESS
SECOND SESSION
__________
SPECIAL HEARING
DECEMBER 11, 2002--BILLINGS, MONTANA
__________
Printed for the use of the Committee on Appropriations
Available via the World Wide Web: http://www.access.gpo.gov/congress/
senate
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COMMITTEE ON APPROPRIATIONS
ROBERT C. BYRD, West Virginia, Chairman
DANIEL K. INOUYE, Hawaii TED STEVENS, Alaska
ERNEST F. HOLLINGS, South Carolina THAD COCHRAN, Mississippi
PATRICK J. LEAHY, Vermont ARLEN SPECTER, Pennsylvania
TOM HARKIN, Iowa PETE V. DOMENICI, New Mexico
BARBARA A. MIKULSKI, Maryland CHRISTOPHER S. BOND, Missouri
HARRY REID, Nevada MITCH McCONNELL, Kentucky
HERB KOHL, Wisconsin CONRAD BURNS, Montana
PATTY MURRAY, Washington RICHARD C. SHELBY, Alabama
BYRON L. DORGAN, North Dakota JUDD GREGG, New Hampshire
DIANNE FEINSTEIN, California ROBERT F. BENNETT, Utah
RICHARD J. DURBIN, Illinois BEN NIGHTHORSE CAMPBELL, Colorado
TIM JOHNSON, South Dakota LARRY CRAIG, Idaho
MARY L. LANDRIEU, Louisiana KAY BAILEY HUTCHISON, Texas
JACK REED, Rhode Island MIKE DeWINE, Ohio
Terrence E. Sauvain, Staff Director
Charles Kieffer, Deputy Staff Director
Steven J. Cortese, Minority Staff Director
Lisa Sutherland, Minority Deputy Staff Director
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Subcommittee on Agriculture, Rural Development, and Related Agencies
HERB KOHL, Wisconsin, Chairman
TOM HARKIN, Iowa THAD COCHRAN, Mississippi
BYRON L. DORGAN, North Dakota ARLEN SPECTER, Pennsylvania
DIANNE FEINSTEIN, California CHRISTOPHER S. BOND, Missouri
RICHARD J. DURBIN, Illinois MITCH McCONNELL, Kentucky
TIM JOHNSON, South Dakota CONRAD BURNS, Montana
PATTY MURRAY, Washington LARRY CRAIG, Idaho
ROBERT C. BYRD, West Virginia TED STEVENS, Alaska
(ex officio) (ex officio)
Professional Staff
Galen Fountain
Jessica Arden
William Simpson
Rebecca M. Davies (Minority)
Les Spivey (Minority)
Rachelle Schroeder (Minority)
Administrative Support
Meaghan L. McCarthy
Wendi D. Dow (Minority)
C O N T E N T S
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Page
Opening statement of Senator Conrad Burns........................ 1
Statement of John Munsell, Montana Quality Foods................. 2
Statement of John Swanz, President, Montana Stockgrowers
Association.................................................... 5
Statement of Bernard Shire, Director, Legislative and Regulatory
Affairs, American Association of Meat Processors............... 6
Statement of William C. Smith, Deputy Administrator, Food Safety
and Inspection Service, Department of Agriculture.............. 8
FOOD SAFETY RECALL PROCEDURES
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WEDNESDAY, DECEMBER 11, 2002
U.S. Senate,
Subcommittee on Agriculture, Rural
Development, and Related Agencies,
Committee on Appropriations,
Billings, Montana.
The subcommittee met at 3:02 p.m., in the Ballroom of the
Student Union Building at Montana State University-Billings in
Billings, Montana, Senator Conrad Burns presiding.
Present: Senator Burns.
opening statement of senator conrad burns
Senator Burns. We'll call this subcommittee to order. This
is a subcommittee of the Senate Appropriations Committee. This
is Appropriations on Agriculture, and something we've been
trying to schedule here for quite a while and--about what I
think is a very important subject. It affects--even though we
are going to talk about meat processors, and we are going to
talk about health, and we're going to talk about reliability,
and the public safety and all of this, but what it boils down
to is if there's a link broken in the chain, it is the
producers who pay for it.
And we are in the business right now where we can't afford
to let what we think is a good product--the dollars invested
and the kind of livestock that we like to present to the
public--and after we're done with it, we lose, completely,
control of it. We have no say. When that animal walks off of
our truck, it is in the hands of somebody else. Even though
we've spent millions and millions of dollars producing the kind
of an animal that is acceptable to the public and acceptable to
the meat-processing industry and the retailing industry, we
lose control of it, and we pay the price for either
irresponsibility or turning a blind eye to powerful interests
that have the responsibility of presenting our product to the
public.
We know we produce a good product. We try every way that we
can as a producer to give the industry, on down the line, a
product that's acceptable, is nutritious, and, when it leaves
our gate, it's healthful. And so that's what we want to talk
about today.
I appreciate--I want to thank Montana State University at
Billings here for giving us this facility today, and I want to
thank all the folks here that will testify.
And this is an official hearing. All your testimony that I
have read today, and what you will give here today will be
entered in the record.
This is a little bit better than the Authorizing Committee,
because we get--we've got the purse strings. And so if we can
see where we can help or hinder, we will make that judgment
later on when the appropriations process happens.
I noticed that the order of testimony here today is Mr.
Smith, who is deputy administrator of Food Safety and
Inspection Service. We appreciate you being here today. Are you
on any kind of a time-line?
Mr. Smith. No, sir.
Senator Burns. Well, I'll tell you what I'm going to do.
I'm going to let the other three go ahead, and let you listen
to what they have to say. I've done this two or three times in
Washington, whenever we've had hearings, and usually the
administrator--or the Administration shows up, gives their
testimony and then they run away. And I don't want to do that
today. I want to--I want the Administration to hear the
problems and--or, well, problems--perceived problems that we
have in this industry.
So I'm going to ask Mr. Munsell to lead off today. And he
runs Montana Quality Foods over at Miles City, Montana. I've
only known his dad since dirt. And he's here today. And it's
good to see you here.
So, with that--and I want to apologize for being just a
couple of minutes late. It seems like everything didn't fall
together at the house like it was supposed to when I got there
a little while ago. But nonetheless, thank you for coming
today. And, Mr. Munsell, we'll hear from you as of this--now,
you can either--you can consolidate your statement, or you can
pick highlights of it and--or whatever you want to do, but we
look forward to your testimony.
STATEMENT OF JOHN MUNSELL, MONTANA QUALITY FOODS
Mr. Munsell. Thank you, Senator Burns.
My name is John Munsell, and I operate a small, family-
owned USDA-inspected slaughter and processing facility in Miles
City, Montana.
In January and February of this year, USDA inspectors at
our plant took several samples of our ground beef, four of
which were E. coli positive. Oral and written statements from
USDA field staff which took the samples documented that all
four positives originated from coarse ground beef which we had
purchased from big packers. Part of the USDA's documentation
included a handwritten letter authored and signed by Dr. Daryl
Burden and the plant inspector, whose name is Ronald Irvine.
This letter included the following statements, and I quote,
``Review of the three consecutive E. coli 0157:H7 failures
strongly suggests a common source of the contaminant--coarse
ground product of a single identified lot received from
establishment number 969, which is ConAgra in Greeley,
Colorado. I recommend acceptance of establishment 7679, which
is Montana Quality Foods--I recommend''--they recommended,
``acceptance of our response and implemented measures and
suggest a follow-up investigation of the source of the product
considering the serious public health implications of other
possible E. coli adulterated product from the same production
lot,'' end quote.
In addition to the USDA's own documentation, our company
staff copiously documented the exact origin of three of the
four positives, including the preservation of labels which are
taken from the very boxes of meat which produced the
contaminated samples. In spite of the scientifically thorough
trail of evidence compiled in these cases, USDA hierarchy in
Minneapolis and Washington, D.C., have summarily rejected all
this evidence. They refer to the letter authored by their own
field staff as mere opinion. If the contents of this letter had
coincided with what Washington, D.C., had wanted to hear, then
the letter would have been accepted as conclusive evidence.
So some of USDA's unscientific policies include the
following. Number one, when a USDA inspector takes a ground-
beef sample for USDA lab analysis, the inspector is prohibited
from documenting the origin of the meat which provided the
sample. Number two, E. coli is considered an adulterant only in
the form of ground beef. Therefore, if E. coli exists in
boneless trimmings which are not yet ground, the USDA does not
consider this deadly E. coli bacteria to be an adulterant at
that point. This means that all responsibility for contaminated
ground beef rests upon the establishment which performs the
final grind. Of course, this prevents any meaningful corrective
action from taking place, since no trace back to the source of
the contamination ever took place.
The third policy problem I see is USDA Directive 10,010.1
was designed to reward large packers with several advantages,
all of which imperil consumers. Those advantages are, number
one, when a packer qualifies for this directive, then from that
point on, only the packer performs in-plant sampling. Number
two, simultaneously the USDA performs no sampling. Number
three, USDA is denied access to the results of the in-plant
sampling since the plant now claims such important data to be
``proprietary.'' And I must say that just within the last month
there has been a pronouncement from the USDA that says that no
plants anymore will be excluded from sampling, which is
certainly a step in the right direction.
