[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2749 Referred in Senate (RFS)]
111th CONGRESS
1st Session
H. R. 2749
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
August 3, 2009
Received; read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
AN ACT
To amend the Federal Food, Drug, and Cosmetic Act to improve the safety
of food in the global market, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Food Safety Enhancement Act of
2009''.
SEC. 2. TABLE OF CONTENTS.
The table of contents of this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. References.
Sec. 4. Rules of construction.
Sec. 5. USDA exemptions.
Sec. 6. Alcohol-related facilities.
TITLE I--FOOD SAFETY
Subtitle A--Prevention
Sec. 101. Changes in registration of food facilities.
Sec. 102. Hazard analysis, risk-based preventive controls, food safety
plan, finished product test results from
category 1 facilities.
Sec. 103. Performance standards.
Sec. 104. Safety standards for produce and certain other raw
agricultural commodities.
Sec. 105. Risk-based inspection schedule.
Sec. 106. Access to records.
Sec. 107. Traceability of food.
Sec. 108. Reinspection and food recall fees applicable to facilities.
Sec. 109. Certification and accreditation.
Sec. 110. Testing by accredited laboratories.
Sec. 111. Notification, nondistribution, and recall of adulterated or
misbranded food.
Sec. 112. Reportable food registry; exchange of information.
Sec. 113. Safe and secure food importation program.
Sec. 114. Infant formula.
Subtitle B--Intervention
Sec. 121. Surveillance.
Sec. 122. Public education and advisory system.
Sec. 123. Research.
Subtitle C--Response
Sec. 131. Procedures for seizure.
Sec. 132. Administrative detention.
Sec. 133. Authority to prohibit or restrict the movement of food.
Sec. 134. Criminal penalties.
Sec. 135. Civil penalties for violations relating to food.
Sec. 136. Improper import entry filings.
TITLE II--MISCELLANEOUS
Sec. 201. Food substances generally recognized as safe.
Sec. 202. Country of origin labeling.
Sec. 203. Exportation certificate program.
Sec. 204. Registration for commercial importers of food; fee.
Sec. 205. Registration for customs brokers.
Sec. 206. Unique identification number for food facilities, importers,
and custom brokers.
Sec. 207. Prohibition against delaying, limiting, or refusing
inspection.
Sec. 208. Dedicated foreign inspectorate.
Sec. 209. Plan and review of continued operation of field laboratories.
Sec. 210. False or misleading reporting to FDA.
Sec. 211. Subpoena authority.
Sec. 212. Whistleblower protections.
Sec. 213. Extraterritorial jurisdiction.
Sec. 214. Support for training institutes.
Sec. 215. Bisphenol A in food and beverage containers.
Sec. 216. Lead content labeling requirement for ceramic tableware and
cookware.
SEC. 3. REFERENCES.
Except as otherwise specified, whenever in this Act an amendment is
expressed in terms of an amendment to a section or other provision, the
reference shall be considered to be made to a section or other
provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et
seq.).
SEC. 4. RULES OF CONSTRUCTION.
(a) Nothing in this Act or the amendments made by this Act shall be
construed to prohibit or limit--
(1) any cause of action under State law; or
(2) the introduction of evidence of compliance or
noncompliance with the requirements of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 301 et seq.).
(b) Nothing in this Act or any amendment made by this Act shall be
construed to--
(1) alter the jurisdiction between the Secretary of
Agriculture and the Secretary of Health and Human Services,
under applicable statutes and regulations;
(2) limit the authority of the Secretary of Health and
Human Services to issue regulations related to the safety of
food under--
(A) the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.) as in effect on the day before the
date of the enactment of this Act; or
(B) the Public Health Service Act (42 U.S.C. 301 et
seq.) as in effect on the day before the date of the
enactment of this Act; or
(3) impede, minimize, or affect the authority of the
Secretary of Agriculture to prevent, control, or mitigate a
plant or animal health emergency, or a food emergency involving
products regulated under the Federal Meat Inspection Act (21
U.S.C. 601 et seq.), the Poultry Products Inspection Act (21
U.S.C. 451 et seq.), or the Egg Products Inspection Act (21
U.S.C. 1031 et seq.).
SEC. 5. USDA EXEMPTIONS.
(a) USDA-regulated Products.--Food is exempt from the requirements
of this Act to the extent that such food is regulated by the Secretary
of Agriculture under the Federal Meat Inspection Act (21 U.S.C. 601 et
seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or
the Egg Products Inspection Act (21 U.S.C. 1031 et seq.).
(b) Livestock and Poultry.--Livestock and poultry that are intended
to be presented for slaughter pursuant to the regulations by the
Secretary of Agriculture under the Federal Meat Inspection Act or the
Poultry Products Inspection Act are exempt from the requirements of
this Act. A cow, sheep, or goat that is used for the production of milk
is exempt from the requirements of this Act.
(c) USDA-regulated Facilities.--A facility is exempt from the
requirements of this Act to the extent such facility is regulated as an
official establishment by the Secretary of Agriculture under the
Federal Meat Inspection Act, the Poultry Products Inspection Act, or
the Egg Products Inspection Act or under a program recognized by the
Secretary of Agriculture as at least equal to Federal regulation under
the Federal Meat Inspection Act, the Poultry Products Inspection Act,
or the Egg Products Inspection Act.
(d) Farms.--A farm is exempt from the requirements of this Act to
the extent such farm raises animals from which food is derived that is
regulated under the Federal Meat Inspection Act, the Poultry Products
Inspection Act, or the Egg Products Inspection Act.
SEC. 6. ALCOHOL-RELATED FACILITIES.
(a) In General.--With the exception of the amendments made by
section 101(a) and (b) and section 113 of this Act, nothing in this
Act, or the amendments made by this Act, shall be construed to apply to
a facility that--
(1) under the Federal Alcohol Administration Act (27 U.S.C.
201 et seq.) or chapter 51 of subtitle E of the Internal
Revenue Code of 1986 (26 U.S.C. 5291 et seq.) is required to
obtain a permit or to register with the Secretary of the
Treasury as a condition of doing business in the United States;
and
(2) under section 415 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 350d), as amended by this Act, is
required to register as a facility because such facility is
engaged in manufacturing, processing, packing, or holding 1 or
more alcoholic beverages.
(b) Limited Receipt and Distribution of Non-alcohol Food.--
Subsection (a) shall not apply to a facility engaged in the
distributing of any non-alcohol food, except that subsection (a) shall
apply to a facility described in paragraphs (1) and (2) of subsection
(a) that receives and distributes non-alcohol food provided such food
is received and distributed--
(1) in a prepackaged form that prevents any direct human
contact with such food; and
(2) in amounts that constitute not more than 5 percent of
the overall sales of such facility, as determined by the
Secretary of the Treasury.
(c) Rule of Construction.--This section shall not be construed to
exempt any food, apart from distilled spirits, wine, and malt
beverages, as defined in section 211 of the Federal Alcohol
Administration Act (27 U.S.C. 211), from the requirements of this Act
and the amendments made by this Act.
TITLE I--FOOD SAFETY
Subtitle A--Prevention
SEC. 101. CHANGES IN REGISTRATION OF FOOD FACILITIES.
(a) Misbranding.--Section 403 (21 U.S.C. 343) is amended by adding
at the end the following:
``(z) If it was manufactured, processed, packed, or held in a
facility that is not duly registered under section 415, including a
facility whose registration is canceled or suspended under such
section.''.
(b) Annual Registration.--
(1) Definition of facility.--Paragraph (1) of section
415(b) (21 U.S.C. 350d(b)) is amended to read as follows:
``(1)(A) The term `facility' means any factory, warehouse,
or establishment (including a factory, warehouse, or
establishment of an importer) that manufactures, processes,
packs, or holds food.
``(B) Such term does not include farms; private residences
of individuals; restaurants; other retail food establishments;
nonprofit food establishments in which food is prepared for or
served directly to the consumer; or fishing vessels (except
such vessels engaged in processing as defined in section
123.3(k) of title 21, Code of Federal Regulations, or any
successor regulations).
``(C)(i) The term `retail food establishment' means an
establishment that, as its primary function, sells food
products (including those food products that it manufactures,
processes, packs, or holds) directly to consumers (including by
Internet or mail order).
``(ii) Such term includes--
``(I) grocery stores;
``(II) convenience stores;
``(III) vending machine locations; and
``(IV) stores that sell bagged feed, pet
food, and feed ingredients or additives over-
the-counter directly to consumers and final
purchasers for their own personal animals.
``(iii) A retail food establishment's primary
function is to sell food directly to consumers if the
annual monetary value of sales of food products
directly to consumers exceeds the annual monetary value
of sales of food products to all other buyers.
``(D)(i) The term `farm' means an operation in one general
physical location devoted to the growing and harvesting of
crops, the raising of animals (including seafood), or both.
``(ii) Such term includes--
``(I) such an operation that packs or holds food,
provided that all food used in such activities is
grown, raised, or consumed on such farm or another farm
under the same ownership;
``(II) such an operation that manufactures or
processes food, provided that all food used in such
activities is consumed on such farm or another farm
under the same ownership;
``(III) such an operation that sells food directly
to consumers if the annual monetary value of sales of
the food products from the farm or by an agent of the
farm to consumers exceeds the annual monetary value of
sales of the food products to all other buyers;
``(IV) such an operation that manufactures grains
or other feed stuffs that are grown and harvested on
such farm or another farm under the same ownership and
are distributed directly to 1 or more farms for
consumption as food by humans or animals on such farm;
and
``(V) a fishery, including a wild fishery, an
aquaculture operation or bed, a fresh water fishery,
and a saltwater fishery.
``(iii) Such term does not include such an operation that
receives manufactured feed from another farm as described in
clause (ii)(IV) if the receiving farm releases the feed to
another farm or facility under different ownership.
``(iv) The term `harvesting' includes washing, trimming of
outer leaves of, and cooling produce.
``(E) The term `consumer' does not include a business.''.
(2) Registration.--Section 415(a) (21 U.S.C. 350d(a)) is
amended--
(A) in the first sentence of paragraph (1)--
(i) by striking ``require that'' and
inserting ``require that, on or before December
31 of each year,''; and
(ii) by striking ``food for consumption in
the United States'' and inserting ``food for
consumption in the United States or for export
from the United States'';
(B) in subparagraphs (A) and (B) of paragraph (1),
by inserting ``and pay the registration fee required
under section 743'' after ``submit a registration to
the Secretary'' each place it appears;
(C) in the first sentence of paragraph (2), by
inserting ``in electronic format'' after ``submit'';
and
(D) in paragraph (4), by inserting after the first
sentence the following: ``The Secretary shall remove
from such list the name of any facility that fails to
reregister in accordance with this section, that fails
to pay the registration fee required under section 743,
or whose registration is canceled by the registrant,
canceled by the Secretary in accordance with this
section, or suspended by the Secretary in accordance
with this section.''.
(3) Contents of registration.--Paragraph (2) of section
415(a) (21 U.S.C. 350d(a)), as amended by paragraph (1), is
amended by striking ``containing information'' and all that
follows and inserting the following: ``containing information
that identifies the following:
``(A) The name, address, and emergency contact
information of the facility being registered.
``(B) The primary purpose and business activity of
the facility, including the dates of operation if the
facility is seasonal.
``(C) The general food category (as defined by the
Secretary by guidance) of each food manufactured,
processed, packed, or held at the facility.
``(D) All trade names under which the facility
conducts business related to food.
``(E) The name, address, and 24-hour emergency
contact information of the United States distribution
agent for the facility, which agent shall have access
to the information required to be maintained under
section 414(d) for food that is manufactured,
processed, packed, or held at the facility.
``(F) If the facility is located outside of the
United States, the name, address, and emergency contact
information for a United States agent.
``(G) The unique facility identifier of the
facility, as specified under section 1011.
``(H) Such additional information pertaining to the
facility as the Secretary may require by regulation.
The registrant shall notify the Secretary of any change in the
submitted information not later than 30 days after the date of
such change, unless otherwise specified by the Secretary.''.
(4) Suspension and cancellation authority.--Section 415(a)
(21 U.S.C. 350d(a)), as amended by paragraphs (1) and (2), is
further amended by adding at the end the following:
``(5) Suspension of registration.--
``(A) In general.--The Secretary may suspend the
registration of any facility registered under this
section for a violation of this Act that could result
in serious adverse health consequences or death to
humans or animals.
``(B) Notice of suspension.--Suspension of a
registration shall be preceded by--
``(i) notice to the facility of the intent
to suspend the registration; and
``(ii) an opportunity for an informal
hearing, as defined in guidance or regulations
issued by the Secretary, concerning the
suspension of such registration for such
facility.
``(C) Request.--The owner, operator, or agent in
charge of a facility whose registration is suspended
may request that the Secretary vacate the suspension of
registration when such owner, operator, or agent has
corrected the violation that is the basis for such
suspension.
``(D) Vacating of suspension.--If, based on an
inspection of the facility or other information, the
Secretary determines that adequate reasons do not exist
to continue the suspension of a registration, the
Secretary shall vacate such suspension.
``(6) Cancellation of registration.--
``(A) In general.--Not earlier than 10 days after
providing the notice under subparagraph (B), the
Secretary may cancel a registration if the Secretary
determines that--
``(i) the registration was not updated in
accordance with this section or otherwise
contains false, incomplete, or inaccurate
information; or
``(ii) the required registration fee has
not been paid within 30 days after the date
due.
``(B) Notice of cancellation.--Cancellation shall
be preceded by notice to the facility of the intent to
cancel the registration and the basis for such
cancellation.
``(C) Timely update or correction.--If the
registration for the facility is updated or corrected
no later than 7 days after notice is provided under
subparagraph (B), the Secretary shall not cancel such
registration.
``(7) Report to congress.--Not later than March 30th of
each year, the Secretary shall submit to the Congress a report,
based on the registrations on or before December 31 of the
previous year, on the following:
``(A) The number of facilities registered under
this section.
``(B) The number of such facilities that are
domestic.
``(C) The number of such facilities that are
foreign.
``(D) The number of such facilities that are high-
risk.
``(E) The number of such facilities that are low-
risk.
``(F) The number of such facilities that hold food.
``(8) Limitation on delegation.--The authority conferred by
this subsection to issue an order to suspend a registration or
cancel a registration shall not be delegated to any officer or
employee other than the Commissioner of Food and Drugs, the
Principal Deputy Commissioner, the Associate Commissioner for
Regulatory Affairs, or the Director for the Center for Food
Safety and Applied Nutrition, of the Food and Drug
Administration.''.
(c) Registration Fee.--Chapter VII (21 U.S.C. 371 et seq.) is
amended by adding at the end of subchapter C the following:
``PART 6--FEES RELATING TO FOOD
``SEC. 743. FACILITY REGISTRATION FEE.
``(a) In General.--
``(1) Assessment and collection.--Beginning in fiscal year
2010, the Secretary shall assess and collect an annual fee for
the registration of a facility under section 415.
``(2) Payable date.--A fee under this section shall be
payable--
``(A) for a facility that was not registered under
section 415 for the preceding fiscal year, on the date
of registration; and
``(B) for any other facility--
``(i) for fiscal year 2010, not later than
the sooner of 90 days after the date of the
enactment of this part or December 31, 2009;
and
``(ii) for a subsequent fiscal year, not
later than December 31 of such fiscal year.
``(b) Fee Amounts.--
``(1) In general.--The registration fee under subsection
(a) shall be--
``(A) for fiscal year 2010, $500; and
``(B) for fiscal year 2011 and each subsequent
fiscal year, the fee for fiscal year 2010 as adjusted
under subsection (c).
``(2) Annual fee setting.--The Secretary shall, not later
than 60 days before the start of fiscal year 2011 and each
subsequent fiscal year, establish, for the next fiscal year,
registration fees under subsection (a), as described in
paragraph (1).
``(3) Maximum amount.--Notwithstanding paragraph (1), a
person who owns or operates multiple facilities for which a fee
must be paid under this section for a fiscal year shall be
liable for not more than $175,000 in aggregate fees under this
section for such fiscal year.
``(c) Inflation Adjustment.--For fiscal year 2011 and each
subsequent fiscal year, the fee amount under subsection (b)(1) shall be
adjusted by the Secretary by notice, published in the Federal Register,
to reflect the greater of--
``(1) the total percentage change that occurred in the
Consumer Price Index for all urban consumers (all items; U.S.
city average) for the 12-month period ending June 30 preceding
the fiscal year for which fees are being established;
``(2) the total percentage change for the previous fiscal
year in basic pay under the General Schedule in accordance with
section 5332 of title 5, United States Code, as adjusted by any
locality-based comparability payment pursuant to section 5304
of such title for Federal employees stationed in the District
of Columbia; or
``(3) the average annual change in the cost, per full-time
equivalent position of the Food and Drug Administration, of all
personnel compensation and benefits paid with respect to such
positions for the first 5 years of the preceding 6 fiscal
years.
The adjustment made each fiscal year under this subsection shall be
added on a compounded basis to the sum of all adjustments made each
fiscal year after fiscal year 2010 under this subsection.
``(d) Limitations.--
``(1) In general.--Fees under subsection (a) shall be
refunded for a fiscal year beginning after fiscal year 2010
unless appropriations for salaries and expenses of the Food and
Drug Administration for such fiscal year (excluding the amount
of fees appropriated for such fiscal year) are equal to or
greater than the amount of appropriations for the salaries and
expenses of the Food and Drug Administration for fiscal year
2010 (excluding the amount of fees appropriated for such fiscal
year) multiplied by the adjustment factor applicable to the
fiscal year involved.
