[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2751 Enrolled Bill (ENR)]
H.R.2751
One Hundred Eleventh Congress
of the
United States of America
AT THE SECOND SESSION
Begun and held at the City of Washington on Tuesday,
the fifth day of January, two thousand and ten
An Act
To amend the Federal Food, Drug, and Cosmetic Act with respect to the
safety of the food supply.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,

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(a) Short Title.--This Act may be cited as the ``FDA Food Safety
Modernization Act''.
(b) 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.).
(c) Table of Contents.--The table of contents for this Act is as
follows:

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TITLE I

-IMPROVING CAPACITY TO PREVENT FOOD SAFETY PROBLEMS

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foreign facilities, and ports of entry; annual report.

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TITLE II

-IMPROVING CAPACITY TO DETECT AND RESPOND TO FOOD SAFETY

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TITLE III

-IMPROVING THE SAFETY OF IMPORTED FOOD

(a) In General.--Section 414(a) (21 U.S.C. 350c(a)) is amended--
(1) by striking the heading and all that follows through ``of
food is'' and inserting the following: ``Records Inspection.--
``(1) Adulterated food.--If the Secretary has a reasonable
belief that an article of food, and any other article of food that
the Secretary reasonably believes is likely to be affected in a
similar manner, is'';
(2) by inserting ``, and to any other article of food that the
Secretary reasonably believes is likely to be affected in a similar
manner,'' after ``relating to such article'';
(3) by striking the last sentence; and
(4) by inserting at the end the following:
``(2) Use of or exposure to food of concern.--If the Secretary
believes that there is a reasonable probability that the use of or
exposure to an article of food, and any other article of food that
the Secretary reasonably believes is likely to be affected in a
similar manner, will cause 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 and to
any other article of food that the Secretary reasonably believes is
likely to be affected in a similar manner, that are needed to
assist the Secretary in determining whether there is a reasonable
probability that the use of or exposure to the food will cause
serious adverse health consequences or death to humans or animals.
``(3) Application.--The requirement under paragraphs (1) and
(2) 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) Conforming Amendment.--Section 704(a)(1)(B) (21 U.S.C.
374(a)(1)(B)) is amended by striking ``section 414 when'' and all that
follows through ``subject to'' and inserting ``section 414, when the
standard for records inspection under paragraph (1) or (2) of section
414(a) applies, subject to''.

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(a) Updating of Food Category Regulations; Biennial Registration
Renewal.--Section 415(a) (21 U.S.C. 350d(a)) is amended--
(1) in paragraph (2), by--
(A) striking ``conducts business and'' and inserting
``conducts business, the e-mail address for the contact person
of the facility or, in the case of a foreign facility, the
United States agent for the facility, and''; and
(B) inserting ``, or any other food categories as
determined appropriate by the Secretary, including by
guidance'' after ``Code of Federal Regulations'';
(2) by redesignating paragraphs (3) and (4) as paragraphs (4)
and (5), respectively; and
(3) by inserting after paragraph (2) the following:
``(3) Biennial registration renewal.--During the period
beginning on October 1 and ending on December 31 of each even-
numbered year, a registrant that has submitted a registration under
paragraph (1) shall submit to the Secretary a renewal registration
containing the information described in paragraph (2). The
Secretary shall provide for an abbreviated registration renewal
process for any registrant that has not had any changes to such
information since the registrant submitted the preceding
registration or registration renewal for the facility involved.''.
(b) Suspension of Registration.--
(1) In general.--Section 415 (21 U.S.C. 350d) is amended--
(A) in subsection (a)(2), by inserting after the first
sentence the following: ``The registration shall contain an
assurance that the Secretary will be permitted to inspect such
facility at the times and in the manner permitted by this
Act.'';
(B) by redesignating subsections (b) and (c) as subsections
(c) and (d), respectively; and
(C) by inserting after subsection (a) the following:
``(b) Suspension of Registration.--
``(1) In general.--If the Secretary determines that food
manufactured, processed, packed, received, or held by a facility
registered under this section has a reasonable probability of
causing serious adverse health consequences or death to humans or
animals, the Secretary may by order suspend the registration of a
facility--
``(A) that created, caused, or was otherwise responsible
for such reasonable probability; or
``(B)(i) that knew of, or had reason to know of, such
reasonable probability; and
``(ii) packed, received, or held such food.
``(2) Hearing on suspension.--The Secretary shall provide the
registrant subject to an order under paragraph (1) with an
opportunity for an informal hearing, to be held as soon as possible
but not later than 2 business days after the issuance of the order
or such other time period, as agreed upon by the Secretary and the
registrant, on the actions required for reinstatement of
registration and why the registration that is subject to suspension
should be reinstated. The Secretary shall reinstate a registration
if the Secretary determines, based on evidence presented, that
adequate grounds do not exist to continue the suspension of the
registration.
``(3) Post-hearing corrective action plan; vacating of order.--
``(A) Corrective action plan.--If, after providing
opportunity for an informal hearing under paragraph (2), the
Secretary determines that the suspension of registration
remains necessary, the Secretary shall require the registrant
to submit a corrective action plan to demonstrate how the
registrant plans to correct the conditions found by the
Secretary. The Secretary shall review such plan not later than
14 days after the submission of the corrective action plan or
such other time period as determined by the Secretary.
``(B) Vacating of order.--Upon a determination by the
Secretary that adequate grounds do not exist to continue the
suspension actions required by the order, or that such actions
should be modified, the Secretary shall promptly vacate the
order and reinstate the registration of the facility subject to
the order or modify the order, as appropriate.
``(4) Effect of suspension.--If the registration of a facility
is suspended under this subsection, no person shall import or
export food into the United States from such facility, offer to
import or export food into the United States from such facility, or
otherwise introduce food from such facility into interstate or
intrastate commerce in the United States.
``(5) Regulations.--
``(A) In general.--The Secretary shall promulgate
regulations to implement this subsection. The Secretary may
promulgate such regulations on an interim final basis.
``(B) Registration requirement.--The Secretary may require
that registration under this section be submitted in an
electronic format. Such requirement may not take effect before
the date that is 5 years after the date of enactment of the FDA
Food Safety Modernization Act.
``(6) Application date.--Facilities shall be subject to the
requirements of this subsection beginning on the earlier of--
``(A) the date on which the Secretary issues regulations
under paragraph (5); or
``(B) 180 days after the date of enactment of the FDA Food
Safety Modernization Act.
``(7) No delegation.--The authority conferred by this
subsection to issue an order to suspend a registration or vacate an
order of suspension shall not be delegated to any officer or
employee other than the Commissioner.''.
(2) Small entity compliance policy guide.--Not later than 180
days after the issuance of the regulations promulgated under
section 415(b)(5) of the Federal Food, Drug, and Cosmetic Act (as
added by this section), the Secretary shall issue a small entity
compliance policy guide setting forth in plain language the
requirements of such regulations to assist small entities in
complying with registration requirements and other activities
required under such section.
(3) Imported food.--Section 801(l) (21 U.S.C. 381(l)) is
amended by inserting ``(or for which a registration has been
suspended under such section)'' after ``section 415''.
(c) Clarification of Intent.--
(1) Retail food establishment.--The Secretary shall amend the
definition of the term ``retail food establishment'' in section in
1.227(b)(11) of title 21, Code of Federal Regulations to clarify
that, in determining the primary function of an establishment or a
retail food establishment under such section, the sale of food
products directly to consumers by such establishment and the sale
of food directly to consumers by such retail food establishment
include--
(A) the sale of such food products or food directly to
consumers by such establishment at a roadside stand or farmers'
market where such stand or market is located other than where
the food was manufactured or processed;
(B) the sale and distribution of such food through a
community supported agriculture program; and
(C) the sale and distribution of such food at any other
such direct sales platform as determined by the Secretary.
(2) Definitions.--For purposes of paragraph (1)--
(A) the term ``community supported agriculture program''
has the same meaning given the term ``community supported
agriculture (CSA) program'' in section 249.2 of title 7, Code
of Federal Regulations (or any successor regulation); and
(B) the term ``consumer'' does not include a business.
(d) Conforming Amendments.--
(1) Section 301(d) (21 U.S.C. 331(d)) is amended by inserting
``415,'' after ``404,''.
(2) Section 415(d), as redesignated by subsection (b), is
amended by adding at the end before the period ``for a facility to
be registered, except with respect to the reinstatement of a
registration that is suspended under subsection (b)''.

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modify the definition of the term ``facility'' under such
section.
(C) Science-based risk analysis.--In promulgating
regulations under subparagraph (A), the Secretary shall conduct
a science-based risk analysis of--
(i) specific types of on-farm packing or holding of
food that is not grown, raised, or consumed on such farm or
another farm under the same ownership, as such packing and
holding relates to specific foods; and
(ii) specific on-farm manufacturing and processing
activities as such activities relate to specific foods that
are not consumed on that farm or on another farm under
common ownership.
(D) Authority with respect to certain facilities.--
(i) In general.--In promulgating the regulations under
subparagraph (A), the Secretary shall consider the results
of the science-based risk analysis conducted under
subparagraph (C), and shall exempt certain facilities from
the requirements in section 418 of the Federal Food, Drug,
and Cosmetic Act (as added by this section), including
hazard analysis and preventive controls, and the mandatory
inspection frequency in section 421 of such Act (as added
by section 201), or modify the requirements in such
sections 418 or 421, as the Secretary determines
appropriate, if such facilities are engaged only in
specific types of on-farm manufacturing, processing,
packing, or holding activities that the Secretary
determines to be low risk involving specific foods the
Secretary determines to be low risk.
(ii) Limitation.--The exemptions or modifications under
clause (i) shall not include an exemption from the
requirement to register under section 415 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 350d), as amended
by this Act, if applicable, and shall apply only to small
businesses and very small businesses, as defined in the
regulation promulgated under section 418(n) of the Federal
Food, Drug, and Cosmetic Act (as added under subsection
(a)).
(2) Final regulations.--Not later than 9 months after the close
of the comment period for the proposed rulemaking under paragraph
(1), the Secretary shall adopt final rules with respect to--
(A) activities that constitute on-farm packing or holding
of food that is not grown, raised, or consumed on such farm or
another farm under the same ownership for purposes of section
415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
350d), as amended by this Act;
(B) activities that constitute on-farm manufacturing or
processing of food that is not consumed on that farm or on
another farm under common ownership for purposes of such
section 415; and
(C) the requirements under sections 418 and 421 of the
Federal Food, Drug, and Cosmetic Act, as added by this Act,
from which the Secretary may issue exemptions or modifications
of the requirements for certain types of facilities.
(d) Small Entity Compliance Policy Guide.--Not later than 180 days
after the issuance of the regulations promulgated under subsection (n)
of section 418 of the Federal Food, Drug, and Cosmetic Act (as added by
subsection (a)), the Secretary shall issue a small entity compliance
policy guide setting forth in plain language the requirements of such
section 418 and this section to assist small entities in complying with
the hazard analysis and other activities required under such section
418 and this section.
(e) Prohibited Acts.--Section 301 (21 U.S.C. 331) is amended by
adding at the end the following:
``(uu) The operation of a facility that manufactures, processes,
packs, or holds food for sale in the United States if the owner,
operator, or agent in charge of such facility is not in compliance with
section 418.''.
(f) No Effect on HACCP Authorities.--Nothing in 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.) to revise, issue, or enforce
Hazard Analysis Critical Control programs and the Thermally Processed
Low-Acid Foods Packaged in Hermetically Sealed Containers standards.
(g) Dietary Supplements.--Nothing in the amendments made by this
section shall apply to any facility with regard to the manufacturing,
processing, packing, or holding of a dietary supplement that is in
compliance with the requirements of sections 402(g)(2) and 761 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(g)(2), 379aa-1).
(h) Updating Guidance Relating to Fish and Fisheries Products
Hazards and Controls.--The Secretary shall, not later than 180 days
after the date of enactment of this Act, update the Fish and Fisheries
Products Hazards and Control Guidance to take into account advances in
technology that have occurred since the previous publication of such
Guidance by the Secretary.
(i) Effective Dates.--
(1) General rule.--The amendments made by this section shall
take effect 18 months after the date of enactment of this Act.
(2) Flexibility for small businesses.--Notwithstanding
paragraph (1)--
(A) the amendments made by this section shall apply to a
small business (as defined in the regulations promulgated under
section 418(n) of the Federal Food, Drug, and Cosmetic Act (as
added by this section)) beginning on the date that is 6 months
after the effective date of such regulations; and
(B) the amendments made by this section shall apply to a
very small business (as defined in such regulations) beginning
on the date that is 18 months after the effective date of such
regulations.

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(a) In General.--The Secretary shall, in coordination with the
Secretary of Agriculture, not less frequently than every 2 years,
review and evaluate relevant health data and other relevant
information, including from toxicological and epidemiological studies
and analyses, current Good Manufacturing Practices issued by the
Secretary relating to food, and relevant recommendations of relevant
advisory committees, including the Food Advisory Committee, to
determine the most significant foodborne contaminants.
(b) Guidance Documents and Regulations.--Based on the review and
evaluation conducted under subsection (a), and when appropriate to
reduce the risk of serious illness or death to humans or animals or to
prevent adulteration of the food under section 402 of the Federal Food,
Drug, or Cosmetic Act (21 U.S.C. 342) or to prevent the spread by food
of communicable disease under section 361 of the Public Health Service
Act (42 U.S.C. 264), the Secretary shall issue contaminant-specific and
science-based guidance documents, including guidance documents
regarding action levels, or regulations. Such guidance, including
guidance regarding action levels, or regulations--
(1) shall apply to products or product classes;
(2) shall, where appropriate, differentiate between food for
human consumption and food intended for consumption by animals
other than humans; and
(3) shall not be written to be facility-specific.
(c) No Duplication of Efforts.--The Secretary shall coordinate with
the Secretary of Agriculture to avoid issuing duplicative guidance on
the same contaminants.
(d) Review.--The Secretary shall periodically review and revise, as
appropriate, the guidance documents, including guidance documents
regarding action levels, or regulations promulgated under this section.

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(a) In General.--Chapter IV (21 U.S.C. 341 et seq.), as amended by
section 103, is amended by adding at the end the following:
``SEC. 419. STANDARDS FOR PRODUCE SAFETY.
``(a) Proposed Rulemaking.--
``(1) In general.--
``(A) Rulemaking.--Not later than 1 year after the date of
enactment of the FDA Food Safety Modernization Act, the
Secretary, in coordination with the Secretary of Agriculture
and representatives of State departments of agriculture
(including with regard to the national organic program
established under the Organic Foods Production Act of 1990),
and in consultation with the Secretary of Homeland Security,
shall publish a notice of proposed rulemaking to establish
science-based minimum standards for the safe production and
harvesting of those types of fruits and vegetables, including
specific mixes or categories of fruits and vegetables, that are
raw agricultural commodities for which the Secretary has
determined that such standards minimize the risk of serious
adverse health consequences or death.
``(B) Determination by secretary.--With respect to small
businesses and very small businesses (as such terms are defined
in the regulation promulgated under subparagraph (A)) that
produce and harvest those types of fruits and vegetables that
are raw agricultural commodities that the Secretary has
determined are low risk and do not present a risk of serious
adverse health consequences or death, the Secretary may
determine not to include production and harvesting of such
fruits and vegetables in such rulemaking, or may modify the
applicable requirements of regulations promulgated pursuant to
this section.
``(2) Public input.--During the comment period on the notice of
proposed rulemaking under paragraph (1), the Secretary shall
conduct not less than 3 public meetings in diverse geographical
areas of the United States to provide persons in different regions
an opportunity to comment.
``(3) Content.--The proposed rulemaking under paragraph (1)
shall--
``(A) provide sufficient flexibility to be applicable to
various types of entities engaged in the production and
harvesting of fruits and vegetables that are raw agricultural
commodities, including small businesses and entities that sell
directly to consumers, and be appropriate to the scale and
diversity of the production and harvesting of such commodities;
``(B) include, with respect to growing, harvesting,
sorting, packing, and storage operations, science-based minimum
standards related to soil amendments, hygiene, packaging,
temperature controls, animals in the growing area, and water;
``(C) consider hazards that occur naturally, may be
unintentionally introduced, or may be intentionally introduced,
including by acts of terrorism;
``(D) take into consideration, consistent with ensuring
enforceable public health protection, conservation and
environmental practice standards and policies established by
Federal natural resource conservation, wildlife conservation,
and environmental agencies;
``(E) in the case of production that is certified organic,
not include any requirements that conflict with or duplicate
the requirements of the national organic program established
under the Organic Foods Production Act of 1990, while providing
the same level of public health protection as the requirements
under guidance documents, including guidance documents
regarding action levels, and regulations under the FDA Food
Safety Modernization Act; and
``(F) define, for purposes of this section, the terms
`small business' and `very small business'.
``(4) Prioritization.--The Secretary shall prioritize the
implementation of the regulations under this section for specific
fruits and vegetables that are raw agricultural commodities based
on known risks which may include a history and severity of
foodborne illness outbreaks.
``(b) Final Regulation.--
``(1) In general.--Not later than 1 year after the close of the
comment period for the proposed rulemaking under subsection (a),
the Secretary shall adopt a final regulation to provide for minimum
science-based standards for those types of fruits and vegetables,
including specific mixes or categories of fruits or vegetables,
that are raw agricultural commodities, based on known safety risks,
which may include a history of foodborne illness outbreaks.
``(2) Final regulation.--The final regulation shall--
``(A) provide for coordination of education and enforcement
activities by State and local officials, as designated by the
Governors of the respective States or the appropriate elected
State official as recognized by State statute; and
``(B) include a description of the variance process under
subsection (c) and the types of permissible variances the
Secretary may grant.
``(3) Flexibility for small businesses.--Notwithstanding
paragraph (1)--
``(A) the regulations promulgated under this section shall
apply to a small business (as defined in the regulation
promulgated under subsection (a)(1)) after the date that is 1
year after the effective date of the final regulation under
paragraph (1); and
``(B) the regulations promulgated under this section shall
apply to a very small business (as defined in the regulation
promulgated under subsection (a)(1)) after the date that is 2
years after the effective date of the final regulation under
paragraph (1).
``(c) Criteria.--
``(1) In general.--The regulations adopted under subsection (b)
shall--
``(A) set forth those procedures, processes, and practices
that the Secretary determines to minimize the risk of serious
adverse health consequences or death, including procedures,
processes, and practices that the Secretary determines to be
reasonably necessary 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 fruits and vegetables,
including specific mixes or categories of fruits and
vegetables, that are raw agricultural commodities and to
provide reasonable assurances that the produce is not
adulterated under section 402;
``(B) provide sufficient flexibility to be practicable for
all sizes and types of businesses, including small businesses
such as a small food processing facility co-located on a farm;
``(C) comply with chapter 35 of title 44, United States
Code (commonly known as the `Paperwork Reduction Act'), with
special attention to minimizing the burden (as defined in
section 3502(2) of such Act) on the business, and collection of
information (as defined in section 3502(3) of such Act),
associated with such regulations;
``(D) acknowledge differences in risk and minimize, as
appropriate, the number of separate standards that apply to
separate foods; and
``(E) not require a business to hire a consultant or other
third party to identify, implement, certify, compliance with
these procedures, processes, and practices, except in the case
of negotiated enforcement resolutions that may require such a
consultant or third party; and
``(F) permit States and foreign countries from which food
is imported into the United States to request from the
Secretary variances from the requirements of the regulations,
subject to paragraph (2), where the State or foreign country
determines that the variance is necessary in light of local
growing conditions and that the procedures, processes, and
practices to be followed under the variance are reasonably
likely to ensure that the produce is not adulterated under
section 402 and to provide the same level of public health
protection as the requirements of the regulations adopted under
subsection (b).
``(2) Variances.--
``(A) Requests for variances.--A State or foreign country
from which food is imported into the United States may in
writing request a variance from the Secretary. Such request
shall describe the variance requested and present information
demonstrating that the variance does not increase the
likelihood that the food for which the variance is requested
will be adulterated under section 402, and that the variance
provides the same level of public health protection as the
requirements of the regulations adopted under subsection (b).
The Secretary shall review such requests in a reasonable
timeframe.
``(B) Approval of variances.--The Secretary may approve a
variance in whole or in part, as appropriate, and may specify
the scope of applicability of a variance to other similarly
situated persons.
``(C) Denial of variances.--The Secretary may deny a
variance request if the Secretary determines that such variance
is not reasonably likely to ensure that the food is not
adulterated under section 402 and is not reasonably likely to
provide the same level of public health protection as the
requirements of the regulation adopted under subsection (b).
The Secretary shall notify the person requesting such variance
of the reasons for the denial.
``(D) Modification or revocation of a variance.--The
Secretary, after notice and an opportunity for a hearing, may
modify or revoke a variance if the Secretary determines that
such variance is not reasonably likely to ensure that the food
is not adulterated under section 402 and is not reasonably
likely to provide the same level of public health protection as
the requirements of the regulations adopted under subsection
(b).
``(d) Enforcement.--The Secretary may coordinate with the Secretary
of Agriculture and, as appropriate, shall contract and coordinate with
the agency or department designated by the Governor of each State to
perform activities to ensure compliance with this section.
``(e) Guidance.--
``(1) In general.--Not later than 1 year after the date of
enactment of the FDA Food Safety Modernization Act, the Secretary
shall publish, after consultation with the Secretary of
Agriculture, representatives of State departments of agriculture,
farmer representatives, and various types of entities engaged in
the production and harvesting or importing of fruits and vegetables
that are raw agricultural commodities, including small businesses,
updated good agricultural practices and guidance for the safe
production and harvesting of specific types of fresh produce under
this section.
``(2) Public meetings.--The Secretary shall conduct not fewer
than 3 public meetings in diverse geographical areas of the United
States as part of an effort to conduct education and outreach
regarding the guidance described in paragraph (1) for persons in
different regions who are involved in the production and harvesting
of fruits and vegetables that are raw agricultural commodities,
including persons that sell directly to consumers and farmer
representatives, and for importers of fruits and vegetables that
are raw agricultural commodities.
``(3) Paperwork reduction.--The Secretary shall ensure that any
updated guidance under this section will--
``(A) provide sufficient flexibility to be practicable for
all sizes and types of facilities, including small businesses
such as a small food processing facility co-located on a farm;
and
``(B) acknowledge differences in risk and minimize, as
appropriate, the number of separate standards that apply to
separate foods.
``(f) Exemption for Direct Farm Marketing.--
``(1) In general.--A farm shall be exempt from the requirements
under this section in a calendar year if--
``(A) during the previous 3-year period, the average annual
monetary value of the food sold by such farm directly to
qualified end-users during such period exceeded the average
annual monetary value of the food sold by such farm to all
other buyers during such period; and
``(B) the average annual monetary value of all food sold
during such period was less than $500,000, adjusted for
inflation.
``(2) Notification to consumers.--
``(A) In general.--A farm that is exempt from the
requirements under this section shall--
``(i) with respect to a food for which a food packaging
label is required by the Secretary under any other
provision of this Act, include prominently and
conspicuously on such label the name and business address
of the farm where the produce was grown; or
``(ii) with respect to a food for which a food
packaging label is not required by the Secretary under any
other provision of this Act, prominently and conspicuously
display, at the point of purchase, the name and business
address of the farm where the produce was grown, on a
label, poster, sign, placard, or documents delivered
contemporaneously with the food in the normal course of
business, or, in the case of Internet sales, in an
electronic notice.
``(B) No additional label.--Subparagraph (A) does not
provide authority to the Secretary to require a label that is
in addition to any label required under any other provision of
this Act.
``(3) Withdrawal; rule of construction.--
``(A) In general.--In the event of an active investigation
of a foodborne illness outbreak that is directly linked to a
farm subject to an exemption under this subsection, or if the
Secretary determines that it is necessary to protect the public
health and prevent or mitigate a foodborne illness outbreak
based on conduct or conditions associated with a farm that are
material to the safety of the food produced or harvested at
such farm, the Secretary may withdraw the exemption provided to
such farm under this subsection.
``(B) Rule of construction.--Nothing in this subsection
shall be construed to expand or limit the inspection authority
of the Secretary.
``(4) Definitions.--
``(A) Qualified end-user.--In this subsection, the term
`qualified end-user', with respect to a food means--
``(i) the consumer of the food; or
``(ii) a restaurant or retail food establishment (as
those terms are defined by the Secretary for purposes of
section 415) that is located--
``(I) in the same State as the farm that produced
the food; or
``(II) not more than 275 miles from such farm.
``(B) Consumer.--For purposes of subparagraph (A), the term
`consumer' does not include a business.
``(5) No preemption.--Nothing in this subsection preempts
State, local, county, or other non-Federal law regarding the safe
production, harvesting, holding, transportation, and sale of fresh
fruits and vegetables. Compliance with this subsection shall not
relieve any person from liability at common law or under State
statutory law.
``(6) Limitation of effect.--Nothing in this subsection shall
prevent the Secretary from exercising any authority granted in the
other sections of this Act.
``(g) Clarification.--This section shall not apply to produce that
is produced by an individual for personal consumption.
``(h) Exception for Activities of Facilities Subject to Section
418.--This section shall not apply to activities of a facility that are
subject to section 418.''.
(b) Small Entity Compliance Policy Guide.--Not later than 180 days
after the issuance of regulations under section 419 of the Federal
Food, Drug, and Cosmetic Act (as added by subsection (a)), the
Secretary of Health and Human Services shall issue a small entity
compliance policy guide setting forth in plain language the
requirements of such section 419 and to assist small entities in
complying with standards for safe production and harvesting and other
activities required under such section.
(c) Prohibited Acts.--Section 301 (21 U.S.C. 331), as amended by
section 103, is amended by adding at the end the following:
``(vv) The failure to comply with the requirements under section
419.''.
(d) No Effect on HACCP Authorities.--Nothing in 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.) 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.

