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[111th Congress Public Law 353]
[From the U.S. Government Printing Office]

[[Page 124 STAT. 3885]]

Public Law 111-353
111th Congress

                                 An Act

 
 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
    safety of the food supply. <<NOTE: Jan. 4, 2011 -  [H.R. 2751]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, <<NOTE: FDA Food Safety 
Modernization Act.>> 
SECTION 1. SHORT TITLE; REFERENCES; TABLE OF CONTENTS.

    (a) <<NOTE: 21 USC 2201 note.>>  Short Title.--This Act may be cited 
as the ``FDA Food Safety Modernization Act''.

    (b) References.--Except as otherwise specified, whenever in this Act 
an amendment is expressed in terms of an amendment to a section or other 
provision, the reference shall be considered to be made to a section or 
other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
301 et seq.).
    (c) Table of Contents.--The table of contents for this Act is as 
follows:

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

       TITLE I--IMPROVING CAPACITY TO PREVENT FOOD SAFETY PROBLEMS

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

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

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

[[Page 124 STAT. 3886]]

Sec. 211. Improving the reportable food registry.

            TITLE III--IMPROVING THE SAFETY OF IMPORTED FOOD

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

                   TITLE IV--MISCELLANEOUS PROVISIONS

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

       TITLE I--IMPROVING CAPACITY TO PREVENT FOOD SAFETY PROBLEMS

SEC. 101. INSPECTIONS OF RECORDS.

    (a) In General.--Section 414(a) (21 U.S.C. 350c(a)) is amended--
            (1) by striking the heading and all that follows through 
        ``of food is'' and inserting the following: ``Records 
        Inspection.--
            ``(1) Adulterated food.--If the Secretary has a reasonable 
        belief that an article of food, and any other article of food 
        that the Secretary reasonably believes is likely to be affected 
        in a similar manner, is'';
            (2) by inserting ``, and to any other article of food that 
        the Secretary reasonably believes is likely to be affected in a 
        similar manner,'' after ``relating to such article'';
            (3) by striking the last sentence; and
            (4) by inserting at the end the following:
            ``(2) Use of or exposure to food of 
        concern. <<NOTE: Notice.>> --If the Secretary believes that 
        there is a reasonable probability that the use of or exposure to 
        an article of food, and any other article of food that the 
        Secretary reasonably believes is likely to be affected in a 
        similar manner, will cause serious adverse health consequences 
        or death to humans or animals, each person (excluding farms and 
        restaurants) who manufactures, processes, packs, distributes, 
        receives, holds, or imports such article shall, at the request 
        of an officer or employee duly designated by the Secretary, 
        permit such officer or employee, upon presentation of 
        appropriate credentials and a written notice to such person, at 
        reasonable times and within reasonable limits and in a 
        reasonable manner, to have access to and copy all records 
        relating to such article and to any other article of food that 
        the Secretary reasonably believes is likely to be affected in a 
        similar manner, that are needed to assist the Secretary in 
        determining whether there is a reasonable probability that the 
        use of or exposure to the food will cause serious adverse health 
        consequences or death to humans or animals.
            ``(3) Application.--The requirement under paragraphs (1) and 
        (2) applies to all records relating to the manufacture, 
        processing, packing, distribution, receipt, holding, or 
        importation of such article maintained by or on behalf of such 
        person

[[Page 124 STAT. 3887]]

        in any format (including paper and electronic formats) and at 
        any location.''.

    (b) Conforming Amendment.--Section 704(a)(1)(B) (21 U.S.C. 
374(a)(1)(B)) is amended by striking ``section 414 when'' and all that 
follows through ``subject to'' and inserting ``section 414, when the 
standard for records inspection under paragraph (1) or (2) of section 
414(a) applies, subject to''.
SEC. 102. REGISTRATION OF FOOD FACILITIES.

    (a) Updating of Food Category Regulations; Biennial Registration 
Renewal.--Section 415(a) (21 U.S.C. 350d(a)) is amended--
            (1) in paragraph (2), by--
                    (A) striking ``conducts business and'' and inserting 
                ``conducts business, the e-mail address for the contact 
                person of the facility or, in the case of a foreign 
                facility, the United States agent for the facility, 
                and''; and
                    (B) inserting ``, or any other food categories as 
                determined appropriate by the Secretary, including by 
                guidance'' after ``Code of Federal Regulations'';
            (2) by redesignating paragraphs (3) and (4) as paragraphs 
        (4) and (5), respectively; and
            (3) by inserting after paragraph (2) the following:
            ``(3) Biennial registration renewal. <<NOTE: Time 
        period.>> --During the period beginning on October 1 and ending 
        on December 31 of each even-numbered year, a registrant that has 
        submitted a registration under paragraph (1) shall submit to the 
        Secretary a renewal registration containing the information 
        described in paragraph (2). The Secretary shall provide for an 
        abbreviated registration renewal process for any registrant that 
        has not had any changes to such information since the registrant 
        submitted the preceding registration or registration renewal for 
        the facility involved.''.

    (b) Suspension of Registration.--
            (1) In general.--Section 415 (21 U.S.C. 350d) is amended--
                    (A) in subsection (a)(2), by inserting after the 
                first sentence the following: ``The registration shall 
                contain an assurance that the Secretary will be 
                permitted to inspect such facility at the times and in 
                the manner permitted by this Act.'';
                    (B) by redesignating subsections (b) and (c) as 
                subsections (c) and (d), respectively; and
                    (C) by inserting after subsection (a) the following:

    ``(b) Suspension of Registration.--
            ``(1) In general.--If the Secretary determines that food 
        manufactured, processed, packed, received, or held by a facility 
        registered under this section has a reasonable probability of 
        causing serious adverse health consequences or death to humans 
        or animals, the Secretary may by order suspend the registration 
        of a facility--
                    ``(A) that created, caused, or was otherwise 
                responsible for such reasonable probability; or
                    ``(B)(i) that knew of, or had reason to know of, 
                such reasonable probability; and
                    ``(ii) packed, received, or held such food.

[[Page 124 STAT. 3888]]

            ``(2) Hearing on suspension. <<NOTE: Deadline.>> --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. <<NOTE: Deadline.>>  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. <<NOTE: Effective dates.>> --
        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) <<NOTE: Deadline. 21 USC 350d note.>>  Small entity 
        compliance policy guide.--Not later than 180 days after the 
        issuance of the regulations promulgated

[[Page 124 STAT. 3889]]

        under section 415(b)(5) of the Federal Food, Drug, and Cosmetic 
        Act (as added by this section), the Secretary shall issue a 
        small entity compliance policy guide setting forth in plain 
        language the requirements of such regulations to assist small 
        entities in complying with registration requirements and other 
        activities required under such section.
            (3) Imported food.--Section 801(l) (21 U.S.C. 381(l)) is 
        amended by inserting ``(or for which a registration has been 
        suspended under such section)'' after ``section 415''.

    (c) <<NOTE: 21 USC 350d note.>>  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), <<NOTE: 21 USC 350d.>>  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. <<NOTE: 21 USC 350g.>>  HAZARD ANALYSIS AND RISK-BASED 
                        PREVENTIVE CONTROLS.

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

[[Page 124 STAT. 3890]]

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

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

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

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

[[Page 124 STAT. 3891]]

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

    ``(g) Recordkeeping. <<NOTE: Time period.>> --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. <<NOTE: Deadline.>> --The owner, 
operator, or agent in charge of a facility shall conduct a reanalysis 
under subsection (b) whenever a significant change is made in the 
activities conducted at a facility operated by such owner, operator, or 
agent if the change creates a reasonable potential for a new hazard or a 
significant increase in a previously identified hazard or not less 
frequently than once every 3 years, whichever is earlier. Such 
reanalysis shall be completed and additional preventive controls needed 
to address the hazard identified, if any, shall be implemented before 
the change in activities at the facility is operative. Such owner, 
operator, or agent shall revise the written plan required under 
subsection (h) if such a significant change is made or document the 
basis for the conclusion that no additional or revised preventive 
controls are needed. The Secretary may require a reanalysis under this 
section to respond to new hazards and developments in scientific 
understanding, including, as appropriate, results from the Department of 
Homeland Security biological, chemical, radiological, or other terrorism 
risk assessment.

    ``(j) Exemption for Seafood, Juice, and Low-acid Canned Food 
Facilities Subject to HACCP.--
            ``(1) In general.--This section shall not apply to a 
        facility if the owner, operator, or agent in charge of such 
        facility is required to comply with, and is in compliance with, 
        1 of the following standards and regulations with respect to 
        such facility:
                    ``(A) The Seafood Hazard Analysis Critical Control 
                Points Program of the Food and Drug Administration.
                    ``(B) The Juice Hazard Analysis Critical Control 
                Points Program of the Food and Drug Administration.
                    ``(C) The Thermally Processed Low-Acid Foods 
                Packaged in Hermetically Sealed Containers standards of 
                the Food and Drug Administration (or any successor 
                standards).
            ``(2) Applicability.--The exemption under paragraph (1)(C) 
        shall apply only with respect to microbiological hazards that 
        are regulated under the standards for Thermally Processed

[[Page 124 STAT. 3892]]

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

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

[[Page 124 STAT. 3893]]

                          ``(i)(I) documentation that demonstrates that 
                      the owner, operator, or agent in charge of the 
                      facility has identified potential hazards 
                      associated with the food being produced, is 
                      implementing preventive controls to address the 
                      hazards, and is monitoring the preventive controls 
                      to ensure that such controls are effective; or
                          ``(II) documentation (which may include 
                      licenses, inspection reports, certificates, 
                      permits, credentials, certification by an 
                      appropriate agency (such as a State department of 
                      agriculture), or other evidence of oversight), as 
                      specified by the Secretary, that the facility is 
                      in compliance with State, local, county, or other 
                      applicable non-Federal food safety law; and
                          ``(ii) <<NOTE: Deadline.>>  documentation, as 
                      specified by the Secretary in a guidance document 
                      issued not later than 1 year after the date of 
                      enactment of this section, that the facility is a 
                      qualified facility under paragraph (1)(B) or 
                      (1)(C).
            ``(3) Withdrawal; rule of construction.--
                    ``(A) In general.--In the event of an active 
                investigation of a foodborne illness outbreak that is 
                directly linked to a qualified facility subject to an 
                exemption under this subsection, or if the Secretary 
                determines that it is necessary to protect the public 
                health and prevent or mitigate a foodborne illness 
                outbreak based on conduct or conditions associated with 
                a qualified facility that are material to the safety of 
                the food manufactured, processed, packed, or held at 
                such facility, the Secretary may withdraw the exemption 
                provided to such facility under this subsection.
                    ``(B) Rule of construction.--Nothing in this 
                subsection shall be construed to expand or limit the 
                inspection authority of the Secretary.
            ``(4) Definitions.--In this subsection:
                    ``(A) Affiliate.--The term `affiliate' means any 
                facility that controls, is controlled by, or is under 
                common control with another facility.
                    ``(B) Qualified end-user.--The term `qualified end-
                user', with respect to a food, means--
                          ``(i) the consumer of the food; or
                          ``(ii) a restaurant or retail food 
                      establishment (as those terms are defined by the 
                      Secretary for purposes of section 415) that--
                                    ``(I) is located--
                                            ``(aa) in the same State as 
                                        the qualified facility that sold 
                                        the food to such restaurant or 
                                        establishment; or
                                            ``(bb) not more than 275 
                                        miles from such facility; and
                                    ``(II) is purchasing the food for 
                                sale directly to consumers at such 
                                restaurant or retail food establishment.
                    ``(C) Consumer.--For purposes of subparagraph (B), 
                the term `consumer' does not include a business.
                    ``(D) Subsidiary.--The term `subsidiary' means any 
                company which is owned or controlled directly or 
                indirectly by another company.

[[Page 124 STAT. 3894]]

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

[[Page 124 STAT. 3895]]

                      food was manufactured or processed, on a label, 
                      poster, sign, placard, or documents delivered 
                      contemporaneously with the food in the normal 
                      course of business, or, in the case of Internet 
                      sales, in an electronic notice.
                    ``(B) No additional label.--Subparagraph (A) does 
                not provide authority to the Secretary to require a 
                label that is in addition to any label required under 
                any other provision of this Act.

    ``(m) Authority With Respect to Certain Facilities.--The Secretary 
may, by regulation, exempt or modify the requirements for compliance 
under this section with respect to facilities that are solely engaged in 
the production of food for animals other than man, the storage of raw 
agricultural commodities (other than fruits and vegetables) intended for 
further distribution or processing, or the storage of packaged foods 
that are not exposed to the environment.
    ``(n) Regulations.--
            ``(1) In general. <<NOTE: Deadline.>> --Not later than 18 
        months after the date of enactment of the FDA Food Safety 
        Modernization Act, the Secretary shall promulgate regulations--
                    ``(A) to establish science-based minimum standards 
                for conducting a hazard analysis, documenting hazards, 
                implementing preventive controls, and documenting the 
                implementation of the preventive controls under this 
                section; and
                    ``(B) to define, for purposes of this section, the 
                terms `small business' and `very small business', taking 
                into consideration the study described in subsection 
                (l)(5).
            ``(2) Coordination.--In promulgating the regulations under 
        paragraph (1)(A), with regard to hazards that may be 
        intentionally introduced, including by acts of terrorism, the 
        Secretary shall coordinate with the Secretary of Homeland 
        Security, as appropriate.
            ``(3) Content.--The regulations promulgated under paragraph 
        (1)(A) shall--
                    ``(A) provide sufficient flexibility to be 
                practicable for all sizes and types of facilities, 
                including small businesses such as a small food 
                processing facility co-located on a farm;
                    ``(B) comply with chapter 35 of title 44, United 
                States Code (commonly known as the `Paperwork Reduction 
                Act'), with special attention to minimizing the burden 
                (as defined in section 3502(2) of such Act) on the 
                facility, and collection of information (as defined in 
                section 3502(3) of such Act), associated with such 
                regulations;
                    ``(C) acknowledge differences in risk and minimize, 
                as appropriate, the number of separate standards that 
                apply to separate foods; and
                    ``(D) not require a facility to hire a consultant or 
                other third party to identify, implement, certify, or 
                audit preventative controls, except in the case of 
                negotiated enforcement resolutions that may require such 
                a consultant or third party.
            ``(4) Rule of construction.--Nothing in this subsection 
        shall be construed to provide the Secretary with the authority 
        to prescribe specific technologies, practices, or critical 
        controls for an individual facility.

[[Page 124 STAT. 3896]]

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

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

    (b) <<NOTE: 21 USC 350g note.>>  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) <<NOTE: 21 USC 350d note.>>  Rulemaking.--
            (1) Proposed rulemaking.--
                    (A) In general. <<NOTE: Deadline. Federal Register, 
                publication. Notice.>> --Not later than 9 months after 
                the date of enactment of this Act, the Secretary of 
                Health and Human Services (referred to in this 
                subsection as the ``Secretary'') shall publish a notice 
                of proposed rulemaking in the Federal Register to 
                promulgate regulations with respect to--
                          (i) activities that constitute on-farm packing 
                      or holding of food that is not grown, raised, or 
                      consumed

[[Page 124 STAT. 3897]]

                      on such farm or another farm under the same 
                      ownership for purposes of section 415 of the 
                      Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                      350d), as amended by this Act; and
                          (ii) activities that constitute on-farm 
                      manufacturing or processing of food that is not 
                      consumed on that farm or on another farm under 
                      common ownership for purposes of such section 415.
                    (B) Clarification.--The rulemaking described under 
                subparagraph (A) shall enhance the implementation of 
                such section 415 and clarify the activities that are 
                included as part of the definition of the term 
                ``facility'' under such section 415. Nothing in this Act 
                authorizes the Secretary to modify the definition of the 
                term ``facility'' under such section.
                    (C) Science-based risk analysis.--In promulgating 
                regulations under subparagraph (A), the Secretary shall 
                conduct a science-based risk analysis of--
                          (i) specific types of on-farm packing or 
                      holding of food that is not grown, raised, or 
                      consumed on such farm or another farm under the 
                      same ownership, as such packing and holding 
                      relates to specific foods; and
                          (ii) specific on-farm manufacturing and 
                      processing activities as such activities relate to 
                      specific foods that are not consumed on that farm 
                      or on another farm under common ownership.
                    (D) Authority with respect to certain facilities.--
                          (i) In general.--In promulgating the 
                      regulations under subparagraph (A), the Secretary 
                      shall consider the results of the science-based 
                      risk analysis conducted under subparagraph (C), 
                      and shall exempt certain facilities from the 
                      requirements in section 418 of the Federal Food, 
                      Drug, and Cosmetic Act (as added by this section), 
                      including hazard analysis and preventive controls, 
                      and the mandatory inspection frequency in section 
                      421 of such Act (as added by section 201), or 
                      modify the requirements in such sections 418 or 
                      421, as the Secretary determines appropriate, if 
                      such facilities are engaged only in specific types 
                      of on-farm manufacturing, processing, packing, or 
                      holding activities that the Secretary determines 
                      to be low risk involving specific foods the 
                      Secretary determines to be low risk.
                          (ii) Limitation. <<NOTE: Applicability.>> --
                      The exemptions or modifications under clause (i) 
                      shall not include an exemption from the 
                      requirement to register under section 415 of the 
                      Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                      350d), as amended by this Act, if applicable, and 
                      shall apply only to small businesses and very 
                      small businesses, as defined in the regulation 
                      promulgated under section 418(n) of the Federal 
                      Food, Drug, and Cosmetic Act (as added under 
                      subsection (a)).
            (2) Final regulations.--Not later than 9 months after the 
        close of the comment period for the proposed rulemaking under 
        paragraph (1), the Secretary shall adopt final rules with 
        respect to--

[[Page 124 STAT. 3898]]

                    (A) activities that constitute on-farm packing or 
                holding of food that is not grown, raised, or consumed 
                on such farm or another farm under the same ownership 
                for purposes of section 415 of the Federal Food, Drug, 
                and Cosmetic Act (21 U.S.C. 350d), as amended by this 
                Act;
                    (B) activities that constitute on-farm manufacturing 
                or processing of food that is not consumed on that farm 
                or on another farm under common ownership for purposes 
                of such section 415; and
                    (C) the requirements under sections 418 and 421 of 
                the Federal Food, Drug, and Cosmetic Act, as added by 
                this Act, from which the Secretary may issue exemptions 
                or modifications of the requirements for certain types 
                of facilities.

    (d) Small Entity Compliance Policy Guide. <<NOTE: Deadline. 21 USC 
350g note.>> --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) <<NOTE: 21 USC 350g note.>>  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) <<NOTE: Applicability. 21 USC 350g note.>>  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) <<NOTE: 21 USC 342 note.>>  Updating Guidance Relating to Fish 
and Fisheries Products Hazards and Controls. <<NOTE: Deadline.>> --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) <<NOTE: 21 USC 350g.>>  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) <<NOTE: Applicability. Effective dates.>>  Flexibility 
        for small businesses.--Notwithstanding paragraph (1)--
                    (A) the amendments made by this section shall apply 
                to a small business (as defined in the regulations 
                promulgated under section 418(n) of the Federal Food, 
                Drug, and Cosmetic Act (as added by this section)) 
                beginning on the

[[Page 124 STAT. 3899]]

                date that is 6 months after the effective date of such 
                regulations; and
                    (B) the amendments made by this section shall apply 
                to a very small business (as defined in such 
                regulations) beginning on the date that is 18 months 
                after the effective date of such regulations.
SEC. 104. <<NOTE: 21 USC 2201.>>  PERFORMANCE STANDARDS.