An incident which occurred at our plant exposes USDA's lack
of commitment towards promoting consumer food safety. After our
firm experienced our first positive E. coli sample in January,
we knew that the sample was taken from brand-X coarse ground
beef purchased from outside packers. We had coarse ground beef
in our plant from both of these packers, but we weren't sure
which source was used for the positive sample. Inspector Dan
Ellis also knew and made the statement in front of four
witnesses that the sample originated from brand-X coarse ground
beef, but he was prohibited from documenting this fact until
the Office of Inspector General interviewed him in late August,
a full 7 months after the incident occurred.
When Compliance Officer DuWayne Hansen investigated the
details of this E. coli-positive sample, I offered Mr. Hansen
unopened, intact tubes of coarse ground beef from both sources,
which would have allowed the USDA lab to pinpoint the true
origin of the contaminated meat. He refused our offer, replying
that USDA policy didn't allow him to accept intact chubs of
meat previously inspected and passed by the USDA.
It is interesting to note that this procedure was used at
Galligans Wholesale Meats in Denver this summer, directly
resulting in the 18.6 million-pound ConAgra recall. So you can
see that this procedure of accepting intact samples directly
benefits all meat consumers.
Now, months later we discovered the full truth why Officer
Hansen was prohibited from accepting intact chubs of coarse
ground beef. This truth was exposed on Thursday, August the
29th after the two OIG auditors--they were at our plant--the
two auditors finished their review of our plant and departed.
Dr. Grady Skaggs, who was the USDA circuit supervisor,
remained in our office for a while and visited. He voluntarily
made the statement that Compliance Officer DuWayne Hansen
wanted to accept our offer of intact chubs of brand-X coarse
ground beef, but that John Hopperstad, who is the Minneapolis
compliance officer, instructed DuWayne to reject our offer
because the USDA was afraid that ConAgra would sue the USDA.
Dr. Skaggs' statement shows that the USDA knew all along that
ConAgra was the source of the contaminated meat, and that the
USDA intentionally circumvented its duty to trace back to the
origin because of the discomfort and potential legal liability
it might experience for admitting the whole truth.
A similar situation occurred when I called Compliance
Officer DuWayne Hansen and requested a copy of his interview
with Inspector Dan Ellis in which Mr. Ellis would have
identified coarse ground beef as the origin of the positive
January sample. Officer Hansen replied that although he did
interview Mr. Ellis, he, Mr. Hansen, did not ask or document
information regarding the origin of the meat. Mr. Hansen then
stated, and I quote, ``If I had recorded such information, I
would be walking down the street,'' end quote.
All consumers, as well as the entire cattle industry,
deserve an explanation from the USDA as to why a compliance
officer would lose his job if he was so audacious as to
document the whole truth about the origin of contaminated meat.
This sordid scenario which occurred at our plant this year
will undoubtedly be repeated many times across America until
USDA willingly adopts major policy changes. The large volume of
recalls will continue unabated for the same reasons.
Now is the time for consumers, the cattle industry, meat
processors, and especially our elected officials to demand that
USDA eliminate its woefully inadequate and ill-intentioned
policies and establish safe food as its number one objective
regardless of the discomfort that the USDA will experience as
it requires big packers to accept sanitary procedures. A
contemporary example of this is improvement is the slower chain
speed recently implemented at the former ConAgra plant in
Greeley, Colorado, which now operates under the Swift name.
In summary, not only does the existing policy imperil meat
consumers and the viability of the final grinding plants or the
processing industry, but it jeopardizes the cattle industry,
which will have the most to lose as consumers lose confidence
in beef, which diminishes not only demand, but also eventually
diminishes cattle prices.
Thank you.
Senator Burns. Thank you.
Let's go to John Swanz. John represents the Montana
Stockgrowers Association, has been associated with the cattle
industry since day one, and we look forward to hearing your
testimony.
STATEMENT OF JOHN SWANZ, PRESIDENT, MONTANA
STOCKGROWERS ASSOCIATION
Mr. Swanz. Thank you. Thank you, Senator Burns. Thank you
for the opportunity to testify here today.
My name is John Swanz. In addition to being the incoming
president of the Montana Stockgrowers, which represents 2,500
cattle producers throughout the State of Montana, I am also a
fourth-generation rancher of Judith Gap, which is in Central
Montana.
As a producer of cattle, the raw commodity that ultimately
passes through the beef production chain before reaching
consumers, we have a vested interest in the beef inspection
practice in place through the USDA FSIS. Food safety issues are
of the utmost concern to us as producers because we are reliant
on a strong market that is driven by consumer attitude and
perception. If there is a perception, no matter how slight,
that inspection practices are not adequately protecting U.S.
beef supply, the market suffers irreparable damages and affects
ranching families around the country, including mine. We cannot
afford to take these risks.
The National Cattlemen's Beef Association, of which Montana
Stockgrowers is a state affiliate, spends an average of $2.5
million a year on food safety research and technology.
Techniques resulting from this research include steam-vacuuming
beef carcasses, which effectively removes E. coli 0157:H7 and
other harmful bacteria. Thermal pasteurization, a rinse for
beef carcasses with 180-degree water and a mild organic
solution, have also proven to reduce pathogens.
More than 85 percent of the research projects beef
producers, like me, have funded with their beef checkoff
dollars have directly and immediately led to the implementation
of technology and procedures that increase beef safety.
As a beef cattle producer, we know we have the
responsibility to be part of the solution to the E. coli
problem in the U.S. Current checkoff-funded E. coli 0157 safety
research on live cattle centers is developing a testing and
cattle-cleaning system, and experimenting with cattle feed
additives to reduce pathogen incidence on the ranch and in the
feed lots before the cattle are shipped for processing.
Additionally, beef safety research is working on an
intervention system for subprimals and trimmings, finding more
statistically valid ways to sample and test for our beef E.
coli 0157:H7, examining the impact of environmental factors
such as equipment, water, and air on E. coli and beef products,
and reviewing beef-safety research on non-intact beef products.
But our concern as cattle producers is that these measures
are meaningless if the infrastructure within USDA FSIS does not
exist in the name of ensuring a safe, pathogen-free product to
the consumer. I am pleased that John Munsell, of Montana
Quality Foods in Miles City, is here today to share his story.
While we'd like to believe his experience with regard to USDA
FSIS testing and recall procedures is an isolated incident, the
fear remains that the bureaucracy in Washington, D.C., is not
protecting the consumer by doing everything possible to ensure
adequate food safety inspection and recall system.
In line with the Montana Stockgrowers Association's
grassroots policy, we are calling for immediate approval of
active steps to reduce the incidence of pathogen occurrences in
meat, which includes ensuring that meat recall protocol within
the USDA is not only swift and science-based, but holds all
meat processors to similar standards, regardless of size. Our
ultimate goal must be to reassure the beef consumer that we
will not settle for anything less.
Thank you for the opportunity to testify.
Senator Burns. Thank you, Mr. Swanz. I appreciate that very
much.
We have with us today Bernard Shire, who is director of
Legislative and Regulatory Affairs, American Association of
Meat Processors. Mr. Shire, thank you for making the trip
today, and we appreciate that very much. We look forward to
your testimony.
STATEMENT OF BERNARD SHIRE, DIRECTOR, LEGISLATIVE AND
REGULATORY AFFAIRS, AMERICAN ASSOCIATION OF
MEAT PROCESSORS
Mr. Shire. Thank you. Thank you, Senator Burns.
My name is Bernard Shire. I am with the American
Association of Meat Processors. We're a trade association with
members across the United States and Canada and several foreign
countries.
Our members are meat and poultry slaughterers, processors,
wholesalers, retailers, caterers, home food-service companies,
and suppliers and consultants to the meat and poultry industry.
Most of our members are small, very small, and medium-sized
businesses. Many of them are family-owned operations. And we
have a number of members here in the State of Montana.
The small meat- and poultry-slaughtering and processing
industry is impacted in a very negative way by product recalls
conducted by USDA, for many reasons. These recalls are eroding
the confidence of small meat-plant operators that they can
survive, and I will detail some of these reasons for you.
As you know, there have been more and more recalls of
ground beef for E. coli, a deadly pathogen. Many of our small
members grind beef. In many cases, they buy the raw materials
to use in grinding, such as trimmings, from the very largest
meat packers in the country, the big slaughterers.
E. coli generally gets onto the meat, the carcasses, from
fecal material. Some large plants may not be taking the time to
do the evisceration properly, or the plant may fail to take
other interventions to make sure, as much as possible, that
there isn't any E. coli on the trimmings that go to the
grinder.
But no one can guarantee 100 percent that all E. coli will
be removed from the processing system. All the plants can
really do is try to reduce it as much as possible. The large
plant is the logical place to do this because most other
processors, large and small, buy their materials from the large
slaughter plants.
A major reason for the problems that do exist is the
tremendously fast line speeds used in the huge meat-packing
plants when they are killing the cattle and converting them to
carcasses. Unfortunately, speeds sometimes don't allow a very
good job of trimming or other interventions to make sure that
no fecal material, the source of the E. coli, remains on the
carcasses. But a major problem is that the bung breaks or is
punctured rather than being removed in an intact state. That's
one major problem.
The other major problem, we believe, is that there is a
shortage of slaughter inspectors, so at the very high line
speeds in the big packing plants, the fewer inspectors have a
harder time seeing what's going on. That's the reason for
USDA's experimental HACCP-based Inspection Models Project which
would allow plant employees to do more of the inspection in
plants where young animals are slaughtered. We think, instead,
that FSIS needs to study ways to attract more slaughter
inspectors to the agency.