``(2) Authority.--If the Secretary does not assess fees
under subsection (a) during any portion of a fiscal year
because of paragraph (1) and if at a later date in such fiscal
year the Secretary may assess such fees, the Secretary may
assess and collect such fees, without any modification in the
rate, for registration under section 415 at any time in such
fiscal year.
``(3) Adjustment factor.--In this subsection, the term
`adjustment factor' applicable to a fiscal year is the Consumer
Price Index for all urban consumers (all items; United States
city average) for October of the preceding fiscal year divided
by such Index for October 2009.
``(e) Crediting and Availability of Fees.--
``(1) In general.--Fees authorized under subsection (a)
shall be collected and available for obligation only to the
extent and in the amount provided in advance in appropriations
Acts. Such fees are authorized to remain available until
expended. Such sums as may be necessary may be transferred from
the Food and Drug Administration salaries and expenses
appropriation account without fiscal year limitation to such
appropriation account for salaries and expenses with such
fiscal year limitation.
``(2) Collections and appropriations acts.--The fees
authorized by this section--
``(A) shall be retained in each fiscal year in an
amount not to exceed the amount specified in
appropriation Acts, or otherwise made available for
obligation, for such fiscal year; and
``(B) shall only be collected and available to
defray the costs of food safety activities.
``(3) Authorization of appropriations.--For each of fiscal
years 2010 through 2014, there are authorized to be
appropriated for fees under this section such sums as may be
necessary.
``(4) Public meetings.--For each fiscal year, the Secretary
shall hold a public meeting on how fees collected under this
section will be used to defray the costs of food safety
activities in order to solicit the views of the regulated
industry, consumers, and other interested stakeholders.
``(f) Collection of Unpaid Fees.--In any case where the Secretary
does not receive payment of a fee assessed under subsection (a) within
30 days after it is due, such fee shall be treated as a claim of the
United States Government subject to subchapter II of chapter 37 of
title 31, United States Code.
``(g) Construction.--This section may not be construed to require
that the number of full-time equivalent positions in the Department of
Health and Human Services, for officers, employees, and advisory
committees not engaged in food safety activities, be reduced to offset
the number of officers, employees, and advisory committees so engaged.
``(h) Annual Fiscal Reports.--Beginning with fiscal year 2011, not
later than 120 days after the end of each fiscal year for which fees
are collected under this section, the Secretary shall prepare and
submit to the Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education, Labor, and
Pensions of the Senate a report on the implementation of the authority
for such fees during such fiscal year and the use, by the Food and Drug
Administration, of the fees collected for such fiscal year.
``(i) Definitions.--In this section:
``(1) The term `costs of food safety activities' means the
expenses incurred in connection with food safety activities
for--
``(A) officers and employees of the Food and Drug
Administration, contractors of the Food and Drug
Administration, advisory committees, and costs related
to such officers, employees, and committees and to
contracts with such contractors;
``(B) laboratory capacity;
``(C) management of information, and the
acquisition, maintenance, and repair of technology
resources;
``(D) leasing, maintenance, renovation, and repair
of facilities and acquisition, maintenance, and repair
of fixtures, furniture, scientific equipment, and other
necessary materials and supplies; and
``(E) collecting fees under this section and
accounting for resources allocated for food safety
activities.
``(2) The term `food safety activities' means activities
related to compliance by facilities registered under section
415 with the requirements of this Act relating to food
(including research related to and the development of standards
(such as performance standards and preventive controls), risk
assessments, hazard analyses, inspection planning and
inspections, third-party inspections, compliance review and
enforcement, import review, information technology support,
test development, product sampling, risk communication, and
administrative detention).''.
(d) Transitional Provisions.--
(1) Fees.--The Secretary of Health and Human Services shall
first impose the fee established under section 743 of the
Federal Food, Drug, and Cosmetic Act, as added by subsection
(c), for fiscal years beginning with fiscal year 2010.
(2) Modification of registration form.--Not later than 180
days after the date of the enactment of this Act, the Secretary
of Health and Human Services shall modify the registration form
under section 415 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 350d) to comply with the amendments made by this
section.
(3) Application.--The amendments made by this section,
other than subsections (b)(2) and (c), shall take effect on the
date that is 30 days after the date on which such modified
registration form takes effect, but not later than 210 days
after the date of the enactment of this Act.
(4) Sunset date.--Section 743 of the Federal Food, Drug,
and Cosmetic Act, as added by subsection (c), does not
authorize the assessment or collection of a fee for
registration under section 415 of such Act (21 U.S.C. 360)
occurring after fiscal year 2014.
SEC. 102. HAZARD ANALYSIS, RISK-BASED PREVENTIVE CONTROLS, FOOD SAFETY
PLAN, FINISHED PRODUCT TEST RESULTS FROM CATEGORY 1
FACILITIES.
(a) Hazard Analysis, Risk-based Preventive Controls, Food Safety
Plan.--
(1) Adulterated food.--Section 402 (21 U.S.C. 342) is
amended by adding at the end the following:
``(j) If it has been manufactured, processed, packed, transported,
or held under conditions that do not meet the requirements of sections
418 and 418A.''.
(2) Requirements.--Chapter IV (21 U.S.C. 341 et seq.) is
amended by adding at the end the following:
``SEC. 418. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS.
``(a) In General.--The owner, operator, or agent of a facility
shall, in accordance with this section--
``(1) conduct a hazard analysis (or more than one if
appropriate);
``(2) identify and implement effective preventive controls;
``(3) monitor preventive controls;
``(4) institute corrective actions when--
``(A) monitoring shows that preventive controls
have not been properly implemented; or
``(B) monitoring and verification show that such
controls were ineffective;
``(5) conduct verification activities;
``(6) maintain records of monitoring, corrective action,
and verification; and
``(7) reanalyze for hazards.
``(b) Identification of Hazards.--
``(1) In general.--The owner, operator, or agent of a
facility shall evaluate whether there are any hazards,
including hazards due to the source of the ingredients, that
are reasonably likely to occur in the absence of preventive
controls that may affect the safety, wholesomeness, or
sanitation of the food manufactured, processed, packed,
transported, or held by the facility, including--
``(A) biological, chemical, physical, and
radiological hazards, natural toxins, pesticides, drug
residues, filth, decomposition, parasites, allergens,
and unapproved food and color additives; and
``(B) hazards that occur naturally or that may be
unintentionally introduced.
``(2) Identified by the secretary.--The Secretary may, by
regulation or guidance, identify hazards that are reasonably
likely to occur in the absence of preventive controls.
``(3) Hazard analysis.--The owner, operator, or agent of a
facility shall identify and describe the hazards evaluated
under paragraph (1) or identified under paragraph (2), to the
extent applicable to the facility, in a hazard analysis.
``(c) Preventive Controls.--
``(1) In general.--The owner, operator, or agent of a
facility shall identify and implement effective preventive
controls to prevent, eliminate, or reduce to acceptable levels
the occurrence of any hazards identified in the hazard analysis
under subsection (b)(3).
``(2) Identified by the secretary.--
``(A) Establishment.--The Secretary may establish
by regulation or guidance preventive controls for
specific product types to prevent unintentional
contamination throughout the supply chain. The owner,
operator, or agent of a facility shall implement any
preventive controls identified by the Secretary under
this paragraph.
``(B) Alternative controls.--Such regulation or
guidance shall allow the owner, operator, or agent of a
facility to implement an alternative preventive control
to one established by the Secretary, provided that, in
response to a request by the Secretary, the owner,
operator, or agent can present to the Secretary data or
other information sufficient to demonstrate that the
alternative control effectively addresses the hazard,
including meeting any applicable performance standard.
``(C) Limitation.--Subparagraph (B) shall not apply
to any preventive control described in subparagraph
(A), (B), or (E) of subsection (i)(2).
``(d) Monitoring.--The owner, operator, or agent of a facility
shall monitor the implementation of preventive controls under
subsection (c) to identify any circumstances in which the preventive
controls are not fully implemented or verification shows that such
controls were ineffective.
``(e) Corrective Actions.--The owner, operator, or agent of a
facility shall establish and implement procedures to ensure that, if
the preventive controls under subsection (c) are not fully implemented
or are not found effective--
``(1) no affected product from such facility enters
commerce; and
``(2) appropriate action is taken to reduce the likelihood
of recurrence of the implementation failure.
``(f) Verification.--The owner, operator, or agent of a facility
shall ensure that--
``(1) the system of preventive controls identified under
subsection (c) has been validated as scientifically and
technically sound so that, if such system is implemented, the
hazards identified in the hazard analysis under subsection
(b)(3) will be prevented, eliminated, or reduced to an
acceptable level;
``(2) the facility is conducting monitoring in accordance
with subsection (d);
``(3) the facility is taking effective corrective actions
under subsection (e); and
``(4) the preventive controls are effectively preventing,
eliminating, or reducing to an acceptable level the occurrence
of identified hazards, including through the use of
environmental and product testing programs and other
appropriate means.
``(g) Requirement to Reanalyze and Revise.--
``(1) Requirement.--The owner, operator, or agent of a
facility shall--
``(A) review the evaluation under subsection (b)
for the facility and, as necessary, revise the hazard
analysis under subsection (b)(3) for the facility--
``(i) not less than every 2 years;
``(ii) if there is a change in the process
or product that could affect the hazard
analysis; and
``(iii) if the Secretary determines that it
is appropriate to protect public health; and
``(B) whenever there is a change in the hazard
analysis, revise the preventive controls under
subsection (c) for the facility as necessary to ensure
that all hazards that are reasonably likely to occur
are prevented, eliminated, or reduced to an acceptable
level, or document the basis for the conclusion that no
such revision is needed.
``(2) Nondelegation.--Any revisions ordered by the
Secretary under this subsection shall be ordered by the
Secretary or an official designated by the Secretary. An
official may not be so designated unless the official is the
director of the district under this Act in which the facility
involved is located, or is an official senior to such director.
``(h) Recordkeeping.--The owner, operator, or agent of a facility
shall maintain, for not less than 2 years, records documenting the
activities described in subsections (a) through (g).
``(i) Definitions.--For purposes of this section:
``(1) Facility.--The term `facility' means a domestic
facility or a foreign facility that is required to be
registered under section 415.
``(2) Preventive controls.--The term `preventive controls'
means those risk-based procedures, practices, and processes
that a person knowledgeable about the safe manufacturing,
processing, packing, transporting, or holding of food would
employ to prevent, eliminate, or reduce to an acceptable level
the hazards identified in the hazard analysis under subsection
(b)(3) and that are consistent with the current scientific
understanding of safe food manufacturing, processing, packing,
transporting, or holding at the time of the analysis. Those
procedures, practices, and processes shall include the
following, as appropriate to the type of facility or food:
``(A) Sanitation procedures and practices.
``(B) Supervisor, manager, and employee hygiene
training.
``(C) Process controls.
``(D) An allergen control program to minimize
potential allergic reactions in humans from ingestion
of, or contact with, human and animal food.
``(E) Good manufacturing practices.
``(F) Verification procedures, practices, and
processes for suppliers and incoming ingredients, which
may include onsite auditing of suppliers and testing of
incoming ingredients.
``(G) Other procedures, practices, and processes
established by the Secretary under subsection (c)(2).
``(3) Hazard that is reasonably likely to occur.--A food
safety hazard that is reasonably likely to occur is one for
which a prudent person who, as applicable, manufactures,
processes, packs, transports, or holds food, would establish
controls because experience, illness data, scientific reports,
or other information provides a basis to conclude that there is
a reasonable possibility that the hazard will occur in the type
of food being manufactured, processed, packed, transported, or
held in the absence of those controls.
``SEC. 418A. FOOD SAFETY PLAN.
``(a) In General.--Before a facility (as defined in section 418(i))
introduces or delivers for introduction into interstate commerce any
shipment of food, the owner, operator, or agent of the facility shall
develop and implement a written food safety plan (in this section
referred to as a `food safety plan').
``(b) Contents.--The food safety plan shall include each of the
following elements:
``(1) The hazard analysis and any reanalysis conducted
under section 418.
``(2) A description of the preventive controls being
implemented under subsection 418(c), including those to address
hazards identified by the Secretary under subsection 418(b)(2).
``(3) A description of the procedures for monitoring
preventive controls.
``(4) A description of the procedures for taking corrective
actions.
``(5) A description of verification activities for the
preventive controls, including validation that the system of
controls, if implemented, will prevent, eliminate, or reduce to
an acceptable level the identified hazards, review of
monitoring and corrective action records, and procedures for
determining whether the system of controls as implemented is
effectively preventing, eliminating, or reducing to an
acceptable level the occurrence of identified hazards,
including the use of environmental and product testing
programs.
``(6) A description of the facility's recordkeeping
procedures.
``(7) A description of the facility's procedures for the
recall of articles of food, whether voluntarily or when
required under section 422.
``(8) A description of the facility's procedures for
tracing the distribution history of articles of food, whether
voluntarily or when required under section 414.
``(9) A description of the facility's procedures to ensure
a safe and secure supply chain for the ingredients or
components used in making the food manufactured, processed,
packed, transported, or held by such facility.
``(10) A description of the facility's procedures to
implement the science-based performance standards issued under
section 419.''.
(3) Guidance or regulations.--
(A) In general.--The Secretary of Health and Human
Services (referred to in this subsection as the
``Secretary'') shall issue guidance or promulgate
regulations to establish science-based standards for
conducting a hazard analysis, documenting hazards,
identifying and implementing preventive controls, and
documenting the implementation of the preventive
controls, including verification and corrective actions
under sections 418 and 418A of the Federal Food, Drug,
and Cosmetic Act (as added by paragraph (2)).
(B) International standards.--In issuing guidance
or regulations under subparagraph (A), the Secretary
shall review international hazard analysis and
preventive control standards that are in existence on
the date of the enactment of this Act and relevant to
such guidelines or regulations to ensure that the
programs under sections 418 and 418A of the Federal
Food, Drug, and Cosmetic Act (as added by paragraph (2)
are consistent, to the extent the Secretary determines
practicable and appropriate, with such standards.
(C) Authority with respect to certain facilities.--
The Secretary may, by regulation, exempt or modify the
requirements for compliance under this section and the
amendments made by this section with respect to
facilities that are solely engaged in--
(i) the production of food for animals
other than man or the storage of packaged foods
that are not exposed to the environment; or
(ii) the storage of raw agricultural
commodities for further distribution or
processing.
(D) Small businesses.--The Secretary--
(i) shall consider the impact of any
guidance or regulations under this section on
small businesses; and
(ii) shall issue guidance to assist small
businesses in complying with the requirements
of this section and the amendments made by this
section.
(4) No effect on existing haccp authorities.--Nothing in
this section or the amendments made by this section limits the
authority of the Secretary under the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.) or the Public Health
Service Act (42 U.S.C. 201 et seq.), as in effect on the day
before the date of the enactment of this Act, to revise, issue,
or enforce product- and category-specific regulations, such as
the Seafood Hazard Analysis Critical Controls Points Program,
the Juice Hazard Analysis Critical Control Program, and the
Thermally Processed Low-Acid Foods Packaged in Hermetically
Sealed Containers standards.
(5) Consideration.--When implementing sections 418 and 418A
of the Federal Food, Drug, and Cosmetic Act, as added by
paragraph (2), the Secretary may take into account differences
between food intended for human consumption and food intended
for consumption by animals other than man.
(6) Effective date.--
(A) General rule.--The amendments made by
subsection (a) and this subsection shall take effect 18
months after the date of the enactment of this Act.
(B) Exceptions.--Notwithstanding subparagraph (A)--
(i) the amendments made by subsection (a)
and this subsection shall apply to a small
business (as defined by the Secretary) after
the date that is 2 years after the date of the
enactment of this Act; and
(ii) the amendments made by subsection (a)
and this subsection shall apply to a very small
business (as defined by the Secretary) after
the date that is 3 years after the date of the
enactment of this Act.
(b) Finished Product Test Results From Category 1 Facilities.--
(1) Adulteration.--Section 402 (21 U.S.C. 342), as amended
by subsection (a), is amended by adding at the end the
following:
``(k) If it is manufactured or processed in a facility that is in
violation of section 418B.''.
(2) Requirements.--Chapter IV (21 U.S.C. 341 et seq.), as
amended, is further amended by adding at the end the following:
``SEC. 418B. FINISHED PRODUCT TEST RESULTS FROM CATEGORY 1 FACILITIES.
``(a) Authority.--Beginning on the date specified in subsection
(c), the Secretary shall require, after public notice and an
opportunity for comment, the submission to the Secretary of finished
product test results by the owner, operator, or agent of each category
1 facility subject to good manufacturing practices regulations
documenting the presence of contaminants in food in the possession or
control of such facility posing a risk of severe adverse health
consequences or death.
``(b) Considerations.--The Secretary shall require submissions
under subsection (a)--
``(1) as the Secretary determines feasible and appropriate;
and
``(2) taking into consideration available data and
information on the potential risks posed by the facility.
``(c) Beginning Date.--The date specified in this subsection is the
sooner of--
``(1) the date of completion of the pilot projects and
feasibility study under subsections (d) and (e); and
``(2) the date that is 2 years after the date of the
enactment of this section.
``(d) Pilot Projects.--The Secretary shall conduct 2 or more pilot
projects to evaluate the feasibility of collecting positive finished
product testing results from category 1 facilities, including the value
and feasibility of reporting corrective actions taken when positive
finished product test results are reported to the Secretary.
``(e) Feasibility Study.--The Secretary shall assess the
feasibility and benefits of the reporting by facilities subject to good
manufacturing practices regulations of appropriate finished product
testing results from category 1 facilities to the Secretary, including
the extent to which the collection of such finished product testing
results will help the Secretary assess the risk presented by a facility
or product category.
