[House Report 111-234]
[From the U.S. Government Publishing Office]
111th Congress Report
HOUSE OF REPRESENTATIVES
1st Session 111-234
======================================================================
FOOD SAFETY ENHANCEMENT ACT OF 2009
_______
July 29, 2009.--Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
_______
Mr. Waxman, from the Committee on Energy and Commerce, submitted the
following
R E P O R T
[To accompany H.R. 2749]
[Including cost estimate of the Congressional Budget Office]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 2749) to amend the Federal Food, Drug, and
Cosmetic Act to improve the safety of food in the global
market, and for other purposes, having considered the same,
report favorably thereon with an amendment and recommend that
the bill as amended do pass.
CONTENTS
Page
Purpose and Summary.............................................. 35
Background and Need for Legislation.............................. 36
Legislative History.............................................. 36
Committee Consideration.......................................... 36
Committee Votes.................................................. 37
Committee Oversight Findings and Recommendations................. 37
New Budget Authority, Entitlement Authority, and Tax Expenditures 37
Statement of General Performance Goals and Objectives............ 37
Constitutional Authority Statement............................... 37
Earmarks and Tax and Tariff Benefits............................. 37
Advisory Committee Statement..................................... 38
Applicability of Law to Legislative Branch....................... 38
Federal Mandates Statement....................................... 38
Committee Cost Estimate.......................................... 38
Congressional Budget Office Estimate............................. 38
Section-by-Section Analysis of the Legislation................... 43
Explanation of Amendments........................................ 57
Changes in Existing Law Made by the Bill, as Reported............ 58
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
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. Quarantine authority for foods.
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; disclosure of source of
ingredients.
Sec. 203. Exportation certificate program.
Sec. 204. Registration for commercial importers of food; fee.
Sec. 205. Registration for customs brokers and filers; fee.
Sec. 206. Unique identification number for food facilities, importers,
custom brokers, and filers.
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. 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 any amendment 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 if such food is regulated by the Secretary of Agriculture
under the Federal Meat Inspection Act, the Poultry Products Inspection
Act, or the Egg Products Inspection Act.
(b) USDA-regulated Facilities.--A facility is exempt from the
requirements of this Act if such facility is regulated exclusively 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.
(c) 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 or chapter
51 of subtitle E of the Internal Revenue Code, 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, as amended by this Act, is required to register as a
facility solely because such facility is engaged in
manufacturing, processing, packing, or holding 1 or more
alcoholic beverages.
(b) 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, 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) In general.--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.''.
(2) 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 911.
``(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.''.
(3) 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, implement, and validate 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, may be
unintentionally introduced, or may be intentionally
introduced, including by acts of terrorism.
``(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, implement, and validate 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 intentional or 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 effective--
``(1) no 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 preventive controls identified under subsection (c)
have been validated as adequate to control the hazards
identified in the hazard analysis under subsection (b)(3);
``(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 article 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:
``(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 or conditions 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, review of monitoring
and corrective action records, and procedures for determining
whether the preventive controls are effectively preventing,
eliminating, or reducing to an acceptable level the occurrence
of identified hazards or conditions, 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 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.) is
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).''.
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.
``(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) 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 shall establish by regulation
scientific and risk-based standards for the safe growing, harvesting,
processing, packing, sorting, transporting, and holding of those types
of raw agricultural commodities--
``(1) that are from a plant or a 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
from a plant or a 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) Enforcement.--The Secretary may coordinate with the Secretary
of Agriculture and 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(p); and
``(D) such other factors as the Secretary determines by
guidance to be relevant to assessing the risk presented by the
facility.''.
(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 the following--
(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.--Each person who produces,
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
production, 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.
``(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.''.
(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, may by regulation establish requirements regarding the
establishment and maintenance, for not longer than 3 years, of records
by persons who produce, 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 section. 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 first sentence--
(A) by inserting ``farm,'' before ``factory'' each
place it appears; and
(B) by inserting ``produced,'' before
``manufactured'';
(2) in the second sentence--
(A) by striking ``(excluding farms and
restaurants)'';
(B) by inserting ``produces,'' before
``manufactures'';
(C) by inserting ``receives,'' before ``holds'';
(D) by striking ``described in section 414'' and
inserting ``described in or required under section
414''; and
(E) 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
(3) 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 911; 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.
``(3) Regulation.--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. The Secretary may include in such
regulation--
``(A) the establishment and maintenance of lot
numbers;
``(B) a standardized format for pedigree information;
and
``(C) the use of a common nomenclature for food.
``(4) Exemptions.--
``(A) Direct sales by farms.--Food is exempt from the
requirements of this subsection if such food is--
``(i) produced on a farm or fishery
(including an oyster bed, a wild fishery, an
aquaculture facility, a fresh water fishery,
and a saltwater fishery); and
``(ii) sold by the owner, operator, or agent
in charge of such farm or fishery directly to a
consumer or to a restaurant or grocery store.
``(B) 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.
``(C) Previous sources and subsequent recipients.--
For a food covered by an exemption under subparagraph
(B), the Secretary shall require each person who
produces, manufactures, processes, packs, transports,
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.
``(D) 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.
``(E) Farms and fisheries.--For a food covered by an
exemption under subparagraph (A), farms and fisheries
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(p) (requiring a
certification to accompany 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 an
article of food being imported or offered for import into the
United States is not in compliance with the requirement of
subsection (p) (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:
``(p) Certifications Concerning Imported Articles.--
``(1) In general.--
``(A) Requirement.--The Secretary shall 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 specified requirements of this Act if--
``(i) for food imported from a particular
country or region, based on the adequacy of
government controls in such country or region
or other information relevant to such food,
certification would assist the Secretary in
determining whether to refuse to admit such
article under subsection (a);
``(ii) for a type of food that could pose a
significant risk to health, certification would
assist the Secretary in determining whether
such article poses such risk; or
``(iii) for an article imported from a
particular country, there is an agreement
between the Secretary and the government of
such country providing for such certification.
``(B) Contents of certification.--Such certification
shall include such information regarding compliance as
the Secretary may specify, and may be provided in the
form of shipment-specific certificates, a listing of
certified facilities or other entities, or in such
other form as the Secretary may specify.
``(C) 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).
``(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.
``(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
maintain records pertaining to the financial
interests of the personnel involved in audits;
``(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) Anything of value.--In this paragraph, the term
`anything of value' includes gifts, gratuities,
reimbursement of expenses, entertainment, loans, or any
other form of compensation in cash or in kind.
``(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) Electronic submission.--The Secretary shall provide for
the electronic submission of certifications under this
subsection.
``(6) 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:
``(oo) 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) 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:
``(pp)(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(r) 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 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 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 a reasonable belief
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(pp)(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(r) with respect to importation of such
food.'';
(2) in subsection (b), by adding at the end the following:
``(3) Reporting by 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 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 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 safety and
security guidelines applicable to the importation of food.
``(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 of the Federal Food, Drug, and Cosmetic
Act (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 it is not the subject of a
letter from the Secretary provided pursuant to section 412(c)(1)(C).''.
(b) Requirements.--Section 412 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 350a) is amended--
(1) in subsection (b)(1), by adding at the end the following:
``The quality factor requirements established under this
paragraph may include requirements for one or more clinical
studies to demonstrate that the new infant formula supports
normal physical growth of infants.'';
(2) in subsection (b)(4), by amending subparagraph (B) to
read as follows:
``(B) Records required under subparagraph (A) with respect to an
infant formula shall be retained for at least one year after the
expiration of the shelf life of such infant formula. Such records shall
be made available to the Secretary for review and duplication upon
request of the Secretary.'';
(3) in subsection (c)(1)--
(A) in subparagraph (A), by striking ``and'' at the
end;
(B) in subparagraph (B), by striking ``(c)(1).'' at
the end and inserting ``(d)(1), and''; and
(C) by adding at the end the following:
``(C) the Secretary has by letter informed such person that
the registration requirements and the requirements in
subsection (d)(1) have been satisfied.''; and
(4) in subsection (d)(1), by striking subparagraphs (C) and
(D) and inserting the following:
``(C) scientific evidence and other evidence, as identified
in regulations promulgated by the Secretary, that demonstrates
that the infant formula satisfies the requirements of
subsection (b)(1), and, as demonstrated by the testing required
under subsection (b)(3), that it satisfies the requirements of
subsection (i), and
``(D) scientific evidence and other evidence, as identified
in regulations promulgated by the Secretary, that demonstrate
that the processing of the infant formula complies with the
requirements of subsection (b)(2).''.
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, 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 of 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. QUARANTINE AUTHORITY FOR FOODS.
(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:
``(qq) The violation of a quarantine under section 304(i).''.
(b) In General.--Section 304 (21 U.S.C. 334) is amended by adding at
the end the following:
``(i) Quarantine of Geographic Location.--
``(1) Authority to quarantine.--If the Secretary determines
that there is credible evidence or information that an article
of food presents an imminent threat of serious adverse health
consequences or death to humans or animals, the Secretary may
quarantine any geographic area within the United States where
the Secretary reasonably believes such food is located or from
which such food originated. The authority to quarantine
includes prohibiting or restricting the movement of food or of
any vehicle being used or that has been used to transport or
hold such food within the geographic area. Any quarantine under
this paragraph shall be no greater than is appropriate, as
determined by the Secretary, to protect the public health.
``(2) Notification procedures.--Before any quarantine action
is taken in any State under this subsection, the Secretary
shall notify an appropriate official of the State affected and
shall issue a public announcement of--
``(A) the Secretary's findings that support the
quarantine action;
``(B) the area affected by the intended quarantine
action;
``(C) the reasons for the intended quarantine action;
and
``(D) where practicable, an estimate of the
anticipated duration of the quarantine.
The Secretary is not required to make such announcement by
publication in the Federal Register, but may use a newspaper,
radio or television, the Internet, or any reasonable means to
make such announcement.
``(3) Nondelegation.--The authority to quarantine under this
subsection is limited to the Commissioner of Food and Drugs,
the Principal Deputy Commissioner, and the Associate
Commissioner for Regulatory Affairs of the Food and Drug
Administration.''.
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:
``(rr) The submission of information relating to food that is
required by or under section 801 that is inaccurate or incomplete.
``(ss) 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:
``(q) 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.
``(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; DISCLOSURE OF SOURCE OF
INGREDIENTS.
(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 labeling 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:
``(tt) The failure to register in accordance with section 801(r).''.
(2) Misbranding.--Section 403 (21 U.S.C. 343) as amended by
sections 101(a), 109(a), 114(a), and 202(a), 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(r).''.
(3) Registration.--Section 801, as amended by sections 109
and 136, is amended by adding at the end the following:
``(r) 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 911, 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. Good importer practices shall
include the verification of good manufacturing practices and
preventive controls of the importer's foreign suppliers, as
applicable.
``(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 24 months after the date of
the enactment of this Act, the Secretary of Health and Human
Services shall promulgate the regulations required to carry out
section 801(r) of the Federal Food, Drug, and Cosmetic Act, as
added by paragraph (3).
(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(r).
``(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(r), 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(r) 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 AND FILERS; FEE.
(a) Registration.--
(1) Prohibitions.--Section 301(tt) (21 U.S.C. 331), as added
by section 204, is amended by inserting ``or 801(s)'' after
``801(r)''.
(2) Misbranding.--Section 403(ee) (21 U.S.C. 343), as added
by section 204, is amended--
(A) by inserting ``or a customs broker or filer''
after ``by an importer''; and
(B) by inserting ``or 801(s)'' after ``801(r)''.
(3) Registration.--Section 801, as amended by sections 109,
136, and 204, is amended by adding at the end the following:
``(s) Registration of Customs Brokers and Filers.--
``(1) Registration.--The Secretary shall require a customs
broker or filer, 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 911, to submit
appropriate unique facility identifiers as a condition
of registration.
``(2) 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 customs broker or filer whose
registration is suspended may request that the
Secretary vacate the suspension of registration when
such customs broker or filer 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.
``(3) 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 or filer 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 or filer is updated
or corrected no later than 7 days after notice is
provided under subparagraph (B), the Secretary shall
not cancel such registration.
``(4) 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 24 months after the date of
the enactment of this Act, the Secretary of Health and Human
Services shall promulgate the regulations required to carry out
section 801(s) of the Federal Food, Drug, and Cosmetic Act, as
added by paragraph (3).
