[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2751 Enrolled Bill (ENR)]

        H.R.2751

                      One Hundred Eleventh Congress

                                 of the

                        United States of America


                          AT THE SECOND SESSION

          Begun and held at the City of Washington on Tuesday,
             the fifth day of January, two thousand and ten


                                 An Act


 
 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
                       safety of the food supply.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,
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.
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 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.
        ``(2) Hearing on suspension.--The Secretary shall provide the 
    registrant subject to an order under paragraph (1) with an 
    opportunity for an informal hearing, to be held as soon as possible 
    but not later than 2 business days after the issuance of the order 
    or such other time period, as agreed upon by the Secretary and the 
    registrant, on the actions required for reinstatement of 
    registration and why the registration that is subject to suspension 
    should be reinstated. The Secretary shall reinstate a registration 
    if the Secretary determines, based on evidence presented, that 
    adequate grounds do not exist to continue the suspension of the 
    registration.
        ``(3) Post-hearing corrective action plan; vacating of order.--
            ``(A) Corrective action plan.--If, after providing 
        opportunity for an informal hearing under paragraph (2), the 
        Secretary determines that the suspension of registration 
        remains necessary, the Secretary shall require the registrant 
        to submit a corrective action plan to demonstrate how the 
        registrant plans to correct the conditions found by the 
        Secretary. The Secretary shall review such plan not later than 
        14 days after the submission of the corrective action plan or 
        such other time period as determined by the Secretary.
            ``(B) Vacating of order.--Upon a determination by the 
        Secretary that adequate grounds do not exist to continue the 
        suspension actions required by the order, or that such actions 
        should be modified, the Secretary shall promptly vacate the 
        order and reinstate the registration of the facility subject to 
        the order or modify the order, as appropriate.
        ``(4) Effect of suspension.--If the registration of a facility 
    is suspended under this subsection, no person shall import or 
    export food into the United States from such facility, offer to 
    import or export food into the United States from such facility, or 
    otherwise introduce food from such facility into interstate or 
    intrastate commerce in the United States.
        ``(5) Regulations.--
            ``(A) In general.--The Secretary shall promulgate 
        regulations to implement this subsection. The Secretary may 
        promulgate such regulations on an interim final basis.
            ``(B) Registration requirement.--The Secretary may require 
        that registration under this section be submitted in an 
        electronic format. Such requirement may not take effect before 
        the date that is 5 years after the date of enactment of the FDA 
        Food Safety Modernization Act.
        ``(6) Application date.--Facilities shall be subject to the 
    requirements of this subsection beginning on the earlier of--
            ``(A) the date on which the Secretary issues regulations 
        under paragraph (5); or
            ``(B) 180 days after the date of enactment of the FDA Food 
        Safety Modernization Act.
        ``(7) No delegation.--The authority conferred by this 
    subsection to issue an order to suspend a registration or vacate an 
    order of suspension shall not be delegated to any officer or 
    employee other than the Commissioner.''.
        (2) Small entity compliance policy guide.--Not later than 180 
    days after the issuance of the regulations promulgated under 
    section 415(b)(5) of the Federal Food, Drug, and Cosmetic Act (as 
    added by this section), the Secretary shall issue a small entity 
    compliance policy guide setting forth in plain language the 
    requirements of such regulations to assist small entities in 
    complying with registration requirements and other activities 
    required under such section.
        (3) Imported food.--Section 801(l) (21 U.S.C. 381(l)) is 
    amended by inserting ``(or for which a registration has been 
    suspended under such section)'' after ``section 415''.
    (c) Clarification of Intent.--
        (1) Retail food establishment.--The Secretary shall amend the 
    definition of the term ``retail food establishment'' in section in 
    1.227(b)(11) of title 21, Code of Federal Regulations to clarify 
    that, in determining the primary function of an establishment or a 
    retail food establishment under such section, the sale of food 
    products directly to consumers by such establishment and the sale 
    of food directly to consumers by such retail food establishment 
    include--
            (A) the sale of such food products or food directly to 
        consumers by such establishment at a roadside stand or farmers' 
        market where such stand or market is located other than where 
        the food was manufactured or processed;
            (B) the sale and distribution of such food through a 
        community supported agriculture program; and
            (C) the sale and distribution of such food at any other 
        such direct sales platform as determined by the Secretary.
        (2) Definitions.--For purposes of paragraph (1)--
            (A) the term ``community supported agriculture program'' 
        has the same meaning given the term ``community supported 
        agriculture (CSA) program'' in section 249.2 of title 7, Code 
        of Federal Regulations (or any successor regulation); and
            (B) the term ``consumer'' does not include a business.
    (d) Conforming Amendments.--
        (1) Section 301(d) (21 U.S.C. 331(d)) is amended by inserting 
    ``415,'' after ``404,''.
        (2) Section 415(d), as redesignated by subsection (b), is 
    amended by adding at the end before the period ``for a facility to 
    be registered, except with respect to the reinstatement of a 
    registration that is suspended under subsection (b)''.
    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.
    ``(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
        ``(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 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--
                ``(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.
        ``(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 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.
        ``(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 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--
            (A) activities that constitute on-farm packing or holding 
        of food that is not grown, raised, or consumed on such farm or 
        another farm under the same ownership for purposes of section 
        415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        350d), as amended by this Act;
            (B) activities that constitute on-farm manufacturing or 
        processing of food that is not consumed on that farm or on 
        another farm under common ownership for purposes of such 
        section 415; and
            (C) the requirements under sections 418 and 421 of the 
        Federal Food, Drug, and Cosmetic Act, as added by this Act, 
        from which the Secretary may issue exemptions or modifications 
        of the requirements for certain types of facilities.
    (d) Small Entity Compliance Policy Guide.--Not later than 180 days 
after the issuance of the regulations promulgated under subsection (n) 
of section 418 of the Federal Food, Drug, and Cosmetic Act (as added by 
subsection (a)), the Secretary shall issue a small entity compliance 
policy guide setting forth in plain language the requirements of such 
section 418 and this section to assist small entities in complying with 
the hazard analysis and other activities required under such section 
418 and this section.
    (e) Prohibited Acts.--Section 301 (21 U.S.C. 331) is amended by 
adding at the end the following:
    ``(uu) The operation of a facility that manufactures, processes, 
packs, or holds food for sale in the United States if the owner, 
operator, or agent in charge of such facility is not in compliance with 
section 418.''.
    (f) No Effect on HACCP Authorities.--Nothing in the amendments made 
by this section limits the authority of the Secretary under the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or the Public 
Health Service Act (42 U.S.C. 201 et seq.) to revise, issue, or enforce 
Hazard Analysis Critical Control programs and the Thermally Processed 
Low-Acid Foods Packaged in Hermetically Sealed Containers standards.
    (g) Dietary Supplements.--Nothing in the amendments made by this 
section shall apply to any facility with regard to the manufacturing, 
processing, packing, or holding of a dietary supplement that is in 
compliance with the requirements of sections 402(g)(2) and 761 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(g)(2), 379aa-1).
    (h) Updating Guidance Relating to Fish and Fisheries Products 
Hazards and Controls.--The Secretary shall, not later than 180 days 
after the date of enactment of this Act, update the Fish and Fisheries 
Products Hazards and Control Guidance to take into account advances in 
technology that have occurred since the previous publication of such 
Guidance by the Secretary.
    (i) Effective Dates.--
        (1) General rule.--The amendments made by this section shall 
    take effect 18 months after the date of enactment of this Act.
        (2) Flexibility for small businesses.--Notwithstanding 
    paragraph (1)--
            (A) the amendments made by this section shall apply to a 
        small business (as defined in the regulations promulgated under 
        section 418(n) of the Federal Food, Drug, and Cosmetic Act (as 
        added by this section)) beginning on the date that is 6 months 
        after the effective date of such regulations; and
            (B) the amendments made by this section shall apply to a 
        very small business (as defined in such regulations) beginning 
        on the date that is 18 months after the effective date of such 
        regulations.
    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 and vegetables, including 
        specific mixes or categories of fruits and vegetables, that are 
        raw agricultural commodities for which the Secretary has 
        determined that such standards minimize the risk of serious 
        adverse health consequences or death.
            ``(B) Determination by secretary.--With respect to small 
        businesses and very small businesses (as such terms are defined 
        in the regulation promulgated under subparagraph (A)) that 
        produce and harvest those types of fruits and vegetables that 
        are raw agricultural commodities that the Secretary has 
        determined are low risk and do not present a risk of serious 
        adverse health consequences or death, the Secretary may 
        determine not to include production and harvesting of such 
        fruits and vegetables in such rulemaking, or may modify the 
        applicable requirements of regulations promulgated pursuant to 
        this section.
        ``(2) Public input.--During the comment period on the notice of 
    proposed rulemaking under paragraph (1), the Secretary shall 
    conduct not less than 3 public meetings in diverse geographical 
    areas of the United States to provide persons in different regions 
    an opportunity to comment.
        ``(3) Content.--The proposed rulemaking under paragraph (1) 
    shall--
            ``(A) provide sufficient flexibility to be applicable to 
        various types of entities engaged in the production and 
        harvesting of fruits and vegetables that are raw agricultural 
        commodities, including small businesses and entities that sell 
        directly to consumers, and be appropriate to the scale and 
        diversity of the production and harvesting of such commodities;
            ``(B) include, with respect to growing, harvesting, 
        sorting, packing, and storage operations, science-based minimum 
        standards related to soil amendments, hygiene, packaging, 
        temperature controls, animals in the growing area, and water;
            ``(C) consider hazards that occur naturally, may be 
        unintentionally introduced, or may be intentionally introduced, 
        including by acts of terrorism;
            ``(D) take into consideration, consistent with ensuring 
        enforceable public health protection, conservation and 
        environmental practice standards and policies established by 
        Federal natural resource conservation, wildlife conservation, 
        and environmental agencies;
            ``(E) in the case of production that is certified organic, 
        not include any requirements that conflict with or duplicate 
        the requirements of the national organic program established 
        under the Organic Foods Production Act of 1990, while providing 
        the same level of public health protection as the requirements 
        under guidance documents, including guidance documents 
        regarding action levels, and regulations under the FDA Food 
        Safety Modernization Act; and
            ``(F) define, for purposes of this section, the terms 
        `small business' and `very small business'.
        ``(4) Prioritization.--The Secretary shall prioritize the 
    implementation of the regulations under this section for specific 
    fruits and vegetables that are raw agricultural commodities based 
    on known risks which may include a history and severity of 
    foodborne illness outbreaks.
    ``(b) Final Regulation.--
        ``(1) In general.--Not later than 1 year after the close of the 
    comment period for the proposed rulemaking under subsection (a), 
    the Secretary shall adopt a final regulation to provide for minimum 
    science-based standards for those types of fruits and vegetables, 
    including specific mixes or categories of fruits or vegetables, 
    that are raw agricultural commodities, based on known safety risks, 
    which may include a history of foodborne illness outbreaks.
        ``(2) Final regulation.--The final regulation shall--
            ``(A) provide for coordination of education and enforcement 
        activities by State and local officials, as designated by the 
        Governors of the respective States or the appropriate elected 
        State official as recognized by State statute; and
            ``(B) include a description of the variance process under 
        subsection (c) and the types of permissible variances the 
        Secretary may grant.
        ``(3) Flexibility for small businesses.--Notwithstanding 
    paragraph (1)--
            ``(A) the regulations promulgated under this section shall 
        apply to a small business (as defined in the regulation 
        promulgated under subsection (a)(1)) after the date that is 1 
        year after the effective date of the final regulation under 
        paragraph (1); and
            ``(B) the regulations promulgated under this section shall 
        apply to a very small business (as defined in the regulation 
        promulgated under subsection (a)(1)) after the date that is 2 
        years after the effective date of the final regulation under 
        paragraph (1).
    ``(c) Criteria.--
        ``(1) In general.--The regulations adopted under subsection (b) 
    shall--
            ``(A) set forth those procedures, processes, and practices 
        that the Secretary determines to minimize the risk of serious 
        adverse health consequences or death, including procedures, 
        processes, and practices that the Secretary determines to be 
        reasonably necessary to prevent the introduction of known or 
        reasonably foreseeable biological, chemical, and physical 
        hazards, including hazards that occur naturally, may be 
        unintentionally introduced, or may be intentionally introduced, 
        including by acts of terrorism, into fruits and vegetables, 
        including specific mixes or categories of fruits and 
        vegetables, that are raw agricultural commodities and to 
        provide reasonable assurances that the produce is not 
        adulterated under section 402;
            ``(B) provide sufficient flexibility to be practicable for 
        all sizes and types of businesses, including small businesses 
        such as a small food processing facility co-located on a farm;
            ``(C) comply with chapter 35 of title 44, United States 
        Code (commonly known as the `Paperwork Reduction Act'), with 
        special attention to minimizing the burden (as defined in 
        section 3502(2) of such Act) on the business, and collection of 
        information (as defined in section 3502(3) of such Act), 
        associated with such regulations;
            ``(D) acknowledge differences in risk and minimize, as 
        appropriate, the number of separate standards that apply to 
        separate foods; and
            ``(E) not require a business to hire a consultant or other 
        third party to identify, implement, certify, compliance with 
        these procedures, processes, and practices, except in the case 
        of negotiated enforcement resolutions that may require such a 
        consultant or third party; and
            ``(F) permit States and foreign countries from which food 
        is imported into the United States to request from the 
        Secretary variances from the requirements of the regulations, 
        subject to paragraph (2), where the State or foreign country 
        determines that the variance is necessary in light of local 
        growing conditions and that the procedures, processes, and 
        practices to be followed under the variance are reasonably 
        likely to ensure that the produce is not adulterated under 
        section 402 and to provide the same level of public health 
        protection as the requirements of the regulations adopted under 
        subsection (b).
        ``(2) Variances.--
            ``(A) Requests for variances.--A State or foreign country 
        from which food is imported into the United States may in 
        writing request a variance from the Secretary. Such request 
        shall describe the variance requested and present information 
        demonstrating that the variance does not increase the 
        likelihood that the food for which the variance is requested 
        will be adulterated under section 402, and that the variance 
        provides the same level of public health protection as the 
        requirements of the regulations adopted under subsection (b). 
        The Secretary shall review such requests in a reasonable 
        timeframe.
            ``(B) Approval of variances.--The Secretary may approve a 
        variance in whole or in part, as appropriate, and may specify 
        the scope of applicability of a variance to other similarly 
        situated persons.
            ``(C) Denial of variances.--The Secretary may deny a 
        variance request if the Secretary determines that such variance 
        is not reasonably likely to ensure that the food is not 
        adulterated under section 402 and is not reasonably likely to 
        provide the same level of public health protection as the 
        requirements of the regulation adopted under subsection (b). 
        The Secretary shall notify the person requesting such variance 
        of the reasons for the denial.
            ``(D) Modification or revocation of a variance.--The 
        Secretary, after notice and an opportunity for a hearing, may 
        modify or revoke a variance if the Secretary determines that 
        such variance is not reasonably likely to ensure that the food 
        is not adulterated under section 402 and is not reasonably 
        likely to provide the same level of public health protection as 
        the requirements of the regulations adopted under subsection 
        (b).
    ``(d) Enforcement.--The Secretary may coordinate with the Secretary 
of Agriculture and, as appropriate, shall contract and coordinate with 
the agency or department designated by the Governor of each State to 
perform activities to ensure compliance with this section.
    ``(e) Guidance.--
        ``(1) In general.--Not later than 1 year after the date of 
    enactment of the FDA Food Safety Modernization Act, the Secretary 
    shall publish, after consultation with the Secretary of 
    Agriculture, representatives of State departments of agriculture, 
    farmer representatives, and various types of entities engaged in 
    the production and harvesting or importing of fruits and vegetables 
    that are raw agricultural commodities, including small businesses, 
    updated good agricultural practices and guidance for the safe 
    production and harvesting of specific types of fresh produce under 
    this section.
        ``(2) Public meetings.--The Secretary shall conduct not fewer 
    than 3 public meetings in diverse geographical areas of the United 
    States as part of an effort to conduct education and outreach 
    regarding the guidance described in paragraph (1) for persons in 
    different regions who are involved in the production and harvesting 
    of fruits and vegetables that are raw agricultural commodities, 
    including persons that sell directly to consumers and farmer 
    representatives, and for importers of fruits and vegetables that 
    are raw agricultural commodities.
        ``(3) Paperwork reduction.--The Secretary shall ensure that any 
    updated guidance under this section will--
            ``(A) provide sufficient flexibility to be practicable for 
        all sizes and types of facilities, including small businesses 
        such as a small food processing facility co-located on a farm; 
        and
            ``(B) acknowledge differences in risk and minimize, as 
        appropriate, the number of separate standards that apply to 
        separate foods.
    ``(f) Exemption for Direct Farm Marketing.--
        ``(1) In general.--A farm shall be exempt from the requirements 
    under this section in a calendar year if--
            ``(A) during the previous 3-year period, the average annual 
        monetary value of the food sold by such farm directly to 
        qualified end-users during such period exceeded the average 
        annual monetary value of the food sold by such farm to all 
        other buyers during such period; and
            ``(B) the average annual monetary value of all food sold 
        during such period was less than $500,000, adjusted for 
        inflation.
        ``(2) Notification to consumers.--
            ``(A) In general.--A farm that is exempt from the 
        requirements under this section shall--
                ``(i) with respect to a food for which a food packaging 
            label is required by the Secretary under any other 
            provision of this Act, include prominently and 
            conspicuously on such label the name and business address 
            of the farm where the produce was grown; or
                ``(ii) with respect to a food for which a food 
            packaging label is not required by the Secretary under any 
            other provision of this Act, prominently and conspicuously 
            display, at the point of purchase, the name and business 
            address of the farm where the produce was grown, on a 
            label, poster, sign, placard, or documents delivered 
            contemporaneously with the food in the normal course of 
            business, or, in the case of Internet sales, in an 
            electronic notice.
            ``(B) No additional label.--Subparagraph (A) does not 
        provide authority to the Secretary to require a label that is 
        in addition to any label required under any other provision of 
        this Act.
        ``(3) Withdrawal; rule of construction.--
            ``(A) In general.--In the event of an active investigation 
        of a foodborne illness outbreak that is directly linked to a 
        farm subject to an exemption under this subsection, or if the 
        Secretary determines that it is necessary to protect the public 
        health and prevent or mitigate a foodborne illness outbreak 
        based on conduct or conditions associated with a farm that are 
        material to the safety of the food produced or harvested at 
        such farm, the Secretary may withdraw the exemption provided to 
        such farm under this subsection.
            ``(B) Rule of construction.--Nothing in this subsection 
        shall be construed to expand or limit the inspection authority 
        of the Secretary.
        ``(4) Definitions.--
            ``(A) Qualified end-user.--In this subsection, the term 
        `qualified end-user', with respect to a food means--
                ``(i) the consumer of the food; or
                ``(ii) a restaurant or retail food establishment (as 
            those terms are defined by the Secretary for purposes of 
            section 415) that is located--

