    [United States Statutes at Large, Volume 124, 111th Congress, 2nd Session]
    [From the U.S. Government Publishing Office, www.gpo.gov]

    Public Law 111-353
    111th Congress

    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, <>
    SECTION 1. SHORT TITLE; REFERENCES; TABLE OF CONTENTS.

    (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:

    Sec. 1. Short title; references; table of contents.

    TITLE I--IMPROVING CAPACITY TO PREVENT FOOD SAFETY PROBLEMS

    Sec. 101. Inspections of records.
    Sec. 102. Registration of food facilities.
    Sec. 103. Hazard analysis and risk-based preventive controls.
    Sec. 104. Performance standards.
    Sec. 105. Standards for produce safety.
    Sec. 106. Protection against intentional adulteration.
    Sec. 107. Authority to collect fees.
    Sec. 108. National agriculture and food defense strategy.
    Sec. 109. Food and Agriculture Coordinating Councils.
    Sec. 110. Building domestic capacity.
    Sec. 111. Sanitary transportation of food.
    Sec. 112. Food allergy and anaphylaxis management.
    Sec. 113. New dietary ingredients.
    Sec. 114. Requirement for guidance relating to post harvest processing
    of raw oysters.
    Sec. 115. Port shopping.
    Sec. 116. Alcohol-related facilities.

    TITLE II--IMPROVING CAPACITY TO DETECT AND RESPOND TO FOOD SAFETY
    PROBLEMS

    Sec. 201. Targeting of inspection resources for domestic facilities,
    foreign facilities, and ports of entry; annual report.
    Sec. 202. Laboratory accreditation for analyses of foods.
    Sec. 203. Integrated consortium of laboratory networks.
    Sec. 204. Enhancing tracking and tracing of food and recordkeeping.
    Sec. 205. Surveillance.
    Sec. 206. Mandatory recall authority.
    Sec. 207. Administrative detention of food.
    Sec. 208. Decontamination and disposal standards and plans.
    Sec. 209. Improving the training of State, local, territorial, and
    tribal food safety officials.
    Sec. 210. Enhancing food safety.

    [[Page 3886]]

    Sec. 211. Improving the reportable food registry.

    TITLE III--IMPROVING THE SAFETY OF IMPORTED FOOD

    Sec. 301. Foreign supplier verification program.
    Sec. 302. Voluntary qualified importer program.
    Sec. 303. Authority to require import certifications for food.
    Sec. 304. Prior notice of imported food shipments.
    Sec. 305. Building capacity of foreign governments with respect to food
    safety.
    Sec. 306. Inspection of foreign food facilities.
    Sec. 307. Accreditation of third-party auditors.
    Sec. 308. Foreign offices of the Food and Drug Administration.
    Sec. 309. Smuggled food.

    TITLE IV--MISCELLANEOUS PROVISIONS

    Sec. 401. Funding for food safety.
    Sec. 402. Employee protections.
    Sec. 403. Jurisdiction; authorities.
    Sec. 404. Compliance with international agreements.
    Sec. 405. Determination of budgetary effects.

    TITLE I--IMPROVING CAPACITY TO PREVENT FOOD SAFETY PROBLEMS

    SEC. 101. INSPECTIONS OF RECORDS.

    (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

    [[Page 3887]]

    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''.
    SEC. 102. REGISTRATION OF FOOD FACILITIES.

    (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.

    [[Page 3888]]

    ``(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

    [[Page 3889]]

    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)''.
    SEC. 103. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS.

    (a) In General.--Chapter IV (21 U.S.C. 341 et seq.) is amended by
    adding at the end the following:
    ``SEC. 418. <>  HAZARD ANALYSIS AND RISK-BASED
    PREVENTIVE CONTROLS.

    ``(a) In General.--The owner, operator, or agent in charge of a
    facility shall, in accordance with this section, evaluate the hazards
    that could affect food manufactured, processed, packed, or held by such
    facility, identify and implement preventive controls to significantly
    minimize or prevent the occurrence of such hazards and provide
    assurances that such food is not adulterated under section 402 or
    misbranded under section 403(w), monitor the performance of those
    controls, and maintain records of this monitoring as a matter of routine
    practice.

    [[Page 3890]]

    ``(b) Hazard Analysis.--The owner, operator, or agent in charge of a
    facility shall--
    ``(1) identify and evaluate known or reasonably foreseeable
    hazards that may be associated with the facility, including--
    ``(A) biological, chemical, physical, and
    radiological hazards, natural toxins, pesticides, drug
    residues, decomposition, parasites, allergens, and
    unapproved food and color additives; and
    ``(B) hazards that occur naturally, or may be
    unintentionally introduced; and
    ``(2) identify and evaluate hazards that may be
    intentionally introduced, including by acts of terrorism; and
    ``(3) develop a written analysis of the hazards.

    ``(c) Preventive Controls.--The owner, operator, or agent in charge
    of a facility shall identify and implement preventive controls,
    including at critical control points, if any, to provide assurances
    that--
    ``(1) hazards identified in the hazard analysis conducted
    under subsection (b)(1) will be significantly minimized or
    prevented;
    ``(2) any hazards identified in the hazard analysis
    conducted under subsection (b)(2) will be significantly
    minimized or prevented and addressed, consistent with section
    420, as applicable; and
    ``(3) the food manufactured, processed, packed, or held by
    such facility will not be adulterated under section 402 or
    misbranded under section 403(w).

    ``(d) Monitoring of Effectiveness.--The owner, operator, or agent in
    charge of a facility shall monitor the effectiveness of the preventive
    controls implemented under subsection (c) to provide assurances that the
    outcomes described in subsection (c) shall be achieved.
    ``(e) Corrective Actions. <> --The owner,
    operator, or agent in charge of a facility shall establish procedures to
    ensure that, if the preventive controls implemented under subsection (c)
    are not properly implemented or are found to be ineffective--
    ``(1) appropriate action is taken to reduce the likelihood
    of recurrence of the implementation failure;
    ``(2) all affected food is evaluated for safety; and
    ``(3) all affected food is prevented from entering into
    commerce if the owner, operator or agent in charge of such
    facility cannot ensure that the affected food is not adulterated
    under section 402 or misbranded under section 403(w).