What happens then is that the carcasses are cut into
primal, subprimals, and trimmings and shipped to the grinder.
If there is E. coli on those raw materials that come into a
grinding plant, there is no way they can be removed because the
grinding plant is basically a fresh-meat-in/fresh-meat-out
operation. There is no ``kill step'' in the grinding plant to
remove pathogens or bacteria.
So the grinder grinds the beef. But if USDA, through its
random testing, finds E. coli in the grinding plant, or
possibly in ground beef at the grocery store, the next step in
the food chain, who is responsible for doing the recall? The
grinder, not the supplier or the originating packing plant
where the pathogen originated. So grinders, especially small
ones, are being put in the position of being the regulators and
accepting the blame for a problem that they did not create.
Why does this happen? Well, one reason is that USDA policy
really discourages trace-back to the original large packing and
slaughter plant. Even the new--USDA's new policy on E. coli
encourages suppliers to look for the pathogens, but it doesn't
require them to. Why not? Grinders will be forced to ask
suppliers for a letter indicating that they have taken steps to
remove E. coli from the raw materials they are grinding. But
there is nothing requiring the big packers to provide
assurances. What if they don't?
And that brings us to the next question, What does the USDA
inspection mark mean? Does it mean anything anymore? The raw
meat that is shipped from the big packers for further
processing has already been inspected by USDA inspectors at the
originating plant. The USDA ``inspected and passed'' mark of
inspection has been put on it. Doesn't that mean that the meat
is okay? Why does the small processor or grinder have to get
additional assurances about the meat? When we asked the USDA
people in Washington about this, they just shrugged their
shoulders. If the USDA mark of inspection doesn't mean anything
anymore, then why is our meat going through this extensive
inspection process to begin with?
A major problem with recalls is uncertainty with USDA about
what circumstances should or should not lead to a recall. There
are often disagreements between people inside the USDA Recall
Division about the necessity of a recall. And this results in
USDA giving confusing information to a plant about the recall,
not telling a plant all the information that it should know,
and a conflict between protecting the public health versus
``let's make sure we have all the facts right before we go
ahead with this.''
What effect does this have on the small meat-processing
business? Well, many of the small meat processors are becoming
scared to death to make certain products, whether it's ground
beef or ready-to-eat products. The USDA attitude, ``It may not
be your fault, but it is your problem,'' may result in more and
more plants giving up grinding beef, or giving up making the
ethnic and specialty products for which we--they are well-
known, leaving more and more meat products--processing in the
hands of the big meat packers. Are these recalls going to mean
the end of the small meat-processing industry in the United
States?
And there's one other point I want to make. The closing of
small meat and poultry processing plants poses a serious threat
to the economy in the rural areas of the United States, in
States like Montana. A plant shutdown would put many people out
of work in these small, rural communities, places where it's
hard enough for their residents to find jobs. In many cases, a
small processing plant is an important employer in a small
rural town. Also, small livestock producers in rural areas,
like Montana, are dependent on small local slaughterers and
processors--are markets for their animals. If these plants go
out of business, what will these--what will these producers and
herdsmen do with their animals?
What is the answer to the recall situation? The meat-
processing industry, especially the small industry, is looking
for cooperative recalls as the most effective way to protect
public health by removing product from the marketplace that may
be harmful to the public, but not to punish the plant that
inadvertently manufactured product that is carrying bacteria.
Thank you.
Senator Burns. We thank you, Mr. Shire. I appreciate your
making the trip all the way out here.
And we really appreciate William Smith, who is deputy
administrator of Food Safety and Inspection Service. And we
appreciate you making the trip, and we look forward to your
testimony. And I hope you've heard we do an awfully good job of
identifying the problem. Now maybe can--maybe we can hear some
solutions and some steps that the USDA is taking, or should
take. Thank you for coming.
STATEMENT OF WILLIAM C. SMITH, DEPUTY ADMINISTRATOR,
FOOD SAFETY AND INSPECTION SERVICE
DEPARTMENT OF AGRICULTURE
Mr. Smith. Well, thank you for the opportunity to discuss
food safety today.
I am Bill Smith, the Deputy Administrator for Field
Operations at the U.S. Department of Agriculture's Food Safety
and Inspection Service, FSIS. As Deputy Administrator, I manage
the regulatory activities carried out daily in meat, poultry,
and egg product establishments by more than 7,600 food
inspectors, consumer safety officers, and veterinarians. I have
been with FSIS for more than 25 years, serving in many
positions within the Agency, including in-plant food inspector
in Pennsylvania, acting regional director of the Northeast
region, executive director of District Inspection Operations,
and, most recently, as the Associate Deputy Administrator for
Inspection Operations.
FSIS' mission is to ensure meat, poultry, and egg products
are safe, wholesome, and accurately labeled. This goal has not
changed during my years at FSIS, though I have seen agency
policies and procedures evolve to best address emerging public
health issues and improve food safety. When Dr. Garry McKee
arrived at FSIS this fall as the new administrator, he brought
with him a clear vision of making FSIS the Nation's premier
regulatory public health agency.
While great advancements have been made over the last
century, the most dramatic evolutions have occurred in recent
years with the implementation of the science-based Hazard
Analysis and Critical Control Points, HACCP, inspection system.
The HACCP system is a tool for preventing contamination before
it occurs.
All slaughter and processing establishments are required to
adopt a system of process controls designed to prevent food
safety hazards. Under HACCP, plants identify critical control
points during their processes where hazards such as microbial
contamination can occur. They establish controls to prevent and
reduce those hazards, and maintain records documenting that the
controls are working as intended. HACCP is representative of
FSIS' efforts to continually improve Agency programs and now
serves as the cornerstone of the Agency's current inspection
system.
The issue of E. coli 0157:H7 in ground beef emerged in the
1990s, and FSIS' microbiological testing program to detect E.
coli 0157:H7 in raw ground beef began in October 1994. Since
then, nearly 54,000 raw ground-beef samples have been analyzed.
Each month, a random sample of approximately 1,700
establishments that produce ground beef under Federal
inspection and 100,000 retail stores that grind beef on a
regular basis are sampled for sample collection. So far in
2002, over 6,000 samples have been analyzed for E. coli
0157:H7. Since FSIS' E. coli 0157:H7 testing program began, it
has been continuously amended to incorporate the most up-to-
date data and technologies.
An outbreak of illness in Midwestern States this summer
that was caused by E. coli 0157:H7 is one example of why our
testing program is so critical in helping to keep contaminated
products out of the marketplace. Our ultimate goal is to
prevent outbreaks from happening in the first place. Testing
ground beef samples to remove contaminated products from the
marketplace helps to minimize cases of foodborne illness.
Now that I've explained our HACCP program and testing
program for E. coli 0157:H7, let me specifically discuss recent
events at Montana Quality.
On January 23rd, 2002, FSIS collected a routine, raw
ground-beef monitoring sample for E. coli 0157:H7 from Montana
Quality Foods and Processing in Miles City, Montana. The sample
was analyzed in FSIS' laboratory and was confirmed positive for
E. coli 0157:H7 on January 28th. As a result, the establishment
initiated a Class 1 voluntary recall of approximately 270
pounds of fresh ground beef.
The purpose of a recall is to remove meat or poultry from
commerce when there is a reason to believe it may be
adulterated or misbranded. All recalls are voluntary and may be
initiated by the manufacturer or the distributor of the meat
and poultry plants, or at the request of FSIS. A Class 1 recall
indicates that there is a reasonable probability that the
product will cause serious adverse health consequences.
Contamination of product with pathogenic bacteria such as
Listeria monocytogenes in ready-to-eat product or E. coli
0157:H7 in raw ground beef would be a Class 1 recall.
As a result of the positive E. coli 0157:H7 sample on
January 28th, FSIS issued to Montana Quality Foods two non-
compliance records. Non-compliance records are documentation
produced by an inspector that the establishment has failed to
meet HACCP requirements. As a standard practice following all
product recalls, FSIS inspection program personnel conduct a
set of 15 consecutive follow-up samples to verify that the
establishment's corrective actions are effective.
FSIS initiated follow-up sampling at Montana Quality Foods
on February 12th. Samples collected on February 19th, February
20th and 21st tested positive for E. coli 0157:H7. Since these
samples were taken as follow-up samples, Montana Quality Foods
was required to hold the product, pending test results. As a
result, none of the product that tested positive for 0157 in
follow-up sampling was released into commerce. FSIS advised the
establishment that these positive results indicated that there
was a problem with their food safety system, which required
more corrective action.
On February 26th, FSIS issued a Notice of Intended
Enforcement (NOIE) to Montana Quality Foods, notifying the
establishment of the Agency's intent to suspend the assignment
of inspectors for its raw ground processes. FSIS' actions were
based on an inadequate HACCP system for the establishment's raw
ground process and three positive E. coli 0157:H7 samples found
in February.
Montana Quality Foods management contend that the source of
the E. coli 0157:H7 problem did not originate in their
establishment. Rather, they stated that the problem was coarse
ground beef from one of Montana Quality Foods' suppliers,
another federally-inspected establishment.