                    ``(I) in the same State as the farm that produced 
                the food; or
                    ``(II) not more than 275 miles from such farm.

            ``(B) Consumer.--For purposes of subparagraph (A), the term 
        `consumer' does not include a business.
        ``(5) No preemption.--Nothing in this subsection preempts 
    State, local, county, or other non-Federal law regarding the safe 
    production, harvesting, holding, transportation, and sale of fresh 
    fruits and vegetables. Compliance with this subsection shall not 
    relieve any person from liability at common law or under State 
    statutory law.
        ``(6) Limitation of effect.--Nothing in this subsection shall 
    prevent the Secretary from exercising any authority granted in the 
    other sections of this Act.
    ``(g) Clarification.--This section shall not apply to produce that 
is produced by an individual for personal consumption.
    ``(h) Exception for Activities of Facilities Subject to Section 
418.--This section shall not apply to activities of a facility that are 
subject to section 418.''.
    (b) Small Entity Compliance Policy Guide.--Not later than 180 days 
after the issuance of regulations under section 419 of the Federal 
Food, Drug, and Cosmetic Act (as added by subsection (a)), the 
Secretary of Health and Human Services shall issue a small entity 
compliance policy guide setting forth in plain language the 
requirements of such section 419 and to assist small entities in 
complying with standards for safe production and harvesting and other 
activities required under such section.
    (c) Prohibited Acts.--Section 301 (21 U.S.C. 331), as amended by 
section 103, is amended by adding at the end the following:
    ``(vv) The failure to comply with the requirements under section 
419.''.
    (d) No Effect on HACCP Authorities.--Nothing in the amendments made 
by this section limits the authority of the Secretary under the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or the Public 
Health Service Act (42 U.S.C. 201 et seq.) to revise, issue, or enforce 
product and category-specific regulations, such as the Seafood Hazard 
Analysis Critical Controls Points Program, the Juice Hazard Analysis 
Critical Control Program, and the Thermally Processed Low-Acid Foods 
Packaged in Hermetically Sealed Containers standards.
    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
        ``(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 for each 
        foreign facility subject to a reinspection in such fiscal year, 
        to cover reinspection-related costs for such year;
            ``(B) the responsible party for a domestic facility (as 
        defined in section 415(b)) and an importer who does not comply 
        with a recall order under section 423 or under section 412(f) 
        in such fiscal year, to cover food recall activities associated 
        with such order performed by the Secretary, including technical 
        assistance, follow-up effectiveness checks, and public 
        notifications, for such year;
            ``(C) each importer participating in the voluntary 
        qualified importer program under section 806 in such year, to 
        cover the administrative costs of such program for such year; 
        and
            ``(D) each importer subject to a reinspection in such 
        fiscal year, to cover reinspection-related costs for such year.
        ``(2) Definitions.--For purposes of this section--
            ``(A) the term `reinspection' means--
                ``(i) with respect to domestic facilities (as defined 
            in section 415(b)), 1 or more inspections conducted under 
            section 704 subsequent to an inspection conducted under 
            such provision which identified noncompliance materially 
            related to a food safety requirement of this Act, 
            specifically to determine whether compliance has been 
            achieved to the Secretary's satisfaction; and
                ``(ii) with respect to importers, 1 or more 
            examinations conducted under section 801 subsequent to an 
            examination conducted under such provision which identified 
            noncompliance materially related to a food safety 
            requirement of this Act, specifically to determine whether 
            compliance has been achieved to the Secretary's 
            satisfaction;
            ``(B) the term `reinspection-related costs' means all 
        expenses, including administrative expenses, incurred in 
        connection with--
                ``(i) arranging, conducting, and evaluating the results 
            of reinspections; and
                ``(ii) assessing and collecting reinspection fees under 
            this section; and
            ``(C) the term `responsible party' has the meaning given 
        such term in section 417(a)(1).
    ``(b) Establishment of Fees.--
        ``(1) In general.--Subject to subsections (c) and (d), the 
    Secretary shall establish the fees to be collected under this 
    section for each fiscal year specified in subsection (a)(1), based 
    on the methodology described under paragraph (2), and shall publish 
    such fees in a Federal Register notice not later than 60 days 
    before the start of each such year.
        ``(2) Fee methodology.--
            ``(A) Fees.--Fees amounts established for collection--
                ``(i) under subparagraph (A) of subsection (a)(1) for a 
            fiscal year shall be based on the Secretary's estimate of 
            100 percent of the costs of the reinspection-related 
            activities (including by type or level of reinspection 
            activity, as the Secretary determines applicable) described 
            in such subparagraph (A) for such year;
                ``(ii) under subparagraph (B) of subsection (a)(1) for 
            a fiscal year shall be based on the Secretary's estimate of 
            100 percent of the costs of the activities described in 
            such subparagraph (B) for such year;
                ``(iii) under subparagraph (C) of subsection (a)(1) for 
            a fiscal year shall be based on the Secretary's estimate of 
            100 percent of the costs of the activities described in 
            such subparagraph (C) for such year; and
                ``(iv) under subparagraph (D) of subsection (a)(1) for 
            a fiscal year shall be based on the Secretary's estimate of 
            100 percent of the costs of the activities described in 
            such subparagraph (D) for such year.
            ``(B) Other considerations.--
                ``(i) Voluntary qualified importer program.--In 
            establishing the fee amounts under subparagraph (A)(iii) 
            for a fiscal year, the Secretary shall provide for the 
            number of importers who have submitted to the Secretary a 
            notice under section 806(c) informing the Secretary of the 
            intent of such importer to participate in the program under 
            section 806 in such fiscal year.

                    ``(II) Recoupment.--In establishing the fee amounts 
                under subparagraph (A)(iii) for the first 5 fiscal 
                years after the date of enactment of this section, the 
                Secretary shall include in such fee a reasonable 
                surcharge that provides a recoupment of the costs 
                expended by the Secretary to establish and implement 
                the first year of the program under section 806.

                ``(ii) Crediting of fees.--In establishing the fee 
            amounts under subparagraph (A) for a fiscal year, the 
            Secretary shall provide for the crediting of fees from the 
            previous year to the next year if the Secretary 
            overestimated the amount of fees needed to carry out such 
            activities, and consider the need to account for any 
            adjustment of fees and such other factors as the Secretary 
            determines appropriate.
                ``(iii) Published guidelines.--Not later than 180 days 
            after the date of enactment of the FDA Food Safety 
            Modernization Act, the Secretary shall publish in the 
            Federal Register a proposed set of guidelines in 
            consideration of the burden of fee amounts on small 
            business. Such consideration may include reduced fee 
            amounts for small businesses. The Secretary shall provide 
            for a period of public comment on such guidelines. The 
            Secretary shall adjust the fee schedule for small 
            businesses subject to such fees only through notice and 
            comment rulemaking.
        ``(3) Use of fees.--The Secretary shall make all of the fees 
    collected pursuant to clause (i), (ii), (iii), and (iv) of 
    paragraph (2)(A) available solely to pay for the costs referred to 
    in such clause (i), (ii), (iii), and (iv) of paragraph (2)(A), 
    respectively.
    ``(c) Limitations.--
        ``(1) In general.--Fees under subsection (a) shall be refunded 
    for a fiscal year beginning after fiscal year 2010 unless the 
    amount of the total appropriations for food safety activities at 
    the Food and Drug Administration for such fiscal year (excluding 
    the amount of fees appropriated for such fiscal year) is equal to 
    or greater than the amount of appropriations for food safety 
    activities at the Food and Drug Administration for fiscal year 2009 
    (excluding the amount of fees appropriated for such fiscal year), 
    multiplied by the adjustment factor under paragraph (3).
        ``(2) Authority.--If--
            ``(A) the Secretary does not assess fees under subsection 
        (a) for a portion of a fiscal year because paragraph (1) 
        applies; and
            ``(B) at a later date in such fiscal year, such paragraph 
        (1) ceases to apply,
    the Secretary may assess and collect such fees under subsection 
    (a), without any modification to the rate of such fees, 
    notwithstanding the provisions of subsection (a) relating to the 
    date fees are to be paid.
        ``(3) Adjustment factor.--
            ``(A) In general.--The adjustment factor described in 
        paragraph (1) shall be the total percentage change that 
        occurred in the Consumer Price Index for all urban consumers 
        (all items; United States city average) for the 12-month period 
        ending June 30 preceding the fiscal year, but in no case shall 
        such adjustment factor be negative.
            ``(B) Compounded basis.--The adjustment under subparagraph 
        (A) made each fiscal year shall be added on a compounded basis 
        to the sum of all adjustments made each fiscal year after 
        fiscal year 2009.
        ``(4) Limitation on amount of certain fees.--
            ``(A) In general.--Notwithstanding any other provision of 
        this section and subject to subparagraph (B), the Secretary may 
        not collect fees in a fiscal year such that the amount 
        collected--
                ``(i) under subparagraph (B) of subsection (a)(1) 
            exceeds $20,000,000; and
                ``(ii) under subparagraphs (A) and (D) of subsection 
            (a)(1) exceeds $25,000,000 combined.
            ``(B) Exception.--If a domestic facility (as defined in 
        section 415(b)) or an importer becomes subject to a fee 
        described in subparagraph (A), (B), or (D) of subsection (a)(1) 
        after the maximum amount of fees has been collected by the 
        Secretary under subparagraph (A), the Secretary may collect a 
        fee from such facility or importer.
    ``(d) Crediting and Availability of Fees.--Fees authorized under 
subsection (a) shall be collected and available for obligation only to 
the extent and in the amount provided in appropriations Acts. Such fees 
are authorized to remain available until expended. Such sums as may be 
necessary may be transferred from the Food and Drug Administration 
salaries and expenses account without fiscal year limitation to such 
appropriation account for salaries and expenses with such fiscal year 
limitation. The sums transferred shall be available solely for the 
purpose of paying the operating expenses of the Food and Drug 
Administration employees and contractors performing activities 
associated with these food safety fees.
    ``(e) Collection of Fees.--
        ``(1) In general.--The Secretary shall specify in the Federal 
    Register notice described in subsection (b)(1) the time and manner 
    in which fees assessed under this section shall be collected.
        ``(2) Collection of unpaid fees.--In any case where the 
    Secretary does not receive payment of a fee assessed under this 
    section within 30 days after it is due, such fee shall be treated 
    as a claim of the United States Government subject to provisions of 
    subchapter II of chapter 37 of title 31, United States Code.
    ``(f) Annual Report to Congress.--Not later than 120 days after 
each fiscal year for which fees are assessed under this section, the 
Secretary shall submit a report to the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Committee on Energy and 
Commerce of the House of Representatives, to include a description of 
fees assessed and collected for each such year and a summary 
description of the entities paying such fees and the types of business 
in which such entities engage.
    ``(g) Authorization of Appropriations.--For fiscal year 2010 and 
each fiscal year thereafter, there is authorized to be appropriated for 
fees under this section an amount equal to the total revenue amount 
determined under subsection (b) for the fiscal year, as adjusted or 
otherwise affected under the other provisions of this section.''.
    (b) Export Certification Fees for Foods and Animal Feed.--
        (1) Authority for export certifications for food, including 
    animal feed.--Section 801(e)(4)(A) (21 U.S.C. 381(e)(4)(A)) is 
    amended--
            (A) in the matter preceding clause (i), by striking ``a 
        drug'' and inserting ``a food, drug'';
            (B) in clause (i) by striking ``exported drug'' and 
        inserting ``exported food, drug''; and
            (C) in clause (ii) by striking ``the drug'' each place it 
        appears and inserting ``the food, drug''.
        (2) Clarification of certification.--Section 801(e)(4) (21 
    U.S.C. 381(e)(4)) is amended by inserting after subparagraph (B) 
    the following new subparagraph:
            ``(C) For purposes of this paragraph, a certification by 
        the Secretary shall be made on such basis, and in such form 
        (including a publicly available listing) as the Secretary 
        determines appropriate.''.
        (3) Limitations on the use and amount of fees.--Paragraph (4) 
    of section 801(e) (21 U.S.C. 381(e)) is amended by adding at the 
    end the following:
            ``(D) With regard to fees pursuant to subparagraph (B) in 
        connection with written export certifications for food:
                ``(i) Such fees shall be collected and available solely 
            for the costs of the Food and Drug Administration 
            associated with issuing such certifications.
                ``(ii) Such fees may not be retained in an amount that 
            exceeds such costs for the respective fiscal year.''
    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 to the 
    relevant committees of Congress, and make publicly available on the 
    Internet Web sites of the Department of Health and Human Services 
    and the Department of Agriculture, the National Agriculture and 
    Food Defense Strategy.
        (2) Implementation plan.--The strategy shall include an 
    implementation plan for use by the Secretaries described under 
    paragraph (1) in carrying out the strategy.
        (3) Research.--The strategy shall include a coordinated 
    research agenda for use by the Secretaries described under 
    paragraph (1) in conducting research to support the goals and 
    activities described in paragraphs (1) and (2) of subsection (b).
        (4) Revisions.--Not later than 4 years after the date on which 
    the strategy is submitted to the relevant committees of Congress 
    under paragraph (1), and not less frequently than every 4 years 
    thereafter, the Secretary of Health and Human Services and the 
    Secretary of Agriculture, in coordination with the Secretary of 
    Homeland Security, shall revise and submit to the relevant 
    committees of Congress the strategy.
        (5) Consistency with existing plans.--The strategy described in 
    paragraph (1) shall be consistent with--
            (A) the National Incident Management System;
            (B) the National Response Framework;
            (C) the National Infrastructure Protection Plan;
            (D) the National Preparedness Goals; and
            (E) other relevant national strategies.
    (b) Components.--
        (1) In general.--The strategy shall include a description of 
    the process to be used by the Department of Health and Human 
    Services, the Department of Agriculture, and the Department of 
    Homeland Security--
            (A) to achieve each goal described in paragraph (2); and
            (B) to evaluate the progress made by Federal, State, local, 
        and tribal governments towards the achievement of each goal 
        described in paragraph (2).
        (2) Goals.--The strategy shall include a description of the 
    process to be used by the Department of Health and Human Services, 
    the Department of Agriculture, and the Department of Homeland 
    Security to achieve the following goals:
            (A) Preparedness goal.--Enhance the preparedness of the 
        agriculture and food system by--
                (i) conducting vulnerability assessments of the 
            agriculture and food system;
                (ii) mitigating vulnerabilities of the system;
                (iii) improving communication and training relating to 
            the system;
                (iv) developing and conducting exercises to test 
            decontamination and disposal plans;
                (v) developing modeling tools to improve event 
            consequence assessment and decision support; and
                (vi) preparing risk communication tools and enhancing 
            public awareness through outreach.
            (B) Detection goal.--Improve agriculture and food system 
        detection capabilities by--
                (i) identifying contamination in food products at the 
            earliest possible time; and
                (ii) conducting surveillance to prevent the spread of 
            diseases.
            (C) Emergency response goal.--Ensure an efficient response 
        to agriculture and food emergencies by--
                (i) immediately investigating animal disease outbreaks 
            and suspected food contamination;
                (ii) preventing additional human illnesses;
                (iii) organizing, training, and equipping animal, 
            plant, and food emergency response teams of--