    (a) In General. <<NOTE: Deadline.>> --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) <<NOTE: Applicability.>>  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. <<NOTE: 21 USC 350h.>>  STANDARDS FOR PRODUCE SAFETY.

    ``(a) Proposed Rulemaking.--
            ``(1) In general.--
                    ``(A) 
                Rulemaking. <<NOTE: Deadline. Publication. Notice.>> --
                Not later than 1 year after the date of enactment of the 
                FDA Food Safety Modernization Act, the Secretary, in 
                coordination with the Secretary of Agriculture and 
                representatives of State departments of agriculture 
                (including with regard to the national organic program 
                established under the Organic Foods Production Act of 
                1990), and in consultation with the Secretary of 
                Homeland Security, shall publish a notice of proposed 
                rulemaking to establish science-based minimum standards 
                for the safe production and harvesting of those types of 
                fruits

[[Page 124 STAT. 3900]]

                and vegetables, including specific mixes or categories 
                of fruits and vegetables, that are raw agricultural 
                commodities for which the Secretary has determined that 
                such standards minimize the risk of serious adverse 
                health consequences or death.
                    ``(B) Determination by secretary.--With respect to 
                small businesses and very small businesses (as such 
                terms are defined in the regulation promulgated under 
                subparagraph (A)) that produce and harvest those types 
                of fruits and vegetables that are raw agricultural 
                commodities that the Secretary has determined are low 
                risk and do not present a risk of serious adverse health 
                consequences or death, the Secretary may determine not 
                to include production and harvesting of such fruits and 
                vegetables in such rulemaking, or may modify the 
                applicable requirements of regulations promulgated 
                pursuant to this section.
            ``(2) Public input.--During the comment period on the notice 
        of proposed rulemaking under paragraph (1), the Secretary shall 
        conduct not less than 3 public meetings in diverse geographical 
        areas of the United States to provide persons in different 
        regions an opportunity to comment.
            ``(3) Content.--The proposed rulemaking under paragraph (1) 
        shall--
                    ``(A) provide sufficient flexibility to be 
                applicable to various types of entities engaged in the 
                production and harvesting of fruits and vegetables that 
                are raw agricultural commodities, including small 
                businesses and entities that sell directly to consumers, 
                and be appropriate to the scale and diversity of the 
                production and harvesting of such commodities;
                    ``(B) include, with respect to growing, harvesting, 
                sorting, packing, and storage operations, science-based 
                minimum standards related to soil amendments, hygiene, 
                packaging, temperature controls, animals in the growing 
                area, and water;
                    ``(C) consider hazards that occur naturally, may be 
                unintentionally introduced, or may be intentionally 
                introduced, including by acts of terrorism;
                    ``(D) take into consideration, consistent with 
                ensuring enforceable public health protection, 
                conservation and environmental practice standards and 
                policies established by Federal natural resource 
                conservation, wildlife conservation, and environmental 
                agencies;
                    ``(E) in the case of production that is certified 
                organic, not include any requirements that conflict with 
                or duplicate the requirements of the national organic 
                program established under the Organic Foods Production 
                Act of 1990, while providing the same level of public 
                health protection as the requirements under guidance 
                documents, including guidance documents regarding action 
                levels, and regulations under the FDA Food Safety 
                Modernization Act; and
                    ``(F) define, for purposes of this section, the 
                terms `small business' and `very small business'.
            ``(4) Prioritization.--The Secretary shall prioritize the 
        implementation of the regulations under this section for 
        specific fruits and vegetables that are raw agricultural 
        commodities

[[Page 124 STAT. 3901]]

        based on known risks which may include a history and severity of 
        foodborne illness outbreaks.

    ``(b) Final Regulation.--
            ``(1) In general. <<NOTE: Deadline.>> --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. <<NOTE: Applicability. Effective dates.>> --
        Notwithstanding paragraph (1)--
                    ``(A) the regulations promulgated under this section 
                shall apply to a small business (as defined in the 
                regulation promulgated under subsection (a)(1)) after 
                the date that is 1 year after the effective date of the 
                final regulation under paragraph (1); and
                    ``(B) the regulations promulgated under this section 
                shall apply to a very small business (as defined in the 
                regulation promulgated under subsection (a)(1)) after 
                the date that is 2 years after the effective date of the 
                final regulation under paragraph (1).

    ``(c) Criteria.--
            ``(1) In general.--The regulations adopted under subsection 
        (b) shall--
                    ``(A) set forth those procedures, processes, and 
                practices that the Secretary determines to minimize the 
                risk of serious adverse health consequences or death, 
                including procedures, processes, and practices that the 
                Secretary determines to be reasonably necessary to 
                prevent the introduction of known or reasonably 
                foreseeable biological, chemical, and physical hazards, 
                including hazards that occur naturally, may be 
                unintentionally introduced, or may be intentionally 
                introduced, including by acts of terrorism, into fruits 
                and vegetables, including specific mixes or categories 
                of fruits and vegetables, that are raw agricultural 
                commodities and to provide reasonable assurances that 
                the produce is not adulterated under section 402;
                    ``(B) provide sufficient flexibility to be 
                practicable for all sizes and types of businesses, 
                including small businesses such as a small food 
                processing facility co-located on a farm;
                    ``(C) comply with chapter 35 of title 44, United 
                States Code (commonly known as the `Paperwork Reduction 
                Act'), with special attention to minimizing the burden 
                (as defined in section 3502(2) of such Act) on the 
                business, and collection of information (as defined in 
                section 3502(3) of such Act), associated with such 
                regulations;

[[Page 124 STAT. 3902]]

                    ``(D) acknowledge differences in risk and minimize, 
                as appropriate, the number of separate standards that 
                apply to separate foods; and
                    ``(E) not require a business to hire a consultant or 
                other third party to identify, implement, certify, 
                compliance with these procedures, processes, and 
                practices, except in the case of negotiated enforcement 
                resolutions that may require such a consultant or third 
                party; and
                    ``(F) permit States and foreign countries from which 
                food is imported into the United States to request from 
                the Secretary variances from the requirements of the 
                regulations, subject to paragraph (2), where the State 
                or foreign country determines that the variance is 
                necessary in light of local growing conditions and that 
                the procedures, processes, and practices to be followed 
                under the variance are reasonably likely to ensure that 
                the produce is not adulterated under section 402 and to 
                provide the same level of public health protection as 
                the requirements of the regulations adopted under 
                subsection (b).
            ``(2) Variances.--
                    ``(A) Requests for variances.--A State or foreign 
                country from which food is imported into the United 
                States may in writing request a variance from the 
                Secretary. Such request shall describe the variance 
                requested and present information demonstrating that the 
                variance does not increase the likelihood that the food 
                for which the variance is requested will be adulterated 
                under section 402, and that the variance provides the 
                same level of public health protection as the 
                requirements of the regulations adopted under subsection 
                (b). The Secretary shall review such requests in a 
                reasonable timeframe.
                    ``(B) Approval of variances.--The Secretary may 
                approve a variance in whole or in part, as appropriate, 
                and may specify the scope of applicability of a variance 
                to other similarly situated persons.
                    ``(C) Denial of variances.--The Secretary may deny a 
                variance request if the Secretary determines that such 
                variance is not reasonably likely to ensure that the 
                food is not adulterated under section 402 and is not 
                reasonably likely to provide the same level of public 
                health protection as the requirements of the regulation 
                adopted under subsection (b). <<NOTE: Notification.>>  
                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. <<NOTE: Contracts.>> --The Secretary may 
coordinate with the Secretary of Agriculture and, as appropriate, shall 
contract and coordinate with the agency or department designated by the 
Governor of each State to perform activities to ensure compliance with 
this section.

    ``(e) Guidance.--

[[Page 124 STAT. 3903]]

            ``(1) In 
        general. <<NOTE: Deadline. Publication. Consultation.>> --Not 
        later than 1 year after the date of enactment of the FDA Food 
        Safety Modernization Act, the Secretary shall publish, after 
        consultation with the Secretary of Agriculture, representatives 
        of State departments of agriculture, farmer representatives, and 
        various types of entities engaged in the production and 
        harvesting or importing of fruits and vegetables that are raw 
        agricultural commodities, including small businesses, updated 
        good agricultural practices and guidance for the safe production 
        and harvesting of specific types of fresh produce under this 
        section.
            ``(2) Public meetings.--The Secretary shall conduct not 
        fewer than 3 public meetings in diverse geographical areas of 
        the United States as part of an effort to conduct education and 
        outreach regarding the guidance described in paragraph (1) for 
        persons in different regions who are involved in the production 
        and harvesting of fruits and vegetables that are raw 
        agricultural commodities, including persons that sell directly 
        to consumers and farmer representatives, and for importers of 
        fruits and vegetables that are raw agricultural commodities.
            ``(3) Paperwork reduction.--The Secretary shall ensure that 
        any updated guidance under this section will--
                    ``(A) provide sufficient flexibility to be 
                practicable for all sizes and types of facilities, 
                including small businesses such as a small food 
                processing facility co-located on a farm; and
                    ``(B) acknowledge differences in risk and minimize, 
                as appropriate, the number of separate standards that 
                apply to separate foods.

    ``(f) Exemption for Direct Farm Marketing.--
            ``(1) In general.--A farm shall be exempt from the 
        requirements under this section in a calendar year if--
                    ``(A) during the previous 3-year period, the average 
                annual monetary value of the food sold by such farm 
                directly to qualified end-users during such period 
                exceeded the average annual monetary value of the food 
                sold by such farm to all other buyers during such 
                period; and
                    ``(B) the average annual monetary value of all food 
                sold during such period was less than $500,000, adjusted 
                for inflation.
            ``(2) Notification to consumers.--
                    ``(A) In general.--A farm that is exempt from the 
                requirements under this section shall--
                          ``(i) with respect to a food for which a food 
                      packaging label is required by the Secretary under 
                      any other provision of this Act, include 
                      prominently and conspicuously on such label the 
                      name and business address of the farm where the 
                      produce was grown; or
                          ``(ii) with respect to a food for which a food 
                      packaging label is not required by the Secretary 
                      under any other provision of this Act, prominently 
                      and conspicuously display, at the point of 
                      purchase, the name and business address of the 
                      farm where the produce was grown, on a label, 
                      poster, sign, placard, or documents delivered 
                      contemporaneously with the

[[Page 124 STAT. 3904]]

                      food in the normal course of business, or, in the 
                      case of Internet sales, in an electronic notice.
                    ``(B) No additional label.--Subparagraph (A) does 
                not provide authority to the Secretary to require a 
                label that is in addition to any label required under 
                any other provision of this Act.
            ``(3) Withdrawal; rule of construction.--
                    ``(A) In general.--In the event of an active 
                investigation of a foodborne illness outbreak that is 
                directly linked to a farm subject to an exemption under 
                this subsection, or if the Secretary determines that it 
                is necessary to protect the public health and prevent or 
                mitigate a foodborne illness outbreak based on conduct 
                or conditions associated with a farm that are material 
                to the safety of the food produced or harvested at such 
                farm, the Secretary may withdraw the exemption provided 
                to such farm under this subsection.
                    ``(B) Rule of construction.--Nothing in this 
                subsection shall be construed to expand or limit the 
                inspection authority of the Secretary.
            ``(4) Definitions.--
                    ``(A) Qualified end-user.--In this subsection, the 
                term `qualified end-user', with respect to a food 
                means--
                          ``(i) the consumer of the food; or
                          ``(ii) a restaurant or retail food 
                      establishment (as those terms are defined by the 
                      Secretary for purposes of section 415) that is 
                      located--
                                    ``(I) in the same State as the farm 
                                that produced the food; or
                                    ``(II) not more than 275 miles from 
                                such farm.
                    ``(B) Consumer.--For purposes of subparagraph (A), 
                the term `consumer' does not include a business.
            ``(5) No preemption.--Nothing in this subsection preempts 
        State, local, county, or other non-Federal law regarding the 
        safe production, harvesting, holding, transportation, and sale 
        of fresh fruits and vegetables. Compliance with this subsection 
        shall not relieve any person from liability at common law or 
        under State statutory law.
            ``(6) Limitation of effect.--Nothing in this subsection 
        shall prevent the Secretary from exercising any authority 
        granted in the other sections of this Act.

    ``(g) Clarification.--This section shall not apply to produce that 
is produced by an individual for personal consumption.
    ``(h) Exception for Activities of Facilities Subject to Section 
418.--This section shall not apply to activities of a facility that are 
subject to section 418.''.
    (b) Small Entity Compliance Policy Guide. <<NOTE: Deadline. 21 USC 
350h note.>> --Not later than 180 days after the issuance of regulations 
under section 419 of the Federal Food, Drug, and Cosmetic Act (as added 
by subsection (a)), the Secretary of Health and Human Services shall 
issue a small entity compliance policy guide setting forth in plain 
language the requirements of such section 419 and to assist small 
entities in complying with standards for safe production and harvesting 
and other activities required under such section.

    (c) Prohibited Acts.--Section 301 (21 U.S.C. 331), as amended by 
section 103, is amended by adding at the end the following:

[[Page 124 STAT. 3905]]

    ``(vv) The failure to comply with the requirements under section 
419.''.
    (d) <<NOTE: 21 USC 350h note.>>  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. <<NOTE: 21 USC 350i.>>  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) <<NOTE: Determination.>>  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. <<NOTE: Deadline.>> --Not later than 18 months 
after the date of enactment of the FDA Food Safety Modernization Act, 
the Secretary, in coordination with the Secretary of Homeland Security 
and in consultation with the Secretary of Agriculture, shall promulgate 
regulations to protect against the intentional adulteration of food 
subject to this Act. Such regulations shall--
            ``(1) specify how a person shall assess whether the person 
        is required to implement mitigation strategies or measures 
        intended to protect against the intentional adulteration of 
        food; and
            ``(2) specify appropriate science-based mitigation 
        strategies or measures to prepare and protect the food supply 
        chain at specific vulnerable points, as appropriate.

    ``(c) Applicability.--Regulations promulgated under subsection (b) 
shall apply only to food for which there is a high risk of intentional 
contamination, as determined by the Secretary, in consultation with the 
Secretary of Homeland Security, under subsection (a), that could cause 
serious adverse health consequences or death to humans or animals and 
shall include those foods--
            ``(1) for which the Secretary has identified clear 
        vulnerabilities (including short shelf-life or susceptibility to 
        intentional contamination at critical control points); and

[[Page 124 STAT. 3906]]

            ``(2) in bulk or batch form, prior to being packaged for the 
        final consumer.

    ``(d) Exception.--This section shall not apply to farms, except for 
those that produce milk.
    ``(e) Definition.--For purposes of this section, the term `farm' has 
the meaning given that term in section 1.227 of title 21, Code of 
Federal Regulations (or any successor regulation).''.
    (b) Guidance Documents.--
            (1) In general. <<NOTE: Deadline.>> --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) <<NOTE: 21 USC 350i note.>>  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. <<NOTE: 21 USC 379j-31.>>  AUTHORITY TO COLLECT AND 
                        USE FEES.

    ``(a) In General.--
            ``(1) Purpose and authority.--For fiscal year 2010 and each 
        subsequent fiscal year, the Secretary shall, in accordance with 
        this section, assess and collect fees from--
                    ``(A) the responsible party for each domestic 
                facility (as defined in section 415(b)) and the United 
                States agent

[[Page 124 STAT. 3907]]

                for each foreign facility subject to a reinspection in 
                such fiscal year, to cover reinspection-related costs 
                for such year;
                    ``(B) the responsible party for a domestic facility 
                (as defined in section 415(b)) and an importer who does 
                not comply with a recall order under section 423 or 
                under section 412(f) in such fiscal year, to cover food 
                recall activities associated with such order performed 
                by the Secretary, including technical assistance, 
                follow-up effectiveness checks, and public 
                notifications, for such year;
                    ``(C) each importer participating in the voluntary 
                qualified importer program under section 806 in such 
                year, to cover the administrative costs of such program 
                for such year; and
                    ``(D) each importer subject to a reinspection in 
                such fiscal year, to cover reinspection-related costs 
                for such year.
            ``(2) Definitions.--For purposes of this section--
                    ``(A) the term `reinspection' means--
                          ``(i) with respect to domestic facilities (as 
                      defined in section 415(b)), 1 or more inspections 
                      conducted under section 704 subsequent to an 
                      inspection conducted under such provision which 
                      identified noncompliance materially related to a 
                      food safety requirement of this Act, specifically 
                      to determine whether compliance has been achieved 
                      to the Secretary's satisfaction; and
                          ``(ii) with respect to importers, 1 or more 
                      examinations conducted under section 801 
                      subsequent to an examination conducted under such 
                      provision which identified noncompliance 
                      materially related to a food safety requirement of 
                      this Act, specifically to determine whether 
                      compliance has been achieved to the Secretary's 
                      satisfaction;
                    ``(B) the term `reinspection-related costs' means 
                all expenses, including administrative expenses, 
                incurred in connection with--
                          ``(i) arranging, conducting, and evaluating 
                      the results of reinspections; and
                          ``(ii) assessing and collecting reinspection 
                      fees under this section; and
                    ``(C) the term `responsible party' has the meaning 
                given such term in section 417(a)(1).

    ``(b) Establishment of Fees.--
            ``(1) In general. <<NOTE: Federal Register, 
        publication. Notice. Deadline.>> --Subject to subsections (c) 
        and (d), the Secretary shall establish the fees to be collected 
        under this section for each fiscal year specified in subsection 
        (a)(1), based on the methodology described under paragraph (2), 
        and shall publish such fees in a Federal Register notice not 
        later than 60 days before the start of each such year.
            ``(2) Fee methodology.--
                    ``(A) Fees.--Fees amounts established for 
                collection--
                          ``(i) under subparagraph (A) of subsection 
                      (a)(1) for a fiscal year shall be based on the 
                      Secretary's estimate of 100 percent of the costs 
                      of the reinspection-related activities (including 
                      by type or level of reinspection activity, as the 
                      Secretary determines applicable) described in such 
                      subparagraph (A) for such year;

[[Page 124 STAT. 3908]]

                          ``(ii) under subparagraph (B) of subsection 
                      (a)(1) for a fiscal year shall be based on the 
                      Secretary's estimate of 100 percent of the costs 
                      of the activities described in such subparagraph 
                      (B) for such year;
                          ``(iii) under subparagraph (C) of subsection 
                      (a)(1) for a fiscal year shall be based on the 
                      Secretary's estimate of 100 percent of the costs 
                      of the activities described in such subparagraph 
                      (C) for such year; and
                          ``(iv) under subparagraph (D) of subsection 
                      (a)(1) for a fiscal year shall be based on the 
                      Secretary's estimate of 100 percent of the costs 
                      of the activities described in such subparagraph 
                      (D) for such year.
                    ``(B) Other considerations.--
                          ``(i) Voluntary qualified importer program.--
                      In establishing the fee amounts under subparagraph 
                      (A)(iii) for a fiscal year, the Secretary shall 
                      provide for the number of importers who have 
                      submitted to the Secretary a notice under section 
                      806(c) informing the Secretary of the intent of 
                      such importer to participate in the program under 
                      section 806 in such fiscal year.
                                    ``(II) Recoupment.--In establishing 
                                the fee amounts under subparagraph 
                                (A)(iii) for the first 5 fiscal years 
                                after the date of enactment of this 
                                section, the Secretary shall include in 
                                such fee a reasonable surcharge that 
                                provides a recoupment of the costs 
                                expended by the Secretary to establish 
                                and implement the first year of the 
                                program under section 806.
                          ``(ii) Crediting of fees.--In establishing the 
                      fee amounts under subparagraph (A) for a fiscal 
                      year, the Secretary shall provide for the 
                      crediting of fees from the previous year to the 
                      next year if the Secretary overestimated the 
                      amount of fees needed to carry out such 
                      activities, and consider the need to account for 
                      any adjustment of fees and such other factors as 
                      the Secretary determines appropriate.
                          ``(iii) Published 
                      guidelines. <<NOTE: Deadline. Federal Register, 
                      publication. Comment period.>> --Not later than 
                      180 days after the date of enactment of the FDA 
                      Food Safety Modernization Act, the Secretary shall 
                      publish in the Federal Register a proposed set of 
                      guidelines in consideration of the burden of fee 
                      amounts on small business. Such consideration may 
                      include reduced fee amounts for small businesses. 
                      The Secretary shall provide for a period of public 
                      comment on such guidelines. The Secretary shall 
                      adjust the fee schedule for small businesses 
                      subject to such fees only through notice and 
                      comment rulemaking.
            ``(3) Use of fees.--The Secretary shall make all of the fees 
        collected pursuant to clause (i), (ii), (iii), and (iv) of 
        paragraph (2)(A) available solely to pay for the costs referred 
        to in such clause (i), (ii), (iii), and (iv) of paragraph 
        (2)(A), respectively.