    ``(f) Verification.--The owner, operator, or agent in charge of a
    facility shall verify that--
    ``(1) the preventive controls implemented under subsection
    (c) are adequate to control the hazards identified under
    subsection (b);
    ``(2) the owner, operator, or agent is conducting monitoring
    in accordance with subsection (d);
    ``(3) the owner, operator, or agent is making appropriate
    decisions about corrective actions taken under subsection (e);
    ``(4) the preventive controls implemented under subsection
    (c) are effectively and significantly minimizing or preventing
    the occurrence of identified hazards, including through the use
    of environmental and product testing programs and other
    appropriate means; and

    [[Page 3891]]

    ``(5) there is documented, periodic reanalysis of the plan
    under subsection (i) to ensure that the plan is still relevant
    to the raw materials, conditions and processes in the facility,
    and new and emerging threats.

    ``(g) Recordkeeping. <> --The owner, operator,
    or agent in charge of a facility shall maintain, for not less than 2
    years, records documenting the monitoring of the preventive controls
    implemented under subsection (c), instances of nonconformance material
    to food safety, the results of testing and other appropriate means of
    verification under subsection (f)(4), instances when corrective actions
    were implemented, and the efficacy of preventive controls and corrective
    actions.

    ``(h) Written Plan and Documentation.--The owner, operator, or agent
    in charge of a facility shall prepare a written plan that documents and
    describes the procedures used by the facility to comply with the
    requirements of this section, including analyzing the hazards under
    subsection (b) and identifying the preventive controls adopted under
    subsection (c) to address those hazards. Such written plan, together
    with the documentation described in subsection (g), shall be made
    promptly available to a duly authorized representative of the Secretary
    upon oral or written request.
    ``(i) Requirement To Reanalyze. <> --The owner,
    operator, or agent in charge of a facility shall conduct a reanalysis
    under subsection (b) whenever a significant change is made in the
    activities conducted at a facility operated by such owner, operator, or
    agent if the change creates a reasonable potential for a new hazard or a
    significant increase in a previously identified hazard or not less
    frequently than once every 3 years, whichever is earlier. Such
    reanalysis shall be completed and additional preventive controls needed
    to address the hazard identified, if any, shall be implemented before
    the change in activities at the facility is operative. Such owner,
    operator, or agent shall revise the written plan required under
    subsection (h) if such a significant change is made or document the
    basis for the conclusion that no additional or revised preventive
    controls are needed. The Secretary may require a reanalysis under this
    section to respond to new hazards and developments in scientific
    understanding, including, as appropriate, results from the Department of
    Homeland Security biological, chemical, radiological, or other terrorism
    risk assessment.

    ``(j) Exemption for Seafood, Juice, and Low-acid Canned Food
    Facilities Subject to HACCP.--
    ``(1) In general.--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:
    ``(A) The Seafood Hazard Analysis Critical Control
    Points Program of the Food and Drug Administration.
    ``(B) The Juice Hazard Analysis Critical Control
    Points Program of the Food and Drug Administration.
    ``(C) The Thermally Processed Low-Acid Foods
    Packaged in Hermetically Sealed Containers standards of
    the Food and Drug Administration (or any successor
    standards).
    ``(2) Applicability.--The exemption under paragraph (1)(C)
    shall apply only with respect to microbiological hazards that
    are regulated under the standards for Thermally Processed

    [[Page 3892]]

    Low-Acid Foods Packaged in Hermetically Sealed Containers under
    part 113 of chapter 21, Code of Federal Regulations (or any
    successor regulations).

    ``(k) Exception for Activities of Facilities Subject to Section
    419.--This section shall not apply to activities of a facility that are
    subject to section 419.
    ``(l) Modified Requirements for Qualified Facilities.--
    ``(1) Qualified facilities.--
    ``(A) In general.--A facility is a qualified
    facility for purposes of this subsection if the facility
    meets the conditions under subparagraph (B) or (C).
    ``(B) Very small business.--A facility is a
    qualified facility under this subparagraph--
    ``(i) if the facility, including any
    subsidiary or affiliate of the facility, is,
    collectively, a very small business (as defined in
    the regulations promulgated under subsection (n));
    and
    ``(ii) in the case where the facility is a
    subsidiary or affiliate of an entity, if such
    subsidiaries or affiliates, are, collectively, a
    very small business (as so defined).
    ``(C) <>  Limited annual
    monetary value of sales.--
    ``(i) In general.--A facility is a qualified
    facility under this subparagraph if clause (ii)
    applies--
    ``(I) to the facility, including any
    subsidiary or affiliate of the facility,
    collectively; and
    ``(II) to the subsidiaries or
    affiliates, collectively, of any entity
    of which the facility is a subsidiary or
    affiliate.
    ``(ii) Average annual monetary value.--This
    clause applies if--
    ``(I) during the 3-year period
    preceding the applicable calendar year,
    the average annual monetary value of the
    food manufactured, processed, packed, or
    held at such facility (or the collective
    average annual monetary value of such
    food at any subsidiary or affiliate, as
    described in clause (i)) that is sold
    directly to qualified end-users during
    such period exceeded the average annual
    monetary value of the food manufactured,
    processed, packed, or held at such
    facility (or the collective average
    annual monetary value of such food at
    any subsidiary or affiliate, as so
    described) sold by such facility (or
    collectively by any such subsidiary or
    affiliate) to all other purchasers
    during such period; and
    ``(II) the average annual monetary
    value of all food sold by such facility
    (or the collective average annual
    monetary value of such food sold by any
    subsidiary or affiliate, as described in
    clause (i)) during such period was less
    than $500,000, adjusted for inflation.
    ``(2) Exemption.--A qualified facility--
    ``(A) shall not be subject to the requirements under
    subsections (a) through (i) and subsection (n) in an
    applicable calendar year; and
    ``(B) shall submit to the Secretary--