a363571d4e8363917ae202d241ed27a5d3fbc308155d74817c71472713bbd2b6

(a) In General.--Chapter IV (21 U.S.C. 341 et seq.), as amended by
section 105, is amended by adding at the end the following:
``SEC. 420. PROTECTION AGAINST INTENTIONAL ADULTERATION.
``(a) Determinations.--
``(1) In general.--The Secretary shall--
``(A) conduct a vulnerability assessment of the food
system, including by consideration of the Department of
Homeland Security biological, chemical, radiological, or other
terrorism risk assessments;
``(B) consider the best available understanding of
uncertainties, risks, costs, and benefits associated with
guarding against intentional adulteration of food at vulnerable
points; and
``(C) determine the types of science-based mitigation
strategies or measures that are necessary to protect against
the intentional adulteration of food.
``(2) Limited distribution.--In the interest of national
security, the Secretary, in consultation with the Secretary of
Homeland Security, may determine the time, manner, and form in
which determinations made under paragraph (1) are made publicly
available.
``(b) Regulations.--Not later than 18 months after the date of
enactment of the FDA Food Safety Modernization Act, the Secretary, in
coordination with the Secretary of Homeland Security and in
consultation with the Secretary of Agriculture, shall promulgate
regulations to protect against the intentional adulteration of food
subject to this Act. Such regulations shall--
``(1) specify how a person shall assess whether the person is
required to implement mitigation strategies or measures intended to
protect against the intentional adulteration of food; and
``(2) specify appropriate science-based mitigation strategies
or measures to prepare and protect the food supply chain at
specific vulnerable points, as appropriate.
``(c) Applicability.--Regulations promulgated under subsection (b)
shall apply only to food for which there is a high risk of intentional
contamination, as determined by the Secretary, in consultation with the
Secretary of Homeland Security, under subsection (a), that could cause
serious adverse health consequences or death to humans or animals and
shall include those foods--
``(1) for which the Secretary has identified clear
vulnerabilities (including short shelf-life or susceptibility to
intentional contamination at critical control points); and
``(2) in bulk or batch form, prior to being packaged for the
final consumer.
``(d) Exception.--This section shall not apply to farms, except for
those that produce milk.
``(e) Definition.--For purposes of this section, the term `farm'
has the meaning given that term in section 1.227 of title 21, Code of
Federal Regulations (or any successor regulation).''.
(b) Guidance Documents.--
(1) In general.--Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human Services,
in consultation with the Secretary of Homeland Security and the
Secretary of Agriculture, shall issue guidance documents related to
protection against the intentional adulteration of food, including
mitigation strategies or measures to guard against such
adulteration as required under section 420 of the Federal Food,
Drug, and Cosmetic Act, as added by subsection (a).
(2) Content.--The guidance documents issued under paragraph (1)
shall--
(A) include a model assessment for a person to use under
subsection (b)(1) of section 420 of the Federal Food, Drug, and
Cosmetic Act, as added by subsection (a);
(B) include examples of mitigation strategies or measures
described in subsection (b)(2) of such section; and
(C) specify situations in which the examples of mitigation
strategies or measures described in subsection (b)(2) of such
section are appropriate.
(3) Limited distribution.--In the interest of national
security, the Secretary of Health and Human Services, in
consultation with the Secretary of Homeland Security, may determine
the time, manner, and form in which the guidance documents issued
under paragraph (1) are made public, including by releasing such
documents to targeted audiences.
(c) Periodic Review.--The Secretary of Health and Human Services
shall periodically review and, as appropriate, update the regulations
under section 420(b) of the Federal Food, Drug, and Cosmetic Act, as
added by subsection (a), and the guidance documents under subsection
(b).
(d) Prohibited Acts.--Section 301 (21 U.S.C. 331 et seq.), as
amended by section 105, is amended by adding at the end the following:
``(ww) The failure to comply with section 420.''.

f4f6e3745c6f5294a81706e1cc386c8fa7d5752c38615149cba9aecb1d95f69c

(a) Fees for Reinspection, Recall, and Importation Activities.--
Subchapter C of chapter VII (21 U.S.C. 379f et seq.) is amended by
adding at the end the following:
``PART 6--FEES RELATED TO FOOD
``SEC. 743. AUTHORITY TO COLLECT AND USE FEES.
``(a) In General.--
``(1) Purpose and authority.--For fiscal year 2010 and each
subsequent fiscal year, the Secretary shall, in accordance with
this section, assess and collect fees from--
``(A) the responsible party for each domestic facility (as
defined in section 415(b)) and the United States agent for each
foreign facility subject to a reinspection in such fiscal year,
to cover reinspection-related costs for such year;
``(B) the responsible party for a domestic facility (as
defined in section 415(b)) and an importer who does not comply
with a recall order under section 423 or under section 412(f)
in such fiscal year, to cover food recall activities associated
with such order performed by the Secretary, including technical
assistance, follow-up effectiveness checks, and public
notifications, for such year;
``(C) each importer participating in the voluntary
qualified importer program under section 806 in such year, to
cover the administrative costs of such program for such year;
and
``(D) each importer subject to a reinspection in such
fiscal year, to cover reinspection-related costs for such year.
``(2) Definitions.--For purposes of this section--
``(A) the term `reinspection' means--
``(i) with respect to domestic facilities (as defined
in section 415(b)), 1 or more inspections conducted under
section 704 subsequent to an inspection conducted under
such provision which identified noncompliance materially
related to a food safety requirement of this Act,
specifically to determine whether compliance has been
achieved to the Secretary's satisfaction; and
``(ii) with respect to importers, 1 or more
examinations conducted under section 801 subsequent to an
examination conducted under such provision which identified
noncompliance materially related to a food safety
requirement of this Act, specifically to determine whether
compliance has been achieved to the Secretary's
satisfaction;
``(B) the term `reinspection-related costs' means all
expenses, including administrative expenses, incurred in
connection with--
``(i) arranging, conducting, and evaluating the results
of reinspections; and
``(ii) assessing and collecting reinspection fees under
this section; and
``(C) the term `responsible party' has the meaning given
such term in section 417(a)(1).
``(b) Establishment of Fees.--
``(1) In general.--Subject to subsections (c) and (d), the
Secretary shall establish the fees to be collected under this
section for each fiscal year specified in subsection (a)(1), based
on the methodology described under paragraph (2), and shall publish
such fees in a Federal Register notice not later than 60 days
before the start of each such year.
``(2) Fee methodology.--
``(A) Fees.--Fees amounts established for collection--
``(i) under subparagraph (A) of subsection (a)(1) for a
fiscal year shall be based on the Secretary's estimate of
100 percent of the costs of the reinspection-related
activities (including by type or level of reinspection
activity, as the Secretary determines applicable) described
in such subparagraph (A) for such year;
``(ii) under subparagraph (B) of subsection (a)(1) for
a fiscal year shall be based on the Secretary's estimate of
100 percent of the costs of the activities described in
such subparagraph (B) for such year;
``(iii) under subparagraph (C) of subsection (a)(1) for
a fiscal year shall be based on the Secretary's estimate of
100 percent of the costs of the activities described in
such subparagraph (C) for such year; and
``(iv) under subparagraph (D) of subsection (a)(1) for
a fiscal year shall be based on the Secretary's estimate of
100 percent of the costs of the activities described in
such subparagraph (D) for such year.
``(B) Other considerations.--
``(i) Voluntary qualified importer program.--In
establishing the fee amounts under subparagraph (A)(iii)
for a fiscal year, the Secretary shall provide for the
number of importers who have submitted to the Secretary a
notice under section 806(c) informing the Secretary of the
intent of such importer to participate in the program under
section 806 in such fiscal year.
``(II) Recoupment.--In establishing the fee amounts
under subparagraph (A)(iii) for the first 5 fiscal
years after the date of enactment of this section, the
Secretary shall include in such fee a reasonable
surcharge that provides a recoupment of the costs
expended by the Secretary to establish and implement
the first year of the program under section 806.
``(ii) Crediting of fees.--In establishing the fee
amounts under subparagraph (A) for a fiscal year, the
Secretary shall provide for the crediting of fees from the
previous year to the next year if the Secretary
overestimated the amount of fees needed to carry out such
activities, and consider the need to account for any
adjustment of fees and such other factors as the Secretary
determines appropriate.
``(iii) Published guidelines.--Not later than 180 days
after the date of enactment of the FDA Food Safety
Modernization Act, the Secretary shall publish in the
Federal Register a proposed set of guidelines in
consideration of the burden of fee amounts on small
business. Such consideration may include reduced fee
amounts for small businesses. The Secretary shall provide
for a period of public comment on such guidelines. The
Secretary shall adjust the fee schedule for small
businesses subject to such fees only through notice and
comment rulemaking.
``(3) Use of fees.--The Secretary shall make all of the fees
collected pursuant to clause (i), (ii), (iii), and (iv) of
paragraph (2)(A) available solely to pay for the costs referred to
in such clause (i), (ii), (iii), and (iv) of paragraph (2)(A),
respectively.
``(c) Limitations.--
``(1) In general.--Fees under subsection (a) shall be refunded
for a fiscal year beginning after fiscal year 2010 unless the
amount of the total appropriations for food safety activities at
the Food and Drug Administration for such fiscal year (excluding
the amount of fees appropriated for such fiscal year) is equal to
or greater than the amount of appropriations for food safety
activities at the Food and Drug Administration for fiscal year 2009
(excluding the amount of fees appropriated for such fiscal year),
multiplied by the adjustment factor under paragraph (3).
``(2) Authority.--If--
``(A) the Secretary does not assess fees under subsection
(a) for a portion of a fiscal year because paragraph (1)
applies; and
``(B) at a later date in such fiscal year, such paragraph
(1) ceases to apply,
the Secretary may assess and collect such fees under subsection
(a), without any modification to the rate of such fees,
notwithstanding the provisions of subsection (a) relating to the
date fees are to be paid.
``(3) Adjustment factor.--
``(A) In general.--The adjustment factor described in
paragraph (1) shall be 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, but in no case shall
such adjustment factor be negative.
``(B) Compounded basis.--The adjustment under subparagraph
(A) made each fiscal year shall be added on a compounded basis
to the sum of all adjustments made each fiscal year after
fiscal year 2009.
``(4) Limitation on amount of certain fees.--
``(A) In general.--Notwithstanding any other provision of
this section and subject to subparagraph (B), the Secretary may
not collect fees in a fiscal year such that the amount
collected--
``(i) under subparagraph (B) of subsection (a)(1)
exceeds $20,000,000; and
``(ii) under subparagraphs (A) and (D) of subsection
(a)(1) exceeds $25,000,000 combined.
``(B) Exception.--If a domestic facility (as defined in
section 415(b)) or an importer becomes subject to a fee
described in subparagraph (A), (B), or (D) of subsection (a)(1)
after the maximum amount of fees has been collected by the
Secretary under subparagraph (A), the Secretary may collect a
fee from such facility or importer.
``(d) Crediting and Availability of Fees.--Fees authorized under
subsection (a) shall be collected and available for obligation only to
the extent and in the amount provided 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 account without fiscal year limitation to such
appropriation account for salaries and expenses with such fiscal year
limitation. The sums transferred shall be available solely for the
purpose of paying the operating expenses of the Food and Drug
Administration employees and contractors performing activities
associated with these food safety fees.
``(e) Collection of Fees.--
``(1) In general.--The Secretary shall specify in the Federal
Register notice described in subsection (b)(1) the time and manner
in which fees assessed under this section shall be collected.
``(2) Collection of unpaid fees.--In any case where the
Secretary does not receive payment of a fee assessed under this
section within 30 days after it is due, such fee shall be treated
as a claim of the United States Government subject to provisions of
subchapter II of chapter 37 of title 31, United States Code.
``(f) Annual Report to Congress.--Not later than 120 days after
each fiscal year for which fees are assessed under this section, the
Secretary shall submit a report to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives, to include a description of
fees assessed and collected for each such year and a summary
description of the entities paying such fees and the types of business
in which such entities engage.
``(g) Authorization of Appropriations.--For fiscal year 2010 and
each fiscal year thereafter, there is authorized to be appropriated for
fees under this section an amount equal to the total revenue amount
determined under subsection (b) for the fiscal year, as adjusted or
otherwise affected under the other provisions of this section.''.
(b) Export Certification Fees for Foods and Animal Feed.--
(1) Authority for export certifications for food, including
animal feed.--Section 801(e)(4)(A) (21 U.S.C. 381(e)(4)(A)) is
amended--
(A) in the matter preceding clause (i), by striking ``a
drug'' and inserting ``a food, drug'';
(B) in clause (i) by striking ``exported drug'' and
inserting ``exported food, drug''; and
(C) in clause (ii) by striking ``the drug'' each place it
appears and inserting ``the food, drug''.
(2) Clarification of certification.--Section 801(e)(4) (21
U.S.C. 381(e)(4)) is amended by inserting after subparagraph (B)
the following new subparagraph:
``(C) For purposes of this paragraph, a certification by
the Secretary shall be made on such basis, and in such form
(including a publicly available listing) as the Secretary
determines appropriate.''.
(3) Limitations on the use and amount of fees.--Paragraph (4)
of section 801(e) (21 U.S.C. 381(e)) is amended by adding at the
end the following:
``(D) With regard to fees pursuant to subparagraph (B) in
connection with written export certifications for food:
``(i) Such fees shall be collected and available solely
for the costs of the Food and Drug Administration
associated with issuing such certifications.
``(ii) Such fees may not be retained in an amount that
exceeds such costs for the respective fiscal year.''