``(f) Limitations.--Nothing in this section shall be construed--
``(1) to require the Secretary to mandate testing or
submission of test results that the Secretary determines would
not provide useful information in assessing the potential risk
presented by a facility or product category; or
``(2) to limit the Secretary's authority under any other
provisions of law to require any person to provide access, or
to submit information or test results, to the Secretary,
including the ability of the Secretary to require field or
other testing and to obtain test results in the course of an
investigation of a potential food-borne illness or
contamination incident.
``(g) Definition.--In this section, the term `category 1 facility'
means a category 1 facility within the meaning of section 704(h).''.
(c) Food Defense.--
(1) Adulteration.--Section 402(j), as added by subsection
(a), is amended by striking ``and 418A'' and inserting ``,
418A, or 418C''.
(2) Requirements.--Chapter IV (21 U.S.C. 341 et seq.), as
amended, is further amended by adding at the end the following:
``SEC. 418C. FOOD DEFENSE.
``(a) In General.--Before a facility (as defined in section 418(i))
introduces or delivers for introduction into interstate commerce any
shipment of food, the owner, operator, or agent of the facility shall
develop and implement a written food defense plan (in this section
referred to as a `food defense plan').
``(b) Contents.--The food defense plan shall include each of the
following elements:
``(1) A food defense assessment to identify conditions and
practices that may permit a hazard that may be intentionally
introduced, including by an act of terrorism. This assessment
shall evaluate processing security, cybersecurity, material
security (including ingredients, finished product, and
packaging), personnel security, storage security, shipping and
receiving security, and utility security.
``(2) A description of the preventive measures being
implemented as a result of such assessment to minimize the risk
of intentional contamination.
``(3) A description of the procedures to check for and
identify any circumstances in which the preventive measures are
not fully implemented or were ineffective.
``(4) A description of the procedures for taking corrective
actions to ensure that when preventive measures have not been
properly implemented or have been ineffective, appropriate
action is taken--
``(A) to reduce the likelihood of recurrence of the
failure; and
``(B) to assess the consequences of the failure.
``(5) A description of evaluation activities for the
preventive measures, including a review of records provided for
under paragraph (6) and procedures to periodically test the
effectiveness of the plan.
``(6) A description of the facility's record-keeping
procedures, including records documenting implementation of the
procedures under paragraphs (3), (4), and (5).
``(c) Hazard.--For purposes of this section, the term `hazard that
may be intentionally introduced, including by an act of terrorism'
means a hazard for which a prudent person who, as applicable,
manufactures, processes, packs, transports, or holds food, would
establish preventive measures because the hazard has been identified by
a food defense assessment by application of--
``(1) a targeting assessment tool recommended by the
Secretary by guidance; or
``(2) a comparable targeting assessment tool.
``(d) Food Defense Hazards Identified by the Secretary.--
``(1) Establishment.--The Secretary may establish by
regulation or guidance preventive measures for specific product
types to prevent intentional contamination throughout the
supply chain. The owner, operator, or agent of a facility shall
implement any preventive measures identified by the Secretary
under this paragraph.
``(2) Alternative measures.--Such regulation or guidance
shall allow the owner, operator, or agent of a facility to
implement an alternative preventive measure to one established
by the Secretary, provided that, in response to a request by
the Secretary, the owner, operator, or agent can present to the
Secretary data or other information sufficient to demonstrate
that the alternative measure effectively addresses the hazard.
``(e) Requirement to Reassess and Revise.--
``(1) Requirement.--The owner, operator, or agent of a
facility shall--
``(A) review the food defense assessment under
subsection (b)(1) for the facility and, as necessary,
revise the food defense assessment under subsection
(b)(1) for the facility--
``(i) not less than every 2 years;
``(ii) if there is a change in the process
or product that could affect the food defense
assessment; and
``(iii) if the Secretary determines that it
is appropriate to protect public health; and
``(B) whenever there is a change in the food
defense assessment, revise the preventive measures
under subsection (b)(2) for the facility as necessary
to ensure that for all hazards identified, the risk is
minimized, or document the basis for the conclusion
that no such revision is needed.
``(2) Nondelegation.--Any revisions ordered by the
Secretary under this subsection shall be ordered by the
Secretary or an official designated by the Secretary. An
official may not be so designated unless the official is the
director of the district under this Act in which the facility
involved is located, or is an official senior to such director.
``(f) Recordkeeping.--The owner, operator, or agent of a facility
shall maintain, for not less than 2 years, records documenting the
activities described in subsections (b) and (e).
``(g) Access to Plan.--
``(1) On inspection.--An officer or employee of the
Secretary shall have access to the food defense plan of a
facility under section 414(a) only if the Secretary, through an
official who is the director of the district under this Act in
which the facility is located or an official who is senior to
such a director, provides notice under section 414(a)(1)(C).
``(2) Nondisclosure.--A food defense plan, and any
information derived from such a plan, shall be exempt from
disclosure under section 552 of title 5, United States Code.''.
(3) Prohibition.--Section 301(j) (21 U.S.C. 331(j)) is
amended by inserting after ``entitled to protection'' the
following: ``or a food defense plan, or any information derived
from such a plan, under section 418C''.
SEC. 103. PERFORMANCE STANDARDS.
(a) Adulterated Food.--Section 402 (21 U.S.C. 342), as amended by
section 102, is amended by adding at the end the following:
``(l) If it has been manufactured, processed, packed, transported,
or held under conditions that do not meet the standards issued under
section 419.''.
(b) Requirements.--Chapter IV (21 U.S.C. 341 et seq.), as amended
by section 102(b), is further amended by adding at the end the
following:
``SEC. 419. PERFORMANCE STANDARDS.
``(a) Performance Standards.--The Secretary shall, not less
frequently than every 2 years, review and evaluate epidemiological data
and other appropriate sources of information, including research under
section 123 of the Food Safety Enhancement Act of 2009, to identify the
most significant food-borne contaminants and the most significant
resulting hazards. The Secretary shall issue, as soon as practicable,
through guidance or by regulation, science-based performance standards
(which may include action levels) applicable to foods or food classes,
as appropriate, to minimize to an acceptable level, prevent, or
eliminate the occurrence of such hazards. Such standards shall be
applicable to foods and food classes. Notwithstanding the timelines set
forth in this paragraph, the Secretary shall as appropriate establish
such science-based performance standards for identified contaminants as
necessary to protect the public health.
``(b) List of Contaminants.--Following each review under subsection
(a), the Secretary shall publish in the Federal Register a list of
food-borne contaminants that have the greatest adverse impact on public
health. In determining whether a particular food-borne contaminant
should be added to such list, the Secretary shall consider the number
and severity of illnesses and the number of deaths associated with the
foods associated with such contaminants.
``(c) Sampling Program.--In conjunction with the establishment of a
performance standard under this section, the Secretary may make
recommendations to industry for conducting product sampling.
``(d) Revocation by Secretary.--All performance standards of the
Food and Drug Administration applicable to foods or food classes in
effect on the date of the enactment of this section, or issued under
this section, shall remain in effect until revised or revoked by the
Secretary.''.
(c) Report to Congress.--The Secretary of Health and Human Services
shall submit to the Congress by March 30th of the year following each
review under section 419 of the Federal Food, Drug, and Cosmetic Act,
as added by subsection (b), a report on the results of such review and
the Secretary's plans to address the significant food-borne hazards
identified, or the basis for not addressing any significant food-borne
hazards identified, including any resource limitations or limitations
in data that preclude further action at that time.
SEC. 104. SAFETY STANDARDS FOR PRODUCE AND CERTAIN OTHER RAW
AGRICULTURAL COMMODITIES.
(a) Adulterated Food.--Section 402 (21 U.S.C. 342), as amended by
sections 102 and 103(a), is amended by adding at the end the following:
``(m) If it has been grown, harvested, processed, packed, sorted,
transported, or held under conditions that do not meet the standards
established under section 419A.''.
(b) Standards.--Chapter IV (21 U.S.C. 341 et seq.), as amended by
sections 102(b) and 103(b), is amended by adding at the end the
following:
``SEC. 419A. SAFETY STANDARDS FOR PRODUCE AND CERTAIN OTHER RAW
AGRICULTURAL COMMODITIES.
``(a) Standards.--The Secretary, in coordination with the Secretary
of Agriculture, shall establish by regulation scientific and risk-based
food safety standards for the growing, harvesting, processing, packing,
sorting, transporting, and holding of those types of raw agricultural
commodities--
``(1) that are a fruit, vegetable, nut, or fungus; and
``(2) for which the Secretary has determined that such
standards are reasonably necessary to minimize the risk of
serious adverse health consequences or death to humans or
animals.
``(b) Contents.--The regulations under subsection (a)--
``(1) may set forth such procedures, processes, and
practices as the Secretary determines to be reasonably
necessary--
``(A) to prevent the introduction of known or
reasonably foreseeable biological, chemical, and
physical hazards, including hazards that occur
naturally, may be unintentionally introduced, or may be
intentionally introduced, including by acts of
terrorism, into raw agricultural commodities that are a
fruit, vegetable, nut, or fungus; and
``(B) to provide reasonable assurances that such
commodity is not adulterated under section 402;
``(2) may include, with respect to growing, harvesting,
processing, packing, sorting, transporting, and storage
operations, standards for safety as the Secretary determines to
be reasonably necessary;
``(3) may include standards addressing manure use, water
quality, employee hygiene, sanitation and animal control, and
temperature controls, as the Secretary determines to be
reasonably necessary;
``(4) may include standards for such other elements as the
Secretary determines necessary to carry out subsection (a);
``(5) shall provide a reasonable period of time for
compliance, taking into account the needs of small businesses
for additional time to comply;
``(6) may provide for coordination of education and
enforcement activities;
``(7) shall take into consideration, consistent with
ensuring enforceable public health protection, the impact on
small-scale and diversified farms, and on wildlife habitat,
conservation practices, watershed-protection efforts, and
organic production methods;
``(8) may provide for coordination of education and
training with other government agencies, universities, private
entities, and others with experience working directly with
farmers; and
``(9) may provide for recognition through guidance of other
existing publicly available procedures, processes, and
practices that the Secretary determines to be equivalent to
those established under paragraph (1).
``(c) Education and Compliance.--The Secretary shall coordinate
with the Secretary of Agriculture to provide for effective
implementation of education and compliance activities. The Secretary
may contract and coordinate with the agency or department designated by
the Governor of each State to perform activities to ensure compliance
with this section.''.
(c) Timing.--
(1) Proposed rule.--Not later than 18 months after the date
of enactment of this Act, the Secretary of Health and Human
Services shall issue a proposed rule to carry out section 419A
of the Federal Food, Drug, and Cosmetic Act, as added by
subsection (b).
(2) Final rule.--Not later than 3 years after such date,
the Secretary of Health and Human Services shall issue a final
rule under such section.
(d) No Effect on Existing HACCP Authorities.--Nothing in this
section or the amendments made by this section limits the authority of
the Secretary under the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
301 et seq.) or the Public Health Service Act (42 U.S.C. 201 et seq.),
as in effect on the day before the date of the enactment of this Act,
to revise, issue, or enforce product- and category-specific
regulations, such as the Seafood Hazard Analysis Critical Controls
Points Program, the Juice Hazard Analysis Critical Control Program, and
the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed
Containers standards.
(e) Update Existing Guidance.--Not later than 1 year after the date
of the enactment of this Act, the Secretary of Health and Human
Services shall update the guidance document entitled ``Guidance For
Industry: Guide To Minimize Microbial Food Safety Hazards For Fresh
Fruits And Vegetables'' (issued on October 26, 1998) in accordance with
this section and the amendments made by this section.
SEC. 105. RISK-BASED INSPECTION SCHEDULE.
(a) In General.--Section 704 (21 U.S.C. 374) is amended by adding
at the end the following:
``(h)(1) Each facility registered under section 415 shall be
inspected--
``(A)(i) by one or more officers duly designated under
section 702 or other statutory authority by the Secretary;
``(ii) for domestic facilities, by a Federal, State, or
local official recognized by the Secretary under paragraph (2);
or
``(iii) for foreign facilities, by an agency or a
representative of a country that is recognized by the Secretary
under paragraph (2); and
``(B) at a frequency determined pursuant to a risk-based
schedule.
``(2) For purposes of paragraph (1)(A), the Secretary--
``(A) may recognize Federal, State, and local officials and
agencies and representatives of foreign countries as meeting
standards established by the Secretary for conducting
inspections under this Act; and
``(B) may limit such recognition to inspections of specific
commodities or food types.
``(3) The risk-based schedule under paragraph (1)(B) shall be
implemented beginning not later than 18 months after the date of the
enactment of this subsection.
``(4) Such risk-based schedule shall provide for a frequency of
inspections commensurate with the risk presented by the facility and
shall be based on the following categories and inspection frequencies:
``(A) Category 1.--A category 1 food facility is a high-
risk facility that manufactures or processes food. The
Secretary shall randomly inspect a category 1 food facility at
least every 6 to 12 months.
``(B) Category 2.--A category 2 food facility is a low-risk
facility that manufactures or processes food or a facility that
packs or labels food. The Secretary shall randomly inspect a
category 2 facility at least every 18 months to 3 years.
``(C) Category 3.--A category 3 food facility is a facility
that holds food. The Secretary shall randomly inspect a
category 3 facility at least every 5 years.
``(5) The Secretary--
``(A) may, by guidance, modify the types of food facilities
within a category under paragraph (4);
``(B) may alter the inspection frequencies specified in
paragraph (4) based on the need to respond to food-borne
illness outbreaks and food recalls; and
``(C) may inspect a facility more frequently than the
inspection frequency provided by paragraph (4);
``(D) beginning 6 months after submitting the report
required by section 105(b)(2) of the Food Safety Enhancement
Act of 2009, may--
``(i) publish in the Federal Register adjustments
to the inspection frequencies specified in
subparagraphs (B) and (C) of paragraph (4) for category
2 and category 3 food facilities, which adjustments
shall be in accordance with the Secretary's
recommendations in such report; and
``(ii) after such publication, implement the
adjustments; and
``(E) except as provided in subparagraphs (B) and (C), may
not alter the inspection frequency specified in paragraph
(4)(A) for category 1 food facilities.
``(6) In determining the appropriate frequency of inspection, the
Secretary shall consider--
``(A) the type of food manufactured, processed, packed, or
held at the facility;
``(B) the compliance history of the facility;
``(C) whether the facility importing or offering for import
into the United States food is certified by a qualified
certifying entity in accordance with section 801(q); and
``(D) such other factors as the Secretary determines by
guidance to be relevant to assessing the risk presented by the
facility.
``(7) Before establishing or modifying the categorization under
paragraph (4) of any food facility or type of food facility, the
Secretary shall publish a notice of the proposed categorization in the
Federal Register and provide a period of not less than 60 days for
public comment on the proposed categorization.''.
(b) Reports on Risk-based Inspections of Food Facilities.--
(1) Annual report.--Not later than December 31 of each
year, the Secretary of Health and Human Services shall submit a
report to the Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education, Labor,
and Pensions of the Senate describing--
(A) the number of foreign and domestic facilities,
by risk category, inspected under the risk-based
inspection schedule established under section 704(h) of
the Federal Food, Drug, and Cosmetic Act, as added by
subsection (a), in the preceding fiscal year; and
(B) the costs of implementing the risk-based
inspection schedule for the preceding 12 months.
(2) Third-year report.--Not later than 3 years after the
date of the enactment of this Act, the Secretary of Health and
Human Services shall submit a report to the Committee on Energy
and Commerce of the House of Representatives and the Committee
on Health, Education, Labor, and Pensions of the Senate
describing recommendations on the risk-based inspection
schedule under section 704(h) of the Federal Food, Drug, and
Cosmetic Act, as added by subsection (a), including
recommendations for adjustments to the timing of the schedule
and other ways to improve the risk-based allocation of
resources by the Food and Drug Administration. In making such
recommendations, the Secretary shall consider--
(A) the nature of the food products being
processed, stored, or transported;
(B) the manner in which food products are
processed, stored, or transported;
(C) the inherent likelihood that the products will
contribute to the risk of food-borne illness;
(D) the best available evidence concerning reported
illnesses associated with the foods processed, stored,
held, or transported in the category of facilities; and
(E) the overall record of compliance with food
safety law among facilities in the category, including
compliance with applicable performance standards and
the frequency of recalls.
SEC. 106. ACCESS TO RECORDS.
(a) Records Access.--Subsection (a) of section 414 (21 U.S.C. 350c)
is amended to read as follows:
``(a) Records Access.--
``(1) Records access during an inspection.--
``(A) In general.--Except as provided in paragraph
(3), each person who manufactures, processes, packs,
transports, distributes, receives, or holds an article
of food in the United States or for import into the
United States shall, at the request of an officer or
employee duly designated by the Secretary, permit such
officer or employee, upon presentation of appropriate
credentials, at reasonable times and within reasonable
limits and in a reasonable manner, to have access to
and copy all records relating to such article bearing
on whether the food may be adulterated, misbranded, or
otherwise in violation of this Act, including all
records collected or developed to comply with section
418 or 418A.
``(B) Scope of records.--The requirement under
subparagraph (A) applies to all records relating to the
manufacture, processing, packing, transporting,
distribution, receipt, holding, or importation of such
article maintained by or on behalf of such person in
any format (including paper and electronic formats) and
at any location.
``(C) Immediate availability with notice.--Records
not required to be made available immediately on
commencement of an inspection under subparagraph (A)
shall nonetheless be made available immediately on
commencement of such an inspection if, by a reasonable
time before such inspection, the Secretary by letter to
the person identifies the records to be made available
during such inspection. Nothing in this subparagraph
shall be construed as permitting a person to refuse to
produce records required under and in accordance with
subparagraph (A) due to failure of the Secretary to
provide notice under this paragraph.