(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 and Filers.--Every person engaged in the brokering for
import or filing for import 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. 206. UNIQUE IDENTIFICATION NUMBER FOR FOOD FACILITIES, IMPORTERS,
CUSTOM BROKERS, AND FILERS.
Chapter IX (21 U.S.C. 391 et seq) is amended by adding at the end the
following:
``SEC. 911. 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, Custom Brokers, and Filers.--A
person required to register pursuant to section 801(r) or 801(s) 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(r) or 801(s).
``(c) Guidance.--The Secretary may, by guidance, 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.
``(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
sections 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: ``or 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 the following: ``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.
``(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 IX (21 U.S.C. 391 et seq.), as amended by section 206, is
amended by adding at the end the following:
``SEC. 912. PROTECTIONS FOR EMPLOYEES WHO REFUSE TO VIOLATE, OR WHO
DISCLOSE VIOLATIONS OF, THIS ACT OR SECTION 351 OF
THE PUBLIC HEALTH SERVICE 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 and to the employer.
``(C) Burdens of proof.--An action brought under
paragraph (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) 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 subsection (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 backpay); 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:
``(uu) 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.
Purpose and Summary
H.R. 2749, the Food Safety Enhancement Act of 2009, is to
amend the Federal Food, Drug, and Cosmetic Act to improve the
safety of food, and for other purposes.
A primary focus of H.R. 2749 is preventing food safety
problems before they occur. Under the legislation, food
facilities must implement preventive food safety plans in order
to identify potential food hazards and take steps to prevent
them from occurring. H.R. 2749 grants the Secretary the
authority to issue mandatory performance standards for reducing
hazards. The legislation also requires the Secretary to conduct
more frequent risk-based inspections and expands the
Secretary's access to food safety records. H.R. 2749 increases
the Secretary's ability to oversee the safety of imported food
by permitting the Secretary to require safety-related
documentation for potentially unsafe imported food as a
condition of import.
H.R. 2749 provides the Secretary with enhanced tools to
address food-borne illness outbreaks when they do occur. H.R.
2749 requires the Secretary to establish, by regulation after a
public input process, a system for the rapid tracing of the
origin of food. The legislation also grants the Secretary the
authority to mandate recalls of contaminated food and to
quarantine geographic areas of the United States from which the
Secretary reasonably believes contaminated food originated.
To enable the Secretary to better account for entities
involved in the manufacture, processing, packing, holding, and
import of food, H.R. 2749 requires food facilities, importers,
custom brokers, and filers to register with the Secretary
annually and to provide certain information related to the
entity. Facilities and importers are also required to pay an
annual registration fee in the amount of $500.
To increase the development and dissemination of food
safety information, H.R. 2749 requires the Secretary to enhance
food-borne illness surveillance systems, to design and
implement a national public education program on food safety,
and to conduct extensive food safety-related research.
H.R. 2749 provides the Secretary with enhanced enforcement
tools for food-related violations, including civil monetary
penalties, increased criminal penalties, and subpoena
authority.
Background and Need for Legislation
There is substantial evidence that the nation's food safety
system could be improved to better address potential food
safety threats. There has been a string of food-borne illness
outbreaks in recent years in foods consumed by millions of
Americans each day such as pistachios, peanuts, and spinach. As
numerous reports and congressional hearings have shown, the
ability of the Food and Drug Administration (FDA) to oversee
the safety of our food supply is compromised by inadequate
authorities and insufficient resources.\1\
---------------------------------------------------------------------------
\1\See, e.g., Food and Drug Administration, Science and Mission at
Risk, Report of the Subcommittee on Science and Technology (Nov. 2007)
(online at www.fda.gov/ohrms/dockets/ac/07/briefing/2007-
4329b_02_01_FDA%20Report%20on%20 Science%20and%20Technology.pdf); U.S.
Government Accountability Office, High Risk Series: An Update (Jan.
2009) (online at www.gao.gov/new.items/d09271.pdf); U.S. Government
Accountability Office, Food Safety: Improvements Needed in FDA
Oversight of Fresh Produce (Sept. 26, 2008) (online at www.gao.gov/
new.items/d081047.pdf); House Committee on Energy and Commerce,
Subcommittee on Oversight and Investigations, The Salmonella Outbreak:
The Continued Failure to Protect the Food Supply, 111th Cong. (Feb. 11,
2009) (online at http://energycommerce.house.gov/
index.php?option=com_content&task=view&id=1492&Itemid=95); House
Committee on Energy and Commerce, Subcommittee on Oversight and
Investigations, The Recent Salmonella Outbreak: Lessons Learned and
Consequences to Industry and Public Health (July 31, 2008); House
Committee on Energy and Commerce, Subcommittee on Oversight and
Investigations, American Lives Still at Risk: When Will FDA's Food
Protection Plan Be Fully Funded and Implemented? (June 12, 2008)
(online at http://energycommerce.house.gov/
index.php?option=com_content&task=view&id=1392&Itemid=106); House
Committee on Energy and Commerce, Subcommittee on Health, Discussion
Draft of the `Food and Drug Administration Globalization Act'
Legislation: Food Provisions (Apr. 24, 2008) (online at http://
energycommerce.house.gov/
index.php?option=com_content&task=view&id=655&Itemid=106).
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Legislative History
H.R. 2749 was introduced on June 8, 2009, by Chairman
Emeritus Dingell, Chairman Waxman, Subcommittee on Health
Chairman Pallone, and Reps. DeGette and Sutton. H.R. 2749
builds upon the food-related provisions in H.R. 759, the Food
and Drug Administration Globalization Act of 2009, introduced
by Chairmen Dingell, Pallone, and Stupak on January 28, 2009.
Prior to the bill's introduction, the Subcommittee on Health
held a legislative hearing on the discussion draft of the Food
Safety Enhancement Act of 2009 on June 3, 2009. There were
three hearings on food safety held in the 111th Congress by the
Subcommittee on Oversight and Investigations (February 11,
2009, and March 19, 2009) and by the Subcommittee on Health
(March 11, 2009). These hearings built upon the hearings held
in the 110th Congress on the safety of the nation's food
supply.
Committee Consideration
The Subcommittee on Health met in open markup session on
Wednesday, June 10, 2009, to consider H.R. 2749. An amendment
in the nature of a substitute, offered as a manager's amendment
by Chairman Pallone to H.R. 2749, made substantive changes to
the bill as introduced. The Pallone manager's amendment was
adopted by a voice vote. The Subcommittee favorably forwarded
H.R. 2749, amended, to the full Committee by a voice vote.
The Committee on Energy and Commerce met in open markup
session on Wednesday, June 17, 2009, to consider H.R. 2749, as
amended by the Subcommittee on Health on June 10, 2009. An
amendment in the nature of a substitute, offered by Mr. Waxman
as a manager's amendment, to the bill as forwarded by the
Subcommittee on Health, was adopted by a voice vote. H.R. 2749
was then ordered favorably reported to the House, amended, by a
voice vote.
Committee Votes
Clause 3(b) of rule XIII of the Rules of the House of
Representatives requires the Committee to list the record votes
on the motion to report legislation and amendments thereto. The
Committee agreed to a motion by Mr. Waxman to order H.R. 2749
favorably reported to the House, amended, by a voice vote.
There were no record votes during consideration of the
legislation.
Committee Oversight Findings and Recommendations
In compliance with clause 3(c)(1) of rule XIII and clause
2(b)(1) of rule X of the Rules of the House of Representatives,
the oversight findings and recommendations of the Committee are
reflected in the descriptive portions of this report.
New Budget Authority, Entitlement Authority, and Tax Expenditures
Regarding compliance with clause 3(c)(2) of rule XIII of
the Rules of the House of Representatives, the Committee adopts
as its own the estimate prepared on H.R. 2749 by the Director
of the Congressional Budget Office pursuant to section 402 of
the Congressional Budget Act of 1974.
Statement of General Performance Goals and Objectives
In accordance with clause 3(c)(4) of rule XIII of the Rules
of the House of Representatives, the performance goals and
objectives of the Committee are reflected in the descriptive
portions of this report.
Constitutional Authority Statement
Pursuant to clause 3(d)(1) of rule XIII of the Rules of the
House of Representatives, the Committee finds that the
constitutional authority for this legislation is provided in
Article I, section 8, clause 18 of the Constitution of the
United States.
Earmarks and Tax and Tariff Benefits
H.R. 2749 does not include any congressional earmarks,
limited tax benefits, or limited tariff benefits as defined in
clause 9(e), 9(f), or 9(g) of rule XXI of the Rules of the
House of Representatives.
Advisory Committee Statement
The Committee finds that the legislation does not establish
or authorize the establishment of advisory committees within
the definition of section 5 U.S.C. App., section 5(b) of the
Federal Advisory Committee Act.
Applicability of Law to the Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act of 1985.
Federal Mandates Statement
The Committee adopts as its own the estimates of federal
mandates on H.R. 2749 prepared by the Director of the
Congressional Budget Office pursuant to section 423 of the
Unfunded Mandates Reform Act.
Committee Cost Estimate
The Committee adopts as its own the cost estimate on H.R.
2749 prepared by the Director of the Congressional Budget
Office pursuant to section 402 of the Congressional Budget Act.
Congressional Budget Office Estimate
Pursuant to clause 3(c)(3) of rule XIII of the Rules of the
House of Representatives, the following is the cost estimate on
H.R. 2749 provided by the Congressional Budget Office pursuant
to section 402 of the Congressional Budget Act of 1974:
U.S. Congress,
Congressional Budget Office,
Washington, DC, July 24, 2009.
Hon. Henry A. Waxman,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for H.R. 2749, the Food
Safety Enhancement Act of 2009.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contact is Ellen Werble.
Sincerely,
Douglas W. Elmendorf.
Enclosure.
H.R. 2749--Food Safety Enhancement Act of 2009
Summary: H.R. 2749 would require the Department of Health
and Human Services (HHS) to strengthen federal efforts related
to ensuring the safety of commercially distributed food. H.R.
2749 would also broaden the Food and Drug Administration's
(FDA's) authority to regulate food products, and would require
the agency to assess fees on food facilities, as well as
importers and exporters of food products to cover the costs of
registering and inspecting facilities authorized in the bill.
Such fees could be collected and made available for obligation
only to the extent and in the amounts provided in advance in
appropriations acts.
CBO estimates that:
Implementing the bill would increase
spending subject to appropriation, on net, by about
$2.0 billion over the 2010-2014 period, assuming annual
appropriation action consistent with the bill; and
Federal revenues from civil penalties for
food related violations of the Federal Food, Drug, and
Cosmetic Act would increase by $10 million over the
2010-2014 period and by $20 million over the 2010-2019
period.
H.R. 2749 would impose a number of mandates, as defined in
the Unfunded Mandates Reform Act (UMRA), on individuals and
entities involved in producing, manufacturing, processing,
packing, transporting, distributing, receiving, holding,
importing, or exporting articles of food. CBO estimates that
the total cost of those mandates would exceed the threshold
established in UMRA for private-sector entities ($139 million
in 2009, adjusted annually for inflation) in each year,
beginning with 2010. Given the limited number of public
entities affected by the requirements, CBO estimates that the
costs of intergovernmental mandates would fall below the
threshold established in UMRA ($69 million in 2009, adjusted
annually for inflation).
Estimated cost to the Federal Government: The estimated
budgetary impact of H.R. 2749 is shown in the following table.
The costs of this legislation fall within budget function 550
(health).
----------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
-------------------------------------------------------------
2010 2011 2012 2013 2014 2010-2014
----------------------------------------------------------------------------------------------------------------
CHANGES IN SPENDING SUBJECT TO APPROPRIATION
Food and Drug Administration (FDA):
Collection of New Fees:
Estimated Authorization Level............. -209 -241 -290 -333 -368 -1,441
Estimated Outlays......................... -209 -241 -290 -333 -368 -1,441
Spending of New Fees:
Estimated Authorization Level............. 209 241 290 333 368 1,441
Estimated Outlays......................... 66 199 309 352 372 1,298
Net Changes from Fee Authority:
Estimated Authorization Level............. 0 0 0 0 0 0
Estimated Outlays......................... -143 -43 19 19 4 -144
FDA Activities Not Supported by Fees:
Estimated Authorization Level................. -35 4 459 777 1,109 2,314
Estimated Outlays............................. -35 -9 368 749 1,084 2,157
Total Changes in Spending Subject to
Appropriation:
Estimated Authorization Level................. -35 4 459 777 1,109 2,314
Estimated Outlays............................. -178 -51 387 768 1,088 2,014
CHANGES IN REVENUES
Estimated Revenues from Civil Penalties........... 2 2 2 2 2 10
----------------------------------------------------------------------------------------------------------------
Note: Components may not sum to totals because of rounding.