    [[Page 3893]]

    ``(i)(I) documentation that demonstrates that
    the owner, operator, or agent in charge of the
    facility has identified potential hazards
    associated with the food being produced, is
    implementing preventive controls to address the
    hazards, and is monitoring the preventive controls
    to ensure that such controls are effective; or
    ``(II) documentation (which may include
    licenses, inspection reports, certificates,
    permits, credentials, certification by an
    appropriate agency (such as a State department of
    agriculture), or other evidence of oversight), as
    specified by the Secretary, that the facility is
    in compliance with State, local, county, or other
    applicable non-Federal food safety law; and
    ``(ii) <>  documentation, as
    specified by the Secretary in a guidance document
    issued not later than 1 year after the date of
    enactment of this section, that the facility is a
    qualified facility under paragraph (1)(B) or
    (1)(C).
    ``(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 qualified facility 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 qualified facility that are material to the safety of
    the food manufactured, processed, packed, or held at
    such facility, the Secretary may withdraw the exemption
    provided to such facility 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.--In this subsection:
    ``(A) Affiliate.--The term `affiliate' means any
    facility that controls, is controlled by, or is under
    common control with another facility.
    ``(B) Qualified end-user.--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--
    ``(I) is located--
    ``(aa) in the same State as
    the qualified facility that sold
    the food to such restaurant or
    establishment; or
    ``(bb) not more than 275
    miles from such facility; and
    ``(II) is purchasing the food for
    sale directly to consumers at such
    restaurant or retail food establishment.
    ``(C) Consumer.--For purposes of subparagraph (B),
    the term `consumer' does not include a business.
    ``(D) Subsidiary.--The term `subsidiary' means any
    company which is owned or controlled directly or
    indirectly by another company.

    [[Page 3894]]

    ``(5) Study.--
    ``(A) In general.--The Secretary, in consultation
    with the Secretary of Agriculture, shall conduct a study
    of the food processing sector regulated by the Secretary
    to determine--
    ``(i) the distribution of food production by
    type and size of operation, including monetary
    value of food sold;
    ``(ii) the proportion of food produced by each
    type and size of operation;
    ``(iii) the number and types of food
    facilities co-located on farms, including the
    number and proportion by commodity and by
    manufacturing or processing activity;
    ``(iv) the incidence of foodborne illness
    originating from each size and type of operation
    and the type of food facilities for which no
    reported or known hazard exists; and
    ``(v) the effect on foodborne illness risk
    associated with commingling, processing,
    transporting, and storing food and raw
    agricultural commodities, including differences in
    risk based on the scale and duration of such
    activities.
    ``(B) Size.--The results of the study conducted
    under subparagraph (A) shall include the information
    necessary to enable the Secretary to define the terms
    `small business' and `very small business', for purposes
    of promulgating the regulation under subsection (n). In
    defining such terms, the Secretary shall include
    consideration of harvestable acres, income, the number
    of employees, and the volume of food harvested.
    ``(C) Submission of report.--Not later than 18
    months after the date of enactment the FDA Food Safety
    Modernization Act, the Secretary shall submit to
    Congress a report that describes the results of the
    study conducted under subparagraph (A).
    ``(6) No preemption.--Nothing in this subsection preempts
    State, local, county, or other non-Federal law regarding the
    safe production of food. Compliance with this subsection shall
    not relieve any person from liability at common law or under
    State statutory law.
    ``(7) Notification to consumers.--
    ``(A) In general.--A qualified facility that is
    exempt from the requirements under subsections (a)
    through (i) and subsection (n) and does not prepare
    documentation under paragraph (2)(B)(i)(I) 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 facility where
    the food was manufactured or processed; or
    ``(ii) with respect to a food for which a food
    packaging label is not required by the Secretary
    under any other provisions of this Act,
    prominently and conspicuously display, at the
    point of purchase, the name and business address
    of the facility where the

    [[Page 3895]]

    food was manufactured or processed, 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.

    ``(m) Authority With Respect to Certain Facilities.--The Secretary
    may, by regulation, exempt or modify the requirements for compliance
    under this section with respect to facilities that are solely engaged in
    the production of food for animals other than man, the storage of raw
    agricultural commodities (other than fruits and vegetables) intended for
    further distribution or processing, or the storage of packaged foods
    that are not exposed to the environment.
    ``(n) Regulations.--
    ``(1) In general. <> --Not later than 18
    months after the date of enactment of the FDA Food Safety
    Modernization Act, the Secretary shall promulgate regulations--
    ``(A) to establish science-based minimum standards
    for conducting a hazard analysis, documenting hazards,
    implementing preventive controls, and documenting the
    implementation of the preventive controls under this
    section; and
    ``(B) to define, for purposes of this section, the
    terms `small business' and `very small business', taking
    into consideration the study described in subsection
    (l)(5).
    ``(2) Coordination.--In promulgating the regulations under
    paragraph (1)(A), with regard to hazards that may be
    intentionally introduced, including by acts of terrorism, the
    Secretary shall coordinate with the Secretary of Homeland
    Security, as appropriate.
    ``(3) Content.--The regulations promulgated under paragraph
    (1)(A) shall--
    ``(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;
    ``(B) 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
    facility, and collection of information (as defined in
    section 3502(3) of such Act), associated with such
    regulations;
    ``(C) acknowledge differences in risk and minimize,
    as appropriate, the number of separate standards that
    apply to separate foods; and
    ``(D) not require a facility to hire a consultant or
    other third party to identify, implement, certify, or
    audit preventative controls, except in the case of
    negotiated enforcement resolutions that may require such
    a consultant or third party.
    ``(4) Rule of construction.--Nothing in this subsection
    shall be construed to provide the Secretary with the authority
    to prescribe specific technologies, practices, or critical
    controls for an individual facility.