                    (I) the Federal Government; and
                    (II) State, local, and tribal governments;

                (iv) designing, developing, and evaluating training and 
            exercises carried out under agriculture and food defense 
            plans; and
                (v) ensuring consistent and organized risk 
            communication to the public by--

                    (I) the Federal Government;
                    (II) State, local, and tribal governments; and
                    (III) the private sector.

            (D) Recovery goal.--Secure agriculture and food production 
        after an agriculture or food emergency by--
                (i) working with the private sector to develop business 
            recovery plans to rapidly resume agriculture, food 
            production, and international trade;
                (ii) conducting exercises of the plans described in 
            subparagraph (C) with the goal of long-term recovery 
            results;
                (iii) rapidly removing, and effectively disposing of--

                    (I) contaminated agriculture and food products; and
                    (II) infected plants and animals; and

                (iv) decontaminating and restoring areas affected by an 
            agriculture or food emergency.
        (3) Evaluation.--The Secretary, in coordination with the 
    Secretary of Agriculture and the Secretary of Homeland Security, 
    shall--
            (A) develop metrics to measure progress for the evaluation 
        process described in paragraph (1)(B); and
            (B) report on the progress measured in subparagraph (A) as 
        part of the National Agriculture and Food Defense strategy 
        described in subsection (a)(1).
    (c) Limited Distribution.--In the interest of national security, 
the Secretary of Health and Human Services and the Secretary of 
Agriculture, in coordination with the Secretary of Homeland Security, 
may determine the manner and format in which the National Agriculture 
and Food Defense strategy established under this section is made 
publicly available on the Internet Web sites of the Department of 
Health and Human Services, the Department of Homeland Security, and the 
Department of Agriculture, as described in subsection (a)(1).
    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, 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.
            (G) The estimated resources needed to effectively implement 
        the programs and practices identified in the report developed 
        in this section over a 5-year period.
            (H) The impact of requirements under this Act (including 
        amendments made by this Act) on certified organic farms and 
        facilities (as defined in section 415 (21 U.S.C. 350d).
            (I) Specific efforts taken pursuant to the agreements 
        authorized under section 421(c) of the Federal Food, Drug, and 
        Cosmetic Act (as added by section 201), together with, as 
        necessary, a description of any additional authorities 
        necessary to improve seafood safety.
        (2) Biennial reports.--On a biennial basis following the 
    submission of the report under paragraph (1), the Secretary shall 
    submit to Congress a report that--
            (A) reviews previous food safety programs and practices;
            (B) outlines the success of those programs and practices;
            (C) identifies future programs and practices; and
            (D) includes information related to any matter described in 
        subparagraphs (A) through (H) of paragraph (1), as necessary.
    (b) Risk-based Activities.--The report developed under subsection 
(a)(1) shall describe methods that seek to ensure that resources 
available to the Secretary for food safety-related activities are 
directed at those actions most likely to reduce risks from food, 
including the use of preventive strategies and allocation of inspection 
resources. The Secretary shall promptly undertake those risk-based 
actions that are identified during the development of the report as 
likely to contribute to the safety and security of the food supply.
    (c) Capability for Laboratory Analyses; Research.--The report 
developed under subsection (a)(1) shall provide a description of 
methods to increase capacity to undertake analyses of food samples 
promptly after collection, to identify new and rapid analytical 
techniques, including commercially-available techniques that can be 
employed at ports of entry and by Food Emergency Response Network 
laboratories, and to provide for well-equipped and staffed laboratory 
facilities and progress toward laboratory accreditation under section 
422 of the Federal Food, Drug, and Cosmetic Act (as added by section 
202).
    (d) Information Technology.--The report developed under subsection 
(a)(1) shall include a description of such information technology 
systems as may be needed to identify risks and receive data from 
multiple sources, including foreign governments, State, local, and 
tribal governments, other Federal agencies, the food industry, 
laboratories, laboratory networks, and consumers. The information 
technology systems that the Secretary describes shall also provide for 
the integration of the facility registration system under section 415 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d), and the 
prior notice system under section 801(m) of such Act (21 U.S.C. 381(m)) 
with other information technology systems that are used by the Federal 
Government for the processing of food offered for import into the 
United States.
    (e) Automated Risk Assessment.--The report developed under 
subsection (a)(1) shall include a description of progress toward 
developing and improving an automated risk assessment system for food 
safety surveillance and allocation of resources.
    (f) Traceback and Surveillance Report.--The Secretary shall include 
in the report developed under subsection (a)(1) an analysis of the Food 
and Drug Administration's performance in foodborne illness outbreaks 
during the 5-year period preceding the date of enactment of this Act 
involving fruits and vegetables that are raw agricultural commodities 
(as defined in section 201(r) (21 U.S.C. 321(r)) and recommendations 
for enhanced surveillance, outbreak response, and traceability. Such 
findings and recommendations shall address communication and 
coordination with the public, industry, and State and local 
governments, as such communication and coordination relates to outbreak 
identification and traceback.
    (g) Biennial Food Safety and Food Defense Research Plan.--The 
Secretary, the Secretary of Agriculture, and the Secretary of Homeland 
Security shall, on a biennial basis, submit to Congress a joint food 
safety and food defense research plan which may include studying the 
long-term health effects of foodborne illness. Such biennial plan shall 
include a list and description of projects conducted during the 
previous 2-year period and the plan for projects to be conducted during 
the subsequent 2-year period.
    (h) Effectiveness of Programs Administered by the Department of 
Health and Human Services.--
        (1) In general.--To determine whether existing Federal programs 
    administered by the Department of Health and Human Services are 
    effective in achieving the stated goals of such programs, the 
    Secretary shall, beginning not later than 1 year after the date of 
    enactment of this Act--
            (A) conduct an annual evaluation of each program of such 
        Department to determine the effectiveness of each such program 
        in achieving legislated intent, purposes, and objectives; and
            (B) submit to Congress a report concerning such evaluation.
        (2) Content.--The report described under paragraph (1)(B) 
    shall--
            (A) include conclusions concerning the reasons that such 
        existing programs have proven successful or not successful and 
        what factors contributed to such conclusions;
            (B) include recommendations for consolidation and 
        elimination to reduce duplication and inefficiencies in such 
        programs at such Department as identified during the evaluation 
        conduct under this subsection; and
            (C) be made publicly available in a publication entitled 
        ``Guide to the U.S. Department of Health and Human Services 
        Programs''.
    (i) Unique Identification Numbers.--
        (1) In general.--Not later than 1 year after the date of 
    enactment of this Act, the Secretary, acting through the 
    Commissioner of Food and Drugs, shall conduct a study regarding the 
    need for, and challenges associated with, development and 
    implementation of a program that requires a unique identification 
    number for each food facility registered with the Secretary and, as 
    appropriate, each broker that imports food into the United States. 
    Such study shall include an evaluation of the costs associated with 
    development and implementation of such a system, and make 
    recommendations about what new authorities, if any, would be 
    necessary to develop and implement such a system.
        (2) Report.--Not later than 15 months after the date of 
    enactment of this Act, the Secretary shall submit to Congress a 
    report that describes the findings of the study conducted under 
    paragraph (1) and that includes any recommendations determined 
    appropriate by the Secretary.
    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.
            (B) Applicability of ferpa.--Each plan described in 
        subparagraph (A) that is developed for an individual shall be 
        considered an education record for the purpose of section 444 
        of the General Education Provisions Act (commonly referred to 
        as the ``Family Educational Rights and Privacy Act of 1974'') 
        (20 U.S.C. 1232g).
        (2) Contents.--The voluntary guidelines developed by the 
    Secretary under paragraph (1) shall address each of the following 
    and may be updated as the Secretary determines necessary:
            (A) Parental obligation to provide the school or early 
        childhood education program, prior to the start of every school 
        year, with--
                (i) documentation from their child's physician or 
            nurse--

                    (I) supporting a diagnosis of food allergy, and any 
                risk of anaphylaxis, if applicable;
                    (II) identifying any food to which the child is 
                allergic;
                    (III) describing, if appropriate, any prior history 
                of anaphylaxis;
                    (IV) listing any medication prescribed for the 
                child for the treatment of anaphylaxis;
                    (V) detailing emergency treatment procedures in the 
                event of a reaction;
                    (VI) listing the signs and symptoms of a reaction; 
                and
                    (VII) assessing the child's readiness for self-
                administration of prescription medication; and

                (ii) a list of substitute meals that may be offered to 
            the child by school or early childhood education program 
            food service personnel.
            (B) The creation and maintenance of an individual plan for 
        food allergy management, in consultation with the parent, 
        tailored to the needs of each child with a documented risk for 
        anaphylaxis, including any procedures for the self-
        administration of medication by such children in instances 
        where--
                (i) the children are capable of self-administering 
            medication; and
                (ii) such administration is not prohibited by State 
            law.
            (C) Communication strategies between individual schools or 
        early childhood education programs and providers of emergency 
        medical services, including appropriate instructions for 
        emergency medical response.
            (D) Strategies to reduce the risk of exposure to 
        anaphylactic causative agents in classrooms and common school 
        or early childhood education program areas such as cafeterias.
            (E) The dissemination of general information on life-
        threatening food allergies to school or early childhood 
        education program staff, parents, and children.
            (F) Food allergy management training of school or early 
        childhood education program personnel who regularly come into 
        contact with children with life-threatening food allergies.
            (G) The authorization and training of school or early 
        childhood education program personnel to administer epinephrine 
        when the nurse is not immediately available.
            (H) The timely accessibility of epinephrine by school or 
        early childhood education program personnel when the nurse is 
        not immediately available.
            (I) The creation of a plan contained in each individual 
        plan for food allergy management that addresses the appropriate 
        response to an incident of anaphylaxis of a child while such 
        child is engaged in extracurricular programs of a school or 
        early childhood education program, such as non-academic outings 
        and field trips, before- and after-school programs or before- 
        and after-early child education program programs, and school-
        sponsored or early childhood education program-sponsored 
        programs held on weekends.
            (J) Maintenance of information for each administration of 
        epinephrine to a child at risk for anaphylaxis and prompt 
        notification to parents.
            (K) Other elements the Secretary determines necessary for 
        the management of food allergies and anaphylaxis in schools and 
        early childhood education programs.
        (3) Relation to state law.--Nothing in this section or the 
    guidelines developed by the Secretary under paragraph (1) shall be 
    construed to preempt State law, including any State law regarding 
    whether students at risk for anaphylaxis may self-administer 
    medication.
    (c) School-based Food Allergy Management Grants.--
        (1) In general.--The Secretary may award grants to local 
    educational agencies to assist such agencies with implementing 
    voluntary food allergy and anaphylaxis management guidelines 
    described in subsection (b).
        (2) Application.--
            (A) In general.--To be eligible to receive a grant under 
        this subsection, a local educational agency shall submit an 
        application to the Secretary at such time, in such manner, and 
        including such information as the Secretary may reasonably 
        require.
            (B) Contents.--Each application submitted under 
        subparagraph (A) shall include--
                (i) an assurance that the local educational agency has 
            developed plans in accordance with the food allergy and 
            anaphylaxis management guidelines described in subsection 
            (b);
                (ii) a description of the activities to be funded by 
            the grant in carrying out the food allergy and anaphylaxis 
            management guidelines, including--

                    (I) how the guidelines will be carried out at 
                individual schools served by the local educational 
                agency;
                    (II) how the local educational agency will inform 
                parents and students of the guidelines in place;
                    (III) how school nurses, teachers, administrators, 
                and other school-based staff will be made aware of, and 
                given training on, when applicable, the guidelines in 
                place; and
                    (IV) any other activities that the Secretary 
                determines appropriate;