``(2) Additional authorities to access records remotely;
submission of records to the secretary.--
``(A) Remote access in emergencies.--If the
Secretary has a reasonable belief that an article of
food presents a threat of serious adverse health
consequences or death to humans or animals, the
Secretary may require each person who manufactures,
processes, packs, transports, distributes, receives,
holds, or imports such article of food, or any article
of food that the Secretary determines may be affected
in a similar manner, to submit to the Secretary all
records reasonably related to such article of food as
soon as is reasonably practicable, after receiving
written notice (including by notice served personally
and outside normal business hours to an agent
identified under subparagraph (E) or (F) of section
415(a)(2)) of such requirement.
``(B) Remote access to records related to food
safety plans.--With respect to a facility subject to
section 418 and 418A, the Secretary may require the
owner, operator, or agent of such facility to submit to
the Secretary, as soon as reasonably practicable after
receiving written notice of such requirement, the food
safety plan, supporting information relied on by the
facility to select the preventive controls to include
in its food safety plan, and documentation of
corrective actions, if any, taken under section 418(e)
within the preceding 2 years
``(C) Electronic submission.--If the records
required to be submitted to the Secretary under
subparagraph (A) or (B) are available in electronic
format, such records shall be submitted electronically
unless the Secretary specifies otherwise in the notice
under such subparagraph.
``(3) Limited records access on farms.--
``(A) Application.--Paragraphs (1) and (2) do not
apply with respect to farms, except as provided in this
paragraph.
``(B) In general.--A person who is the owner,
operator, or agent of a farm (as defined in section
415) shall, at the request of an officer or employee
duly designated by the Secretary, permit such officer
or employee, at reasonable times and within reasonable
limits and in a reasonable manner, to have access to
and copy all records relating to an article of food
produced, manufactured, processed, packed, or held on
such farm as specified in paragraphs (1) and (2) if--
``(i) such article of food is a fruit,
vegetable, nut, or fungus that is the subject
of a standard issued under section 419A; or
``(ii) such article of food is the subject
of an active investigation by the Secretary of
a food borne illness outbreak and is not a
grain or similarly handled commodity as defined
in subsection (c)(4)(C)(ii).
``(C) Records access on farms prior to
rulemaking.--
``(i) In general.--As soon as practicable
after the enactment of this paragraph, the
Secretary shall, in coordination with the
Secretary of Agriculture, identify 1 or more
fruits, vegetables, nuts, or fungi for which
the Secretary shall have access to records on
farms. Such identification shall be made by
guidance, following notice and public comment.
``(ii) Identification of raw agricultural
commodities.--The Secretary, in coordination
with the Secretary of Agriculture, shall make
the identification in clause (i), based on any
past food borne illness outbreak attributed to
the fruit, vegetable, nut, or fungus--
``(I) in the United States and the
risk that a similar outbreak could
occur again in the United States; or
``(II) in a foreign country and the
risk that a similar outbreak could
occur in the United States.
``(iii) Duration of authority.--The
authority to have access to records for a
fruit, vegetable, nut, or fungus under this
subparagraph shall begin on the date on which
the Secretary identifies such fruit, vegetable,
nut, or fungus under clause (i) and shall
terminate on the effective date of a final rule
issued by the Secretary under section 419A.
``(iv) Scope of records access.--In the
guidance under clause (i), and for the period
specified in clause (iii), the Secretary, in
coordination with the Secretary of Agriculture,
shall determine the scope of the records to
which the Secretary shall have access under
this subparagraph.
``(D) Rule of construction.--This paragraph shall
not be construed as limiting access to any records
authorized under--
``(i) this Act or the Public Health Service
Act, as in effect on the day before the date of
the enactment of this paragraph; or
``(ii) regulations issued under such Acts
on any date before the date of the enactment of
this paragraph.''.
(b) Regulations Concerning Recordkeeping.--
(1) Amendment.--Subsection (b) of section 414 (21 U.S.C.
350c) is amended to read as follows:
``(b) Regulations Concerning Recordkeeping.--The Secretary, in
consultation and coordination, as appropriate, with other Federal
departments and agencies with responsibilities for regulating food
safety, shall by regulation establish requirements regarding the
establishment and maintenance, for not longer than 3 years, of records
by persons who manufacture, process, pack, transport, distribute,
receive, or hold food in the United States or for import into the
United States. The Secretary shall take into account the size of a
business in promulgating regulations under this subsection. The
Secretary shall consult with the Secretary of Agriculture in
promulgating regulations with respect to farms under this subsection
and shall take into account the nature of and impact on farms in
promulgating such regulations. The only distribution records which may
be required of restaurants under this subsection are those showing the
restaurant's suppliers and subsequent distribution other than to
consumers.''.
(2) Application.--The Secretary of Health and Human
Services shall promulgate revised regulations to implement
section 414(b) of the Federal Food, Drug, and Cosmetic Act, as
amended by this subsection. Section 414(b) of the Federal Food,
Drug, and Cosmetic Act and regulations thereunder, as in effect
on the day before the date of the enactment of this Act, shall
apply to acts and omissions occurring before the effective date
of such revised regulations.
(c) Conforming Amendments.--Section 704(a)(1) (21 U.S.C. 374(a)(1))
is amended--
(1) in the second sentence--
(A) by striking ``(excluding farms or
restaurants)'' and inserting ``(excluding farms, except
as provided in section 414(a)(3))'';
(B) by inserting ``receives,'' before ``holds'';
(C) by striking ``described in section 414'' and
inserting ``described in or required under section
414''; and
(D) by striking ``when the Secretary has a
reasonable belief that an article of food is
adulterated and presents a threat of serious adverse
health consequences or death to humans or animals'' and
inserting ``bearing on whether such food is
adulterated, misbranded, or otherwise in violation of
this Act, including all records collected or developed
to comply with section 418 or 418A''; and
(2) in the fourth sentence--
(A) by striking ``the preceding sentence'' and
inserting ``either of the preceding two sentences'';
and
(B) by inserting ``recipes for food,'' before
``financial data,''.
SEC. 107. TRACEABILITY OF FOOD.
(a) Prohibited Act.--Section 301(e) (21 U.S.C. 331(e)) is amended
by inserting ``, the violation of any requirement of the food tracing
system under section 414(c);'' before ``or the refusal to permit access
to or verification or copying of any such required record''.
(b) Imports.--Section 801(a) (21 U.S.C. 381(a)) is amended by
inserting ``or (4) the requirements of section 414 have not been
complied with regarding such article,'' before ``then such article
shall be refused admission''.
(c) Product Tracing for Food.--Section 414 (21 U.S.C. 350c), as
amended by section 106, is amended--
(1) by redesignating subsections (c) and (d) as subsections
(d) and (e), respectively; and
(2) by inserting after subsection (b) the following:
``(c) Tracing System for Food.--
``(1) In general.--The Secretary shall by regulation
establish a tracing system for food that is located in the
United States or is for import into the United States.
``(2) Information gathering.--
``(A) Tracing technologies.--Before issuing a
proposed regulation under this subsection, the
Secretary shall--
``(i) identify technologies and
methodologies for tracing the distribution
history of a food that are, or may be, used by
members of different sectors of the food
industry, including technologies and
methodologies to enable each person who
produces, manufactures, processes, pack,
transports, or holds a food to--
``(I) maintain the full pedigree of
the origin and previous distribution
history of the food;
``(II) link that history with the
subsequent distribution of the food;
``(III) establish and maintain a
system for tracing the food that is
interoperable with the systems
established and maintained by other
such persons; and
``(IV) use a unique identifier for
each facility owned or operated by such
person for such purpose, as specified
under section 1011; and
``(ii) to the extent practicable, assess--
``(I) the costs and benefits
associated with the adoption and use of
such technologies;
``(II) the feasibility of such
technologies for different sectors of
the food industry; and
``(III) whether such technologies
are compatible with the requirements of
this subsection.
``(B) Public meetings.--Before issuing a proposed
regulation under this subsection, the Secretary shall
conduct not less than 2 public meetings in diverse
geographical areas of the United States to provide
persons in different regions an opportunity to provide
input and information to the Secretary.
``(C) Pilot projects.--Before issuing a proposed
regulation under this subsection, the Secretary shall
conduct 1 or more pilot projects in coordination with 1
or more sectors of the food industry to explore and
evaluate tracing systems for food. The Secretary shall
coordinate with the Secretary of Agriculture in
conducting pilot projects with respect to farms under
this subsection.
``(3) Regulation.--
``(A) In general.--Taking into account information
obtained through information gathering under paragraph
(2), the Secretary shall issue regulations establishing
a tracing system that enables the Secretary to identify
each person who grows, produces, manufactures,
processes, packs, transports, holds, or sells such food
in as short a timeframe as practicable but no longer
than 2 business days.
``(B) Scope of regulation.--The Secretary may
include in the regulations establishing a tracing
system--
``(i) the establishment and maintenance of
lot numbers;
``(ii) a standardized format for pedigree
information; and
``(iii) the use of a common nomenclature
for food.
``(C) Coordination regarding farm impact.--In
issuing regulations under this paragraph that will
impact farms, the Secretary--
``(i) shall coordinate with the Secretary
of Agriculture; and
``(ii) take into account the nature of the
impact of the regulations on farms.
``(4) Exemptions and limitations.--
``(A) Direct sales by farms.--Food is exempt from
the requirements of this subsection if such food is--
``(i) produced on a farm; and
``(ii) sold by the owner, operator, or
agent in charge of such farm directly to a
consumer or to a restaurant or grocery store.
``(B) Fishing vessels.--Food is exempt from the
requirements of this subsection if such food is
produced through the use of a fishing vessel as defined
in section 3(18) of the Magnuson-Stevens Fishery
Conservation and Management Act until such time as the
food is sold by the owner, operator, or agent in charge
of such fishing vessel.
``(C) Grains and similarly handled commodities.--
``(i) Limitation on extent of tracing.--In
addition to the exemption under subparagraph
(A), any tracing system established under this
subsection with regard to any grain or
similarly handled commodity shall be limited to
enabling the Secretary to identify persons who
received, processed, packed, transported,
distributed, held, or sold the grain or
similarly handled commodity from the initial
warehouse operator that held the grain or
similarly handled commodity for any period of
time to the ultimate consumer.
``(ii) Definitions.--In this subparagraph:
``(I) The term `grain or similarly
handled commodity' means wheat, corn,
grain sorghum, barley, oats, rice, wild
rice, rye, soybeans, legumes, sugar
cane, sugar beets, sunflower seed,
rapeseed, canola, safflower, flaxseed,
mustard seed, crambe, sesame seed,
camelina, cottonseed, cocoa beans,
grass hay, and honey. The term may
include any other commodity as
determined by the Secretary in
coordination with the Secretary of
Agriculture.
``(II) The term `warehouse
operator' has the meaning given that
term in section 2 of the United States
Warehouse Act (7 U.S.C. 241), except
that the term also includes any person
or entity that handles or stores
agricultural products for other persons
or entities or, in the case of a
cooperative, handles or stores
agricultural products for its members,
as determined by the Secretary in
coordination with the Secretary of
Agriculture.
``(D) Exemption of other foods.--The Secretary may
by notice in the Federal Register exempt a food or a
type of facility, farm, or restaurant from, or modify
the requirements with respect to, the requirements of
this subsection if the Secretary determines that a
tracing system for such food or type of facility, farm,
or restaurant is not necessary to protect the public
health.
``(E) Recordkeeping regarding previous sources and
subsequent recipients.--For a food or person covered by
a limitation or exemption under subparagraph (B), (C),
or (D), the Secretary shall require each person who
produces, receives, manufactures, processes, packs,
transports, distributes, or holds such food to maintain
records to identify the immediate previous sources of
such food and its ingredients and the immediate
subsequent recipients of such food.
``(F) Recordkeeping by restaurants and grocery
stores.--For a food covered by an exemption under
subparagraph (A), restaurants and grocery stores shall
keep records documenting the farm that was the source
of the food.
``(G) Recordkeeping by farms.--For a food covered
by an exemption under subparagraph (A), farms shall
keep records, in electronic or non-electronic format,
for at least 6 months documenting the restaurant or
grocery store to which the food was sold.''.
SEC. 108. REINSPECTION AND FOOD RECALL FEES APPLICABLE TO FACILITIES.
(a) In General.--Part 6 of subchapter C of chapter VII (21 U.S.C.
371 et seq.), as added by section 101(c), is amended by adding at the
end the following:
``SEC. 743A. REINSPECTION AND FOOD RECALL FEES APPLICABLE TO
FACILITIES.
``(a) In General.--The Secretary shall assess and collect fees from
each entity in a fiscal year--
``(1) that--
``(A) during such fiscal year commits a violation
of any requirement of this Act relating to food,
including any such requirement relating to good
manufacturing practices; and
``(B) because of such violation, undergoes
additional inspection by the Food and Drug
Administration; or
``(2) during such fiscal year is subject to a food recall.
``(b) Amount of Fees.--The Secretary shall set the amount of the
fees under this section to fully cover the costs of--
``(1) in the case of fees collected under subsection
(a)(1), conducting the additional inspections referred to in
such subsection; and
``(2) in the case of fees collected under subsection
(a)(2), conducting food recall activities, including technical
assistance, follow-up effectiveness checks, and public
notifications, during the fiscal year involved.
``(c) Crediting and Availability of Fees.--
``(1) In general.--Fees authorized under subsection (a)
shall be collected and available for obligation only to the
extent and in the amount provided in advance in appropriations
Acts. Such fees are authorized to remain available until
expended. Such sums as may be necessary may be transferred from
the Food and Drug Administration salaries and expenses
appropriation account without fiscal year limitation to such
appropriation account for salaries and expenses with such
fiscal year limitation.
``(2) Collections and appropriations acts.--The fees
authorized by this section--
``(A) shall be retained in each fiscal year in an
amount not to exceed the amount specified in
appropriation Acts, or otherwise made available for
obligation, for such fiscal year; and
``(B) shall only be collected and available to
defray the costs referred to in subsection (b).
``(3) Authorization of appropriations.--For each of fiscal
years 2010 through 2014, there are authorized to be
appropriated for fees under this section such sums as may be
necessary.
``(d) Waiver.--The Secretary shall waive and, if applicable, refund
the amount of any fee collected under this section from an entity as a
result of a food recall that the Secretary determines was
inappropriately ordered.''.
(b) Effective Date.--The amendment made by subsection (a) shall
apply to additional inspections and food recall activities occurring
after the date of the enactment of this Act.
SEC. 109. CERTIFICATION AND ACCREDITATION.
(a) Misbranding.--
(1) In general.--Section 403 (21 U.S.C. 343), as amended by
section 101(a), is amended by adding at the end the following:
``(aa) If it is part of a shipment offered for import into the
United States and such shipment is in violation of section 801(q)
(requiring a certification of compliance for certain food
shipments).''.
(2) Effective date.--The amendment made by paragraph (1)
shall apply to shipments offered for import on or after the
date that is 3 years after the date of the enactment of this
Act.
(b) Certification of Compliance for Imports.--Chapter VIII (21
U.S.C. 381 et seq.) is amended--
(1) in section 801(a), as amended by section 107(b), by
inserting after the third sentence the following: ``If such
article is food being imported or offered for import into the
United States and is not in compliance with the requirement of
subsection (q) (relating to certifications of compliance with
this Act), then such article shall be refused admission.'';
(2) in the second sentence of section 801(b), by striking
``the fourth sentence'' and inserting ``the fifth sentence'';
and
(3) by adding at the end of section 801 the following:
``(q) Certifications Concerning Imported Articles.--
``(1) In general.--
``(A) Requirement.--The Secretary may require, as
an additional condition of granting admission to an
article of food being imported or offered for import
into the United States, that a qualified certifying
entity provide a certification that the article
complies with requirements of this Act as specified by
the Secretary if--
``(i) for food imported from a particular
country, territory, or region, the Secretary
finds, based on scientific, risk-based
evidence, that the government controls in such
country, territory, or region are inadequate to
ensure that the article is safe and that
certification would assist the Secretary in
determining whether to refuse to admit such
article under subsection (a);
``(ii) for a type of food for which there
is scientific evidence that there is a
particular risk associated with the food that
presents a threat of serious adverse health
consequences or death, the Secretary finds that
certification would assist the Secretary in
determining whether to refuse to admit such
article under subsection (a); or
``(iii) for an article imported from a
particular country or territory, there is an
agreement between the Secretary and the
government of such country or territory
providing for such certification.
``(B) Form of certification.--A certification under
subparagraph (A) may take the form of a statement that
the article or the facility or farm that manufactured,
processed, packed, held, grew, harvested, sorted, or
transported the article, as the case may be, complies
with requirements of this Act as specified by the
Secretary, or any other form as the Secretary may
specify, including a listing of certified facilities or
other entities. The Secretary may require that the
certification include additional information regarding
compliance.
``(C) Adequate government controls.--
``(i) Process.--Before requiring a
certification under clause (ii) of subparagraph
(A) with respect to a food, the Secretary shall
establish a process by which a country or
territory may demonstrate that its government
controls are adequate to ensure that such food
exported from its territory to the United
States is safe.
``(ii) Demonstration.--The Secretary shall
not require a certification under clause (ii)
of subparagraph (A) for a food exported from a
country or territory, if that country or
territory has demonstrated, pursuant to the
process established by the Secretary under
clause (i), that its government controls are
adequate to ensure that such food exported from
its territory to the United States is safe.