    ``(c) Limitations.--
            ``(1) In general.--Fees under subsection (a) shall be 
        refunded for a fiscal year beginning after fiscal year 2010 
        unless the amount of the total appropriations for food safety

[[Page 124 STAT. 3909]]

        activities at the Food and Drug Administration for such fiscal 
        year (excluding the amount of fees appropriated for such fiscal 
        year) is equal to or greater than the amount of appropriations 
        for food safety activities at the Food and Drug Administration 
        for fiscal year 2009 (excluding the amount of fees appropriated 
        for such fiscal year), multiplied by the adjustment factor under 
        paragraph (3).
            ``(2) Authority.--If--
                    ``(A) the Secretary does not assess fees under 
                subsection (a) for a portion of a fiscal year because 
                paragraph (1) applies; and
                    ``(B) at a later date in such fiscal year, such 
                paragraph (1) ceases to apply,
        the Secretary may assess and collect such fees under subsection 
        (a), without any modification to the rate of such fees, 
        notwithstanding the provisions of subsection (a) relating to the 
        date fees are to be paid.
            ``(3) Adjustment factor.--
                    ``(A) In general.--The adjustment factor described 
                in paragraph (1) shall be the total percentage change 
                that occurred in the Consumer Price Index for all urban 
                consumers (all items; United States city average) for 
                the 12-month period ending June 30 preceding the fiscal 
                year, but in no case shall such adjustment factor be 
                negative.
                    ``(B) Compounded basis.--The adjustment under 
                subparagraph (A) made each fiscal year shall be added on 
                a compounded basis to the sum of all adjustments made 
                each fiscal year after fiscal year 2009.
            ``(4) Limitation on amount of certain fees.--
                    ``(A) In general.--Notwithstanding any other 
                provision of this section and subject to subparagraph 
                (B), the Secretary may not collect fees in a fiscal year 
                such that the amount collected--
                          ``(i) under subparagraph (B) of subsection 
                      (a)(1) exceeds $20,000,000; and
                          ``(ii) under subparagraphs (A) and (D) of 
                      subsection (a)(1) exceeds $25,000,000 combined.
                    ``(B) Exception.--If a domestic facility (as defined 
                in section 415(b)) or an importer becomes subject to a 
                fee described in subparagraph (A), (B), or (D) of 
                subsection (a)(1) after the maximum amount of fees has 
                been collected by the Secretary under subparagraph (A), 
                the Secretary may collect a fee from such facility or 
                importer.

    ``(d) Crediting and Availability of Fees.--Fees authorized under 
subsection (a) shall be collected and available for obligation only to 
the extent and in the amount provided in appropriations Acts. Such fees 
are authorized to remain available until expended. Such sums as may be 
necessary may be transferred from the Food and Drug Administration 
salaries and expenses account without fiscal year limitation to such 
appropriation account for salaries and expenses with such fiscal year 
limitation. The sums transferred shall be available solely for the 
purpose of paying the operating expenses of the Food and Drug 
Administration employees and contractors performing activities 
associated with these food safety fees.
    ``(e) Collection of Fees.--
            ``(1) In general.--The Secretary shall specify in the 
        Federal Register notice described in subsection (b)(1) the time

[[Page 124 STAT. 3910]]

        and manner in which fees assessed under this section shall be 
        collected.
            ``(2) Collection of unpaid fees. <<NOTE: Deadline.>> --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. <<NOTE: 21 USC 2202.>>  NATIONAL AGRICULTURE AND FOOD 
                        DEFENSE STRATEGY.

    (a) Development and Submission of Strategy.--
            (1) In general. <<NOTE: Deadline. Web posting.>> --Not later 
        than 1 year after the date of enactment of this Act, the 
        Secretary of Health and Human Services and the Secretary of 
        Agriculture, in coordination with the Secretary of Homeland 
        Security, shall prepare and transmit

[[Page 124 STAT. 3911]]

        to the relevant committees of Congress, and make publicly 
        available on the Internet Web sites of the Department of Health 
        and Human Services and the Department of Agriculture, the 
        National Agriculture and Food Defense Strategy.
            (2) Implementation plan.--The strategy shall include an 
        implementation plan for use by the Secretaries described under 
        paragraph (1) in carrying out the strategy.
            (3) Research.--The strategy shall include a coordinated 
        research agenda for use by the Secretaries described under 
        paragraph (1) in conducting research to support the goals and 
        activities described in paragraphs (1) and (2) of subsection 
        (b).
            (4) Revisions. <<NOTE: Deadlines.>> --Not later than 4 years 
        after the date on which the strategy is submitted to the 
        relevant committees of Congress under paragraph (1), and not 
        less frequently than every 4 years thereafter, the Secretary of 
        Health and Human Services and the Secretary of Agriculture, in 
        coordination with the Secretary of Homeland Security, shall 
        revise and submit to the relevant committees of Congress the 
        strategy.
            (5) Consistency with existing plans.--The strategy described 
        in paragraph (1) shall be consistent with--
                    (A) the National Incident Management System;
                    (B) the National Response Framework;
                    (C) the National Infrastructure Protection Plan;
                    (D) the National Preparedness Goals; and
                    (E) other relevant national strategies.

    (b) Components.--
            (1) In general.--The strategy shall include a description of 
        the process to be used by the Department of Health and Human 
        Services, the Department of Agriculture, and the Department of 
        Homeland Security--
                    (A) to achieve each goal described in paragraph (2); 
                and
                    (B) to evaluate the progress made by Federal, State, 
                local, and tribal governments towards the achievement of 
                each goal described in paragraph (2).
            (2) Goals.--The strategy shall include a description of the 
        process to be used by the Department of Health and Human 
        Services, the Department of Agriculture, and the Department of 
        Homeland Security to achieve the following goals:
                    (A) Preparedness goal.--Enhance the preparedness of 
                the agriculture and food system by--
                          (i) conducting vulnerability assessments of 
                      the agriculture and food system;
                          (ii) mitigating vulnerabilities of the system;
                          (iii) improving communication and training 
                      relating to the system;
                          (iv) developing and conducting exercises to 
                      test decontamination and disposal plans;
                          (v) developing modeling tools to improve event 
                      consequence assessment and decision support; and
                          (vi) preparing risk communication tools and 
                      enhancing public awareness through outreach.
                    (B) Detection goal.--Improve agriculture and food 
                system detection capabilities by--
                          (i) identifying contamination in food products 
                      at the earliest possible time; and

[[Page 124 STAT. 3912]]

                          (ii) conducting surveillance to prevent the 
                      spread of diseases.
                    (C) Emergency response goal.--Ensure an efficient 
                response to agriculture and food emergencies by--
                          (i) immediately investigating animal disease 
                      outbreaks and suspected food contamination;
                          (ii) preventing additional human illnesses;
                          (iii) organizing, training, and equipping 
                      animal, plant, and food emergency response teams 
                      of--
                                    (I) the Federal Government; and
                                    (II) State, local, and tribal 
                                governments;
                          (iv) designing, developing, and evaluating 
                      training and exercises carried out under 
                      agriculture and food defense plans; and
                          (v) ensuring consistent and organized risk 
                      communication to the public by--
                                    (I) the Federal Government;
                                    (II) State, local, and tribal 
                                governments; and
                                    (III) the private sector.
                    (D) Recovery goal.--Secure agriculture and food 
                production after an agriculture or food emergency by--
                          (i) working with the private sector to develop 
                      business recovery plans to rapidly resume 
                      agriculture, food production, and international 
                      trade;
                          (ii) conducting exercises of the plans 
                      described in subparagraph (C) with the goal of 
                      long-term recovery results;
                          (iii) rapidly removing, and effectively 
                      disposing of--
                                    (I) contaminated agriculture and 
                                food products; and
                                    (II) infected plants and animals; 
                                and
                          (iv) decontaminating and restoring areas 
                      affected by an agriculture or food emergency.
            (3) Evaluation.--The Secretary, in coordination with the 
        Secretary of Agriculture and the Secretary of Homeland Security, 
        shall--
                    (A) develop metrics to measure progress for the 
                evaluation process described in paragraph (1)(B); and
                    (B) <<NOTE: Reports.>>  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. <<NOTE: Deadlines. Web posting. Reports. 21 USC 2203.>>  
                        FOOD AND AGRICULTURE COORDINATING 
                        COUNCILS.

    The Secretary of Homeland Security, in coordination with the 
Secretary of Health and Human Services and the Secretary of Agriculture, 
shall within 180 days of enactment of this Act, and annually thereafter, 
submit to the relevant committees of Congress,

[[Page 124 STAT. 3913]]

and make publicly available on the Internet Web site of the Department 
of Homeland Security, a report on the activities of the Food and 
Agriculture Government Coordinating Council and the Food and Agriculture 
Sector Coordinating Council, including the progress of such Councils 
on--
            (1) facilitating partnerships between public and private 
        entities to help coordinate and enhance the protection of the 
        agriculture and food system of the United States;
            (2) providing for the regular and timely interchange of 
        information between each council relating to the security of the 
        agriculture and food system (including intelligence 
        information);
            (3) identifying best practices and methods for improving the 
        coordination among Federal, State, local, and private sector 
        preparedness and response plans for agriculture and food 
        defense; and
            (4) recommending methods by which to protect the economy and 
        the public health of the United States from the effects of--
                    (A) animal or plant disease outbreaks;
                    (B) food contamination; and
                    (C) natural disasters affecting agriculture and 
                food.
SEC. 110. <<NOTE: 21 USC 2204.>>  BUILDING DOMESTIC CAPACITY.

    (a) In General.--
            (1) Initial report.--The Secretary, in coordination with the 
        Secretary of Agriculture and the Secretary of Homeland Security, 
        shall, not later than 2 years after the date of enactment of 
        this Act, submit to Congress a comprehensive report that 
        identifies programs and practices that are intended to promote 
        the safety and supply chain security of food and to prevent 
        outbreaks of foodborne illness and other food-related hazards 
        that can be addressed through preventive activities. Such report 
        shall include a description of the following:
                    (A) Analysis of the need for further regulations or 
                guidance to industry.
                    (B) Outreach to food industry sectors, including 
                through the Food and Agriculture Coordinating Councils 
                referred to in section 109, to identify potential 
                sources of emerging threats to the safety and security 
                of the food supply and preventive strategies to address 
                those threats.
                    (C) Systems to ensure the prompt distribution to the 
                food industry of information and technical assistance 
                concerning preventive strategies.
                    (D) Communication systems to ensure that information 
                about specific threats to the safety and security of the 
                food supply are rapidly and effectively disseminated.
                    (E) Surveillance systems and laboratory networks to 
                rapidly detect and respond to foodborne illness 
                outbreaks and other food-related hazards, including how 
                such systems and networks are integrated.
                    (F) Outreach, education, and training provided to 
                States and local governments to build State and local 
                food safety and food defense capabilities, including 
                progress implementing strategies developed under 
                sections 108 and 205.

[[Page 124 STAT. 3914]]

                    (G) The estimated resources needed to effectively 
                implement the programs and practices identified in the 
                report developed in this section over a 5-year period.
                    (H) The impact of requirements under this Act 
                (including amendments made by this Act) on certified 
                organic farms and facilities (as defined in section 415 
                (21 U.S.C. 350d).
                    (I) Specific efforts taken pursuant to the 
                agreements authorized under section 421(c) of the 
                Federal Food, Drug, and Cosmetic Act (as added by 
                section 201), together with, as necessary, a description 
                of any additional authorities necessary to improve 
                seafood safety.
            (2) Biennial reports.--On a biennial basis following the 
        submission of the report under paragraph (1), the Secretary 
        shall submit to Congress a report that--
                    (A) reviews previous food safety programs and 
                practices;
                    (B) outlines the success of those programs and 
                practices;
                    (C) identifies future programs and practices; and
                    (D) includes information related to any matter 
                described in subparagraphs (A) through (H) of paragraph 
                (1), as necessary.

    (b) Risk-based Activities.--The report developed under subsection 
(a)(1) shall describe methods that seek to ensure that resources 
available to the Secretary for food safety-related activities are 
directed at those actions most likely to reduce risks from food, 
including the use of preventive strategies and allocation of inspection 
resources. The Secretary shall promptly undertake those risk-based 
actions that are identified during the development of the report as 
likely to contribute to the safety and security of the food supply.
    (c) Capability for Laboratory Analyses; Research.--The report 
developed under subsection (a)(1) shall provide a description of methods 
to increase capacity to undertake analyses of food samples promptly 
after collection, to identify new and rapid analytical techniques, 
including commercially-available techniques that can be employed at 
ports of entry and by Food Emergency Response Network laboratories, and 
to provide for well-equipped and staffed laboratory facilities and 
progress toward laboratory accreditation under section 422 of the 
Federal Food, Drug, and Cosmetic Act (as added by section 202).
    (d) Information Technology.--The report developed under subsection 
(a)(1) shall include a description of such information technology 
systems as may be needed to identify risks and receive data from 
multiple sources, including foreign governments, State, local, and 
tribal governments, other Federal agencies, the food industry, 
laboratories, laboratory networks, and consumers. The information 
technology systems that the Secretary describes shall also provide for 
the integration of the facility registration system under section 415 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d), and the prior 
notice system under section 801(m) of such Act (21 U.S.C. 381(m)) with 
other information technology systems that are used by the Federal 
Government for the processing of food offered for import into the United 
States.
    (e) Automated Risk Assessment.--The report developed under 
subsection (a)(1) shall include a description of progress toward

[[Page 124 STAT. 3915]]

developing and improving an automated risk assessment system for food 
safety surveillance and allocation of resources.
    (f) Traceback and Surveillance Report.--The Secretary shall include 
in the report developed under subsection (a)(1) an analysis of the Food 
and Drug Administration's performance in foodborne illness outbreaks 
during the 5-year period preceding the date of enactment of this Act 
involving fruits and vegetables that are raw agricultural commodities 
(as defined in section 201(r) (21 U.S.C. 321(r)) and recommendations for 
enhanced surveillance, outbreak response, and traceability. Such 
findings and recommendations shall address communication and 
coordination with the public, industry, and State and local governments, 
as such communication and coordination relates to outbreak 
identification and traceback.
    (g) Biennial Food Safety and Food Defense Research Plan.--The 
Secretary, the Secretary of Agriculture, and the Secretary of Homeland 
Security shall, on a biennial basis, submit to Congress a joint food 
safety and food defense research plan which may include studying the 
long-term health effects of foodborne illness. Such biennial plan shall 
include a list and description of projects conducted during the previous 
2-year period and the plan for projects to be conducted during the 
subsequent 2-year period.
    (h) Effectiveness of Programs Administered by the Department of 
Health and Human Services.--
            (1) In general. <<NOTE: Deadline.>> --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) <<NOTE: Reports.>>  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) <<NOTE: Publication.>>  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. <<NOTE: Deadline. Study.>> --Not later than 
        1 year after the date of enactment of this Act, the Secretary, 
        acting through the Commissioner of Food and Drugs, shall conduct 
        a study regarding the need for, and challenges associated with, 
        development and implementation of a program that requires a 
        unique identification number for each food facility registered 
        with the Secretary and, as appropriate, each broker that imports 
        food into the United States. Such study shall include an 
        evaluation of the costs associated with development and 
        implementation

[[Page 124 STAT. 3916]]

        of such a system, and make recommendations about what new 
        authorities, if any, would be necessary to develop and implement 
        such a system.
            (2) Report.--Not later than 15 months after the date of 
        enactment of this Act, the Secretary shall submit to Congress a 
        report that describes the findings of the study conducted under 
        paragraph (1) and that includes any recommendations determined 
        appropriate by the Secretary.
SEC. 111. SANITARY TRANSPORTATION OF FOOD.

    (a) In General. <<NOTE: Deadline. Regulations. 21 USC 350e 
note.>> --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. <<NOTE: 21 USC 2205.>>  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. <<NOTE: Deadline.>> --Not later than 
                1 year after the date of enactment of this Act, the 
                Secretary, in consultation with the Secretary of 
                Education, shall--
                          (i) develop guidelines to be used on a 
                      voluntary basis to develop plans for individuals 
                      to manage the risk of food allergy and anaphylaxis 
                      in schools and early childhood education programs; 
                      and
                          (ii) make such guidelines available to local 
                      educational agencies, schools, early childhood 
                      education programs, and other interested entities 
                      and individuals to be implemented on a voluntary 
                      basis only.

[[Page 124 STAT. 3917]]

                    (B) Applicability of ferpa.--Each plan described in 
                subparagraph (A) that is developed for an individual 
                shall be considered an education record for the purpose 
                of section 444 of the General Education Provisions Act 
                (commonly referred to as the ``Family Educational Rights 
                and Privacy Act of 1974'') (20 U.S.C. 1232g).
            (2) Contents.--The voluntary guidelines developed by the 
        Secretary under paragraph (1) shall address each of the 
        following and may be updated as the Secretary determines 
        necessary:
                    (A) Parental obligation to provide the school or 
                early childhood education program, prior to the start of 
                every school year, with--
                          (i) documentation from their child's physician 
                      or nurse--
                                    (I) supporting a diagnosis of food 
                                allergy, and any risk of anaphylaxis, if 
                                applicable;
                                    (II) identifying any food to which 
                                the child is allergic;
                                    (III) describing, if appropriate, 
                                any prior history of anaphylaxis;
                                    (IV) listing any medication 
                                prescribed for the child for the 
                                treatment of anaphylaxis;
                                    (V) detailing emergency treatment 
                                procedures in the event of a reaction;
                                    (VI) listing the signs and symptoms 
                                of a reaction; and
                                    (VII) assessing the child's 
                                readiness for self-administration of 
                                prescription medication; and
                          (ii) a list of substitute meals that may be 
                      offered to the child by school or early childhood 
                      education program food service personnel.
                    (B) The creation and maintenance of an individual 
                plan for food allergy management, in consultation with 
                the parent, tailored to the needs of each child with a 
                documented risk for anaphylaxis, including any 
                procedures for the self-administration of medication by 
                such children in instances where--
                          (i) the children are capable of self-
                      administering medication; and
                          (ii) such administration is not prohibited by 
                      State law.
                    (C) Communication strategies between individual 
                schools or early childhood education programs and 
                providers of emergency medical services, including 
                appropriate instructions for emergency medical response.
                    (D) Strategies to reduce the risk of exposure to 
                anaphylactic causative agents in classrooms and common 
                school or early childhood education program areas such 
                as cafeterias.
                    (E) The dissemination of general information on 
                life-threatening food allergies to school or early 
                childhood education program staff, parents, and 
                children.
                    (F) Food allergy management training of school or 
                early childhood education program personnel who 
                regularly come into contact with children with life-
                threatening food allergies.