After the NOIE was issued on February 26th, FSIS compliance
officers found that Montana Quality Foods had purchased frozen
ConAgra coarse ground beef. And on March 4th, 2002, compliance
officers attempted to locate additional intact samples of the
ConAgra coarse ground beef that Montana Quality Foods had named
as the source of the E. coli 0157:H7 contamination. However,
since this lot of coarse ground product in question was
produced on August 30th, 2001, no fresh or frozen coarse ground
products remained for testing. As a result, FSIS could not
confirm the link between Montana Quality Foods' product and the
supplied product.
FSIS actions related to Montana Quality Foods were
consistent with established policies and procedures. FSIS is a
public health regulatory agency that must act when a regulatory
sample tests positive for pathogens.
And as you well know, in the summer of 2002, an intensive
investigation by numerous Federal and State agencies ultimately
linked an outbreak of E. coli 0157:H7 illnesses to product from
a ConAgra plant in Greeley, Colorado. As a result of this--the
investigation, ConAgra recalled millions of pounds of ground-
beef products and trimmings.
And as I said earlier, HACCP is not a static system. As
information becomes available, we adjust. For instance,
information from the ConAgra investigation combined with data
from the Agricultural Research Service and the Centers for
Disease Control and Prevention, as well as FSIS' draft risk
assessment of E. coli 0157:H7, indicates the E. coli 0157:H7 is
more prevalent than previously believed. The combination of
these events led FSIS to further strengthen its E. coli 0157:H7
policies and implement additional safeguards to increase food
safety.
In July 2002, FSIS initiated a new policy regarding
supplier notification of E. coli 0157-positive samples. Under
the new policy, if a sample taken from a grinding facility is
found to be positive, the grinding facility's suppliers will be
notified both orally and in writing. This policy will allow
FSIS and those involved in the meat distribution chain to
respond more quickly to indicators of potential problems.
Additionally, in October of 2002, we published a Federal
Register notice with a series of new measures designed to
reduce the incidence of E. coli 0157 contamination in raw
ground beef. All facilities handling raw ground beef will now
have to consider E. coli 0157:H7 in their HACCP plans as a
pathogen reasonably likely to occur.
Our new policy also addresses some of the concerns of
grinders such as Montana Quality Foods. Establishments that
receive product for grinding may determine that no additional
steps are necessary at grinding facilities to address E. coli
0157 if appropriate purchase specifications are built into
their food safety systems. These specifications must require
that all suppliers have one or more validated critical control
points to eliminate or reduce E. coli 0157 below detectable
sampling levels, and some means to ensure that these
specifications are met. For example, grinders may choose to
have a third-party audit done to ensure that their suppliers
are complying with FSIS regulations.
FSIS has provided guidance materials along with the Federal
Register notice to assist the industry in implementing the
effective control steps. The FSIS guidance is based on three
points. First, grinders and suppliers should address hazards
such as E. coli 0157:H7 in their raw materials. They are
responsible under HACCP to identify and address all hazards
reasonably likely to occur. Second, grinders and their
suppliers should realize that they are in an excellent position
to implement process and distribution controls that address
public health hazards associated with ground beef. And third,
there must be an emphasis throughout the production and
distribution chain on maintaining the records that are
necessary to identify, trace, and retrieve from commerce any
ground-beef products that may pose a public health problem.
To ensure compliance with the Federal Register notice, FSIS
inspection program personnel have begun determining whether
reassessments are being conducted. They are also assuring that
establishments that have not yet reassessed their HACCP plans
do so by agency deadlines. Large plants, those with 500 or more
employees, were required to comply by December 6th, 2002. We
now have consumer safety officers throughout the Nation
beginning to verify in those reassessments. Small plants need
to comply--and those are plants with less than 500 or more than
ten employees--will be required to comply by February 4th. Very
small plants--those fewer than ten employees or annual sales of
less than $2.5 million--will be required to comply by April
7th, 2003.
FSIS is also modifying its current E. coli 0157 sampling
and testing programs to include all plants. In the past, FSIS
did not typically collect raw ground-beef samples at
establishments that conduct their own E. coli 0157:H7 tests.
However, FSIS has recently found, in spite of this testing,
some of these establishments have had problems with E. coli
0157 contamination. In response, FSIS is revising its current
directive to discontinue exemptions from FSIS sampling and
testing for E. coli 0157:H7.
FSIS is also developing a risk-based verification program
that takes into account factors such as volume of production,
effectiveness of interventions in determining testing
frequencies. In addition to continuing to test for E. coli 0157
in ground beef, FSIS is considering testing E. coli 0157:H7
testing in trimmings and other intact materials used to make
ground beef, and beef carcasses and parts that will be
processed in the ground beef. We believe the controls that
reduce the risk of 0157 on intact product may be one of the
most effective ways to control the hazard overall. We believe
that these changes are critical to protecting public health.
As our Administrator, Dr. Garry McKee has made clear,
protecting the public health is the Agency's highest priority.
He has repeatedly stated that FSIS will strictly enforce HACCP,
holding the industry and ourselves responsible. Industry is
responsible for fully implementing HACCP, and for validating
the effectiveness of HACCP plans. FSIS is responsible for
making sure that this is done. We each play a role in ensuring
that meat and poultry products are produced safely.
For its part, FSIS has recently strengthened its internal
program and policy review capacity. This allows for an ongoing,
more timely assessment of how effectively program improvements
are working. This will also allow managers to recognize where
changes need to be made.
At FSIS, employee training is a key priority for improving
food safety. We will be providing more adequate and thorough
field training. This effort with our inspectors will help us to
more consistently and effectively implement science-based
policies and programs within FSIS by increasing the scientific
knowledge available to our front-line workers.
While the Agency is holding industry accountable for
producing safe products, we are also holding ourselves
accountable for improving and safeguarding public health.
Ensuring food safety is an ever-evolving process. For this
reason, we constantly reassess our policies and procedures to
ensure that strong prevention and enforcement programs are in
place to best protect consumers from potential adulterants such
as E. coli 0157. Protecting the public health is FSIS' number
one priority. Therefore, the Agency will continue to work to
ensure a strong food-safety system and to thoroughly examine
ways to enhance its programs through the best available
scientific resources, and the implementation of sound policies.
Thank you for the opportunity to testify, and I welcome
your questions.
Senator Burns. Thank you.
I think we'll go back to our little dialogue at the table
today. And it seems like that's when I learn more than me
asking questions and you responding.
I would say, though, in your changes, the points that Mr.
Munsell brought up in his testimony regarding the unscientific
policies, and the points that he made in his testimony, have
you looked at those questions? And can you respond--can you
respond to this? ``When a USDA inspector takes a ground-beef
sample for the USDA lab analysis, the inspector is prohibited
from documenting the origin of the meat which provided the
sample.'' Can you--is there--in your changes--and can you
respond to that and why that has to happen?
Mr. Smith. Well, I don't believe it does happen. The
regulations--and these particular regulations have been in
effect for well over 50 years--require the plant to maintain
those records. I can supply those regulations for the record.
[The information follows:]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 320--RECORDS, REGISTRATION, AND REPORTS--Table of Contents
Sec. 320.1 Records required to be kept.
(a) Every person (including every firm or corporation) within any
of the classes specified in paragraph (a) (1), (2), or (3) of this
section is required by the Act to keep records which will fully and
correctly disclose all transactions involved in his or its business
subject to the Act:
(1) Any person that engages, for commerce, in the business
of slaughtering any cattle, sheep, swine, goats, horses, mules,
or other equines, or preparing, freezing, packaging, or
labeling any carcasses, or parts or products of carcasses, of
any such animals, for use as human food or animal food;
(2) Any person that engages in the business of buying or
selling (as a meat broker, wholesaler, or otherwise), or
transporting in commerce, or storing in or for commerce, or
importing, any carcasses, or parts or products of carcasses, of
any such animals;
(3) Any person that engages in business, in or for
commerce, as a renderer, or engages in the business of buying,
selling, or transporting in commerce, or importing, any dead,
dying, disabled, or diseased cattle, sheep, swine, goats,
horses, mules, or other equines, or parts of the carcasses of
any such animals that died otherwise than by slaughter.
(b) The required records are:
(1) Records, such as bills of sale, invoices, bills of
lading, and receiving and shipping papers, giving the following
information with respect to each transaction in which any
livestock or carcass, part thereof, meat or meat food product
is purchased, sold, shipped, received, transported, or
otherwise handled by said person in connection with any
business subject to the Act:
(i) The name or description of the livestock or
article;
(ii) The net weight of the livestock or article;
(iii) The number of outside containers (if any);
(iv) The name and address of the buyer of livestock
or article sold by such person, and the name and
address of the seller of livestock or articles
purchased by such person;
(v) The name and address of the consignee or
receiver (if other than the buyer);
(vi) The method of shipment;
(vii) The date of shipment; and
(viii) The name and address of the carrier.
(ix) In the case of a person belonging to the class
specified in paragraph (a)(1), and engaged, for
commerce, in the business of slaughtering any swine for
use as human or animal food, the name and address
(including the city and state, or the township, county,
and state) of each person from whom the person
belonging to the class so specified purchased or
otherwise obtained each swine, and the telephone
number, if available, of the person from whom the swine
were purchased or otherwise obtained, and all serial
numbers and other approved means of identification
appearing on all test swine selected at antemortem
inspection by FSIS representatives for residue testing.
(2) Shipper's certificates and permits required to be kept
by shippers and carriers of articles under part 325 of this
subchapter.
(3) A record of seal numbers required to be kept by
consignees of inedible products shipped under unofficial seals
under Sec. 325.11(b) or (e) of this subchapter, and a record of
new consignees of inedible products diverted under Sec.