Basis of estimate: For this estimate, CBO assumes that H.R.
2749 will be enacted near the start of fiscal year 2010, that
the full amounts authorized will be collected (starting in
fiscal year 2010) to fund FDA's regulatory activities
authorized under the bill, and that outlays will follow
historical patterns for similar activities.
H.R. 2749 would broaden the FDA's authority to regulate
food facilities. Such authority would include:
Mandating the annual registration of all
establishments that import, export, manufacture,
process, pack, or hold food for consumption in the
United States, and specifying certain inspection,
recordkeeping, and reporting requirements for such
facilities;
Requiring any person who produces,
manufactures, processes, packs, transports,
distributes, receives, imports, or holds an article of
food to permit an officer or employee designated by the
Secretary of HHS to have access to their records
relating to articles of food that may be adulterated,
misbranded, or otherwise in violation of the Federal
Food, Drug, and Cosmetic Act;
Requiring any food facility that violates a
food-related requirement of the Federal Food, Drug, and
Cosmetic Act that consequently requires a reinspection
or food recall shall pay a fee to cover the costs of
the reinspection or food recall; and
Reviewing and evaluating epidemiological
data every two years to identify the most significant
food-borne contaminants and resulting hazards, and
setting national performance standards to minimize the
occurrence of such hazards, and establishing national
standards for risk-based preventive controls, hazard
analysis, safe growing, harvesting, processing,
packing, sorting, transporting, and holding of raw
agricultural products.
H.R. 2749 also would require the FDA to inspect registered
food facilities on a risk-based schedule beginning no later
than 18 months after enactment. The Secretary of Health and
Human Services may recognize federal, state, and local
officials, and agencies and representatives of foreign
countries to conduct inspections. The frequency of the
inspections shall be determined by the category of the
facility:
A category 1 facility is a high-risk
facility that manufactures or processes food and must
be inspected at least once every 6 to 12 months;
A category 2 facility is a low-risk facility
that manufactures or processes food and must be
inspected at least every 18 months to 3 years; and
A category 3 facility is a facility that
holds food and must be inspected at least every 5
years.
Based on information from the FDA, CBO estimates this bill
would require about 360,000 domestic and foreign food
facilities be inspected on a risk-based frequency schedule.
This estimate assumes the magnitude of the inspections required
in the risk-based inspection schedule will lead the FDA to
recognize agencies and representatives of foreign countries to
help fulfill the bill's requirements for inspection frequency.
The bill also would require the Secretary of HHS to design
and implement a tracing system for food located in the United
States or for import into the country. The bill would
explicitly exempt all food products and facilities regulated by
the Secretary of Agriculture under the Federal Meat Inspection
Act, the Poultry Products Inspection Act, or the Egg Products
Inspection Act from the requirements in H.R. 2749.
Spending subject to appropriation
CBO estimates that implementing H.R. 2749 would increase
spending subject to appropriation, on net, by $2.0 billion over
the 2010-2014 period, assuming appropriation action consistent
with the bill. The effect on discretionary spending by federal
programs reflects the authorized funding relating to the
federal regulation of food products.
The gross costs for FDA to administer the new regulatory
activities authorized under the legislation--about $3.5 billion
over the 2010-2014 period--would be partially covered by fees
assessed on registered food facilities, importers, and
exporters.
Collection of new fees
H.R. 2749 would amend and modify the Federal Food, Drug,
and Cosmetic Act to authorize the FDA to collect fees to help
defray some of FDA's costs of performing food safety
activities. The bill would create two new fee programs: a
facility reinspection and recall fee program, and an importer
registration fee program. The bill also would amend two current
categories of fees: food facility registration fees, and export
certification fees.
Under current law, both domestic and foreign food
facilities are required to register with the FDA; however,
periodic renewal is not required and the FDA does not have
authority to collect fees. The bill would mandate annual
registration for all food facilities and require an annual fee
of $500 adjusted for inflation. The legislation also would
authorize the FDA to collect fees for food (including animal
feed) export certificates under the current export
certification program. Fees authorized by the bill would be
collected and made available for obligation only to the extent
and in the amounts provided in advance in appropriations acts.
As a result, those collections would be credited as an offset
to discretionary spending.
Spending of fees by FDA to regulate food products
Spending of the new fees assessed by FDA to regulate food
products would be classified as discretionary spending because
the authorized amounts would be available for obligation
subject to appropriation action. Amounts collected would be
available to cover FDA's administrative costs to regulate food
products at any point in the future.
Importer registration fees could only be collected and made
available to defray the costs of registering importers and
enforcing compliance with good importer practices. Export
certification fees could only be collected and made available
to cover the cost of issuing such certifications. Reinspection
and recall fees could also only be collected and made available
to cover the costs of such activities. The fees program for
food facility registration could be collected and made
available to defray the costs of food safety activities, which
are defined in the bill as expenses incurred in connection with
food safety activities.
Assuming appropriation action consistent with the bill, CBO
estimates that implementing the program to assess fees to cover
new FDA costs associated with regulating food products would
increase collections and subsequent spending of those fees by
about $1.4 billion over five years, and would result in a net
decrease in discretionary outlays of about $140 million over
the 2010-2014 period. (Spending of fees would lag slightly
behind their collection.)
FDA activities not supported by fees
Because of the magnitude of the inspections required under
the bill, CBO estimates the fees collected would not offset all
of the costs of the new requirements. The net additional
inspections and administrative activities not covered by fees
would increase discretionary outlays, on net, by $2.2 billion
over five years. This amount incorporates savings to the FDA
for food safety activities conducted under current law that
would be replaced by fees in the bill. For example, in 2010,
CBO anticipates the FDA will save $35 million relative to its
current appropriation level for activities that would be funded
through new fees.
Revenues
The bill would expand the FDA's authority to assess civil
penalties for food related violations of the Federal Food,
Drug, and Cosmetic Act. Such violations include the
introduction into interstate commerce of certain adulterated or
misbranded foods. Based on information provided by the FDA
regarding recent enforcement activity, CBO estimates that the
bill would increase revenues from civil penalties by $20
million over the 2010-2019 period.
The bill could also increase revenues from criminal
penalties, which are recorded as revenues, deposited in the
Crime Victims Fund, and later spent. CBO expects that any
additional revenues from criminal penalties would not be
significant.
Intergovernmental and Private-Sector Impact: H.R. 2749
would impose a number of mandates, as defined in the UMRA, on
individuals and entities involved in producing, manufacturing,
processing, packing, transporting, distributing, receiving,
holding, importing, or exporting articles of food. CBO
estimates that the total cost of those mandates would exceed
the threshold established in UMRA for private-sector entities
($139 million in 2009, adjusted annually for inflation) in each
year, beginning with 2010. Given the limited number of public
entities affected by the requirements, CBO estimates that the
costs of intergovernmental mandates would fall below the
threshold established in UMRA ($69 million in 2009, adjusted
annually for inflation).
The bill would require facilities engaged in manufacturing,
processing, packing, or holding food for consumption in the
United States or export to other countries to register with the
Secretary of HHS and pay an annual fee. Under current law, all
of those facilities are required to register with the Secretary
except for facilities holding food for export, but the annual
fee would be a new requirement. CBO estimates fees would total
almost $210 million in 2010 and rise to almost $370 million by
2014. The costs of those payments alone would exceed the
threshold established by UMRA.
The bill also would place new requirements on entities
involved in producing, manufacturing, processing, packing,
transporting, distributing, receiving, holding, importing, or
exporting articles of food. In general, the costs of those
mandates on the private sector would depend on future guidance
and regulations established by the Secretary. For example, the
Secretary would be required to develop science- and risk-based
standards, to establish a tracing system for food located in
the United States or for import into the country, and to
develop safety and security guidelines for the importation of
food. It is unclear how those requirements would be implemented
and how they would affect the food industry. Therefore, CBO
cannot estimate the cost to private entities of those
provisions.
The bill would require owners, operators, and agents of
facilities to conduct hazard analyses, implement and monitor
preventive controls, institute corrective actions when
necessary, repeat hazard analyses at least every two years, and
maintain records of these activities. They also would have to
develop food safety plans that outline how facilities would
meet these requirements. High-risk facilities that manufacture
or process food, also referred to as ``category 1 facilities,''
would be required to test finished products for the presence of
contaminants and submit the results of the tests to the
Secretary. The Secretary would have the option to establish
guidance or regulations, which would determine the extent of
the requirements for complying with these provisions of the
legislation.
The bill also would require entities, among other things,
to be prepared to present all records related to the
production, manufacture, processing, packing, transporting,
distribution, receipt, holding or importation of an article of
food; to report to a food registry; to use accredited
laboratories recognized by the Secretary for analytical testing
of an article of food; to notify the Secretary of the identity
and location of an article of food that is believed to be
adulterated or misbranded; to maintain records with respect to
infant formula for at least one year after the expiration of
the shelf life; and to identify the country in which the final
processing occurred and for unprocessed food to identify the
country of origin of the food. Under current law, many entities
may already have the capability to meet some of those
requirements, but entities such as farms and restaurants that
are not currently subject to any of those requirements
previously could incur significant costs to comply with their
respective mandates.
Mandates in the bill would extend to some public entities,
including public colleges and universities that operate farms
and a limited number of tribal entities that produce and
package food items for resale. Given the limited number of
public entities affected, however, CBO estimates that the costs
of the mandates would fall below the intergovernmental
threshold ($69 million in 2009, adjusted annually for
inflation).
Estimate prepared by: Federal Spending: Ellen Werble,
Rebecca Yip; Federal Revenues: Zachary Epstein; Impact on
State, Local, and Tribal Governments: Leo Lex; Impact on the
Private Sector: Keisuke Nakagawa.
Estimate approved by: Peter H. Fontaine, Assistant Director
for Budget Analysis.
Section-by-Section Analysis of the Legislation
Section 1. Short title
The short title is designated as the ``Food Safety
Enhancement Act of 2009''.
Section 2. Table of contents
Section 2 provides the table of contents.
Section 3. References
Section 3 establishes that unless otherwise specified,
amendments made to a section or other provisions are considered
to be made to a section or provision of the Federal Food, Drug,
and Cosmetic Act (FFDCA).
Section 4. Rules of construction
Section 4 establishes that the Food Safety Enhancement Act
of 2009 shall not be construed as modifying or otherwise
affecting any action or the liability of any person under the
law of any State.
Section 4 further establishes that the Food Safety
Enhancement Act of 2009 shall not be construed to alter the
jurisdiction between the Secretary of Agriculture and the
Secretary of Health and Human Services; to limit the authority
of the Secretary of Health and Human Services to issue
regulations related to the safety of food under the Federal
Food, Drug, and Cosmetic Act or the Public Health Service Act;
or to 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, the
Poultry Products Inspection Act, or the Egg Products Inspection
Act.
Section 5. USDA exemptions
Section 5 clarifies the effect of the Food Safety
Enhancement Act of 2009 on USDA-regulated foods, farms, and
facilities.
A food is exempt from the requirements of the Food Safety
Enhancement Act of 2009 if such food is regulated by the
Secretary of Agriculture under the Federal Meat Inspection Act,
the Poultry Products Inspection Act, or the Egg Products
Inspection Act.
A facility is exempt from the requirements of this Act if
such facility is regulated exclusively 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.
A farm is exempt from the requirements of this Act to the
extent that such farm raises animals from which food is derived
that is regulated by the Secretary of Agriculture under the
Federal Meat Inspection Act, the Poultry Products Inspection
Act, or the Egg Products Inspection Act. The portions of a farm
that produce FDA-regulated foods are covered by the provisions
of the bill.