                (iii) an itemization of how grant funds received under 
            this subsection will be expended;
                (iv) a description of how adoption of the guidelines 
            and implementation of grant activities will be monitored; 
            and
                (v) an agreement by the local educational agency to 
            report information required by the Secretary to conduct 
            evaluations under this subsection.
        (3) Use of funds.--Each local educational agency that receives 
    a grant under this subsection may use the grant funds for the 
    following:
            (A) Purchase of materials and supplies, including limited 
        medical supplies such as epinephrine and disposable wet wipes, 
        to support carrying out the food allergy and anaphylaxis 
        management guidelines described in subsection (b).
            (B) In partnership with local health departments, school 
        nurse, teacher, and personnel training for food allergy 
        management.
            (C) Programs that educate students as to the presence of, 
        and policies and procedures in place related to, food allergies 
        and anaphylactic shock.
            (D) Outreach to parents.
            (E) Any other activities consistent with the guidelines 
        described in subsection (b).
        (4) Duration of awards.--The Secretary may award grants under 
    this subsection for a period of not more than 2 years. In the event 
    the Secretary conducts a program evaluation under this subsection, 
    funding in the second year of the grant, where applicable, shall be 
    contingent on a successful program evaluation by the Secretary 
    after the first year.
        (5) Limitation on grant funding.--The Secretary may not provide 
    grant funding to a local educational agency under this subsection 
    after such local educational agency has received 2 years of grant 
    funding under this subsection.
        (6) Maximum amount of annual awards.--A grant awarded under 
    this subsection may not be made in an amount that is more than 
    $50,000 annually.
        (7) Priority.--In awarding grants under this subsection, the 
    Secretary shall give priority to local educational agencies with 
    the highest percentages of children who are counted under section 
    1124(c) of the Elementary and Secondary Education Act of 1965 (20 
    U.S.C. 6333(c)).
        (8) Matching funds.--
            (A) In general.--The Secretary may not award a grant under 
        this subsection unless the local educational agency agrees 
        that, with respect to the costs to be incurred by such local 
        educational agency in carrying out the grant activities, the 
        local educational agency shall make available (directly or 
        through donations from public or private entities) non-Federal 
        funds toward such costs in an amount equal to not less than 25 
        percent of the amount of the grant.
            (B) Determination of amount of non-federal contribution.--
        Non-Federal funds required under subparagraph (A) may be cash 
        or in kind, including plant, equipment, or services. Amounts 
        provided by the Federal Government, and any portion of any 
        service subsidized by the Federal Government, may not be 
        included in determining the amount of such non-Federal funds.
        (9) Administrative funds.--A local educational agency that 
    receives a grant under this subsection may use not more than 2 
    percent of the grant amount for administrative costs related to 
    carrying out this subsection.
        (10) Progress and evaluations.--At the completion of the grant 
    period referred to in paragraph (4), a local educational agency 
    shall provide the Secretary with information on how grant funds 
    were spent and the status of implementation of the food allergy and 
    anaphylaxis management guidelines described in subsection (b).
        (11) Supplement, not supplant.--Grant funds received under this 
    subsection shall be used to supplement, and not supplant, non-
    Federal funds and any other Federal funds available to carry out 
    the activities described in this subsection.
        (12) Authorization of appropriations.--There is authorized to 
    be appropriated to carry out this subsection $30,000,000 for fiscal 
    year 2011 and such sums as may be necessary for each of the 4 
    succeeding fiscal years.
    (d) Voluntary Nature of Guidelines.--
        (1) In general.--The food allergy and anaphylaxis management 
    guidelines developed by the Secretary under subsection (b) are 
    voluntary. Nothing in this section or the guidelines developed by 
    the Secretary under subsection (b) shall be construed to require a 
    local educational agency to implement such guidelines.
        (2) Exception.--Notwithstanding paragraph (1), the Secretary 
    may enforce an agreement by a local educational agency to implement 
    food allergy and anaphylaxis management guidelines as a condition 
    of the receipt of a grant under subsection (c).
    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 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).
    (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 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.
            ``(B) Domestic high-risk facilities.--The Secretary shall 
        increase the frequency of inspection of domestic facilities 
        identified under paragraph (1) as high-risk facilities such 
        that each such facility is inspected--
                ``(i) not less often than once in the 5-year period 
            following the date of enactment of the FDA Food Safety 
            Modernization Act; and
                ``(ii) not less often than once every 3 years 
            thereafter.
            ``(C) Domestic non-high-risk facilities.--The Secretary 
        shall ensure that each domestic facility that is not identified 
        under paragraph (1) as a high-risk facility is inspected--
                ``(i) not less often than once in the 7-year period 
            following the date of enactment of the FDA Food Safety 
            Modernization Act; and
                ``(ii) not less often than once every 5 years 
            thereafter.
            ``(D) Foreign facilities.--
                ``(i) Year 1.--In the 1-year period following the date 
            of enactment of the FDA Food Safety Modernization Act, the 
            Secretary shall inspect not fewer than 600 foreign 
            facilities.
                ``(ii) Subsequent years.--In each of the 5 years 
            following the 1-year period described in clause (i), the 
            Secretary shall inspect not fewer than twice the number of 
            foreign facilities inspected by the Secretary during the 
            previous year.
            ``(E) Reliance on federal, state, or local inspections.--In 
        meeting the inspection requirements under this subsection for 
        domestic facilities, the Secretary may rely on inspections 
        conducted by other Federal, State, or local agencies under 
        interagency agreement, contract, memoranda of understanding, or 
        other obligation.
    ``(b) Identification and Inspection at Ports of Entry.--The 
Secretary, in consultation with the Secretary of Homeland Security, 
shall allocate resources to inspect any article of food imported into 
the United States according to the known safety risks of the article of 
food, which shall be based on the following factors:
        ``(1) The known safety risks of the food imported.
        ``(2) The known safety risks of the countries or regions of 
    origin and countries through which such article of food is 
    transported.
        ``(3) The compliance history of the importer, including with 
    regard to food recalls, outbreaks of foodborne illness, and 
    violations of food safety standards.
        ``(4) The rigor and effectiveness of the activities conducted 
    by the importer of such article of food to satisfy the requirements 
    of the foreign supplier verification program under section 805.
        ``(5) Whether the food importer participates in the voluntary 
    qualified importer program under section 806.
        ``(6) Whether the food meets the criteria for priority under 
    section 801(h)(1).
        ``(7) Whether the food or the facility that manufactured, 
    processed, packed, or held such food received a certification as 
    described in section 801(q) or 806.
        ``(8) Any other criteria deemed necessary and appropriate by 
    the Secretary for purposes of allocating inspection resources.
    ``(c) Interagency Agreements With Respect to Seafood.--
        ``(1) In general.--The Secretary of Health and Human Services, 
    the Secretary of Commerce, the Secretary of Homeland Security, the 
    Chairman of the Federal Trade Commission, and the heads of other 
    appropriate agencies may enter into such agreements as may be 
    necessary or appropriate to improve seafood safety.
        ``(2) Scope of agreements.--The agreements under paragraph (1) 
    may include--
            ``(A) cooperative arrangements for examining and testing 
        seafood imports that leverage the resources, capabilities, and 
        authorities of each party to the agreement;
            ``(B) coordination of inspections of foreign facilities to 
        increase the percentage of imported seafood and seafood 
        facilities inspected;
            ``(C) standardization of data on seafood names, inspection 
        records, and laboratory testing to improve interagency 
        coordination;
            ``(D) coordination to detect and investigate violations 
        under applicable Federal law;
            ``(E) a process, including the use or modification of 
        existing processes, by which officers and employees of the 
        National Oceanic and Atmospheric Administration may be duly 
        designated by the Secretary to carry out seafood examinations 
        and investigations under section 801 of this Act or section 203 
        of the Food Allergen Labeling and Consumer Protection Act of 
        2004;
            ``(F) the sharing of information concerning observed non-
        compliance with United States food requirements domestically 
        and in foreign nations and new regulatory decisions and 
        policies that may affect the safety of food imported into the 
        United States;
            ``(G) conducting joint training on subjects that affect and 
        strengthen seafood inspection effectiveness by Federal 
        authorities; and
            ``(H) outreach on Federal efforts to enhance seafood safety 
        and compliance with Federal food safety requirements.
    ``(d) Coordination.--The Secretary shall improve coordination and 
cooperation with the Secretary of Agriculture and the Secretary of 
Homeland Security to target food inspection resources.
    ``(e) Facility.--For purposes of this section, the term `facility' 
means a domestic facility or a foreign facility that is required to 
register under section 415.''.
    (b) Annual Report.--Section 1003 (21 U.S.C. 393) is amended by 
adding at the end the following:
    ``(h) Annual Report Regarding Food.--Not later than February 1 of 
each year, the Secretary shall submit to Congress a report, including 
efforts to coordinate and cooperate with other Federal agencies with 
responsibilities for food inspections, regarding--
        ``(1) information about food facilities including--
            ``(A) the appropriations used to inspect facilities 
        registered pursuant to section 415 in the previous fiscal year;
            ``(B) the average cost of both a non-high-risk food 
        facility inspection and a high-risk food facility inspection, 
        if such a difference exists, in the previous fiscal year;
            ``(C) the number of domestic facilities and the number of 
        foreign facilities registered pursuant to section 415 that the 
        Secretary inspected in the previous fiscal year;
            ``(D) the number of domestic facilities and the number of 
        foreign facilities registered pursuant to section 415 that were 
        scheduled for inspection in the previous fiscal year and which 
        the Secretary did not inspect in such year;
            ``(E) the number of high-risk facilities identified 
        pursuant to section 421 that the Secretary inspected in the 
        previous fiscal year; and
            ``(F) the number of high-risk facilities identified 
        pursuant to section 421 that were scheduled for inspection in 
        the previous fiscal year and which the Secretary did not 
        inspect in such year.
        ``(2) information about food imports including--
            ``(A) the number of lines of food imported into the United 
        States that the Secretary physically inspected or sampled in 
        the previous fiscal year;
            ``(B) the number of lines of food imported into the United 
        States that the Secretary did not physically inspect or sample 
        in the previous fiscal year; and
            ``(C) the average cost of physically inspecting or sampling 
        a line of food subject to this Act that is imported or offered 
        for import into the United States; and
        ``(3) information on the foreign offices of the Food and Drug 
    Administration including--
            ``(A) the number of foreign offices established; and
            ``(B) the number of personnel permanently stationed in each 
        foreign office.
    ``(i) Public Availability of Annual Food Reports.--The Secretary 
shall make the reports required under subsection (h) available to the 
public on the Internet Web site of the Food and Drug Administration.''.
    (c) Advisory Committee Consultation.--In allocating inspection 
resources as described in section 421 of the Federal Food, Drug, and 
Cosmetic Act (as added by subsection (a)), the Secretary may, as 
appropriate, consult with any relevant advisory committee within the 
Department of Health and Human Services.
    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 accredited by a recognized accreditation body, 
        including the name of, contact information for, and other 
        information deemed appropriate by the Secretary about such 
        bodies and laboratories; and
            ``(C) require, as a condition of recognition or 
        accreditation, as appropriate, that recognized accreditation 
        bodies and accredited laboratories report to the Secretary any 
        changes that would affect the recognition of such accreditation 
        body or the accreditation of such laboratory.
        ``(2) Program requirements.--The program established under 
    paragraph (1)(A) shall provide for the recognition of laboratory 
    accreditation bodies that meet criteria established by the 
    Secretary for accreditation of laboratories, including independent 
    private laboratories and laboratories run and operated by a Federal 
    agency (including the Department of Commerce), State, or locality 
    with a demonstrated capability to conduct 1 or more sampling and 
    analytical testing methodologies for food.
        ``(3) Increasing the number of qualified laboratories.--The 
    Secretary shall work with the laboratory accreditation bodies 
    recognized under paragraph (1), as appropriate, to increase the 
    number of qualified laboratories that are eligible to perform 
    testing under subparagraph (b) beyond the number so qualified on 
    the date of enactment of the FDA Food Safety Modernization Act.
        ``(4) Limited distribution.--In the interest of national 
    security, the Secretary, in coordination with the Secretary of 
    Homeland Security, may determine the time, manner, and form in 
    which the registry established under paragraph (1)(B) is made 
    publicly available.
        ``(5) Foreign laboratories.--Accreditation bodies recognized by 
    the Secretary under paragraph (1) may accredit laboratories that 
    operate outside the United States, so long as such laboratories 
    meet the accreditation standards applicable to domestic 
    laboratories accredited under this section.
        ``(6) Model laboratory standards.--The Secretary shall develop 
    model standards that a laboratory shall meet to be accredited by a 
    recognized accreditation body for a specified sampling or 
    analytical testing methodology and included in the registry 
    provided for under paragraph (1). In developing the model 
    standards, the Secretary shall consult existing standards for 
    guidance. The model standards shall include--
            ``(A) methods to ensure that--
                ``(i) appropriate sampling, analytical procedures 
            (including rapid analytical procedures), and commercially 
            available techniques are followed and reports of analyses 
            are certified as true and accurate;
                ``(ii) internal quality systems are established and 
            maintained;
                ``(iii) procedures exist to evaluate and respond 
            promptly to complaints regarding analyses and other 
            activities for which the laboratory is accredited; and
                ``(iv) individuals who conduct the sampling and 
            analyses are qualified by training and experience to do so; 
            and
            ``(B) any other criteria determined appropriate by the 
        Secretary.
        ``(7) Review of recognition.--To ensure compliance with the 
    requirements of this section, the Secretary--
            ``(A) shall periodically, and in no case less than once 
        every 5 years, reevaluate accreditation bodies recognized under 
        paragraph (1) and may accompany auditors from an accreditation 
        body to assess whether the accreditation body meets the 
        criteria for recognition; and
            ``(B) shall promptly revoke the recognition of any 
        accreditation body found not to be in compliance with the 
        requirements of this section, specifying, as appropriate, any 
        terms and conditions necessary for laboratories accredited by 
        such body to continue to perform testing as described in this 
        section.
    ``(b) Testing Procedures.--
        ``(1) In general.--Not later than 30 months after the date of 
    enactment of the FDA Food Safety Modernization Act, food testing 
    shall be conducted by Federal laboratories or non-Federal 
    laboratories that have been accredited for the appropriate sampling 
    or analytical testing methodology or methodologies by a recognized 
    accreditation body on the registry established by the Secretary 
    under subsection (a)(1)(B) whenever such testing is conducted--
            ``(A) by or on behalf of an owner or consignee--
                ``(i) in response to a specific testing requirement 
            under this Act or implementing regulations, when applied to 
            address an identified or suspected food safety problem; and
                ``(ii) as required by the Secretary, as the Secretary 
            deems appropriate, to address an identified or suspected 
            food safety problem; or
            ``(B) on behalf of an owner or consignee--
                ``(i) in support of admission of an article of food 
            under section 801(a); and
                ``(ii) under an Import Alert that requires successful 
            consecutive tests.
        ``(2) Results of testing.--The results of any such testing 
    shall be sent directly to the Food and Drug Administration, except 
    the Secretary may by regulation exempt test results from such 
    submission requirement if the Secretary determines that such 
    results do not contribute to the protection of public health. Test 
    results required to be submitted may be submitted to the Food and 
    Drug Administration through electronic means.
        ``(3) Exception.--The Secretary may waive requirements under 
    this subsection if--
            ``(A) a new methodology or methodologies have been 
        developed and validated but a laboratory has not yet been 
        accredited to perform such methodology or methodologies; and
            ``(B) the use of such methodology or methodologies are 
        necessary to prevent, control, or mitigate a food emergency or 
        foodborne illness outbreak.
    ``(c) Review by Secretary.--If food sampling and testing performed 
by a laboratory run and operated by a State or locality that is 
accredited by a recognized accreditation body on the registry 
established by the Secretary under subsection (a) result in a State 
recalling a food, the Secretary shall review the sampling and testing 
results for the purpose of determining the need for a national recall 
or other compliance and enforcement activities.
    ``(d) No Limit on Secretarial Authority.--Nothing in this section 
shall be construed to limit the ability of the Secretary to review and 
act upon information from food testing, including determining the 
sufficiency of such information and testing.''.
    (b) Food Emergency Response Network.--The Secretary, in 
coordination with the Secretary of Agriculture, the Secretary of 
Homeland Security, and State, local, and tribal governments shall, not 
later than 180 days after the date of enactment of this Act, and 
biennially thereafter, submit to the relevant committees of Congress, 
and make publicly available on the Internet Web site of the Department 
of Health and Human Services, a report on the progress in implementing 
a national food emergency response laboratory network that--
        (1) provides ongoing surveillance, rapid detection, and surge 
    capacity for large-scale food-related emergencies, including 
    intentional adulteration of the food supply;
        (2) coordinates the food laboratory capacities of State, local, 
    and tribal food laboratories, including the adoption of novel 