[[Page 124 STAT. 3918]]

                    (G) The authorization and training of school or 
                early childhood education program personnel to 
                administer epinephrine when the nurse is not immediately 
                available.
                    (H) The timely accessibility of epinephrine by 
                school or early childhood education program personnel 
                when the nurse is not immediately available.
                    (I) The creation of a plan contained in each 
                individual plan for food allergy management that 
                addresses the appropriate response to an incident of 
                anaphylaxis of a child while such child is engaged in 
                extracurricular programs of a school or early childhood 
                education program, such as non-academic outings and 
                field trips, before- and after-school programs or 
                before- and after-early child education program 
                programs, and school-sponsored or early childhood 
                education program-sponsored programs held on weekends.
                    (J) Maintenance of information for each 
                administration of epinephrine to a child at risk for 
                anaphylaxis and prompt notification to parents.
                    (K) Other elements the Secretary determines 
                necessary for the management of food allergies and 
                anaphylaxis in schools and early childhood education 
                programs.
            (3) Relation to state law.--Nothing in this section or the 
        guidelines developed by the Secretary under paragraph (1) shall 
        be construed to preempt State law, including any State law 
        regarding whether students at risk for anaphylaxis may self-
        administer medication.

    (c) School-based Food Allergy Management Grants.--
            (1) In general.--The Secretary may award grants to local 
        educational agencies to assist such agencies with implementing 
        voluntary food allergy and anaphylaxis management guidelines 
        described in subsection (b).
            (2) Application.--
                    (A) In general.--To be eligible to receive a grant 
                under this subsection, a local educational agency shall 
                submit an application to the Secretary at such time, in 
                such manner, and including such information as the 
                Secretary may reasonably require.
                    (B) Contents.--Each application submitted under 
                subparagraph (A) shall include--
                          (i) an assurance that the local educational 
                      agency has developed plans in accordance with the 
                      food allergy and anaphylaxis management guidelines 
                      described in subsection (b);
                          (ii) a description of the activities to be 
                      funded by the grant in carrying out the food 
                      allergy and anaphylaxis management guidelines, 
                      including--
                                    (I) how the guidelines will be 
                                carried out at individual schools served 
                                by the local educational agency;
                                    (II) how the local educational 
                                agency will inform parents and students 
                                of the guidelines in place;
                                    (III) how school nurses, teachers, 
                                administrators, and other school-based 
                                staff will be made aware of, and given 
                                training on, when applicable, the 
                                guidelines in place; and

[[Page 124 STAT. 3919]]

                                    (IV) any other activities that the 
                                Secretary determines appropriate;
                          (iii) an itemization of how grant funds 
                      received under this subsection will be expended;
                          (iv) a description of how adoption of the 
                      guidelines and implementation of grant activities 
                      will be monitored; and
                          (v) an agreement by the local educational 
                      agency to report information required by the 
                      Secretary to conduct evaluations under this 
                      subsection.
            (3) Use of funds.--Each local educational agency that 
        receives a grant under this subsection may use the grant funds 
        for the following:
                    (A) Purchase of materials and supplies, including 
                limited medical supplies such as epinephrine and 
                disposable wet wipes, to support carrying out the food 
                allergy and anaphylaxis management guidelines described 
                in subsection (b).
                    (B) In partnership with local health departments, 
                school nurse, teacher, and personnel training for food 
                allergy management.
                    (C) Programs that educate students as to the 
                presence of, and policies and procedures in place 
                related to, food allergies and anaphylactic shock.
                    (D) Outreach to parents.
                    (E) Any other activities consistent with the 
                guidelines described in subsection (b).
            (4) Duration of awards.--The Secretary may award grants 
        under this subsection for a period of not more than 2 years. In 
        the event the Secretary conducts a program evaluation under this 
        subsection, funding in the second year of the grant, where 
        applicable, shall be contingent on a successful program 
        evaluation by the Secretary after the first year.
            (5) Limitation on grant funding.--The Secretary may not 
        provide grant funding to a local educational agency under this 
        subsection after such local educational agency has received 2 
        years of grant funding under this subsection.
            (6) Maximum amount of annual awards.--A grant awarded under 
        this subsection may not be made in an amount that is more than 
        $50,000 annually.
            (7) Priority.--In awarding grants under this subsection, the 
        Secretary shall give priority to local educational agencies with 
        the highest percentages of children who are counted under 
        section 1124(c) of the Elementary and Secondary Education Act of 
        1965 (20 U.S.C. 6333(c)).
            (8) Matching funds.--
                    (A) In general.--The Secretary may not award a grant 
                under this subsection unless the local educational 
                agency agrees that, with respect to the costs to be 
                incurred by such local educational agency in carrying 
                out the grant activities, the local educational agency 
                shall make available (directly or through donations from 
                public or private entities) non-Federal funds toward 
                such costs in an amount equal to not less than 25 
                percent of the amount of the grant.

[[Page 124 STAT. 3920]]

                    (B) Determination of amount of non-federal 
                contribution.--Non-Federal funds required under 
                subparagraph (A) may be cash or in kind, including 
                plant, equipment, or services. Amounts provided by the 
                Federal Government, and any portion of any service 
                subsidized by the Federal Government, may not be 
                included in determining the amount of such non-Federal 
                funds.
            (9) Administrative funds.--A local educational agency that 
        receives a grant under this subsection may use not more than 2 
        percent of the grant amount for administrative costs related to 
        carrying out this subsection.
            (10) Progress and evaluations.--At the completion of the 
        grant period referred to in paragraph (4), a local educational 
        agency shall provide the Secretary with information on how grant 
        funds were spent and the status of implementation of the food 
        allergy and anaphylaxis management guidelines described in 
        subsection (b).
            (11) Supplement, not supplant.--Grant funds received under 
        this subsection shall be used to supplement, and not supplant, 
        non-Federal funds and any other Federal funds available to carry 
        out the activities described in this subsection.
            (12) Authorization of appropriations.--There is authorized 
        to be appropriated to carry out this subsection $30,000,000 for 
        fiscal year 2011 and such sums as may be necessary for each of 
        the 4 succeeding fiscal years.

    (d) Voluntary Nature of Guidelines.--
            (1) In general.--The food allergy and anaphylaxis management 
        guidelines developed by the Secretary under subsection (b) are 
        voluntary. Nothing in this section or the guidelines developed 
        by the Secretary under subsection (b) shall be construed to 
        require a local educational agency to implement such guidelines.
            (2) Exception.--Notwithstanding paragraph (1), the Secretary 
        may enforce an agreement by a local educational agency to 
        implement food allergy and anaphylaxis management guidelines as 
        a condition of the receipt of a grant under subsection (c).
SEC. 113. NEW DIETARY INGREDIENTS.

    (a) In General.--Section 413 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 350b) is amended--
            (1) by redesignating subsection (c) as subsection (d); and
            (2) by inserting after subsection (b) the following:

    ``(c) Notification.--
            ``(1) In general.--If the Secretary determines that the 
        information in a new dietary ingredient notification submitted 
        under this section for an article purported to be a new dietary 
        ingredient is inadequate to establish that a dietary supplement 
        containing such article will reasonably be expected to be safe 
        because the article may be, or may contain, an anabolic steroid 
        or an analogue of an anabolic steroid, the Secretary shall 
        notify the Drug Enforcement Administration of such 
        determination. Such notification by the Secretary shall include, 
        at a minimum, the name of the dietary supplement or article, the 
        name of the person or persons who marketed the product or made

[[Page 124 STAT. 3921]]

        the submission of information regarding the article to the 
        Secretary under this section, and any contact information for 
        such person or persons that the Secretary has.
            ``(2) Definitions.--For purposes of this subsection--
                    ``(A) the term `anabolic steroid' has the meaning 
                given such term in section 102(41) of the Controlled 
                Substances Act; and
                    ``(B) the term `analogue of an anabolic steroid' 
                means a substance whose chemical structure is 
                substantially similar to the chemical structure of an 
                anabolic steroid.''.

    (b) Guidance. <<NOTE: Deadline. Publication. 21 USC 350b note.>> --
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. <<NOTE: 21 USC 342 note.>>  REQUIREMENT FOR GUIDANCE 
                        RELATING TO POST HARVEST PROCESSING OF RAW 
                        OYSTERS.

    (a) In General. <<NOTE: Deadline. Reports.>> --Not later than 90 
days prior to the issuance of any guidance, regulation, or suggested 
amendment by the Food and Drug Administration to the National Shellfish 
Sanitation Program's Model Ordinance, or the issuance of any guidance or 
regulation by the Food and Drug Administration relating to the Seafood 
Hazard Analysis Critical Control Points Program of the Food and Drug 
Administration (parts 123 and 1240 of title 21, Code of Federal 
Regulations (or any successor regulations), where such guidance, 
regulation or suggested amendment relates to post harvest processing for 
raw oysters, the Secretary shall prepare and submit to the Committee on 
Health, Education, Labor, and Pensions of the Senate and the Committee 
on Energy and Commerce of the House of Representatives a report which 
shall include--
            (1) an assessment of how post harvest processing or other 
        equivalent controls feasibly may be implemented in the fastest, 
        safest, and most economical manner;
            (2) the projected public health benefits of any proposed 
        post harvest processing;
            (3) the projected costs of compliance with such post harvest 
        processing measures;
            (4) the impact post harvest processing is expected to have 
        on the sales, cost, and availability of raw oysters;
            (5) criteria for ensuring post harvest processing standards 
        will be applied equally to shellfish imported from all nations 
        of origin;
            (6) an evaluation of alternative measures to prevent, 
        eliminate, or reduce to an acceptable level the occurrence of 
        foodborne illness; and
            (7) the extent to which the Food and Drug Administration has 
        consulted with the States and other regulatory agencies, as 
        appropriate, with regard to post harvest processing measures.

    (b) Limitation.--Subsection (a) shall not apply to the guidance 
described in section 103(h).

[[Page 124 STAT. 3922]]

    (c) Review and Evaluation.--Not later than 30 days after the 
Secretary issues a proposed regulation or guidance described in 
subsection (a), the Comptroller General of the United States shall--
            (1) review and evaluate the report described in (a) and 
        report to Congress on the findings of the estimates and analysis 
        in the report;
            (2) compare such proposed regulation or guidance to similar 
        regulations or guidance with respect to other regulated foods, 
        including a comparison of risks the Secretary may find 
        associated with seafood and the instances of those risks in such 
        other regulated foods; and
            (3) evaluate the impact of post harvest processing on the 
        competitiveness of the domestic oyster industry in the United 
        States and in international markets.

    (d) Waiver.--The requirement of preparing a report under subsection 
(a) shall be waived if the Secretary issues a guidance that is adopted 
as a consensus agreement between Federal and State regulators and the 
oyster industry, acting through the Interstate Shellfish Sanitation 
Conference.
    (e) Public Access.--Any report prepared under this section shall be 
made available to the public.
SEC. 115. <<NOTE: 21 USC 381 note.>>  PORT SHOPPING.

     <<NOTE: Notification.>> 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. <<NOTE: 21 USC 2206.>>  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. <<NOTE: Applicability.>> --Subsection (a) shall not apply to a 
facility engaged in the receipt and distribution of any non-alcohol 
food, except that such paragraph shall apply to a facility described in 
such paragraph

[[Page 124 STAT. 3923]]

that receives and distributes non-alcohol food, provided such food is 
received and distributed--
            (1) in a prepackaged form that prevents any direct human 
        contact with such food; and
            (2) in amounts that constitute not more than 5 percent of 
        the overall sales of such facility, as determined by the 
        Secretary of the Treasury.

    (c) Rule of Construction.--Except as provided in subsections (a) and 
(b), this section shall not be construed to exempt any food, other than 
alcoholic beverages, as defined in section 214 of the Federal Alcohol 
Administration Act (27 U.S.C. 214), from the requirements of this Act 
(including the amendments made by this Act).

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

SEC. 201. TARGETING OF INSPECTION RESOURCES FOR DOMESTIC 
                        FACILITIES, FOREIGN FACILITIES, AND PORTS 
                        OF ENTRY; ANNUAL REPORT.

    (a) Targeting of Inspection Resources for Domestic Facilities, 
Foreign Facilities, and Ports of Entry.--Chapter IV (21 U.S.C. 341 et 
seq.), as amended by section 106, is amended by adding at the end the 
following:
``SEC. 421. <<NOTE: 21 USC 350j.>>  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. <<NOTE: Effective date.>> --
                Beginning on the date of enactment of the FDA Food 
                Safety Modernization Act, the Secretary shall increase 
                the frequency of inspection of all facilities.

[[Page 124 STAT. 3924]]

                    ``(B) Domestic high-risk 
                facilities. <<NOTE: Deadlines.>> --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. <<NOTE: Deadlines.>> --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) <<NOTE: Time period.>>  Foreign facilities.--
                          ``(i) Year 1.--In the 1-year period following 
                      the date of enactment of the FDA Food Safety 
                      Modernization Act, the Secretary shall inspect not 
                      fewer than 600 foreign facilities.
                          ``(ii) Subsequent years.--In each of the 5 
                      years following the 1-year period described in 
                      clause (i), the Secretary shall inspect not fewer 
                      than twice the number of foreign facilities 
                      inspected by the Secretary during the previous 
                      year.
                    ``(E) Reliance on federal, state, or local 
                inspections.--In meeting the inspection requirements 
                under this subsection for domestic facilities, the 
                Secretary may rely on inspections conducted by other 
                Federal, State, or local agencies under interagency 
                agreement, contract, memoranda of understanding, or 
                other obligation.

    ``(b) Identification and Inspection at Ports of Entry.--The 
Secretary, in consultation with the Secretary of Homeland Security, 
shall allocate resources to inspect any article of food imported into 
the United States according to the known safety risks of the article of 
food, which shall be based on the following factors:
            ``(1) The known safety risks of the food imported.
            ``(2) The known safety risks of the countries or regions of 
        origin and countries through which such article of food is 
        transported.
            ``(3) The compliance history of the importer, including with 
        regard to food recalls, outbreaks of foodborne illness, and 
        violations of food safety standards.
            ``(4) The rigor and effectiveness of the activities 
        conducted by the importer of such article of food to satisfy the 
        requirements of the foreign supplier verification program under 
        section 805.
            ``(5) Whether the food importer participates in the 
        voluntary qualified importer program under section 806.
            ``(6) Whether the food meets the criteria for priority under 
        section 801(h)(1).

[[Page 124 STAT. 3925]]

            ``(7) Whether the food or the facility that manufactured, 
        processed, packed, or held such food received a certification as 
        described in section 801(q) or 806.
            ``(8) Any other criteria deemed necessary and appropriate by 
        the Secretary for purposes of allocating inspection resources.

    ``(c) Interagency Agreements With Respect to Seafood.--
            ``(1) In general.--The Secretary of Health and Human 
        Services, the Secretary of Commerce, the Secretary of Homeland 
        Security, the Chairman of the Federal Trade Commission, and the 
        heads of other appropriate agencies may enter into such 
        agreements as may be necessary or appropriate to improve seafood 
        safety.
            ``(2) Scope of agreements.--The agreements under paragraph 
        (1) may include--
                    ``(A) cooperative arrangements for examining and 
                testing seafood imports that leverage the resources, 
                capabilities, and authorities of each party to the 
                agreement;
                    ``(B) coordination of inspections of foreign 
                facilities to increase the percentage of imported 
                seafood and seafood facilities inspected;
                    ``(C) standardization of data on seafood names, 
                inspection records, and laboratory testing to improve 
                interagency coordination;
                    ``(D) coordination to detect and investigate 
                violations under applicable Federal law;
                    ``(E) a process, including the use or modification 
                of existing processes, by which officers and employees 
                of the National Oceanic and Atmospheric Administration 
                may be duly designated by the Secretary to carry out 
                seafood examinations and investigations under section 
                801 of this Act or section 203 of the Food Allergen 
                Labeling and Consumer Protection Act of 2004;
                    ``(F) the sharing of information concerning observed 
                non-compliance with United States food requirements 
                domestically and in foreign nations and new regulatory 
                decisions and policies that may affect the safety of 
                food imported into the United States;
                    ``(G) conducting joint training on subjects that 
                affect and strengthen seafood inspection effectiveness 
                by Federal authorities; and
                    ``(H) outreach on Federal efforts to enhance seafood 
                safety and compliance with Federal food safety 
                requirements.

    ``(d) Coordination.--The Secretary shall improve coordination and 
cooperation with the Secretary of Agriculture and the Secretary of 
Homeland Security to target food inspection resources.
    ``(e) Facility. <<NOTE: Definition.>> --For purposes of this 
section, the term `facility' means a domestic facility or a foreign 
facility that is required to register under section 415.''.

    (b) Annual Report.--Section 1003 (21 U.S.C. 393) is amended by 
adding at the end the following:
    ``(h) Annual Report Regarding Food.--Not later than February 1 of 
each year, the Secretary shall submit to Congress a report, including 
efforts to coordinate and cooperate with other Federal agencies with 
responsibilities for food inspections, regarding--
            ``(1) information about food facilities including--

[[Page 124 STAT. 3926]]

                    ``(A) the appropriations used to inspect facilities 
                registered pursuant to section 415 in the previous 
                fiscal year;
                    ``(B) the average cost of both a non-high-risk food 
                facility inspection and a high-risk food facility 
                inspection, if such a difference exists, in the previous 
                fiscal year;
                    ``(C) the number of domestic facilities and the 
                number of foreign facilities registered pursuant to 
                section 415 that the Secretary inspected in the previous 
                fiscal year;
                    ``(D) the number of domestic facilities and the 
                number of foreign facilities registered pursuant to 
                section 415 that were scheduled for inspection in the 
                previous fiscal year and which the Secretary did not 
                inspect in such year;
                    ``(E) the number of high-risk facilities identified 
                pursuant to section 421 that the Secretary inspected in 
                the previous fiscal year; and
                    ``(F) the number of high-risk facilities identified 
                pursuant to section 421 that were scheduled for 
                inspection in the previous fiscal year and which the 
                Secretary did not inspect in such year.
            ``(2) information about food imports including--
                    ``(A) the number of lines of food imported into the 
                United States that the Secretary physically inspected or 
                sampled in the previous fiscal year;
                    ``(B) the number of lines of food imported into the 
                United States that the Secretary did not physically 
                inspect or sample in the previous fiscal year; and
                    ``(C) the average cost of physically inspecting or 
                sampling a line of food subject to this Act that is 
                imported or offered for import into the United States; 
                and
            ``(3) information on the foreign offices of the Food and 
        Drug Administration including--
                    ``(A) the number of foreign offices established; and
                    ``(B) the number of personnel permanently stationed 
                in each foreign office.