    [[Page 3896]]

    ``(5) Review.--In promulgating the regulations under
    paragraph (1)(A), the Secretary shall review regulatory hazard
    analysis and preventive control programs in existence on the
    date of enactment of the FDA Food Safety Modernization Act,
    including the Grade `A' Pasteurized Milk Ordinance to ensure
    that such regulations are consistent, to the extent practicable,
    with applicable domestic and internationally-recognized
    standards in existence on such date.

    ``(o) Definitions.--For purposes of this section:
    ``(1) Critical control point.--The term `critical control
    point' means a point, step, or procedure in a food process at
    which control can be applied and is essential to prevent or
    eliminate a food safety hazard or reduce such hazard to an
    acceptable level.
    ``(2) Facility.--The term `facility' means a domestic
    facility or a foreign facility that is required to register
    under section 415.
    ``(3) Preventive controls.--The term `preventive controls'
    means those risk-based, reasonably appropriate procedures,
    practices, and processes that a person knowledgeable about the
    safe manufacturing, processing, packing, or holding of food
    would employ to significantly minimize or prevent the hazards
    identified under the hazard analysis conducted under subsection
    (b) and that are consistent with the current scientific
    understanding of safe food manufacturing, processing, packing,
    or holding at the time of the analysis. Those procedures,
    practices, and processes may include the following:
    ``(A) Sanitation procedures for food contact
    surfaces and utensils and food-contact surfaces of
    equipment.
    ``(B) Supervisor, manager, and employee hygiene
    training.
    ``(C) An environmental monitoring program to verify
    the effectiveness of pathogen controls in processes
    where a food is exposed to a potential contaminant in
    the environment.
    ``(D) A food allergen control program.
    ``(E) A recall plan.
    ``(F) Current Good Manufacturing Practices (cGMPs)
    under part 110 of title 21, Code of Federal Regulations
    (or any successor regulations).
    ``(G) Supplier verification activities that relate
    to the safety of food.''.

    (b) <>  Guidance Document.--The Secretary
    shall issue a guidance document related to the regulations promulgated
    under subsection (b)(1) with respect to the hazard analysis and
    preventive controls under section 418 of the Federal Food, Drug, and
    Cosmetic Act (as added by subsection (a)).

    (c) <>  Rulemaking.--
    (1) Proposed rulemaking.--
    (A) In general. <> --Not later than 9 months after
    the date of enactment of this Act, the Secretary of
    Health and Human Services (referred to in this
    subsection as the ``Secretary'') shall publish a notice
    of proposed rulemaking in the Federal Register to
    promulgate regulations with respect to--
    (i) activities that constitute on-farm packing
    or holding of food that is not grown, raised, or
    consumed

    [[Page 3897]]

    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; and
    (ii) 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.
    (B) Clarification.--The rulemaking described under
    subparagraph (A) shall enhance the implementation of
    such section 415 and clarify the activities that are
    included as part of the definition of the term
    ``facility'' under such section 415. Nothing in this Act
    authorizes the Secretary to 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--

    [[Page 3898]]

    (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

    [[Page 3899]]

    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.
    SEC. 104. <>  PERFORMANCE STANDARDS.

    (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.
    SEC. 105. STANDARDS FOR PRODUCE SAFETY.

    (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

    [[Page 3900]]

    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

    [[Page 3901]]

    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;

    [[Page 3902]]

    ``(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.--

    [[Page 3903]]

    ``(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

    [[Page 3904]]

    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:

    [[Page 3905]]

    ``(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.
    SEC. 106. PROTECTION AGAINST INTENTIONAL ADULTERATION.

    (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

    [[Page 3906]]

    ``(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.''.
    SEC. 107. AUTHORITY TO COLLECT FEES.

    (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

    [[Page 3907]]

    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;

    [[Page 3908]]

    ``(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

    [[Page 3909]]

    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

    [[Page 3910]]

    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.''
    SEC. 108. <>  NATIONAL AGRICULTURE AND FOOD
    DEFENSE STRATEGY.

    (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

    [[Page 3911]]

    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

    [[Page 3912]]

    (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).
    SEC. 109. <>
    FOOD AND AGRICULTURE COORDINATING
    COUNCILS.

    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,

    [[Page 3913]]

    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.
    SEC. 110. <>  BUILDING DOMESTIC CAPACITY.

    (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.

    [[Page 3914]]

    (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

    [[Page 3915]]

    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

    [[Page 3916]]

    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.
    SEC. 111. SANITARY TRANSPORTATION OF FOOD.

    (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.
    SEC. 112. <>  FOOD ALLERGY AND ANAPHYLAXIS
    MANAGEMENT.

    (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.

    [[Page 3917]]

    (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.

    [[Page 3918]]

    (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

    [[Page 3919]]

    (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.

    [[Page 3920]]

    (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).
    SEC. 113. NEW DIETARY INGREDIENTS.

    (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

    [[Page 3921]]

    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.
    SEC. 114. <>  REQUIREMENT FOR GUIDANCE
    RELATING TO POST HARVEST 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).

    [[Page 3922]]

    (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.
    SEC. 115. <>  PORT SHOPPING.

    <> 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.
    SEC. 116. <>  ALCOHOL-RELATED FACILITIES.

    (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

    [[Page 3923]]

    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).

    TITLE II--IMPROVING CAPACITY TO DETECT AND RESPOND TO FOOD SAFETY
    PROBLEMS

    SEC. 201. TARGETING OF INSPECTION RESOURCES FOR DOMESTIC
    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.

    [[Page 3924]]

    ``(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).

    [[Page 3925]]

    ``(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--

    [[Page 3926]]

    ``(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.
    SEC. 202. LABORATORY ACCREDITATION FOR ANALYSES OF FOODS.