fcd1e14d261690c68259d0638d28dd87e9f8e1d311273bd95456039a5f300b03

(a) Development and Submission of Strategy.--
(1) In general.--Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human Services
and the Secretary of Agriculture, in coordination with the
Secretary of Homeland Security, shall prepare and transmit to the
relevant committees of Congress, and make publicly available on the
Internet Web sites of the Department of Health and Human Services
and the Department of Agriculture, the National Agriculture and
Food Defense Strategy.
(2) Implementation plan.--The strategy shall include an
implementation plan for use by the Secretaries described under
paragraph (1) in carrying out the strategy.
(3) Research.--The strategy shall include a coordinated
research agenda for use by the Secretaries described under
paragraph (1) in conducting research to support the goals and
activities described in paragraphs (1) and (2) of subsection (b).
(4) Revisions.--Not later than 4 years after the date on which
the strategy is submitted to the relevant committees of Congress
under paragraph (1), and not less frequently than every 4 years
thereafter, the Secretary of Health and Human Services and the
Secretary of Agriculture, in coordination with the Secretary of
Homeland Security, shall revise and submit to the relevant
committees of Congress the strategy.
(5) Consistency with existing plans.--The strategy described in
paragraph (1) shall be consistent with--
(A) the National Incident Management System;
(B) the National Response Framework;
(C) the National Infrastructure Protection Plan;
(D) the National Preparedness Goals; and
(E) other relevant national strategies.
(b) Components.--
(1) In general.--The strategy shall include a description of
the process to be used by the Department of Health and Human
Services, the Department of Agriculture, and the Department of
Homeland Security--
(A) to achieve each goal described in paragraph (2); and
(B) to evaluate the progress made by Federal, State, local,
and tribal governments towards the achievement of each goal
described in paragraph (2).
(2) Goals.--The strategy shall include a description of the
process to be used by the Department of Health and Human Services,
the Department of Agriculture, and the Department of Homeland
Security to achieve the following goals:
(A) Preparedness goal.--Enhance the preparedness of the
agriculture and food system by--
(i) conducting vulnerability assessments of the
agriculture and food system;
(ii) mitigating vulnerabilities of the system;
(iii) improving communication and training relating to
the system;
(iv) developing and conducting exercises to test
decontamination and disposal plans;
(v) developing modeling tools to improve event
consequence assessment and decision support; and
(vi) preparing risk communication tools and enhancing
public awareness through outreach.
(B) Detection goal.--Improve agriculture and food system
detection capabilities by--
(i) identifying contamination in food products at the
earliest possible time; and
(ii) conducting surveillance to prevent the spread of
diseases.
(C) Emergency response goal.--Ensure an efficient response
to agriculture and food emergencies by--
(i) immediately investigating animal disease outbreaks
and suspected food contamination;
(ii) preventing additional human illnesses;
(iii) organizing, training, and equipping animal,
plant, and food emergency response teams of--
(I) the Federal Government; and
(II) State, local, and tribal governments;
(iv) designing, developing, and evaluating training and
exercises carried out under agriculture and food defense
plans; and
(v) ensuring consistent and organized risk
communication to the public by--
(I) the Federal Government;
(II) State, local, and tribal governments; and
(III) the private sector.
(D) Recovery goal.--Secure agriculture and food production
after an agriculture or food emergency by--
(i) working with the private sector to develop business
recovery plans to rapidly resume agriculture, food
production, and international trade;
(ii) conducting exercises of the plans described in
subparagraph (C) with the goal of long-term recovery
results;
(iii) rapidly removing, and effectively disposing of--
(I) contaminated agriculture and food products; and
(II) infected plants and animals; and
(iv) decontaminating and restoring areas affected by an
agriculture or food emergency.
(3) Evaluation.--The Secretary, in coordination with the
Secretary of Agriculture and the Secretary of Homeland Security,
shall--
(A) develop metrics to measure progress for the evaluation
process described in paragraph (1)(B); and
(B) report on the progress measured in subparagraph (A) as
part of the National Agriculture and Food Defense strategy
described in subsection (a)(1).
(c) Limited Distribution.--In the interest of national security,
the Secretary of Health and Human Services and the Secretary of
Agriculture, in coordination with the Secretary of Homeland Security,
may determine the manner and format in which the National Agriculture
and Food Defense strategy established under this section is made
publicly available on the Internet Web sites of the Department of
Health and Human Services, the Department of Homeland Security, and the
Department of Agriculture, as described in subsection (a)(1).

eb1eb78bb6359620f9df36a07da5b285da50e2800db8fabb115a03e2a630253c

The Secretary of Homeland Security, in coordination with the
Secretary of Health and Human Services and the Secretary of
Agriculture, shall within 180 days of enactment of this Act, and
annually thereafter, submit to the relevant committees of Congress, and
make publicly available on the Internet Web site of the Department of
Homeland Security, a report on the activities of the Food and
Agriculture Government Coordinating Council and the Food and
Agriculture Sector Coordinating Council, including the progress of such
Councils on--
(1) facilitating partnerships between public and private
entities to help coordinate and enhance the protection of the
agriculture and food system of the United States;
(2) providing for the regular and timely interchange of
information between each council relating to the security of the
agriculture and food system (including intelligence information);
(3) identifying best practices and methods for improving the
coordination among Federal, State, local, and private sector
preparedness and response plans for agriculture and food defense;
and
(4) recommending methods by which to protect the economy and
the public health of the United States from the effects of--
(A) animal or plant disease outbreaks;
(B) food contamination; and
(C) natural disasters affecting agriculture and food.

307cb66f165d2c85147b04d09f4161eca9badedb01db6220d36ada42be98b790

(a) In General.--
(1) Initial report.--The Secretary, in coordination with the
Secretary of Agriculture and the Secretary of Homeland Security,
shall, not later than 2 years after the date of enactment of this
Act, submit to Congress a comprehensive report that identifies
programs and practices that are intended to promote the safety and
supply chain security of food and to prevent outbreaks of foodborne
illness and other food-related hazards that can be addressed
through preventive activities. Such report shall include a
description of the following:
(A) Analysis of the need for further regulations or
guidance to industry.
(B) Outreach to food industry sectors, including through
the Food and Agriculture Coordinating Councils referred to in
section 109, to identify potential sources of emerging threats
to the safety and security of the food supply and preventive
strategies to address those threats.
(C) Systems to ensure the prompt distribution to the food
industry of information and technical assistance concerning
preventive strategies.
(D) Communication systems to ensure that information about
specific threats to the safety and security of the food supply
are rapidly and effectively disseminated.
(E) Surveillance systems and laboratory networks to rapidly
detect and respond to foodborne illness outbreaks and other
food-related hazards, including how such systems and networks
are integrated.
(F) Outreach, education, and training provided to States
and local governments to build State and local food safety and
food defense capabilities, including progress implementing
strategies developed under sections 108 and 205.
(G) The estimated resources needed to effectively implement
the programs and practices identified in the report developed
in this section over a 5-year period.
(H) The impact of requirements under this Act (including
amendments made by this Act) on certified organic farms and
facilities (as defined in section 415 (21 U.S.C. 350d).
(I) Specific efforts taken pursuant to the agreements
authorized under section 421(c) of the Federal Food, Drug, and
Cosmetic Act (as added by section 201), together with, as
necessary, a description of any additional authorities
necessary to improve seafood safety.
(2) Biennial reports.--On a biennial basis following the
submission of the report under paragraph (1), the Secretary shall
submit to Congress a report that--
(A) reviews previous food safety programs and practices;
(B) outlines the success of those programs and practices;
(C) identifies future programs and practices; and
(D) includes information related to any matter described in
subparagraphs (A) through (H) of paragraph (1), as necessary.
(b) Risk-based Activities.--The report developed under subsection
(a)(1) shall describe methods that seek to ensure that resources
available to the Secretary for food safety-related activities are
directed at those actions most likely to reduce risks from food,
including the use of preventive strategies and allocation of inspection
resources. The Secretary shall promptly undertake those risk-based
actions that are identified during the development of the report as
likely to contribute to the safety and security of the food supply.
(c) Capability for Laboratory Analyses; Research.--The report
developed under subsection (a)(1) shall provide a description of
methods to increase capacity to undertake analyses of food samples
promptly after collection, to identify new and rapid analytical
techniques, including commercially-available techniques that can be
employed at ports of entry and by Food Emergency Response Network
laboratories, and to provide for well-equipped and staffed laboratory
facilities and progress toward laboratory accreditation under section
422 of the Federal Food, Drug, and Cosmetic Act (as added by section
202).
(d) Information Technology.--The report developed under subsection
(a)(1) shall include a description of such information technology
systems as may be needed to identify risks and receive data from
multiple sources, including foreign governments, State, local, and
tribal governments, other Federal agencies, the food industry,
laboratories, laboratory networks, and consumers. The information
technology systems that the Secretary describes shall also provide for
the integration of the facility registration system under section 415
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d), and the
prior notice system under section 801(m) of such Act (21 U.S.C. 381(m))
with other information technology systems that are used by the Federal
Government for the processing of food offered for import into the
United States.
(e) Automated Risk Assessment.--The report developed under
subsection (a)(1) shall include a description of progress toward
developing and improving an automated risk assessment system for food
safety surveillance and allocation of resources.
(f) Traceback and Surveillance Report.--The Secretary shall include
in the report developed under subsection (a)(1) an analysis of the Food
and Drug Administration's performance in foodborne illness outbreaks
during the 5-year period preceding the date of enactment of this Act
involving fruits and vegetables that are raw agricultural commodities
(as defined in section 201(r) (21 U.S.C. 321(r)) and recommendations
for enhanced surveillance, outbreak response, and traceability. Such
findings and recommendations shall address communication and
coordination with the public, industry, and State and local
governments, as such communication and coordination relates to outbreak
identification and traceback.
(g) Biennial Food Safety and Food Defense Research Plan.--The
Secretary, the Secretary of Agriculture, and the Secretary of Homeland
Security shall, on a biennial basis, submit to Congress a joint food
safety and food defense research plan which may include studying the
long-term health effects of foodborne illness. Such biennial plan shall
include a list and description of projects conducted during the
previous 2-year period and the plan for projects to be conducted during
the subsequent 2-year period.
(h) Effectiveness of Programs Administered by the Department of
Health and Human Services.--
(1) In general.--To determine whether existing Federal programs
administered by the Department of Health and Human Services are
effective in achieving the stated goals of such programs, the
Secretary shall, beginning not later than 1 year after the date of
enactment of this Act--
(A) conduct an annual evaluation of each program of such
Department to determine the effectiveness of each such program
in achieving legislated intent, purposes, and objectives; and
(B) submit to Congress a report concerning such evaluation.
(2) Content.--The report described under paragraph (1)(B)
shall--
(A) include conclusions concerning the reasons that such
existing programs have proven successful or not successful and
what factors contributed to such conclusions;
(B) include recommendations for consolidation and
elimination to reduce duplication and inefficiencies in such
programs at such Department as identified during the evaluation
conduct under this subsection; and
(C) be made publicly available in a publication entitled
``Guide to the U.S. Department of Health and Human Services
Programs''.
(i) Unique Identification Numbers.--
(1) In general.--Not later than 1 year after the date of
enactment of this Act, the Secretary, acting through the
Commissioner of Food and Drugs, shall conduct a study regarding the
need for, and challenges associated with, development and
implementation of a program that requires a unique identification
number for each food facility registered with the Secretary and, as
appropriate, each broker that imports food into the United States.
Such study shall include an evaluation of the costs associated with
development and implementation of such a system, and make
recommendations about what new authorities, if any, would be
necessary to develop and implement such a system.
(2) Report.--Not later than 15 months after the date of
enactment of this Act, the Secretary shall submit to Congress a
report that describes the findings of the study conducted under
paragraph (1) and that includes any recommendations determined
appropriate by the Secretary.

1a68903eac782fde29b5c1d15fccaeb04ba59313cf13523605bf67709c0a1726

(a) In General.--Not later than 18 months after the date of
enactment of this Act, the Secretary shall promulgate regulations
described in section 416(b) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 350e(b)).
(b) Food Transportation Study.--The Secretary, acting through the
Commissioner of Food and Drugs, shall conduct a study of the
transportation of food for consumption in the United States, including
transportation by air, that includes an examination of the unique needs
of rural and frontier areas with regard to the delivery of safe food.

b586d7342e08738bf5bc88108430c35fa1e0a6f86c33ef42a85e6c61e08d6568

(a) Definitions.--In this section:
(1) Early childhood education program.--The term ``early
childhood education program'' means--
(A) a Head Start program or an Early Head Start program
carried out under the Head Start Act (42 U.S.C. 9831 et seq.);
(B) a State licensed or regulated child care program or
school; or
(C) a State prekindergarten program that serves children
from birth through kindergarten.
(2) ESEA definitions.--The terms ``local educational agency'',
``secondary school'', ``elementary school'', and ``parent'' have
the meanings given the terms in section 9101 of the Elementary and
Secondary Education Act of 1965 (20 U.S.C. 7801).
(3) School.--The term ``school'' includes public--
(A) kindergartens;
(B) elementary schools; and
(C) secondary schools.
(4) Secretary.--The term ``Secretary'' means the Secretary of
Health and Human Services.
(b) Establishment of Voluntary Food Allergy and Anaphylaxis
Management Guidelines.--
(1) Establishment.--
(A) In general.--Not later than 1 year after the date of
enactment of this Act, the Secretary, in consultation with the
Secretary of Education, shall--
(i) develop guidelines to be used on a voluntary basis
to develop plans for individuals to manage the risk of food
allergy and anaphylaxis in schools and early childhood
education programs; and
(ii) make such guidelines available to local
educational agencies, schools, early childhood education
programs, and other interested entities and individuals to
be implemented on a voluntary basis only.
(B) Applicability of ferpa.--Each plan described in
subparagraph (A) that is developed for an individual shall be
considered an education record for the purpose of section 444
of the General Education Provisions Act (commonly referred to
as the ``Family Educational Rights and Privacy Act of 1974'')
(20 U.S.C. 1232g).
(2) Contents.--The voluntary guidelines developed by the
Secretary under paragraph (1) shall address each of the following
and may be updated as the Secretary determines necessary:
(A) Parental obligation to provide the school or early
childhood education program, prior to the start of every school
year, with--
(i) documentation from their child's physician or
nurse--
(I) supporting a diagnosis of food allergy, and any
risk of anaphylaxis, if applicable;
(II) identifying any food to which the child is
allergic;
(III) describing, if appropriate, any prior history
of anaphylaxis;
(IV) listing any medication prescribed for the
child for the treatment of anaphylaxis;
(V) detailing emergency treatment procedures in the
event of a reaction;
(VI) listing the signs and symptoms of a reaction;
and
(VII) assessing the child's readiness for self-
administration of prescription medication; and
(ii) a list of substitute meals that may be offered to
the child by school or early childhood education program
food service personnel.
(B) The creation and maintenance of an individual plan for
food allergy management, in consultation with the parent,
tailored to the needs of each child with a documented risk for
anaphylaxis, including any procedures for the self-
administration of medication by such children in instances
where--
(i) the children are capable of self-administering
medication; and
(ii) such administration is not prohibited by State
law.
(C) Communication strategies between individual schools or
early childhood education programs and providers of emergency
medical services, including appropriate instructions for
emergency medical response.
(D) Strategies to reduce the risk of exposure to
anaphylactic causative agents in classrooms and common school
or early childhood education program areas such as cafeterias.
(E) The dissemination of general information on life-
threatening food allergies to school or early childhood
education program staff, parents, and children.
(F) Food allergy management training of school or early
childhood education program personnel who regularly come into
contact with children with life-threatening food allergies.
(G) The authorization and training of school or early
childhood education program personnel to administer epinephrine
when the nurse is not immediately available.
(H) The timely accessibility of epinephrine by school or
early childhood education program personnel when the nurse is
not immediately available.
(I) The creation of a plan contained in each individual
plan for food allergy management that addresses the appropriate
response to an incident of anaphylaxis of a child while such
child is engaged in extracurricular programs of a school or
early childhood education program, such as non-academic outings
and field trips, before- and after-school programs or before-
and after-early child education program programs, and school-
sponsored or early childhood education program-sponsored
programs held on weekends.
(J) Maintenance of information for each administration of
epinephrine to a child at risk for anaphylaxis and prompt
notification to parents.
(K) Other elements the Secretary determines necessary for
the management of food allergies and anaphylaxis in schools and
early childhood education programs.
(3) Relation to state law.--Nothing in this section or the
guidelines developed by the Secretary under paragraph (1) shall be
construed to preempt State law, including any State law regarding
whether students at risk for anaphylaxis may self-administer
medication.
(c) School-based Food Allergy Management Grants.--
(1) In general.--The Secretary may award grants to local
educational agencies to assist such agencies with implementing
voluntary food allergy and anaphylaxis management guidelines
described in subsection (b).
(2) Application.--
(A) In general.--To be eligible to receive a grant under
this subsection, a local educational agency shall submit an
application to the Secretary at such time, in such manner, and
including such information as the Secretary may reasonably
require.
(B) Contents.--Each application submitted under
subparagraph (A) shall include--
(i) an assurance that the local educational agency has
developed plans in accordance with the food allergy and
anaphylaxis management guidelines described in subsection
(b);
(ii) a description of the activities to be funded by
the grant in carrying out the food allergy and anaphylaxis
management guidelines, including--
(I) how the guidelines will be carried out at
individual schools served by the local educational
agency;
(II) how the local educational agency will inform
parents and students of the guidelines in place;
(III) how school nurses, teachers, administrators,
and other school-based staff will be made aware of, and
given training on, when applicable, the guidelines in
place; and
(IV) any other activities that the Secretary
determines appropriate;
(iii) an itemization of how grant funds received under
this subsection will be expended;
(iv) a description of how adoption of the guidelines
and implementation of grant activities will be monitored;
and
(v) an agreement by the local educational agency to
report information required by the Secretary to conduct
evaluations under this subsection.
(3) Use of funds.--Each local educational agency that receives
a grant under this subsection may use the grant funds for the
following:
(A) Purchase of materials and supplies, including limited
medical supplies such as epinephrine and disposable wet wipes,
to support carrying out the food allergy and anaphylaxis
management guidelines described in subsection (b).
(B) In partnership with local health departments, school
nurse, teacher, and personnel training for food allergy
management.
(C) Programs that educate students as to the presence of,
and policies and procedures in place related to, food allergies
and anaphylactic shock.
(D) Outreach to parents.
(E) Any other activities consistent with the guidelines
described in subsection (b).
(4) Duration of awards.--The Secretary may award grants under
this subsection for a period of not more than 2 years. In the event
the Secretary conducts a program evaluation under this subsection,
funding in the second year of the grant, where applicable, shall be
contingent on a successful program evaluation by the Secretary
after the first year.
(5) Limitation on grant funding.--The Secretary may not provide
grant funding to a local educational agency under this subsection
after such local educational agency has received 2 years of grant
funding under this subsection.
(6) Maximum amount of annual awards.--A grant awarded under
this subsection may not be made in an amount that is more than
$50,000 annually.
(7) Priority.--In awarding grants under this subsection, the
Secretary shall give priority to local educational agencies with
the highest percentages of children who are counted under section
1124(c) of the Elementary and Secondary Education Act of 1965 (20
U.S.C. 6333(c)).
(8) Matching funds.--
(A) In general.--The Secretary may not award a grant under
this subsection unless the local educational agency agrees
that, with respect to the costs to be incurred by such local
educational agency in carrying out the grant activities, the
local educational agency shall make available (directly or
through donations from public or private entities) non-Federal
funds toward such costs in an amount equal to not less than 25
percent of the amount of the grant.
(B) Determination of amount of non-federal contribution.--
Non-Federal funds required under subparagraph (A) may be cash
or in kind, including plant, equipment, or services. Amounts
provided by the Federal Government, and any portion of any
service subsidized by the Federal Government, may not be
included in determining the amount of such non-Federal funds.
(9) Administrative funds.--A local educational agency that
receives a grant under this subsection may use not more than 2
percent of the grant amount for administrative costs related to
carrying out this subsection.
(10) Progress and evaluations.--At the completion of the grant
period referred to in paragraph (4), a local educational agency
shall provide the Secretary with information on how grant funds
were spent and the status of implementation of the food allergy and
anaphylaxis management guidelines described in subsection (b).
(11) Supplement, not supplant.--Grant funds received under this
subsection shall be used to supplement, and not supplant, non-
Federal funds and any other Federal funds available to carry out
the activities described in this subsection.
(12) Authorization of appropriations.--There is authorized to
be appropriated to carry out this subsection $30,000,000 for fiscal
year 2011 and such sums as may be necessary for each of the 4
succeeding fiscal years.
(d) Voluntary Nature of Guidelines.--
(1) In general.--The food allergy and anaphylaxis management
guidelines developed by the Secretary under subsection (b) are
voluntary. Nothing in this section or the guidelines developed by
the Secretary under subsection (b) shall be construed to require a
local educational agency to implement such guidelines.
(2) Exception.--Notwithstanding paragraph (1), the Secretary
may enforce an agreement by a local educational agency to implement
food allergy and anaphylaxis management guidelines as a condition
of the receipt of a grant under subsection (c).