    ``(i) Public Availability of Annual Food Reports. <<NOTE: Web 
posting.>> --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) <<NOTE: 21 USC 350j note.>>  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. <<NOTE: 21 USC 350k.>>  LABORATORY ACCREDITATION FOR 
                        ANALYSES OF FOODS.

    ``(a) Recognition of Laboratory Accreditation.--
            ``(1) In general. <<NOTE: Deadline.>> --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) <<NOTE: Establishment.>>  establish a publicly 
                available registry of accreditation bodies recognized by 
                the Secretary and laboratories

[[Page 124 STAT. 3927]]

                accredited by a recognized accreditation body, including 
                the name of, contact information for, and other 
                information deemed appropriate by the Secretary about 
                such bodies and laboratories; and
                    ``(C) require, as a condition of recognition or 
                accreditation, as appropriate, that recognized 
                accreditation bodies and accredited laboratories report 
                to the Secretary any changes that would affect the 
                recognition of such accreditation body or the 
                accreditation of such laboratory.
            ``(2) Program requirements.--The program established under 
        paragraph (1)(A) shall provide for the recognition of laboratory 
        accreditation bodies that meet criteria established by the 
        Secretary for accreditation of laboratories, including 
        independent private laboratories and laboratories run and 
        operated by a Federal agency (including the Department of 
        Commerce), State, or locality with a demonstrated capability to 
        conduct 1 or more sampling and analytical testing methodologies 
        for food.
            ``(3) Increasing the number of qualified laboratories.--The 
        Secretary shall work with the laboratory accreditation bodies 
        recognized under paragraph (1), as appropriate, to increase the 
        number of qualified laboratories that are eligible to perform 
        testing under subparagraph (b) beyond the number so qualified on 
        the date of enactment of the FDA Food Safety Modernization Act.
            ``(4) Limited distribution.--In the interest of national 
        security, the Secretary, in coordination with the Secretary of 
        Homeland Security, may determine the time, manner, and form in 
        which the registry established under paragraph (1)(B) is made 
        publicly available.
            ``(5) Foreign laboratories.--Accreditation bodies recognized 
        by the Secretary under paragraph (1) may accredit laboratories 
        that operate outside the United States, so long as such 
        laboratories meet the accreditation standards applicable to 
        domestic laboratories accredited under this section.
            ``(6) Model laboratory standards.--The Secretary shall 
        develop model standards that a laboratory shall meet to be 
        accredited by a recognized accreditation body for a specified 
        sampling or analytical testing methodology and included in the 
        registry provided for under paragraph (1). In developing the 
        model standards, the Secretary shall consult existing standards 
        for guidance. The model standards shall include--
                    ``(A) methods to ensure that--
                          ``(i) appropriate sampling, analytical 
                      procedures (including rapid analytical 
                      procedures), and commercially available techniques 
                      are followed and reports of analyses are certified 
                      as true and accurate;
                          ``(ii) internal quality systems are 
                      established and maintained;
                          ``(iii) procedures exist to evaluate and 
                      respond promptly to complaints regarding analyses 
                      and other activities for which the laboratory is 
                      accredited; and
                          ``(iv) individuals who conduct the sampling 
                      and analyses are qualified by training and 
                      experience to do so; and
                    ``(B) any other criteria determined appropriate by 
                the Secretary.

[[Page 124 STAT. 3928]]

            ``(7) Review of recognition.--To ensure compliance with the 
        requirements of this section, the Secretary--
                    ``(A) shall periodically, and in no case less than 
                once every 5 years, reevaluate accreditation bodies 
                recognized under paragraph (1) and may accompany 
                auditors from an accreditation body to assess whether 
                the accreditation body meets the criteria for 
                recognition; and
                    ``(B) shall promptly revoke the recognition of any 
                accreditation body found not to be in compliance with 
                the requirements of this section, specifying, as 
                appropriate, any terms and conditions necessary for 
                laboratories accredited by such body to continue to 
                perform testing as described in this section.

    ``(b) Testing Procedures.--
            ``(1) In general.--Not later than 30 months after the date 
        of enactment of the FDA Food Safety Modernization Act, food 
        testing shall be conducted by Federal laboratories or non-
        Federal laboratories that have been accredited for the 
        appropriate sampling or analytical testing methodology or 
        methodologies by a recognized accreditation body on the registry 
        established by the Secretary under subsection (a)(1)(B) whenever 
        such testing is conducted--
                    ``(A) by or on behalf of an owner or consignee--
                          ``(i) in response to a specific testing 
                      requirement under this Act or implementing 
                      regulations, when applied to address an identified 
                      or suspected food safety problem; and
                          ``(ii) as required by the Secretary, as the 
                      Secretary deems appropriate, to address an 
                      identified or suspected food safety problem; or
                    ``(B) on behalf of an owner or consignee--
                          ``(i) in support of admission of an article of 
                      food under section 801(a); and
                          ``(ii) under an Import Alert that requires 
                      successful consecutive tests.
            ``(2) Results of testing.--The results of any such testing 
        shall be sent directly to the Food and Drug Administration, 
        except the Secretary may by regulation exempt test results from 
        such submission requirement if the Secretary determines that 
        such results do not contribute to the protection of public 
        health. Test results required to be submitted may be submitted 
        to the Food and Drug Administration through electronic means.
            ``(3) Exception. <<NOTE: Waiver authority.>> --The Secretary 
        may waive requirements under this subsection if--
                    ``(A) a new methodology or methodologies have been 
                developed and validated but a laboratory has not yet 
                been accredited to perform such methodology or 
                methodologies; and
                    ``(B) the use of such methodology or methodologies 
                are necessary to prevent, control, or mitigate a food 
                emergency or foodborne illness outbreak.

    ``(c) Review by Secretary.--If food sampling and testing performed 
by a laboratory run and operated by a State or locality that is 
accredited by a recognized accreditation body on the registry 
established by the Secretary under subsection (a) result in a State 
recalling a food, the Secretary shall review the sampling and testing

[[Page 124 STAT. 3929]]

results for the purpose of determining the need for a national recall or 
other compliance and enforcement activities.
    ``(d) No Limit on Secretarial Authority.--Nothing in this section 
shall be construed to limit the ability of the Secretary to review and 
act upon information from food testing, including determining the 
sufficiency of such information and testing.''.
    (b) Food Emergency Response Network. <<NOTE: Deadlines. Web 
posting. Reports. 21 USC 2221.>> --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. <<NOTE: 21 USC 2222.>>  INTEGRATED CONSORTIUM OF 
                        LABORATORY NETWORKS.

    (a) In General. <<NOTE: Contracts.>> --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. <<NOTE: Web posting.>> --The Secretary of 
Homeland Security shall, on a biennial basis, submit to the relevant 
committees of Congress, and make publicly available on the Internet Web 
site of the Department of Homeland Security, a report on the progress of 
the integrated consortium of laboratory networks, as established under 
subsection (a), in carrying out this section.

[[Page 124 STAT. 3930]]

SEC. 204. <<NOTE: 21 USC 2223.>>  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. <<NOTE: Recommenda- tions.>> --Not later than 18 
        months after the date of enactment of this Act, the Secretary 
        shall report to Congress on the findings of the pilot projects 
        under this subsection together with recommendations for 
        improving the tracking and tracing of food.

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

[[Page 124 STAT. 3931]]

                    (A) evaluate domestic and international product 
                tracing practices in commercial use;
                    (B) consider international efforts, including an 
                assessment of whether product tracing requirements 
                developed under this section are compatible with global 
                tracing systems, as appropriate; and
                    (C) <<NOTE: Consultation.>>  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. <<NOTE: Deadline. Publication. Notice.>> --
        In order to rapidly and effectively identify recipients of a 
        food to prevent or mitigate a foodborne illness outbreak and to 
        address credible threats of serious adverse health consequences 
        or death to humans or animals as a result of such food being 
        adulterated under section 402 of the Federal Food, Drug, and 
        Cosmetic Act or misbranded under section 403(w) of such Act, not 
        later than 2 years after the date of enactment of this Act, the 
        Secretary shall publish a notice of proposed rulemaking to 
        establish recordkeeping requirements, in addition to the 
        requirements under section 414 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 350c) and subpart J of part 1 of title 
        21, Code of Federal Regulations (or any successor regulations), 
        for facilities that manufacture, process, pack, or hold foods 
        that the Secretary designates under paragraph (2) as high-risk 
        foods. The Secretary shall set an appropriate effective date of 
        such additional requirements for foods designated as high risk 
        that takes into account the length of time necessary to comply 
        with such requirements. Such requirements shall--
                    (A) relate only to information that is reasonably 
                available and appropriate;
                    (B) be science-based;
                    (C) not prescribe specific technologies for the 
                maintenance of records;
                    (D) ensure that the public health benefits of 
                imposing additional recordkeeping requirements outweigh 
                the cost of compliance with such requirements;
                    (E) be scale-appropriate and practicable for 
                facilities of varying sizes and capabilities with 
                respect to costs and recordkeeping burdens, and not 
                require the creation and maintenance of duplicate 
                records where the information is contained in other 
                company records kept in the normal course of business;

[[Page 124 STAT. 3932]]

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

[[Page 124 STAT. 3933]]

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

[[Page 124 STAT. 3934]]

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

[[Page 124 STAT. 3935]]

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

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

[[Page 124 STAT. 3936]]

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

    (f) Farms.--
            (1) Request for information.--Notwithstanding subsection 
        (d), during an active investigation of a foodborne illness 
        outbreak, or if the Secretary determines it is necessary to 
        protect the public health and prevent or mitigate a foodborne 
        illness outbreak, the Secretary, in consultation and 
        coordination with State and local agencies responsible for food 
        safety, as appropriate, may request that the owner, operator, or 
        agent of a farm identify potential immediate recipients, other 
        than consumers, of an article of the food that is the subject of 
        such investigation if the Secretary reasonably believes such 
        article of food--
                    (A) is adulterated under section 402 of the Federal 
                Food, Drug, and Cosmetic Act;
                    (B) presents a threat of serious adverse health 
                consequences or death to humans or animals; and
                    (C) was adulterated as described in subparagraph (A) 
                on a particular farm (as defined in section 1.227 of 
                chapter 21, Code of Federal Regulations (or any 
                successor regulation)).
            (2) Manner of request. <<NOTE: Notice.>> --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. <<NOTE: Applicability.>>  
        Section 301(j) of the Federal Food, Drug, and Cosmetic Act and 
        the Freedom of Information Act shall apply with respect to any 
        confidential commercial information that is disclosed to the 
        Food and Drug Administration in the course of responding to a 
        request under paragraph (1).
            (5) Records.--Except with respect to identifying potential 
        immediate recipients in response to a request under this 
        subsection, nothing in this subsection shall require the 
        establishment or maintenance by farms of new records.

[[Page 124 STAT. 3937]]

    (g) No Limitation on Commingling of Food.--Nothing in this section 
shall be construed to authorize the Secretary to impose any limitation 
on the commingling of food.
    (h) Small Entity Compliance Guide. <<NOTE: Deadline.>> --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. <<NOTE: Applicability. Deadlines. Effective dates.>> --
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. <<NOTE: 21 USC 2224.>>  SURVEILLANCE.

    (a) Definition of Foodborne Illness Outbreak.--In this Act, the term 
``foodborne illness outbreak'' means the occurrence of 2 or more cases 
of a similar illness resulting from the ingestion of a certain food.
    (b) Foodborne Illness Surveillance Systems.--
            (1) In general.--The Secretary, acting through the Director 
        of the Centers for Disease Control and Prevention, shall enhance 
        foodborne illness surveillance systems to improve the 
        collection, analysis, reporting, and usefulness of data on 
        foodborne illnesses by--
                    (A) coordinating Federal, State and local foodborne 
                illness surveillance systems, including complaint 
                systems, and increasing participation in national 
                networks of public health and food regulatory agencies 
                and laboratories;
                    (B) facilitating sharing of surveillance information 
                on a more timely basis among governmental agencies, 
                including the Food and Drug Administration, the 
                Department of Agriculture, the Department of Homeland 
                Security, and State and local agencies, and with the 
                public;

[[Page 124 STAT. 3938]]

                    (C) developing improved epidemiological tools for 
                obtaining quality exposure data and microbiological 
                methods for classifying cases;
                    (D) augmenting such systems to improve attribution 
                of a foodborne illness outbreak to a specific food;
                    (E) expanding capacity of such systems, including 
                working toward automatic electronic searches, for 
                implementation of identification practices, including 
                fingerprinting strategies, for foodborne infectious 
                agents, in order to identify new or rarely documented 
                causes of foodborne illness and submit standardized 
                information to a centralized database;
                    (F) allowing timely public access to aggregated, de-
                identified surveillance data;
                    (G) at least annually, publishing current reports on 
                findings from such systems;
                    (H) establishing a flexible mechanism for rapidly 
                initiating scientific research by academic institutions;
                    (I) integrating foodborne illness surveillance 
                systems and data with other biosurveillance and public 
                health situational awareness capabilities at the 
                Federal, State, and local levels, including by sharing 
                foodborne illness surveillance data with the National 
                Biosurveillance Integration Center; and
                    (J) other activities as determined appropriate by 
                the Secretary.
            (2) Working group.--The Secretary shall support and maintain 
        a diverse working group of experts and stakeholders from 
        Federal, State, and local food safety and health agencies, the 
        food and food testing industries, consumer organizations, and 
        academia. <<NOTE: Deadline. Reports. Recommenda- tions.>>  Such 
        working group shall provide the Secretary, through at least 
        annual meetings of the working group and an annual public 
        report, advice and recommendations on an ongoing and regular 
        basis regarding the improvement of foodborne illness 
        surveillance and implementation of this section, including 
        advice and recommendations on--
                    (A) the priority needs of regulatory agencies, the 
                food industry, and consumers for information and 
                analysis on foodborne illness and its causes;
                    (B) opportunities to improve the effectiveness of 
                initiatives at the Federal, State, and local levels, 
                including coordination and integration of activities 
                among Federal agencies, and between the Federal, State, 
                and local levels of government;
                    (C) improvement in the timeliness and depth of 
                access by regulatory and health agencies, the food 
                industry, academic researchers, and consumers to 
                foodborne illness aggregated, de-identified surveillance 
                data collected by government agencies at all levels, 
                including data compiled by the Centers for Disease 
                Control and Prevention;
                    (D) key barriers at Federal, State, and local levels 
                to improving foodborne illness surveillance and the 
                utility of such surveillance for preventing foodborne 
                illness;
                    (E) the capabilities needed for establishing 
                automatic electronic searches of surveillance data; and
                    (F) specific actions to reduce barriers to 
                improvement, implement the working group's 
                recommendations, and

[[Page 124 STAT. 3939]]

                achieve the purposes of this section, with measurable 
                objectives and timelines, and identification of resource 
                and staffing needs.
            (3) Authorization of appropriations.--To carry out the 
        activities described in paragraph (1), there is authorized to be 
        appropriated $24,000,000 for each fiscal years 2011 through 
        2015.

    (c) Improving Food Safety and Defense Capacity at the State and 
Local Level.--
            (1) In general. <<NOTE: Strategies.>> --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. <<NOTE: Deadline.>> --In developing of the 
        strategies required by paragraph (1), the Secretary shall, not 
        later than 1 year after the date of enactment of the FDA Food 
        Safety Modernization Act, complete a review of State and local 
        capacities, and needs for enhancement, which may include a 
        survey with respect to--
                    (A) staffing levels and expertise available to 
                perform food safety and defense functions;
                    (B) laboratory capacity to support surveillance, 
                outbreak response, inspection, and enforcement 
                activities;
                    (C) information systems to support data management 
                and sharing of food safety and defense information among 
                State and local agencies and with counterparts at the 
                Federal level; and
                    (D) other State and local activities and needs as 
                determined appropriate by the Secretary.

    (d) Food Safety Capacity Building Grants.--Section 317R(b) of the 
Public Health Service Act (42 U.S.C. 247b-20(b)) is amended--
            (1) by striking ``2002'' and inserting ``2010''; and
            (2) by striking ``2003 through 2006'' and inserting ``2011 
        through 2015''.
SEC. 206. MANDATORY RECALL AUTHORITY.

    (a) In General.--Chapter IV (21 U.S.C. 341 et seq.), as amended by 
section 202, is amended by adding at the end the following:

[[Page 124 STAT. 3940]]

``SEC. 423. <<NOTE: 21 USC 350l.>>  MANDATORY RECALL AUTHORITY.

    ``(a) Voluntary Procedures. <<NOTE: Determination.>> --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. <<NOTE: Deadline.>> --The Secretary shall 
provide the responsible party subject to an order under subsection (b) 
with an opportunity for an informal hearing, to be held as soon as 
possible, but not later than 2 days after the issuance of the order,

[[Page 124 STAT. 3941]]

on the actions required by the order and on why the article that is the 
subject of the order should not be recalled.

    ``(d) Post-hearing Recall Order and Modification of Order.--
            ``(1) Amendment of order.--If, after providing opportunity 
        for an informal hearing under subsection (c), the Secretary 
        determines that removal of the article from commerce is 
        necessary, the Secretary shall, as appropriate--
                    ``(A) amend the order to require recall of such 
                article or other appropriate action;
                    ``(B) specify a timetable in which the recall shall 
                occur;
                    ``(C) require periodic reports to the Secretary 
                describing the progress of the recall; and
                    ``(D) provide notice to consumers to whom such 
                article was, or may have been, distributed.
            ``(2) Vacating of order.--If, after such hearing, the 
        Secretary determines that adequate grounds do not exist to 
        continue the actions required by the order, or that such actions 
        should be modified, the Secretary shall vacate the order or 
        modify the order.

    ``(e) Rule Regarding Alcoholic Beverages.--The Secretary shall not 
initiate a mandatory recall or take any other action under this section 
with respect to any alcohol beverage until the Secretary has provided 
the Alcohol and Tobacco Tax and Trade Bureau with a reasonable 
opportunity to cease distribution and recall such article under the 
Alcohol and Tobacco Tax and Trade Bureau authority.
    ``(f) Cooperation and Consultation.--The Secretary shall work with 
State and local public health officials in carrying out this section, as 
appropriate.
    ``(g) Public Notification.--In conducting a recall under this 
section, the Secretary shall--
            ``(1) <<NOTE: Publication. Notices.>> 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) <<NOTE: Web posting.>>  if available, publish on the 
        Internet Web site of the Food and Drug Administration an image 
        of the article that is the subject of the press release 
        described in (1).

    ``(h) No Delegation.--The authority conferred by this section to 
order a recall or vacate a recall order shall not be delegated to any 
officer or employee other than the Commissioner.