Section 6. Alcohol-related facilities
Section 6 establishes that an alcohol-related facility that
is required to register as a facility under section 415 of the
Federal Food, Drug, and Cosmetic Act, as amended by this Act,
solely because such facility is engaged in manufacturing,
processing, packing, or holding one or more alcoholic
beverages, is not subject to the requirements of the Food
Safety Enhancement Act of 2009 if such facility is required to
obtain a permit or to register with the Secretary of the
Treasury as a condition of doing business. Such facility is,
however, still subject to the registration requirements set
forth in section 101 (a) and (b) of the Food Safety Enhancement
Act of 2009 and may participate in the Safe and Secure Food
Importation Program established under section 113 of the Act.
Section 6 shall not be construed to exempt any food, apart
from alcoholic beverages, from the requirements of the FSEA.
TITLE I--FOOD SAFETY
Subtitle A--Prevention
Section 101. Changes in registration of food facilities
Section 101 amends section 415 of the FFDCA to require
annual facility registration. Registrants are required to
provide additional information pertaining to the facility,
including contact information, the primary purpose and business
activity of the facility, all trade names under which the
facility conducts business related to food, and for foreign
facilities, the United States agent for the facility. The
registrant is required to notify the Secretary of any change in
the submitted information no later than 30 days after the date
of such change.
The Committee does not intend to alter FDA's current
regulatory definition of ``facility'' governing which entities
must register. For example, the Committee believes that any
storage facility located on a farm does not need to be
registered with the FDA if the commodities stored in such
facility originate on that farm or another farm under the same
ownership.
The Secretary is authorized to suspend the registration of
a facility for a violation of the Act that could result in
serious adverse health consequences or death. The Secretary is
also granted authority to cancel a registration that the
Secretary determines was not updated or otherwise contains
false, incomplete, or inaccurate information, or if the
required registration fee has not been paid within 30 days
after the due date. However, an order to suspend or cancel a
registration shall not be delegated to any officer or employee
other than the Commissioner, the Principal Deputy Commissioner,
the Associate Commissioner for Regulatory Affairs, or the
Director for the Center for Food Safety and Applied Nutrition.
The Secretary is required to provide a report to Congress
annually detailing the number and type of facilities registered
under this section.
Section 101 requires the Secretary to assess and collect an
annual fee of $500 for the registration of a facility under
section 415 of the FFDCA. The fee shall be collected and
available to defray the costs of food safety activities
(activities related to compliance by facilities registered
under section 415 with the requirements of this Act relating to
food). The registration fee shall not exceed $175,000 for an
individual company. The Secretary is required to hold a public
meeting to allow stakeholders to provide input into how the fee
revenue will be allocated.
The bill provides that revenues generated by new
registration fees be directed to specified food safety
activities. Because an effective food safety program must be a
combined effort of the scientific and regulatory food safety
activities of the Center for Food Safety and Applied Nutrition
(CFSAN) and support for the food safety inspection-related
activities of the Office of Regulatory Affairs (ORA), the
Committee expresses its intent that the agency give highest
priority for use of these funds to activities that directly
support implementation of this bill, including: (1) regulations
and guidance, particularly with respect to hazard analyses,
preventive controls, and food safety plans, both with respect
to packaged food and to fresh produce; (2) risk assessment
activities underlying development of performance standards; (3)
information gathering steps prior to developing regulations on
traceability and reporting results of finished product testing,
including required pilot projects, technology assessments, and
feasibility studies; (4) maintenance of an enhanced
registration system; (5) maintenance of an up-to-date
reportable food registry; (6) information technology systems to
support domestic and import inspectional activities; (7)
scientific equipment to conduct needed research and perform
product sampling; (8) training of agency and state officials in
the proper conduct of inspectional activities; (9) development
of an expedited safe and secure importation program; (10)
surveillance, public education, and research activities in
support of improving food safety; (11) review of infant formula
and GRAS submissions; and (12) creation and implementation of a
risk-based inspection schedule.
The bill seeks to ensure that the revenues collected from
registration fees be additive to the existing FDA appropriated
resource base for food safety activities, adjusted for
inflation in future years, and that funds from food safety-
related activities not be redirected to meet responsibilities
of other FDA programs. The bill seeks to accomplish this by
stating that user fees may not be collected in any fiscal year
in which the salaries and expenses for the Food and Drug
Administration do not equal that for fiscal year 2010, adjusted
for inflation.
Section 102. Hazard analysis, risk-based preventive controls, food
safety plan, finished product test results from category 1
facilities
Section 102 requires the owner, operator, or agent of a
facility to develop and implement a written food safety plan.
As part of this food safety plan, the owner, operator, or agent
shall conduct a hazard analysis; identify and implement
effective preventive controls; monitor preventive controls;
institute corrective actions when monitoring shows that
preventive controls have not been properly implemented or were
ineffective; conduct verification activities; maintain records
of monitoring, corrective action, and verification; and
reanalyze for hazards. The food safety plan shall also include
a description of the facility's procedures for recordkeeping;
recall; trace back; supply chain safety; and science-based
performance standards. When developing food safety plans under
Section 102, facilities should evaluate whether there are
hazards that could affect the safety, sanitation, or
wholesomeness of the food manufactured, processed, packed,
transported, or held by the facility. This analysis should
include consideration of biological, chemical, physical, and
radiological hazards, natural toxins, pesticides, drug
residues, filth, decomposition, parasites, allergens, and
unapproved food and color additives, and should include
consideration of such contamination on surfaces or in the air
or from other possible vectors.
The requirements of this section shall take effect 18
months after the date of enactment. Small businesses and very
small businesses will have 2 years and 3 years, respectively,
to comply.
Section 102 also requires certain high-risk facilities to
submit finished product test results documenting the presence
of contaminants in food posing a risk of severe adverse health
consequences or death. Before requiring the reporting of such
test results, the Secretary must conduct two or more pilot
projects and a study to evaluate the feasibility of such a
reporting system.
Section 103. Performance standards
Section 103 requires the Secretary, not less frequently
than every 2 years, to identify the most significant food-borne
contaminants and the most significant resulting hazards. The
Secretary shall issue science-based performance standards, as
appropriate, to minimize to an acceptable level, prevent, or
eliminate the occurrence of such hazards.
Section 103 also requires the Secretary to 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 is required to consider the number and
severity of illnesses and the number of deaths associated with
the foods associated with such contaminants.
Section 104. Safety standards for produce and certain other raw
agricultural commodities
Section 104 requires the Secretary to establish by
regulation science-based standards for the safe growing,
harvesting, packing, sorting, transporting, and holding of raw
agricultural commodities for which the Secretary has determined
that such standards minimize the risk of serious adverse health
consequences or death to humans or animals. The Secretary shall
provide a reasonable period of time for compliance, taking into
account the needs of small business for additional time to
comply.
Section 104 requires the Secretary, in issuing the
regulations under this section, to take into consideration,
consistent with ensuring enforceable public health protection,
the impact of any regulations issued under this section on
small-scale and diversified farms, and on wildlife habitat,
conservation practices, water-shed protection efforts, and
organic production methods. The Secretary is permitted to
provide for coordination with other entities and provide for
recognition through guidance of other existing publicly
available procedures, processes, and practices that the
Secretary determines to be equivalent to the goals established
under this section.
Section 104 requires the Secretary to update the guidance
document entitled ''Guidance for Industry: Guide to Minimize
Microbial Food Safety Hazards for Fresh Fruits and
Vegetables.''
Section 105. Risk-based inspection schedule
Section 105 requires that each facility registered under
section 415 be inspected by the Secretary, by a federal, state,
or local official in the case of a domestic facility, or by an
agency or representative of a country in the case of a foreign
facility, according to a risk-based schedule. The risk-based
schedule shall be implemented not later than 18 months after
enactment and 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:
Category 1 (high-risk)--the Secretary shall randomly
inspect a category 1 food facility at least every 6 to 12
months.
Category 2 (low-risk)--the Secretary shall randomly inspect
a category 2 facility at least every 18 months to 3 years.
Category 3 (facility that holds food)--the Secretary shall
randomly inspect a category 3 facility at least every 5 years.
Section 105 requires the Secretary to provide an annual
report to Congress on the number of facilities inspected and
the costs of implementing the risk-based inspection schedule
for the preceding 12 months. In the third year after enactment,
the Secretary is also required to submit to Congress a report
describing recommendations on the risk-based inspection
schedule, including recommendations for adjustments to the
timing of the schedule. In making recommendations to change the
inspection schedule, the Secretary shall consider the nature of
the food products being processed, stored, or transported; the
manner in which food products are processed, stored, or
transported; the inherent likelihood that the products will
contribute to the risk of food-borne illness; the best
available evidence concerning reported illnesses associated
with the foods processed, stored, held, or transported in the
category of facilities; and 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.
Six months after submitting the Third-Year Report, the
Secretary may implement the adjustments to the inspection
schedule recommended in the Third-Year Report with respect to
category 2 and category 3 facilities only. The new inspection
schedule and a justification for the changes must be published
in the Federal Register.
Section 106. Access to records
Section 106 requires each person who produces,
manufactures, processes, packs, transports, distributes,
receives, or holds an article of food in the United States or
for import into the United States to permit an officer or
employee duly designated by the Secretary 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 during an inspection.
If the Secretary has a reasonable belief that an article of
food presents a threat of serious adverse health consequences
of death to human or animals, the Secretary is authorized to
remotely access records reasonably related to that food. The
Secretary may also remotely access records related to 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
within the preceding two years. The Committee expects FDA, when
notifying the company of the need for such ``remote access'' to
records, to specify which types of food safety records FDA
seeks, including for what product(s) and over what time frame.
This will ensure that the records collection process is
properly tailored to assist FDA in its investigation and that
the agency will not waste time sorting through a broader array
of records that are not pertinent to its investigation.
This authority is intended to provide FDA with a mechanism
to gain a better understanding of a facility's food safety
program, but it is not intended as a substitute for an on-site
inspection. The Committee expects that FDA would use this
authority as an initial survey and triage tool, to help the
agency prioritize which facilities to inspect and where to
focus the inspection, when conducted. The Committee underscores
the importance of on-site inspections for FDA to have a clear
and complete understanding of the facility's food safety
program.
The Committee recognizes that large document productions
are not the most efficient way to provide FDA with information,
and that additional mechanisms are needed if FDA is to
accomplish its public health goal in a timely way. Therefore,
it is the Committee's view that when FDA believes it can
accomplish its goal of conducting smarter investigations by
first sending a food company written questions for the company
to answer, with a request for supporting documentation, as
needed, it should do so. The Committee expects companies to
respond in a timely manner to FDA's questions by providing
information reasonably known at the time. The Committee expects
companies to supply such information as soon as reasonably
possible. The Committee's goal is to facilitate good
communication between FDA and the company to help FDA determine
whether appropriate preventive controls are in place, whether
there is a need for additional preventive controls, guidance,
or regulations, and what circumstances caused food
contamination. This provision should be applied by FDA with
that goal in mind.
Section 106 allows the Secretary to establish requirements
regarding the establishment and maintenance, for not longer
than three years, of records by persons who produce,
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 section. The
Secretary is only authorized to require restaurants to maintain
distribution records showing their suppliers, and subsequent
distribution other than to consumers.
Section 107. Traceability of food
Section 107 requires the Secretary to establish, by
regulation, a tracing system for food that is located in the
United States or is for import into the United States. Before
issuing a proposed regulation, the Secretary shall conduct
information gathering to (1) identify technologies and
methodologies for tracing to enable each person who produces,
manufactures, processes, packs, transports, or holds a food to
maintain the full pedigree of the origin and previous
distribution history of the food, link that history with the
subsequent distribution of the food, establish and maintain a
system for tracing the food that is interoperable with the
systems established and maintained by other such persons, and
to use a unique identifier; and (2) to the extent practicable,
assess the costs and benefits associated with the adoption of
such technologies, the feasibility of such technologies for
different sectors for the food industry, and whether such
technologies are compatible with the requirements of this
subsection.