    (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

    [[Page 3927]]

    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.

    [[Page 3928]]

    ``(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

    [[Page 3929]]

    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.
    SEC. 203. <>  INTEGRATED CONSORTIUM OF
    LABORATORY NETWORKS.

    (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.

    [[Page 3930]]

    SEC. 204. <>  ENHANCING TRACKING AND TRACING
    OF FOOD AND RECORDKEEPING.

    (a) Pilot Projects.--
    (1) In general.--Not later than 270 days after the date of
    enactment of this Act, the Secretary of Health and Human
    Services (referred to in this section as the ``Secretary''),
    taking into account recommendations from the Secretary of
    Agriculture and representatives of State departments of health
    and agriculture, shall establish pilot projects in coordination
    with the food industry to explore and evaluate methods to
    rapidly and effectively identify recipients of food to prevent
    or mitigate a foodborne illness outbreak and to address credible
    threats of serious adverse health consequences or death to
    humans or animals as a result of such food being adulterated
    under section 402 of the Federal Food, Drug, and Cosmetic Act
    (21 U.S.C. 342) or misbranded under section 403(w) of such Act
    (21 U.S.C. 343(w)).
    (2) Content.--The Secretary shall conduct 1 or more pilot
    projects under paragraph (1) in coordination with the processed
    food sector and 1 or more such pilot projects in coordination
    with processors or distributors of fruits and vegetables that
    are raw agricultural commodities. The Secretary shall ensure
    that the pilot projects under paragraph (1) reflect the
    diversity of the food supply and include at least 3 different
    types of foods that have been the subject of significant
    outbreaks during the 5-year period preceding the date of
    enactment of this Act, and are selected in order to--
    (A) develop and demonstrate methods for rapid and
    effective tracking and tracing of foods in a manner that
    is practicable for facilities of varying sizes,
    including small businesses;
    (B) develop and demonstrate appropriate
    technologies, including technologies existing on the
    date of enactment of this Act, that enhance the tracking
    and tracing of food; and
    (C) inform the promulgation of regulations under
    subsection (d).
    (3) Report. <> --Not later than 18
    months after the date of enactment of this Act, the Secretary
    shall report to Congress on the findings of the pilot projects
    under this subsection together with recommendations for
    improving the tracking and tracing of food.

    (b) Additional Data Gathering.--
    (1) In general.--The Secretary, in coordination with the
    Secretary of Agriculture and multiple representatives of State
    departments of health and agriculture, shall assess--
    (A) the costs and benefits associated with the
    adoption and use of several product tracing
    technologies, including technologies used in the pilot
    projects under subsection (a);
    (B) the feasibility of such technologies for
    different sectors of the food industry, including small
    businesses; and
    (C) whether such technologies are compatible with
    the requirements of this subsection.
    (2) Requirements.--To the extent practicable, in carrying
    out paragraph (1), the Secretary shall--

    [[Page 3931]]

    (A) evaluate domestic and international product
    tracing practices in commercial use;
    (B) consider international efforts, including an
    assessment of whether product tracing requirements
    developed under this section are compatible with global
    tracing systems, as appropriate; and
    (C) <>  consult with a diverse
    and broad range of experts and stakeholders, including
    representatives of the food industry, agricultural
    producers, and nongovernmental organizations that
    represent the interests of consumers.

    (c) Product Tracing System.--The Secretary, in consultation with the
    Secretary of Agriculture, shall, as appropriate, establish within the
    Food and Drug Administration a product tracing system to receive
    information that improves the capacity of the Secretary to effectively
    and rapidly track and trace food that is in the United States or offered
    for import into the United States. Prior to the establishment of such
    product tracing system, the Secretary shall examine the results of
    applicable pilot projects and shall ensure that the activities of such
    system are adequately supported by the results of such pilot projects.
    (d) Additional Recordkeeping Requirements for High Risk Foods.--
    (1) In general. <> --
    In order to rapidly and effectively identify recipients of a
    food to prevent or mitigate a foodborne illness outbreak and to
    address credible threats of serious adverse health consequences
    or death to humans or animals as a result of such food being
    adulterated under section 402 of the Federal Food, Drug, and
    Cosmetic Act or misbranded under section 403(w) of such Act, not
    later than 2 years after the date of enactment of this Act, the
    Secretary shall publish a notice of proposed rulemaking to
    establish recordkeeping requirements, in addition to the
    requirements under section 414 of the Federal Food, Drug, and
    Cosmetic Act (21 U.S.C. 350c) and subpart J of part 1 of title
    21, Code of Federal Regulations (or any successor regulations),
    for facilities that manufacture, process, pack, or hold foods
    that the Secretary designates under paragraph (2) as high-risk
    foods. The Secretary shall set an appropriate effective date of
    such additional requirements for foods designated as high risk
    that takes into account the length of time necessary to comply
    with such requirements. Such requirements shall--
    (A) relate only to information that is reasonably
    available and appropriate;
    (B) be science-based;
    (C) not prescribe specific technologies for the
    maintenance of records;
    (D) ensure that the public health benefits of
    imposing additional recordkeeping requirements outweigh
    the cost of compliance with such requirements;
    (E) be scale-appropriate and practicable for
    facilities of varying sizes and capabilities with
    respect to costs and recordkeeping burdens, and not
    require the creation and maintenance of duplicate
    records where the information is contained in other
    company records kept in the normal course of business;

    [[Page 3932]]