[[Page 124 STAT. 3942]]

    ``(i) Effect.--Nothing in this section shall affect the authority of 
the Secretary to request or participate in a voluntary recall, or to 
issue an order to cease distribution or to recall under any other 
provision of this Act or under the Public Health Service Act.
    ``(j) Coordinated Communication.--
            ``(1) In general.--To assist in carrying out the 
        requirements of this subsection, the Secretary shall establish 
        an incident command operation or a similar operation within the 
        Department of Health and Human Services that will operate not 
        later than 24 hours after the initiation of a mandatory recall 
        or the recall of an article of food for which the use of, or 
        exposure to, such article will cause serious adverse health 
        consequences or death to humans or animals.
            ``(2) Requirements.--To reduce the potential for 
        miscommunication during recalls or regarding investigations of a 
        food borne illness outbreak associated with a food that is 
        subject to a recall, each incident command operation or similar 
        operation under paragraph (1) shall use regular staff and 
        resources of the Department of Health and Human Services to--
                    ``(A) ensure timely and coordinated communication 
                within the Department, including enhanced communication 
                and coordination between different agencies and 
                organizations within the Department;
                    ``(B) ensure timely and coordinated communication 
                from the Department, including public statements, 
                throughout the duration of the investigation and related 
                foodborne illness outbreak;
                    ``(C) identify a single point of contact within the 
                Department for public inquiries regarding any actions by 
                the Secretary related to a recall;
                    ``(D) coordinate with Federal, State, local, and 
                tribal authorities, as appropriate, that have 
                responsibilities related to the recall of a food or a 
                foodborne illness outbreak associated with a food that 
                is subject to the recall, including notification of the 
                Secretary of Agriculture and the Secretary of Education 
                in the event such recalled food is a commodity intended 
                for use in a child nutrition program (as identified in 
                section 25(b) of the Richard B. Russell National School 
                Lunch Act (42 U.S.C. 1769f(b))); and
                    ``(E) conclude operations at such time as the 
                Secretary determines appropriate.
            ``(3) Multiple recalls.--The Secretary may establish 
        multiple or concurrent incident command operations or similar 
        operations in the event of multiple recalls or foodborne illness 
        outbreaks necessitating such action by the Department of Health 
        and Human Services.''.

    (b) Search Engine. <<NOTE: Deadline. Web posting. 21 USC 350l 
note.>> --Not later than 90 days after the date of enactment of this 
Act, the Secretary shall modify the Internet Web site of the Food and 
Drug Administration to include a search engine that--
            (1) is consumer-friendly, as determined by the Secretary; 
        and
            (2) provides a means by which an individual may locate 
        relevant information regarding each article of food subject to a 
        recall under section 423 of the Federal Food, Drug, and

[[Page 124 STAT. 3943]]

        Cosmetic Act and the status of such recall (such as whether a 
        recall is ongoing or has been completed).

    (c) Civil Penalty.--Section 303(f)(2)(A) (21 U.S.C. 333(f)(2)(A)) is 
amended by inserting ``or any person who does not comply with a recall 
order under section 423'' after ``section 402(a)(2)(B)''.
    (d) Prohibited Acts.--Section 301 (21 U.S.C. 331 et seq.), as 
amended by section 106, is amended by adding at the end the following:
    ``(xx) The refusal or failure to follow an order under section 
423.''.
    (e) GAO Review.--
            (1) In general. <<NOTE: Deadline. Reports.>> --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. <<NOTE: Deadline. Study.>> --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. <<NOTE: Reports.>>  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) <<NOTE: 21 USC 350l-1.>>  Annual Report to Congress.--
            (1) In general.--Not later than 2 years after the date of 
        enactment of this Act and annually thereafter, the Secretary of 
        Health and Human Services (referred to in this subsection as the 
        ``Secretary'') shall submit a report to the Committee

[[Page 124 STAT. 3944]]

        on Health, Education, Labor, and Pensions of the Senate and the 
        Committee on Energy and Commerce of the House of Representatives 
        on the use of recall authority under section 423 of the Federal 
        Food, Drug, and Cosmetic Act (as added by subsection (a)) and 
        any public health advisories issued by the Secretary that advise 
        against the consumption of an article of food on the ground that 
        the article of food is adulterated and poses an imminent danger 
        to health.
            (2) Content.--The report under paragraph (1) shall include, 
        with respect to the report year--
                    (A) the identity of each article of food that was 
                the subject of a public health advisory described in 
                paragraph (1), an opportunity to cease distribution and 
                recall under subsection (a) of section 423 of the 
                Federal Food, Drug, and Cosmetic Act, or a mandatory 
                recall order under subsection (b) of such section;
                    (B) the number of responsible parties, as defined in 
                section 417 of the Federal Food, Drug, and Cosmetic Act, 
                formally given the opportunity to cease distribution of 
                an article of food and recall such article, as described 
                in section 423(a) of such Act;
                    (C) the number of responsible parties described in 
                subparagraph (B) who did not cease distribution of or 
                recall an article of food after given the opportunity to 
                cease distribution or recall under section 423(a) of the 
                Federal Food, Drug, and Cosmetic Act;
                    (D) the number of recall orders issued under section 
                423(b) of the Federal Food, Drug, and Cosmetic Act; and
                    (E) a description of any instances in which there 
                was no testing that confirmed adulteration of an article 
                of food that was the subject of a recall under section 
                423(b) of the Federal Food, Drug, and Cosmetic Act or a 
                public health advisory described in paragraph (1).
SEC. 207. ADMINISTRATIVE DETENTION OF FOOD.

    (a) In General.--Section 304(h)(1)(A) (21 U.S.C. 334(h)(1)(A)) is 
amended by--
            (1) striking ``credible evidence or information indicating'' 
        and inserting ``reason to believe''; and
            (2) striking ``presents a threat of serious adverse health 
        consequences or death to humans or animals'' and inserting ``is 
        adulterated or misbranded''.

    (b) Regulations.-- <<NOTE: Deadline. 21 USC 334 note.>> 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) <<NOTE: 21 USC 334 note.>>  Effective Date.--The amendment made 
by this section shall take effect 180 days after the date of enactment 
of this Act.
SEC. 208. <<NOTE: 21 USC 2225.>>  DECONTAMINATION AND DISPOSAL 
                        STANDARDS AND PLANS.

    (a) In General.--The Administrator of the Environmental Protection 
Agency (referred to in this section as the ``Administrator''), in 
coordination with the Secretary of Health and Human Services, Secretary 
of Homeland Security, and Secretary of Agriculture, shall provide 
support for, and technical assistance to, State, local, and tribal 
governments in preparing for, assessing, decontaminating, and recovering 
from an agriculture or food emergency.

[[Page 124 STAT. 3945]]

    (b) Development of Standards.--In carrying out subsection (a), the 
Administrator, in coordination with the Secretary of Health and Human 
Services, Secretary of Homeland Security, Secretary of Agriculture, and 
State, local, and tribal governments, shall develop and disseminate 
specific standards and protocols to undertake clean-up, clearance, and 
recovery activities following the decontamination and disposal of 
specific threat agents and foreign animal diseases.
    (c) Development of Model Plans.--In carrying out subsection (a), the 
Administrator, the Secretary of Health and Human Services, and the 
Secretary of Agriculture shall jointly develop and disseminate model 
plans for--
            (1) the decontamination of individuals, equipment, and 
        facilities following an intentional contamination of agriculture 
        or food; and
            (2) the disposal of large quantities of animals, plants, or 
        food products that have been infected or contaminated by 
        specific threat agents and foreign animal diseases.

    (d) Exercises. <<NOTE: Deadline.>> --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. <<NOTE: 21 USC 399c.>>  IMPROVING THE TRAINING OF 
                          STATE, LOCAL, TERRITORIAL, AND TRIBAL 
                          FOOD SAFETY OFFICIALS.

    ``(a) Training.--The Secretary shall set standards and administer 
training and education programs for the employees of State, local, 
territorial, and tribal food safety officials relating to the regulatory 
responsibilities and policies established by this Act, including 
programs for--
            ``(1) scientific training;
            ``(2) training to improve the skill of officers and 
        employees authorized to conduct inspections under sections 702 
        and 704;
            ``(3) training to achieve advanced product or process 
        specialization in such inspections;

[[Page 124 STAT. 3946]]

            ``(4) training that addresses best practices;
            ``(5) training in administrative process and procedure and 
        integrity issues;
            ``(6) training in appropriate sampling and laboratory 
        analysis methodology; and
            ``(7) training in building enforcement actions following 
        inspections, examinations, testing, and investigations.

    ``(b) Partnerships With State and Local Officials.--
            ``(1) In general.--The Secretary, pursuant to a contract or 
        memorandum of understanding between the Secretary and the head 
        of a State, local, territorial, or tribal department or agency, 
        is authorized and encouraged to conduct examinations, testing, 
        and investigations for the purposes of determining compliance 
        with the food safety provisions of this Act through the officers 
        and employees of such State, local, territorial, or tribal 
        department or agency.
            ``(2) Content.--A contract or memorandum described under 
        paragraph (1) shall include provisions to ensure adequate 
        training of such officers and employees to conduct such 
        examinations, testing, and investigations. The contract or 
        memorandum shall contain provisions regarding reimbursement. 
        Such provisions may, at the sole discretion of the head of the 
        other department or agency, require reimbursement, in whole or 
        in part, from the Secretary for the examinations, testing, or 
        investigations performed pursuant to this section by the 
        officers or employees of the State, territorial, or tribal 
        department or agency.
            ``(3) Effect.--Nothing in this subsection shall be construed 
        to limit the authority of the Secretary under section 702.

    ``(c) Extension Service.--The Secretary shall ensure coordination 
with the extension activities of the National Institute of Food and 
Agriculture of the Department of Agriculture in advising producers and 
small processors transitioning into new practices required as a result 
of the enactment of the FDA Food Safety Modernization Act and assisting 
regulated industry with compliance with such Act.
    ``(d) National Food Safety Training, Education, Extension, Outreach 
and Technical Assistance Program.--
            ``(1) In general. <<NOTE: Deadline. Contracts. Grants.>> --
        In order to improve food safety and reduce the incidence of 
        foodborne illness, the Secretary shall, not later than 180 days 
        after the date of enactment of the FDA Food Safety Modernization 
        Act, enter into one or more memoranda of understanding, or enter 
        into other cooperative agreements, with the Secretary of 
        Agriculture to establish a competitive grant program within the 
        National Institute for Food and Agriculture to provide food 
        safety training, education, extension, outreach, and technical 
        assistance to--
                    ``(A) owners and operators of farms;
                    ``(B) small food processors; and
                    ``(C) small fruit and vegetable merchant 
                wholesalers.
            ``(2) Implementation.--The competitive grant program 
        established under paragraph (1) shall be carried out in 
        accordance with section 405 of the Agricultural Research, 
        Extension, and Education Reform Act of 1998.

    ``(e) Authorization of Appropriations.--There are authorized to be 
appropriated such sums as may be necessary to carry out this section for 
fiscal years 2011 through 2015.''.

[[Page 124 STAT. 3947]]

    (b) National Food Safety Training, Education, Extension, Outreach, 
and Technical Assistance Program.--Title IV of the Agricultural 
Research, Extension, and Education Reform Act of 1998 is amended by 
inserting after section 404 (7 U.S.C. 7624) the following:
``SEC. 405. <<NOTE: 7 USC 7625.>>  NATIONAL FOOD SAFETY TRAINING, 
                        EDUCATION, EXTENSION, OUTREACH, AND 
                        TECHNICAL ASSISTANCE PROGRAM.

    ``(a) In General. <<NOTE: Grants.>> --The Secretary shall award 
grants under this section to carry out the competitive grant program 
established under section 1011(d) of the Federal Food, Drug, and 
Cosmetic Act, pursuant to any memoranda of understanding entered into 
under such section.

    ``(b) Integrated Approach.--The grant program described under 
subsection (a) shall be carried out under this section in a manner that 
facilitates the integration of food safety standards and guidance with 
the variety of agricultural production systems, encompassing 
conventional, sustainable, organic, and conservation and environmental 
practices.
    ``(c) Priority.--In awarding grants under this section, the 
Secretary shall give priority to projects that target small and medium-
sized farms, beginning farmers, socially disadvantaged farmers, small 
processors, or small fresh fruit and vegetable merchant wholesalers.
    ``(d) Program Coordination.--
            ``(1) In general.--The Secretary shall coordinate 
        implementation of the grant program under this section with the 
        National Integrated Food Safety Initiative.
            ``(2) Interaction.--The Secretary shall--
                    ``(A) in carrying out the grant program under this 
                section, take into consideration applied research, 
                education, and extension results obtained from the 
                National Integrated Food Safety Initiative; and
                    ``(B) in determining the applied research agenda for 
                the National Integrated Food Safety Initiative, take 
                into consideration the needs articulated by participants 
                in projects funded by the program under this section.

    ``(e) Grants.--
            ``(1) In general.--In carrying out this section, the 
        Secretary shall make competitive grants to support training, 
        education, extension, outreach, and technical assistance 
        projects that will help improve public health by increasing the 
        understanding and adoption of established food safety standards, 
        guidance, and protocols.
            ``(2) Encouraged features.--The Secretary shall encourage 
        projects carried out using grant funds under this section to 
        include co-management of food safety, conservation systems, and 
        ecological health.
            ``(3) Maximum term and size of grant.--
                    ``(A) In general.--A grant under this section shall 
                have a term that is not more than 3 years.
                    ``(B) Limitation on grant funding.--The Secretary 
                may not provide grant funding to an entity under this 
                section after such entity has received 3 years of grant 
                funding under this section.

    ``(f) Grant Eligibility.--

[[Page 124 STAT. 3948]]

            ``(1) In general.--To be eligible for a grant under this 
        section, an entity shall be--
                    ``(A) a State cooperative extension service;
                    ``(B) a Federal, State, local, or tribal agency, a 
                nonprofit community-based or non-governmental 
                organization, or an organization representing owners and 
                operators of farms, small food processors, or small 
                fruit and vegetable merchant wholesalers that has a 
                commitment to public health and expertise in 
                administering programs that contribute to food safety;
                    ``(C) an institution of higher education (as defined 
                in section 101(a) of the Higher Education Act of 1965 
                (20 U.S.C. 1001(a))) or a foundation maintained by an 
                institution of higher education;
                    ``(D) a collaboration of 2 of more eligible entities 
                described in this subsection; or
                    ``(E) such other appropriate entity, as determined 
                by the Secretary.
            ``(2) Multistate partnerships.--Grants under this section 
        may be made for projects involving more than 1 State.

    ``(g) Regional Balance.--In making grants under this section, the 
Secretary shall, to the maximum extent practicable, ensure--
            ``(1) geographic diversity; and
            ``(2) diversity of types of agricultural production.

    ``(h) Technical Assistance.--The Secretary may use funds made 
available under this section to provide technical assistance to grant 
recipients to further the purposes of this section.
    ``(i) Best Practices and Model Programs.--Based on evaluations of, 
and responses arising from, projects funded under this section, the 
Secretary may issue a set of recommended best practices and models for 
food safety training programs for agricultural producers, small food 
processors, and small fresh fruit and vegetable merchant wholesalers.
    ``(j) Authorization of Appropriations.--For the purposes of making 
grants under this section, there are authorized to be appropriated such 
sums as may be necessary for fiscal years 2011 through 2015.''.
SEC. 210. ENHANCING FOOD SAFETY.

    (a) Grants To Enhance Food Safety.--Section 1009 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 399) is amended to read as 
follows:
``SEC. 1009. GRANTS TO ENHANCE FOOD SAFETY.

    ``(a) In General.--The Secretary is authorized to make grants to 
eligible entities to--
            ``(1) undertake examinations, inspections, and 
        investigations, and related food safety activities under section 
        702;
            ``(2) train to the standards of the Secretary for the 
        examination, inspection, and investigation of food 
        manufacturing, processing, packing, holding, distribution, and 
        importation, including as such examination, inspection, and 
        investigation relate to retail food establishments;
            ``(3) build the food safety capacity of the laboratories of 
        such eligible entity, including the detection of zoonotic 
        diseases;
            ``(4) build the infrastructure and capacity of the food 
        safety programs of such eligible entity to meet the standards as 
        outlined in the grant application; and

[[Page 124 STAT. 3949]]

            ``(5) take appropriate action to protect the public health 
        in response to--
                    ``(A) a notification under section 1008, including 
                planning and otherwise preparing to take such action; or
                    ``(B) a recall of food under this Act.

    ``(b) Eligible Entities; Application.--
            ``(1) In general. <<NOTE: Definition.>> --In this section, 
        the term `eligible entity' means an entity--
                    ``(A) that is--
                          ``(i) a State;
                          ``(ii) a locality;
                          ``(iii) a territory;
                          ``(iv) an Indian tribe (as defined in section 
                      4(e) of the Indian Self-Determination and 
                      Education Assistance Act); or
                          ``(v) a nonprofit food safety training entity 
                      that collaborates with 1 or more institutions of 
                      higher education; and
                    ``(B) that submits an application to the Secretary 
                at such time, in such manner, and including such 
                information as the Secretary may reasonably require.
            ``(2) Contents.--Each application submitted under paragraph 
        (1) shall include--
                    ``(A) an assurance that the eligible entity has 
                developed plans to engage in the types of activities 
                described in subsection (a);
                    ``(B) a description of the types of activities to be 
                funded by the grant;
                    ``(C) an itemization of how grant funds received 
                under this section will be expended;
                    ``(D) a description of how grant activities will be 
                monitored; and
                    ``(E) an agreement by the eligible entity to report 
                information required by the Secretary to conduct 
                evaluations under this section.

    ``(c) Limitations.--The funds provided under subsection (a) shall be 
available to an eligible entity that receives a grant under this section 
only to the extent such entity funds the food safety programs of such 
entity independently of any grant under this section in each year of the 
grant at a level equal to the level of such funding in the previous 
year, increased by the Consumer Price Index. Such non-Federal matching 
funds may be provided directly or through donations from public or 
private entities and may be in cash or in-kind, fairly evaluated, 
including plant, equipment, or services.
    ``(d) Additional Authority.--The Secretary may--
            ``(1) award a grant under this section in each subsequent 
        fiscal year without reapplication for a period of not more than 
        3 years, provided the requirements of subsection (c) are met for 
        the previous fiscal year; and
            ``(2) award a grant under this section in a fiscal year for 
        which the requirement of subsection (c) has not been met only if 
        such requirement was not met because such funding was diverted 
        for response to 1 or more natural disasters or in other 
        extenuating circumstances that the Secretary may determine 
        appropriate.

[[Page 124 STAT. 3950]]

    ``(e) Duration of Awards.--The Secretary may award grants to an 
individual grant recipient under this section for periods of not more 
than 3 years. In the event the Secretary conducts a program evaluation, 
funding in the second year or third year of the grant, where applicable, 
shall be contingent on a successful program evaluation by the Secretary 
after the first year.
    ``(f) Progress and Evaluation.--
            ``(1) In general.--The Secretary shall measure the status 
        and success of each grant program authorized under the FDA Food 
        Safety Modernization Act (and any amendment made by such Act), 
        including the grant program under this section. A recipient of a 
        grant described in the preceding sentence shall, at the end of 
        each grant year, provide the Secretary with information on how 
        grant funds were spent and the status of the efforts by such 
        recipient to enhance food safety. To the extent practicable, the 
        Secretary shall take the performance of such a grant recipient 
        into account when determining whether to continue funding for 
        such recipient.
            ``(2) No duplication.--In carrying out paragraph (1), the 
        Secretary shall not duplicate the efforts of the Secretary under 
        other provisions of this Act or the FDA Food Safety 
        Modernization Act that require measurement and review of the 
        activities of grant recipients under either such Act.

    ``(g) Supplement Not Supplant.--Grant funds received under this 
section shall be used to supplement, and not supplant, non-Federal funds 
and any other Federal funds available to carry out the activities 
described in this section.
    ``(h) Authorization of Appropriations.--For the purpose of making 
grants under this section, there are authorized to be appropriated such 
sums as may be necessary for fiscal years 2011 through 2015.''.
    (b) Centers of Excellence.--Part P of the Public Health Service Act 
(42 U.S.C. 280g et seq.) is amended by adding at the end the following:
``SEC. 399V-5. <<NOTE: 42 USC 280g-16.>>  FOOD SAFETY INTEGRATED 
                              CENTERS OF EXCELLENCE.