Section 107 requires the Secretary to take into account
information obtained through the information gathering process,
and to conduct at least two public meetings and one or more
pilot projects. After completing this public input process, the
Secretary shall issue proposed regulations establishing a
tracing system that enables the Secretary to identify each
person who grows, produces, manufacturers, processes, packs,
transports, holds or sells such food in as short a timeframe as
practicable, but in no longer than two business days. The
Secretary may include in such regulation: the establishment and
maintenance of lot numbers; a standardized format for pedigree
information; and the use of a common nomenclature for food.
Food produced on a farm or a fishery and sold directly to a
consumer, restaurant, or grocery store is exempt from the
tracing system requirements, although restaurants and grocery
stores must keep records documenting the farm that was the
source of the food. The Secretary is also granted authority to
exempt a food or type of facility from the tracing system
requirements if the Secretary determines application of these
requirements is not necessary to protect the public health. For
a food so exempted, each person who produces, manufactures,
processes, packs, transports, or holds such food is required to
maintain records to identify the immediate previous sources of
such food and its ingredients and the immediate subsequent
recipients of such food.
Section 108. Reinspection and food recall fees applicable to facilities
Section 108 requires the Secretary to assess and collect
fees from each facility in a fiscal year that undergoes
additional inspection by the FDA due to a violation of any
requirement of the Federal Food, Drug, and Cosmetic Act or is
subject to a recall.
Section 108 establishes that there will be an exemption
from the fees for a recall that FDA inappropriately ordered.
Section 109. Certification and accreditation
Section 109 establishes that certain imported foods be
accompanied by a certification that the food complies with
specified requirements of the Federal Food, Drug, and Cosmetic
Act. The Secretary shall require certification for food
imported from a particular country or region if certification
would assist the Secretary in determining whether to refuse to
admit such article; for a type of food that could pose a
significant risk to health, certification would assist the
Secretary in determining whether such article poses such risk;
or for an article imported from a particular country, there is
an agreement between the Secretary and the government of such
country providing for such certification. Certifications under
this section must be provided by a ``qualified certifying
entity.'' A qualified certifying entity may be an agency or a
representative of the government of the country from which the
article originated, an individual or entity determined by the
Secretary, or an accredited body recognized by the Secretary.
The Secretary is required to issue regulations to ensure that
any qualified certifying entity and its auditors are free from
conflicts of interest.
Section 110. Testing by accredited laboratories
Section 110 requires that whenever analytical testing of an
article of food is conducted as part of testimony in a food
import detention hearing or for other purposes as the Secretary
deems appropriate, such testing shall be conducted by a
laboratory that is accredited for the analytical method used,
by a laboratory accreditation body that has been recognized by
the Secretary; and samples such article with adequate controls
for ensuring the integrity of the samples analyzed. When
testing is required for purposes of a food import detention
hearing, in response to a finding of non-compliance by the
Secretary, or for certain products designated by the Secretary,
the test must be conducted by an accredited, independent
laboratory that is independent of the person on whose behalf
such testing is being conducted.
The Secretary shall establish and implement a program for
the recognition of laboratory accreditation bodies that
accredit laboratories to perform analytical testing for the
purposes of this section.
Whenever such analytical testing is conducted, the
laboratory conducting such testing shall submit, directly to
the Secretary the results of all analyses conducted by the
laboratory on each sample of such article; and all information
the Secretary deems appropriate to determine whether the
laboratory is accredited by a recognized laboratory
accreditation body, identify the article tested, evaluate the
analytical results, and determine whether the requirements of
this section have been met.
Section 111. Notification, nondistribution, and recall of adulterated
or misbranded food
Section 111 requires food facilities, importers, customs
brokers, and filers that have reason to believe that an article
of food is adulterated or misbranded in a manner that presents
a reasonable probability that the use or consumption of, or
exposure to, the article will cause a threat of serious adverse
health consequences or death to humans or animals to notify the
Secretary of the identity and location of the article as soon
as practicable.
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 recall such article.
The Secretary shall have the authority to issue an order
requiring any person who distributes an article of food to
immediately cease distribution of such article if the Secretary
has reason to believe that the use or consumption of, or
exposure to, the article of food may cause serious adverse
health consequences or death to humans or animals. The person
subject to the order may appeal the order and request an
informal hearing. 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. Only the
Secretary or an official designated by the Secretary may order
the recall. 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, nor is an official
senior to such director.
If the Secretary has a reasonable belief that an article of
food subject to an order to cease distribution presents an
imminent threat of serious health consequences or death to
humans or animals, the Secretary may issue an emergency recall
order requiring any person who distributes such article to
immediately recall such article. An informal hearing shall be
granted following the cease distribution and emergency recall.
Section 111 requires that an emergency recall order come from
the FDA Commissioner, Principal Deputy Commissioner or
Associate Commissioner for Regulatory Affairs.
Section 112. Reportable food registry; exchange of information
Section 112 amends section 417 of the Federal Food, Drug,
and Cosmetic Act to require an owner of a food facility, farm,
or restaurant to submit a report to FDA following a timely
review of any reasonably available data and information and a
determination that there is a reasonable probability that use
of, or exposure to, a particular article of food will cause
serious adverse health consequences or death to humans or
animals. Section 112 requires the report to also include
analytical results from testing of such article and such
additional information as the Secretary deems appropriate.
Section 112 requires the Secretary to make available other
means of reporting for restaurants and other retail food
establishments that have limited ability to report via
electronic means.
Section 112 authorizes the Secretary to share certain
confidential information relating to food with any federal
agency, state, local, or foreign government, or any person.
This information shall not be publicly disclosed.
Section 113. Safe and secure food importation program
Section 113 permits the Secretary to establish by
regulation or guidance a program to facilitate the movement of
food through the importation process if the importer of such
food verifies that each facility involved in the production,
manufacture, processing, packaging, and holding of the food has
been determined to be in compliance with food safety and
security guidelines developed by the Secretary.
Section 114. Infant formula
Section 114 requires that no person shall introduce or
deliver for introduction into interstate commerce infant
formula prior to receiving a letter from the Secretary
informing such person that the following have been satisfied:
(1) the registration requirement and (2) a demonstration that
the infant formula satisfies the quality factor requirements
established by the Secretary. The Committee anticipates that
the language of this section will change as this legislation
moves through the legislative process.
Subtitle B--Intervention
Section 121. Surveillance
Section 121 requires the Secretary to enhance the current
food safety surveillance systems to include the collection,
analysis, reporting, and usefulness of data on food-borne
illnesses by coordinating federal, state, and local
surveillance systems, and increasing participation in national
networks of public health and food regulatory agencies and
laboratories; facilitating the timely sharing of food safety
findings and data with the public; developing improved
epidemiological tools for obtaining better data; improving
attribution of a food-borne illness outbreak to a specific
food; expanding capacity of surveillance systems to identify
new or rarely documented causes of food-borne illness; and
other activities deemed appropriate by the Secretary. Section
121 requires the Secretary to develop and implement strategies
to leverage and enhance the food safety and defense capacities
of State and local agencies.
Section 122. Public education and advisory system
Section 122 requires the Secretary, in collaboration with
private and public organizations, to design and implement a
national public education program on food safety that would
educate the public on how to reduce their risk of food-borne
illness and injury and provide information to health care
professionals to improve diagnosis and treatment of food-borne
illnesses. This section also directs the Secretary to work with
the states and other entities to develop and distribute
regional and national advisories concerning food safety;
develop standardized formats for written and broadcast
advisories; and incorporate State and local advisories into the
national public education program.
Section 123. Research
Section 123 requires the Secretary to conduct research to
assist in the implementation of the Food Safety Enhancement Act
of 2009, including studies to improve sanitation and food
safety practices; develop improved monitoring and inspection
techniques; develop rapid and sensitive food testing methods;
determine the sources of food contamination, including critical
points of risk for fresh produce and other raw agricultural
commodities; develop consumption data for food products;
utilize DNA matching systems to identify and control pathogens;
address common and emerging zoonotic diseases; develop methods
to destroy pathogens before, during, and after processing; and
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.
Subtitle C--Response
Section 131. Procedures for seizure
Section 131 amends section 304 of the FFDCA to stipulate
that with respect to seizure proceedings relating to food, Rule
G of the Supplemental Rules of Admiralty or Maritime Claims and
Asset Forfeiture Actions shall not apply.
Section 132. Administrative detention
Section 132 amends section 304 of the Federal Food, Drug,
and Cosmetic Act to allow an official or qualified employee of
the FDA to order the detention of any article of food if they
have reason to believe that such article is adulterated,
misbranded, or otherwise in violation of this Act.
Section 132 extends the time period during which a food may
be detained from 30 to 60 days, and extends from 5 to 15 days
the deadline for an informal hearing when such detention is
challenged.
Section 133. Quarantine authority for foods
Section 133 permits the Secretary authority to quarantine
any geographic area within the United States if the Secretary
determines that there is credible evidence or information that
an article of food that is located in such area presents an
imminent threat of serious adverse health consequences or death
to humans or animals. The authority to quarantine includes
prohibiting or restricting the movement of food or of any
vehicle being used to hold such food.
Before exercising authority to quarantine a geographic
area, the Secretary is required to notify an appropriate
official of the state affected and to issue a public
announcement of the Secretary's findings that support the
action; the area affected by the intended quarantine; the
reasons for the quarantine; and where practicable, an estimate
of the anticipated duration of the quarantine.
Section 133 requires that a quarantine order must come from
the FDA Commissioner, Principal Deputy Commissioner, or
Associate Commissioner for Regulatory Affairs.
Section 134. Criminal penalties
Section 134 amends section 303 of the Federal Food, Drug,
and Cosmetic Act to require that any person who knowingly
violates section 301 of the FFDCA 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.
Section 135. Civil penalties for violations relating to food
Section 135 amends section 303 of the FFDCA to require that
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 $20,000 in the case of an
individual, not to exceed $50,000 in a single proceeding;
$250,000 in the case of any other person, not to exceed
$1,000,000 in a single proceeding. 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 $50,000 in the case of an individual, not to exceed
$100,000 in a single proceeding; and $500,000 in the case of
any other person, not to exceed $7,500,000 in a single
proceeding.
Section 136. Improper import entry filings
Section 136 makes the submission of information relating to
imported food that is inaccurate or incomplete, or the failure
to submit information that is required to be submitted related
to imported food a prohibited act. Section 136 allows the
Secretary to require the submission of documentation or other
information for articles of food that are imported or offered
for import into the United States.
TITLE II--MISCELLANEOUS
Section 201. Food substances generally recognized as safe
Section 201 requires the Secretary to post on FDA's website
a ``generally recognized as safe'' (GRAS) determination as well
as the supporting scientific justifications no later than 60
days after receipt by the Secretary of such determination.
Section 202. Country of origin labeling; disclosure of source of
ingredients
Section 202 requires that all processed food labels
identify the country in which the final processing occurred. If
the label of a processed food is already in compliance with
country of origin requirements from the U.S. Customs and Border
Protection, the food will be deemed in compliance with this
section. All non-processed foods must be labeled with the
country of origin of the food. If a non-processed food already
lists the country of origin pursuant to farm bill requirements,
the food will be deemed in compliance with this section.
Section 203. Exportation certificate program
Section 203 authorizes the Secretary to impose a fee for
the issuance of export certificates for foods and animal feeds.
Such fee shall not exceed such amount as the Secretary
determines is reasonably related to the cost of issuing
certificates with respect to the export of food and animal
feed.
Section 204. Registration for commercial importers of food; fee
Section 204 requires all importers of foods to register
with the FDA annually and to pay a registration fee in the
amount of $500. An importer that is also a registered facility
under section 101 is subject to only one fee. Each registered
importer must comply with good importer practices, which the
Secretary must establish through regulation. The Secretary may
suspend an importer's registration, after notice and
opportunity for an informal hearing, if the importer is found
in violation of the Federal Food, Drug, and Cosmetic Act, or
found to have knowingly or repeatedly made inaccurate or
incomplete statements or submissions of information related to
the importation of food. The Secretary may cancel an importer's
registration if, after notice, the Secretary determines that
the registration was not updated correctly or otherwise
contains false, incomplete, or inaccurate information. If the
importer's registration is updated or corrected no later than 7
days after notice is provided, the Secretary shall not cancel
the importer's registration.