325.11(e) of this subchapter.
(4) [Reserved]
(5) Guaranties provided by suppliers of packaging materials
under Sec. 317.20.
(6) Records of canning as required by subpart G of this
subchapter A, 9 CFR chapter III.
(7) Sample results and calculation results as required by
processing procedures to destroy trichinae in Sec.
318.10(c)(3)(iv) (Methods 5 and 6).
(8) Records of nutrition labeling as required by subpart B,
part 317, of this subchapter.
(9) Records as required in Sec. 318.23(b) and (c).
(10) Records of calcium content in meat derived from
advanced meat/ bone separation machinery and meat recovery
systems as required by Sec. 318.24 of this subchapter.
(11) Records of all labeling, along with the product
formulation and processing procedures, as prescribed in Sec.
317.4 and Sec. 317.5.
(Approved by the Office of Management and Budget under control
number 0583-0015)
[35 FR 15603, Oct. 3, 1970, as amended at 36 FR 12004, June 24,
1971; 37 FR 1229, Jan. 27, 1972; 43 FR 30793, July 18, 1978; 47 FR 746,
Jan. 7, 1982; 47 FR 17274, Apr. 22, 1982; 49 FR 2235, Jan. 19, 1984; 51
FR 45633, Dec. 19, 1986; 53 FR 40387, Oct. 14, 1988; 57 FR 27877, June
22, 1992; 58 FR 675, Jan. 6, 1993; 58 FR 41152, Aug. 2, 1993; 59 FR
6897, Feb. 14, 1994; 59 FR 62562, Dec. 6, 1994; 60 FR 67456, Dec. 29,
1995; 64 FR 745, Jan. 6, 1999]
Sec. 320.2 Place of maintenance of records.
Every person engaged in any business described in Sec. 320.1 and
required by this part to keep records shall maintain such records at
the place where such business is conducted except that if such person
conducts such business at multiple locations, he may maintain such
records at his headquarters' office. When not in actual use, all such
records shall be kept in a safe place at the prescribed location in
accordance with good commercial practices.
Sec. 320.3 Record retention period.
(a) Every record required to be maintained under this part shall be
retained for a period of 2 years after December 31 of the year in which
the transaction to which the record relates has occurred and for such
further period as the Administrator may require for purposes of any
investigation or litigation under the Act, by written notice to the
person required to keep such records under this part.
(b) Records of canning as required in subpart G of this subchapter
A, 9 CFR chapter III, shall be retained as required in Sec. 318.307(e);
except that records required by 4Sec. 318.302 (b) and (c) shall be
retained as required by those sections. [35 FR 15603, Oct. 3, 1970, as
amended at 51 FR 45633, Dec. 19, 1986]
Sec. 320.4 Access to and inspection of records, facilities and
inventory; copying and sampling.
Every person (including every firm or corporation) within any of
the classes specified in Sec. 320.1 shall upon the presentation of
official credentials by any duly authorized representative of the
Secretary, during ordinary business hours, permit such representative
to enter his or its place of business and examine the records required
to be kept by Sec. 320.1 and the process schedules, facilities and
inventory pertaining to the business of such person subject to the Act,
and to copy all such records and to take reasonable samples of the
inventory upon payment of the fair market value therefor. Any necessary
facilities (other than reproduction equipment) for such examination and
copying of records and for such examination and sampling of inventory
shall be afforded to such authorized representative of the Secretary.
[35 FR 15603, Oct. 3, 1970, as amended at 64 FR 745, Jan. 6, 1999]
Mr. Smith. As I have said, now--and starting--not now, but
on July 15th, 2002, what we were doing is, when we take a
sample, if we have a presumptive sample result--and when you
say, ``That's not confirmed, only presumptive,'' because 80 to
90 percent of those sample results that are presumptive aren't
confirmed positive--we notify the suppliers and then start
collecting the distribution information. So if there is recall,
we can move into action quickly. We can also then--on a
positive, notify the suppliers both verbally, and in writing
that their product--and they're not always the only ones--
there's usually a combination of products that are made in to
ground beef. So we will notify them so they can start checking
their products and their programs. And our people would be
verifying, upon that notification, those plants that the
systems are producing safe product. And that, we put in place
in July 2002.
We have a database of all the suppliers that we've
notified, and we're constantly watching that database also to
make sure that we have supplier names that have frequent
entries, that we have conducted a food-safety investigation in
those facilities. And we have a number of those that we have
done through this also.
Senator Burns. Upon notification--in other words, there's
documentation that we've got a problem here--and you notify the
supplier----
Mr. Smith. Yes.
Senator Burns [continuing]. In other words, it's been
determined that it's--the problem is coming from that
particular lot of whatever is to be ground----
Mr. Smith. We don't specifically know--sorry--we don't
specifically know that it came from that plant, typically.
They, a plant, uses a mixture of ground beef; more than a
single source. And so we notify all the suppliers that their
product that a particular grind has been associated with an E.
coli 0157 positive.
Senator Burns. Okay, now what about--now, let me ask it in
another way--what if the grinder has proof perfect and
documented that it came from this lot, can you call that
supplier? You can't do that?
Mr. Smith. We have a policy of trace-back on a sole-source
single supplier, and have been doing that since--I can think of
numerous instances in 1998 and 1999 when we did that. When we
have the ability to trace back to a single supplier, we will do
that.
Senator Burns. Then what?
Mr. Smith. In the case here, again, on the January sample--
the recall division also reports to my office--and we filed a
recall worksheet. The ConAgra supplier--or ConAgra product was
not identified on that worksheet in that information supplied
by the manufacturer as the source of material in the January
positive.
In the February positive, as I said, on March 4th, we
initiated an investigation--a trace-back because of the
statements from the company at our headquarters. What we have
to do is coordinate that, because that's another district. And
so we coordinated the investigation and compliance officers
going to the distribution facility in ConAgra. And so in that
scenario, we had a single. We had that information, we did
trace back that product. We couldn't find them in common to do
a follow-up sample.
Senator Burns. Then what happens if--you say you go back,
and it's been documented, and you find a problem at ConAgra.
Then what happens?
Mr. Smith. Well, we had a real-life scenario of that this
year in our plant--that very scenario, similar condition. We
had a random sample, with the suppliers who initiated our
random sample not associated with ConAgra, and the follow-up
sampling through the documentation and having product on-site
intact, unopened, we then took those samples contained in that
product, sent it to the lab, found it was positive, initiated
the recall. And, at the same time, I led a food-safety
investigation team into ConAgra in Greeley, Colorado. And, from
that, we took enforcement action and we expanded the recall
based on that.
Senator Burns. Give me the time-line. How long did it take
you? From the time that--the time that you--from the time you
collected it, how much time in the lab--give me some kind of
a--of how much time was involved.
Mr. Smith. I believe we found product to contain--on the
20th. We shipped off on the 24th. You have 5 days. You can
certainly have 5 days until we can confirm the positive. I
believe the recall was on the 30th of June. We initiated a
recall. That was when the first recall occurred. At the same
time, we were working with State and other Federal agencies,
because we had outbreak information. The week of July 10th, I
assembled a team. And when I assembled the team, I had to get
microbiologists, epidemiologists, compliance officers. And we
were there at ConAgra on July 15th.
Senator Burns. In other words, there are, what--10 plus 15-
25 days elapsed.
Mr. Smith. June 30th, the sample was determined to be
positive. We were there 2 weeks later.
Senator Burns. But 5 days in the lab work.
Mr. Smith. No. The sample was taken on the--submitted on
the 24th.
Senator Burns. Okay.
Mr. Smith. It takes 5 days. We had to overnight ship it to
go out for culture to perform the methodology, but to
confirmation, it's a 5-day process, yes.
Senator Burns. Correct me if I'm wrong on this, but I think
that involved, what, around 16 million pounds? Is that correct?
Mr. Smith. The initial recall was 350,000 pounds, based on
that sample. After the food safety investigation, it was
expanded another 15 million, yes. After we went there and
collected our information and did our assessment, yes, it was
expanded.
Senator Burns. Can you tell me, or--you may not have this
information--but could you tell me, of the amount of pounds
that were involved, how many pounds of those made it back to
the packer?
Mr. Smith. I wouldn't want to guess on that, but I can get
you that information. I can submit it to you.
[The information follows:]
FSIS' focus during a voluntary recall is to provide oversight to
ensure that customers receiving the recalled product have been
notified. FSIS field compliance officers conduct effectiveness checks
to ensure that the establishment is making all reasonable efforts to
retrieve the recalled product. Upon compliance, the firm is officially
notified by letter that the recall is completed and no further action
is expected. The ConAgra recall from July 19, 2002 has not been
completed and the total amount of recalled product recovered has not
been supplied by the establishment.
Senator Burns. Because it seems like, in that--in that
amount of time, you didn't--you couldn't stop the consumption.
It was already out there. I would imagine they move this meat
pretty rapidly. And I'd just like to know, on--that amount of
time.
Tell me about your--Mr. Shire made the point that more
inspectors are needed. Can you respond to that?