37c1fd7829df3cd02564ab3e7c624cb0bb5193871181eae902c29e0fba5321b8

(a) In General.--Section 413 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 350b) is amended--
(1) by redesignating subsection (c) as subsection (d); and
(2) by inserting after subsection (b) the following:
``(c) Notification.--
``(1) In general.--If the Secretary determines that the
information in a new dietary ingredient notification submitted
under this section for an article purported to be a new dietary
ingredient is inadequate to establish that a dietary supplement
containing such article will reasonably be expected to be safe
because the article may be, or may contain, an anabolic steroid or
an analogue of an anabolic steroid, the Secretary shall notify the
Drug Enforcement Administration of such determination. Such
notification by the Secretary shall include, at a minimum, the name
of the dietary supplement or article, the name of the person or
persons who marketed the product or made the submission of
information regarding the article to the Secretary under this
section, and any contact information for such person or persons
that the Secretary has.
``(2) Definitions.--For purposes of this subsection--
``(A) the term `anabolic steroid' has the meaning given
such term in section 102(41) of the Controlled Substances Act;
and
``(B) the term `analogue of an anabolic steroid' means a
substance whose chemical structure is substantially similar to
the chemical structure of an anabolic steroid.''.
(b) Guidance.--Not later than 180 days after the date of enactment
of this Act, the Secretary shall publish guidance that clarifies when a
dietary supplement ingredient is a new dietary ingredient, when the
manufacturer or distributor of a dietary ingredient or dietary
supplement should provide the Secretary with information as described
in section 413(a)(2) of the Federal Food, Drug, and Cosmetic Act, the
evidence needed to document the safety of new dietary ingredients, and
appropriate methods for establishing the identify of a new dietary
ingredient.

368a97417762525dc387a52c8f5fa3f6b70fa09670c5077f1ab6d51d3fbbfa26

PROCESSING OF RAW OYSTERS.
(a) In General.--Not later than 90 days prior to the issuance of
any guidance, regulation, or suggested amendment by the Food and Drug
Administration to the National Shellfish Sanitation Program's Model
Ordinance, or the issuance of any guidance or regulation by the Food
and Drug Administration relating to the Seafood Hazard Analysis
Critical Control Points Program of the Food and Drug Administration
(parts 123 and 1240 of title 21, Code of Federal Regulations (or any
successor regulations), where such guidance, regulation or suggested
amendment relates to post harvest processing for raw oysters, the
Secretary shall prepare and submit to the Committee on Health,
Education, Labor, and Pensions of the Senate and the Committee on
Energy and Commerce of the House of Representatives a report which
shall include--
(1) an assessment of how post harvest processing or other
equivalent controls feasibly may be implemented in the fastest,
safest, and most economical manner;
(2) the projected public health benefits of any proposed post
harvest processing;
(3) the projected costs of compliance with such post harvest
processing measures;
(4) the impact post harvest processing is expected to have on
the sales, cost, and availability of raw oysters;
(5) criteria for ensuring post harvest processing standards
will be applied equally to shellfish imported from all nations of
origin;
(6) an evaluation of alternative measures to prevent,
eliminate, or reduce to an acceptable level the occurrence of
foodborne illness; and
(7) the extent to which the Food and Drug Administration has
consulted with the States and other regulatory agencies, as
appropriate, with regard to post harvest processing measures.
(b) Limitation.--Subsection (a) shall not apply to the guidance
described in section 103(h).
(c) Review and Evaluation.--Not later than 30 days after the
Secretary issues a proposed regulation or guidance described in
subsection (a), the Comptroller General of the United States shall--
(1) review and evaluate the report described in (a) and report
to Congress on the findings of the estimates and analysis in the
report;
(2) compare such proposed regulation or guidance to similar
regulations or guidance with respect to other regulated foods,
including a comparison of risks the Secretary may find associated
with seafood and the instances of those risks in such other
regulated foods; and
(3) evaluate the impact of post harvest processing on the
competitiveness of the domestic oyster industry in the United
States and in international markets.
(d) Waiver.--The requirement of preparing a report under subsection
(a) shall be waived if the Secretary issues a guidance that is adopted
as a consensus agreement between Federal and State regulators and the
oyster industry, acting through the Interstate Shellfish Sanitation
Conference.
(e) Public Access.--Any report prepared under this section shall be
made available to the public.

79149874ddfe4051d89e323a2d74ee67c6222d743085f9d5462a4fce4897ca27

Until the date on which the Secretary promulgates a final rule that
implements the amendments made by section 308 of the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002,
(Public Law 107-188), the Secretary shall notify the Secretary of
Homeland Security of all instances in which the Secretary refuses to
admit a food into the United States under section 801(a) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) so that the Secretary
of Homeland Security, acting through the Commissioner of Customs and
Border Protection, may prevent food refused admittance into the United
States by a United States port of entry from being admitted by another
United States port of entry, through the notification of other such
United States ports of entry.

7393adf4833a2c94c1f9a4375188a596749ac18aae4af2a28feb542e353c7598

(a) In General.--Except as provided by sections 102, 206, 207, 302,
304, 402, 403, and 404 of this Act, and the amendments made by such
sections, nothing in this Act, or the amendments made by this Act,
shall be construed to apply to a facility that--
(1) under the Federal Alcohol Administration Act (27 U.S.C. 201
et seq.) or chapter 51 of subtitle E of the Internal Revenue Code
of 1986 (26 U.S.C. 5001 et seq.) is required to obtain a permit or
to register with the Secretary of the Treasury as a condition of
doing business in the United States; and
(2) under section 415 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 350d) is required to register as a facility because
such facility is engaged in manufacturing, processing, packing, or
holding 1 or more alcoholic beverages, with respect to the
activities of such facility that relate to the manufacturing,
processing, packing, or holding of alcoholic beverages.
(b) Limited Receipt and Distribution of Non-alcohol Food.--
Subsection (a) shall not apply to a facility engaged in the receipt and
distribution of any non-alcohol food, except that such paragraph shall
apply to a facility described in such paragraph that receives and
distributes non-alcohol food, provided such food is received and
distributed--
(1) in a prepackaged form that prevents any direct human
contact with such food; and
(2) in amounts that constitute not more than 5 percent of the
overall sales of such facility, as determined by the Secretary of
the Treasury.
(c) Rule of Construction.--Except as provided in subsections (a)
and (b), this section shall not be construed to exempt any food, other
than alcoholic beverages, as defined in section 214 of the Federal
Alcohol Administration Act (27 U.S.C. 214), from the requirements of
this Act (including the amendments made by this Act).
PROBLEMS

137ee576a36f8df64e7acc695eabe8fb34d0e122dccfc468c70ba9c54f9d3748

FACILITIES, FOREIGN FACILITIES, AND PORTS OF ENTRY; ANNUAL
REPORT.
(a) Targeting of Inspection Resources for Domestic Facilities,
Foreign Facilities, and Ports of Entry.--Chapter IV (21 U.S.C. 341 et
seq.), as amended by section 106, is amended by adding at the end the
following:
``SEC. 421. TARGETING OF INSPECTION RESOURCES FOR DOMESTIC
FACILITIES, FOREIGN FACILITIES, AND PORTS OF ENTRY; ANNUAL
REPORT.
``(a) Identification and Inspection of Facilities.--
``(1) Identification.--The Secretary shall identify high-risk
facilities and shall allocate resources to inspect facilities
according to the known safety risks of the facilities, which shall
be based on the following factors:
``(A) The known safety risks of the food manufactured,
processed, packed, or held at the facility.
``(B) The compliance history of a facility, including with
regard to food recalls, outbreaks of foodborne illness, and
violations of food safety standards.
``(C) The rigor and effectiveness of the facility's hazard
analysis and risk-based preventive controls.
``(D) Whether the food manufactured, processed, packed, or
held at the facility meets the criteria for priority under
section 801(h)(1).
``(E) Whether the food or the facility that manufactured,
processed, packed, or held such food has received a
certification as described in section 801(q) or 806, as
appropriate.
``(F) Any other criteria deemed necessary and appropriate
by the Secretary for purposes of allocating inspection
resources.
``(2) Inspections.--
``(A) In general.--Beginning on the date of enactment of
the FDA Food Safety Modernization Act, the Secretary shall
increase the frequency of inspection of all facilities.
``(B) Domestic high-risk facilities.--The Secretary shall
increase the frequency of inspection of domestic facilities
identified under paragraph (1) as high-risk facilities such
that each such facility is inspected--
``(i) not less often than once in the 5-year period
following the date of enactment of the FDA Food Safety
Modernization Act; and
``(ii) not less often than once every 3 years
thereafter.
``(C) Domestic non-high-risk facilities.--The Secretary
shall ensure that each domestic facility that is not identified
under paragraph (1) as a high-risk facility is inspected--
``(i) not less often than once in the 7-year period
following the date of enactment of the FDA Food Safety
Modernization Act; and
``(ii) not less often than once every 5 years
thereafter.
``(D) Foreign facilities.--
``(i) Year 1.--In the 1-year period following the date
of enactment of the FDA Food Safety Modernization Act, the
Secretary shall inspect not fewer than 600 foreign
facilities.
``(ii) Subsequent years.--In each of the 5 years
following the 1-year period described in clause (i), the
Secretary shall inspect not fewer than twice the number of
foreign facilities inspected by the Secretary during the
previous year.
``(E) Reliance on federal, state, or local inspections.--In
meeting the inspection requirements under this subsection for
domestic facilities, the Secretary may rely on inspections
conducted by other Federal, State, or local agencies under
interagency agreement, contract, memoranda of understanding, or
other obligation.
``(b) Identification and Inspection at Ports of Entry.--The
Secretary, in consultation with the Secretary of Homeland Security,
shall allocate resources to inspect any article of food imported into
the United States according to the known safety risks of the article of
food, which shall be based on the following factors:
``(1) The known safety risks of the food imported.
``(2) The known safety risks of the countries or regions of
origin and countries through which such article of food is
transported.
``(3) The compliance history of the importer, including with
regard to food recalls, outbreaks of foodborne illness, and
violations of food safety standards.
``(4) The rigor and effectiveness of the activities conducted
by the importer of such article of food to satisfy the requirements
of the foreign supplier verification program under section 805.
``(5) Whether the food importer participates in the voluntary
qualified importer program under section 806.
``(6) Whether the food meets the criteria for priority under
section 801(h)(1).
``(7) Whether the food or the facility that manufactured,
processed, packed, or held such food received a certification as
described in section 801(q) or 806.
``(8) Any other criteria deemed necessary and appropriate by
the Secretary for purposes of allocating inspection resources.
``(c) Interagency Agreements With Respect to Seafood.--
``(1) In general.--The Secretary of Health and Human Services,
the Secretary of Commerce, the Secretary of Homeland Security, the
Chairman of the Federal Trade Commission, and the heads of other
appropriate agencies may enter into such agreements as may be
necessary or appropriate to improve seafood safety.
``(2) Scope of agreements.--The agreements under paragraph (1)
may include--
``(A) cooperative arrangements for examining and testing
seafood imports that leverage the resources, capabilities, and
authorities of each party to the agreement;
``(B) coordination of inspections of foreign facilities to
increase the percentage of imported seafood and seafood
facilities inspected;
``(C) standardization of data on seafood names, inspection
records, and laboratory testing to improve interagency
coordination;
``(D) coordination to detect and investigate violations
under applicable Federal law;
``(E) a process, including the use or modification of
existing processes, by which officers and employees of the
National Oceanic and Atmospheric Administration may be duly
designated by the Secretary to carry out seafood examinations
and investigations under section 801 of this Act or section 203
of the Food Allergen Labeling and Consumer Protection Act of
2004;
``(F) the sharing of information concerning observed non-
compliance with United States food requirements domestically
and in foreign nations and new regulatory decisions and
policies that may affect the safety of food imported into the
United States;
``(G) conducting joint training on subjects that affect and
strengthen seafood inspection effectiveness by Federal
authorities; and
``(H) outreach on Federal efforts to enhance seafood safety
and compliance with Federal food safety requirements.
``(d) Coordination.--The Secretary shall improve coordination and
cooperation with the Secretary of Agriculture and the Secretary of
Homeland Security to target food inspection resources.
``(e) Facility.--For purposes of this section, the term `facility'
means a domestic facility or a foreign facility that is required to
register under section 415.''.
(b) Annual Report.--Section 1003 (21 U.S.C. 393) is amended by
adding at the end the following:
``(h) Annual Report Regarding Food.--Not later than February 1 of
each year, the Secretary shall submit to Congress a report, including
efforts to coordinate and cooperate with other Federal agencies with
responsibilities for food inspections, regarding--
``(1) information about food facilities including--
``(A) the appropriations used to inspect facilities
registered pursuant to section 415 in the previous fiscal year;
``(B) the average cost of both a non-high-risk food
facility inspection and a high-risk food facility inspection,
if such a difference exists, in the previous fiscal year;
``(C) the number of domestic facilities and the number of
foreign facilities registered pursuant to section 415 that the
Secretary inspected in the previous fiscal year;
``(D) the number of domestic facilities and the number of
foreign facilities registered pursuant to section 415 that were
scheduled for inspection in the previous fiscal year and which
the Secretary did not inspect in such year;
``(E) the number of high-risk facilities identified
pursuant to section 421 that the Secretary inspected in the
previous fiscal year; and
``(F) the number of high-risk facilities identified
pursuant to section 421 that were scheduled for inspection in
the previous fiscal year and which the Secretary did not
inspect in such year.
``(2) information about food imports including--
``(A) the number of lines of food imported into the United
States that the Secretary physically inspected or sampled in
the previous fiscal year;
``(B) the number of lines of food imported into the United
States that the Secretary did not physically inspect or sample
in the previous fiscal year; and
``(C) the average cost of physically inspecting or sampling
a line of food subject to this Act that is imported or offered
for import into the United States; and
``(3) information on the foreign offices of the Food and Drug
Administration including--
``(A) the number of foreign offices established; and
``(B) the number of personnel permanently stationed in each
foreign office.
``(i) Public Availability of Annual Food Reports.--The Secretary
shall make the reports required under subsection (h) available to the
public on the Internet Web site of the Food and Drug Administration.''.
(c) Advisory Committee Consultation.--In allocating inspection
resources as described in section 421 of the Federal Food, Drug, and
Cosmetic Act (as added by subsection (a)), the Secretary may, as
appropriate, consult with any relevant advisory committee within the
Department of Health and Human Services.

020fefeefb4a9eb7705442057d4d8842689b9ed1ff535c809bdcc3e5eeebf8f1

(a) In General.--Chapter IV (21 U.S.C. 341 et seq.), as amended by
section 201, is amended by adding at the end the following:
``SEC. 422. LABORATORY ACCREDITATION FOR ANALYSES OF FOODS.
``(a) Recognition of Laboratory Accreditation.--
``(1) In general.--Not later than 2 years after the date of
enactment of the FDA Food Safety Modernization Act, the Secretary
shall--
``(A) establish a program for the testing of food by
accredited laboratories;
``(B) establish a publicly available registry of
accreditation bodies recognized by the Secretary and
laboratories accredited by a recognized accreditation body,
including the name of, contact information for, and other
information deemed appropriate by the Secretary about such
bodies and laboratories; and
``(C) require, as a condition of recognition or
accreditation, as appropriate, that recognized accreditation
bodies and accredited laboratories report to the Secretary any
changes that would affect the recognition of such accreditation
body or the accreditation of such laboratory.
``(2) Program requirements.--The program established under
paragraph (1)(A) shall provide for the recognition of laboratory
accreditation bodies that meet criteria established by the
Secretary for accreditation of laboratories, including independent
private laboratories and laboratories run and operated by a Federal
agency (including the Department of Commerce), State, or locality
with a demonstrated capability to conduct 1 or more sampling and
analytical testing methodologies for food.
``(3) Increasing the number of qualified laboratories.--The
Secretary shall work with the laboratory accreditation bodies
recognized under paragraph (1), as appropriate, to increase the
number of qualified laboratories that are eligible to perform
testing under subparagraph (b) beyond the number so qualified on
the date of enactment of the FDA Food Safety Modernization Act.
``(4) Limited distribution.--In the interest of national
security, the Secretary, in coordination with the Secretary of
Homeland Security, may determine the time, manner, and form in
which the registry established under paragraph (1)(B) is made
publicly available.
``(5) Foreign laboratories.--Accreditation bodies recognized by
the Secretary under paragraph (1) may accredit laboratories that
operate outside the United States, so long as such laboratories
meet the accreditation standards applicable to domestic
laboratories accredited under this section.
``(6) Model laboratory standards.--The Secretary shall develop
model standards that a laboratory shall meet to be accredited by a
recognized accreditation body for a specified sampling or
analytical testing methodology and included in the registry
provided for under paragraph (1). In developing the model
standards, the Secretary shall consult existing standards for
guidance. The model standards shall include--
``(A) methods to ensure that--
``(i) appropriate sampling, analytical procedures
(including rapid analytical procedures), and commercially
available techniques are followed and reports of analyses
are certified as true and accurate;
``(ii) internal quality systems are established and
maintained;
``(iii) procedures exist to evaluate and respond
promptly to complaints regarding analyses and other
activities for which the laboratory is accredited; and
``(iv) individuals who conduct the sampling and
analyses are qualified by training and experience to do so;
and
``(B) any other criteria determined appropriate by the
Secretary.
``(7) Review of recognition.--To ensure compliance with the
requirements of this section, the Secretary--
``(A) shall periodically, and in no case less than once
every 5 years, reevaluate accreditation bodies recognized under
paragraph (1) and may accompany auditors from an accreditation
body to assess whether the accreditation body meets the
criteria for recognition; and
``(B) shall promptly revoke the recognition of any
accreditation body found not to be in compliance with the
requirements of this section, specifying, as appropriate, any
terms and conditions necessary for laboratories accredited by
such body to continue to perform testing as described in this
section.
``(b) Testing Procedures.--
``(1) In general.--Not later than 30 months after the date of
enactment of the FDA Food Safety Modernization Act, food testing
shall be conducted by Federal laboratories or non-Federal
laboratories that have been accredited for the appropriate sampling
or analytical testing methodology or methodologies by a recognized
accreditation body on the registry established by the Secretary
under subsection (a)(1)(B) whenever such testing is conducted--
``(A) by or on behalf of an owner or consignee--
``(i) in response to a specific testing requirement
under this Act or implementing regulations, when applied to
address an identified or suspected food safety problem; and
``(ii) as required by the Secretary, as the Secretary
deems appropriate, to address an identified or suspected
food safety problem; or
``(B) on behalf of an owner or consignee--
``(i) in support of admission of an article of food
under section 801(a); and
``(ii) under an Import Alert that requires successful
consecutive tests.
``(2) Results of testing.--The results of any such testing
shall be sent directly to the Food and Drug Administration, except
the Secretary may by regulation exempt test results from such
submission requirement if the Secretary determines that such
results do not contribute to the protection of public health. Test
results required to be submitted may be submitted to the Food and
Drug Administration through electronic means.
``(3) Exception.--The Secretary may waive requirements under
this subsection if--
``(A) a new methodology or methodologies have been
developed and validated but a laboratory has not yet been
accredited to perform such methodology or methodologies; and
``(B) the use of such methodology or methodologies are
necessary to prevent, control, or mitigate a food emergency or
foodborne illness outbreak.
``(c) Review by Secretary.--If food sampling and testing performed
by a laboratory run and operated by a State or locality that is
accredited by a recognized accreditation body on the registry
established by the Secretary under subsection (a) result in a State
recalling a food, the Secretary shall review the sampling and testing
results for the purpose of determining the need for a national recall
or other compliance and enforcement activities.
``(d) No Limit on Secretarial Authority.--Nothing in this section
shall be construed to limit the ability of the Secretary to review and
act upon information from food testing, including determining the
sufficiency of such information and testing.''.
(b) Food Emergency Response Network.--The Secretary, in
coordination with the Secretary of Agriculture, the Secretary of
Homeland Security, and State, local, and tribal governments shall, not
later than 180 days after the date of enactment of this Act, and
biennially thereafter, submit to the relevant committees of Congress,
and make publicly available on the Internet Web site of the Department
of Health and Human Services, a report on the progress in implementing
a national food emergency response laboratory network that--
(1) provides ongoing surveillance, rapid detection, and surge
capacity for large-scale food-related emergencies, including
intentional adulteration of the food supply;
(2) coordinates the food laboratory capacities of State, local,
and tribal food laboratories, including the adoption of novel
surveillance and identification technologies and the sharing of
data between Federal agencies and State laboratories to develop
national situational awareness;
(3) provides accessible, timely, accurate, and consistent food
laboratory services throughout the United States;
(4) develops and implements a methods repository for use by
Federal, State, and local officials;
(5) responds to food-related emergencies; and
(6) is integrated with relevant laboratory networks
administered by other Federal agencies.