    (F) minimize the number of different recordkeeping
    requirements for facilities that handle more than 1 type
    of food;
    (G) to the extent practicable, not require a
    facility to change business systems to comply with such
    requirements;
    (H) allow any person subject to this subsection to
    maintain records required under this subsection at a
    central or reasonably accessible location provided that
    such records can be made available to the Secretary not
    later than 24 hours after the Secretary requests such
    records; and
    (I) include a process by which the Secretary may
    issue a waiver of the requirements under this subsection
    if the Secretary determines that such requirements would
    result in an economic hardship for an individual
    facility or a type of facility;
    (J) be commensurate with the known safety risks of
    the designated food;
    (K) take into account international trade
    obligations;
    (L) not require--
    (i) a full pedigree, or a record of the
    complete previous distribution history of the food
    from the point of origin of such food;
    (ii) records of recipients of a food beyond
    the immediate subsequent recipient of such food;
    or
    (iii) product tracking to the case level by
    persons subject to such requirements; and
    (M) include a process by which the Secretary may
    remove a high-risk food designation developed under
    paragraph (2) for a food or type of food.
    (2) Designation of high-risk foods.--
    (A) In general. <> --Not later than
    1 year after the date of enactment of this Act, and
    thereafter as the Secretary determines necessary, the
    Secretary shall designate high-risk foods for which the
    additional recordkeeping requirements described in
    paragraph (1) are appropriate and necessary to protect
    the public health. Each such designation shall be based
    on--
    (i) the known safety risks of a particular
    food, including the history and severity of
    foodborne illness outbreaks attributed to such
    food, taking into consideration foodborne illness
    data collected by the Centers for Disease Control
    and Prevention;
    (ii) the likelihood that a particular food has
    a high potential risk for microbiological or
    chemical contamination or would support the growth
    of pathogenic microorganisms due to the nature of
    the food or the processes used to produce such
    food;
    (iii) the point in the manufacturing process
    of the food where contamination is most likely to
    occur;
    (iv) the likelihood of contamination and steps
    taken during the manufacturing process to reduce
    the possibility of contamination;
    (v) the likelihood that consuming a particular
    food will result in a foodborne illness due to
    contamination of the food; and

    [[Page 3933]]

    (vi) the likely or known severity, including
    health and economic impacts, of a foodborne
    illness attributed to a particular food.
    (B) List of high-risk foods. <> --At the time the Secretary promulgates the
    final rules under paragraph (1), the Secretary shall
    publish the list of the foods designated under
    subparagraph (A) as high-risk foods on the Internet
    website of the Food and Drug
    Administration. <>  The Secretary may update the
    list to designate new high-risk foods and to remove
    foods that are no longer deemed to be high-risk foods,
    provided that each such update to the list is consistent
    with the requirements of this subsection and notice of
    such update is published in the Federal Register.
    (3) Protection of sensitive information.--In promulgating
    regulations under this subsection, the Secretary shall take
    appropriate measures to ensure that there are effective
    procedures to prevent the unauthorized disclosure of any trade
    secret or confidential information that is obtained by the
    Secretary pursuant to this section, including periodic risk
    assessment and planning to prevent unauthorized release and
    controls to--
    (A) prevent unauthorized reproduction of trade
    secret or confidential information;
    (B) prevent unauthorized access to trade secret or
    confidential information; and
    (C) maintain records with respect to access by any
    person to trade secret or confidential information
    maintained by the agency.
    (4) Public input.--During the comment period in 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.
    (5) Retention of records.--Except as otherwise provided in
    this subsection, the Secretary may require that a facility
    retain records under this subsection for not more than 2 years,
    taking into consideration the risk of spoilage, loss of value,
    or loss of palatability of the applicable food when determining
    the appropriate timeframes.
    (6) Limitations.--
    (A) Farm to school programs.--In establishing
    requirements under this subsection, the Secretary shall,
    in consultation with the Secretary of Agriculture,
    consider the impact of requirements on farm to school or
    farm to institution programs of the Department of
    Agriculture and other farm to school and farm to
    institution programs outside such agency, and shall
    modify the requirements under this subsection, as
    appropriate, with respect to such programs so that the
    requirements do not place undue burdens on farm to
    school or farm to institution programs.
    (B) Identity-preserved labels with respect to farm
    sales of food that is produced and packaged on a farm.--
    The requirements under this subsection shall not apply
    to a food that is produced and packaged on a farm if--

    [[Page 3934]]

    (i) the packaging of the food maintains the
    integrity of the product and prevents subsequent
    contamination or alteration of the product; and
    (ii) the labeling of the food includes the
    name, complete address (street address, town,
    State, country, and zip or other postal code), and
    business phone number of the farm, unless the
    Secretary waives the requirement to include a
    business phone number of the farm, as appropriate,
    in order to accommodate a religious belief of the
    individual in charge of such farm.
    (C) Fishing vessels.--The requirements under this
    subsection with respect to a food that is produced
    through the use of a fishing vessel (as defined in
    section 3(18) of the Magnuson-Stevens Fishery
    Conservation and Management Act (16 U.S.C. 1802(18)))
    shall be limited to the requirements under subparagraph
    (F) until such time as the food is sold by the owner,
    operator, or agent in charge of such fishing vessel.
    (D) Commingled raw agricultural commodities.--
    (i) Limitation on extent of tracing.--
    Recordkeeping requirements under this subsection
    with regard to any commingled raw agricultural
    commodity shall be limited to the requirements
    under subparagraph (F).
    (ii) Definitions.--For the purposes of this
    subparagraph--
    (I) the term ``commingled raw
    agricultural commodity'' means any
    commodity that is combined or mixed
    after harvesting, but before processing;
    (II) the term ``commingled raw
    agricultural commodity'' shall not
    include types of fruits and vegetables
    that are raw agricultural commodities
    for which the Secretary has determined
    that standards promulgated under section
    419 of the Federal Food, Drug, and
    Cosmetic Act (as added by section 105)
    would minimize the risk of serious
    adverse health consequences or death;
    and
    (III) the term ``processing'' means
    operations that alter the general state
    of the commodity, such as canning,
    cooking, freezing, dehydration, milling,
    grinding, pasteurization, or
    homogenization.
    (E) Exemption of other foods.--The Secretary may, by
    notice in the Federal Register, modify the requirements
    under this subsection with respect to, or exempt a food
    or a type of facility from, the requirements of this
    subsection (other than the requirements under
    subparagraph (F), if applicable) if the Secretary
    determines that product tracing requirements for such
    food (such as bulk or commingled ingredients that are
    intended to be processed to destroy pathogens) or type
    of facility is not necessary to protect the public
    health.
    (F) Recordkeeping regarding previous sources and
    subsequent recipients.--In the case of a person or food
    to which a limitation or exemption under subparagraph
    (C), (D), or (E) applies, if such person, or a person
    who