Mr. Smith. I sure can. The staffing of slaughter plants in
this country is defined by line speed. And the line speed then
dictates how many FSIS inspectors are on the line. The
establishment cannot work unless we have our full complement of
people there. So, in some plants--if there's not a full
complement, then they either have to slow the line down, or
they wouldn't work. So they have to have the full complement of
on-line inspectors in order to be able to slaughter. A shortage
of inspectors would not result in a plant--in a daily
shortage--let's say, a snow storm, traffic, and people--if they
don't have the full complement there--they cannot run at full
speed until we have a full complement in place. And those line
speeds and those inspector configurations associated with those
line speeds are in the regulations, and we can provide those,
also.
[The information follows:]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 310--POST-MORTEM INSPECTION--Table of Contents
Sec. 310.1 Extent and time of post-mortem inspection; post-mortem
inspection staffing standards.
(a) A careful post-mortem examination and inspection shall be made
of the carcasses and parts thereof of all livestock slaughtered at
official establishments. Such inspection and examination shall be made
at the time of slaughter unless, because of unusual circumstances,
prior arrangements acceptable to the Administrator have been made in
specific cases by the circuit supervisor for making such inspection and
examination at a later time.
(b)(1) The staffing standards on the basis of the number of
carcasses to be inspected per hour are outlined in the following
tables. Standards for multiple inspector lines are based on inspectors
rotating through the different types of inspection stations during each
shift to equalize the workload. The inspector in charge shall have the
authority to require the establishment to reduce slaughter line speeds
where, in his judgment, the inspection procedure cannot be adequately
performed at the current line speed because of particular deficiencies
in carcass preparation and presentation by the plant at the higher
speed, or because the health condition of the particular animals
indicates a need for more extensive inspection.
(2) Cattle Inspection.--For all cattle staffing standards, an ``a''
in the ``Number of Inspectors by Stations'' column means that one
inspector performs the entire inspection procedure and a ``b'' means
that one inspector performs the head and lower carcass inspection and a
second inspector performs the viscera and upper carcass inspection.\1\
---------------------------------------------------------------------------
\1\ The ``Maximum Slaughter Rates'' figures listed in paragraph
(b)(2)(i) of this section for one (a) and two (b) inspector kills are
overstated because the time required to walk from one inspection
station to another is not included. To determine the proper adjusted
maximum slaughter line speed, paragraph (b)(2)(i)(A) of this section
for one inspector kills or paragraph (b)(2)(i)(B) of this section for
two inspector kills must be used along with their accompanying rules.
---------------------------------------------------------------------------
(i) Inspection Using the Viscera Truck.--
STEERS AND HEIFERS
------------------------------------------------------------------------
Number of inspectors by
stations
Maximum slaughter rates (head per hour) --------------------------------
Head Viscera Carcass
------------------------------------------------------------------------
1 to 27................................ a a a
28 to 56............................... b b b
57 to 84............................... 1 1 1
85 to 86............................... 1 2 1
87 to 143.............................. 2 2 1
------------------------------------------------------------------------
COWS AND BULLS
------------------------------------------------------------------------
Number of inspectors by
stations
Maximum slaughter rates (head per hour) --------------------------------
Head Viscera Carcass
------------------------------------------------------------------------
1 to 27................................ a a a
28 to 55............................... b b b
56 to 77............................... 1 1 1
78 to 81............................... 1 2 1
82 to 134.............................. 2 2 1
------------------------------------------------------------------------
(A) Rules for determining adjusted maximum
slaughter rates for single-inspector kills considering
walking distance according to the table in this
subdivision: Determine the distances the inspector
actually walks between the points shown in columns 2
through 14 of the following table. For each column,
determine the deduction figure opposite the appropriate
number of feet in column 1. Compute the total of the
deduction figures for columns 2 through 14. The
adjusted maximum rate is the maximum rate in paragraph
(b)(2)(i) of this section minus total of the deduction
figures. If the resultant number is not a whole number,
it must be rounded off to the next lowest whole number.
(B) Rules for determining adjusted maximum
slaughter rates for two- inspector kills considering
walking distance according to the table in this
subdivision: Determine the distances the inspectors
actually walk between the points shown in columns 2
through 9 of the following table. Column 9 is used only
if the condemned brands and tags the viscera inspector
uses are kept at a location other than at the
washbasin- sterilizer. For each column, determine the
deduction figure opposite the appropriate number of
feet in column 1. Compute the total of the deduction
figures for columns 2 through 9. Divide this total by
2. The adjusted maximum rate is the maximum rate in
paragraph (b)(2)(i) of this section minus the number
calculated above. If the resultant number is not a
whole number, it must be rounded off to the next lowest
whole number.
(ii) Inspection Using Viscera Table, Tongue-In Presentation
of Heads.--
STEERS AND HEIFERS
------------------------------------------------------------------------
Number of inspectors by station
Maximum slaughter rates (head per hour) --------------------------------
Head Viscera Carcass
------------------------------------------------------------------------
1 to 32................................ a a a
33 to 58............................... b b b
59 to 84............................... 1 1 1
85 to 86............................... 1 2 1
87 to 143.............................. 2 2 1
144 to 171............................. 3 2 1
172 to 198............................. 3 3 1
199 to 226............................. 3 3 2
227 to 253............................. 4 3 2
254 to 280............................. 4 4 2
281 to 306............................. 5 4 2
307 to 333............................. 5 5 2
------------------------------------------------------------------------
COWS AND BULLS
------------------------------------------------------------------------
Number of inspectors by station
Maximum slaughter rates (head per hour) --------------------------------
Head Viscera Carcass
------------------------------------------------------------------------
1 to 29................................ a a a
30 to 56............................... b b b
57 to 77............................... 1 1 1
78 to 81............................... 1 2 1
82 to 134.............................. 2 2 1
135 to 159............................. 2 3 1
160 to 187............................. 3 3 1
188 to 213............................. 3 4 1
214 to 234............................. 3 4 2
235 to 264............................. 4 4 2
265 to 289............................. 5 4 2
290 to 314............................. 5 5 2
------------------------------------------------------------------------
(iii) Inspection Using Viscera Table, Tongue-Out
Presentation of Heads.--
STEERS AND HEIFERS
------------------------------------------------------------------------
Number of inspectors by station
Maximum slaughter rates (head per hour) --------------------------------
Head Viscera Carcass
------------------------------------------------------------------------
1 to 32................................ a a a
33 to 58............................... b b b
59 to 86............................... 1 1 1
87 to 103.............................. 1 2 1
104 to 156............................. 2 2 1
157 to 186............................. 2 3 1
187 to 216............................. 3 3 1
217 to 246............................. 3 3 2
247 to 275............................. 3 4 2
276 to 304............................. 4 4 2
305 to 333............................. 4 5 2
334 to 362............................. 5 5 2
363 to 390............................. 5 6 2
------------------------------------------------------------------------
COWS AND BULLS
------------------------------------------------------------------------
Number of inspectors by station
Maximum slaughter rates (head per hour) --------------------------------
Head Viscera Carcass
------------------------------------------------------------------------
1 to 29................................ a a a
30 to 56............................... b b b
57 to 79............................... 1 1 1
80 to 98............................... 1 2 1
99 to 147.............................. 2 2 1
148 to 174............................. 2 3 1
175 to 205............................. 3 3 1
206 to 233............................. 3 4 1
234 to 256............................. 3 4 2
257 to 288............................. 4 4 2
289 to 316............................. 5 4 2
317 to 343............................. 5 5 2
------------------------------------------------------------------------
(3) Swine Inspection.--The following inspection staffing standards
are applicable to swine slaughter configurations. The inspection
standards for all slaughter lines are based upon the observation rather
than palpation, at the viscera inspection station, of the spleen,
liver, heart, lungs, and mediastinal lymph nodes. In addition, for one-
and two-inspector lines, the standards are based upon the distance
walked (in feet) by the inspector between work stations; and for three
or more inspector slaughter lines, upon the use of a mirror, as
described in Sec. 307.2(m)(6), at the carcass inspection station.
Although not required in a one-or two-inspector slaughter
configuration, except in certain cases as determined by the inspection
service, if a mirror is used, it must comply with the requirements of
Sec. 307.2(m)(6).
TABLE 1.--ONE INSPECTOR--STAFFING STANDARDS FOR SWINE
----------------------------------------------------------------------------------------------------------------
Maximum inspection rates (head per hour)
---------------------------------------------------------------
Market hogs (heads attached Sows and boars (heads
Distance walked \1\ in feet is (heads detached) detached)
---------------------------------------------------------------
Without mirror With mirror Without mirror With mirror
----------------------------------------------------------------------------------------------------------------
0 to 5.......................................... 140 150 131 143
6 to 10......................................... 134 144 126 137
11 to 15........................................ 129 137 122 132
16 to 20........................................ 124 132 117 127
21 to 35........................................ 120 127 113 122
26 to 30........................................ 116 122 110 118
31 to 35........................................ 112 118 106 114
36 to 40........................................ 108 114 103 110
41 to 45........................................ 105 110 100 106
46 to 50........................................ 101 107 97 103
51 to 55........................................ 98 103 94 100
56 to 60........................................ 96 100 91 97
61 to 65........................................ 93 97 89 94
66 to 70........................................ 90 95 87 92
71 to 75........................................ 88 92 85 89
76 to 80........................................ 86 89 82 87
81 to 85........................................ 84 87 80 85
86 to 90........................................ 82 85 79 83
91 to 95........................................ 80 83 77 81
96 to 100....................................... 78 81 75 79
----------------------------------------------------------------------------------------------------------------
\1\ Distance walked is the total distance that the inspector will have to walk between work stations during one
inspection cycle (e.g., between viscera, carcass, head, and wash-basin).