    surveillance and identification technologies and the sharing of 
    data between Federal agencies and State laboratories to develop 
    national situational awareness;
        (3) provides accessible, timely, accurate, and consistent food 
    laboratory services throughout the United States;
        (4) develops and implements a methods repository for use by 
    Federal, State, and local officials;
        (5) responds to food-related emergencies; and
        (6) is integrated with relevant laboratory networks 
    administered by other Federal agencies.
    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.
    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--
            (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;
            (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
                (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--
                (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 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 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.
    (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;
            (C) developing improved epidemiological tools for obtaining 
        quality exposure data and microbiological methods for 
        classifying cases;
            (D) augmenting such systems to improve attribution of a 
        foodborne illness outbreak to a specific food;
            (E) expanding capacity of such systems, including working 
        toward automatic electronic searches, for implementation of 
        identification practices, including fingerprinting strategies, 
        for foodborne infectious agents, in order to identify new or 
        rarely documented causes of foodborne illness and submit 
        standardized information to a centralized database;
            (F) allowing timely public access to aggregated, de-
        identified surveillance data;
            (G) at least annually, publishing current reports on 
        findings from such systems;
            (H) establishing a flexible mechanism for rapidly 
        initiating scientific research by academic institutions;
            (I) integrating foodborne illness surveillance systems and 
        data with other biosurveillance and public health situational 
        awareness capabilities at the Federal, State, and local levels, 
        including by sharing foodborne illness surveillance data with 
        the National Biosurveillance Integration Center; and
            (J) other activities as determined appropriate by the 
        Secretary.
        (2) Working group.--The Secretary shall support and maintain a 
    diverse working group of experts and stakeholders from Federal, 
    State, and local food safety and health agencies, the food and food 
    testing industries, consumer organizations, and academia. Such 
    working group shall provide the Secretary, through at least annual 
    meetings of the working group and an annual public report, advice 
    and recommendations on an ongoing and regular basis regarding the 
    improvement of foodborne illness surveillance and implementation of 
    this section, including advice and recommendations on--
            (A) the priority needs of regulatory agencies, the food 
        industry, and consumers for information and analysis on 
        foodborne illness and its causes;
            (B) opportunities to improve the effectiveness of 
        initiatives at the Federal, State, and local levels, including 
        coordination and integration of activities among Federal 
        agencies, and between the Federal, State, and local levels of 
        government;
            (C) improvement in the timeliness and depth of access by 
        regulatory and health agencies, the food industry, academic 
        researchers, and consumers to foodborne illness aggregated, de-
        identified surveillance data collected by government agencies 
        at all levels, including data compiled by the Centers for 
        Disease Control and Prevention;
            (D) key barriers at Federal, State, and local levels to 
        improving foodborne illness surveillance and the utility of 
        such surveillance for preventing foodborne illness;
            (E) the capabilities needed for establishing automatic 
        electronic searches of surveillance data; and
            (F) specific actions to reduce barriers to improvement, 
        implement the working group's recommendations, and achieve the 
        purposes of this section, with measurable objectives and 
        timelines, and identification of resource and staffing needs.
        (3) Authorization of appropriations.--To carry out the 
    activities described in paragraph (1), there is authorized to be 
    appropriated $24,000,000 for each fiscal years 2011 through 2015.
    (c) Improving Food Safety and Defense Capacity at the State and 
Local Level.--
        (1) In general.--The Secretary shall develop and implement 
    strategies to leverage and enhance the food safety and defense 
    capacities of State and local agencies in order to achieve the 
    following goals:
            (A) Improve foodborne illness outbreak response and 
        containment.
            (B) Accelerate foodborne illness surveillance and outbreak 
        investigation, including rapid shipment of clinical isolates 
        from clinical laboratories to appropriate State laboratories, 
        and conducting more standardized illness outbreak interviews.
            (C) Strengthen the capacity of State and local agencies to 
        carry out inspections and enforce safety standards.
            (D) Improve the effectiveness of Federal, State, and local 
        partnerships to coordinate food safety and defense resources 
        and reduce the incidence of foodborne illness.
            (E) Share information on a timely basis among public health 
        and food regulatory agencies, with the food industry, with 
        health care providers, and with the public.
            (F) Strengthen the capacity of State and local agencies to 
        achieve the goals described in section 108.
        (2) Review.--In developing of the strategies required by 
    paragraph (1), the Secretary shall, not later than 1 year after the 
    date of enactment of the FDA Food Safety Modernization Act, 
    complete a review of State and local capacities, and needs for 
    enhancement, which may include a survey with respect to--
            (A) staffing levels and expertise available to perform food 
        safety and defense functions;
            (B) laboratory capacity to support surveillance, outbreak 
        response, inspection, and enforcement activities;
            (C) information systems to support data management and 
        sharing of food safety and defense information among State and 
        local agencies and with counterparts at the Federal level; and
            (D) other State and local activities and needs as 
        determined appropriate by the Secretary.
    (d) Food Safety Capacity Building Grants.--Section 317R(b) of the 
Public Health Service Act (42 U.S.C. 247b-20(b)) is amended--
        (1) by striking ``2002'' and inserting ``2010''; and
        (2) by striking ``2003 through 2006'' and inserting ``2011 
    through 2015''.
    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:
    ``SEC. 423. MANDATORY RECALL AUTHORITY.
    ``(a) Voluntary Procedures.--If the Secretary determines, based on 
information gathered through the reportable food registry under section 
417 or through any other means, that there is a reasonable probability 
that an article of food (other than infant formula) is adulterated 
under section 402 or misbranded under section 403(w) and the use of or 
exposure to such article will cause serious adverse health consequences 
or death to humans or animals, the Secretary shall provide the 
responsible party (as defined in section 417) with an opportunity to 
cease distribution and recall such article.
    ``(b) Prehearing Order To Cease Distribution and Give Notice.--
        ``(1) In general.--If the responsible party refuses to or does 
    not voluntarily cease distribution or recall such article within 
    the time and in the manner prescribed by the Secretary (if so 
    prescribed), the Secretary may, by order require, as the Secretary 
    deems necessary, such person to--
            ``(A) immediately cease distribution of such article; and
            ``(B) as applicable, immediately notify all persons--
                ``(i) manufacturing, processing, packing, transporting, 
            distributing, receiving, holding, or importing and selling 
            such article; and
                ``(ii) to which such article has been distributed, 
            transported, or sold, to immediately cease distribution of 
            such article.
        ``(2) Required additional information.--
            ``(A) In general.--If an article of food covered by a 
        recall order issued under paragraph (1)(B) has been distributed 
        to a warehouse-based third party logistics provider without 
        providing such provider sufficient information to know or 
        reasonably determine the precise identity of the article of 
        food covered by a recall order that is in its possession, the 
        notice provided by the responsible party subject to the order 
        issued under paragraph (1)(B) shall include such information as 
        is necessary for the warehouse-based third party logistics 
        provider to identify the food.
            ``(B) Rules of construction.--Nothing in this paragraph 
        shall be construed--
                ``(i) to exempt a warehouse-based third party logistics 
            provider from the requirements of this Act, including the 
            requirements in this section and section 414; or
                ``(ii) to exempt a warehouse-based third party 
            logistics provider from being the subject of a mandatory 
            recall order.
        ``(3) Determination to limit areas affected.--If the Secretary 
    requires a responsible party to cease distribution under paragraph 
    (1)(A) of an article of food identified in subsection (a), the 
    Secretary may limit the size of the geographic area and the markets 
    affected by such cessation if such limitation would not compromise 
    the public health.
    ``(c) Hearing on Order.--The Secretary shall provide the 
responsible party subject to an order under subsection (b) with an 
opportunity for an informal hearing, to be held as soon as possible, 
but not later than 2 days after the issuance of the order, on the 
actions required by the order and on why the article that is the 
subject of the order should not be recalled.
    ``(d) Post-hearing Recall Order and Modification of Order.--
        ``(1) Amendment of order.--If, after providing opportunity for 
    an informal hearing under subsection (c), the Secretary determines 
    that removal of the article from commerce is necessary, the 
    Secretary shall, as appropriate--
            ``(A) amend the order to require recall of such article or 
        other appropriate action;
            ``(B) specify a timetable in which the recall shall occur;
            ``(C) require periodic reports to the Secretary describing 
        the progress of the recall; and
            ``(D) provide notice to consumers to whom such article was, 
        or may have been, distributed.
        ``(2) Vacating of order.--If, after such hearing, the Secretary 
    determines that adequate grounds do not exist to continue the 
    actions required by the order, or that such actions should be 
    modified, the Secretary shall vacate the order or modify the order.
    ``(e) Rule Regarding Alcoholic Beverages.--The Secretary shall not 
initiate a mandatory recall or take any other action under this section 
with respect to any alcohol beverage until the Secretary has provided 
the Alcohol and Tobacco Tax and Trade Bureau with a reasonable 
opportunity to cease distribution and recall such article under the 
Alcohol and Tobacco Tax and Trade Bureau authority.
    ``(f) Cooperation and Consultation.--The Secretary shall work with 
State and local public health officials in carrying out this section, 
as appropriate.
    ``(g) Public Notification.--In conducting a recall under this 
section, the Secretary shall--
        ``(1) ensure that a press release is published regarding the 
    recall, as well as alerts and public notices, as appropriate, in 
    order to provide notification--
            ``(A) of the recall to consumers and retailers to whom such 
        article was, or may have been, distributed; and
            ``(B) that includes, at a minimum--
                ``(i) the name of the article of food subject to the 
            recall;
                ``(ii) a description of the risk associated with such 
            article; and
                ``(iii) to the extent practicable, information for 
            consumers about similar articles of food that are not 
            affected by the recall;
        ``(2) consult the policies of the Department of Agriculture 
    regarding providing to the public a list of retail consignees 
    receiving products involved in a Class I recall and shall consider 
    providing such a list to the public, as determined appropriate by 
    the Secretary; and
        ``(3) if available, publish on the Internet Web site of the 
    Food and Drug Administration an image of the article that is the 
    subject of the press release described in (1).
    ``(h) No Delegation.--The authority conferred by this section to 
order a recall or vacate a recall order shall not be delegated to any 
officer or employee other than the Commissioner.
    ``(i) Effect.--Nothing in this section shall affect the authority 
of the Secretary to request or participate in a voluntary recall, or to 
issue an order to cease distribution or to recall under any other 
provision of this Act or under the Public Health Service Act.
    ``(j) Coordinated Communication.--
        ``(1) In general.--To assist in carrying out the requirements 
    of this subsection, the Secretary shall establish an incident 
    command operation or a similar operation within the Department of 
    Health and Human Services that will operate not later than 24 hours 
    after the initiation of a mandatory recall or the recall of an 
    article of food for which the use of, or exposure to, such article 
    will cause serious adverse health consequences or death to humans 
    or animals.
        ``(2) Requirements.--To reduce the potential for 
    miscommunication during recalls or regarding investigations of a 
    food borne illness outbreak associated with a food that is subject 
    to a recall, each incident command operation or similar operation 
    under paragraph (1) shall use regular staff and resources of the 
    Department of Health and Human Services to--
            ``(A) ensure timely and coordinated communication within 
        the Department, including enhanced communication and 
        coordination between different agencies and organizations 
        within the Department;
            ``(B) ensure timely and coordinated communication from the 
        Department, including public statements, throughout the 
        duration of the investigation and related foodborne illness 
        outbreak;
            ``(C) identify a single point of contact within the 
        Department for public inquiries regarding any actions by the 
        Secretary related to a recall;
            ``(D) coordinate with Federal, State, local, and tribal 
        authorities, as appropriate, that have responsibilities related 
        to the recall of a food or a foodborne illness outbreak 
        associated with a food that is subject to the recall, including 
        notification of the Secretary of Agriculture and the Secretary 
        of Education in the event such recalled food is a commodity 
        intended for use in a child nutrition program (as identified in 
        section 25(b) of the Richard B. Russell National School Lunch 
        Act (42 U.S.C. 1769f(b))); and
            ``(E) conclude operations at such time as the Secretary 
        determines appropriate.
        ``(3) Multiple recalls.--The Secretary may establish multiple 
    or concurrent incident command operations or similar operations in 
    the event of multiple recalls or foodborne illness outbreaks 
    necessitating such action by the Department of Health and Human 
    Services.''.
    (b) Search Engine.--Not later than 90 days after the date of 
enactment of this Act, the Secretary shall modify the Internet Web site 
of the Food and Drug Administration to include a search engine that--
        (1) is consumer-friendly, as determined by the Secretary; and
        (2) provides a means by which an individual may locate relevant 
    information regarding each article of food subject to a recall 
    under section 423 of the Federal Food, Drug, and Cosmetic Act and 
    the status of such recall (such as whether a recall is ongoing or 
    has been completed).
    (c) Civil Penalty.--Section 303(f)(2)(A) (21 U.S.C. 333(f)(2)(A)) 
is amended by inserting ``or any person who does not comply with a 
recall order under section 423'' after ``section 402(a)(2)(B)''.
    (d) Prohibited Acts.--Section 301 (21 U.S.C. 331 et seq.), as 
amended by section 106, is amended by adding at the end the following:
    ``(xx) The refusal or failure to follow an order under section 
423.''.
    (e) GAO Review.--
        (1) In general.--Not later than 90 days after the date of 
    enactment of this Act, the Comptroller General of the United States 
    shall submit to Congress a report that--
            (A) identifies State and local agencies with the authority 
        to require the mandatory recall of food, and evaluates use of 
        such authority with regard to frequency, effectiveness, and 
        appropriateness, including consideration of any new or existing 
        mechanisms available to compensate persons for general and 
        specific recall-related costs when a recall is subsequently 
        determined by the relevant authority to have been an error;
            (B) identifies Federal agencies, other than the Department 
        of Health and Human Services, with mandatory recall authority 
        and examines use of that authority with regard to frequency, 
        effectiveness, and appropriateness, including any new or 
        existing mechanisms available to compensate persons for general 
        and specific recall-related costs when a recall is subsequently 
        determined by the relevant agency to have been an error;
            (C) considers models for farmer restitution implemented in 
        other nations in cases of erroneous recalls; and
            (D) makes recommendations to the Secretary regarding use of 
        the authority under section 423 of the Federal Food, Drug, and 
        Cosmetic Act (as added by this section) to protect the public 
        health while seeking to minimize unnecessary economic costs.
        (2) Effect of review.--If the Comptroller General of the United 
    States finds, after the review conducted under paragraph (1), that 
    the mechanisms described in such paragraph do not exist or are 
    inadequate, then, not later than 90 days after the conclusion of 
    such review, the Secretary of Agriculture shall conduct a study of 
    the feasibility of implementing a farmer indemnification program to 
    provide restitution to agricultural producers for losses sustained 
    as a result of a mandatory recall of an agricultural commodity by a 
    Federal or State regulatory agency that is subsequently determined 
    to be in error. The Secretary of Agriculture shall submit to the 
    Committee on Agriculture of the House of Representatives and the 
    Committee on Agriculture, Nutrition, and Forestry of the Senate a 
    report that describes the results of the study, including any 
    recommendations.
    (f) Annual Report to Congress.--
        (1) In general.--Not later than 2 years after the date of 
    enactment of this Act and annually thereafter, the Secretary of 
    Health and Human Services (referred to in this subsection as the 
    ``Secretary'') shall submit a report to the Committee on Health, 
    Education, Labor, and Pensions of the Senate and the Committee on 
    Energy and Commerce of the House of Representatives on the use of 
    recall authority under section 423 of the Federal Food, Drug, and 
    Cosmetic Act (as added by subsection (a)) and any public health 
    advisories issued by the Secretary that advise against the 
    consumption of an article of food on the ground that the article of 
    food is adulterated and poses an imminent danger to health.
        (2) Content.--The report under paragraph (1) shall include, 
    with respect to the report year--
            (A) the identity of each article of food that was the 
        subject of a public health advisory described in paragraph (1), 
        an opportunity to cease distribution and recall under 
        subsection (a) of section 423 of the Federal Food, Drug, and 
        Cosmetic Act, or a mandatory recall order under subsection (b) 
        of such section;
            (B) the number of responsible parties, as defined in 
        section 417 of the Federal Food, Drug, and Cosmetic Act, 
        formally given the opportunity to cease distribution of an 
        article of food and recall such article, as described in 
        section 423(a) of such Act;
            (C) the number of responsible parties described in 
        subparagraph (B) who did not cease distribution of or recall an 
        article of food after given the opportunity to cease 
        distribution or recall under section 423(a) of the Federal 
        Food, Drug, and Cosmetic Act;
            (D) the number of recall orders issued under section 423(b) 
        of the Federal Food, Drug, and Cosmetic Act; and