Section 205. Registration for customs brokers and filers
Section 205 requires all customs brokers or filers with
respect to the importation of foods to register with the FDA in
a form and manner specified by the Secretary and to submit
appropriate unique facility identifiers as a condition of
registration. The Secretary may suspend an importer's
registration, after notice and opportunity for an informal
hearing, if the customs broker or filer is found in violation
of Federal Food, Drug, and Cosmetic Act, or found to have
knowingly or repeatedly made inaccurate or incomplete
statements or submissions of information related to the
importation of food. The Secretary may cancel an importer's
registration if, after notice, the Secretary determines that
the registration was not updated correctly or otherwise
contains false, incomplete, or inaccurate information.
Section 206. Unique identification number for food facilities,
importers, custom brokers, and filers
Section 206 requires that a person required to register a
facility under section 415 or importers, custom brokers, and
filers required to register pursuant to section 801 submit, at
the time of registration, a unique facility identifier. Section
206 requires the Secretary to refuse admission of an imported
food into the U.S. for interstate commerce unless the unique
facility identifiers are provided for such article.
Section 207. Prohibition against delaying, limiting, or refusing
inspection
Section 207 makes it unlawful for the owner, operator, or
agent of a farm, factory, warehouse, or establishment to delay
or limit an inspection, or refuse to permit entry or
inspection. In addition, Section 207 makes it unlawful for an
agent of a governmental authority in the foreign country within
which the farm, factory, warehouse, or establishment is located
to delay, limit, or refuses to permit entry or inspection.
Section 208. Dedicated foreign inspectorate
Section 208 requires the Secretary to establish and
maintain inspectors dedicated to inspections of foreign food
facilities.
Section 209. Plan and review of continued operation of field
laboratories
Section 209 requires the Secretary, no later than 90 days
before the Secretary terminates or consolidates any laboratory
responsible for analyzing food, district office with
responsibility for food safety, or the functions of any such
laboratory or district office, to submit a reorganization plan
to the Comptroller General of the U.S., the Committee on Energy
and Commerce of the House of Representatives, and the Committee
on Health, Education, Labor, and Pensions of the Senate.
Section 210. False or misleading reporting to FDA
Section 210 amends Section 301 of the Federal Food, Drug,
and Cosmetic Act to establish that the submission of any report
relating to food that is required by or under the Act that is
false or misleading in any material respect is a prohibited
act.
Section 211. Subpoena authority
Section 211 grants the Commissioner the power to issue
subpoenas for the purpose of any hearing, investigation, or
other proceeding respecting a violation of the Federal Food,
Drug, and Cosmetic Act, the Public Health Service Act, or the
Federal Anti-Tampering Act relating to food; or to determine if
a person is in violation of a specific provision of the Federal
Food, Drug, and Cosmetic Act, the Public Health Service Act, or
the Federal Anti-Tampering Act relating to food. A subpoena may
be issued only by a district director or an individual senior
to the district director.
Section 212. Whistleblower protections
Section 212 grants protections for employees who refuse to
violate, or who disclose violations of this Act, or Section 351
of the Public Health Service Act. No person who submits any
information related to a food, or any officer, employee,
contractor, subcontractor, or agent may discharge, demote,
suspend, threaten, harass or in any other manner discriminate
against an employee in retaliation for assisting in any
investigation regarding any conduct which the employee
reasonably believes constitutes a violation of federal law.
Section 212 ensures an employee shall be entitled to all relief
necessary against retaliation by an employer.
Section 213. Extraterritorial jurisdiction
Section 213 establishes that there is extraterritorial
federal jurisdiction over any violation of this Act relating to
any article of food intended for import into the United States
or if any act in furtherance of the violation was committed in
the United States.
Section 214. Support for training institutes
Section 214 requires the Secretary, acting through the
Commissioner, to provide financial and other assistance to
appropriate entities to establish and maintain one or more
university-affiliated food protection training institutes in
order to conduct training related to food protection activities
for Federal, State, local, territorial, and tribal officials;
and meet standards developed by the Secretary.
Section 215. Bisphenol A in food and beverage containers
Section 215 requires the Secretary to notify Congress no
later than December 31, 2009, 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. If the Secretary is unable to make such a
determination, the Secretary must notify Congress of the
actions the Secretary intends to take to protect the public
health.
Explanation of Amendments
During full Committee markup, the Chairman offered a
manager's amendment (amendment in the nature of a substitute)
making several changes to the bill, which was adopted by the
Committee on a voice vote. The manager's amendment clarifies
that the bill applies to FDA-regulated farms and facilities and
delineates the ways in which the bill applies--and does not
apply--to facilities manufacturing alcoholic beverages.
In the area of preventive food safety plans, the manager's
amendment clarifies that the Secretary must permit the use of
alternative preventive controls which have sufficiently
demonstrated to effectively address the hazard. The manager's
amendment clarifies that the Secretary may require finished
product testing at high-risk facilities if such testing or
reporting would provide useful risk information. Before doing
so, the Secretary must complete two or more pilot projects and
a feasibility study.
The manager's amendment clarifies the circumstances under
which the Secretary may access food records remotely.
The manager's amendment specifies that importers must pay a
$500 annual registration fee as other registered facilities are
required to do in the bill.
The manager's amendment revises section 205 to require
customs brokers to register with the Secretary but removes the
requirement that customs brokers pay a fee.
The manager's amendment adds two new sections. Section 214
requires the Secretary to support and provide assistance to
establish and maintain one or more university-affiliated food
protection training institutes that conduct training related to
food protection activities for Federal, State, local,
territorial, and tribal officials. Section 215 requires the
Secretary to assess the risks associated with bisphenol A in
food and beverage containers, to report back to Congress on the
findings, and to take appropriate actions to address any risks
identified.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italic, existing law in which no change is
proposed is shown in roman):
FEDERAL FOOD, DRUG, AND COSMETIC ACT
* * * * * * *
CHAPTER III--PROHIBITED ACTS AND PENALTIES
PROHIBITED ACTS
Sec. 301. The following acts and the causing thereof are
hereby prohibited:
(a) * * *
* * * * * * *
(e) The refusal to permit access to or copying of any record
as required by section 412, 414, 417(g), 416, 504, 564, 703,
704(a), 760, or 761; or the failure to establish or maintain
any record, or make any report, required under section 412,
414(b), 417, 416, 504, 505 (i) or (k), 512(a)(4)(C), 512 (j),
(l) or (m), 572(i), 515(f), 519, 564, 760, or 761, the
violation of any requirement of the food tracing system under
section 414(c); or the refusal to permit access to or
verification or copying of any such required record.
(f) The refusal to permit entry or inspection as authorized
by section 704 or the failure or refusal to obey a subpoena
issued pursuant to section 311.
* * * * * * *
(j) The using by any person to his own advantage, or
revealing, other than to the Secretary or officers or employees
of the Department, [or to the courts when relevant in any
judicial proceeding under this Act,] to the courts when
relevant in any judicial proceeding under this Act, or as
specified in section 708, any information acquired under
authority of section 404, 409, 412, 414, 505, 510, 512, 513,
514, 515, 516, 518, 519, 520, 571, 572, 573., 704, 708, or 721
concerning any method or process which as a trade secret is
entitled to protection; or the violating of section 408(i)(2)
or any regulation issued under that section.. This paragraph
does not authorize the withholding of information from either
House of Congress or from, to the extent of matter within its
jurisdiction, any committee or subcommittee of such committee
or any joint committee of Congress or any subcommittee of such
joint committee.
* * * * * * *
(q)(1) * * *
(2) With respect to any device or food, the submission of any
report that is required by or under this Act that is false or
misleading in any material respect.
* * * * * * *
(oo) The violation of any requirement of section 714
(relating to testing by accredited laboratories).
(pp)(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.
(qq) The violation of a quarantine under section 304(i).
(rr) The submission of information relating to food that is
required by or under section 801 that is inaccurate or
incomplete.
(ss) The failure to submit information relating to food that
is required by or under section 801.
(tt) The failure to register in accordance with section
801(r) or 801(s).
(uu) 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.
* * * * * * *
PENALTIES
Sec. 303. (a)(1) [Any] Except as provided in paragraph (2) or
(3), any person who violates a provision of section 301 shall
be imprisoned for not more than one year or fined not more than
$1,000, or both.
* * * * * * *
(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.
* * * * * * *
(f)(1) * * *
[(2)(A) Any person who introduces into interstate commerce or
delivers for introduction into interstate commerce an article
of food that is adulterated within the meaning of section
402(a)(2)(B) shall be subject to a civil money penalty of not
more than $50,000 in the case of an individual and $250,000 in
the case of any other person for such introduction or delivery,
not to exceed $500,000 for all such violations adjudicated in a
single proceeding.
[(B) This paragraph shall not apply to any person who grew
the article of food that is adulterated. If the Secretary
assesses a civil penalty against any person under this
paragraph, the Secretary may not use the criminal authorities
under this section to sanction such person for the introduction
or delivery for introduction into interstate commerce of the
article of food that is adulterated. If the Secretary assesses
a civil penalty against any person under this paragraph, the
Secretary may not use the seizure authorities of section 304 or
the injunction authorities of section 302 with respect to the
article of food that is adulterated.
[(C) In a hearing to assess a civil penalty under this
paragraph, the presiding officer shall have the same authority
with regard to compelling testimony or production of documents
as a presiding officer has under section 408(g)(2)(B). The
third sentence of paragraph (5)(A) shall not apply to any
investigation under this paragraph.]
(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.
* * * * * * *
SEIZURE
Sec. 304. (a) * * *
(b) The article, equipment, or other thing proceeded against
shall be liable to seizure by process pursuant to the libel,
and the procedure in cases under this section shall conform, as
nearly as may be, to the procedure in admiralty; except that on
demand of either party any issue of fact joined in any such
case shall be tried by jury 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. When libel
for condemnation proceedings under this section, involving the
same claimant and the same issues of adulteration or
misbranding, are pending in two or more jurisdictions, such
pending proceedings, upon application of the claimant
seasonably made to the court of one such jurisdiction, shall be
consolidated for trial by order of such court, and tried in (1)
any district selected by the claimant where one of such
proceedings is pending; or (2) a district agreed upon by
stipulation between the parties. If no order for consolidation
is so made within a reasonable time, the claimant may apply to
the court of one such jurisdiction, and such court (after
giving the United States attorney for such district reasonable
notice and opportunity to be heard) shall by order, unless good
cause to the contrary is shown, specify a district of
reasonable proximity to the claimant's principal place of
business, in which all such pending proceedings shall be
consolidated for trial and tried. Such order of consolidation
shall not apply so as to require the removal of any case the
date for trial of which has been fixed. The court granting such
order shall give prompt notification thereof to the other
courts having jurisdiction of the cases covered thereby.
* * * * * * *
(h) Administrative Detention of Foods.--
(1) Detention authority.--
(A) In general.--An officer or qualified
employee of the Food and Drug Administration
may order the detention, in accordance with
this subsection, of any article of food that is
found during an inspection, examination, or
investigation under this Act conducted by such
officer or qualified employee, if the officer
or qualified employee has [credible evidence or
information indicating] reason to believe that
such article [presents a threat of serious
adverse health consequences or death to humans
or animals] is adulterated, misbranded, or
otherwise in violation of this Act.
* * * * * * *
(2) Period of detention.--An article of food may be
detained under paragraph (1) for a reasonable period,
not to exceed 20 days, unless a greater period, not to
exceed [30] 60 days, is necessary, to enable the
Secretary to institute an action under subsection (a)
or section 302. The Secretary shall by regulation
provide for procedures for instituting such action on
an expedited basis with respect to perishable foods.
(3) Security of detained article.--An order under
paragraph (1) with respect to an article of food may
require that such article be labeled or marked as
detained, and shall require that the article be removed
to a secure facility, as appropriate. An article
subject to such an order shall not be transferred by
any person from the place at which the article is
ordered detained, or from the place to which the
article is so removed, as the case may be, until
released by the Secretary or until the expiration of
the detention period applicable under such order,
whichever occurs first. [This subsection may not be
construed as authorizing the delivery of the article
pursuant to the execution of a bond while the article
is subject to the order, and section 801(b) does not
authorize the delivery of the article pursuant to the
execution of a bond while the article is subject to the
order.]