    ``(a) In General. <<NOTE: Deadline. Designation.>> --Not later than 
1 year after the date of enactment of the FDA Food Safety Modernization 
Act, the Secretary, acting through the Director of the Centers for 
Disease Control and Prevention and in consultation with the working 
group described in subsection (b)(2), shall designate 5 Integrated Food 
Safety Centers of Excellence (referred to in this section as the 
`Centers of Excellence') to serve as resources for Federal, State, and 
local public health professionals to respond to foodborne illness 
outbreaks. The Centers of Excellence shall be headquartered at selected 
State health departments.

    ``(b) Selection of Centers of Excellence.--
            ``(1) Eligible entities.--To be eligible to be designated as 
        a Center of Excellence under subsection (a), an entity shall--
                    ``(A) be a State health department;
                    ``(B) partner with 1 or more institutions of higher 
                education that have demonstrated knowledge, expertise, 
                and meaningful experience with regional or national food 
                production, processing, and distribution, as well as 
                leadership in the laboratory, epidemiological, and 
                environmental detection and investigation of foodborne 
                illness; and

[[Page 124 STAT. 3951]]

                    ``(C) provide to the Secretary such information, at 
                such time, and in such manner, as the Secretary may 
                require.
            ``(2) Working group. <<NOTE: Deadline.>> --Not later than 
        180 days after the date of enactment of the FDA Food Safety 
        Modernization Act, the Secretary shall establish a diverse 
        working group of experts and stakeholders from Federal, State, 
        and local food safety and health agencies, the food industry, 
        including food retailers and food manufacturers, consumer 
        organizations, and academia to make recommendations to the 
        Secretary regarding designations of the Centers of Excellence.
            ``(3) Additional centers of excellence.--The Secretary may 
        designate eligible entities to be regional Food Safety Centers 
        of Excellence, in addition to the 5 Centers designated under 
        subsection (a).

    ``(c) Activities.--Under the leadership of the Director of the 
Centers for Disease Control and Prevention, each Center of Excellence 
shall be based out of a selected State health department, which shall 
provide assistance to other regional, State, and local departments of 
health through activities that include--
            ``(1) providing resources, including timely information 
        concerning symptoms and tests, for frontline health 
        professionals interviewing individuals as part of routine 
        surveillance and outbreak investigations;
            ``(2) providing analysis of the timeliness and effectiveness 
        of foodborne disease surveillance and outbreak response 
        activities;
            ``(3) providing training for epidemiological and 
        environmental investigation of foodborne illness, including 
        suggestions for streamlining and standardizing the investigation 
        process;
            ``(4) establishing fellowships, stipends, and scholarships 
        to train future epidemiological and food-safety leaders and to 
        address critical workforce shortages;
            ``(5) training and coordinating State and local personnel;
            ``(6) strengthening capacity to participate in existing or 
        new foodborne illness surveillance and environmental assessment 
        information systems; and
            ``(7) conducting research and outreach activities focused on 
        increasing prevention, communication, and education regarding 
        food safety.

    ``(d) Report to Congress.--Not later than 2 years after the date of 
enactment of the FDA Food Safety Modernization Act, the Secretary shall 
submit to Congress a report that--
            ``(1) describes the effectiveness of the Centers of 
        Excellence; and
            ``(2) provides legislative recommendations or describes 
        additional resources required by the Centers of Excellence.

    ``(e) Authorization of Appropriations.--There is authorized to be 
appropriated such sums as may be necessary to carry out this section.
    ``(f) No Duplication of Effort.--In carrying out activities of the 
Centers of Excellence or other programs under this section, the 
Secretary shall not duplicate other Federal foodborne illness response 
efforts.''.
SEC. 211. IMPROVING THE REPORTABLE FOOD REGISTRY.

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

[[Page 124 STAT. 3952]]

            (1) by redesignating subsections (f) through (k) as 
        subsections (i) through (n), respectively; and
            (2) by inserting after subsection (e) the following:

    ``(f) Critical Information. <<NOTE: Deadline.>> --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) <<NOTE: Publication. Web 
                posting. Notification.>>  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) <<NOTE: Deadlines.>>  Consumer Notification.--
            ``(1) In general. <<NOTE: Time period.>> --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. <<NOTE: Publication.>> --Not more than 1 year after 
        the date of enactment of the FDA Food Safety Modernization Act, 
        the Secretary shall develop and publish a list of acceptable 
        conspicuous locations and manners, from which grocery stores 
        shall select at least one, for providing the notification 
        required in paragraph (1). Such list shall include--
                    ``(A) posting the notification at or near the 
                register;
                    ``(B) providing the location of the reportable food;
                    ``(C) providing targeted recall information given to 
                customers upon purchase of a food; and
                    ``(D) other such prominent and conspicuous locations 
                and manners utilized by grocery stores as of the date of 
                the enactment of the FDA Food Safety Modernization Act 
                to provide notice of such recalls to consumers as 
                considered appropriate by the Secretary.''.

[[Page 124 STAT. 3953]]

    (b) Prohibited Act.--Section 301 (21 U.S.C. 331), as amended by 
section 206, is amended by adding at the end the following:
    ``(yy) The knowing and willful failure to comply with the 
notification requirement under section 417(h).''.
    (c) Conforming Amendment.--Section 301(e) (21 U.S.C. 331(e)) is 
amended by striking ``417(g)'' and inserting ``417(j)''.

            TITLE III--IMPROVING THE SAFETY OF IMPORTED FOOD

SEC. 301. FOREIGN SUPPLIER VERIFICATION PROGRAM.

    (a) In General.--Chapter VIII (21 U.S.C. 381 et seq.) is amended by 
adding at the end the following:
``SEC. 805. <<NOTE: 21 USC 384a.>>  FOREIGN SUPPLIER VERIFICATION 
                        PROGRAM.

    ``(a) In General.--
            ``(1) Verification requirement.--Except as provided under 
        subsections (e) and (f), each importer shall perform risk-based 
        foreign supplier verification activities for the purpose of 
        verifying that the food imported by the importer or agent of an 
        importer is--
                    ``(A) produced in compliance with the requirements 
                of section 418 or section 419, as appropriate; and
                    ``(B) is not adulterated under section 402 or 
                misbranded under section 403(w).
            ``(2) Importer defined.--For purposes of this section, the 
        term `importer' means, with respect to an article of food--
                    ``(A) the United States owner or consignee of the 
                article of food at the time of entry of such article 
                into the United States; or
                    ``(B) in the case when there is no United States 
                owner or consignee as described in subparagraph (A), the 
                United States agent or representative of a foreign owner 
                or consignee of the article of food at the time of entry 
                of such article into the United States.

    ``(b) Guidance.--Not later than 1 year after the date of enactment 
of the FDA Food Safety Modernization Act, the Secretary shall issue 
guidance to assist importers in developing foreign supplier verification 
programs.
    ``(c) Regulations.--
            ``(1) In general.--Not later than 1 year after the date of 
        enactment of the FDA Food Safety Modernization Act, the 
        Secretary shall promulgate regulations to provide for the 
        content of the foreign supplier verification program established 
        under subsection (a).
            ``(2) Requirements.--The regulations promulgated under 
        paragraph (1)--
                    ``(A) shall require that the foreign supplier 
                verification program of each importer be adequate to 
                provide assurances that each foreign supplier to the 
                importer produces the imported food in compliance with--
                          ``(i) processes and procedures, including 
                      reasonably appropriate risk-based preventive 
                      controls, that provide the same level of public 
                      health protection as those required under section 
                      418 or section 419 (taking into

[[Page 124 STAT. 3954]]

                      consideration variances granted under section 
                      419), as appropriate; and
                          ``(ii) section 402 and section 403(w).
                    ``(B) shall include such other requirements as the 
                Secretary deems necessary and appropriate to verify that 
                food imported into the United States is as safe as food 
                produced and sold within the United States.
            ``(3) Considerations.--In promulgating regulations under 
        this subsection, the Secretary shall, as appropriate, take into 
        account differences among importers and types of imported foods, 
        including based on the level of risk posed by the imported food.
            ``(4) Activities.--Verification activities under a foreign 
        supplier verification program under this section may include 
        monitoring records for shipments, lot-by-lot certification of 
        compliance, annual on-site inspections, checking the hazard 
        analysis and risk-based preventive control plan of the foreign 
        supplier, and periodically testing and sampling shipments.

    ``(d) Record Maintenance and Access. <<NOTE: Time period.>> --
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).

<<NOTE: Applicability.>> 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. <<NOTE: Notice. Federal Register, 
publication.>> --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. <<NOTE: Web posting.>> --
The Secretary shall publish and maintain on the Internet Web site of the 
Food and Drug Administration a current list that includes the name of, 
location of, and other information deemed necessary by the Secretary 
about, importers participating under this section.''.

    (b) Prohibited Act.--Section 301 (21 U.S.C. 331), as amended by 
section 211, is amended by adding at the end the following:
    ``(zz) The importation or offering for importation of a food if the 
importer (as defined in section 805) does not have in place

[[Page 124 STAT. 3955]]

a foreign supplier verification program in compliance with such section 
805.''.
    (c) Imports.--Section 801(a) (21 U.S.C. 381(a)) is amended by adding 
``or the importer (as defined in section 805) is in violation of such 
section 805'' after ``or in violation of section 505''.
    (d) <<NOTE: 21 USC 331 note.>>  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. <<NOTE: 21 USC 384b.>>  VOLUNTARY QUALIFIED IMPORTER 
                        PROGRAM.

    ``(a) In General. <<NOTE: Deadline.>> --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) <<NOTE: Guidelines.>>  issue a guidance document 
        related to participation in, revocation of such participation 
        in, reinstatement in, and compliance with, such program.

    ``(b) Voluntary Participation.--An importer may request the 
Secretary to provide for the expedited review and importation of 
designated foods in accordance with the program established by the 
Secretary under subsection (a).
    ``(c) Notice of Intent To Participate.--An importer that intends to 
participate in the program under this section in a fiscal year shall 
submit a notice and application to the Secretary of such intent at the 
time and in a manner established by the Secretary.
    ``(d) Eligibility.--Eligibility shall be limited to an importer 
offering food for importation from a facility that has a certification 
described in subsection (a). In reviewing the applications and making 
determinations on such applications, the Secretary shall consider the 
risk of the food to be imported based on factors, such as the following:
            ``(1) The known safety risks of the food to be imported.
            ``(2) The compliance history of foreign suppliers used by 
        the importer, as appropriate.
            ``(3) The capability of the regulatory system of the country 
        of export to ensure compliance with United States food safety 
        standards for a designated food.
            ``(4) The compliance of the importer with the requirements 
        of section 805.
            ``(5) The recordkeeping, testing, inspections and audits of 
        facilities, traceability of articles of food, temperature 
        controls, and sourcing practices of the importer.
            ``(6) The potential risk for intentional adulteration of the 
        food.
            ``(7) Any other factor that the Secretary determines 
        appropriate.

[[Page 124 STAT. 3956]]

    ``(e) Review and Revocation. <<NOTE: Deadline.>> --Any importer 
qualified by the Secretary in accordance with the eligibility criteria 
set forth in this section shall be reevaluated not less often than once 
every 3 years and the Secretary shall promptly revoke the qualified 
importer status of any importer found not to be in compliance with such 
criteria.

    ``(f) False Statements.--Any statement or representation made by an 
importer to the Secretary shall be subject to section 1001 of title 18, 
United States Code.
    ``(g) Definition.--For purposes of this section, the term `importer' 
means the person that brings food, or causes food to be brought, from a 
foreign country into the customs territory of the United States.''.
SEC. 303. AUTHORITY TO REQUIRE IMPORT CERTIFICATIONS FOR FOOD.

    (a) In General.--Section 801(a) (21 U.S.C. 381(a)) is amended by 
inserting after the third sentence the following: ``With respect to an 
article of food, if importation of such food is subject to, but not 
compliant with, the requirement under subsection (q) that such food be 
accompanied by a certification or other assurance that the food meets 
applicable requirements of this Act, then such article shall be refused 
admission.''.
    (b) Addition of Certification Requirement.--Section 801 (21 U.S.C. 
381) is amended by adding at the end the following new subsection:
    ``(q) Certifications Concerning Imported Foods.--
            ``(1) In general.--The Secretary may require, as a condition 
        of granting admission to an article of food imported or offered 
        for import into the United States, that an entity described in 
        paragraph (3) provide a certification, or such other assurances 
        as the Secretary determines appropriate, that the article of 
        food complies with applicable requirements of this Act. Such 
        certification or assurances may be provided in the form of 
        shipment-specific certificates, a listing of certified 
        facilities that manufacture, process, pack, or hold such food, 
        or in such other form as the Secretary may specify.
            ``(2) Factors to be considered in requiring certification.--
        The Secretary shall base the determination that an article of 
        food is required to have a certification described in paragraph 
        (1) on the risk of the food, including--
                    ``(A) known safety risks associated with the food;
                    ``(B) known food safety risks associated with the 
                country, territory, or region of origin of the food;
                    ``(C) a finding by the Secretary, supported by 
                scientific, risk-based evidence, that--
                          ``(i) the food safety programs, systems, and 
                      standards in the country, territory, or region of 
                      origin of the food are inadequate to ensure that 
                      the article of food is as safe as a similar 
                      article of food that is manufactured, processed, 
                      packed, or held in the United States in accordance 
                      with the requirements of this Act; and
                          ``(ii) the certification would assist the 
                      Secretary in determining whether to refuse or 
                      admit the article of food under subsection (a); 
                      and

[[Page 124 STAT. 3957]]

                    ``(D) information submitted to the Secretary in 
                accordance with the process established in paragraph 
                (7).
            ``(3) Certifying entities.--For purposes of paragraph (1), 
        entities that shall provide the certification or assurances 
        described in such paragraph are--
                    ``(A) an agency or a representative of the 
                government of the country from which the article of food 
                at issue originated, as designated by the Secretary; or
                    ``(B) such other persons or entities accredited 
                pursuant to section 808 to provide such certification or 
                assurance.
            ``(4) Renewal and refusal of certifications.--The Secretary 
        may--
                    ``(A) require that any certification or other 
                assurance provided by an entity specified in paragraph 
                (2) be renewed by such entity at such times as the 
                Secretary determines appropriate; and
                    ``(B) refuse to accept any certification or 
                assurance if the Secretary determines that such 
                certification or assurance is not valid or reliable.
            ``(5) Electronic submission.--The Secretary shall provide 
        for the electronic submission of certifications under this 
        subsection.
            ``(6) False statements.--Any statement or representation 
        made by an entity described in paragraph (2) to the Secretary 
        shall be subject to section 1001 of title 18, United States 
        Code.
            ``(7) Assessment of food safety programs, systems, and 
        standards.--If the Secretary determines that the food safety 
        programs, systems, and standards in a foreign region, country, 
        or territory are inadequate to ensure that an article of food is 
        as safe as a similar article of food that is manufactured, 
        processed, packed, or held in the United States in accordance 
        with the requirements of this Act, the Secretary shall, to the 
        extent practicable, identify such inadequacies and establish a 
        process by which the foreign region, country, or territory may 
        inform the Secretary of improvements made to such food safety 
        program, system, or standard and demonstrate that those controls 
        are adequate to ensure that an article of food is as safe as a 
        similar article of food that is manufactured, processed, packed, 
        or held in the United States in accordance with the requirements 
        of this Act.''.

    (c) Conforming Technical Amendment.--Section 801(b) (21 U.S.C. 
381(b)) is amended in the second sentence by striking ``with respect to 
an article included within the provision of the fourth sentence of 
subsection (a)'' and inserting ``with respect to an article described in 
subsection (a) relating to the requirements of sections 760 or 761,''.
    (d) <<NOTE: 21 USC 381 note.>>  No Limit on Authority.--Nothing in 
the amendments made by this section shall limit the authority of the 
Secretary to conduct inspections of imported food or to take such other 
steps as the Secretary deems appropriate to determine the admissibility 
of imported food.
SEC. 304. PRIOR NOTICE OF IMPORTED FOOD SHIPMENTS.

    (a) In General.--Section 801(m)(1) (21 U.S.C. 381(m)(1)) is amended 
by inserting ``any country to which the article has been refused 
entry;'' after ``the country from which the article is shipped;''.

[[Page 124 STAT. 3958]]

    (b) Regulations. <<NOTE: Deadline. 21 USC 381 note.>> --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) <<NOTE: 21 USC 381 note.>>  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. <<NOTE: Plans.>> --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. <<NOTE: 21 USC 384c.>>  INSPECTION OF FOREIGN FOOD 
                        FACILITIES.

    ``(a) Inspection.--The Secretary--
            ``(1) may enter into arrangements and agreements with 
        foreign governments to facilitate the inspection of foreign 
        facilities registered under section 415; and
            ``(2) shall direct resources to inspections of foreign 
        facilities, suppliers, and food types, especially such 
        facilities, suppliers, and food types that present a high risk 
        (as identified by the Secretary), to help ensure the safety and 
        security of the food supply of the United States.

[[Page 124 STAT. 3959]]

    ``(b) Effect of Inability To Inspect.--Notwithstanding any other 
provision of law, food shall be refused admission into the United States 
if it is from a foreign factory, warehouse, or other establishment of 
which the owner, operator, or agent in charge, or the government of the 
foreign country, refuses to permit entry of United States inspectors or 
other individuals duly designated by the Secretary, upon request, to 
inspect such factory, warehouse, or other establishment. For purposes of 
this subsection, such an owner, operator, or agent in charge shall be 
considered to have refused an inspection if such owner, operator, or 
agent in charge does not permit an inspection of a factory, warehouse, 
or other establishment during the 24-hour period after such request is 
submitted, or after such other time period, as agreed upon by the 
Secretary and the foreign factory, warehouse, or other establishment.''.
    (b) <<NOTE: 21 USC 2241.>>  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) <<NOTE: Time period.>>  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. <<NOTE: 21 USC 384d.>>  ACCREDITATION OF THIRD-PARTY 
                        AUDITORS.