``(D) Notice of cancellation or suspension of
certification.--As a condition on acceptance of
certifications from a qualified certifying entity, the
Secretary shall require the qualified certifying entity
to notify the Secretary whenever the qualified
certifying entity cancels or suspends the certification
of any facility or other entity included in a listing
under subparagraph (B).
``(E) Consistency with international obligations.--
The Secretary shall apply this paragraph consistently
with United States obligations under international
agreements.
``(2) Qualified certifying entity.--For purposes of this
subsection, the term `qualified certifying entity' means--
``(A) an agency or a representative of the
government of the country from which the article
originated, as designated by such government or the
Secretary; or
``(B) an individual or entity determined by the
Secretary or an accredited body recognized by the
Secretary to be qualified to provide a certification
under paragraph (1).
``(3) No conflicts of interest.--
``(A) In general.--The Secretary shall issue
regulations to ensure that any qualified certifying
entity and its auditors are free from conflicts of
interest. In issuing these regulations, the Secretary
may rely on or incorporate international certification
standards.
``(B) Regulations.--Such regulations shall require
that--
``(i) the qualified certifying entity shall
have a committee or management structure for
safeguarding impartiality;
``(ii) conflict of interest policies for a
qualified certifying entity and auditors acting
for the qualified certifying entity shall be
written;
``(iii) the qualified certifying entity
shall not be owned, operated, or controlled by
a producer, manufacturer, processor, packer,
holder, supplier, or vendor of any article of
the type it certifies;
``(iv) the qualified certifying entity
shall not have any ownership or financial
interest in any product, producer,
manufacturer, processor, packer, holder,
supplier or vendor of the type it certifies;
``(v) no auditor acting for the qualified
certifying entity (or spouse or minor children)
shall have any significant ownership or other
financial interest regarding any product of the
type it certifies;
``(vi) the qualified certifying entity
shall--
``(I) obtain and maintain annual
declarations from all personnel who may
be directly involved in the performance
of audits as to whether they do or do
not have direct financial interests in
any producer, manufacturer, processor,
packer, holder, supplier, or vendor of
foods, and a list of any such companies
in which they do have financial
interests or by which they were
employed in the past year; and
``(II) when an auditor is assigned
to audit a facility, require that
individual to affirm that he or she has
no financial interest in the company
that owns or operates that facility and
was not employed by that facility in
the previous year;
``(vii) neither the qualified certifying
entity nor any of its auditors acting for the
qualified certifying entity shall participate
in the production, manufacture, processing,
packing, holding, promotion, or sale of any
product of the type it certifies;
``(viii) neither the qualified certifying
entity nor any of its auditors shall provide
consultative services to any facility certified
by the qualified certifying entity, or the
owner, operator, or agent in charge of such a
facility, unless the qualified certifying
entity has procedures in place, approved by the
Secretary, to ensure separation of functions
between auditors providing consultative
services and auditors providing certification
services under this subsection;
``(ix) no auditors acting for the qualified
certifying entity shall participate in an audit
of a facility they were employed by within the
last 12 months;
``(x) fees charged or accepted shall not be
contingent or based upon the report made by the
qualified certifying entity or any personnel
involved in the audit process;
``(xi) neither the qualified certifying
entity nor any of its auditors shall accept
anything of value from anyone in connection
with the facility being audited other than the
audit fee;
``(xii) the qualified certifying entity
shall not be owned, operated, or controlled by
a trade association whose member companies
operate facilities that it certifies;
``(xiii) the qualified certifying entity
and its auditors shall be free from any other
conflicts of interest that threaten
impartiality;
``(xiv) the qualified certifying entity and
its auditors shall sign a statement attesting
to compliance with the conflict of interests
requirements under this paragraph; and
``(xv) the qualified certifying entity
shall ensure that any subcontractors that might
be used (such as laboratories and sampling
services) provide similar assurances, except
that it shall not be a violation of this
subsection to the extent such subcontractors
perform additional nutritional testing services
unrelated to the testing under this subsection.
``(C) Definitions.--In this paragraph:
``(i) The term `anything of value' includes
gifts, gratuities, reimbursement of non-audit-
related expenses, entertainment, loans, or any
other form of compensation in cash or in kind.
``(ii) The term `direct financial interest'
does not include any ownership of mutual funds
that have a financial interest in a company.
``(4) Renewal and refusal of certifications.--The Secretary
shall--
``(A) require that, to the extent applicable, any
certification provided by a qualified certifying entity
be renewed by such entity at such times as the
Secretary determines appropriate; and
``(B) refuse to accept any certification if the
Secretary determines that such certification is no
longer valid or reliable.
``(5) On-site audits.--In evaluating whether an
accreditation body meets, or continues to meet, the standards
for recognition under this subsection, or whether to accept
certifications from a qualified certifying entity, the
Secretary may--
``(A) observe on-site audits of qualified
certifying entities by such accreditation body; or
``(B) for any facility that is certified by a
qualified certifying entity, upon request of an officer
or employee designated by the Secretary and upon
presentation of appropriate credentials, at reasonable
times and within reasonable limits and in a reasonable
manner, conduct an on-site audit of the facility, which
shall include access to, and copying and verification
of, any related records.
``(6) Electronic submission.--The Secretary shall provide,
in coordination with the Commissioner responsible for Customs
and Border Protection, for the electronic submission of
certifications under this subsection.
``(7) No limit on authority.--This subsection shall not be
construed to limit the authority of the Secretary to conduct
random inspections of imported articles or facilities of
importers, issue import alerts for detention without physical
examination, require submission to the Secretary of
documentation or other information about an article imported or
offered for import, or to take such other steps as the
Secretary deems appropriate to determine the admissibility of
imported articles.''.
SEC. 110. TESTING BY ACCREDITED LABORATORIES.
(a) Prohibited Act.--Section 301 (21 U.S.C. 331) is amended by
adding at the end the following:
``(uu) The violation of any requirement of section 714 (relating to
testing by accredited laboratories).''.
(b) Laboratory Accreditation.--Subchapter A of chapter VII (21
U.S.C. 371 et seq.) is amended by adding at the end the following:
``SEC. 714. TESTING BY ACCREDITED LABORATORIES.
``(a) In General.--
``(1) Requirement.--Whenever analytical testing of an
article of food is conducted as part of testimony for the
purposes of section 801(a), or for such other purposes as the
Secretary deems appropriate through regulation or guidance,
such testing shall be conducted by a laboratory that--
``(A) is accredited, for the analytical method
used, by a laboratory accreditation body that has been
recognized by the Secretary; and
``(B) samples such article with adequate controls
for ensuring the integrity of the samples analyzed.
``(2) Independence of laboratory.--
``(A) Certain tests.--Tests required for purposes
of section 801(a) or in response to a finding of
noncompliance by the Secretary shall be conducted by a
laboratory independent of the person on whose behalf
such testing is conducted and analyzed.
``(B) Certain products.--The Secretary may require
that testing for certain products under paragraph (1)
be conducted by a laboratory independent of the person
on whose behalf such testing is conducted.
``(b) Recognition of Laboratory Accreditation Bodies.--The
Secretary shall establish and implement a program for the recognition,
based on standards the Secretary deems appropriate, of laboratory
accreditation bodies that accredit laboratories to perform analytical
testing for the purposes of this section. The Secretary shall issue
regulations or guidance to implement this program.
``(c) Onsite Audits.--In evaluating whether an accreditation body
meets, or continues to meet, the standards for recognition under
subsection (b), the Secretary may--
``(1) observe onsite audits of laboratories by such
accreditation bodies; or
``(2) for any laboratory that is accredited by such
accreditation body under this section, upon request of an
officer or employee designated by the Secretary and upon
presentation of appropriate credentials, at reasonable times
and within reasonable limits and in a reasonable manner,
conduct an onsite audit of the laboratory, which shall include
access to, and copying and verification of, any related
records.
``(d) Publication of List of Recognized Accreditation Bodies.--The
Secretary shall publish and maintain on the public Web site of the Food
and Drug Administration a list of accreditation bodies recognized by
the Secretary under subsection (b).
``(e) Notification of Accreditation of Laboratory.--An
accreditation body that has been recognized pursuant to this section
shall promptly notify the Secretary whenever it accredits a laboratory
for the purposes of this section and whenever it withdraws or suspends
such accreditation.
``(f) Advance Notice.--Whenever analytical testing is conducted
pursuant to subsection (a), the person on whose behalf the testing is
conducted shall notify the Secretary before any sample of the article
is collected. Such notice shall contain information the Secretary
determines is appropriate to identify the article, the location of the
article, and each laboratory that will analyze the sample on the
person's behalf.
``(g) Contents of Laboratory Packages.--Whenever analytical testing
is conducted pursuant to subsection (a), the laboratory conducting such
testing shall submit, directly to the Secretary--
``(1) the results of all analyses conducted by the
laboratory on each sample of such article; and
``(2) all information the Secretary deems appropriate to--
``(A) determine whether the laboratory is
accredited by a recognized laboratory accreditation
body;
``(B) identify the article tested;
``(C) evaluate the analytical results; and
``(D) determine whether the requirements of this
section have been met.
``(h) Exigent Circumstances.--The Secretary may waive the
requirement of subsection (a)(1)(A) (relating to analytical methods) on
a laboratory or method basis due to exigent or other circumstances.
``(i) Federal Laboratory Testing.--If Customs and Border Protection
laboratory testing concludes that an article of food is adulterated or
misbranded, the Secretary shall consider and utilize as appropriate the
testing results issued by the Customs and Border Protection
laboratories in making a decision about the admissibility of the
product.
``(j) No Limit on Authority.--Nothing in this section shall be
construed to limit--
``(1) the ability of the Secretary to review and act upon
information from the analytical testing of food (including
under this section), including determining the sufficiency of
such information and testing; or
``(2) the authority of the Secretary to conduct, require,
or consider the results of analytical testing pursuant to any
other provision of law.''.
SEC. 111. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR
MISBRANDED FOOD.
(a) Prohibited Acts.--Section 301 (21 U.S.C. 331), as amended by
section 110, is amended by adding at the end the following:
``(vv)(1) The failure to notify the Secretary in violation of
section 420(a).
``(2) The failure to comply with any order issued under section
420.''.
(b) Notification, Nondistribution, and Recall of Adulterated or
Misbranded Food.--Chapter IV (21 U.S.C. 341 et seq.), as amended by
sections 102, 103, and 104, is amended by adding at the end the
following:
``SEC. 420. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR
MISBRANDED FOOD.
``(a) Notification, Nondistribution, and Recall of Adulterated or
Misbranded Food.--
``(1) In general.--A responsible party as that term is
defined in section 417(a)(1) or a person required to register
under section 801(s) that has reason to believe that an article
of food when introduced into or while in interstate commerce,
or while held for sale (regardless of whether the first sale)
after shipment in interstate commerce, is adulterated or
misbranded in a manner that presents a reasonable probability
that the use or consumption of, or exposure to, the article (or
an ingredient or component used in any such article) will cause
a threat of serious adverse health consequences or death to
humans or animals shall, as soon as practicable, notify the
Secretary of the identity and location of the article.
``(2) Manner of notification.--Notification under paragraph
(1) shall be made in such manner and by such means as the
Secretary may require by regulation or guidance.
``(b) Voluntary Recall.--The Secretary may request that any person
who distributes an article of food that the Secretary has reason to
believe is adulterated, misbranded, or otherwise in violation of this
Act voluntarily--
``(1) recall such article; and
``(2) provide for notice, including to individuals as
appropriate, to persons who may be affected by the recall.
``(c) Order to Cease Distribution.--If the Secretary has reason to
believe that the use or consumption of, or exposure to, an article of
food may cause serious adverse health consequences or death to humans
or animals, the Secretary shall have the authority to issue an order
requiring any person who distributes such article to immediately cease
distribution of such article.
``(d) Action Following Order.--Any person who is subject to an
order under subsection (c) shall immediately cease distribution of such
article and provide notification as required by such order, and may
appeal within 24 hours of issuance such order to the Secretary. Such
appeal may include a request for an informal hearing and a description
of any efforts to recall such article undertaken voluntarily by the
person, including after a request under subsection (b). Except as
provided in subsection (f), an informal hearing shall be held as soon
as practicable, but not later than 5 calendar days, or less as
determined by the Secretary, after such an appeal is filed, unless the
parties jointly agree to an extension. After affording an opportunity
for an informal hearing, the Secretary shall determine whether the
order should be amended to require a recall of such article. If, after
providing an opportunity for such a hearing, the Secretary determines
that inadequate grounds exist to support the actions required by the
order, the Secretary shall vacate the order.
``(e) Order to Recall.--
``(1) Amendment.--Except as provided under subsection (f),
if after providing an opportunity for an informal hearing under
subsection (d), the Secretary determines that the order should
be amended to include a recall of the article with respect to
which the order was issued, the Secretary shall amend the order
to require a recall.
``(2) Contents.--An amended order under paragraph (1)
shall--
``(A) specify a timetable in which the recall will
occur;
``(B) require periodic reports to the Secretary
describing the progress of the recall; and
``(C) provide for notice, including to individuals
as appropriate, to persons who may be affected by the
recall.
In providing for such notice, the Secretary may allow for the
assistance of health professionals, State or local officials,
or other individuals designated by the Secretary.
``(3) Nondelegation.--An amended order under this
subsection shall be ordered by the Secretary or an official
designated by the Secretary. An official may not be so
designated unless the official is the director of the district
under this Act in which the article involved is located, or is
an official senior to such director.
``(f) Emergency Recall Order.--
``(1) In general.--If the Secretary has credible evidence
or information that an article of food subject to an order
under subsection (c) presents an imminent threat of serious
adverse health consequences or death to humans or animals, the
Secretary may issue an order requiring any person who
distributes such article--
``(A) to immediately recall such article; and
``(B) to provide for notice, including to
individuals as appropriate, to persons who may be
affected by the recall.
``(2) Action following order.--Any person who is subject to
an emergency recall order under this subsection shall
immediately recall such article and provide notification as
required by such order, and may appeal within 24 hours after
issuance such order to the Secretary. An informal hearing shall
be held within as soon as practicable but not later than 5
calendar days, or less as determined by the Secretary, after
such an appeal is filed, unless the parties jointly agree to an
extension. After affording an opportunity for an informal
hearing, the Secretary shall determine whether the order should
be amended pursuant to subsection (e)(1). If, after providing
an opportunity for such a hearing, the Secretary determines
that inadequate grounds exist to support the actions required
by the order, the Secretary shall vacate the order.
``(3) Nondelegation.--An order under this subsection shall
be issued by the Commissioner of Food and Drugs, the Principal
Deputy Commissioner, or the Associate Commissioner for
Regulatory Affairs of the Food and Drug Administration.
``(g) Notice to Consumers and Health Officials.--The Secretary
shall, as the Secretary determines to be necessary, provide notice of a
recall order under this section to consumers to whom the article was,
or may have been, distributed and to appropriate State and local health
officials.
``(h) Savings Clause.--Nothing contained in this section shall be
construed as limiting--
``(1) the authority of the Secretary to issue an order to
cease distribution of, or to recall, an article under any other
provision of this Act or the Public Health Service Act; or
``(2) the ability of the Secretary to request any person to
perform a voluntary activity related to any article subject to
this Act or the Public Health Service Act.''.
(c) Articles Subject to Refusal.--The third sentence of subsection
(a) of section 801 (21 U.S.C. 381), as amended by section 107(b), is
amended by inserting ``or (5) such article is subject to an order under
section 420 to cease distribution of or recall the article,'' before
``then such article shall be refused admission''.
(d) Effective Date.--Sections 301(vv)(1) and 420 of the Federal
Food, Drug, and Cosmetic Act, as added by subsections (a) and (b),
shall apply with respect to articles of food as of such date, not later
than 1 year after the date of the enactment of this Act, as the
Secretary of Health and Human Services shall specify.
SEC. 112. REPORTABLE FOOD REGISTRY; EXCHANGE OF INFORMATION.
(a) Reportable Food Registry.--Section 417 (21 U.S.C. 350f) is
amended--
(1) in subsection (a)(1), by striking ``means a person''
and all that follows through the end of paragraph (1) and
inserting the following: ``means--
``(A) a person who submits the registration under
section 415(a) for a food facility that is required to
be registered under section 415(a), at which such food
is manufactured, processed, packed, or held;
``(B) a person who owns, operates, is an agent of,
or is otherwise responsible for such food on a farm (as
such term is defined in section 1.227(b)(3) of title
21, Code of Federal Regulations, or successor
regulations) at which such food is produced for sale or
distribution in interstate commerce;
``(C) a person who owns, operates, or is an agent
of a restaurant or other retail food establishment (as
such terms are defined in section 1.227(b)(11) and
(12), respectively, of title 21, Code of Federal
Regulations, or successor regulations) at which such
food is offered for sale; or
``(D) a person that is required to register
pursuant to section 801(s) with respect to importation
of such food.'';
(2) in subsection (b), by adding at the end the following:
``(3) Reporting by farms, restaurants, and retail food
establishments.--In addition to the electronic portal described
in paragraph (1), the Secretary shall make available
alternative means of reporting under this section with respect
to farms, restaurants, and other retail food establishments
with limited ability for such reporting.'';
(3) in subsection (d)(1)--
(A) in the matter preceding subparagraph (A), by
inserting ``following a timely review of any reasonably
available data and information,'' after ``reportable
food,'';
(B) in subparagraph (A), by striking ``and'' at the
end;
(C) by redesignating subparagraph (B) as
subparagraph (C); and
(D) by inserting after subparagraph (A) the
following:
``(B) submit, with such report, through the
electronic portal, documentation of results from any
sampling and testing of such article, including--
``(i) analytical results from testing of
such article conducted by or on behalf of the
responsible party under section 418, 418A, 419,
419A, or 714;
``(ii) analytical results from testing
conducted by or on behalf of such responsible
party of a component of such article;
``(iii) analytical results of environmental
testing of any facility at which such article,
or a component of such article, is
manufactured, processed, packed, or held; and
``(iv) any other information the Secretary
determines is necessary to evaluate the
adulteration of such article, any component of
such article, any other article of food
manufactured, processed, packed or held in the
same manner as, or at the same facility as,
such article, or any other article containing a
component from the same source as a component
of such article; and''; and
(4) in subsection (e)--
(A) in paragraph (1), by inserting ``if the
responsible party is required to register'' after
``415(a)(3)''; and
(B) by adding at the end the following:
``(12) Such additional information as the Secretary deems
appropriate.''.