            (E) a description of any instances in which there was no 
        testing that confirmed adulteration of an article of food that 
        was the subject of a recall under section 423(b) of the Federal 
        Food, Drug, and Cosmetic Act or a public health advisory 
        described in paragraph (1).
    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.
    (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;
        ``(4) training that addresses best practices;
        ``(5) training in administrative process and procedure and 
    integrity issues;
        ``(6) training in appropriate sampling and laboratory analysis 
    methodology; and
        ``(7) training in building enforcement actions following 
    inspections, examinations, testing, and investigations.
    ``(b) Partnerships With State and Local Officials.--
        ``(1) In general.--The Secretary, pursuant to a contract or 
    memorandum of understanding between the Secretary and the head of a 
    State, local, territorial, or tribal department or agency, is 
    authorized and encouraged to conduct examinations, testing, and 
    investigations for the purposes of determining compliance with the 
    food safety provisions of this Act through the officers and 
    employees of such State, local, territorial, or tribal department 
    or agency.
        ``(2) Content.--A contract or memorandum described under 
    paragraph (1) shall include provisions to ensure adequate training 
    of such officers and employees to conduct such examinations, 
    testing, and investigations. The contract or memorandum shall 
    contain provisions regarding reimbursement. Such provisions may, at 
    the sole discretion of the head of the other department or agency, 
    require reimbursement, in whole or in part, from the Secretary for 
    the examinations, testing, or investigations performed pursuant to 
    this section by the officers or employees of the State, 
    territorial, or tribal department or agency.
        ``(3) Effect.--Nothing in this subsection shall be construed to 
    limit the authority of the Secretary under section 702.
    ``(c) Extension Service.--The Secretary shall ensure coordination 
with the extension activities of the National Institute of Food and 
Agriculture of the Department of Agriculture in advising producers and 
small processors transitioning into new practices required as a result 
of the enactment of the FDA Food Safety Modernization Act and assisting 
regulated industry with compliance with such Act.
    ``(d) National Food Safety Training, Education, Extension, Outreach 
and Technical Assistance Program.--
        ``(1) In general.--In order to improve food safety and reduce 
    the incidence of foodborne illness, the Secretary shall, not later 
    than 180 days after the date of enactment of the FDA Food Safety 
    Modernization Act, enter into one or more memoranda of 
    understanding, or enter into other cooperative agreements, with the 
    Secretary of Agriculture to establish a competitive grant program 
    within the National Institute for Food and Agriculture to provide 
    food safety training, education, extension, outreach, and technical 
    assistance to--
            ``(A) owners and operators of farms;
            ``(B) small food processors; and
            ``(C) small fruit and vegetable merchant wholesalers.
        ``(2) Implementation.--The competitive grant program 
    established under paragraph (1) shall be carried out in accordance 
    with section 405 of the Agricultural Research, Extension, and 
    Education Reform Act of 1998.
    ``(e) Authorization of Appropriations.--There are authorized to be 
appropriated such sums as may be necessary to carry out this section 
for fiscal years 2011 through 2015.''.
    (b) National Food Safety Training, Education, Extension, Outreach, 
and Technical Assistance Program.--Title IV of the Agricultural 
Research, Extension, and Education Reform Act of 1998 is amended by 
inserting after section 404 (7 U.S.C. 7624) the following:
    ``SEC. 405. NATIONAL FOOD SAFETY TRAINING, EDUCATION, EXTENSION, 
      OUTREACH, AND TECHNICAL ASSISTANCE PROGRAM.
    ``(a) In General.--The Secretary shall award grants under this 
section to carry out the competitive grant program established under 
section 1011(d) of the Federal Food, Drug, and Cosmetic Act, pursuant 
to any memoranda of understanding entered into under such section.
    ``(b) Integrated Approach.--The grant program described under 
subsection (a) shall be carried out under this section in a manner that 
facilitates the integration of food safety standards and guidance with 
the variety of agricultural production systems, encompassing 
conventional, sustainable, organic, and conservation and environmental 
practices.
    ``(c) Priority.--In awarding grants under this section, the 
Secretary shall give priority to projects that target small and medium-
sized farms, beginning farmers, socially disadvantaged farmers, small 
processors, or small fresh fruit and vegetable merchant wholesalers.
    ``(d) Program Coordination.--
        ``(1) In general.--The Secretary shall coordinate 
    implementation of the grant program under this section with the 
    National Integrated Food Safety Initiative.
        ``(2) Interaction.--The Secretary shall--
            ``(A) in carrying out the grant program under this section, 
        take into consideration applied research, education, and 
        extension results obtained from the National Integrated Food 
        Safety Initiative; and
            ``(B) in determining the applied research agenda for the 
        National Integrated Food Safety Initiative, take into 
        consideration the needs articulated by participants in projects 
        funded by the program under this section.
    ``(e) Grants.--
        ``(1) In general.--In carrying out this section, the Secretary 
    shall make competitive grants to support training, education, 
    extension, outreach, and technical assistance projects that will 
    help improve public health by increasing the understanding and 
    adoption of established food safety standards, guidance, and 
    protocols.
        ``(2) Encouraged features.--The Secretary shall encourage 
    projects carried out using grant funds under this section to 
    include co-management of food safety, conservation systems, and 
    ecological health.
        ``(3) Maximum term and size of grant.--
            ``(A) In general.--A grant under this section shall have a 
        term that is not more than 3 years.
            ``(B) Limitation on grant funding.--The Secretary may not 
        provide grant funding to an entity under this section after 
        such entity has received 3 years of grant funding under this 
        section.
    ``(f) Grant Eligibility.--
        ``(1) In general.--To be eligible for a grant under this 
    section, an entity shall be--
            ``(A) a State cooperative extension service;
            ``(B) a Federal, State, local, or tribal agency, a 
        nonprofit community-based or non-governmental organization, or 
        an organization representing owners and operators of farms, 
        small food processors, or small fruit and vegetable merchant 
        wholesalers that has a commitment to public health and 
        expertise in administering programs that contribute to food 
        safety;
            ``(C) an institution of higher education (as defined in 
        section 101(a) of the Higher Education Act of 1965 (20 U.S.C. 
        1001(a))) or a foundation maintained by an institution of 
        higher education;
            ``(D) a collaboration of 2 of more eligible entities 
        described in this subsection; or
            ``(E) such other appropriate entity, as determined by the 
        Secretary.
        ``(2) Multistate partnerships.--Grants under this section may 
    be made for projects involving more than 1 State.
    ``(g) Regional Balance.--In making grants under this section, the 
Secretary shall, to the maximum extent practicable, ensure--
        ``(1) geographic diversity; and
        ``(2) diversity of types of agricultural production.
    ``(h) Technical Assistance.--The Secretary may use funds made 
available under this section to provide technical assistance to grant 
recipients to further the purposes of this section.
    ``(i) Best Practices and Model Programs.--Based on evaluations of, 
and responses arising from, projects funded under this section, the 
Secretary may issue a set of recommended best practices and models for 
food safety training programs for agricultural producers, small food 
processors, and small fresh fruit and vegetable merchant wholesalers.
    ``(j) Authorization of Appropriations.--For the purposes of making 
grants under this section, there are authorized to be appropriated such 
sums as may be necessary for fiscal years 2011 through 2015.''.
    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
        ``(5) take appropriate action to protect the public health in 
    response to--
            ``(A) a notification under section 1008, including planning 
        and otherwise preparing to take such action; or
            ``(B) a recall of food under this Act.
    ``(b) Eligible Entities; Application.--
        ``(1) In general.--In this section, the term `eligible entity' 
    means an entity--
            ``(A) that is--
                ``(i) a State;
                ``(ii) a locality;
                ``(iii) a territory;
                ``(iv) an Indian tribe (as defined in section 4(e) of 
            the Indian Self-Determination and Education Assistance 
            Act); or
                ``(v) a nonprofit food safety training entity that 
            collaborates with 1 or more institutions of higher 
            education; and
            ``(B) that submits an application to the Secretary at such 
        time, in such manner, and including such information as the 
        Secretary may reasonably require.
        ``(2) Contents.--Each application submitted under paragraph (1) 
    shall include--
            ``(A) an assurance that the eligible entity has developed 
        plans to engage in the types of activities described in 
        subsection (a);
            ``(B) a description of the types of activities to be funded 
        by the grant;
            ``(C) an itemization of how grant funds received under this 
        section will be expended;
            ``(D) a description of how grant activities will be 
        monitored; and
            ``(E) an agreement by the eligible entity to report 
        information required by the Secretary to conduct evaluations 
        under this section.
    ``(c) Limitations.--The funds provided under subsection (a) shall 
be available to an eligible entity that receives a grant under this 
section only to the extent such entity funds the food safety programs 
of such entity independently of any grant under this section in each 
year of the grant at a level equal to the level of such funding in the 
previous year, increased by the Consumer Price Index. Such non-Federal 
matching funds may be provided directly or through donations from 
public or private entities and may be in cash or in-kind, fairly 
evaluated, including plant, equipment, or services.
    ``(d) Additional Authority.--The Secretary may--
        ``(1) award a grant under this section in each subsequent 
    fiscal year without reapplication for a period of not more than 3 
    years, provided the requirements of subsection (c) are met for the 
    previous fiscal year; and
        ``(2) award a grant under this section in a fiscal year for 
    which the requirement of subsection (c) has not been met only if 
    such requirement was not met because such funding was diverted for 
    response to 1 or more natural disasters or in other extenuating 
    circumstances that the Secretary may determine appropriate.
    ``(e) Duration of Awards.--The Secretary may award grants to an 
individual grant recipient under this section for periods of not more 
than 3 years. In the event the Secretary conducts a program evaluation, 
funding in the second year or third year of the grant, where 
applicable, shall be contingent on a successful program evaluation by 
the Secretary after the first year.
    ``(f) Progress and Evaluation.--
        ``(1) In general.--The Secretary shall measure the status and 
    success of each grant program authorized under the FDA Food Safety 
    Modernization Act (and any amendment made by such Act), including 
    the grant program under this section. A recipient of a grant 
    described in the preceding sentence shall, at the end of each grant 
    year, provide the Secretary with information on how grant funds 
    were spent and the status of the efforts by such recipient to 
    enhance food safety. To the extent practicable, the Secretary shall 
    take the performance of such a grant recipient into account when 
    determining whether to continue funding for such recipient.
        ``(2) No duplication.--In carrying out paragraph (1), the 
    Secretary shall not duplicate the efforts of the Secretary under 
    other provisions of this Act or the FDA Food Safety Modernization 
    Act that require measurement and review of the activities of grant 
    recipients under either such Act.
    ``(g) Supplement Not Supplant.--Grant funds received under this 
section shall be used to supplement, and not supplant, non-Federal 
funds and any other Federal funds available to carry out the activities 
described in this section.
    ``(h) Authorization of Appropriations.--For the purpose of making 
grants under this section, there are authorized to be appropriated such 
sums as may be necessary for fiscal years 2011 through 2015.''.
    (b) Centers of Excellence.--Part P of the Public Health Service Act 
(42 U.S.C. 280g et seq.) is amended by adding at the end the following:
``SEC. 399V-5. FOOD SAFETY INTEGRATED CENTERS OF EXCELLENCE.
    ``(a) In General.--Not later than 1 year after the date of 
enactment of the FDA Food Safety Modernization Act, the Secretary, 
acting through the Director of the Centers for Disease Control and 
Prevention and in consultation with the working group described in 
subsection (b)(2), shall designate 5 Integrated Food Safety Centers of 
Excellence (referred to in this section as the `Centers of Excellence') 
to serve as resources for Federal, State, and local public health 
professionals to respond to foodborne illness outbreaks. The Centers of 
Excellence shall be headquartered at selected State health departments.
    ``(b) Selection of Centers of Excellence.--
        ``(1) Eligible entities.--To be eligible to be designated as a 
    Center of Excellence under subsection (a), an entity shall--
            ``(A) be a State health department;
            ``(B) partner with 1 or more institutions of higher 
        education that have demonstrated knowledge, expertise, and 
        meaningful experience with regional or national food 
        production, processing, and distribution, as well as leadership 
        in the laboratory, epidemiological, and environmental detection 
        and investigation of foodborne illness; and
            ``(C) provide to the Secretary such information, at such 
        time, and in such manner, as the Secretary may require.
        ``(2) Working group.--Not later than 180 days after the date of 
    enactment of the FDA Food Safety Modernization Act, the Secretary 
    shall establish a diverse working group of experts and stakeholders 
    from Federal, State, and local food safety and health agencies, the 
    food industry, including food retailers and food manufacturers, 
    consumer organizations, and academia to make recommendations to the 
    Secretary regarding designations of the Centers of Excellence.
        ``(3) Additional centers of excellence.--The Secretary may 
    designate eligible entities to be regional Food Safety Centers of 
    Excellence, in addition to the 5 Centers designated under 
    subsection (a).
    ``(c) Activities.--Under the leadership of the Director of the 
Centers for Disease Control and Prevention, each Center of Excellence 
shall be based out of a selected State health department, which shall 
provide assistance to other regional, State, and local departments of 
health through activities that include--
        ``(1) providing resources, including timely information 
    concerning symptoms and tests, for frontline health professionals 
    interviewing individuals as part of routine surveillance and 
    outbreak investigations;
        ``(2) providing analysis of the timeliness and effectiveness of 
    foodborne disease surveillance and outbreak response activities;
        ``(3) providing training for epidemiological and environmental 
    investigation of foodborne illness, including suggestions for 
    streamlining and standardizing the investigation process;
        ``(4) establishing fellowships, stipends, and scholarships to 
    train future epidemiological and food-safety leaders and to address 
    critical workforce shortages;
        ``(5) training and coordinating State and local personnel;
        ``(6) strengthening capacity to participate in existing or new 
    foodborne illness surveillance and environmental assessment 
    information systems; and
        ``(7) conducting research and outreach activities focused on 
    increasing prevention, communication, and education regarding food 
    safety.
    ``(d) Report to Congress.--Not later than 2 years after the date of 
enactment of the FDA Food Safety Modernization Act, the Secretary shall 
submit to Congress a report that--
        ``(1) describes the effectiveness of the Centers of Excellence; 
    and
        ``(2) provides legislative recommendations or describes 
    additional resources required by the Centers of Excellence.
    ``(e) Authorization of Appropriations.--There is authorized to be 
appropriated such sums as may be necessary to carry out this section.
    ``(f) No Duplication of Effort.--In carrying out activities of the 
Centers of Excellence or other programs under this section, the 
Secretary shall not duplicate other Federal foodborne illness response 
efforts.''.
    SEC. 211. IMPROVING THE REPORTABLE FOOD REGISTRY.
    (a) In General.--Section 417 (21 U.S.C. 350f) is amended--
        (1) by redesignating subsections (f) through (k) as subsections 
    (i) through (n), respectively; and
        (2) by inserting after subsection (e) the following:
    ``(f) Critical Information.--Except with respect to fruits and 
vegetables that are raw agricultural commodities, not more than 18 
months after the date of enactment of the FDA Food Safety Modernization 
Act, the Secretary may require a responsible party to submit to the 
Secretary consumer-oriented information regarding a reportable food, 
which shall include--
        ``(1) a description of the article of food as provided in 
    subsection (e)(3);
        ``(2) as provided in subsection (e)(7), affected product 
    identification codes, such as UPC, SKU, or lot or batch numbers 
    sufficient for the consumer to identify the article of food;
        ``(3) contact information for the responsible party as provided 
    in subsection (e)(8); and
        ``(4) any other information the Secretary determines is 
    necessary to enable a consumer to accurately identify whether such 
    consumer is in possession of the reportable food.
    ``(g) Grocery Store Notification.--
        ``(1) Action by secretary.--The Secretary shall--
            ``(A) prepare the critical information described under 
        subsection (f) for a reportable food as a standardized one-page 
        summary;
            ``(B) publish such one-page summary on the Internet website 
        of the Food and Drug Administration in a format that can be 
        easily printed by a grocery store for purposes of consumer 
        notification.
        ``(2) Action by grocery store.--A notification described under 
    paragraph (1)(B) shall include the date and time such summary was 
    posted on the Internet website of the Food and Drug Administration.
    ``(h) Consumer Notification.--
        ``(1) In general.--If a grocery store sold a reportable food 
    that is the subject of the posting and such establishment is part 
    of chain of establishments with 15 or more physical locations, then 
    such establishment shall, not later than 24 hours after a one page 
    summary described in subsection (g) is published, prominently 
    display such summary or the information from such summary via at 
    least one of the methods identified under paragraph (2) and 
    maintain the display for 14 days.
        ``(2) List of conspicuous locations.--Not more than 1 year 
    after the date of enactment of the FDA Food Safety Modernization 
    Act, the Secretary shall develop and publish a list of acceptable 
    conspicuous locations and manners, from which grocery stores shall 
    select at least one, for providing the notification required in 
    paragraph (1). Such list shall include--
            ``(A) posting the notification at or near the register;
            ``(B) providing the location of the reportable food;
            ``(C) providing targeted recall information given to 
        customers upon purchase of a food; and
            ``(D) other such prominent and conspicuous locations and 
        manners utilized by grocery stores as of the date of the 
        enactment of the FDA Food Safety Modernization Act to provide 
        notice of such recalls to consumers as considered appropriate 
        by the Secretary.''.
    (b) Prohibited Act.--Section 301 (21 U.S.C. 331), as amended by 
section 206, is amended by adding at the end the following:
    ``(yy) The knowing and willful failure to comply with the 
notification requirement under section 417(h).''.
    (c) Conforming Amendment.--Section 301(e) (21 U.S.C. 331(e)) is 
amended by striking ``417(g)'' and inserting ``417(j)''.