0cf0daa364b84ca75448c4a4a5df36d794aa17123c1961ae82f4e3248a6b9412

(a) In General.--The Secretary of Homeland Security, in
coordination with the Secretary of Health and Human Services, the
Secretary of Agriculture, the Secretary of Commerce, and the
Administrator of the Environmental Protection Agency, shall maintain an
agreement through which relevant laboratory network members, as
determined by the Secretary of Homeland Security, shall--
(1) agree on common laboratory methods in order to reduce the
time required to detect and respond to foodborne illness outbreaks
and facilitate the sharing of knowledge and information relating to
animal health, agriculture, and human health;
(2) identify means by which laboratory network members could
work cooperatively--
(A) to optimize national laboratory preparedness; and
(B) to provide surge capacity during emergencies; and
(3) engage in ongoing dialogue and build relationships that
will support a more effective and integrated response during
emergencies.
(b) Reporting Requirement.--The Secretary of Homeland Security
shall, on a biennial basis, submit to the relevant committees of
Congress, and make publicly available on the Internet Web site of the
Department of Homeland Security, a report on the progress of the
integrated consortium of laboratory networks, as established under
subsection (a), in carrying out this section.

48df4b31123e4d44f2e67f93028d80ae17abfc5cc3213efa4283032d110026a8

21ab69a33bc1c091d40fd52358b514a5cc724d6489fa879f809d5202c0745cc8

(a) Definition of Foodborne Illness Outbreak.--In this Act, the
term ``foodborne illness outbreak'' means the occurrence of 2 or more
cases of a similar illness resulting from the ingestion of a certain
food.
(b) Foodborne Illness Surveillance Systems.--
(1) In general.--The Secretary, acting through the Director of
the Centers for Disease Control and Prevention, shall enhance
foodborne illness surveillance systems to improve the collection,
analysis, reporting, and usefulness of data on foodborne illnesses
by--
(A) coordinating Federal, State and local foodborne illness
surveillance systems, including complaint systems, and
increasing participation in national networks of public health
and food regulatory agencies and laboratories;
(B) facilitating sharing of surveillance information on a
more timely basis among governmental agencies, including the
Food and Drug Administration, the Department of Agriculture,
the Department of Homeland Security, and State and local
agencies, and with the public;
(C) developing improved epidemiological tools for obtaining
quality exposure data and microbiological methods for
classifying cases;
(D) augmenting such systems to improve attribution of a
foodborne illness outbreak to a specific food;
(E) expanding capacity of such systems, including working
toward automatic electronic searches, for implementation of
identification practices, including fingerprinting strategies,
for foodborne infectious agents, in order to identify new or
rarely documented causes of foodborne illness and submit
standardized information to a centralized database;
(F) allowing timely public access to aggregated, de-
identified surveillance data;
(G) at least annually, publishing current reports on
findings from such systems;
(H) establishing a flexible mechanism for rapidly
initiating scientific research by academic institutions;
(I) integrating foodborne illness surveillance systems and
data with other biosurveillance and public health situational
awareness capabilities at the Federal, State, and local levels,
including by sharing foodborne illness surveillance data with
the National Biosurveillance Integration Center; and
(J) other activities as determined appropriate by the
Secretary.
(2) Working group.--The Secretary shall support and maintain a
diverse working group of experts and stakeholders from Federal,
State, and local food safety and health agencies, the food and food
testing industries, consumer organizations, and academia. Such
working group shall provide the Secretary, through at least annual
meetings of the working group and an annual public report, advice
and recommendations on an ongoing and regular basis regarding the
improvement of foodborne illness surveillance and implementation of
this section, including advice and recommendations on--
(A) the priority needs of regulatory agencies, the food
industry, and consumers for information and analysis on
foodborne illness and its causes;
(B) opportunities to improve the effectiveness of
initiatives at the Federal, State, and local levels, including
coordination and integration of activities among Federal
agencies, and between the Federal, State, and local levels of
government;
(C) improvement in the timeliness and depth of access by
regulatory and health agencies, the food industry, academic
researchers, and consumers to foodborne illness aggregated, de-
identified surveillance data collected by government agencies
at all levels, including data compiled by the Centers for
Disease Control and Prevention;
(D) key barriers at Federal, State, and local levels to
improving foodborne illness surveillance and the utility of
such surveillance for preventing foodborne illness;
(E) the capabilities needed for establishing automatic
electronic searches of surveillance data; and
(F) specific actions to reduce barriers to improvement,
implement the working group's recommendations, and achieve the
purposes of this section, with measurable objectives and
timelines, and identification of resource and staffing needs.
(3) Authorization of appropriations.--To carry out the
activities described in paragraph (1), there is authorized to be
appropriated $24,000,000 for each fiscal years 2011 through 2015.
(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 foodborne illness outbreak response and
containment.
(B) Accelerate foodborne 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 foodborne 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.
(F) Strengthen the capacity of State and local agencies to
achieve the goals described in section 108.
(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 the FDA Food Safety Modernization 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.
(d) Food Safety Capacity Building Grants.--Section 317R(b) of the
Public Health Service Act (42 U.S.C. 247b-20(b)) is amended--
(1) by striking ``2002'' and inserting ``2010''; and
(2) by striking ``2003 through 2006'' and inserting ``2011
through 2015''.

637eab0989310c311a784782ddc92c0712ac97ee4b13312489961b76919c503a

(a) In General.--Chapter IV (21 U.S.C. 341 et seq.), as amended by
section 202, is amended by adding at the end the following:
``SEC. 423. MANDATORY RECALL AUTHORITY.
``(a) Voluntary Procedures.--If the Secretary determines, based on
information gathered through the reportable food registry under section
417 or through any other means, that there is a reasonable probability
that an article of food (other than infant formula) is adulterated
under section 402 or misbranded under section 403(w) and the use of or
exposure to such article will cause serious adverse health consequences
or death to humans or animals, the Secretary shall provide the
responsible party (as defined in section 417) with an opportunity to
cease distribution and recall such article.
``(b) Prehearing Order To Cease Distribution and Give Notice.--
``(1) In general.--If the responsible party refuses to or does
not voluntarily cease distribution or recall such article within
the time and in the manner prescribed by the Secretary (if so
prescribed), the Secretary may, by order require, as the Secretary
deems necessary, such person to--
``(A) immediately cease distribution of such article; and
``(B) as applicable, immediately notify all persons--
``(i) manufacturing, processing, packing, transporting,
distributing, receiving, holding, or importing and selling
such article; and
``(ii) to which such article has been distributed,
transported, or sold, to immediately cease distribution of
such article.
``(2) Required additional information.--
``(A) In general.--If an article of food covered by a
recall order issued under paragraph (1)(B) has been distributed
to a warehouse-based third party logistics provider without
providing such provider sufficient information to know or
reasonably determine the precise identity of the article of
food covered by a recall order that is in its possession, the
notice provided by the responsible party subject to the order
issued under paragraph (1)(B) shall include such information as
is necessary for the warehouse-based third party logistics
provider to identify the food.
``(B) Rules of construction.--Nothing in this paragraph
shall be construed--
``(i) to exempt a warehouse-based third party logistics
provider from the requirements of this Act, including the
requirements in this section and section 414; or
``(ii) to exempt a warehouse-based third party
logistics provider from being the subject of a mandatory
recall order.
``(3) Determination to limit areas affected.--If the Secretary
requires a responsible party to cease distribution under paragraph
(1)(A) of an article of food identified in subsection (a), the
Secretary may limit the size of the geographic area and the markets
affected by such cessation if such limitation would not compromise
the public health.
``(c) Hearing on Order.--The Secretary shall provide the
responsible party subject to an order under subsection (b) with an
opportunity for an informal hearing, to be held as soon as possible,
but not later than 2 days after the issuance of the order, on the
actions required by the order and on why the article that is the
subject of the order should not be recalled.
``(d) Post-hearing Recall Order and Modification of Order.--
``(1) Amendment of order.--If, after providing opportunity for
an informal hearing under subsection (c), the Secretary determines
that removal of the article from commerce is necessary, the
Secretary shall, as appropriate--
``(A) amend the order to require recall of such article or
other appropriate action;
``(B) specify a timetable in which the recall shall occur;
``(C) require periodic reports to the Secretary describing
the progress of the recall; and
``(D) provide notice to consumers to whom such article was,
or may have been, distributed.
``(2) Vacating of order.--If, after such hearing, the Secretary
determines that adequate grounds do not exist to continue the
actions required by the order, or that such actions should be
modified, the Secretary shall vacate the order or modify the order.
``(e) Rule Regarding Alcoholic Beverages.--The Secretary shall not
initiate a mandatory recall or take any other action under this section
with respect to any alcohol beverage until the Secretary has provided
the Alcohol and Tobacco Tax and Trade Bureau with a reasonable
opportunity to cease distribution and recall such article under the
Alcohol and Tobacco Tax and Trade Bureau authority.
``(f) Cooperation and Consultation.--The Secretary shall work with
State and local public health officials in carrying out this section,
as appropriate.
``(g) Public Notification.--In conducting a recall under this
section, the Secretary shall--
``(1) ensure that a press release is published regarding the
recall, as well as alerts and public notices, as appropriate, in
order to provide notification--
``(A) of the recall to consumers and retailers to whom such
article was, or may have been, distributed; and
``(B) that includes, at a minimum--
``(i) the name of the article of food subject to the
recall;
``(ii) a description of the risk associated with such
article; and
``(iii) to the extent practicable, information for
consumers about similar articles of food that are not
affected by the recall;
``(2) consult the policies of the Department of Agriculture
regarding providing to the public a list of retail consignees
receiving products involved in a Class I recall and shall consider
providing such a list to the public, as determined appropriate by
the Secretary; and
``(3) if available, publish on the Internet Web site of the
Food and Drug Administration an image of the article that is the
subject of the press release described in (1).
``(h) No Delegation.--The authority conferred by this section to
order a recall or vacate a recall order shall not be delegated to any
officer or employee other than the Commissioner.
``(i) Effect.--Nothing in this section shall affect the authority
of the Secretary to request or participate in a voluntary recall, or to
issue an order to cease distribution or to recall under any other
provision of this Act or under the Public Health Service Act.
``(j) Coordinated Communication.--
``(1) In general.--To assist in carrying out the requirements
of this subsection, the Secretary shall establish an incident
command operation or a similar operation within the Department of
Health and Human Services that will operate not later than 24 hours
after the initiation of a mandatory recall or the recall of an
article of food for which the use of, or exposure to, such article
will cause serious adverse health consequences or death to humans
or animals.
``(2) Requirements.--To reduce the potential for
miscommunication during recalls or regarding investigations of a
food borne illness outbreak associated with a food that is subject
to a recall, each incident command operation or similar operation
under paragraph (1) shall use regular staff and resources of the
Department of Health and Human Services to--
``(A) ensure timely and coordinated communication within
the Department, including enhanced communication and
coordination between different agencies and organizations
within the Department;
``(B) ensure timely and coordinated communication from the
Department, including public statements, throughout the
duration of the investigation and related foodborne illness
outbreak;
``(C) identify a single point of contact within the
Department for public inquiries regarding any actions by the
Secretary related to a recall;
``(D) coordinate with Federal, State, local, and tribal
authorities, as appropriate, that have responsibilities related
to the recall of a food or a foodborne illness outbreak
associated with a food that is subject to the recall, including
notification of the Secretary of Agriculture and the Secretary
of Education in the event such recalled food is a commodity
intended for use in a child nutrition program (as identified in
section 25(b) of the Richard B. Russell National School Lunch
Act (42 U.S.C. 1769f(b))); and
``(E) conclude operations at such time as the Secretary
determines appropriate.
``(3) Multiple recalls.--The Secretary may establish multiple
or concurrent incident command operations or similar operations in
the event of multiple recalls or foodborne illness outbreaks
necessitating such action by the Department of Health and Human
Services.''.
(b) Search Engine.--Not later than 90 days after the date of
enactment of this Act, the Secretary shall modify the Internet Web site
of the Food and Drug Administration to include a search engine that--
(1) is consumer-friendly, as determined by the Secretary; and
(2) provides a means by which an individual may locate relevant
information regarding each article of food subject to a recall
under section 423 of the Federal Food, Drug, and Cosmetic Act and
the status of such recall (such as whether a recall is ongoing or
has been completed).
(c) Civil Penalty.--Section 303(f)(2)(A) (21 U.S.C. 333(f)(2)(A))
is amended by inserting ``or any person who does not comply with a
recall order under section 423'' after ``section 402(a)(2)(B)''.
(d) Prohibited Acts.--Section 301 (21 U.S.C. 331 et seq.), as
amended by section 106, is amended by adding at the end the following:
``(xx) The refusal or failure to follow an order under section
423.''.
(e) GAO Review.--
(1) In general.--Not later than 90 days after the date of
enactment of this Act, the Comptroller General of the United States
shall submit to Congress a report that--
(A) identifies State and local agencies with the authority
to require the mandatory recall of food, and evaluates use of
such authority with regard to frequency, effectiveness, and
appropriateness, including consideration of any new or existing
mechanisms available to compensate persons for general and
specific recall-related costs when a recall is subsequently
determined by the relevant authority to have been an error;
(B) identifies Federal agencies, other than the Department
of Health and Human Services, with mandatory recall authority
and examines use of that authority with regard to frequency,
effectiveness, and appropriateness, including any new or
existing mechanisms available to compensate persons for general
and specific recall-related costs when a recall is subsequently
determined by the relevant agency to have been an error;
(C) considers models for farmer restitution implemented in
other nations in cases of erroneous recalls; and
(D) makes recommendations to the Secretary regarding use of
the authority under section 423 of the Federal Food, Drug, and
Cosmetic Act (as added by this section) to protect the public
health while seeking to minimize unnecessary economic costs.
(2) Effect of review.--If the Comptroller General of the United
States finds, after the review conducted under paragraph (1), that
the mechanisms described in such paragraph do not exist or are
inadequate, then, not later than 90 days after the conclusion of
such review, the Secretary of Agriculture shall conduct a study of
the feasibility of implementing a farmer indemnification program to
provide restitution to agricultural producers for losses sustained
as a result of a mandatory recall of an agricultural commodity by a
Federal or State regulatory agency that is subsequently determined
to be in error. The Secretary of Agriculture shall submit to the
Committee on Agriculture of the House of Representatives and the
Committee on Agriculture, Nutrition, and Forestry of the Senate a
report that describes the results of the study, including any
recommendations.
(f) Annual Report to Congress.--
(1) In general.--Not later than 2 years after the date of
enactment of this Act and annually thereafter, the Secretary of
Health and Human Services (referred to in this subsection as the
``Secretary'') shall submit a report to the Committee on Health,
Education, Labor, and Pensions of the Senate and the Committee on
Energy and Commerce of the House of Representatives on the use of
recall authority under section 423 of the Federal Food, Drug, and
Cosmetic Act (as added by subsection (a)) and any public health
advisories issued by the Secretary that advise against the
consumption of an article of food on the ground that the article of
food is adulterated and poses an imminent danger to health.
(2) Content.--The report under paragraph (1) shall include,
with respect to the report year--
(A) the identity of each article of food that was the
subject of a public health advisory described in paragraph (1),
an opportunity to cease distribution and recall under
subsection (a) of section 423 of the Federal Food, Drug, and
Cosmetic Act, or a mandatory recall order under subsection (b)
of such section;
(B) the number of responsible parties, as defined in
section 417 of the Federal Food, Drug, and Cosmetic Act,
formally given the opportunity to cease distribution of an
article of food and recall such article, as described in
section 423(a) of such Act;
(C) the number of responsible parties described in
subparagraph (B) who did not cease distribution of or recall an
article of food after given the opportunity to cease
distribution or recall under section 423(a) of the Federal
Food, Drug, and Cosmetic Act;
(D) the number of recall orders issued under section 423(b)
of the Federal Food, Drug, and Cosmetic Act; and
(E) a description of any instances in which there was no
testing that confirmed adulteration of an article of food that
was the subject of a recall under section 423(b) of the Federal
Food, Drug, and Cosmetic Act or a public health advisory
described in paragraph (1).

8b2ca071f3fcbf3913f5ecdb8f2fb591fbfd0588df3cc74083b9bcef6deeda93

(a) In General.--Section 304(h)(1)(A) (21 U.S.C. 334(h)(1)(A)) is
amended by--
(1) striking ``credible evidence or information indicating''
and inserting ``reason to believe''; and
(2) striking ``presents a threat of serious adverse health
consequences or death to humans or animals'' and inserting ``is
adulterated or misbranded''.
(b) Regulations.--Not later than 120 days after the date of
enactment of this Act, the Secretary shall issue an interim final rule
amending subpart K of part 1 of title 21, Code of Federal Regulations,
to implement the amendment made by this section.
(c) Effective Date.--The amendment made by this section shall take
effect 180 days after the date of enactment of this Act.

8929fb727a01c8513de530f6cbf72817d1bd16cc30fa8c29415afe0ccabf40d9

(a) In General.--The Administrator of the Environmental Protection
Agency (referred to in this section as the ``Administrator''), in
coordination with the Secretary of Health and Human Services, Secretary
of Homeland Security, and Secretary of Agriculture, shall provide
support for, and technical assistance to, State, local, and tribal
governments in preparing for, assessing, decontaminating, and
recovering from an agriculture or food emergency.
(b) Development of Standards.--In carrying out subsection (a), the
Administrator, in coordination with the Secretary of Health and Human
Services, Secretary of Homeland Security, Secretary of Agriculture, and
State, local, and tribal governments, shall develop and disseminate
specific standards and protocols to undertake clean-up, clearance, and
recovery activities following the decontamination and disposal of
specific threat agents and foreign animal diseases.
(c) Development of Model Plans.--In carrying out subsection (a),
the Administrator, the Secretary of Health and Human Services, and the
Secretary of Agriculture shall jointly develop and disseminate model
plans for--
(1) the decontamination of individuals, equipment, and
facilities following an intentional contamination of agriculture or
food; and
(2) the disposal of large quantities of animals, plants, or
food products that have been infected or contaminated by specific
threat agents and foreign animal diseases.
(d) Exercises.--In carrying out subsection (a), the Administrator,
in coordination with the entities described under subsection (b), shall
conduct exercises at least annually to evaluate and identify weaknesses
in the decontamination and disposal model plans described in subsection
(c). Such exercises shall be carried out, to the maximum extent
practicable, as part of the national exercise program under section
648(b)(1) of the Post-Katrina Emergency Management Reform Act of 2006
(6 U.S.C. 748(b)(1)).
(e) Modifications.--Based on the exercises described in subsection
(d), the Administrator, in coordination with the entities described in
subsection (b), shall review and modify as necessary the plans
described in subsection (c) not less frequently than biennially.
(f) Prioritization.--The Administrator, in coordination with the
entities described in subsection (b), shall develop standards and plans
under subsections (b) and (c) in an identified order of priority that
takes into account--
(1) highest-risk biological, chemical, and radiological threat
agents;
(2) agents that could cause the greatest economic devastation
to the agriculture and food system; and
(3) agents that are most difficult to clean or remediate.