(b) Exchange of Information.--Section 708 (21 U.S.C. 379) is
amended--
(1) by striking ``The Secretary'' and inserting ``(a) The
Secretary''; and
(2) by adding at the end the following:
``(b)(1)(A) The Secretary may provide to any Federal agency acting
within the scope of its jurisdiction any information relating to food
that is exempt from disclosure pursuant to subsection (a) of section
552 of title 5, United States Code, by reason of subsection (b)(4) of
such section, or that is referred to in section 301(j) or 415(a)(4).
``(B) Any such information provided to another Federal agency shall
not be disclosed by such agency except in any action or proceeding
under the laws of the United States to which the receiving agency or
the United States is a party.
``(2)(A) In carrying out this Act, the Secretary may provide to a
State or local government agency any information relating to food that
is exempt from disclosure pursuant to section 552(a) of title 5, United
States Code, by reason of subsection (b)(4) of such section, or that is
referred to in section 301(j) or 415(a)(4).
``(B) Any such information provided to a State or local government
agency shall not be disclosed by such agency.
``(3) In carrying out this Act, the Secretary may provide to any
person any information relating to food that is exempt from disclosure
pursuant to section 552(a) of title 5, United States Code, by reason of
subsection (b)(4) of such section, if the Secretary determines that
providing the information to the person is appropriate under the
circumstances and the recipient provides adequate assurances to the
Secretary that the recipient will preserve the confidentiality of the
information.
``(4) In carrying out this Act, the Secretary may provide any
information relating to food that is exempt from disclosure pursuant to
section 552(a) of title 5, United States Code, by reason of subsection
(b)(4) of such section, or that is referred to in section 301(j)--
``(A) to any foreign government agency; or
``(B) any international organization established by law,
treaty, or other governmental action and having
responsibility--
``(i) to facilitate global or regional
harmonization of standards and requirements in an area
of responsibility of the Food and Drug Administration;
or
``(ii) to promote and coordinate public health
efforts,
if the agency or organization provides adequate assurances to
the Secretary that the agency or organization will preserve the
confidentiality of the information.
``(c) Except where specifically prohibited by statute, the
Secretary may disclose to the public any information relating to food
that is exempt from disclosure pursuant to section 552(a) of title 5,
United States Code, by reason of subsection (b)(4) of such section, if
the Secretary determines that such disclosure is necessary to protect
the public health.
``(d) Except as provided in subsection (e), the Secretary shall not
be required to disclose under section 552 of title 5, United States
Code, or any other provision of law any information relating to food
obtained from a Federal, State, or local government agency, or from a
foreign government agency, or from an international organization
described in subsection (b)(4), if the agency or organization has
requested that the information be kept confidential, or has precluded
such disclosure under other use limitations, as a condition of
providing the information.
``(e) Nothing in subsection (d) authorizes the Secretary to
withhold information from the Congress or prevents the Secretary from
complying with an order of a court of the United States.
``(f) This section shall not affect the authority of the Secretary
to provide or disclose information under any other provision of law.''.
(c) Conforming Amendment.--Section 301(j) (21 U.S.C. 331(j)) is
amended by striking ``or to the courts when relevant in any judicial
proceeding under this Act,'' and inserting ``to the courts when
relevant in any judicial proceeding under this Act, or as specified in
section 708,''.
SEC. 113. SAFE AND SECURE FOOD IMPORTATION PROGRAM.
Chapter VIII (21 U.S.C. 381 et seq.) is amended by adding at the
end the following:
``SEC. 805. SAFE AND SECURE FOOD IMPORTATION PROGRAM.
``(a) In General.--The Secretary may establish by regulation or
guidance in coordination with the Commissioner responsible for Customs
and Border Protection a program that facilitates the movement of food
through the importation process under this Act if the importer of such
food--
``(1) verifies that each facility involved in the
production, manufacture, processing, packaging, and holding of
the food is in compliance with the food safety and security
guidelines developed under subsection (b) with respect to such
food;
``(2) ensures that appropriate safety and security controls
are in place throughout the supply chain for such food; and
``(3) provides supporting information to the Secretary.
``(b) Guidelines.--
``(1) Development.--For purposes of the program established
under subsection (a), the Secretary shall develop in
consultation with the Commissioner responsible for Customs and
Border Protection safety and security guidelines applicable to
the importation of food taking into account, to the extent
appropriate, other relevant Federal programs, such as the
Customs-Trade Partnership Against Terrorism (C-TPAT) programs
under section 211 of the Security and Accountability for Every
Port Act of 2006.
``(2) Factors.--Such guidelines shall take into account the
following factors:
``(A) The personnel of the person importing the
food.
``(B) The physical and procedural safety and
security of such person's food supply chain.
``(C) The sufficiency of preventive controls for
food and ingredients purchased by such person.
``(D) Vendor and supplier information.
``(E) Other programs for certification or
verification by a qualified certifying entity used by
the importer.
``(F) Such other factors as the Secretary
determines necessary.''.
SEC. 114. INFANT FORMULA.
(a) Misbranding.--Section 403 (21 U.S.C. 343), as amended by
sections 101(a) and 109(a), is amended by adding at the end the
following:
``(bb) If it is a new infant formula and--
``(1) it is not the subject of a registration made pursuant
to section 412(c)(1)(A);
``(2) it is not the subject of a submission made pursuant
to section 412(c)(1)(B), or
``(3) at least 90 days have not passed since the making of
such registration or of such submission to the Secretary.''.
(b) Requirements.--Section 412 (21 U.S.C. 350a) is amended--
(1) in subsection (c)(1)(B), by striking ``(c)(1)'' at the
end and inserting ``(d)(1), subject to subsection (d)(2)(B)'';
(2) in subsection (d)(1)--
(A) by striking ``and'' at the end of subparagraph
(C);
(B) by striking the period at the end of
subparagraph (D) and inserting ``, and''; and
(C) by adding at the end the following:
``(E) information on any new ingredient in
accordance with paragraph (2)(A).'';
(3) in subsection (d), by redesignating paragraphs (2) and
(3) as paragraphs (3) and (4), respectively; and
(4) by inserting after paragraph (1) of subsection (d) the
following:
``(2)(A) The description of any new infant formula required under
paragraph (1) shall include, for any new ingredient for use in the
formula--
``(i) a citation to a prior approval by the Secretary of
the new ingredient for use in infant formula under section 409;
``(ii) a citation to or information showing a prior
consideration of the new ingredient for use in infant formula
under any program established by the Secretary for the review
of ingredients used in food; or
``(iii) for a new ingredient that is not a food additive or
a color additive, information equivalent to that provided under
any program established by the Secretary for the review of
ingredients used in food.
``(B) If the information submitted under subparagraph (A) is the
information described in clause (iii) of such subparagraph, the 90 day
period provided by subsection (c)(1)(B) shall not commence until the
Secretary has completed review of the information submitted under such
clause and has provided the submitter notice of the results of such
review.''.
Subtitle B--Intervention
SEC. 121. SURVEILLANCE.
(a) Definition of Food-Borne Illness Outbreak.--In this section,
the term ``food-borne illness outbreak'' means the occurrence of 2 or
more cases of a similar illness resulting from the ingestion of a food.
(b) Food-Borne Illness Surveillance Systems.--The Secretary of
Health and Human Services (in this subtitle referred to as the
``Secretary''), acting through the Director of the Centers for Disease
Control and Prevention, shall enhance food-borne illness surveillance
systems to improve the collection, analysis, reporting, and usefulness
of data on food-borne illnesses by--
(1) coordinating Federal, State, and local food-borne
illness surveillance systems, including complaint systems, and
increasing participation in national networks of public health
and food regulatory agencies and laboratories;
(2) facilitating sharing of findings on a more timely basis
among governmental agencies, including the Food and Drug
Administration, the Department of Agriculture, and State and
local agencies, and with the public;
(3) developing improved epidemiological tools for obtaining
quality exposure data, and microbiological methods for
classifying cases;
(4) augmenting such systems to improve attribution of a
food-borne illness outbreak to a specific food;
(5) expanding capacity of such systems, including
fingerprinting and other detection strategies for food-borne
infectious agents, in order to identify new or rarely
documented causes of food-borne illness;
(6) allowing timely public access to aggregated, de-
identified surveillance data;
(7) at least annually, publishing current reports on
findings from such systems;
(8) establishing a flexible mechanism for rapidly
initiating scientific research by academic institutions;
(9) integrating food-borne illness surveillance systems and
data with other biosurveillance and public health situational
awareness capabilities at the Federal, State, and local levels;
and
(10) other activities as determined appropriate by the
Secretary.
(c) Improving Food Safety and Defense Capacity at the State and
Local Level.--
(1) In general.--The Secretary shall develop and implement
strategies to leverage and enhance the food safety and defense
capacities of State and local agencies in order to achieve the
following goals:
(A) Improve food-borne illness outbreak response
and containment.
(B) Accelerate food-borne illness surveillance and
outbreak investigation, including rapid shipment of
clinical isolates from clinical laboratories to
appropriate State laboratories, and conducting more
standardized illness outbreak interviews.
(C) Strengthen the capacity of State and local
agencies to carry out inspections and enforce safety
standards.
(D) Improve the effectiveness of Federal, State,
and local partnerships to coordinate food safety and
defense resources and reduce the incidence of food-
borne illness.
(E) Share information on a timely basis among
public health and food regulatory agencies, with the
food industry, with health care providers, and with the
public.
(2) Review.--In developing the strategies required by
paragraph (1), the Secretary shall, not later than 1 year after
the date of enactment of this Act, complete a review of State
and local capacities, and needs for enhancement, which may
include a survey with respect to--
(A) staffing levels and expertise available to
perform food safety and defense functions;
(B) laboratory capacity to support surveillance,
outbreak response, inspection, and enforcement
activities;
(C) information systems to support data management
and sharing of food safety and defense information
among State and local agencies and with counterparts at
the Federal level; and
(D) other State and local activities and needs as
determined appropriate by the Secretary.
SEC. 122. PUBLIC EDUCATION AND ADVISORY SYSTEM.
(a) Public Education.--The Secretary, in cooperation with private
and public organizations, including the appropriate State entities,
shall design and implement a national public education program on food
safety. The program shall provide--
(1) information to the public so that individuals can
understand the potential impact and risk of food-borne illness,
take action to reduce their risk of food-borne illness and
injury, and make healthy dietary choices;
(2) information to health professionals so that they may
improve diagnosis and treatment of food-related illness and
advise individuals whose health conditions place them in
particular risk; and
(3) such other information or advice to consumers and other
persons as the Secretary determines will promote the purposes
of this Act.
(b) Health Advisories.--The Secretary shall work with the States
and other appropriate entities to--
(1) develop and distribute regional and national advisories
concerning food safety;
(2) develop standardized formats for written and broadcast
advisories; and
(3) incorporate State and local advisories into the
national public education program required under subsection
(a).
SEC. 123. RESEARCH.
The Secretary shall conduct research to assist in the
implementation of this Act, including studies to--
(1) improve sanitation and food safety practices in the
production, harvesting, and processing of food products;
(2) develop improved techniques for the monitoring of food
and inspection of food products;
(3) develop efficient, rapid, and sensitive methods for
determining and detecting the presence of contaminants in food
products;
(4) determine the sources of contamination of food and food
products, including critical points of risk for fresh produce
and other raw agricultural commodities;
(5) develop consumption data with respect to food products;
(6) draw upon research and educational programs that exist
at the State and local level;
(7) utilize the DNA matching system and other processes to
identify and control pathogens;
(8) address common and emerging zoonotic diseases;
(9) develop methods to reduce or destroy pathogens before,
during, and after processing;
(10) analyze the incidence of antibiotic resistance as it
pertains to the food supply and evaluate methods to reduce the
transfer of antibiotic resistance to humans; and
(11) conduct other research that supports the purposes of
this Act.
Subtitle C--Response
SEC. 131. PROCEDURES FOR SEIZURE.
Section 304(b) (21 U.S.C. 334(b)) is amended by inserting ``and
except that, with respect to proceedings relating to food, Rule G of
the Supplemental Rules of Admiralty or Maritime Claims and Asset
Forfeiture Actions shall not apply in any such case, exigent
circumstances shall be deemed to exist for all seizures brought under
this section, and the summons and arrest warrant shall be issued by the
clerk of the court without court review in any such case'' after ``in
any such case shall be tried by jury''.
SEC. 132. ADMINISTRATIVE DETENTION.
(a) Amendments.--Section 304(h) (21 U.S.C. 334(h)) is amended--
(1) in paragraph (1)(A), by striking ``credible evidence or
information indicating'' and inserting ``reason to believe'';
(2) in paragraph (1)(A), by striking ``presents a threat of
serious adverse health consequences or death to humans or
animals'' and inserting ``is adulterated, misbranded, or
otherwise in violation of this Act'';
(3) in paragraph (2), by striking ``30'' and inserting
``60'';
(4) in paragraph (3), by striking the third sentence; and
(5) in paragraph (4)(A) by striking the terms ``five'' and
``five-day'' and inserting ``fifteen'' and ``fifteen-day'',
respectively.
(b) Regulations.--The Secretary shall issue regulations or guidance
to implement the amendments made by this section.
(c) Effective Date.--The amendments made by this section shall take
effect 180 days after the date of the enactment of this Act.
SEC. 133. AUTHORITY TO PROHIBIT OR RESTRICT THE MOVEMENT OF FOOD.
(a) Prohibited Act.--Section 301 (21 U.S.C. 331), as amended by
sections 110 and 111, is amended by adding at the end by adding the
following:
``(ww) The violation of a prohibition or restriction under section
304(i).''.
(b) In General.--Section 304 (21 U.S.C. 334) is amended by adding
at the end the following:
``(i) Authority to Prohibit or Restrict the Movement of Food Within
a State or Portion of a State.--
``(1) Authority to prohibit or restrict the movement of
food.--
``(A) In general.--
``(i) After consultation with the Governor
or other appropriate official of an affected
State, if the Secretary determines that there
is credible evidence that an article of food
presents an imminent threat of serious adverse
health consequences or death to humans or
animals, the Secretary may prohibit or restrict
the movement of an article of food within a
State or portion of a State for which the
Secretary has credible evidence that such food
is located within, or originated from, such
State or portion thereof.
``(ii) In carrying out clause (i), the
Secretary may prohibit or restrict the movement
within a State or portion of a State of any
article of food or means of conveyance of such
article of food, if the Secretary determines
that the prohibition or restriction is a
necessary protection from an imminent threat of
serious adverse health consequences or death to
humans or animals.
``(2) Notification procedures.--Subject to paragraph (3),
before any action is taken in a State under this subsection,
the Secretary shall--
``(A) notify the Governor or other appropriate
official of the State affected by the proposed action;
``(B) issue a public announcement of the proposed
action; and
``(C) publish in the Federal Register--
``(i) the findings of the Secretary that
support the proposed action;
``(ii) a statement of the reasons for the
proposed action; and
``(iii) a description of the proposed
action, including--
``(I) the area affected; and
``(II) an estimate of the
anticipated duration of the action.
``(3) Notice after action.--If it is not practicable to
publish in the Federal Register the information required under
paragraph (2)(C) before taking action under paragraph (1), the
Secretary shall publish the information as soon as practicable,
but not later than 10 business days, after commencement of the
action.
``(4) Application of least drastic action.--No action shall
be taken under paragraph (1) unless, in the opinion of the
Secretary, there is no less drastic action that is feasible and
that would be adequate to prevent the imminent threat of
serious adverse health consequences or death to humans or
animals.
``(5) Nondelegation.--An action under paragraph (1) may
only be ordered by the Secretary or an official designated by
the Secretary. An official may not be so designated unless the
official is the Commissioner of Food and Drugs or the Principal
Deputy Commissioner.
``(6) Duration.--Fourteen days after the initiation of an
action under paragraph (1), and each 14 days thereafter, if the
Secretary determines that it is necessary to continue the
action, the Secretary shall--
``(A) notify the Governor or other appropriate
official of the State affected of the continuation of
the action;
``(B) issue a public announcement of the
continuation of the action; and
``(C) publish in the Federal Register the findings
of the Secretary that support the continuation of the
action, including an estimate of the anticipated
duration of the action.
``(7) Rulemaking.--The Secretary shall, consistent with
national security interests and as appropriate for known
hazards, establish by regulation standards for conducting
actions under paragraph (1), including, as appropriate,
sanitation standards and procedures to restore any affected
equipment or means of conveyance to its status prior to an
action under paragraph (1).''.
SEC. 134. CRIMINAL PENALTIES.