            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 
            consideration variances granted under section 419), as 
            appropriate; and
                ``(ii) section 402 and section 403(w).
            ``(B) shall include such other requirements as the 
        Secretary deems necessary and appropriate to verify that food 
        imported into the United States is as safe as food produced and 
        sold within the United States.
        ``(3) Considerations.--In promulgating regulations under this 
    subsection, the Secretary shall, as appropriate, take into account 
    differences among importers and types of imported foods, including 
    based on the level of risk posed by the imported food.
        ``(4) Activities.--Verification activities under a foreign 
    supplier verification program under this section may include 
    monitoring records for shipments, lot-by-lot certification of 
    compliance, annual on-site inspections, checking the hazard 
    analysis and risk-based preventive control plan of the foreign 
    supplier, and periodically testing and sampling shipments.
    ``(d) Record Maintenance and Access.--Records of an importer 
related to a foreign supplier verification program shall be maintained 
for a period of not less than 2 years and shall be made available 
promptly to a duly authorized representative of the Secretary upon 
request.
    ``(e) Exemption of Seafood, Juice, and Low-acid Canned Food 
Facilities in Compliance With HACCP.--This section shall not apply to a 
facility if the owner, operator, or agent in charge of such facility is 
required to comply with, and is in compliance with, 1 of the following 
standards and regulations with respect to such facility:
        ``(1) The Seafood Hazard Analysis Critical Control Points 
    Program of the Food and Drug Administration.
        ``(2) The Juice Hazard Analysis Critical Control Points Program 
    of the Food and Drug Administration.
        ``(3) The Thermally Processed Low-Acid Foods Packaged in 
    Hermetically Sealed Containers standards of the Food and Drug 
    Administration (or any successor standards).
The exemption under paragraph (3) shall apply only with respect to 
microbiological hazards that are regulated under the standards for 
Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed 
Containers under part 113 of chapter 21, Code of Federal Regulations 
(or any successor regulations).
    ``(f) Additional Exemptions.--The Secretary, by notice published in 
the Federal Register, shall establish an exemption from the 
requirements of this section for articles of food imported in small 
quantities for research and evaluation purposes or for personal 
consumption, provided that such foods are not intended for retail sale 
and are not sold or distributed to the public.
    ``(g) Publication of List of Participants.--The Secretary shall 
publish and maintain on the Internet Web site of the Food and Drug 
Administration a current list that includes the name of, location of, 
and other information deemed necessary by the Secretary about, 
importers participating under this section.''.
    (b) Prohibited Act.--Section 301 (21 U.S.C. 331), as amended by 
section 211, is amended by adding at the end the following:
    ``(zz) The importation or offering for importation of a food if the 
importer (as defined in section 805) does not have in place a foreign 
supplier verification program in compliance with such section 805.''.
    (c) Imports.--Section 801(a) (21 U.S.C. 381(a)) is amended by 
adding ``or the importer (as defined in section 805) is in violation of 
such section 805'' after ``or in violation of section 505''.
    (d) Effective Date.--The amendments made by this section shall take 
effect 2 years after the date of enactment of this Act.
    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.
    ``(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
            ``(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;''.
    (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.
    ``(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, foreign 
    cooperative, or any other third party, as the Secretary determines 
    appropriate in accordance with the model standards described in 
    subsection (b)(2), that is eligible to be considered for 
    accreditation to conduct food safety audits to certify that 
    eligible entities meet the applicable requirements of this section. 
    A third-party auditor may be a single individual. A third-party 
    auditor may employ or use audit agents to help conduct consultative 
    and regulatory audits.
        ``(4) Accredited third-party auditor.--The term `accredited 
    third-party auditor' means a third-party auditor accredited by an 
    accreditation body to conduct audits of eligible entities to 
    certify that such eligible entities meet the applicable 
    requirements of this section. An accredited third-party auditor may 
    be an individual who conducts food safety audits to certify that 
    eligible entities meet the applicable requirements of this section.
        ``(5) Consultative audit.--The term `consultative audit' means 
    an audit of an eligible entity--
            ``(A) to determine whether such entity is in compliance 
        with the provisions of this Act and with applicable industry 
        standards and practices; and
            ``(B) the results of which are for internal purposes only.
        ``(6) Eligible entity.--The term `eligible entity' means a 
    foreign entity, including a foreign facility registered under 
    section 415, in the food import supply chain that chooses to be 
    audited by an accredited third-party auditor or the audit agent of 
    such accredited third-party auditor.
        ``(7) Regulatory audit.--The term `regulatory audit' means an 
    audit of an eligible entity--
            ``(A) to determine whether such entity is in compliance 
        with the provisions of this Act; and
            ``(B) the results of which determine--
                ``(i) whether an article of food manufactured, 
            processed, packed, or held by such entity is eligible to 
            receive a food certification under section 801(q); or
                ``(ii) whether a facility is eligible to receive a 
            facility certification under section 806(a) for purposes of 
            participating in the program under section 806.
    ``(b) Accreditation System.--
        ``(1) Accreditation bodies.--
            ``(A) Recognition of accreditation bodies.--
                ``(i) In general.--Not later than 2 years after the 
            date of enactment of the FDA Food Safety Modernization Act, 
            the Secretary shall establish a system for the recognition 
            of accreditation bodies that accredit third-party auditors 
            to certify that eligible entities meet the applicable 
            requirements of this section.
                ``(ii) Direct accreditation.--If, by the date that is 2 
            years after the date of establishment of the system 
            described in clause (i), the Secretary has not identified 
            and recognized an accreditation body to meet the 
            requirements of this section, the Secretary may directly 
            accredit third-party auditors.
            ``(B) Notification.--Each accreditation body recognized by 
        the Secretary shall submit to the Secretary a list of all 
        accredited third-party auditors accredited by such body and the 
        audit agents of such auditors.
            ``(C) Revocation of recognition as an accreditation body.--
        The Secretary shall promptly revoke the recognition of any 
        accreditation body found not to be in compliance with the 
        requirements of this section.
            ``(D) Reinstatement.--The Secretary shall establish 
        procedures to reinstate recognition of an accreditation body if 
        the Secretary determines, based on evidence presented by such 
        accreditation body, that revocation was inappropriate or that 
        the body meets the requirements for recognition under this 
        section.
        ``(2) Model accreditation standards.--Not later than 18 months 
    after the date of enactment of the FDA Food Safety Modernization 
    Act, the Secretary shall develop model standards, including 
    requirements for regulatory audit reports, and each recognized 
    accreditation body shall ensure that third-party auditors and audit 
    agents of such auditors meet such standards in order to qualify 
    such third-party auditors as accredited third-party auditors under 
    this section. In developing the model standards, the Secretary 
    shall look to standards in place on the date of the enactment of 
    this section for guidance, to avoid unnecessary duplication of 
    efforts and costs.
    ``(c) Third-party Auditors.--
        ``(1) Requirements for accreditation as a third-party 
    auditor.--
            ``(A) Foreign governments.--Prior to accrediting a foreign 
        government or an agency of a foreign government as an 
        accredited third-party auditor, the accreditation body (or, in 
        the case of direct accreditation under subsection 
        (b)(1)(A)(ii), the Secretary) shall perform such reviews and 
        audits of food safety programs, systems, and standards of the 
        government or agency of the government as the Secretary deems 
        necessary, including requirements under the model standards 
        developed under subsection (b)(2), to determine that the 
        foreign government or agency of the foreign government is 
        capable of adequately ensuring that eligible entities or foods 
        certified by such government or agency meet the requirements of 
        this Act with respect to food manufactured, processed, packed, 
        or held for import into the United States.
            ``(B) Foreign cooperatives and other third parties.--Prior 
        to accrediting a foreign cooperative that aggregates the 
        products of growers or processors, or any other third party to 
        be an accredited third-party auditor, the accreditation body 
        (or, in the case of direct accreditation under subsection 
        (b)(1)(A)(ii), the Secretary) shall perform such reviews and 
        audits of the training and qualifications of audit agents used 
        by that cooperative or party and conduct such reviews of 
        internal systems and such other investigation of the 
        cooperative or party as the Secretary deems necessary, 
        including requirements under the model standards developed 
        under subsection (b)(2), to determine that each eligible entity 
        certified by the cooperative or party has systems and standards 
        in use to ensure that such entity or food meets the 
        requirements of this Act.
        ``(2) Requirement to issue certification of eligible entities 
    or foods.--
            ``(A) In general.--An accreditation body (or, in the case 
        of direct accreditation under subsection (b)(1)(A)(ii), the 
        Secretary) may not accredit a third-party auditor unless such 
        third-party auditor agrees to issue a written and, as 
        appropriate, electronic food certification, described in 
        section 801(q), or facility certification under section 806(a), 
        as appropriate, to accompany each food shipment for import into 
        the United States from an eligible entity, subject to 
        requirements set forth by the Secretary. Such written or 
        electronic certification may be included with other 
        documentation regarding such food shipment. The Secretary shall 
        consider certifications under section 801(q) and participation 
        in the voluntary qualified importer program described in 
        section 806 when targeting inspection resources under section 
        421.
            ``(B) Purpose of certification.--The Secretary shall use 
        certification provided by accredited third-party auditors to--
                ``(i) determine, in conjunction with any other 
            assurances the Secretary may require under section 801(q), 
            whether a food satisfies the requirements of such section; 
            and
                ``(ii) determine whether a facility is eligible to be a 
            facility from which food may be offered for import under 
            the voluntary qualified importer program under section 806.
            ``(C) Requirements for issuing certification.--
                ``(i) In general.--An accredited third-party auditor 
            shall issue a food certification under section 801(q) or a 
            facility certification described under subparagraph (B) 
            only after conducting a regulatory audit and such other 
            activities that may be necessary to establish compliance 
            with the requirements of such sections.
                ``(ii) Provision of certification.--Only an accredited 
            third-party auditor or the Secretary may provide a facility 
            certification under section 806(a). Only those parties 
            described in 801(q)(3) or the Secretary may provide a food 
            certification under 301(g).
        ``(3) Audit report submission requirements.--
            ``(A) Requirements in general.--As a condition of 
        accreditation, not later than 45 days after conducting an 
        audit, an accredited third-party auditor or audit agent of such 
        auditor shall prepare, and, in the case of a regulatory audit, 
        submit, the audit report for each audit conducted, in a form 
        and manner designated by the Secretary, which shall include--
                ``(i) the identity of the persons at the audited 
            eligible entity responsible for compliance with food safety 
            requirements;
                ``(ii) the dates of the audit;
                ``(iii) the scope of the audit; and
                ``(iv) any other information required by the Secretary 
            that relates to or may influence an assessment of 
            compliance with this Act.
            ``(B) Records.--Following any accreditation of a third-
        party auditor, the Secretary may, at any time, require the 
        accredited third-party auditor to submit to the Secretary an 
        onsite audit report and such other reports or documents 
        required as part of the audit process, for any eligible entity 
        certified by the third-party auditor or audit agent of such 
        auditor. Such report may include documentation that the 
        eligible entity is in compliance with any applicable 
        registration requirements.
            ``(C) Limitation.--The requirement under subparagraph (B) 
        shall not include any report or other documents resulting from 
        a consultative audit by the accredited third-party auditor, 
        except that the Secretary may access the results of a 
        consultative audit in accordance with section 414.
        ``(4) Requirements of accredited third-party auditors and audit 
    agents of such auditors.--
            ``(A) Risks to public health.--If, at any time during an 
        audit, an accredited third-party auditor or audit agent of such 
        auditor discovers a condition that could cause or contribute to 
        a serious risk to the public health, such auditor shall 
        immediately notify the Secretary of--
                ``(i) the identification of the eligible entity subject 
            to the audit; and
                ``(ii) such condition.
            ``(B) Types of audits.--An accredited third-party auditor 
        or audit agent of such auditor may perform consultative and 
        regulatory audits of eligible entities.
            ``(C) Limitations.--
                ``(i) In general.--An accredited third party auditor 
            may not perform a regulatory audit of an eligible entity if 
            such agent has performed a consultative audit or a 
            regulatory audit of such eligible entity during the 
            previous 13-month period.
                ``(ii) Waiver.--The Secretary may waive the application 
            of clause (i) if the Secretary determines that there is 
            insufficient access to accredited third-party auditors in a 
            country or region.
        ``(5) Conflicts of interest.--
            ``(A) Third-party auditors.--An accredited third-party 
        auditor shall--
                ``(i) not be owned, managed, or controlled by any 
            person that owns or operates an eligible entity to be 
            certified by such auditor;
                ``(ii) in carrying out audits of eligible entities 
            under this section, have procedures to ensure against the 
            use of any officer or employee of such auditor that has a 
            financial conflict of interest regarding an eligible entity 
            to be certified by such auditor; and
                ``(iii) annually make available to the Secretary 
            disclosures of the extent to which such auditor and the 
            officers and employees of such auditor have maintained 
            compliance with clauses (i) and (ii) relating to financial 
            conflicts of interest.
            ``(B) Audit agents.--An audit agent shall--
                ``(i) not own or operate an eligible entity to be 
            audited by such agent;
                ``(ii) in carrying out audits of eligible entities 
            under this section, have procedures to ensure that such 
            agent does not have a financial conflict of interest 
            regarding an eligible entity to be audited by such agent; 
            and
                ``(iii) annually make available to the Secretary 
            disclosures of the extent to which such agent has 