c6a30cdf8c1a9e1c067d5bc8e1225eb56d56de4394c7af3540b98699ad17173b

TRIBAL FOOD SAFETY OFFICIALS.
(a) Improving Training.--Chapter X (21 U.S.C. 391 et seq.) is
amended by adding at the end the following:
``SEC. 1011. IMPROVING THE TRAINING OF STATE, LOCAL, TERRITORIAL, AND
TRIBAL FOOD SAFETY OFFICIALS.
``(a) Training.--The Secretary shall set standards and administer
training and education programs for the employees of State, local,
territorial, and tribal food safety officials relating to the
regulatory responsibilities and policies established by this Act,
including programs for--
``(1) scientific training;
``(2) training to improve the skill of officers and employees
authorized to conduct inspections under sections 702 and 704;
``(3) training to achieve advanced product or process
specialization in such inspections;
``(4) training that addresses best practices;
``(5) training in administrative process and procedure and
integrity issues;
``(6) training in appropriate sampling and laboratory analysis
methodology; and
``(7) training in building enforcement actions following
inspections, examinations, testing, and investigations.
``(b) Partnerships With State and Local Officials.--
``(1) In general.--The Secretary, pursuant to a contract or
memorandum of understanding between the Secretary and the head of a
State, local, territorial, or tribal department or agency, is
authorized and encouraged to conduct examinations, testing, and
investigations for the purposes of determining compliance with the
food safety provisions of this Act through the officers and
employees of such State, local, territorial, or tribal department
or agency.
``(2) Content.--A contract or memorandum described under
paragraph (1) shall include provisions to ensure adequate training
of such officers and employees to conduct such examinations,
testing, and investigations. The contract or memorandum shall
contain provisions regarding reimbursement. Such provisions may, at
the sole discretion of the head of the other department or agency,
require reimbursement, in whole or in part, from the Secretary for
the examinations, testing, or investigations performed pursuant to
this section by the officers or employees of the State,
territorial, or tribal department or agency.
``(3) Effect.--Nothing in this subsection shall be construed to
limit the authority of the Secretary under section 702.
``(c) Extension Service.--The Secretary shall ensure coordination
with the extension activities of the National Institute of Food and
Agriculture of the Department of Agriculture in advising producers and
small processors transitioning into new practices required as a result
of the enactment of the FDA Food Safety Modernization Act and assisting
regulated industry with compliance with such Act.
``(d) National Food Safety Training, Education, Extension, Outreach
and Technical Assistance Program.--
``(1) In general.--In order to improve food safety and reduce
the incidence of foodborne illness, the Secretary shall, not later
than 180 days after the date of enactment of the FDA Food Safety
Modernization Act, enter into one or more memoranda of
understanding, or enter into other cooperative agreements, with the
Secretary of Agriculture to establish a competitive grant program
within the National Institute for Food and Agriculture to provide
food safety training, education, extension, outreach, and technical
assistance to--
``(A) owners and operators of farms;
``(B) small food processors; and
``(C) small fruit and vegetable merchant wholesalers.
``(2) Implementation.--The competitive grant program
established under paragraph (1) shall be carried out in accordance
with section 405 of the Agricultural Research, Extension, and
Education Reform Act of 1998.
``(e) Authorization of Appropriations.--There are authorized to be
appropriated such sums as may be necessary to carry out this section
for fiscal years 2011 through 2015.''.
(b) National Food Safety Training, Education, Extension, Outreach,
and Technical Assistance Program.--Title IV of the Agricultural
Research, Extension, and Education Reform Act of 1998 is amended by
inserting after section 404 (7 U.S.C. 7624) the following:
``SEC. 405. NATIONAL FOOD SAFETY TRAINING, EDUCATION, EXTENSION,
OUTREACH, AND TECHNICAL ASSISTANCE PROGRAM.
``(a) In General.--The Secretary shall award grants under this
section to carry out the competitive grant program established under
section 1011(d) of the Federal Food, Drug, and Cosmetic Act, pursuant
to any memoranda of understanding entered into under such section.
``(b) Integrated Approach.--The grant program described under
subsection (a) shall be carried out under this section in a manner that
facilitates the integration of food safety standards and guidance with
the variety of agricultural production systems, encompassing
conventional, sustainable, organic, and conservation and environmental
practices.
``(c) Priority.--In awarding grants under this section, the
Secretary shall give priority to projects that target small and medium-
sized farms, beginning farmers, socially disadvantaged farmers, small
processors, or small fresh fruit and vegetable merchant wholesalers.
``(d) Program Coordination.--
``(1) In general.--The Secretary shall coordinate
implementation of the grant program under this section with the
National Integrated Food Safety Initiative.
``(2) Interaction.--The Secretary shall--
``(A) in carrying out the grant program under this section,
take into consideration applied research, education, and
extension results obtained from the National Integrated Food
Safety Initiative; and
``(B) in determining the applied research agenda for the
National Integrated Food Safety Initiative, take into
consideration the needs articulated by participants in projects
funded by the program under this section.
``(e) Grants.--
``(1) In general.--In carrying out this section, the Secretary
shall make competitive grants to support training, education,
extension, outreach, and technical assistance projects that will
help improve public health by increasing the understanding and
adoption of established food safety standards, guidance, and
protocols.
``(2) Encouraged features.--The Secretary shall encourage
projects carried out using grant funds under this section to
include co-management of food safety, conservation systems, and
ecological health.
``(3) Maximum term and size of grant.--
``(A) In general.--A grant under this section shall have a
term that is not more than 3 years.
``(B) Limitation on grant funding.--The Secretary may not
provide grant funding to an entity under this section after
such entity has received 3 years of grant funding under this
section.
``(f) Grant Eligibility.--
``(1) In general.--To be eligible for a grant under this
section, an entity shall be--
``(A) a State cooperative extension service;
``(B) a Federal, State, local, or tribal agency, a
nonprofit community-based or non-governmental organization, or
an organization representing owners and operators of farms,
small food processors, or small fruit and vegetable merchant
wholesalers that has a commitment to public health and
expertise in administering programs that contribute to food
safety;
``(C) an institution of higher education (as defined in
section 101(a) of the Higher Education Act of 1965 (20 U.S.C.
1001(a))) or a foundation maintained by an institution of
higher education;
``(D) a collaboration of 2 of more eligible entities
described in this subsection; or
``(E) such other appropriate entity, as determined by the
Secretary.
``(2) Multistate partnerships.--Grants under this section may
be made for projects involving more than 1 State.
``(g) Regional Balance.--In making grants under this section, the
Secretary shall, to the maximum extent practicable, ensure--
``(1) geographic diversity; and
``(2) diversity of types of agricultural production.
``(h) Technical Assistance.--The Secretary may use funds made
available under this section to provide technical assistance to grant
recipients to further the purposes of this section.
``(i) Best Practices and Model Programs.--Based on evaluations of,
and responses arising from, projects funded under this section, the
Secretary may issue a set of recommended best practices and models for
food safety training programs for agricultural producers, small food
processors, and small fresh fruit and vegetable merchant wholesalers.
``(j) Authorization of Appropriations.--For the purposes of making
grants under this section, there are authorized to be appropriated such
sums as may be necessary for fiscal years 2011 through 2015.''.

9822cd4d3252edce8b61fd337c120180c76484c7d5bbd0a27353edaf99f039dd

(a) Grants To Enhance Food Safety.--Section 1009 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 399) is amended to read as
follows:
``SEC. 1009. GRANTS TO ENHANCE FOOD SAFETY.
``(a) In General.--The Secretary is authorized to make grants to
eligible entities to--
``(1) undertake examinations, inspections, and investigations,
and related food safety activities under section 702;
``(2) train to the standards of the Secretary for the
examination, inspection, and investigation of food manufacturing,
processing, packing, holding, distribution, and importation,
including as such examination, inspection, and investigation relate
to retail food establishments;
``(3) build the food safety capacity of the laboratories of
such eligible entity, including the detection of zoonotic diseases;
``(4) build the infrastructure and capacity of the food safety
programs of such eligible entity to meet the standards as outlined
in the grant application; and
``(5) take appropriate action to protect the public health in
response to--
``(A) a notification under section 1008, including planning
and otherwise preparing to take such action; or
``(B) a recall of food under this Act.
``(b) Eligible Entities; Application.--
``(1) In general.--In this section, the term `eligible entity'
means an entity--
``(A) that is--
``(i) a State;
``(ii) a locality;
``(iii) a territory;
``(iv) an Indian tribe (as defined in section 4(e) of
the Indian Self-Determination and Education Assistance
Act); or
``(v) a nonprofit food safety training entity that
collaborates with 1 or more institutions of higher
education; and
``(B) that submits an application to the Secretary at such
time, in such manner, and including such information as the
Secretary may reasonably require.
``(2) Contents.--Each application submitted under paragraph (1)
shall include--
``(A) an assurance that the eligible entity has developed
plans to engage in the types of activities described in
subsection (a);
``(B) a description of the types of activities to be funded
by the grant;
``(C) an itemization of how grant funds received under this
section will be expended;
``(D) a description of how grant activities will be
monitored; and
``(E) an agreement by the eligible entity to report
information required by the Secretary to conduct evaluations
under this section.
``(c) Limitations.--The funds provided under subsection (a) shall
be available to an eligible entity that receives a grant under this
section only to the extent such entity funds the food safety programs
of such entity independently of any grant under this section in each
year of the grant at a level equal to the level of such funding in the
previous year, increased by the Consumer Price Index. Such non-Federal
matching funds may be provided directly or through donations from
public or private entities and may be in cash or in-kind, fairly
evaluated, including plant, equipment, or services.
``(d) Additional Authority.--The Secretary may--
``(1) award a grant under this section in each subsequent
fiscal year without reapplication for a period of not more than 3
years, provided the requirements of subsection (c) are met for the
previous fiscal year; and
``(2) award a grant under this section in a fiscal year for
which the requirement of subsection (c) has not been met only if
such requirement was not met because such funding was diverted for
response to 1 or more natural disasters or in other extenuating
circumstances that the Secretary may determine appropriate.
``(e) Duration of Awards.--The Secretary may award grants to an
individual grant recipient under this section for periods of not more
than 3 years. In the event the Secretary conducts a program evaluation,
funding in the second year or third year of the grant, where
applicable, shall be contingent on a successful program evaluation by
the Secretary after the first year.
``(f) Progress and Evaluation.--
``(1) In general.--The Secretary shall measure the status and
success of each grant program authorized under the FDA Food Safety
Modernization Act (and any amendment made by such Act), including
the grant program under this section. A recipient of a grant
described in the preceding sentence shall, at the end of each grant
year, provide the Secretary with information on how grant funds
were spent and the status of the efforts by such recipient to
enhance food safety. To the extent practicable, the Secretary shall
take the performance of such a grant recipient into account when
determining whether to continue funding for such recipient.
``(2) No duplication.--In carrying out paragraph (1), the
Secretary shall not duplicate the efforts of the Secretary under
other provisions of this Act or the FDA Food Safety Modernization
Act that require measurement and review of the activities of grant
recipients under either such Act.
``(g) Supplement Not Supplant.--Grant funds received under this
section shall be used to supplement, and not supplant, non-Federal
funds and any other Federal funds available to carry out the activities
described in this section.
``(h) Authorization of Appropriations.--For the purpose of making
grants under this section, there are authorized to be appropriated such
sums as may be necessary for fiscal years 2011 through 2015.''.
(b) Centers of Excellence.--Part P of the Public Health Service Act
(42 U.S.C. 280g et seq.) is amended by adding at the end the following:
``SEC. 399V-5. FOOD SAFETY INTEGRATED CENTERS OF EXCELLENCE.
``(a) In General.--Not later than 1 year after the date of
enactment of the FDA Food Safety Modernization Act, the Secretary,
acting through the Director of the Centers for Disease Control and
Prevention and in consultation with the working group described in
subsection (b)(2), shall designate 5 Integrated Food Safety Centers of
Excellence (referred to in this section as the `Centers of Excellence')
to serve as resources for Federal, State, and local public health
professionals to respond to foodborne illness outbreaks. The Centers of
Excellence shall be headquartered at selected State health departments.
``(b) Selection of Centers of Excellence.--
``(1) Eligible entities.--To be eligible to be designated as a
Center of Excellence under subsection (a), an entity shall--
``(A) be a State health department;
``(B) partner with 1 or more institutions of higher
education that have demonstrated knowledge, expertise, and
meaningful experience with regional or national food
production, processing, and distribution, as well as leadership
in the laboratory, epidemiological, and environmental detection
and investigation of foodborne illness; and
``(C) provide to the Secretary such information, at such
time, and in such manner, as the Secretary may require.
``(2) Working group.--Not later than 180 days after the date of
enactment of the FDA Food Safety Modernization Act, the Secretary
shall establish a diverse working group of experts and stakeholders
from Federal, State, and local food safety and health agencies, the
food industry, including food retailers and food manufacturers,
consumer organizations, and academia to make recommendations to the
Secretary regarding designations of the Centers of Excellence.
``(3) Additional centers of excellence.--The Secretary may
designate eligible entities to be regional Food Safety Centers of
Excellence, in addition to the 5 Centers designated under
subsection (a).
``(c) Activities.--Under the leadership of the Director of the
Centers for Disease Control and Prevention, each Center of Excellence
shall be based out of a selected State health department, which shall
provide assistance to other regional, State, and local departments of
health through activities that include--
``(1) providing resources, including timely information
concerning symptoms and tests, for frontline health professionals
interviewing individuals as part of routine surveillance and
outbreak investigations;
``(2) providing analysis of the timeliness and effectiveness of
foodborne disease surveillance and outbreak response activities;
``(3) providing training for epidemiological and environmental
investigation of foodborne illness, including suggestions for
streamlining and standardizing the investigation process;
``(4) establishing fellowships, stipends, and scholarships to
train future epidemiological and food-safety leaders and to address
critical workforce shortages;
``(5) training and coordinating State and local personnel;
``(6) strengthening capacity to participate in existing or new
foodborne illness surveillance and environmental assessment
information systems; and
``(7) conducting research and outreach activities focused on
increasing prevention, communication, and education regarding food
safety.
``(d) Report to Congress.--Not later than 2 years after the date of
enactment of the FDA Food Safety Modernization Act, the Secretary shall
submit to Congress a report that--
``(1) describes the effectiveness of the Centers of Excellence;
and
``(2) provides legislative recommendations or describes
additional resources required by the Centers of Excellence.
``(e) Authorization of Appropriations.--There is authorized to be
appropriated such sums as may be necessary to carry out this section.
``(f) No Duplication of Effort.--In carrying out activities of the
Centers of Excellence or other programs under this section, the
Secretary shall not duplicate other Federal foodborne illness response
efforts.''.

d1e467bb1f2a14be7ccf1fc8818caca8262c54f603b50024f42f20ea1aa61215

(a) In General.--Section 417 (21 U.S.C. 350f) is amended--
(1) by redesignating subsections (f) through (k) as subsections
(i) through (n), respectively; and
(2) by inserting after subsection (e) the following:
``(f) Critical Information.--Except with respect to fruits and
vegetables that are raw agricultural commodities, not more than 18
months after the date of enactment of the FDA Food Safety Modernization
Act, the Secretary may require a responsible party to submit to the
Secretary consumer-oriented information regarding a reportable food,
which shall include--
``(1) a description of the article of food as provided in
subsection (e)(3);
``(2) as provided in subsection (e)(7), affected product
identification codes, such as UPC, SKU, or lot or batch numbers
sufficient for the consumer to identify the article of food;
``(3) contact information for the responsible party as provided
in subsection (e)(8); and
``(4) any other information the Secretary determines is
necessary to enable a consumer to accurately identify whether such
consumer is in possession of the reportable food.
``(g) Grocery Store Notification.--
``(1) Action by secretary.--The Secretary shall--
``(A) prepare the critical information described under
subsection (f) for a reportable food as a standardized one-page
summary;
``(B) publish such one-page summary on the Internet website
of the Food and Drug Administration in a format that can be
easily printed by a grocery store for purposes of consumer
notification.
``(2) Action by grocery store.--A notification described under
paragraph (1)(B) shall include the date and time such summary was
posted on the Internet website of the Food and Drug Administration.
``(h) Consumer Notification.--
``(1) In general.--If a grocery store sold a reportable food
that is the subject of the posting and such establishment is part
of chain of establishments with 15 or more physical locations, then
such establishment shall, not later than 24 hours after a one page
summary described in subsection (g) is published, prominently
display such summary or the information from such summary via at
least one of the methods identified under paragraph (2) and
maintain the display for 14 days.
``(2) List of conspicuous locations.--Not more than 1 year
after the date of enactment of the FDA Food Safety Modernization
Act, the Secretary shall develop and publish a list of acceptable
conspicuous locations and manners, from which grocery stores shall
select at least one, for providing the notification required in
paragraph (1). Such list shall include--
``(A) posting the notification at or near the register;
``(B) providing the location of the reportable food;
``(C) providing targeted recall information given to
customers upon purchase of a food; and
``(D) other such prominent and conspicuous locations and
manners utilized by grocery stores as of the date of the
enactment of the FDA Food Safety Modernization Act to provide
notice of such recalls to consumers as considered appropriate
by the Secretary.''.
(b) Prohibited Act.--Section 301 (21 U.S.C. 331), as amended by
section 206, is amended by adding at the end the following:
``(yy) The knowing and willful failure to comply with the
notification requirement under section 417(h).''.
(c) Conforming Amendment.--Section 301(e) (21 U.S.C. 331(e)) is
amended by striking ``417(g)'' and inserting ``417(j)''.

bca780ca24ae6f5ecde15f3e481843f10606a5c4726f33cc96f16d8dd5fba175

(a) In General.--Chapter VIII (21 U.S.C. 381 et seq.) is amended by
adding at the end the following:
``SEC. 805. FOREIGN SUPPLIER VERIFICATION PROGRAM.
``(a) In General.--
``(1) Verification requirement.--Except as provided under
subsections (e) and (f), each importer shall perform risk-based
foreign supplier verification activities for the purpose of
verifying that the food imported by the importer or agent of an
importer is--
``(A) produced in compliance with the requirements of
section 418 or section 419, as appropriate; and
``(B) is not adulterated under section 402 or misbranded
under section 403(w).
``(2) Importer defined.--For purposes of this section, the term
`importer' means, with respect to an article of food--
``(A) the United States owner or consignee of the article
of food at the time of entry of such article into the United
States; or
``(B) in the case when there is no United States owner or
consignee as described in subparagraph (A), the United States
agent or representative of a foreign owner or consignee of the
article of food at the time of entry of such article into the
United States.
``(b) Guidance.--Not later than 1 year after the date of enactment
of the FDA Food Safety Modernization Act, the Secretary shall issue
guidance to assist importers in developing foreign supplier
verification programs.
``(c) Regulations.--
``(1) In general.--Not later than 1 year after the date of
enactment of the FDA Food Safety Modernization Act, the Secretary
shall promulgate regulations to provide for the content of the
foreign supplier verification program established under subsection
(a).
``(2) Requirements.--The regulations promulgated under
paragraph (1)--
``(A) shall require that the foreign supplier verification
program of each importer be adequate to provide assurances that
each foreign supplier to the importer produces the imported
food in compliance with--
``(i) processes and procedures, including reasonably
appropriate risk-based preventive controls, that provide
the same level of public health protection as those
required under section 418 or section 419 (taking into
consideration variances granted under section 419), as
appropriate; and
``(ii) section 402 and section 403(w).
``(B) shall include such other requirements as the
Secretary deems necessary and appropriate to verify that food
imported into the United States is as safe as food produced and
sold within the United States.
``(3) Considerations.--In promulgating regulations under this
subsection, the Secretary shall, as appropriate, take into account
differences among importers and types of imported foods, including
based on the level of risk posed by the imported food.
``(4) Activities.--Verification activities under a foreign
supplier verification program under this section may include
monitoring records for shipments, lot-by-lot certification of
compliance, annual on-site inspections, checking the hazard
analysis and risk-based preventive control plan of the foreign
supplier, and periodically testing and sampling shipments.
``(d) Record Maintenance and Access.--Records of an importer
related to a foreign supplier verification program shall be maintained
for a period of not less than 2 years and shall be made available
promptly to a duly authorized representative of the Secretary upon
request.
``(e) Exemption of Seafood, Juice, and Low-acid Canned Food
Facilities in Compliance With HACCP.--This section shall not apply to a
facility if the owner, operator, or agent in charge of such facility is
required to comply with, and is in compliance with, 1 of the following
standards and regulations with respect to such facility:
``(1) The Seafood Hazard Analysis Critical Control Points
Program of the Food and Drug Administration.
``(2) The Juice Hazard Analysis Critical Control Points Program
of the Food and Drug Administration.
``(3) The Thermally Processed Low-Acid Foods Packaged in
Hermetically Sealed Containers standards of the Food and Drug
Administration (or any successor standards).
The exemption under paragraph (3) shall apply only with respect to
microbiological hazards that are regulated under the standards for
Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed
Containers under part 113 of chapter 21, Code of Federal Regulations
(or any successor regulations).
``(f) Additional Exemptions.--The Secretary, by notice published in
the Federal Register, shall establish an exemption from the
requirements of this section for articles of food imported in small
quantities for research and evaluation purposes or for personal
consumption, provided that such foods are not intended for retail sale
and are not sold or distributed to the public.
``(g) Publication of List of Participants.--The Secretary shall
publish and maintain on the Internet Web site of the Food and Drug
Administration a current list that includes the name of, location of,
and other information deemed necessary by the Secretary about,
importers participating under this section.''.
(b) Prohibited Act.--Section 301 (21 U.S.C. 331), as amended by
section 211, is amended by adding at the end the following:
``(zz) The importation or offering for importation of a food if the
importer (as defined in section 805) does not have in place a foreign
supplier verification program in compliance with such section 805.''.
(c) Imports.--Section 801(a) (21 U.S.C. 381(a)) is amended by
adding ``or the importer (as defined in section 805) is in violation of
such section 805'' after ``or in violation of section 505''.
(d) Effective Date.--The amendments made by this section shall take
effect 2 years after the date of enactment of this Act.