Section 303(a) (21 U.S.C. 333) is amended--
(1) in paragraph (1), by striking ``Any'' and inserting
``Except as provided in paragraph (2) or (3), any''; and
(2) by adding at the end the following:
``(3) Notwithstanding paragraph (1), any person who knowingly
violates paragraph (a), (b), (c), (k), or (v) of section 301 with
respect to any food that is misbranded or adulterated shall be
imprisoned for not more than 10 years or fined in accordance with title
18, United States Code, or both.''.
SEC. 135. CIVIL PENALTIES FOR VIOLATIONS RELATING TO FOOD.
(a) In General.--Paragraph (2) of section 303(f) (21 U.S.C. 331 et
seq.) is amended to read as follows:
``(2)(A) Any person who violates a provision of section 301
relating to food shall be subject to a civil penalty for each
such violation of not more than--
``(i) $20,000 in the case of an individual, not to
exceed $50,000 in a single proceeding; and
``(ii) $250,000 in the case of any other person,
not to exceed $1,000,000 in a single proceeding.
``(B) Any person who knowingly violates a provision of
section 301 relating to food shall be subject to a civil
penalty for each such violation of not more than--
``(i) $50,000 in the case of an individual, not to
exceed $100,000 in a single proceeding; and
``(ii) $500,000 in the case of any other person,
not to exceed $7,500,000 in a single proceeding.
``(C) Each violation described in subparagraph (A) or (B)
and each day during which the violation continues shall be
considered to be a separate offense.''.
(b) Effective Date.--The amendment made by subsection (a) applies
to violations committed on or after the date of the enactment of this
Act.
SEC. 136. IMPROPER IMPORT ENTRY FILINGS.
(a) Prohibited Acts.--Section 301 (21 U.S.C. 331), as amended by
sections 110, 111, and 133, is amended by adding at the end the
following:
``(xx) The submission of information relating to food that is
required by or under section 801 that is inaccurate or incomplete.
``(yy) The failure to submit information relating to food that is
required by or under section 801.''.
(b) Documentation for Imports.--Section 801 (21 U.S.C. 381), as
amended by section 109, is amended by adding at the end the following:
``(r) Documentation.--
``(1) Submission.--The Secretary may require by regulation
or guidance the submission of documentation or other
information for articles of food that are imported or offered
for import into the United States. When developing any
regulation or guidance in accordance with this paragraph, to
the extent that the collection of documentation or other
information involves Customs and Border Protection efforts or
resources, the Secretary shall consult with Customs and Border
Protection.
``(2) Format.--A regulation or guidance under paragraph (1)
may specify the format for submission of the documentation or
other information.''.
TITLE II--MISCELLANEOUS
SEC. 201. FOOD SUBSTANCES GENERALLY RECOGNIZED AS SAFE.
Section 409 (21 U.S.C. 348) is amended by adding at the end the
following:
``Substances Generally Recognized as Safe
``(k)(1) Not later than 60 days after the date of receipt by the
Secretary, after the date of the enactment of this subsection, of a
determination that a substance is a GRAS food substance, the Secretary
shall post notice of such determination and the supporting scientific
justifications on the Food and Drug Administration's public Web site.
``(2) Not later than 60 days after the date of receipt of a request
under paragraph (1), the Secretary shall acknowledge receipt of such
request by informing the requester in writing of the date on which the
request was received.
``(3) In this subsection, the term `GRAS food substance' means a
substance excluded from the definition of the term `food additive' in
section 201(s) because such substance is generally recognized, among
experts qualified by scientific training and experience to evaluate its
safety, as having been adequately shown through scientific procedures
(or, in the case of a substance used in food prior to January 1, 1958,
through either scientific procedures or experience based on common use
in food) to be safe under the conditions of its intended use.''.
SEC. 202. COUNTRY OF ORIGIN LABELING.
(a) Misbranding.--Section 403 (21 U.S.C. 343), as amended by
sections 101(a), 109(a), and 114(a), is amended by adding at the end
the following:
``(cc) In the case of a processed food, if the labeling of the food
fails to identify the country in which the final processing of the food
occurs.
``(dd) In the case of nonprocessed food, if the labeling of the
food fails to identify the country of origin of the food.''.
(b) Regulations.--
(1) Promulgation.--Not later than 180 days after the date
of the enactment of this Act, the Secretary of Health and Human
Services shall promulgate final regulations to carry out
paragraphs (cc) and (dd) of section 403 of the Federal Food,
Drug, and Cosmetic Act, as added by subsection (a).
(2) Relation to other requirements.--Regulations
promulgated under paragraph (1) shall provide that labeling
meets the requirements of paragraphs (cc) and (dd) of section
403 of the Federal Food, Drug, and Cosmetic Act, as added by
subsection (a), if--
(A) in the case of a processed food, the label of
the food informs the consumer of the country where the
final processing of the food occurred in accordance
with country of origin marking requirements of the
United States Customs and Border Protection; or
(B) in the case of a nonprocessed food, the label
of the food informs the consumer of the country of
origin of the food in accordance with labeling
requirements of the Department of Agriculture.
(c) Effective Date.--The requirements of paragraphs (cc) and (dd)
of section 403 of the Federal Food, Drug, and Cosmetic Act, as added by
subsection (a), take effect on the date that is 2 years after the date
of the enactment of this Act.
SEC. 203. EXPORTATION CERTIFICATE PROGRAM.
Section 801(e)(4) (21 U.S.C. 381) is amended--
(1) in the matter preceding clause (i) in subparagraph
(A)--
(A) by inserting ``from the United States'' after
``exports''; and
(B) by striking ``a drug, animal drug, or device''
and inserting ``a food (including animal feed), drug,
animal drug, or device'';
(2) in subparagraph (A)(i)--
(A) by striking ``in writing''; and
(B) by striking ``exported drug, animal drug, or
device'' and inserting ``exported food, drug, animal
drug, or device'';
(3) in subparagraph (A)(ii)--
(A) by striking ``in writing'';
(B) by striking ``the drug, animal drug, or
device'' and inserting ``the food, drug, animal drug,
or device''; and
(C) by striking ``the drug or device'' and
inserting ``the food, drug, or device'';
(4) by redesignating subparagraph (B) as subparagraph (C);
(5) by inserting after subparagraph (A) the following:
``(B) For purposes of this paragraph, a
certification by the Secretary shall be made on such
basis and in such form (such as a publicly available
listing) as the Secretary determines appropriate.'';
and
(6) by adding at the end the following:
``(D) Notwithstanding subparagraph (C), if the Secretary issues an
export certification within the 20 days prescribed by subparagraph (A)
with respect to the export of food, a fee for such certification shall
not exceed such amount as the Secretary determines is reasonably
related to the cost of issuing certificates under subparagraph (A) with
respect to the export of food. The Secretary may adjust this fee
annually to account for inflation and other cost adjustments. Fees
collected for a fiscal year pursuant to this subparagraph shall be
credited to the appropriation account for salaries and expenses of the
Food and Drug Administration and shall be available in accordance with
appropriations Acts until expended, without fiscal year limitation.
Such fees shall be collected in each fiscal year in an amount equal to
the amount specified in appropriations Acts for such fiscal year and
shall only be collected and available for the costs of the Food and
Drug Administration to cover the cost of issuing such certifications.
Such sums as necessary may be transferred from such appropriation
account for salaries and expenses of the Food and Drug Administration
without fiscal year limitation to such appropriation account for
salaries and expenses with fiscal year limitation.''.
SEC. 204. REGISTRATION FOR COMMERCIAL IMPORTERS OF FOOD; FEE.
(a) Registration.--
(1) Prohibitions.--Section 301 (21 U.S.C. 331), as amended
by sections 110, 111, 133, and 136, is amended by adding at the
end the following:
``(zz) The failure to register in accordance with section
801(s).''.
(2) Misbranding.--Section 403 (21 U.S.C. 343) as amended by
sections 101(a), 109(a), 114(a), and 202, is amended by adding
at the end the following:
``(ee) If it is imported or offered for import by an importer not
duly registered under section 801(s).''.
(3) Registration.--Section 801, as amended by sections 109
and 136, is amended by adding at the end the following:
``(s) Registration of Importers.--
``(1) Registration.--The Secretary shall require an
importer of food--
``(A) to be registered with the Secretary in a form
and manner specified by the Secretary; and
``(B) consistent with section 1011, to submit
appropriate unique facility identifiers as a condition
of registration.
``(2) Good importer practices.--The maintenance of
registration under this subsection is conditioned on compliance
with good importer practices in accordance with the following:
``(A) The Secretary, in consultation with Customs
and Border Protection, shall promulgate regulations to
establish good importer practices that specify the
measures an importer shall take to ensure imported food
is in compliance with the requirements of this Act.
``(B) The measures under subparagraph (A) shall
ensure that the importer of a food--
``(i) has adequate information about the
food, its hazards, and the requirements of this
Act applicable to such food;
``(ii) has adequate information or
procedures in place to verify that both the
food and each person that produced,
manufactured, processed, packed, transported,
or held the food, including components of the
food, are in compliance with the requirements
of this Act; and
``(iii) has adequate procedures in place to
take corrective action, such as the ability to
appropriately trace, withhold, and recall
articles of food, if a food imported by the
importer is not in compliance with the
requirements of this Act.
``(C) In promulgating good importer practices
regulations, the Secretary may, as appropriate--
``(i) incorporate certification of
compliance under section 801(q) and
participation in the safe and secure food
importation program under section 805; and
``(ii) take into account differences among
importers and the types of imports, including
based on the level of risk posed by the
imported food.
``(3) Suspension of registration.--
``(A) In general.--Registration under this
subsection is subject to suspension upon a finding by
the Secretary, after notice and an opportunity for an
informal hearing, of--
``(i) a violation of this Act; or
``(ii) the knowing or repeated making of an
inaccurate or incomplete statement or
submission of information relating to the
importation of food.
``(B) Request.--The importer whose registration is
suspended may request that the Secretary vacate the
suspension of registration when such importer has
corrected the violation that is the basis for such
suspension.
``(C) Vacating of suspension.--If the Secretary
determines that adequate reasons do not exist to
continue the suspension of a registration, the
Secretary shall vacate such suspension.
``(4) Cancellation of registration.--
``(A) In general.--Not earlier than 10 days after
providing the notice under subparagraph (B), the
Secretary may cancel a registration that the Secretary
determines was not updated in accordance with this
section or otherwise contains false, incomplete, or
inaccurate information.
``(B) Notice of cancellation.--Cancellation shall
be preceded by notice to the importer of the intent to
cancel the registration and the basis for such
cancellation.
``(C) Timely update or correction.--If the
registration for the importer is updated or corrected
no later than 7 days after notice is provided under
subparagraph (B), the Secretary shall not cancel such
registration.
``(5) Exemptions.--The Secretary, by notice published in
the Federal Register--
``(A) shall establish an exemption from the
requirements of this subsection for importations for
personal use; and
``(B) may establish other exemptions from the
requirements of this subsection.''.
(4) Regulations.--Not later than 36 months after the date
of the enactment of this Act, the Secretary of Health and Human
Services in consultation with the Commissioner responsible for
Customs and Border Protection shall promulgate the regulations
required to carry out section 801(s) of the Federal Food, Drug,
and Cosmetic Act, as added by paragraph (3). In establishing
the effective date of a regulation promulgated under section
801(s), the Secretary shall, in consultation with the
Commissioner responsible for Customs and Border Protection, as
appropriate, provide a reasonable period of time for importers
of food to comply with good importer practices, taking into
account differences among importers and the types of imports,
including based on the level of risk posed by the imported
food.
(5) Effective date.--The amendments made by this subsection
shall take effect on the date that is 24 months after the date
of enactment of this Act.
(b) Fee.--Subchapter C of chapter VII (21 U.S.C. 379f et seq.) as
added and amended by sections 101 and 108, is amended by adding at the
end the following:
``PART 7--IMPORTERS OF FOOD
``SEC. 744. IMPORTERS OF FOOD.
``(a) Importers.--The Secretary shall assess and collect an annual
fee for the registration of an importer of food under section 801(s).
``(b) Amount of Fee.--
``(1) Base amounts.--The registration fee under subsection
(a) shall be--
``(A) for fiscal year 2010, $500; and
``(B) for fiscal year 2011 and each subsequent
fiscal year, the fee for fiscal year 2010 as adjusted
under paragraph (2).
``(2) Adjustment.--For fiscal year 2011 and subsequent
fiscal years, the fees established pursuant to paragraph (1)
shall be adjusted by the Secretary by notice, published in the
Federal Register, for a fiscal year to reflect the greater of--
``(A) the total percentage change that occurred in
the Consumer Price Index for all urban consumers (all
items; United States city average), for the 12-month
period ending June 30 preceding the fiscal year for
which fees are being established;
``(B) the total percentage change for the previous
fiscal year in basic pay under the General Schedule in
accordance with section 5332 of title 5, United States
Code, as adjusted by any locality-based comparability
payment pursuant to section 5304 of such title for
Federal employees stationed in the District of
Columbia; or
``(C) the average annual change in the cost, per
full-time equivalent position of the Food and Drug
Administration, of all personnel compensation and
benefits paid with respect to such positions for the
first 5 years of the preceding 6 fiscal years.
``(3) Compounded basis.--The adjustment made each fiscal
year pursuant this subsection shall be added on a compounded
basis to the sum of all adjustments made each fiscal year after
fiscal year 2010 under this subsection.
``(4) Waiver for importers required to pay registration
fee.--In the case of a person who is required to pay both a fee
under section 743 for registration of one or more facilities
under section 415 and a fee under this section for registration
as an importer of food under section 801(s), the Secretary
shall waive the fees applicable to such person under section
743 or the fee applicable to such person under this section.
``(c) Crediting and Availability of Fees.--
``(1) In general.--Fees authorized under subsection (a)
shall be collected and available for obligation only to the
extent and in the amount provided in advance in appropriations
Acts. Such fees are authorized to remain available until
expended. Such sums as may be necessary may be transferred from
the Food and Drug Administration salaries and expenses
appropriation account without fiscal year limitation to such
appropriation account for salaries and expenses with such
fiscal year limitation.
``(2) Collections and appropriations acts.--The fees
authorized by this section--
``(A) shall be retained in each fiscal year in an
amount not to exceed the amount specified in
appropriation Acts, or otherwise made available for
obligation, for such fiscal year; and
``(B) shall only be collected and available to
cover the costs associated with registering importers
under section 801(s) and with ensuring compliance with
good importer practices respecting food.
``(3) Authorization of appropriations.--For each of fiscal
years 2010 through 2014, there are authorized to be
appropriated for fees under this section such sums as may be
necessary.''.
(c) Inspection.--Section 704 (21 U.S.C. 374), as amended by section
105, is amended by adding at the end the following:
``(i) Importers.--Every person engaged in the importing of any food
shall, upon request of an officer or employee designated by the
Secretary, permit such officer or employee at all reasonable times to
inspect the facilities of such person and have access to, and to copy
and verify, any related records.''.
SEC. 205. REGISTRATION FOR CUSTOMS BROKERS.
(a) Registration.--
(1) Prohibitions.--Section 301(zz) (21 U.S.C. 331), as
added by section 204, is amended by inserting ``or 801(t)''
after ``801(s)''.
(2) Misbranding.--Section 403(ee) (21 U.S.C. 343), as added
by section 204, is amended--
(A) by inserting ``or a customs broker'' after ``by
an importer''; and
(B) by inserting ``or 801(t)'' after ``801(s)''.
(3) Registration.--Section 801, as amended by sections 109,
136, and 204, is amended by adding at the end the following:
``(t) Registration of Customs Broker.--
``(1) Registration.--The Secretary shall require a customs
broker, with respect to the importation of food--
``(A) to be registered with the Secretary in a form
and manner specified by the Secretary; and
``(B) consistent with section 1011, to submit
appropriate unique facility identifiers as a condition
of registration.
``(2) Cancellation of registration.--
``(A) In general.--Not earlier than 10 days after
providing the notice under subparagraph (B), the
Secretary may cancel a registration that the Secretary
determines was not updated in accordance with this
section or otherwise contains false, incomplete, or
inaccurate information.
``(B) Notice of cancellation.--Cancellation shall
be preceded by notice to the customs broker of the
intent to cancel the registration and the basis for
such cancellation.
``(C) Timely update or correction.--If the
registration for the customs broker is updated or
corrected no later than 7 days after notice is provided
under subparagraph (B), the Secretary shall not cancel
such registration.
``(3) Notification.--The Secretary shall notify the
Commissioner responsible for Customs and Border Protection
whenever the Secretary cancels a registration under this
subsection.
``(4) Exemptions.--In consultation with the Commissioner
responsible for Customs and Border Protection, the Secretary,
by notice published in the Federal Register--
``(A) shall establish an exemption from the
requirements of this subsection for importations for
personal use; and
``(B) may establish other exemptions from the
requirements of this subsection.
``(5) Civil penalties.--Notwithstanding any other provision
in this Act, a customs broker who violates section 301 because
of a violation of section 403(ee), or who violates section
301(xx), 301(yy), or 301(zz), shall not be subject to a civil
penalty under section 303(f)(2).''.
(4) Regulations.--Not later than 24 months after the date
of the enactment of this Act, the Secretary of Health and Human
Services, in consultation with the Commissioner responsible for
Customs and Border Protection, shall promulgate the regulations
required to carry out section 801(t) of the Federal Food, Drug,
and Cosmetic Act, as added by paragraph (2).
(5) Effective date.--The amendments made by this subsection
shall take effect on the date that is 24 months after the date
of enactment of this Act.
(b) Inspection.--Section 704 (21 U.S.C. 374), as amended by
sections 105 and 204, is amended by adding at the end the following:
``(j) Brokers.--Every customs broker required to be registered with
the Secretary shall, upon request of an officer or employee designated
by the Secretary, permit such officer or employee at all reasonable
times to inspect the facilities of such person and have access to, and
to copy and verify, any related records.''.