(4) Appeal of detention order.--
(A) In general.--With respect to an article
of food ordered detained under paragraph (1),
any person who would be entitled to be a
claimant for such article if the article were
seized under subsection (a) may appeal the
order to the Secretary. Within [five] fifteen
days after such an appeal is filed, the
Secretary, after providing opportunity for an
informal hearing, shall confirm or terminate
the order involved, and such confirmation by
the Secretary shall be considered a final
agency action for purposes of section 702 of
title 5, United States Code. If during such
[five-day] fifteen-day period the Secretary
fails to provide such an opportunity, or to
confirm or terminate such order, the order is
deemed to be terminated.
* * * * * * *
(i) Quarantine of Geographic Location.--
(1) Authority to quarantine.--If the Secretary
determines that there is credible evidence or
information that an article of food presents an
imminent threat of serious adverse health consequences
or death to humans or animals, the Secretary may
quarantine any geographic area within the United States
where the Secretary reasonably believes such food is
located or from which such food originated. The
authority to quarantine includes prohibiting or
restricting the movement of food or of any vehicle
being used or that has been used to transport or hold
such food within the geographic area. Any quarantine
under this paragraph shall be no greater than is
appropriate, as determined by the Secretary, to protect
the public health.
(2) Notification procedures.--Before any quarantine
action is taken in any State under this subsection, the
Secretary shall notify an appropriate official of the
State affected and shall issue a public announcement
of--
(A) the Secretary's findings that support the
quarantine action;
(B) the area affected by the intended
quarantine action;
(C) the reasons for the intended quarantine
action; and
(D) where practicable, an estimate of the
anticipated duration of the quarantine.
The Secretary is not required to make such announcement
by publication in the Federal Register, but may use a
newspaper, radio or television, the Internet, or any
reasonable means to make such announcement.
(3) Nondelegation.--The authority to quarantine under
this subsection is limited to the Commissioner of Food
and Drugs, the Principal Deputy Commissioner, and the
Associate Commissioner for Regulatory Affairs of the
Food and Drug Administration.
* * * * * * *
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.
(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. 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.
CHAPTER IV--FOOD
* * * * * * *
ADULTERATED FOOD
Sec. 402. A food shall be deemed to be adulterated--
(a) * * *
* * * * * * *
(j) If it has been manufactured, processed, packed,
transported, or held under conditions that do not meet the
requirements of sections 418 and 418A.
(k) If it is manufactured or processed in a facility that is
in violation of section 418B.
(l) If it has been manufactured, processed, packed,
transported, or held under conditions that do not meet the
standards issued under section 419.
(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.
(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.
MISBRANDED FOOD
Sec. 403. A food shall be deemed to be misbranded--
(a) * * *
* * * * * * *
(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.
(aa) If it is part of a shipment offered for import into the
United States and such shipment is in violation of section
801(p) (requiring a certification to accompany certain food
shipments).
(bb) If it is a new infant formula and it is not the subject
of a letter from the Secretary provided pursuant to section
412(c)(1)(C).
(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.
(ee) If it is imported or offered for import by an importer
or a customs broker or filer not duly registered under section
801(r) or 801(s).
* * * * * * *
FOOD ADDITIVES
Sec. 409. (a) * * *
* * * * * * *
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.
* * * * * * *
REQUIREMENTS FOR INFANT FORMULAS
Sec. 412. (a) * * *
(b)(1) The Secretary shall by regulation establish
requirements for quality factors for infant formulas to the
extent possible consistent with current scientific knowledge,
including quality factor requirements for the nutrients
required by subsection (i). The quality factor requirements
established under this paragraph may include requirements for
one or more clinical studies to demonstrate that the new infant
formula supports normal physical growth of infants.
* * * * * * *
(4)(A) * * *
[(B)(i) Records required under subparagraph (A) with respect
to an infant formula shall be retained for at least one year
after the expiration of the shelf life of such infant formula.
Except as provided in clause (ii), such records shall be made
available to the Secretary for review and duplication upon
request of the Secretary.
[(ii) A manufacturer need only provide written assurances to
the Secretary that the regularly scheduled audits required by
paragraph (2)(B)(iv) are being conducted by the manufacturer,
and need not make available to the Secretary the actual written
reports of such audits.]
(B) Records required under subparagraph (A) with respect to
an infant formula shall be retained for at least one year after
the expiration of the shelf life of such infant formula. Such
records shall be made available to the Secretary for review and
duplication upon request of the Secretary.
(c)(1) No person shall introduce or deliver for introduction
into interstate commerce any new infant formula unless--
(A) such person has, before introducing such new
infant formula, or delivering such new infant formula
for introduction, into interstate commerce, registered
with the Secretary the name of such person, the place
of business of such person, and all establishments at
which such person intends to manufacture such new
infant formula, [and]
(B) such person has at least 90 days before marketing
such new infant formula, made the submission to the
Secretary required by subsection [(c)(1).] (d)(1), and
(C) the Secretary has by letter informed such person
that the registration requirements and the requirements
in subsection (d)(1) have been satisfied.
* * * * * * *
(d)(1) A person shall, with respect to any infant formula
subject to subsection (c), make a submission to the Secretary
which shall include--
(A) * * *
* * * * * * *
[(C) assurances that the infant formula will not be
marketed unless it meets the requirements of
subsections (b)(1) and (i), as demonstrated by the
testing required under subsection (b)(3), and
[(D) assurances that the processing of the infant
formula complies with subsection (b)(2).]
(C) scientific evidence and other evidence, as
identified in regulations promulgated by the Secretary,
that demonstrates that the infant formula satisfies the
requirements of subsection (b)(1), and, as demonstrated
by the testing required under subsection (b)(3), that
it satisfies the requirements of subsection (i), and
(D) scientific evidence and other evidence, as
identified in regulations promulgated by the Secretary,
that demonstrate that the processing of the infant
formula complies with the requirements of subsection
(b)(2).
* * * * * * *
SEC. 414. MAINTENANCE AND INSPECTION OF RECORDS.
[(a) Records Inspection.--If 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, each person (excluding farms and
restaurants) who manufactures, processes, packs, distributes,
receives, holds, or imports such article shall, at the request
of an officer or employee duly designated by the Secretary,
permit such officer or employee, upon presentation of
appropriate credentials and a written notice to such person, at
reasonable times and within reasonable limits and in a
reasonable manner, to have access to and copy all records
relating to such article that are needed to assist the
Secretary in determining whether the food is adulterated and
presents a threat of serious adverse health consequences or
death to humans or animals. The requirement under the preceding
sentence applies to all records relating to the manufacture,
processing, packing, 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.
[(b) Regulations Concerning Recordkeeping.--The Secretary, in
consultation and coordination, as appropriate, with other
Federal departments and agencies with responsibilities for
regulating food safety, may by regulation establish
requirements regarding the establishment and maintenance, for
not longer than two years, of records by persons (excluding
farms and restaurants) who manufacture, process, pack,
transport, distribute, receive, hold, or import food, which
records are needed by the Secretary for inspection to allow the
Secretary to identify the immediate previous sources and the
immediate subsequent recipients of food, including its
packaging, in order to address credible threats of serious
adverse health consequences or death to humans or animals. The
Secretary shall take into account the size of a business in
promulgating regulations under this section.]
(a) Records Access.--
(1) Records access during an inspection.--
(A) In general.--Each person who produces,
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 production, 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.
(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.
(b) Regulations Concerning Recordkeeping.--The Secretary, in
consultation and coordination, as appropriate, with other
Federal departments and agencies with responsibilities for
regulating food safety, may by regulation establish
requirements regarding the establishment and maintenance, for
not longer than 3 years, of records by persons who produce,
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 section. 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.
(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 911; 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.
(3) Regulation.--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. The Secretary may include in such
regulation--
(A) the establishment and maintenance of lot
numbers;
(B) a standardized format for pedigree
information; and
(C) the use of a common nomenclature for
food.
(4) Exemptions.--
(A) Direct sales by farms.--Food is exempt
from the requirements of this subsection if
such food is--
(i) produced on a farm or fishery
(including an oyster bed, a wild
fishery, an aquaculture facility, a
fresh water fishery, and a saltwater
fishery); and
(ii) sold by the owner, operator, or
agent in charge of such farm or fishery
directly to a consumer or to a
restaurant or grocery store.
(B) 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.
(C) Previous sources and subsequent
recipients.--For a food covered by an exemption
under subparagraph (B), the Secretary shall
require each person who produces, manufactures,
processes, packs, transports, 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.
(D) 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.
(E) Farms and fisheries.--For a food covered
by an exemption under subparagraph (A), farms
and fisheries 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.
[(c)] (d) Protection of Sensitive Information.--The Secretary
shall take appropriate measures to ensure that there are in
effect effective procedures to prevent the unauthorized
disclosure of any trade secret or confidential information that
is obtained by the Secretary pursuant to this section.
[(d)] (e) Limitations.--This section shall not be construed--
(1) * * *
* * * * * * *
SEC. 415. REGISTRATION OF FOOD FACILITIES.
(a) Registration.--
(1) In general.--The Secretary shall by regulation
[require that] require that, on or before December 31
of each year, any facility engaged in manufacturing,
processing, packing, or holding [food for consumption
in the United States] food for consumption in the
United States or for export from the United States be
registered with the Secretary. To be registered--
(A) for a domestic facility, the owner,
operator, or agent in charge of the facility
shall submit a registration to the Secretary
and pay the registration fee required under
section 743; and
(B) for a foreign facility, the owner,
operator, or agent in charge of the facility
shall submit a registration to the Secretary
and pay the registration fee required under
section 743 and shall include with the
registration the name of the United States
agent for the facility.
(2) Registration.--An entity (referred to in this
section as the ``registrant'') shall submit in
electronic format a registration under paragraph (1) to
the Secretary [containing information necessary to
notify the Secretary of the name and address of each
facility at which, and all trade names under which, the
registrant conducts business and, when determined
necessary by the Secretary through guidance, the
general food category (as identified under section
170.3 of title 21, Code of Federal Regulations) of any
food manufactured, processed, packed, or held at such
facility. The registrant shall notify the Secretary in
a timely manner of changes to such information.]
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 911.
(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) List.--The Secretary shall compile and maintain
an up-to-date list of facilities that are registered
under this section. 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. Such list and any registration
documents submitted pursuant to this subsection shall
not be subject to disclosure under section 552 of title
5, United States Code. Information derived from such
list or registration documents shall not be subject to
disclosure under section 552 of title 5, United States
Code, to the extent that it discloses the identity or
location of a specific registered person.
(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.
* * * * * * *
SEC. 417. REPORTABLE FOOD REGISTRY.
(a) Definitions.--In this section:
(1) Responsible party.--The term ``responsible
party'', with respect to an article of food, [means a
person that submits the registration under section
415(a) for a food facility that is required to register
under section 415(a), at which such article of food is
manufactured, processed, packed, or held.] 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(r) with respect to
importation of such food.
* * * * * * *
(b) Establishment.--
(1) * * *
* * * * * * *
(3) Reporting by 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 restaurants and other retail
food establishments with limited ability for such
reporting.
* * * * * * *
(d) Reporting and Notification.--
(1) In general.--Except as provided in paragraph (2),
as soon as practicable, but in no case later than 24
hours after a responsible party determines that an
article of food is a reportable food, following a
timely review of any reasonably available data and
information, the responsible party shall--
(A) submit a report to the Food and Drug
Administration through the electronic portal
established under subsection (b) that includes
the data elements described in subsection (e)
(except the elements described in paragraphs
(8), (9), and (10) of such subsection); [and]
(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
[(B)] (C) investigate the cause of the
adulteration if the adulteration of the article
of food may have originated with the
responsible party.
* * * * * * *
(e) Data Elements.--The data elements described in this
subsection are the following:
(1) The registration numbers of the responsible party
under section 415(a)(3) if the responsible party is
required to register.
* * * * * * *
(12) Such additional information as the Secretary
deems appropriate.
* * * * * * *
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, implement, and validate 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, may be
unintentionally introduced, or may be
intentionally introduced, including by acts of
terrorism.
(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, implement, and validate
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
intentional or 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 effective--
(1) no 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 preventive controls identified under
subsection (c) have been validated as adequate to
control the hazards identified in the hazard analysis
under subsection (b)(3);
(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 article 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:
(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 or conditions 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, review of
monitoring and corrective action records, and
procedures for determining whether the preventive
controls are effectively preventing, eliminating, or
reducing to an acceptable level the occurrence of
identified hazards or conditions, 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.