d4ed4bdb9a67494e012bb6c5e6b7bd00316b03e4f958434e8b8e0ac29f66a7fd

Chapter VIII (21 U.S.C. 381 et seq.), as amended by section 301, is
amended by adding at the end the following:
``SEC. 806. VOLUNTARY QUALIFIED IMPORTER PROGRAM.
``(a) In General.--Beginning not later than 18 months after the
date of enactment of the FDA Food Safety Modernization Act, the
Secretary shall--
``(1) establish a program, in consultation with the Secretary
of Homeland Security--
``(A) to provide for the expedited review and importation
of food offered for importation by importers who have
voluntarily agreed to participate in such program; and
``(B) consistent with section 808, establish a process for
the issuance of a facility certification to accompany food
offered for importation by importers who have voluntarily
agreed to participate in such program; and
``(2) issue a guidance document related to participation in,
revocation of such participation in, reinstatement in, and
compliance with, such program.
``(b) Voluntary Participation.--An importer may request the
Secretary to provide for the expedited review and importation of
designated foods in accordance with the program established by the
Secretary under subsection (a).
``(c) Notice of Intent To Participate.--An importer that intends to
participate in the program under this section in a fiscal year shall
submit a notice and application to the Secretary of such intent at the
time and in a manner established by the Secretary.
``(d) Eligibility.--Eligibility shall be limited to an importer
offering food for importation from a facility that has a certification
described in subsection (a). In reviewing the applications and making
determinations on such applications, the Secretary shall consider the
risk of the food to be imported based on factors, such as the
following:
``(1) The known safety risks of the food to be imported.
``(2) The compliance history of foreign suppliers used by the
importer, as appropriate.
``(3) The capability of the regulatory system of the country of
export to ensure compliance with United States food safety
standards for a designated food.
``(4) The compliance of the importer with the requirements of
section 805.
``(5) The recordkeeping, testing, inspections and audits of
facilities, traceability of articles of food, temperature controls,
and sourcing practices of the importer.
``(6) The potential risk for intentional adulteration of the
food.
``(7) Any other factor that the Secretary determines
appropriate.
``(e) Review and Revocation.--Any importer qualified by the
Secretary in accordance with the eligibility criteria set forth in this
section shall be reevaluated not less often than once every 3 years and
the Secretary shall promptly revoke the qualified importer status of
any importer found not to be in compliance with such criteria.
``(f) False Statements.--Any statement or representation made by an
importer to the Secretary shall be subject to section 1001 of title 18,
United States Code.
``(g) Definition.--For purposes of this section, the term
`importer' means the person that brings food, or causes food to be
brought, from a foreign country into the customs territory of the
United States.''.

e4141e7d58156c81111de3a2ddd58652eecb46e58d34b769166e5d464a2c4259

(a) In General.--Section 801(a) (21 U.S.C. 381(a)) is amended by
inserting after the third sentence the following: ``With respect to an
article of food, if importation of such food is subject to, but not
compliant with, the requirement under subsection (q) that such food be
accompanied by a certification or other assurance that the food meets
applicable requirements of this Act, then such article shall be refused
admission.''.
(b) Addition of Certification Requirement.--Section 801 (21 U.S.C.
381) is amended by adding at the end the following new subsection:
``(q) Certifications Concerning Imported Foods.--
``(1) In general.--The Secretary may require, as a condition of
granting admission to an article of food imported or offered for
import into the United States, that an entity described in
paragraph (3) provide a certification, or such other assurances as
the Secretary determines appropriate, that the article of food
complies with applicable requirements of this Act. Such
certification or assurances may be provided in the form of
shipment-specific certificates, a listing of certified facilities
that manufacture, process, pack, or hold such food, or in such
other form as the Secretary may specify.
``(2) Factors to be considered in requiring certification.--The
Secretary shall base the determination that an article of food is
required to have a certification described in paragraph (1) on the
risk of the food, including--
``(A) known safety risks associated with the food;
``(B) known food safety risks associated with the country,
territory, or region of origin of the food;
``(C) a finding by the Secretary, supported by scientific,
risk-based evidence, that--
``(i) the food safety programs, systems, and standards
in the country, territory, or region of origin of the food
are inadequate to ensure that the article of food is as
safe as a similar article of food that is manufactured,
processed, packed, or held in the United States in
accordance with the requirements of this Act; and
``(ii) the certification would assist the Secretary in
determining whether to refuse or admit the article of food
under subsection (a); and
``(D) information submitted to the Secretary in accordance
with the process established in paragraph (7).
``(3) Certifying entities.--For purposes of paragraph (1),
entities that shall provide the certification or assurances
described in such paragraph are--
``(A) an agency or a representative of the government of
the country from which the article of food at issue originated,
as designated by the Secretary; or
``(B) such other persons or entities accredited pursuant to
section 808 to provide such certification or assurance.
``(4) Renewal and refusal of certifications.--The Secretary
may--
``(A) require that any certification or other assurance
provided by an entity specified in paragraph (2) be renewed by
such entity at such times as the Secretary determines
appropriate; and
``(B) refuse to accept any certification or assurance if
the Secretary determines that such certification or assurance
is not valid or reliable.
``(5) Electronic submission.--The Secretary shall provide for
the electronic submission of certifications under this subsection.
``(6) False statements.--Any statement or representation made
by an entity described in paragraph (2) to the Secretary shall be
subject to section 1001 of title 18, United States Code.
``(7) Assessment of food safety programs, systems, and
standards.--If the Secretary determines that the food safety
programs, systems, and standards in a foreign region, country, or
territory are inadequate to ensure that an article of food is as
safe as a similar article of food that is manufactured, processed,
packed, or held in the United States in accordance with the
requirements of this Act, the Secretary shall, to the extent
practicable, identify such inadequacies and establish a process by
which the foreign region, country, or territory may inform the
Secretary of improvements made to such food safety program, system,
or standard and demonstrate that those controls are adequate to
ensure that an article of food is as safe as a similar article of
food that is manufactured, processed, packed, or held in the United
States in accordance with the requirements of this Act.''.
(c) Conforming Technical Amendment.--Section 801(b) (21 U.S.C.
381(b)) is amended in the second sentence by striking ``with respect to
an article included within the provision of the fourth sentence of
subsection (a)'' and inserting ``with respect to an article described
in subsection (a) relating to the requirements of sections 760 or
761,''.
(d) No Limit on Authority.--Nothing in the amendments made by this
section shall limit the authority of the Secretary to conduct
inspections of imported food or to take such other steps as the
Secretary deems appropriate to determine the admissibility of imported
food.

4f76613f61d617115352f693a5ab30b17b073daf6f5ef9150b5a27999ac20bb7

(a) In General.--Section 801(m)(1) (21 U.S.C. 381(m)(1)) is amended
by inserting ``any country to which the article has been refused
entry;'' after ``the country from which the article is shipped;''.
(b) Regulations.--Not later than 120 days after the date of
enactment of this Act, the Secretary shall issue an interim final rule
amending subpart I of part 1 of title 21, Code of Federal Regulations,
to implement the amendment made by this section.
(c) Effective Date.--The amendment made by this section shall take
effect 180 days after the date of enactment of this Act.

1f7242678ec3932b809e0b8d851dc01b33d829e9e3ba71c2fab74dfb241e8ff3

FOOD SAFETY.
(a) In General.--The Secretary shall, not later than 2 years of the
date of enactment of this Act, develop a comprehensive plan to expand
the technical, scientific, and regulatory food safety capacity of
foreign governments, and their respective food industries, from which
foods are exported to the United States.
(b) Consultation.--In developing the plan under subsection (a), the
Secretary shall consult with the Secretary of Agriculture, Secretary of
State, Secretary of the Treasury, the Secretary of Homeland Security,
the United States Trade Representative, and the Secretary of Commerce,
representatives of the food industry, appropriate foreign government
officials, nongovernmental organizations that represent the interests
of consumers, and other stakeholders.
(c) Plan.--The plan developed under subsection (a) shall include,
as appropriate, the following:
(1) Recommendations for bilateral and multilateral arrangements
and agreements, including provisions to provide for responsibility
of exporting countries to ensure the safety of food.
(2) Provisions for secure electronic data sharing.
(3) Provisions for mutual recognition of inspection reports.
(4) Training of foreign governments and food producers on
United States requirements for safe food.
(5) Recommendations on whether and how to harmonize
requirements under the Codex Alimentarius.
(6) Provisions for the multilateral acceptance of laboratory
methods and testing and detection techniques.
(d) Rule of Construction.--Nothing in this section shall be
construed to affect the regulation of dietary supplements under the
Dietary Supplement Health and Education Act of 1994 (Public Law 103-
417).

6bc515be3d684991212afbb17b47640c96d5780de1b0c441fb7d260de1361b93

(a) In General.--Chapter VIII (21 U.S.C. 381 et seq.), as amended
by section 302, is amended by inserting at the end the following:
``SEC. 807. INSPECTION OF FOREIGN FOOD FACILITIES.
``(a) Inspection.--The Secretary--
``(1) may enter into arrangements and agreements with foreign
governments to facilitate the inspection of foreign facilities
registered under section 415; and
``(2) shall direct resources to inspections of foreign
facilities, suppliers, and food types, especially such facilities,
suppliers, and food types that present a high risk (as identified
by the Secretary), to help ensure the safety and security of the
food supply of the United States.
``(b) Effect of Inability To Inspect.--Notwithstanding any other
provision of law, food shall be refused admission into the United
States if it is from a foreign factory, warehouse, or other
establishment of which the owner, operator, or agent in charge, or the
government of the foreign country, refuses to permit entry of United
States inspectors or other individuals duly designated by the
Secretary, upon request, to inspect such factory, warehouse, or other
establishment. For purposes of this subsection, such an owner,
operator, or agent in charge shall be considered to have refused an
inspection if such owner, operator, or agent in charge does not permit
an inspection of a factory, warehouse, or other establishment during
the 24-hour period after such request is submitted, or after such other
time period, as agreed upon by the Secretary and the foreign factory,
warehouse, or other establishment.''.
(b) Inspection by the Secretary of Commerce.--
(1) In general.--The Secretary of Commerce, in coordination
with the Secretary of Health and Human Services, may send 1 or more
inspectors to a country or facility of an exporter from which
seafood imported into the United States originates. The inspectors
shall assess practices and processes used in connection with the
farming, cultivation, harvesting, preparation for market, or
transportation of such seafood and may provide technical assistance
related to such activities.
(2) Inspection report.--
(A) In general.--The Secretary of Health and Human
Services, in coordination with the Secretary of Commerce,
shall--
(i) prepare an inspection report for each inspection
conducted under paragraph (1);
(ii) provide the report to the country or exporter that
is the subject of the report; and
(iii) provide a 30-day period during which the country
or exporter may provide a rebuttal or other comments on the
findings of the report to the Secretary of Health and Human
Services.
(B) Distribution and use of report.--The Secretary of
Health and Human Services shall consider the inspection reports
described in subparagraph (A) in distributing inspection
resources under section 421 of the Federal Food, Drug, and
Cosmetic Act, as added by section 201.

fde0171c0cd2796b0fdd4d980bc724d8a88356fe4a961c39b9a42036bb0f4927

Chapter VIII (21 U.S.C. 381 et seq.), as amended by section 306, is
amended by adding at the end the following:
``SEC. 808. ACCREDITATION OF THIRD-PARTY AUDITORS.
``(a) Definitions.--In this section:
``(1) Audit agent.--The term `audit agent' means an individual
who is an employee or agent of an accredited third-party auditor
and, although not individually accredited, is qualified to conduct
food safety audits on behalf of an accredited third-party auditor.
``(2) Accreditation body.--The term `accreditation body' means
an authority that performs accreditation of third-party auditors.
``(3) Third-party auditor.--The term `third-party auditor'
means a foreign government, agency of a foreign government, foreign
cooperative, or any other third party, as the Secretary determines
appropriate in accordance with the model standards described in
subsection (b)(2), that is eligible to be considered for
accreditation to conduct food safety audits to certify that
eligible entities meet the applicable requirements of this section.
A third-party auditor may be a single individual. A third-party
auditor may employ or use audit agents to help conduct consultative
and regulatory audits.
``(4) Accredited third-party auditor.--The term `accredited
third-party auditor' means a third-party auditor accredited by an
accreditation body to conduct audits of eligible entities to
certify that such eligible entities meet the applicable
requirements of this section. An accredited third-party auditor may
be an individual who conducts food safety audits to certify that
eligible entities meet the applicable requirements of this section.
``(5) Consultative audit.--The term `consultative audit' means
an audit of an eligible entity--
``(A) to determine whether such entity is in compliance
with the provisions of this Act and with applicable industry
standards and practices; and
``(B) the results of which are for internal purposes only.
``(6) Eligible entity.--The term `eligible entity' means a
foreign entity, including a foreign facility registered under
section 415, in the food import supply chain that chooses to be
audited by an accredited third-party auditor or the audit agent of
such accredited third-party auditor.
``(7) Regulatory audit.--The term `regulatory audit' means an
audit of an eligible entity--
``(A) to determine whether such entity is in compliance
with the provisions of this Act; and
``(B) the results of which determine--
``(i) whether an article of food manufactured,
processed, packed, or held by such entity is eligible to
receive a food certification under section 801(q); or
``(ii) whether a facility is eligible to receive a
facility certification under section 806(a) for purposes of
participating in the program under section 806.
``(b) Accreditation System.--
``(1) Accreditation bodies.--
``(A) Recognition of accreditation bodies.--
``(i) In general.--Not later than 2 years after the
date of enactment of the FDA Food Safety Modernization Act,
the Secretary shall establish a system for the recognition
of accreditation bodies that accredit third-party auditors
to certify that eligible entities meet the applicable
requirements of this section.
``(ii) Direct accreditation.--If, by the date that is 2
years after the date of establishment of the system
described in clause (i), the Secretary has not identified
and recognized an accreditation body to meet the
requirements of this section, the Secretary may directly
accredit third-party auditors.
``(B) Notification.--Each accreditation body recognized by
the Secretary shall submit to the Secretary a list of all
accredited third-party auditors accredited by such body and the
audit agents of such auditors.
``(C) Revocation of recognition as an accreditation body.--
The Secretary shall promptly revoke the recognition of any
accreditation body found not to be in compliance with the
requirements of this section.
``(D) Reinstatement.--The Secretary shall establish
procedures to reinstate recognition of an accreditation body if
the Secretary determines, based on evidence presented by such
accreditation body, that revocation was inappropriate or that
the body meets the requirements for recognition under this
section.
``(2) Model accreditation standards.--Not later than 18 months
after the date of enactment of the FDA Food Safety Modernization
Act, the Secretary shall develop model standards, including
requirements for regulatory audit reports, and each recognized
accreditation body shall ensure that third-party auditors and audit
agents of such auditors meet such standards in order to qualify
such third-party auditors as accredited third-party auditors under
this section. In developing the model standards, the Secretary
shall look to standards in place on the date of the enactment of
this section for guidance, to avoid unnecessary duplication of
efforts and costs.
``(c) Third-party Auditors.--
``(1) Requirements for accreditation as a third-party
auditor.--
``(A) Foreign governments.--Prior to accrediting a foreign
government or an agency of a foreign government as an
accredited third-party auditor, the accreditation body (or, in
the case of direct accreditation under subsection
(b)(1)(A)(ii), the Secretary) shall perform such reviews and
audits of food safety programs, systems, and standards of the
government or agency of the government as the Secretary deems
necessary, including requirements under the model standards
developed under subsection (b)(2), to determine that the
foreign government or agency of the foreign government is
capable of adequately ensuring that eligible entities or foods
certified by such government or agency meet the requirements of
this Act with respect to food manufactured, processed, packed,
or held for import into the United States.
``(B) Foreign cooperatives and other third parties.--Prior
to accrediting a foreign cooperative that aggregates the
products of growers or processors, or any other third party to
be an accredited third-party auditor, the accreditation body
(or, in the case of direct accreditation under subsection
(b)(1)(A)(ii), the Secretary) shall perform such reviews and
audits of the training and qualifications of audit agents used
by that cooperative or party and conduct such reviews of
internal systems and such other investigation of the
cooperative or party as the Secretary deems necessary,
including requirements under the model standards developed
under subsection (b)(2), to determine that each eligible entity
certified by the cooperative or party has systems and standards
in use to ensure that such entity or food meets the
requirements of this Act.
``(2) Requirement to issue certification of eligible entities
or foods.--
``(A) In general.--An accreditation body (or, in the case
of direct accreditation under subsection (b)(1)(A)(ii), the
Secretary) may not accredit a third-party auditor unless such
third-party auditor agrees to issue a written and, as
appropriate, electronic food certification, described in
section 801(q), or facility certification under section 806(a),
as appropriate, to accompany each food shipment for import into
the United States from an eligible entity, subject to
requirements set forth by the Secretary. Such written or
electronic certification may be included with other
documentation regarding such food shipment. The Secretary shall
consider certifications under section 801(q) and participation
in the voluntary qualified importer program described in
section 806 when targeting inspection resources under section
421.
``(B) Purpose of certification.--The Secretary shall use
certification provided by accredited third-party auditors to--
``(i) determine, in conjunction with any other
assurances the Secretary may require under section 801(q),
whether a food satisfies the requirements of such section;
and
``(ii) determine whether a facility is eligible to be a
facility from which food may be offered for import under
the voluntary qualified importer program under section 806.
``(C) Requirements for issuing certification.--
``(i) In general.--An accredited third-party auditor
shall issue a food certification under section 801(q) or a
facility certification described under subparagraph (B)
only after conducting a regulatory audit and such other
activities that may be necessary to establish compliance
with the requirements of such sections.
``(ii) Provision of certification.--Only an accredited
third-party auditor or the Secretary may provide a facility
certification under section 806(a). Only those parties
described in 801(q)(3) or the Secretary may provide a food
certification under 301(g).
``(3) Audit report submission requirements.--
``(A) Requirements in general.--As a condition of
accreditation, not later than 45 days after conducting an
audit, an accredited third-party auditor or audit agent of such
auditor shall prepare, and, in the case of a regulatory audit,
submit, the audit report for each audit conducted, in a form
and manner designated by the Secretary, which shall include--
``(i) the identity of the persons at the audited
eligible entity responsible for compliance with food safety
requirements;
``(ii) the dates of the audit;
``(iii) the scope of the audit; and
``(iv) any other information required by the Secretary
that relates to or may influence an assessment of
compliance with this Act.
``(B) Records.--Following any accreditation of a third-
party auditor, the Secretary may, at any time, require the
accredited third-party auditor to submit to the Secretary an
onsite audit report and such other reports or documents
required as part of the audit process, for any eligible entity
certified by the third-party auditor or audit agent of such
auditor. Such report may include documentation that the
eligible entity is in compliance with any applicable
registration requirements.
``(C) Limitation.--The requirement under subparagraph (B)
shall not include any report or other documents resulting from
a consultative audit by the accredited third-party auditor,
except that the Secretary may access the results of a
consultative audit in accordance with section 414.
``(4) Requirements of accredited third-party auditors and audit
agents of such auditors.--
``(A) Risks to public health.--If, at any time during an
audit, an accredited third-party auditor or audit agent of such
auditor discovers a condition that could cause or contribute to
a serious risk to the public health, such auditor shall
immediately notify the Secretary of--
``(i) the identification of the eligible entity subject
to the audit; and
``(ii) such condition.
``(B) Types of audits.--An accredited third-party auditor
or audit agent of such auditor may perform consultative and
regulatory audits of eligible entities.
``(C) Limitations.--
``(i) In general.--An accredited third party auditor
may not perform a regulatory audit of an eligible entity if
such agent has performed a consultative audit or a
regulatory audit of such eligible entity during the
previous 13-month period.
``(ii) Waiver.--The Secretary may waive the application
of clause (i) if the Secretary determines that there is
insufficient access to accredited third-party auditors in a
country or region.
``(5) Conflicts of interest.--
``(A) Third-party auditors.--An accredited third-party
auditor shall--
``(i) not be owned, managed, or controlled by any
person that owns or operates an eligible entity to be
certified by such auditor;
``(ii) in carrying out audits of eligible entities
under this section, have procedures to ensure against the
use of any officer or employee of such auditor that has a
financial conflict of interest regarding an eligible entity
to be certified by such auditor; and
``(iii) annually make available to the Secretary
disclosures of the extent to which such auditor and the
officers and employees of such auditor have maintained
compliance with clauses (i) and (ii) relating to financial
conflicts of interest.
``(B) Audit agents.--An audit agent shall--
``(i) not own or operate an eligible entity to be
audited by such agent;
``(ii) in carrying out audits of eligible entities
under this section, have procedures to ensure that such
agent does not have a financial conflict of interest
regarding an eligible entity to be audited by such agent;
and
``(iii) annually make available to the Secretary
disclosures of the extent to which such agent has
maintained compliance with clauses (i) and (ii) relating to
financial conflicts of interest.
``(C) Regulations.--The Secretary shall promulgate
regulations not later than 18 months after the date of
enactment of the FDA Food Safety Modernization Act to implement
this section and to ensure that there are protections against
conflicts of interest between an accredited third-party auditor
and the eligible entity to be certified by such auditor or
audited by such audit agent. Such regulations shall include--
``(i) requiring that audits performed under this
section be unannounced;
``(ii) a structure to decrease the potential for
conflicts of interest, including timing and public
disclosure, for fees paid by eligible entities to
accredited third-party auditors; and
``(iii) appropriate limits on financial affiliations
between an accredited third-party auditor or audit agents
of such auditor and any person that owns or operates an
eligible entity to be certified by such auditor, as
described in subparagraphs (A) and (B).
``(6) Withdrawal of accreditation.--
``(A) In general.--The Secretary shall withdraw
accreditation from an accredited third-party auditor--
``(i) if food certified under section 801(q) or from a
facility certified under paragraph (2)(B) by such third-
party auditor is linked to an outbreak of foodborne illness
that has a reasonable probability of causing serious
adverse health consequences or death in humans or animals;
``(ii) following an evaluation and finding by the
Secretary that the third-party auditor no longer meets the
requirements for accreditation; or
``(iii) following a refusal to allow United States
officials to conduct such audits and investigations as may
be necessary to ensure continued compliance with the
requirements set forth in this section.
``(B) Additional basis for withdrawal of accreditation.--
The Secretary may withdraw accreditation from an accredited
third-party auditor in the case that such third-party auditor
is accredited by an accreditation body for which recognition as
an accreditation body under subsection (b)(1)(C) is revoked, if
the Secretary determines that there is good cause for the
withdrawal.
``(C) Exception.--The Secretary may waive the application
of subparagraph (A)(i) if the Secretary--
``(i) conducts an investigation of the material facts
related to the outbreak of human or animal illness; and
``(ii) reviews the steps or actions taken by the third
party auditor to justify the certification and determines
that the accredited third-party auditor satisfied the
requirements under section 801(q) of certifying the food,
or the requirements under paragraph (2)(B) of certifying
the entity.
``(7) Reaccreditation.--The Secretary shall establish
procedures to reinstate the accreditation of a third-party auditor
for which accreditation has been withdrawn under paragraph (6)--
``(A) if the Secretary determines, based on evidence
presented, that the third-party auditor satisfies the
requirements of this section and adequate grounds for
revocation no longer exist; and
``(B) in the case of a third-party auditor accredited by an
accreditation body for which recognition as an accreditation
body under subsection (b)(1)(C) is revoked--
``(i) if the third-party auditor becomes accredited not
later than 1 year after revocation of accreditation under
paragraph (6)(A), through direct accreditation under
subsection (b)(1)(A)(ii) or by an accreditation body in
good standing; or
``(ii) under such conditions as the Secretary may
require for a third-party auditor under paragraph (6)(B).
``(8) Neutralizing costs.--The Secretary shall establish by
regulation a reimbursement (user fee) program, similar to the
method described in section 203(h) of the Agriculture Marketing Act
of 1946, by which the Secretary assesses fees and requires
accredited third-party auditors and audit agents to reimburse the
Food and Drug Administration for the work performed to establish
and administer the accreditation system under this section. The
Secretary shall make operating this program revenue-neutral and
shall not generate surplus revenue from such a reimbursement
mechanism. Fees authorized under this paragraph shall be collected
and available for obligation only to the extent and in the amount
provided in advance in appropriation Acts. Such fees are authorized
to remain available until expended.
``(d) Recertification of Eligible Entities.--An eligible entity
shall apply for annual recertification by an accredited third-party
auditor if such entity--
``(1) intends to participate in voluntary qualified importer
program under section 806; or
``(2) is required to provide to the Secretary a certification
under section 801(q) for any food from such entity.
``(e) False Statements.--Any statement or representation made--
``(1) by an employee or agent of an eligible entity to an
accredited third-party auditor or audit agent; or
``(2) by an accredited third-party auditor to the Secretary,
shall be subject to section 1001 of title 18, United States Code.
``(f) Monitoring.--To ensure compliance with the requirements of
this section, the Secretary shall--
``(1) periodically, or at least once every 4 years, reevaluate
the accreditation bodies described in subsection (b)(1);
``(2) periodically, or at least once every 4 years, evaluate
the performance of each accredited third-party auditor, through the
review of regulatory audit reports by such auditors, the compliance
history as available of eligible entities certified by such
auditors, and any other measures deemed necessary by the Secretary;
``(3) at any time, conduct an onsite audit of any eligible
entity certified by an accredited third-party auditor, with or
without the auditor present; and
``(4) take any other measures deemed necessary by the
Secretary.
``(g) Publicly Available Registry.--The Secretary shall establish a
publicly available registry of accreditation bodies and of accredited
third-party auditors, including the name of, contact information for,
and other information deemed necessary by the Secretary about such
bodies and auditors.
``(h) Limitations.--
``(1) No effect on section 704 inspections.--The audits
performed under this section shall not be considered inspections
under section 704.
``(2) No effect on inspection authority.--Nothing in this
section affects the authority of the Secretary to inspect any
eligible entity pursuant to this Act.''.