    [[Page 3935]]

    manufactures, processes, packs, or holds such food, is
    required to register with the Secretary under section
    415 of the Federal Food, Drug, and Cosmetic Act (21
    U.S.C. 350d) with respect to the manufacturing,
    processing, packing, or holding of the applicable food,
    the Secretary shall require such person to maintain
    records that identify the immediate previous source of
    such food and the immediate subsequent recipient of such
    food.
    (G) Grocery stores. <> --With
    respect to a sale of a food described in subparagraph
    (H) to a grocery store, the Secretary shall not require
    such grocery store to maintain records under this
    subsection other than records documenting the farm that
    was the source of such food. The Secretary shall not
    require that such records be kept for more than 180
    days.
    (H) Farm sales to consumers.--The Secretary shall
    not require a farm to maintain any distribution records
    under this subsection with respect to a sale of a food
    described in subparagraph (I) (including a sale of a
    food that is produced and packaged on such farm), if
    such sale is made by the farm directly to a consumer.
    (I) Sale of a food.--A sale of a food described in
    this subparagraph is a sale of a food in which--
    (i) the food is produced on a farm; and
    (ii) the sale is made by the owner, operator,
    or agent in charge of such farm directly to a
    consumer or grocery store.
    (7) No impact on non-high-risk foods.--The recordkeeping
    requirements established under paragraph (1) shall have no
    effect on foods that are not designated by the Secretary under
    paragraph (2) as high-risk foods. Foods described in the
    preceding sentence shall be subject solely to the recordkeeping
    requirements under section 414 of the Federal Food, Drug, and
    Cosmetic Act (21 U.S.C. 350c) and subpart J of part 1 of title
    21, Code of Federal Regulations (or any successor regulations).

    (e) Evaluation and Recommendations.--
    (1) Report.--Not later than 1 year after the effective date
    of the final rule promulgated under subsection (d)(1), the
    Comptroller General of the United States shall submit to
    Congress a report, taking into consideration the costs of
    compliance and other regulatory burdens on small businesses and
    Federal, State, and local food safety practices and
    requirements, that evaluates the public health benefits and
    risks, if any, of limiting--
    (A) the product tracing requirements under
    subsection (d) to foods identified under paragraph (2)
    of such subsection, including whether such requirements
    provide adequate assurance of traceability in the event
    of intentional adulteration, including by acts of
    terrorism; and
    (B) the participation of restaurants in the
    recordkeeping requirements.
    (2) Determination and recommendations.--In conducting the
    evaluation and report under paragraph (1), if the Comptroller
    General of the United States determines that the limitations
    described in such paragraph do not adequately protect the public
    health, the Comptroller General shall submit

    [[Page 3936]]

    to Congress recommendations, if appropriate, regarding
    recordkeeping requirements for restaurants and additional foods,
    in order to protect the public health.

    (f) Farms.--
    (1) Request for information.--Notwithstanding subsection
    (d), during an active investigation of a foodborne illness
    outbreak, or if the Secretary determines it is necessary to
    protect the public health and prevent or mitigate a foodborne
    illness outbreak, the Secretary, in consultation and
    coordination with State and local agencies responsible for food
    safety, as appropriate, may request that the owner, operator, or
    agent of a farm identify potential immediate recipients, other
    than consumers, of an article of the food that is the subject of
    such investigation if the Secretary reasonably believes such
    article of food--
    (A) is adulterated under section 402 of the Federal
    Food, Drug, and Cosmetic Act;
    (B) presents a threat of serious adverse health
    consequences or death to humans or animals; and
    (C) was adulterated as described in subparagraph (A)
    on a particular farm (as defined in section 1.227 of
    chapter 21, Code of Federal Regulations (or any
    successor regulation)).
    (2) Manner of request. <> --In making a
    request under paragraph (1), the Secretary, in consultation and
    coordination with State and local agencies responsible for food
    safety, as appropriate, shall issue a written notice to the
    owner, operator, or agent of the farm to which the article of
    food has been traced. The individual providing such notice shall
    present to such owner, operator, or agent appropriate
    credentials and shall deliver such notice at reasonable times
    and within reasonable limits and in a reasonable manner.
    (3) Delivery of information requested.--The owner, operator,
    or agent of a farm shall deliver the information requested under
    paragraph (1) in a prompt and reasonable manner. Such
    information may consist of records kept in the normal course of
    business, and may be in electronic or non-electronic format.
    (4) Limitation.--A request made under paragraph (1) shall
    not include a request for information relating to the finances,
    pricing of commodities produced, personnel, research, sales
    (other than information relating to shipping), or other
    disclosures that may reveal trade secrets or confidential
    information from the farm to which the article of food has been
    traced, other than information necessary to identify potential
    immediate recipients of such food. <>
    Section 301(j) of the Federal Food, Drug, and Cosmetic Act and
    the Freedom of Information Act shall apply with respect to any
    confidential commercial information that is disclosed to the
    Food and Drug Administration in the course of responding to a
    request under paragraph (1).
    (5) Records.--Except with respect to identifying potential
    immediate recipients in response to a request under this
    subsection, nothing in this subsection shall require the
    establishment or maintenance by farms of new records.