TABLE 2--TWO INSPECTORS--STAFFING STANDARDS FOR MARKET HOGS
----------------------------------------------------------------------------------------------------------------
Maximum inspection rates (head per hour with
heads attached or detached)
-----------------------------------------------
Line configuration
Distance walked \1\ in feet by inspector B is -----------------------------------------------
Carcus, \2\ Viscera, \2\
head viscera head carcass Head, \2\ Head
\3\ \3\ carcass \3\
----------------------------------------------------------------------------------------------------------------
Without Mirror
0 to 5.......................................................... 151-253 151-271 151-296
6 to 10......................................................... 151-239 151-255 151-277
11 to 15........................................................ 151-226 151-240 151-260
16 to 20........................................................ 151-214 151-227 151-244
21 to 25........................................................ 151-204 151-215 151-231
With Mirror
0 to 5.......................................................... 151-253 151-303 151-318
6 to 10......................................................... 151-239 151-283 151-304
11 to 15........................................................ 151-226 151-265 151-289
16 to 20........................................................ 151-214 151-249 151-270
21 to 25........................................................ 151-204 151-235 151-254
----------------------------------------------------------------------------------------------------------------
\1\ Distance walked is the total distance that Inspector B will have to walk between work stations during one
inspection cycle (e.g., between viscera, carcass, and washbasin).
\2\ Inspector A.
\3\ Inspector B.
Note: In multiple-inspector plants, the inspectors must rotate between all inspection positions during each
shift to equalize the workload.
TABLE 3.--TWO INSPECTORS--STAFFING STANDARDS FOR SOWS AND BOARS
----------------------------------------------------------------------------------------------------------------
Maximum inspection rates (head per hour)
---------------------------------------------------------------
Line Configuration
---------------------------------------------------------------
Distance walked \1\ in feet by inspector B is Carcass,\2\ Viscera,\2\ Head,\2\ Head,\2\
head head viscera viscera
Viscera,\3\ carcass,\3\ carcass,\3\ carcass,\3\
heads detached heads detached heads detached heads attached
----------------------------------------------------------------------------------------------------------------
Without Mirror
0 to 5.......................................... 144-248 144-254 144-267 144-267
6 to 10......................................... 144-235 144-240 144-253 144-253
11 to 15........................................ 144-222 144-227 144-239 144-239
16 to 20........................................ 144-211 144-215 144-226 144-226
21 to 25........................................ 144-201 144-205 144-214 144-214
With Mirror
0 to 5.......................................... 144-248 144-292 144-305 144-292
6 to 10......................................... 144-235 144-273 144-291 144-280
11 to 15........................................ 144-222 144-256 144-272 144-268
16 to 20........................................ 144-211 144-241 144-255 144-255
21 to 25........................................ 144-201 144-228 144-240 144-240
----------------------------------------------------------------------------------------------------------------
\1\ Distance walked is the total distance that Inspector B will have to walk between work stations during one
inspection cycle (e.g., between viscera, carcass, and washbasin).
\2\ Inspector A.
\3\ Inspector B.
Note: In multiple-inspector plants, the inspectors must rotate between all inspection positions during each
shift to equalize the workload.
TABLE 4.--THREE INSPECTORS OR MORE--STAFFING STANDARDS FOR SWINE
----------------------------------------------------------------------------------------------------------------
Number of inspectors by station
Maximum inspection rates (head per hour with heads attached) ---------------------------------------------------
Head Viscera Carcass Total
----------------------------------------------------------------------------------------------------------------
Market hogs:
319 to 506.............................................. 1 1 1 3
507 to 540.............................................. 1 2 1 4
541 to 859.............................................. 2 2 1 5
860 to 1,022............................................ 2 3 1 6
1,023 to 1,106.......................................... 3 3 1 7
Sows and boars:
306 to 439.............................................. 1 1 1 3
\1\ 306 to 462.......................................... 1 1 1 3
440 to 475.............................................. 2 1 1 4
476 to 752.............................................. 2 2 1 5
753 to 895.............................................. 3 2 1 6
896 to 964.............................................. 3 3 1 7
----------------------------------------------------------------------------------------------------------------
\1\ This rate applies if the heads of sows and boars are detached from the carcasses at the time of inspection.
Note: In multiple-inspector plants, the inspectors must rotate between all inspection positions during each
shift to equalize the workload.
[35 FR 15567, Oct. 3, 1970, as amended at 47 FR 33676, Aug. 4,
1982; 50 FR 19903, May 13, 1985]
Senator Burns. In other words, on that--say your line speed
is hampered some way or other, can you shut a line down?
Mr. Smith. Absolutely. For sanitary dressing procedures,
direct product contamination, environmental contamination--the
online people at each of their stations have that ability, and
then we have alternating people--usually in a beef plant, a
high-speed beef plant, we have head inspectors, we have
eviscera inspectors, and we have slaughter inspectors. And we
have off-line people, off-line inspectors, that are verifying
the fabrication, the grinding, and also are looking at the
final rail product. And then we have a veterinarian there who's
in charge of the supervision. And he is--he or she is also
there to do the disposition of carcasses, because inspectors
cannot condemn an animal. Only veterinarians can do that.
Senator Burns. Mr. Shire, would you like to respond to
that?
Mr. Shire. Well, I--our understanding is that--in
situations that have existed, that the high line speed has
contributed to some of the problems in the plant. Recently, the
problems with trim at Swift have been--have been put to that
very--for that particular reason.
The other thing about the line speeds is that--what Mr.
Smith says, that in cases where the inspectors have been taken
and put on the line in large plants, what--in small plants,
they've ended up being--well, they've been ended up pulling off
of the lines in small plants, and small plants are facing
situations then where they can't do as much slaughter as they
would like to do. If they have a normal course of 2 or 3 or 4
days a week of slaughter when the--there have been instances
where a lot--where the inspectors have been taken and put onto
the line in larger plants, and then the small plants have to
cut back on the amount of slaughter that they're doing, or they
have to shut down.
Senator Burns. Mr. Munsell, would you like to comment?
Mr. Munsell. I have several comments, if I may.
Senator Burns. You may.
Mr. Munsell. Okay. First of all, you asked Mr. Smith a
question about when does the USDA inspector document
information regarding the source of meat-based sampling for an
E. coli analysis. I argued with the USDA for many, many months
about this, that they should be documenting that on the day
that the sample was taken. HACCP is supposedly scientific, and
that--to me, that's the only scientific way to do it. However,
that was not proper procedure for them to document the
information on the day the sample was taken.
But on July 29th, they sent out--the USDA sent out a three-
paragraph memo to all their field staff explaining that
starting in their--the field staff were to start documenting
that information on the day the sample was taken. A great step
forward.
I think it was in September that improvement, that new
policy, was rescinded. The new policy now says that when the--
when the sample is determined to be a presumptive positive,
then at that point in time the inspectors must go back to the
plant management and say, ``What was the origin of that meat?''
I attended a meeting in Great Falls in early October that
was hosted by Dr. Nathaniel Clark, who is the district office
manager of the Minneapolis USDA office. So I asked him that
question in front of everyone else who was in that room, so
they could document whether I'm telling the truth or not. I
said, ``What--what is the current status? Is the inspector to
document the origin when he takes the sample, or 3 days
later?'' Because that's--it takes 3 days before that
presumptive positive is made. Dr. Nathaniel Clark gave me the
comment, and I quote, ``For legal reasons, it has been decided
to wait until the presumptive positive determination has been
made,'' so--end quote. So I asked, ``For legal reasons, who
would possibly legally challenge the USDA if they instructed
their inspectors to document the origin of meat when they took
the sample?'' Well, I need for you to fill in the blanks on
that one. It had to be someone who had something to lose.
Now, it's my contention that it should be done jointly,
that--the day that the sample is taken, it is my contention
that both the inspector and the plant management should work
together and fully document all that information so that, in
the future, 3 days later, if it is presumptive-positive, there
can be no question. The plant can't lie and say, ``Well, nope,
it came from somebody else,'' nor can the USDA make false
accusations to the plant, saying, ``Well, it was your meat.''
In our case, February 19th and 20th, 21st, as Mr. Smith
said, we fully documented all that information. It was observed
by the inspector. He knew that all that documentation was
correct. And for that reason, both he and his supervisor, the
veterinarian, signed that letter that was seen on NBC Nightly
News in which they identified ConAgra as the source.
Well, I'd just ask everybody in this room, even if the USDA
did go back to the policy of instructing that all that
documentation be prepared on the day the sample is taken, that
documentation means nothing, whether we take it or whether the
inspector takes it, yet the hierarchy in Washington, D.C. has
the authority to summarily reject it all and call it mere
``opinion.''
Senator Burns. Mr. Smith, do you want to respond to that?
Mr. Smith. Again, I'm not sure what we're saying was that
we rejected any opinions. What I do know is the regulations
that required plants, for decades, to be responsible for
documenting product coming into the plant and where it goes out
of their plant. So, therefore, it is a matter of when we need
to collect this information, we go to the plant to ask them for
those required records.
We--as I said, we do 54,000 samples to this point. We've
already done 6,000 this year. The number of positive 0157:H7s
is less than 10 percent of those ever confirmed. We'd be
collecting an awful lot of information when we could have
inspectors doing more important things.