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).
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.
(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) 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.
SEC. 419A. SAFETY STANDARDS FOR PRODUCE AND CERTAIN OTHER RAW
AGRICULTURAL COMMODITIES.
(a) Standards.--The Secretary shall establish by regulation
scientific and risk-based standards for the safe growing,
harvesting, processing, packing, sorting, transporting, and
holding of those types of raw agricultural commodities--
(1) that are from a plant or a 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 from a plant
or a 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) Enforcement.--The Secretary may coordinate with the
Secretary of Agriculture and 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.
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(r) 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 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 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 a reasonable
belief 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.
* * * * * * *
CHAPTER VII--GENERAL AUTHORITY
Subchapter A--General Administrative Provisions
* * * * * * *
FACTORY INSPECTION
Sec. 704. (a)(1) For purposes of enforcement of this Act,
officers or employees duly designated by the Secretary, upon
presenting appropriate credentials and a written notice to the
owner, operator, or agent in charge, are authorized (A) to
enter, at reasonable times, any farm, factory, warehouse, or
establishment, including any such food factory, warehouse, or
establishment whether foreign or domestic, in which food,
drugs, devices, or cosmetics are produced, manufactured,
processed, packed, or held, for introduction into interstate
commerce or after such introduction, or to enter any vehicle,
being used to transport or hold such food, drugs, devices, or
cosmetics in interstate commerce; and (B) to inspect, at
reasonable times and within reasonable limits and in a
reasonable manner, such farm, factory, warehouse,
establishment, or vehicle and all pertinent equipment, finished
and unfinished materials, containers, and labeling therein. In
the case of any person [(excluding farms and restaurants)] who
produces, manufactures, processes, packs, transports,
distributes, receives, holds, or imports foods, the inspection
shall extend to all records and other information [described in
section 414 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]
described in or required under section 414 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, subject to the limitations
established in section 414(d). In the case of any farm,
factory, warehouse, establishment, or consulting laboratory,
including any food factory, warehouse, establishment, or
consulting laboratory whether foreign or domestic, in which
prescription drugs, nonprescription drugs intended for human
use, or restricted devices are manufactured, processed, packed,
or held, inspection shall extend to all things therein
(including records, files, papers, processes, controls, and
facilities) bearing on whether prescription drugs,
nonprescription drugs intended for human use, or restricted
devices which are adulterated or misbranded within the meaning
of this Act, or which may not be manufactured, introduced into
interstate commerce, or sold, or offered for sale by reason of
any provision of this Act, have been or are being manufactured,
processed, packed, transported, or held in any such place, or
otherwise bearing on violation of this Act. No inspection
authorized by [the preceding sentence] either of the preceding
two sentences or by paragraph (3) shall extend to recipes for
food, financial data, sales data other than shipment data,
pricing data, personnel data (other than data as to
qualifications of technical and professional personnel
performing functions subject to this Act), and research data
(other than data relating to new drugs, antibiotic drugs, and
devices and subject to reporting and inspection under
regulations lawfully issued pursuant to section 505(i) or (k)
section 519, or 520(g), and data relating to other drugs or
devices which in the case of a new drug would be subject to
reporting or inspection under lawful regulations issued
pursuant to section 505(j)). A separate notice shall be given
for each such inspection, but a notice shall not be required
for each entry made during the period covered by the
inspection. Each such inspection shall be commenced and
completed with reasonable promptness.
* * * * * * *
(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(p); and
(D) such other factors as the Secretary determines by
guidance to be relevant to assessing the risk presented
by the facility.
(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.
(j) Brokers and Filers.--Every person engaged in the
brokering for import or filing for import 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.
(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.
* * * * * * *
CONFIDENTIAL INFORMATION
Sec. 708. [The Secretary] (a) The Secretary may provide any
information which 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 to a person
other than an officer or employee of the Department if the
Secretary determines such other person requires the information
in connection with an activity which is undertaken under
contract with the Secretary, which relates to the
administration of this Act, and with respect to which the
Secretary (or an officer or employee of the Department) is not
prohibited from using such information. The Secretary shall
require as a condition to the provision of information under
this section that the person receiving it take such security
precautions respecting the information as the Secretary may by
regulation prescribe.
(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.
* * * * * * *
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) 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.
* * * * * * *
Subchapter C--Fees
* * * * * * *
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).
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.
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(r).
(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(r), 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(r) 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.
* * * * * * *
CHAPTER VIII--IMPORTS AND EXPORTS
IMPORTS AND EXPORTS
Sec. 801. (a) The Secretary of the Treasury shall deliver to
the Secretary of Health and Human Services, upon his request,
samples of food, drugs, devices, and cosmetics which are being
imported or offered for import into the United States, giving
notice thereof to the owner or consignee, who may appear before
the Secretary of Health and Human Services and have the right
to introduce testimony. The Secretary of Health and Human
Services shall furnish to the Secretary of the Treasury a list
of establishments registered pursuant to subsection (i) of
section 510 and shall request that if any drugs or devices
manufactured, prepared, propagated, compounded, or processed in
an establishment not so registered are imported or offered for
import into the United States, samples of such drugs or devices
be delivered to the Secretary of Health and Human Services,
with notice of such delivery to the owner or consignee, who may
appear before the Secretary of Health and Human Services and
have the right to introduce testimony. If it appears from the
examination of such samples or otherwise that (1) such article
has been manufactured, processed, or packed under insanitary
conditions or, in the case of a device, the methods used in, or
the facilities or controls used for, the manufacture, packing,
storage, or installation of the device do not conform to the
requirements of section 520(f), or (2) such article is
forbidden or restricted in sale in the country in which it was
produced or from which it was exported, or (3) such article is
adulterated, misbranded, or in violation of section 505, or
prohibited from introduction or delivery for introduction into
interstate commerce under section 301(ll), or (4) the
requirements of section 414 have not been complied with
regarding such article, or (5) such article is subject to an
order under section 420 to cease distribution of or recall the
article, then such article shall be refused admission, except
as provided in subsection (b) of this section. If an article of
food being imported or offered for import into the United
States is not in compliance with the requirement of subsection
(p) (relating to certifications of compliance with this Act),
then such article shall be refused admission. If such article
is subject to a requirement under section 760 or 761 and if the
Secretary has credible evidence or information indicating that
the responsible person (as defined in such section 760 or 761)
has not complied with a requirement of such section 760 or 761
with respect to any such article, or has not allowed access to
records described in such section 760 or 761, then such article
shall be refused admission, except as provided in subsection
(b) of this section. The Secretary of the Treasury shall cause
the destruction of any such article refused admission unless
such article is exported, under regulations prescribed by the
Secretary of the Treasury, within ninety days of the date of
notice of such refusal or within such additional time as may be
permitted pursuant to such regulations. Clause (2) of the third
sentence of this paragraph shall not be construed to prohibit
the admission of narcotic drugs the importation of which is
permitted under the Controlled Substances Import and Export
Act.
(b) Pending decision as to the admission of an article being
imported or offered for import, the Secretary of the Treasury
may authorize delivery of such article to the owner or
consignee upon the execution by him of a good and sufficient
bond providing for the payment of such liquidated damages in
the event of default as may be required pursuant to regulations
of the Secretary of the Treasury. If it appears to the
Secretary of Health and Human Services that (1) an article
included within the provisions of clause (3) of subsection (a)
of this section can, by relabeling or other action, be brought
into compliance with the Act or rendered other than a food,
drug, device, or cosmetic, or (2) with respect to an article
included within the provision of [the fourth sentence] the
fifth sentence of subsection (a), the responsible person (as
defined in section 760 or 761) can take action that would
assure that the responsible person is in compliance with
section 760 or 761, as the case may be, final determination as
to admission of such article may be deferred and, upon filing
of timely written application by the owner or consignee and the
execution by him of a bond as provided in the preceding
provisions of this subsection, the Secretary may, in accordance
with regulations, authorize the applicant, or, with respect to
clause (2), the responsible person, to perform such relabeling
or other action specified in such authorization (including
destruction or export of rejected articles or portions thereof,
as may be specified in the Secretary's authorization). All such
relabeling or other action pursuant to such authorization shall
in accordance with regulations be under the supervision of an
officer or employee of the Department of Health and Human
Services designated by the Secretary, or an officer or employee
of the Department of the Treasury designated by the Secretary
of the Treasury.
* * * * * * *
(e)(1) * * *
* * * * * * *
(4)(A) Any person who exports [a drug, animal drug, or
device] from the United States a food (including animal feed),
drug, animal drug, or device may request that the Secretary--
(i) certify [in writing] that the [exported drug,
animal drug, or device] exported food, drug, animal
drug, or device meets the requirements of paragraph (1)
or section 802; or
(ii) certify [in writing] that [the drug, animal
drug, or device] the food, drug, animal drug, or device
being exported meets the applicable requirements of
this Act upon a showing that [the drug or device] the
food, drug, or device meets the applicable requirements
of this Act.
The Secretary shall issue such a certification within 20 days
of the receipt of a request for such certification.
(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.
[(B)] (C) If the Secretary issues a written export
certification within the 20 days prescribed by subparagraph
(A), a fee for such certification may be charged but shall not
exceed $175 for each certification. 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.
(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.
* * * * * * *
(p) Certifications Concerning Imported Articles.--
(1) In general.--
(A) Requirement.--The Secretary shall
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
specified requirements of this Act if--
(i) for food imported from a
particular country or region, based on
the adequacy of government controls in
such country or region or other
information relevant to such food,
certification would assist the
Secretary in determining whether to
refuse to admit such article under
subsection (a);
(ii) for a type of food that could
pose a significant risk to health,
certification would assist the
Secretary in determining whether such
article poses such risk; or
(iii) for an article imported from a
particular country, there is an
agreement between the Secretary and the
government of such country providing
for such certification.
(B) Contents of certification.--Such
certification shall include such information
regarding compliance as the Secretary may
specify, and may be provided in the form of
shipment-specific certificates, a listing of
certified facilities or other entities, or in
such other form as the Secretary may specify.
(C) 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).
(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.
(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 maintain records pertaining to
the financial interests of the
personnel involved in audits;
(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) Anything of value.--In this paragraph,
the term ``anything of value'' includes gifts,
gratuities, reimbursement of expenses,
entertainment, loans, or any other form of
compensation in cash or in kind.
(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) Electronic submission.--The Secretary shall
provide for the electronic submission of certifications
under this subsection.
(6) 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.
(q) 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.
(2) Format.--A regulation or guidance under paragraph
(1) may specify the format for submission of the
documentation or other information.
(r) 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 911, 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. Good importer
practices shall include the verification of good
manufacturing practices and preventive controls of the
importer's foreign suppliers, as applicable.
(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.
(s) Registration of Customs Brokers and Filers.--
(1) Registration.--The Secretary shall require a
customs broker or filer, 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 911, to submit
appropriate unique facility identifiers as a
condition of registration.
(2) 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 customs broker or filer
whose registration is suspended may request
that the Secretary vacate the suspension of
registration when such customs broker or filer
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.
(3) 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 or filer 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 or filer is
updated or corrected no later than 7 days after
notice is provided under subparagraph (B), the
Secretary shall not cancel such registration.
(4) 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.
* * * * * * *
SEC. 805. SAFE AND SECURE FOOD IMPORTATION PROGRAM.
(a) In General.--The Secretary may establish by regulation or
guidance 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 safety and security guidelines applicable to
the importation of food.
(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.
CHAPTER IX--MISCELLANEOUS
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SEC. 911. 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, Custom Brokers, and Filers.--A
person required to register pursuant to section 801(r) or
801(s) 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(r)
or 801(s).
(c) Guidance.--The Secretary may, by guidance, 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.
(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. 912. PROTECTIONS FOR EMPLOYEES WHO REFUSE TO VIOLATE, OR WHO
DISCLOSE VIOLATIONS OF, THIS ACT OR SECTION 351 OF
THE PUBLIC HEALTH SERVICE 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 and to the employer.
(C) Burdens of proof.--An action brought
under paragraph (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) 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 subsection (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 backpay); 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.
* * * * * * *