504278b36f48445db0371eaf91ef36cea5e71be19c9bb02aa77e6c86e0f3ac93

(a) In General.--The Secretary shall establish offices of the Food
and Drug Administration in foreign countries selected by the Secretary,
to provide assistance to the appropriate governmental entities of such
countries with respect to measures to provide for the safety of
articles of food and other products regulated by the Food and Drug
Administration exported by such country to the United States, including
by directly conducting risk-based inspections of such articles and
supporting such inspections by such governmental entity.
(b) Consultation.--In establishing the foreign offices described in
subsection (a), the Secretary shall consult with the Secretary of
State, the Secretary of Homeland Security, and the United States Trade
Representative.
(c) Report.--Not later than October 1, 2011, the Secretary shall
submit to Congress a report on the basis for the selection by the
Secretary of the foreign countries in which the Secretary established
offices, the progress which such offices have made with respect to
assisting the governments of such countries in providing for the safety
of articles of food and other products regulated by the Food and Drug
Administration exported to the United States, and the plans of the
Secretary for establishing additional foreign offices of the Food and
Drug Administration, as appropriate.

55714ef1593df9c39beced6e9fd1740d5a469a114f187319e5c22b225f4a6f48

(a) In General.--Not later than 180 days after the enactment of
this Act, the Secretary shall, in coordination with the Secretary of
Homeland Security, develop and implement a strategy to better identify
smuggled food and prevent entry of such food into the United States.
(b) Notification to Homeland Security.--Not later than 10 days
after the Secretary identifies a smuggled food that the Secretary
believes would cause serious adverse health consequences or death to
humans or animals, the Secretary shall provide to the Secretary of
Homeland Security a notification under section 417(n) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 350f(k)) describing the
smuggled food and, if available, the names of the individuals or
entities that attempted to import such food into the United States.
(c) Public Notification.--If the Secretary--
(1) identifies a smuggled food;
(2) reasonably believes exposure to the food would cause
serious adverse health consequences or death to humans or animals;
and
(3) reasonably believes that the food has entered domestic
commerce and is likely to be consumed,
the Secretary shall promptly issue a press release describing that food
and shall use other emergency communication or recall networks, as
appropriate, to warn consumers and vendors about the potential threat.
(d) Effect of Section.--Nothing in this section shall affect the
authority of the Secretary to issue public notifications under other
circumstances.
(e) Definition.--In this subsection, the term ``smuggled food''
means any food that a person introduces into the United States through
fraudulent means or with the intent to defraud or mislead.

fba56373fe3b2da577f7460cbb994dc69a42fce38ab78d1279cfbdfea9251e41

(a) In General.--There are authorized to be appropriated to carry
out the activities of the Center for Food Safety and Applied Nutrition,
the Center for Veterinary Medicine, and related field activities in the
Office of Regulatory Affairs of the Food and Drug Administration such
sums as may be necessary for fiscal years 2011 through 2015.
(b) Increased Number of Field Staff.--
(1) In general.--To carry out the activities of the Center for
Food Safety and Applied Nutrition, the Center for Veterinary
Medicine, and related field activities of the Office of Regulatory
Affairs of the Food and Drug Administration, the Secretary of
Health and Human Services shall increase the field staff of such
Centers and Office with a goal of not fewer than--
(A) 4,000 staff members in fiscal year 2011;
(B) 4,200 staff members in fiscal year 2012;
(C) 4,600 staff members in fiscal year 2013; and
(D) 5,000 staff members in fiscal year 2014.
(2) Field staff for food defense.--The goal under paragraph (1)
shall include an increase of 150 employees by fiscal year 2011 to--
(A) provide additional detection of and response to food
defense threats; and
(B) detect, track, and remove smuggled food (as defined in
section 309) from commerce.

57799bfcccc54a6fc1d93b829acf28500ff590845d38d68fc23838be1b035ffd

TITLE IV

-MISCELLANEOUS PROVISIONS

Chapter X of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
391 et seq.), as amended by section 209, is further amended by adding
at the end the following:
``SEC. 1012. EMPLOYEE PROTECTIONS.
``(a) In General.--No entity engaged in the manufacture,
processing, packing, transporting, distribution, reception, holding, or
importation of food may discharge an employee or otherwise discriminate
against an employee with respect to compensation, terms, conditions, or
privileges of employment because the employee, whether at the
employee's initiative or in the ordinary course of the employee's
duties (or any person acting pursuant to a request of the employee)--
``(1) provided, caused to be provided, or is about to provide
or cause to be provided to the employer, the Federal Government, or
the attorney general of a State information relating to any
violation of, or any act or omission the employee reasonably
believes to be a violation of any provision of this Act or any
order, rule, regulation, standard, or ban under this Act, or any
order, rule, regulation, standard, or ban under this Act;
``(2) testified or is about to testify in a proceeding
concerning such violation;
``(3) assisted or participated or is about to assist or
participate in such a proceeding; or
``(4) objected to, or refused to participate in, any activity,
policy, practice, or assigned task that the employee (or other such
person) reasonably believed to be in violation of any provision of
this Act, or any order, rule, regulation, standard, or ban under
this Act.
``(b) Process.--
``(1) In general.--A person who believes that he or she has
been discharged or otherwise discriminated against by any person in
violation of subsection (a) may, not later than 180 days after the
date on which such violation occurs, file (or have any person file
on his or her behalf) a complaint with the Secretary of Labor
(referred to in this section as the `Secretary') alleging such
discharge or discrimination and identifying the person responsible
for such act. Upon receipt of such a complaint, the Secretary shall
notify, in writing, the person named in the complaint of the filing
of the complaint, of the allegations contained in the complaint, of
the substance of evidence supporting the complaint, and of the
opportunities that will be afforded to such person under paragraph
(2).
``(2) Investigation.--
``(A) In general.--Not later than 60 days after the date of
receipt of a complaint filed under paragraph (1) and after
affording the complainant and the person named in the complaint
an opportunity to submit to the Secretary a written response to
the complaint and an opportunity to meet with a representative
of the Secretary to present statements from witnesses, the
Secretary shall initiate an investigation and determine whether
there is reasonable cause to believe that the complaint has
merit and notify, in writing, the complainant and the person
alleged to have committed a violation of subsection (a) of the
Secretary's findings.
``(B) Reasonable cause found; preliminary order.--If the
Secretary concludes that there is reasonable cause to believe
that a violation of subsection (a) has occurred, the Secretary
shall accompany the Secretary's findings with a preliminary
order providing the relief prescribed by paragraph (3)(B). Not
later than 30 days after the date of notification of findings
under this paragraph, the person alleged to have committed the
violation or the complainant may file objections to the
findings or preliminary order, or both, and request a hearing
on the record. The filing of such objections shall not operate
to stay any reinstatement remedy contained in the preliminary
order. Any such hearing shall be conducted expeditiously. If a
hearing is not requested in such 30-day period, the preliminary
order shall be deemed a final order that is not subject to
judicial review.
``(C) Dismissal of complaint.--
``(i) Standard for complainant.--The Secretary shall
dismiss a complaint filed under this subsection and shall
not conduct an investigation otherwise required under
subparagraph (A) unless the complainant makes a prima facie
showing that any behavior described in paragraphs (1)
through (4) of subsection (a) was a contributing factor in
the unfavorable personnel action alleged in the complaint.
``(ii) Standard for employer.--Notwithstanding a
finding by the Secretary that the complainant has made the
showing required under clause (i), no investigation
otherwise required under subparagraph (A) shall be
conducted if the employer demonstrates, by clear and
convincing evidence, that the employer would have taken the
same unfavorable personnel action in the absence of that
behavior.
``(iii) Violation standard.--The Secretary may
determine that a violation of subsection (a) has occurred
only if the complainant demonstrates that any behavior
described in paragraphs (1) through (4) of subsection (a)
was a contributing factor in the unfavorable personnel
action alleged in the complaint.
``(iv) Relief standard.--Relief may not be ordered
under subparagraph (A) if the employer demonstrates by
clear and convincing evidence that the employer would have
taken the same unfavorable personnel action in the absence
of that behavior.
``(3) Final order.--
``(A) In general.--Not later than 120 days after the date
of conclusion of any hearing under paragraph (2), the Secretary
shall issue a final order providing the relief prescribed by
this paragraph or denying the complaint. At any time before
issuance of a final order, a proceeding under this subsection
may be terminated on the basis of a settlement agreement
entered into by the Secretary, the complainant, and the person
alleged to have committed the violation.
``(B) Content of order.--If, in response to a complaint
filed under paragraph (1), the Secretary determines that a
violation of subsection (a) has occurred, the Secretary shall
order the person who committed such violation--
``(i) to take affirmative action to abate the
violation;
``(ii) to reinstate the complainant to his or her
former position together with compensation (including back
pay) and restore the terms, conditions, and privileges
associated with his or her employment; and
``(iii) to provide compensatory damages to the
complainant.
``(C) Penalty.--If such an order is issued under this
paragraph, the Secretary, 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 attorneys' 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) Bad faith claim.--If the Secretary finds that a
complaint under paragraph (1) is frivolous or has been brought
in bad faith, the Secretary may award to the prevailing
employer a reasonable attorneys' fee, not exceeding $1,000, to
be paid by the complainant.
``(4) Action in court.--
``(A) In general.--If the Secretary has not issued a final
decision within 210 days after the filing of the complaint, or
within 90 days after receiving a written determination, the
complainant may bring an action at law or equity for de novo
review in the appropriate district court of the United States
with jurisdiction, which shall have jurisdiction over such an
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. The proceedings shall be
governed by the same legal burdens of proof specified in
paragraph (2)(C).
``(B) Relief.--The court shall have jurisdiction to grant
all relief necessary to make the employee whole, including
injunctive relief and compensatory damages, including--
``(i) reinstatement with the same seniority status that
the employee would have had, but for the discharge or
discrimination;
``(ii) the amount of back pay, with interest; and
``(iii) compensation for any special damages sustained
as a result of the discharge or discrimination, including
litigation costs, expert witness fees, and reasonable
attorney's fees.
``(5) Review.--
``(A) In general.--Unless the complainant brings an action
under paragraph (4), any person adversely affected or aggrieved
by a final order issued under paragraph (3) may obtain review
of the order in the United States Court of Appeals for the
circuit in which the violation, with respect to which the order
was issued, allegedly occurred or the circuit in which the
complainant resided on the date of such violation. The petition
for review must be filed not later than 60 days after the date
of the issuance of the final order of the Secretary. Review
shall conform to chapter 7 of title 5, United States Code. The
commencement of proceedings under this subparagraph shall not,
unless ordered by the court, operate as a stay of the order.
``(B) No judicial review.--An order of the Secretary with
respect to which review could have been obtained under
subparagraph (A) shall not be subject to judicial review in any
criminal or other civil proceeding.
``(6) Failure to comply with order.--Whenever any person has
failed to comply with an order issued under paragraph (3), the
Secretary may file a civil action in the United States district
court for the district in which the violation was found to occur,
or in the United States district court for the District of
Columbia, to enforce such order. In actions brought under this
paragraph, the district courts shall have jurisdiction to grant all
appropriate relief including, but not limited to, injunctive relief
and compensatory damages.
``(7) Civil action to require compliance.--
``(A) In general.--A person on whose behalf an order was
issued under paragraph (3) may commence a civil action against
the person to whom such order was issued to require compliance
with such order. The appropriate United States district court
shall have jurisdiction, without regard to the amount in
controversy or the citizenship of the parties, to enforce such
order.
``(B) Award.--The court, in issuing any final order under
this paragraph, may award costs of litigation (including
reasonable attorneys' and expert witness fees) to any party
whenever the court determines such award is appropriate.
``(c) Effect of Section.--
``(1) Other laws.--Nothing in this section preempts or
diminishes any other safeguards against discrimination, demotion,
discharge, suspension, threats, harassment, reprimand, retaliation,
or any other manner of discrimination provided by Federal or State
law.
``(2) Rights of employees.--Nothing in this section shall be
construed 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.
``(d) Enforcement.--Any nondiscretionary duty imposed by this
section shall be enforceable in a mandamus proceeding brought under
section 1361 of title 28, United States Code.
``(e) Limitation.--Subsection (a) shall not apply with respect to
an employee of an entity engaged in the manufacture, processing,
packing, transporting, distribution, reception, holding, or importation
of food who, acting without direction from such entity (or such
entity's agent), deliberately causes a violation of any requirement
relating to any violation or alleged violation of any order, rule,
regulation, standard, or ban under this Act.''.

355aa8bd9a1ce147d7c5245f165deec27ad44dac6f8acfb7712edc1902bc60aa

Nothing in this Act, or an 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, regulations, or agreements regarding voluntary inspection
of non-amenable species under the Agricultural Marketing Act of
1946 (7 U.S.C. 1621 et seq.);
(2) alter the jurisdiction between the Alcohol and Tobacco Tax
and Trade Bureau and the Secretary of Health and Human Services,
under applicable statutes and regulations;
(3) limit the authority of the Secretary of Health and Human
Services 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 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 enactment of this
Act;
(4) alter or limit the authority of the Secretary of
Agriculture under the laws administered by such Secretary,
including--
(A) the Federal Meat Inspection Act (21 U.S.C. 601 et
seq.);
(B) the Poultry Products Inspection Act (21 U.S.C. 451 et
seq.);
(C) the Egg Products Inspection Act (21 U.S.C. 1031 et
seq.);
(D) the United States Grain Standards Act (7 U.S.C. 71 et
seq.);
(E) the Packers and Stockyards Act, 1921 (7 U.S.C. 181 et
seq.);
(F) the United States Warehouse Act (7 U.S.C. 241 et seq.);
(G) the Agricultural Marketing Act of 1946 (7 U.S.C. 1621
et seq.); and
(H) the Agricultural Adjustment Act (7 U.S.C. 601 et seq.),
reenacted with the amendments made by the Agricultural
Marketing Agreement Act of 1937; or
(5) alter, impede, or affect the authority of the Secretary of
Homeland Security under the Homeland Security Act of 2002 (6 U.S.C.
101 et seq.) or any other statute, including any authority related
to securing the borders of the United States, managing ports of
entry, or agricultural import and entry inspection activities.

10c6600fc683d1a4d9ce4bdb3f459198e77f08e1e74d35597cdcc9ca3d1139de

Nothing in this Act (or an amendment made by this Act) shall be
construed in a manner inconsistent with the agreement establishing the
World Trade Organization or any other treaty or international agreement
to which the United States is a party.

c51ed7d9027aff302d5c3b266d4f338469d1c6437bc32c5901ded15b1625c429

The budgetary effects of this Act, for the purpose of complying
with the Statutory Pay-As-You-Go Act of 2010, shall be determined by
reference to the latest statement titled ``Budgetary Effects of PAYGO
Legislation'' for this Act, submitted for printing in the Congressional
Record by the Chairman of the Senate Budget Committee, provided that
such statement has been submitted prior to the vote on passage.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.

e129e189e8bdf217eba471035db72dc5275731d7cd148fdeb468c87ec94a6e28

Consumer Assistance to Recycle and Save Act — HR. 2751

Other Sections

TITLE I

TITLE II

TITLE III

TITLE IV

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