We also know that those records are available to us,
because they're required by regulation. Plants need to document
their incoming products, what they make--that's required by
regulation; I can give you the regulations sites--and where
they distribute them to. Those records are available to us, and
those are the records we would then use to make those
determinations.
What we are doing with the supplier notification process
is--because I said we had a high probability on presumptive
positives, that it seems, would get a jump upon getting those
distribution records together. But what does that mean? That
means we go to the plant owner and ask him for those records
that he or she must maintain in order to get that information
so we can send a notification out, should it become positive.
We can be much clearer. I mean, we're happy to make that
clearer for our inspectors if we need to, but those are the
regulations, those are the records, and those are the way I've
been operating, as far as I know, since I've been in this
agency for 25 years.
Mr. Munsell. But why--but why can't--once you accept a
sample and--why can't you put on that sample the documentation
of where that meat comes from at that time rather than waiting
2 or 3 days or whatever before your determine--presumptive
determination?
Mr. Smith. Again, I think that's something that we can look
at. I think that needs to be vetted in a public process,
because a number of packers would also be very upset about us
collecting information on negative findings. And so I just
think, in fairness to everybody, that we should do a meeting.
We should discuss that. We have meetings every month with
industry and the consumer groups, and that's certainly a topic
that Mr. Shire could bring up, and we could certainly vet that
in a public process.
Right now, we feel we have sufficient record-keeping
requirements to be able to get that information. And to this
point, it has been very effective both for Salmonella testing,
for red meat. All our testing programs are the same way.
Senator Burns. All right. Well, I would say that--maybe the
large packer may have some complaints about that, but that's
tough.
Mr. Munsell?
Mr. Munsell. Mr. Smith says that, ``in all fairness to all
the packers''--and, you know, the system has to be fair to all
the packers--it also has to be common sense. The Wholesome Meat
Act, the primary recipient--the primary beneficiary of the
Wholesome Meat Act is the consumer. To me, every decision
that--every policy that the USDA makes, I believe, should have,
as its primary goal, safe food for consumers. So instead of
saying, ``Let's be fair to all packers,'' I say, ``Let's be
fair to consumers.'' If food safety is our number one goal,
every policy that the USDA and that plant management follows
must be geared toward safe food, not protecting the big
packers.
Mr. Smith. May I respond to that?
Senator Burns. Yes.
Mr. Smith. I agree that our number one priority is food
safety. And when I said ``packers,'' I didn't just say ``large
packers.'' I said ``all packers.''
And I also know--and so maybe this will help clarify--that
we extensively train our compliance officers to do record
investigations and trace-back. We send them to Justice
Department training in New Mexico. We have further training for
them in that we have contracted with Sam Houston University in
law enforcement. Our people are well-trained and able to have
assess records, trace-back records, just so when an outbreak or
an incident occurs, we can quickly protect the consuming
public.
Senator Burns. Tell me about the inspector's mark. What is
it, what's it look like, and when it is applied?
Mr. Smith. The mark of inspection is a shield. It says,
``Inspected for wholesomeness''----
Senator Burns. Whenever you roll the carcass? Is that when
you----
Mr. Smith. No--it goes on the carcass. It also is a
required labeling feature on every label of meat and poultry
product, and egg products, also.
What does the mark of inspection mean? It means--my version
of what it means, and I believe it's the Agency's version of
what it means, is that those products have been produced in
facilities that are safe, constructed a safe environment for
producing product, that the equipment is designed to not
adulterate the product, that the water supply coming into that
product--that plant is potable, that the sewage systems in that
plant cannot cross-contaminate. It means that the plant has
sanitation operating procedures which are required to ensure
the products are not directly contaminated or adulterated. It
means that the products are produced under process-control
systems, HACCP, so that microbiological, chemical, and physical
hazards are either controlled, reduced, or eliminated. It means
that products are verified that they're not economically
adulterated, and that when they go out the door, they are
properly labeled as to net weight and content.
Senator Burns. Now, I've forgotten exactly what it says on
that roll. I guess it says, ``USDA inspected.'' And also, is
the grade put--applied at the same time with regard to the
carcass? Not in regard to the trimmings or----
Mr. Smith. Grading is a voluntary service. Any marketing
service is responsible for that. We do not apply the grade
marks. We only apply the mark of inspection.
Senator Burns. Okay. I--there's another mark here
somewhere. I've got a terrific memory, but it's short.
I think--Mr. Munsell, do you have anymore questions of USDA
here, while we've got him here----
Mr. Munsell. I may.
Senator Burns [continuing]. That we should make part of the
public record?
Mr. Munsell. When I earlier made the comment about the fact
that the--that July 29th policy change had been rescinded in
regards to when is information documented as to the origin of
the meat being sampled--I was wondering if Mr. Smith could
define what Dr. Nathaniel Clark meant when he said, ``For legal
reasons, it's been decided to wait until 3 days later when the
presumptive positive has been determined.'' So what did he mean
by ``legal reasons''? What kind of legal ramifications would
this have to the USDA?
Mr. Smith. Honestly, I do not. Not being in that
conversation, I'm not sure. I can tell you the policy did not
change. The policy was published in a press release on July
15th and said we will notify suppliers when we have a positive
result. We collect the information when we have presumptives
because, again, there's a high probability that a presumptive
will confirm. It's an 80-percent chance. So whether he was
referring to maybe we should collect it when it's potential,
and then potential you have a 10 percent chance of confirming--
I don't know what his thinking was at the time.
I'm telling you the policy was published on July 15th,
2002, an FSIS press release, and I'm not aware of any changes
to it since.
Mr. Munsell. I'm sure that--I have a copy in my briefcase
of the July 29th three-paragraph memo that specifies that they
are to begin documenting that information on the day they
collect the sample. And included with that was a form that
appeared on the Web site that showed the information. So, Mr.
Smith, are you aware of that three-paragraph memo, plus the
chart that they were supposed to use to document the
information?
Mr. Smith. Again, we always are putting up information to
help our people document and collect information. The policy,
again, was made when we announced we were going to notify
suppliers, on July 15th. If there's a July 29th, then I'm not--
I'm just not familiar with it right now. If it's there, my
guess would be, it's instruction to our inspectors on how to
document, especially if it was a worksheet. That would make
sense that we would do something like that to help them
document. I don't know how that would have changed any
policies. And it was instructions to document and collect
information.
Senator Burns. Mr. Smith, give me a--give me some kind of
idea of--on whenever you redo policy and policy changes, if
you--if it's--you say that every 30 days you have a working
team that reviews changes, or suggested changes.
Mr. Smith. Well--how often?
Senator Burns. How often?
Mr. Smith. We meet with our constituents pretty much on a
monthly and never less than every-other monthly basis, and
questions either the consumer groups have or the industry have
on our executing policy, we discuss. And then if there's
changes needed, we try and do that in a public arena, just
like--for instance, we're having a recall meeting tomorrow in
Washington, D.C., to go over some of the issues that Mr. Shire
brought up, and that's, we feel, a very good way to get input
on the execution of how we do things. And if there's changes
needed, then that can be brought forward in the public process,
and everybody can weigh in and talk about it, and then we
hopefully can make the best decision.
The only time we would not wait for that would be, of
course, if we have a food emergency. We will act first, and
discuss any associated issues after we control the food safety
issue.
Senator Burns. Well, I know that--and you can hear the
frustration here among producers and everybody else, because it
just affects all of us. And your procedures, sometimes, I would
imagine, has to stand scrutiny and review all the time, because
there is--let's face it, there are new ways of doing things.
And of course, science turns up new things.
I would--I know there's some more questions out there, and
I'm going to leave the record open for more questions and--to
all of you. We have a--I know two other Senators that don't--
that are interested in this issue, because they have facilities
in their States, and also producers in their States. So I have
no more questions.
I think we've pretty well covered the policy end of it, and
I think probably that you'll see the Senate take a closer look
at or maybe a review with the department on those things. And I
would imagine you could expect some hearings in Washington,
D.C. I don't think this is the end of this, because it causes
lots of heartburn whenever these situations happen.
So I'm going to leave the record open for 30 days. I'm
going to allow other Senators to--if they have questions, I'll
have them send to you for clarification and your response, and
you can respond both to the committee and to the Senator. I
would appreciate that very much.
If there is anything else that could come before this--I do
think that right now our biggest problem is a lack of
communication between, say, an operation like Mr. Munsell runs
in Miles City, Montana, and also--but it looks like if his
records are complete and the documentation is there, I'm not
much concerned about what a larger packer might think is an
inconvenience to them. I'm more concerned about taking care of
the problem and doing it now, because we have the consumers to
be concerned about and also the--and also, if that
documentation also clears a lot of people down the line. It
looks like the--if the dead meat's documented, whenever it goes
to the lab it should say where it comes from. And--now if you
want to put a--if you want to put an embargo on the information
of that until after the--until after the tests are run, I see
no problems with that, but I think it should be on there so
that we know how to react, and react in a proper and speedy
manner. And now that's my opinion. Of course, I may be a
minority here, but that's what I think.
CONCLUSION OF HEARING
So I'm going to--I'm going to close these hearings. I'm
going to leave the record open for 30 days for questions. And
if you can respond to those, I--it would be muchly appreciated.
So as of right now, this session is recessed.
[Whereupon, at 4:20 p.m., Wednesday, December 11, the
hearing was concluded, and the subcommittee was recessed, to
reconvene subject to the call of the Chair.]
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