            maintained compliance with clauses (i) and (ii) relating to 
            financial conflicts of interest.
            ``(C) Regulations.--The Secretary shall promulgate 
        regulations not later than 18 months after the date of 
        enactment of the FDA Food Safety Modernization Act to implement 
        this section and to ensure that there are protections against 
        conflicts of interest between an accredited third-party auditor 
        and the eligible entity to be certified by such auditor or 
        audited by such audit agent. Such regulations shall include--
                ``(i) requiring that audits performed under this 
            section be unannounced;
                ``(ii) a structure to decrease the potential for 
            conflicts of interest, including timing and public 
            disclosure, for fees paid by eligible entities to 
            accredited third-party auditors; and
                ``(iii) appropriate limits on financial affiliations 
            between an accredited third-party auditor or audit agents 
            of such auditor and any person that owns or operates an 
            eligible entity to be certified by such auditor, as 
            described in subparagraphs (A) and (B).
        ``(6) Withdrawal of accreditation.--
            ``(A) In general.--The Secretary shall withdraw 
        accreditation from an accredited third-party auditor--
                ``(i) if food certified under section 801(q) or from a 
            facility certified under paragraph (2)(B) by such third-
            party auditor is linked to an outbreak of foodborne illness 
            that has a reasonable probability of causing serious 
            adverse health consequences or death in humans or animals;
                ``(ii) following an evaluation and finding by the 
            Secretary that the third-party auditor no longer meets the 
            requirements for accreditation; or
                ``(iii) following a refusal to allow United States 
            officials to conduct such audits and investigations as may 
            be necessary to ensure continued compliance with the 
            requirements set forth in this section.
            ``(B) Additional basis for withdrawal of accreditation.--
        The Secretary may withdraw accreditation from an accredited 
        third-party auditor in the case that such third-party auditor 
        is accredited by an accreditation body for which recognition as 
        an accreditation body under subsection (b)(1)(C) is revoked, if 
        the Secretary determines that there is good cause for the 
        withdrawal.
            ``(C) Exception.--The Secretary may waive the application 
        of subparagraph (A)(i) if the Secretary--
                ``(i) conducts an investigation of the material facts 
            related to the outbreak of human or animal illness; and
                ``(ii) reviews the steps or actions taken by the third 
            party auditor to justify the certification and determines 
            that the accredited third-party auditor satisfied the 
            requirements under section 801(q) of certifying the food, 
            or the requirements under paragraph (2)(B) of certifying 
            the entity.
        ``(7) Reaccreditation.--The Secretary shall establish 
    procedures to reinstate the accreditation of a third-party auditor 
    for which accreditation has been withdrawn under paragraph (6)--
            ``(A) if the Secretary determines, based on evidence 
        presented, that the third-party auditor satisfies the 
        requirements of this section and adequate grounds for 
        revocation no longer exist; and
            ``(B) in the case of a third-party auditor accredited by an 
        accreditation body for which recognition as an accreditation 
        body under subsection (b)(1)(C) is revoked--
                ``(i) if the third-party auditor becomes accredited not 
            later than 1 year after revocation of accreditation under 
            paragraph (6)(A), through direct accreditation under 
            subsection (b)(1)(A)(ii) or by an accreditation body in 
            good standing; or
                ``(ii) under such conditions as the Secretary may 
            require for a third-party auditor under paragraph (6)(B).
        ``(8) Neutralizing costs.--The Secretary shall establish by 
    regulation a reimbursement (user fee) program, similar to the 
    method described in section 203(h) of the Agriculture Marketing Act 
    of 1946, by which the Secretary assesses fees and requires 
    accredited third-party auditors and audit agents to reimburse the 
    Food and Drug Administration for the work performed to establish 
    and administer the accreditation system under this section. The 
    Secretary shall make operating this program revenue-neutral and 
    shall not generate surplus revenue from such a reimbursement 
    mechanism. Fees authorized under this paragraph shall be collected 
    and available for obligation only to the extent and in the amount 
    provided in advance in appropriation Acts. Such fees are authorized 
    to remain available until expended.
    ``(d) Recertification of Eligible Entities.--An eligible entity 
shall apply for annual recertification by an accredited third-party 
auditor if such entity--
        ``(1) intends to participate in voluntary qualified importer 
    program under section 806; or
        ``(2) is required to provide to the Secretary a certification 
    under section 801(q) for any food from such entity.
    ``(e) False Statements.--Any statement or representation made--
        ``(1) by an employee or agent of an eligible entity to an 
    accredited third-party auditor or audit agent; or
        ``(2) by an accredited third-party auditor to the Secretary,
shall be subject to section 1001 of title 18, United States Code.
    ``(f) Monitoring.--To ensure compliance with the requirements of 
this section, the Secretary shall--
        ``(1) periodically, or at least once every 4 years, reevaluate 
    the accreditation bodies described in subsection (b)(1);
        ``(2) periodically, or at least once every 4 years, evaluate 
    the performance of each accredited third-party auditor, through the 
    review of regulatory audit reports by such auditors, the compliance 
    history as available of eligible entities certified by such 
    auditors, and any other measures deemed necessary by the Secretary;
        ``(3) at any time, conduct an onsite audit of any eligible 
    entity certified by an accredited third-party auditor, with or 
    without the auditor present; and
        ``(4) take any other measures deemed necessary by the 
    Secretary.
    ``(g) Publicly Available Registry.--The Secretary shall establish a 
publicly available registry of accreditation bodies and of accredited 
third-party auditors, including the name of, contact information for, 
and other information deemed necessary by the Secretary about such 
bodies and auditors.
    ``(h) Limitations.--
        ``(1) No effect on section 704 inspections.--The audits 
    performed under this section shall not be considered inspections 
    under section 704.
        ``(2) No effect on inspection authority.--Nothing in this 
    section affects the authority of the Secretary to inspect any 
    eligible entity pursuant to this Act.''.
    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 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.
    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 committed a violation of subsection (a) of the 
        Secretary's findings.
            ``(B) Reasonable cause found; preliminary order.--If the 
        Secretary concludes that there is reasonable cause to believe 
        that a violation of subsection (a) has occurred, the Secretary 
        shall accompany the Secretary's findings with a preliminary 
        order providing the relief prescribed by paragraph (3)(B). Not 
        later than 30 days after the date of notification of findings 
        under this paragraph, the person alleged to have committed the 
        violation or the complainant may file objections to the 
        findings or preliminary order, or both, and request a hearing 
        on the record. The filing of such objections shall not operate 
        to stay any reinstatement remedy contained in the preliminary 
        order. Any such hearing shall be conducted expeditiously. If a 
        hearing is not requested in such 30-day period, the preliminary 
        order shall be deemed a final order that is not subject to 
        judicial review.
            ``(C) Dismissal of complaint.--
                ``(i) Standard for complainant.--The Secretary shall 
            dismiss a complaint filed under this subsection and shall 
            not conduct an investigation otherwise required under 
            subparagraph (A) unless the complainant makes a prima facie 
            showing that any behavior described in paragraphs (1) 
            through (4) of subsection (a) was a contributing factor in 
            the unfavorable personnel action alleged in the complaint.
                ``(ii) Standard for employer.--Notwithstanding a 
            finding by the Secretary that the complainant has made the 
            showing required under clause (i), no investigation 
            otherwise required under subparagraph (A) shall be 
            conducted if the employer demonstrates, by clear and 
            convincing evidence, that the employer would have taken the 
            same unfavorable personnel action in the absence of that 
            behavior.
                ``(iii) Violation standard.--The Secretary may 
            determine that a violation of subsection (a) has occurred 
            only if the complainant demonstrates that any behavior 
            described in paragraphs (1) through (4) of subsection (a) 
            was a contributing factor in the unfavorable personnel 
            action alleged in the complaint.
                ``(iv) Relief standard.--Relief may not be ordered 
            under subparagraph (A) if the employer demonstrates by 
            clear and convincing evidence that the employer would have 
            taken the same unfavorable personnel action in the absence 
            of that behavior.
        ``(3) Final order.--
            ``(A) In general.--Not later than 120 days after the date 
        of conclusion of any hearing under paragraph (2), the Secretary 
        shall issue a final order providing the relief prescribed by 
        this paragraph or denying the complaint. At any time before 
        issuance of a final order, a proceeding under this subsection 
        may be terminated on the basis of a settlement agreement 
        entered into by the Secretary, the complainant, and the person 
        alleged to have committed the violation.
            ``(B) Content of order.--If, in response to a complaint 
        filed under paragraph (1), the Secretary determines that a 
        violation of subsection (a) has occurred, the Secretary shall 
        order the person who committed such violation--
                ``(i) to take affirmative action to abate the 
            violation;
                ``(ii) to reinstate the complainant to his or her 
            former position together with compensation (including back 
            pay) and restore the terms, conditions, and privileges 
            associated with his or her employment; and
                ``(iii) to provide compensatory damages to the 
            complainant.
            ``(C) Penalty.--If such an order is issued under this 
        paragraph, the Secretary, at the request of the complainant, 
        shall assess against the person against whom the order is 
        issued a sum equal to the aggregate amount of all costs and 
        expenses (including attorneys' and expert witness fees) 
        reasonably incurred, as determined by the Secretary, by the 
        complainant for, or in connection with, the bringing of the 
        complaint upon which the order was issued.
            ``(D) Bad faith claim.--If the Secretary finds that a 
        complaint under paragraph (1) is frivolous or has been brought 
        in bad faith, the Secretary may award to the prevailing 
        employer a reasonable attorneys' fee, not exceeding $1,000, to 
        be paid by the complainant.
        ``(4) Action in court.--
            ``(A) In general.--If the Secretary has not issued a final 
        decision within 210 days after the filing of the complaint, or 
        within 90 days after receiving a written determination, the 
        complainant may bring an action at law or equity for de novo 
        review in the appropriate district court of the United States 
        with jurisdiction, which shall have jurisdiction over such an 
        action without regard to the amount in controversy, and which 
        action shall, at the request of either party to such action, be 
        tried by the court with a jury. The proceedings shall be 
        governed by the same legal burdens of proof specified in 
        paragraph (2)(C).
            ``(B) Relief.--The court shall have jurisdiction to grant 
        all relief necessary to make the employee whole, including 
        injunctive relief and compensatory damages, including--
                ``(i) reinstatement with the same seniority status that 
            the employee would have had, but for the discharge or 
            discrimination;
                ``(ii) the amount of back pay, with interest; and
                ``(iii) compensation for any special damages sustained 
            as a result of the discharge or discrimination, including 
            litigation costs, expert witness fees, and reasonable 
            attorney's fees.
        ``(5) Review.--
            ``(A) In general.--Unless the complainant brings an action 
        under paragraph (4), any person adversely affected or aggrieved 
        by a final order issued under paragraph (3) may obtain review 
        of the order in the United States Court of Appeals for the 
        circuit in which the violation, with respect to which the order 
        was issued, allegedly occurred or the circuit in which the 
        complainant resided on the date of such violation. The petition 
        for review must be filed not later than 60 days after the date 
        of the issuance of the final order of the Secretary. Review 
        shall conform to chapter 7 of title 5, United States Code. The 
        commencement of proceedings under this subparagraph shall not, 
        unless ordered by the court, operate as a stay of the order.
            ``(B) No judicial review.--An order of the Secretary with 
        respect to which review could have been obtained under 
        subparagraph (A) shall not be subject to judicial review in any 
        criminal or other civil proceeding.
        ``(6) Failure to comply with order.--Whenever any person has 
    failed to comply with an order issued under paragraph (3), the 
    Secretary may file a civil action in the United States district 
    court for the district in which the violation was found to occur, 
    or in the United States district court for the District of 
    Columbia, to enforce such order. In actions brought under this 
    paragraph, the district courts shall have jurisdiction to grant all 
    appropriate relief including, but not limited to, injunctive relief 
    and compensatory damages.
        ``(7) Civil action to require compliance.--
            ``(A) In general.--A person on whose behalf an order was 
        issued under paragraph (3) may commence a civil action against 
        the person to whom such order was issued to require compliance 
        with such order. The appropriate United States district court 
        shall have jurisdiction, without regard to the amount in 
        controversy or the citizenship of the parties, to enforce such 
        order.
            ``(B) Award.--The court, in issuing any final order under 
        this paragraph, may award costs of litigation (including 
        reasonable attorneys' and expert witness fees) to any party 
        whenever the court determines such award is appropriate.
    ``(c) Effect of Section.--
        ``(1) Other laws.--Nothing in this section preempts or 
    diminishes any other safeguards against discrimination, demotion, 
    discharge, suspension, threats, harassment, reprimand, retaliation, 
    or any other manner of discrimination provided by Federal or State 
    law.
        ``(2) Rights of employees.--Nothing in this section shall be 
    construed to diminish the rights, privileges, or remedies of any 
    employee under any Federal or State law or under any collective 
    bargaining agreement. The rights and remedies in this section may 
    not be waived by any agreement, policy, form, or condition of 
    employment.
    ``(d) Enforcement.--Any nondiscretionary duty imposed by this 
section shall be enforceable in a mandamus proceeding brought under 
section 1361 of title 28, United States Code.
    ``(e) Limitation.--Subsection (a) shall not apply with respect to 
an employee of an entity engaged in the manufacture, processing, 
packing, transporting, distribution, reception, holding, or importation 
of food who, acting without direction from such entity (or such 
entity's agent), deliberately causes a violation of any requirement 
relating to any violation or alleged violation of any order, rule, 
regulation, standard, or ban under this Act.''.
    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 Congressional 
Record by the Chairman of the Senate Budget Committee, provided that 
such statement has been submitted prior to the vote on passage.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.