    [[Page 3937]]

    (g) No Limitation on Commingling of Food.--Nothing in this section
    shall be construed to authorize the Secretary to impose any limitation
    on the commingling of food.
    (h) Small Entity Compliance Guide. <> --Not later
    than 180 days after promulgation of a final rule under subsection (d),
    the Secretary shall issue a small entity compliance guide setting forth
    in plain language the requirements of the regulations under such
    subsection in order to assist small entities, including farms and small
    businesses, in complying with the recordkeeping requirements under such
    subsection.

    (i) Flexibility for Small
    Businesses. <> --
    Notwithstanding any other provision of law, the regulations promulgated
    under subsection (d) shall apply--
    (1) to small businesses (as defined by the Secretary in
    section 103, not later than 90 days after the date of enactment
    of this Act) beginning on the date that is 1 year after the
    effective date of the final regulations promulgated under
    subsection (d); and
    (2) to very small businesses (as defined by the Secretary in
    section 103, not later than 90 days after the date of enactment
    of this Act) beginning on the date that is 2 years after the
    effective date of the final regulations promulgated under
    subsection (d).

    (j) Enforcement.--
    (1) Prohibited acts.--Section 301(e) (21 U.S.C. 331(e)) is
    amended by inserting ``; or the violation of any recordkeeping
    requirement under section 204 of the FDA Food Safety
    Modernization Act (except when such violation is committed by a
    farm)'' before the period at the end.
    (2) Imports.--Section 801(a) (21 U.S.C. 381(a)) is amended
    by inserting ``or (4) the recordkeeping requirements under
    section 204 of the FDA Food Safety Modernization Act (other than
    the requirements under subsection (f) of such section) have not
    been complied with regarding such article,'' in the third
    sentence before ``then such article shall be refused
    admission''.
    SEC. 205. <>  SURVEILLANCE.

    (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;

    [[Page 3938]]

    (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

    [[Page 3939]]

    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''.
    SEC. 206. MANDATORY RECALL AUTHORITY.

    (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:

    [[Page 3940]]

    ``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,

    [[Page 3941]]

    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.

    [[Page 3942]]

    ``(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

    [[Page 3943]]

    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

    [[Page 3944]]

    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).
    SEC. 207. ADMINISTRATIVE DETENTION OF FOOD.

    (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.
    SEC. 208. <>  DECONTAMINATION AND DISPOSAL
    STANDARDS AND PLANS.

    (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.

    [[Page 3945]]

    (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.
    SEC. 209. IMPROVING THE TRAINING OF STATE, LOCAL, TERRITORIAL, AND
    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;

    [[Page 3946]]

    ``(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.''.

    [[Page 3947]]

    (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.--

    [[Page 3948]]

    ``(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.''.
    SEC. 210. ENHANCING FOOD SAFETY.

    (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

    [[Page 3949]]

    ``(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.

    [[Page 3950]]

    ``(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

    [[Page 3951]]

    ``(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.''.
    SEC. 211. IMPROVING THE REPORTABLE FOOD REGISTRY.

    (a) In General.--Section 417 (21 U.S.C. 350f) is amended--

    [[Page 3952]]

    (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.''.

    [[Page 3953]]

    (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)''.

    TITLE III--IMPROVING THE SAFETY OF IMPORTED FOOD

    SEC. 301. FOREIGN SUPPLIER VERIFICATION PROGRAM.

    (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

    [[Page 3954]]

    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

    [[Page 3955]]

    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.
    SEC. 302. VOLUNTARY QUALIFIED IMPORTER PROGRAM.

    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.

    [[Page 3956]]

    ``(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.''.
    SEC. 303. AUTHORITY TO REQUIRE IMPORT CERTIFICATIONS FOR FOOD.

    (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

    [[Page 3957]]

    ``(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.
    SEC. 304. PRIOR NOTICE OF IMPORTED FOOD SHIPMENTS.

    (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;''.

    [[Page 3958]]

    (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.
    SEC. 305. BUILDING CAPACITY OF FOREIGN GOVERNMENTS WITH RESPECT TO
    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).
    SEC. 306. INSPECTION OF FOREIGN FOOD FACILITIES.

    (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.

    [[Page 3959]]

    ``(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.
    SEC. 307. ACCREDITATION OF THIRD-PARTY AUDITORS.

    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,

    [[Page 3960]]

    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

    [[Page 3961]]

    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.

    [[Page 3962]]

    ``(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.

    [[Page 3963]]

    ``(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;

    [[Page 3964]]

    ``(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

    [[Page 3965]]

    ``(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);

    [[Page 3966]]

    ``(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.''.
    SEC. 308. <>  FOREIGN OFFICES OF THE FOOD AND
    DRUG ADMINISTRATION.

    (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.
    SEC. 309. <>  SMUGGLED FOOD.

    (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

    [[Page 3967]]

    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.

    TITLE IV--MISCELLANEOUS PROVISIONS

    SEC. 401. FUNDING FOR FOOD SAFETY.

    (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.

    [[Page 3968]]

    SEC. 402. EMPLOYEE PROTECTIONS.

    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

    [[Page 3969]]

    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.

    [[Page 3970]]

    ``(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

    [[Page 3971]]

    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.''.

    [[Page 3972]]

    SEC. 403. <>  JURISDICTION; AUTHORITIES.

    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.
    SEC. 404. <>  COMPLIANCE WITH INTERNATIONAL
    AGREEMENTS.

    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.
    SEC. 405. DETERMINATION OF BUDGETARY EFFECTS.

    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

    [[Page 3973]]

    Congressional Record by the Chairman of the Senate Budget Committee,
    provided that such statement has been submitted prior to the vote on
    passage.

    Approved January 4, 2011.

    LEGISLATIVE HISTORY--H.R. 2751:
    ---------------------------------------------------------------------------

    CONGRESSIONAL RECORD:
    Vol. 155 (2009):
    June 9, considered and passed House.
    Vol. 156 (2010):
    Dec. 19, considered and passed
    Senate, amended.
    Dec. 21, House concurred in Senate
    amendments.