SEC. 206. UNIQUE IDENTIFICATION NUMBER FOR FOOD FACILITIES, IMPORTERS,
AND CUSTOM BROKERS.
Chapter X (21 U.S.C. 391 et seq) is amended by adding at the end
the following:
``SEC. 1011. UNIQUE FACILITY IDENTIFIER.
``(a) Registration of Facility or Establishment.--A person required
to register a facility pursuant to section 415 shall submit, at the
time of registration, a unique facility identifier for the facility or
establishment.
``(b) Registration of Importers and Custom Brokers.--A person
required to register pursuant to section 801(s) or 801(t) shall submit,
at the time of registration, a unique facility identifier for the
principal place of business for which such person is required to
register under section 801(s) or 801(t).
``(c) Guidance.--The Secretary may, by guidance, and, with respect
to importers and customs brokers, in consultation with the Commissioner
responsible for Customs and Border Protection, specify the unique
numerical identifier system to be used to meet the requirements of
subsections (a) and (b) and the form, manner, and timing of a
submission under such subsections. Development of such guidelines shall
take into account the utilization of existing unique identification
schemes and compatibility with customs automated systems, such as
integration with the Automated Commercial Environment (ACE) and the
International Trade Data System (ITDS), and any successor systems.
``(d) Importation.--An article of food imported or offered for
import shall be refused admission unless the appropriate unique
facility identifiers, as specified by the Secretary, are provided for
such article.''.
SEC. 207. PROHIBITION AGAINST DELAYING, LIMITING, OR REFUSING
INSPECTION.
(a) Adulteration.--Section 402 (21 U.S.C. 342), as amended by
section 102, 103(a), and 104(a), is amended by adding at the end the
following:
``(n) If it has been produced, manufactured, processed, packed, or
held in any farm, factory, warehouse, or establishment and the owner,
operator, or agent of such farm, factory, warehouse, or establishment,
or any agent of a governmental authority in the foreign country within
which such farm, factory, warehouse, or establishment is located,
delays or limits an inspection, or refuses to permit entry or
inspection, under section 414 or 704.''.
(b) Foreign Inspections.--Section 704(a)(1) (21 U.S.C. 374(a)(1)),
as amended by section 106(c), is amended--
(1) in the first sentence, by inserting ``, including any
such food factory, warehouse, or establishment whether foreign
or domestic,'' after ``factory, warehouse, or establishment'';
and
(2) in the third sentence, by inserting ``, including any
food factory, warehouse, establishment, or consulting
laboratory whether foreign or domestic,'' after ``factory,
warehouse, establishment, or consulting laboratory''.
SEC. 208. DEDICATED FOREIGN INSPECTORATE.
Section 704 (21 U.S.C. 374), as amended by sections 105, 204, and
205, is amended by adding at the end the following:
``(k) Dedicated Foreign Inspectorate.--The Secretary shall
establish and maintain a corps of inspectors dedicated to inspections
of foreign food facilities. This corps shall be staffed and funded by
the Secretary at a level sufficient to enable it to assist the
Secretary in achieving the frequency of inspections for food facilities
as described in this Act.''.
SEC. 209. PLAN AND REVIEW OF CONTINUED OPERATION OF FIELD LABORATORIES.
(a) Submission of Plan.--Not later than 90 days before the
Secretary terminates or consolidates any laboratory, district office,
or the functions (including the inspection and compliance functions) of
any such laboratory or district office, specified in subsection (b),
the Secretary shall submit a reorganization plan to the Comptroller
General of the United States, the Committee on Energy and Commerce of
the House of Representatives, and the Committee on Health, Education,
Labor, and Pensions of the Senate.
(b) Specified Laboratories and Offices.--The laboratories and
offices specified in this subsection are the following:
(1) Any of the 13 field laboratories responsible for
analyzing food that were operated by the Office of Regulatory
Affairs of the Food and Drug Administration as of January 1,
2007.
(2) Any of the 20 district offices of the Food and Drug
Administration with responsibility for food safety functioning
as of January 1, 2007.
(c) Congressional Review.--A reorganization plan described in
subsection (a) is deemed to be a major rule (as defined in section
804(2) of title 5, United States Code) for purposes of chapter 8 of
such title.
SEC. 210. FALSE OR MISLEADING REPORTING TO FDA.
(a) In General.--Section 301(q)(2) (21 U.S.C. 331(q)(2)) is amended
by inserting after ``device'' the following: ``, food,''.
(b) Effective Date.--The amendment made by subsection (a) shall
apply to submissions made on or after the date of the enactment of this
Act.
SEC. 211. SUBPOENA AUTHORITY.
(a) Prohibited Act.--Section 301(f) is amended by inserting before
the period ``or the failure or refusal to obey a subpoena issued
pursuant to section 311''.
(b) Amendment.--Chapter III (21 U.S.C. 331 et seq.) is amended by
adding at the end the following:
``SEC. 311. EXERCISE OF SUBPOENA AUTHORITY.
``(a) In General.--For the purpose of--
``(1) any hearing, investigation, or other proceeding
respecting a violation of a provision of this Act, the Public
Health Service Act, or the Federal Anti-Tampering Act, relating
to food; or
``(2) any hearing, investigation, or other proceeding to
determine if a person is in violation of a specific provision
of this Act, the Public Health Service Act, or the Federal
Anti-Tampering Act, relating to food,
the Commissioner may issue subpoenas requiring the attendance and
testimony of witnesses and the production of records and other things.
``(b) Timing of Compliance.--When the Commissioner deems that
immediate compliance with a subpoena issued under this section is
necessary to address a threat of serious adverse health consequences or
death, the subpoena may require immediate production.
``(c) Service of Subpoena.--
``(1) In general.--Subpoenas of the Commissioner shall be
served by a person authorized by the Commissioner by delivering
a copy thereof to the person named therein or by certified mail
addressed to such person at such person's last known dwelling
place or principal place of business.
``(2) Corporations and other entities.--Service on a
domestic or foreign corporation, partnership, unincorporated
association, or other entity that is subject to suit under a
common name may be made by delivering the subpoena to an
officer, a managing or general agent, or any other agent
authorized by appointment or by law to receive service of
process.
``(3) Person outside u.s. jurisdiction.--Service on any
person not found within the territorial jurisdiction of any
court of the United States may be made in any manner as the
Federal Rules of Civil Procedure prescribe for service in a
foreign nation.
``(4) Proof of service.--A verified return by the person so
serving the subpoena setting forth the manner of service, or,
in the case of service by certified mail, the return post
office receipt therefor signed by the person so served, shall
be proof of service.
``(d) Payment of Witnesses.--Witnesses subpoenaed under subsection
(a) shall be paid the same fees and mileage as are paid witnesses in
the district courts of the United States.
``(e) Enforcement.--In the case of a refusal to obey a subpoena
duly served upon any person under subsection (a), any district court of
the United States for the judicial district in which such person
charged with refusal to obey is found, resides, or transacts business,
upon application by the Commissioner, shall have jurisdiction to issue
an order compelling compliance with the subpoena and requiring such
person to appear and give testimony or to appear and produce records
and other things, or both. The failure to obey such order of the court
may be punished by the court as contempt thereof. If the person charged
with failure or refusal to obey is not found within the territorial
jurisdiction of the United States, the United States District Court for
the District of Columbia shall have the same jurisdiction, consistent
with due process, to take any action respecting compliance with the
subpoena by such person that such district court would have if such
person were personally within the jurisdiction of such district court.
``(f) Nondisclosure.--A United States district court for the
district in which the subpoena is or will be served, upon application
of the Commissioner, may issue an ex parte order that no person or
entity disclose to any other person or entity (other than to an
attorney to obtain legal advice) the existence of such subpoena for a
period of up to 90 days. Such order may be issued on a showing that the
records or things being sought may be relevant to the hearing,
investigation, proceeding, or other matter and that there is reason to
believe that such disclosure may result in--
``(1) furtherance of a potential violation under
investigation;
``(2) endangerment to the life or physical safety of any
person;
``(3) flight or other action to avoid prosecution or other
enforcement remedies;
``(4) destruction of or tampering with evidence; or
``(5) intimidation of potential witnesses.
An order under this subsection may be renewed for additional periods of
up to 90 days upon a showing that any of the circumstances described in
paragraphs (1) through (5) continue to exist.
``(g) Relation to Other Provisions.--The subpoena authority vested
in the Commissioner and the district courts of the United States by
this section is in addition to any such authority vested in the
Commissioner or such courts by other provisions of law, or as is
otherwise authorized by law.
``(h) Nondelegation.--The authority to issue a subpoena under this
section is limited to the Secretary or an official designated by the
Secretary. An official may not be so designated unless the official is
the director of the district under this Act in which the article
involved is located, or is an official senior to such director.''.
SEC. 212. WHISTLEBLOWER PROTECTIONS.
Chapter X (21 U.S.C. 391 et seq.), as amended by section 206, is
amended by adding at the end the following:
``SEC. 1012 PROTECTIONS FOR EMPLOYEES WHO REFUSE TO VIOLATE, OR WHO
DISCLOSE VIOLATIONS OF, THIS ACT.
``(a) In General.--No person who submits or is required under this
Act or the Public Health Service Act to submit any information related
to a food, or any officer, employee, contractor, subcontractor, or
agent of such person may discharge, demote, suspend, threaten, harass,
or in any other manner discriminate against an employee in the terms
and conditions of employment because of any lawful act done by the
employee, including within the ordinary course of the job duties of
such employee--
``(1) to provide information, cause information to be
provided, or otherwise assist in any investigation regarding
any conduct which the employee reasonably believes constitutes
a violation of this Act, or any other provision of Federal law
relating to the safety of a food, if the information or
assistance is provided to, or an investigation stemming from
the provided information is conducted by--
``(A) a Federal regulatory or law enforcement
agency;
``(B) any Member of Congress or any committee of
Congress; or
``(C) a person with supervisory authority over the
employee (or such other person working for the employer
who has the authority to investigate, discover, or
terminate the misconduct);
``(2) to file, cause to be filed, testify, participate in,
or otherwise assist in a proceeding filed, or about to be filed
(with any knowledge of the employer), in any court or
administrative forum relating to any such alleged violation; or
``(3) to refuse to commit or assist in any such violation.
``(b) Enforcement Action.--
``(1) In general.--An employee who alleges discharge or
other discrimination in violation of subsection (a) may seek
relief in accordance with the provisions of subsection (c) by--
``(A) filing a complaint with the Secretary of
Labor; or
``(B) if the Secretary of Labor has not issued a
final decision within 210 days of the filing of the
complaint and there is no showing that such delay is
due to the bad faith of the claimant, or within 90 days
after receiving a final decision or order from the
Secretary, bringing an action at law or equity for de
novo review in the appropriate district court of the
United States, which court shall have jurisdiction over
such action without regard to the amount in
controversy, and which action shall, at the request of
either party to such action, be tried by the court with
a jury.
``(2) Procedure.--
``(A) In general.--Any action under paragraph (1)
shall be governed under the rules and procedures set
forth in section 42121(b) of title 49, United States
Code.
``(B) Exception.--Notification in an action under
paragraph (1) shall be made in accordance with section
42121(b)(1) of title 49, United States Code, except
that such notification shall be made to the person
named in the complaint, the employer, and the
Commissioner of Food and Drugs.
``(C) Burdens of proof.--An action brought under
paragraph (1)(A) or (1)(B) shall be governed by the
legal burdens of proof set forth in section 42121(b) of
title 49, United States Code.
``(D) Statute of limitations.--An action under
paragraph (1)(A) shall be commenced not later than 180
days after the date on which the violation occurs.
``(c) Remedies.--
``(1) In general.--An employee prevailing in any action
under subsection (b)(1) shall be entitled to all relief
necessary to make the employee whole.
``(2) Issuance of order.--If, in response to a complaint
filed under paragraph (b)(1), the Secretary of Labor or the
district court, as applicable, determines that a violation of
subsection (a) has occurred, the Secretary or the court shall
order the person who committed such violation--
``(A) to take affirmative action to abate the
violation;
``(B) to--
``(i) reinstate the complainant to his or
her former position together with compensation
(including back pay); and
``(ii) restore the terms, conditions, and
privileges associated with his or her
employment; and
``(C) to provide compensatory damages to the
complainant.
If such an order is issued under this paragraph, the Secretary
or the court, at the request of the complainant, shall assess
against the person against whom the order is issued a sum equal
to the aggregate amount of all costs and expenses (including
attorney and expert witness fees) reasonably incurred, as
determined by the Secretary, by the complainant for, or in
connection with, the bringing of the complaint upon which the
order was issued.
``(d) Rights Retained by Employee.--Nothing in this section shall
be deemed to diminish the rights, privileges, or remedies of any
employee under any Federal or State law or under any collective
bargaining agreement. The rights and remedies in this section may not
be waived by any agreement, policy, form, or condition of
employment.''.
SEC. 213. EXTRATERRITORIAL JURISDICTION.
(a) Prohibited Act.--Section 301 (21 U.S.C. 331), as amended by
sections 110, 111, 133, 136, and 204, is amended by adding at the end
the following:
``(aaa) The production, manufacture, processing, preparation,
packing, holding, or distribution of an adulterated or misbranded food
with the knowledge or intent that such article will be imported into
the United States.''.
(b) Jurisdiction.--Chapter III (21 U.S.C. 331 et seq.), as amended
by section 211, is amended by adding at the end the following:
``SEC. 312. EXTRATERRITORIAL JURISDICTION.
``There is extraterritorial Federal jurisdiction over any violation
of this Act relating to any article of food if such article was
intended for import into the United States or if any act in furtherance
of the violation was committed in the United States.''.
SEC. 214. SUPPORT FOR TRAINING INSTITUTES.
The Secretary of Health and Human Services, acting through the
Commissioner of Food and Drugs, shall provide financial and other
assistance to appropriate entities to establish and maintain one or
more university-affiliated food protection training institutes that--
(1) conduct training related to food protection activities
for Federal, State, local, territorial, and tribal officials;
and
(2) meet standards developed by the Secretary.
SEC. 215. BISPHENOL A IN FOOD AND BEVERAGE CONTAINERS.
(a) Notice of Determination.--No later than December 31, 2009, the
Secretary of Health and Human Services shall notify the Congress
whether the available scientific data support a determination that
there is a reasonable certainty of no harm, for infants, young
children, pregnant women, and adults, for approved uses of
polycarbonate plastic and epoxy resin made with bisphenol A in food and
beverage containers, including reusable food and beverage containers,
under the conditions of use prescribed in current Food and Drug
Administration regulations.
(b) Notice of Actions to Be Taken.--If the Secretary concludes that
such a determination cannot be made for any approved use, the Secretary
shall notify the Congress of the actions the Secretary intends to take
under the Secretary's authority to regulate food additives to protect
the public health, which may include--
(1) revoking or modifying any of the approved uses of
bisphenol A in food and beverage containers, including reusable
food and beverage containers; and
(2) ensuring that the public is sufficiently informed of
such determination and the steps the public may take in
response to such determination.
(c) Rule of Construction.--Nothing herein is intended or shall be
construed to modify existing Food and Drug Administration authority,
procedures, or policies for assessing scientific data, making safety
determinations, or regulating the safe use of food additives.
SEC. 216. LEAD CONTENT LABELING REQUIREMENT FOR CERAMIC TABLEWARE AND
COOKWARE.
(a) In General.--Section 403 (21 U.S.C. 343), as amended by
sections 101(a), 109(a), 114(a), 202, and 204, is amended by adding at
the end the following:
``(ff) If it is ceramic tableware or cookware and includes a glaze
or decorations containing lead for an intended functional purpose,
unless--
``(1) the product and its packaging bear the statement:
`This product is made with lead-based glaze consistent with
Food and Drug Administration guidelines for such lead.'; or
``(2) the product is in compliance with the requirements
applicable to ornamental and decorative ceramicware in section
109.16 of title 21, Code of Federal Regulations (or any
successor regulation).''.
(b) Effective Date.--Section 403(ff) of the Federal Food, Drug, and
Cosmetic Act, as added by subsection (a), shall apply only to ceramic
tableware or cookware that is manufactured on or after the date that is
1 year after the date of the enactment of this Act.
(c) Consumer Education.--Chapter IV (21 U.S.C. 341 et seq.), as
amended by sections 102, 103, 104, and 111, is amended by adding at the
end the following:
``SEC. 421. CONSUMER EDUCATION ON THE CONTENT OF LEAD IN CERAMICWARE
AND APPLICABLE LABELING REQUIREMENTS.
``(a) In General.--The Secretary shall educate consumers on the
safety of ceramicware for food use by posting information on the Web
site of the Food and Drug Administration with regard to--
``(1) the content of lead in ceramicware and its glaze;
``(2) existing Federal laws and regulations governing lead
in ceramicware;
``(3) as appropriate, existing industry practices and
guidelines; and
``(4) the labeling requirements applicable under this Act.
``(b) Topics.--The education under this section shall address--
``(1) the broad range of ceramicware types, including
traditional pottery, ornamental and decorative ceramicware,
cookware, and everyday dinnerware;
``(2) the safety of ceramicware that is aged or damaged;
``(3) the use of ceramicware in microwave ovens;
``(4) the storage of foods in ceramicware;
``(5) the use of home lead test kits by consumers;
``(6) the use of ceramicware by children and women of
childbearing age; and
``(7) issues that are especially relevant to subpopulations
of consumers who may preferentially use certain types of
ceramicware made with lead.''.
Passed the House of Representatives July 30, 2009.
Attest:
LORRAINE C. MILLER,
Clerk.