    ``(a) Definitions.--In this section:
            ``(1) Audit agent.--The term `audit agent' means an 
        individual who is an employee or agent of an accredited third-
        party auditor and, although not individually accredited, is 
        qualified to conduct food safety audits on behalf of an 
        accredited third-party auditor.
            ``(2) Accreditation body.--The term `accreditation body' 
        means an authority that performs accreditation of third-party 
        auditors.
            ``(3) Third-party auditor.--The term `third-party auditor' 
        means a foreign government, agency of a foreign government,

[[Page 124 STAT. 3960]]

        foreign cooperative, or any other third party, as the Secretary 
        determines appropriate in accordance with the model standards 
        described in subsection (b)(2), that is eligible to be 
        considered for accreditation to conduct food safety audits to 
        certify that eligible entities meet the applicable requirements 
        of this section. A third-party auditor may be a single 
        individual. A third-party auditor may employ or use audit agents 
        to help conduct consultative and regulatory audits.
            ``(4) Accredited third-party auditor.--The term `accredited 
        third-party auditor' means a third-party auditor accredited by 
        an accreditation body to conduct audits of eligible entities to 
        certify that such eligible entities meet the applicable 
        requirements of this section. An accredited third-party auditor 
        may be an individual who conducts food safety audits to certify 
        that eligible entities meet the applicable requirements of this 
        section.
            ``(5) Consultative audit.--The term `consultative audit' 
        means an audit of an eligible entity--
                    ``(A) to determine whether such entity is in 
                compliance with the provisions of this Act and with 
                applicable industry standards and practices; and
                    ``(B) the results of which are for internal purposes 
                only.
            ``(6) Eligible entity.--The term `eligible entity' means a 
        foreign entity, including a foreign facility registered under 
        section 415, in the food import supply chain that chooses to be 
        audited by an accredited third-party auditor or the audit agent 
        of such accredited third-party auditor.
            ``(7) Regulatory audit.--The term `regulatory audit' means 
        an audit of an eligible entity--
                    ``(A) to determine whether such entity is in 
                compliance with the provisions of this Act; and
                    ``(B) the results of which determine--
                          ``(i) whether an article of food manufactured, 
                      processed, packed, or held by such entity is 
                      eligible to receive a food certification under 
                      section 801(q); or
                          ``(ii) whether a facility is eligible to 
                      receive a facility certification under section 
                      806(a) for purposes of participating in the 
                      program under section 806.

    ``(b) Accreditation System.--
            ``(1) Accreditation bodies.--
                    ``(A) Recognition of accreditation bodies.--
                          ``(i) In general. <<NOTE: Deadline.>> --Not 
                      later than 2 years after the date of enactment of 
                      the FDA Food Safety Modernization Act, the 
                      Secretary shall establish a system for the 
                      recognition of accreditation bodies that accredit 
                      third-party auditors to certify that eligible 
                      entities meet the applicable requirements of this 
                      section.
                          ``(ii) Direct accreditation.--If, by the date 
                      that is 2 years after the date of establishment of 
                      the system described in clause (i), the Secretary 
                      has not identified and recognized an accreditation 
                      body to meet the requirements of this section, the 
                      Secretary may directly accredit third-party 
                      auditors.
                    ``(B) Notification.--Each accreditation body 
                recognized by the Secretary shall submit to the 
                Secretary a

[[Page 124 STAT. 3961]]

                list of all accredited third-party auditors accredited 
                by such body and the audit agents of such auditors.
                    ``(C) Revocation of recognition as an accreditation 
                body.--The Secretary shall promptly revoke the 
                recognition of any accreditation body found not to be in 
                compliance with the requirements of this section.
                    ``(D) Reinstatement. <<NOTE: Procedures.>> --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. <<NOTE: Deadline.>> --
        Not later than 18 months after the date of enactment of the FDA 
        Food Safety Modernization Act, the Secretary shall develop model 
        standards, including requirements for regulatory audit reports, 
        and each recognized accreditation body shall ensure that third-
        party auditors and audit agents of such auditors meet such 
        standards in order to qualify such third-party auditors as 
        accredited third-party auditors under this section. In 
        developing the model standards, the Secretary shall look to 
        standards in place on the date of the enactment of this section 
        for guidance, to avoid unnecessary duplication of efforts and 
        costs.

    ``(c) Third-party Auditors.--
            ``(1) Requirements for accreditation as a third-party 
        auditor.--
                    ``(A) Foreign governments.--Prior to accrediting a 
                foreign government or an agency of a foreign government 
                as an accredited third-party auditor, the accreditation 
                body (or, in the case of direct accreditation under 
                subsection (b)(1)(A)(ii), the Secretary) shall perform 
                such reviews and audits of food safety programs, 
                systems, and standards of the government or agency of 
                the government as the Secretary deems necessary, 
                including requirements under the model standards 
                developed under subsection (b)(2), to determine that the 
                foreign government or agency of the foreign government 
                is capable of adequately ensuring that eligible entities 
                or foods certified by such government or agency meet the 
                requirements of this Act with respect to food 
                manufactured, processed, packed, or held for import into 
                the United States.
                    ``(B) Foreign cooperatives and other third 
                parties.--Prior to accrediting a foreign cooperative 
                that aggregates the products of growers or processors, 
                or any other third party to be an accredited third-party 
                auditor, the accreditation body (or, in the case of 
                direct accreditation under subsection (b)(1)(A)(ii), the 
                Secretary) shall perform such reviews and audits of the 
                training and qualifications of audit agents used by that 
                cooperative or party and conduct such reviews of 
                internal systems and such other investigation of the 
                cooperative or party as the Secretary deems necessary, 
                including requirements under the model standards 
                developed under subsection (b)(2), to determine that 
                each eligible entity certified by the cooperative or 
                party has systems and standards in use to ensure that 
                such entity or food meets the requirements of this Act.

[[Page 124 STAT. 3962]]

            ``(2) Requirement to issue certification of eligible 
        entities or foods.--
                    ``(A) In general.--An accreditation body (or, in the 
                case of direct accreditation under subsection 
                (b)(1)(A)(ii), the Secretary) may not accredit a third-
                party auditor unless such third-party auditor agrees to 
                issue a written and, as appropriate, electronic food 
                certification, described in section 801(q), or facility 
                certification under section 806(a), as appropriate, to 
                accompany each food shipment for import into the United 
                States from an eligible entity, subject to requirements 
                set forth by the Secretary. Such written or electronic 
                certification may be included with other documentation 
                regarding such food shipment. The Secretary shall 
                consider certifications under section 801(q) and 
                participation in the voluntary qualified importer 
                program described in section 806 when targeting 
                inspection resources under section 421.
                    ``(B) Purpose of certification.--The Secretary shall 
                use certification provided by accredited third-party 
                auditors to--
                          ``(i) determine, in conjunction with any other 
                      assurances the Secretary may require under section 
                      801(q), whether a food satisfies the requirements 
                      of such section; and
                          ``(ii) determine whether a facility is 
                      eligible to be a facility from which food may be 
                      offered for import under the voluntary qualified 
                      importer program under section 806.
                    ``(C) Requirements for issuing certification.--
                          ``(i) In general. <<NOTE: Audit.>> --An 
                      accredited third-party auditor shall issue a food 
                      certification under section 801(q) or a facility 
                      certification described under subparagraph (B) 
                      only after conducting a regulatory audit and such 
                      other activities that may be necessary to 
                      establish compliance with the requirements of such 
                      sections.
                          ``(ii) Provision of certification.--Only an 
                      accredited third-party auditor or the Secretary 
                      may provide a facility certification under section 
                      806(a). Only those parties described in 801(q)(3) 
                      or the Secretary may provide a food certification 
                      under 301(g).
            ``(3) Audit report submission requirements.--
                    ``(A) Requirements in general.--As a condition of 
                accreditation, not later than 45 days after conducting 
                an audit, an accredited third-party auditor or audit 
                agent of such auditor shall prepare, and, in the case of 
                a regulatory audit, submit, the audit report for each 
                audit conducted, in a form and manner designated by the 
                Secretary, which shall include--
                          ``(i) the identity of the persons at the 
                      audited eligible entity responsible for compliance 
                      with food safety requirements;
                          ``(ii) the dates of the audit;
                          ``(iii) the scope of the audit; and
                          ``(iv) any other information required by the 
                      Secretary that relates to or may influence an 
                      assessment of compliance with this Act.

[[Page 124 STAT. 3963]]

                    ``(B) Records.--Following any accreditation of a 
                third-party auditor, the Secretary may, at any time, 
                require the accredited third-party auditor to submit to 
                the Secretary an onsite audit report and such other 
                reports or documents required as part of the audit 
                process, for any eligible entity certified by the third-
                party auditor or audit agent of such auditor. Such 
                report may include documentation that the eligible 
                entity is in compliance with any applicable registration 
                requirements.
                    ``(C) Limitation.--The requirement under 
                subparagraph (B) shall not include any report or other 
                documents resulting from a consultative audit by the 
                accredited third-party auditor, except that the 
                Secretary may access the results of a consultative audit 
                in accordance with section 414.
            ``(4) Requirements of accredited third-party auditors and 
        audit agents of such auditors.--
                    ``(A) Risks to public 
                health. <<NOTE: Notification.>> --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) <<NOTE: Deadline.>>  annually make 
                      available to the Secretary disclosures of the 
                      extent to which such auditor and the officers and 
                      employees of such auditor have maintained 
                      compliance with clauses (i) and (ii) relating to 
                      financial conflicts of interest.
                    ``(B) Audit agents.--An audit agent shall--
                          ``(i) not own or operate an eligible entity to 
                      be audited by such agent;

[[Page 124 STAT. 3964]]

                          ``(ii) in carrying out audits of eligible 
                      entities under this section, have procedures to 
                      ensure that such agent does not have a financial 
                      conflict of interest regarding an eligible entity 
                      to be audited by such agent; and
                          ``(iii) <<NOTE: Deadline.>>  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. <<NOTE: Deadline.>> --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. <<NOTE: Waiver authority.>> --The 
                Secretary may waive the application of subparagraph 
                (A)(i) if the Secretary--
                          ``(i) conducts an investigation of the 
                      material facts related to the outbreak of human or 
                      animal illness; and

[[Page 124 STAT. 3965]]

                          ``(ii) reviews the steps or actions taken by 
                      the third party auditor to justify the 
                      certification and determines that the accredited 
                      third-party auditor satisfied the requirements 
                      under section 801(q) of certifying the food, or 
                      the requirements under paragraph (2)(B) of 
                      certifying the entity.
            ``(7) Reaccreditation. <<NOTE: Procedures.>> --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) <<NOTE: Deadline.>>  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. <<NOTE: Regulations.>> --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. <<NOTE: Applicability.>> --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) <<NOTE: Deadlines.>>  periodically, or at least once 
        every 4 years, reevaluate the accreditation bodies described in 
        subsection (b)(1);

[[Page 124 STAT. 3966]]

            ``(2) <<NOTE: Deadlines.>>  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. <<NOTE: 21 USC 2242.>>  FOREIGN OFFICES OF THE FOOD AND 
                        DRUG ADMINISTRATION.

    (a) In General. <<NOTE: Establishment.>> --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. <<NOTE: 21 USC 2243.>>  SMUGGLED FOOD.

    (a) In General. <<NOTE: Deadline. Strategy.>> --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. <<NOTE: Deadline.>> --Not 
later than 10 days after the Secretary identifies a smuggled food that 
the Secretary believes would cause serious adverse health consequences

[[Page 124 STAT. 3967]]

or death to humans or animals, the Secretary shall provide to the 
Secretary of Homeland Security a notification under section 417(n) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350f(k)) describing 
the smuggled food and, if available, the names of the individuals or 
entities that attempted to import such food into the United States.

    (c) Public Notification.--If the Secretary--
            (1) identifies a smuggled food;
            (2) reasonably believes exposure to the food would cause 
        serious adverse health consequences or death to humans or 
        animals; and
            (3) reasonably believes that the food has entered domestic 
        commerce and is likely to be consumed,

the Secretary shall promptly issue a press release describing that food 
and shall use other emergency communication or recall networks, as 
appropriate, to warn consumers and vendors about the potential threat.
    (d) Effect of Section.--Nothing in this section shall affect the 
authority of the Secretary to issue public notifications under other 
circumstances.
    (e) Definition.--In this subsection, the term ``smuggled food'' 
means any food that a person introduces into the United States through 
fraudulent means or with the intent to defraud or mislead.

                   TITLE IV--MISCELLANEOUS PROVISIONS

SEC. 401. FUNDING FOR FOOD SAFETY.

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

[[Page 124 STAT. 3968]]

SEC. 402. EMPLOYEE PROTECTIONS.

    Chapter X of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 391 
et seq.), as amended by section 209, is further amended by adding at the 
end the following:
``SEC. 1012. <<NOTE: 21 USC 399d.>>  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. <<NOTE: Deadline.>> --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. <<NOTE: Notification.>>  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. <<NOTE: Deadline. Notification.>> --Not later 
                than 60 days after the date of receipt of a complaint 
                filed under paragraph (1) and after affording the 
                complainant and the person named in the complaint an 
                opportunity to submit to the Secretary a written 
                response to the complaint and an opportunity to meet 
                with a representative of the Secretary to present 
                statements from witnesses, the Secretary shall initiate 
                an investigation and determine whether there is 
                reasonable cause to believe that the complaint has merit 
                and notify, in writing, the complainant and the person 
                alleged to have

[[Page 124 STAT. 3969]]

                committed a violation of subsection (a) of the 
                Secretary's findings.
                    ``(B) Reasonable cause found; preliminary order.--If 
                the Secretary concludes that there is reasonable cause 
                to believe that a violation of subsection (a) has 
                occurred, the Secretary shall accompany the Secretary's 
                findings with a preliminary order providing the relief 
                prescribed by paragraph (3)(B). <<NOTE: Deadline.>>  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. <<NOTE: Deadline.>> --Not later 
                than 120 days after the date of conclusion of any 
                hearing under paragraph (2), the Secretary shall issue a 
                final order providing the relief prescribed by this 
                paragraph or denying the complaint. At any time before 
                issuance of a final order, a proceeding under this 
                subsection may be terminated on the basis of a 
                settlement agreement entered into by the Secretary, the 
                complainant, and the person alleged to have committed 
                the violation.

[[Page 124 STAT. 3970]]

                    ``(B) Content of order.--If, in response to a 
                complaint filed under paragraph (1), the Secretary 
                determines that a violation of subsection (a) has 
                occurred, the Secretary shall order the person who 
                committed such violation--
                          ``(i) to take affirmative action to abate the 
                      violation;
                          ``(ii) to reinstate the complainant to his or 
                      her former position together with compensation 
                      (including back pay) and restore the terms, 
                      conditions, and privileges associated with his or 
                      her employment; and
                          ``(iii) to provide compensatory damages to the 
                      complainant.
                    ``(C) Penalty.--If such an order is issued under 
                this paragraph, the Secretary, at the request of the 
                complainant, shall assess against the person against 
                whom the order is issued a sum equal to the aggregate 
                amount of all costs and expenses (including attorneys' 
                and expert witness fees) reasonably incurred, as 
                determined by the Secretary, by the complainant for, or 
                in connection with, the bringing of the complaint upon 
                which the order was issued.
                    ``(D) Bad faith claim.--If the Secretary finds that 
                a complaint under paragraph (1) is frivolous or has been 
                brought in bad faith, the Secretary may award to the 
                prevailing employer a reasonable attorneys' fee, not 
                exceeding $1,000, to be paid by the complainant.
            ``(4) Action in court.--
                    ``(A) In general. <<NOTE: Deadlines.>> --If the 
                Secretary has not issued a final decision within 210 
                days after the filing of the complaint, or within 90 
                days after receiving a written determination, the 
                complainant may bring an action at law or equity for de 
                novo review in the appropriate district court of the 
                United States with jurisdiction, which shall have 
                jurisdiction over such an action without regard to the 
                amount in controversy, and which action shall, at the 
                request of either party to such action, be tried by the 
                court with a jury. The proceedings shall be governed by 
                the same legal burdens of proof specified in paragraph 
                (2)(C).
                    ``(B) Relief.--The court shall have jurisdiction to 
                grant all relief necessary to make the employee whole, 
                including injunctive relief and compensatory damages, 
                including--
                          ``(i) reinstatement with the same seniority 
                      status that the employee would have had, but for 
                      the discharge or discrimination;
                          ``(ii) the amount of back pay, with interest; 
                      and
                          ``(iii) compensation for any special damages 
                      sustained as a result of the discharge or 
                      discrimination, including litigation costs, expert 
                      witness fees, and reasonable attorney's fees.
            ``(5) Review.--
                    ``(A) In general.--Unless the complainant brings an 
                action under paragraph (4), any person adversely 
                affected or aggrieved by a final order issued under 
                paragraph (3) may obtain review of the order in the 
                United States Court of Appeals for the circuit in which 
                the violation, with respect to which the order was 
                issued, allegedly occurred or the circuit in which the 
                complainant resided on the

[[Page 124 STAT. 3971]]

                date of such violation. <<NOTE: Deadline.>>  The 
                petition for review must be filed not later than 60 days 
                after the date of the issuance of the final order of the 
                Secretary. Review shall conform to chapter 7 of title 5, 
                United States Code. The commencement of proceedings 
                under this subparagraph shall not, unless ordered by the 
                court, operate as a stay of the order.
                    ``(B) No judicial review.--An order of the Secretary 
                with respect to which review could have been obtained 
                under subparagraph (A) shall not be subject to judicial 
                review in any criminal or other civil proceeding.
            ``(6) Failure to comply with order.--Whenever any person has 
        failed to comply with an order issued under paragraph (3), the 
        Secretary may file a civil action in the United States district 
        court for the district in which the violation was found to 
        occur, or in the United States district court for the District 
        of Columbia, to enforce such order. In actions brought under 
        this paragraph, the district courts shall have jurisdiction to 
        grant all appropriate relief including, but not limited to, 
        injunctive relief and compensatory damages.
            ``(7) Civil action to require compliance.--
                    ``(A) In general.--A person on whose behalf an order 
                was issued under paragraph (3) may commence a civil 
                action against the person to whom such order was issued 
                to require compliance with such order. The appropriate 
                United States district court shall have jurisdiction, 
                without regard to the amount in controversy or the 
                citizenship of the parties, to enforce such order.
                    ``(B) Award.--The court, in issuing any final order 
                under this paragraph, may award costs of litigation 
                (including reasonable attorneys' and expert witness 
                fees) to any party whenever the court determines such 
                award is appropriate.

    ``(c) Effect of Section.--
            ``(1) Other laws.--Nothing in this section preempts or 
        diminishes any other safeguards against discrimination, 
        demotion, discharge, suspension, threats, harassment, reprimand, 
        retaliation, or any other manner of discrimination provided by 
        Federal or State law.
            ``(2) Rights of employees.--Nothing in this section shall be 
        construed to diminish the rights, privileges, or remedies of any 
        employee under any Federal or State law or under any collective 
        bargaining agreement. The rights and remedies in this section 
        may not be waived by any agreement, policy, form, or condition 
        of employment.

    ``(d) Enforcement.--Any nondiscretionary duty imposed by this 
section shall be enforceable in a mandamus proceeding brought under 
section 1361 of title 28, United States Code.
    ``(e) Limitation.--Subsection (a) shall not apply with respect to an 
employee of an entity engaged in the manufacture, processing, packing, 
transporting, distribution, reception, holding, or importation of food 
who, acting without direction from such entity (or such entity's agent), 
deliberately causes a violation of any requirement relating to any 
violation or alleged violation of any order, rule, regulation, standard, 
or ban under this Act.''.

[[Page 124 STAT. 3972]]

SEC. 403. <<NOTE: 21 USC 2251.>>  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. <<NOTE: 21 USC 2252.>>  COMPLIANCE WITH INTERNATIONAL 
                        AGREEMENTS.

    Nothing in this Act (or an amendment made by this Act) shall be 
construed in a manner inconsistent with the agreement establishing the 
World Trade Organization or any other treaty or international agreement 
to which the United States is a party.
SEC. 405. DETERMINATION OF BUDGETARY EFFECTS.

    The budgetary effects of this Act, for the purpose of complying with 
the Statutory Pay-As-You-Go Act of 2010, shall be determined by 
reference to the latest statement titled ``Budgetary Effects of PAYGO 
Legislation'' for this Act, submitted for printing in the

[[Page 124 STAT. 3973]]

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

    Approved January 4, 2011.

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

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

                                  <all>
```