[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[S. 510 Engrossed in Senate (ES)]

111th CONGRESS
  2d Session
                                 S. 510

_______________________________________________________________________

                                 AN ACT


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

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE; REFERENCES; TABLE OF CONTENTS.

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

Sec. 1. Short title; references; table of contents.
      TITLE I--IMPROVING CAPACITY TO PREVENT FOOD SAFETY PROBLEMS

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

Sec. 201. Targeting of inspection resources for domestic facilities, 
                            foreign facilities, and ports of entry; 
                            annual report.
Sec. 202. Laboratory accreditation for analyses of foods.
Sec. 203. Integrated consortium of laboratory networks.
Sec. 204. Enhancing tracking and tracing of food and recordkeeping.
Sec. 205. Surveillance.
Sec. 206. Mandatory recall authority.
Sec. 207. Administrative detention of food.
Sec. 208. Decontamination and disposal standards and plans.
Sec. 209. Improving the training of State, local, territorial, and 
                            tribal food safety officials.
Sec. 210. Enhancing food safety.
Sec. 211. Improving the reportable food registry.
            TITLE III--IMPROVING THE SAFETY OF IMPORTED FOOD

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

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

      TITLE I--IMPROVING CAPACITY TO PREVENT FOOD SAFETY PROBLEMS

SEC. 101. INSPECTIONS OF RECORDS.

    (a) In General.--Section 414(a) (21 U.S.C. 350c(a)) is amended--
            (1) by striking the heading and all that follows through 
        ``of food is'' and inserting the following: ``Records 
        Inspection.--
            ``(1) Adulterated food.--If the Secretary has a reasonable 
        belief that an article of food, and any other article of food 
        that the Secretary reasonably believes is likely to be affected 
        in a similar manner, is'';
            (2) by inserting ``, and to any other article of food that 
        the Secretary reasonably believes is likely to be affected in a 
        similar manner,'' after ``relating to such article'';
            (3) by striking the last sentence; and
            (4) by inserting at the end the following:
            ``(2) Use of or exposure to food of concern.--If the 
        Secretary believes that there is a reasonable probability that 
        the use of or exposure to an article of food, and any other 
        article of food that the Secretary reasonably believes is 
        likely to be affected in a similar manner, will cause serious 
        adverse health consequences or death to humans or animals, each 
        person (excluding farms and restaurants) who manufactures, 
        processes, packs, distributes, receives, holds, or imports such 
        article shall, at the request of an officer or employee duly 
        designated by the Secretary, permit such officer or employee, 
        upon presentation of appropriate credentials and a written 
        notice to such person, at reasonable times and within 
        reasonable limits and in a reasonable manner, to have access to 
        and copy all records relating to such article and to any other 
        article of food that the Secretary reasonably believes is 
        likely to be affected in a similar manner, that are needed to 
        assist the Secretary in determining whether there is a 
        reasonable probability that the use of or exposure to the food 
        will cause serious adverse health consequences or death to 
        humans or animals.
            ``(3) Application.--The requirement under paragraphs (1) 
        and (2) applies to all records relating to the manufacture, 
        processing, packing, distribution, receipt, holding, or 
        importation of such article maintained by or on behalf of such 
        person in any format (including paper and electronic formats) 
        and at any location.''.
    (b) Conforming Amendment.--Section 704(a)(1)(B) (21 U.S.C. 
374(a)(1)(B)) is amended by striking ``section 414 when'' and all that 
follows through ``subject to'' and inserting ``section 414, when the 
standard for records inspection under paragraph (1) or (2) of section 
414(a) applies, subject to''.

SEC. 102. REGISTRATION OF FOOD FACILITIES.

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

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

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

``SEC. 418. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS.

    ``(a) In General.--The owner, operator, or agent in charge of a 
facility shall, in accordance with this section, evaluate the hazards 
that could affect food manufactured, processed, packed, or held by such 
facility, identify and implement preventive controls to significantly 
minimize or prevent the occurrence of such hazards and provide 
assurances that such food is not adulterated under section 402 or 
misbranded under section 403(w), monitor the performance of those 
controls, and maintain records of this monitoring as a matter of 
routine practice.
    ``(b) Hazard Analysis.--The owner, operator, or agent in charge of 
a facility shall--
            ``(1) identify and evaluate known or reasonably foreseeable 
        hazards that may be associated with the facility, including--
                    ``(A) biological, chemical, physical, and 
                radiological hazards, natural toxins, pesticides, drug 
                residues, decomposition, parasites, allergens, and 
                unapproved food and color additives; and
                    ``(B) hazards that occur naturally, or may be 
                unintentionally introduced; and
            ``(2) identify and evaluate hazards that may be 
        intentionally introduced, including by acts of terrorism; and
            ``(3) develop a written analysis of the hazards.
    ``(c) Preventive Controls.--The owner, operator, or agent in charge 
of a facility shall identify and implement preventive controls, 
including at critical control points, if any, to provide assurances 
that--
            ``(1) hazards identified in the hazard analysis conducted 
        under subsection (b)(1) will be significantly minimized or 
        prevented;
            ``(2) any hazards identified in the hazard analysis 
        conducted under subsection (b)(2) will be significantly 
        minimized or prevented and addressed, consistent with section 
        420, as applicable; and
            ``(3) the food manufactured, processed, packed, or held by 
        such facility will not be adulterated under section 402 or 
        misbranded under section 403(w).
    ``(d) Monitoring of Effectiveness.--The owner, operator, or agent 
in charge of a facility shall monitor the effectiveness of the 
preventive controls implemented under subsection (c) to provide 
assurances that the outcomes described in subsection (c) shall be 
achieved.
    ``(e) Corrective Actions.--The owner, operator, or agent in charge 
of a facility shall establish procedures to ensure that, if the 
preventive controls implemented under subsection (c) are not properly 
implemented or are found to be ineffective--
            ``(1) appropriate action is taken to reduce the likelihood 
        of recurrence of the implementation failure;
            ``(2) all affected food is evaluated for safety; and
            ``(3) all affected food is prevented from entering into 
        commerce if the owner, operator or agent in charge of such 
        facility cannot ensure that the affected food is not 
        adulterated under section 402 or misbranded under section 
        403(w).
    ``(f) Verification.--The owner, operator, or agent in charge of a 
facility shall verify that--
            ``(1) the preventive controls implemented under subsection 
        (c) are adequate to control the hazards identified under 
        subsection (b);
            ``(2) the owner, operator, or agent is conducting 
        monitoring in accordance with subsection (d);
            ``(3) the owner, operator, or agent is making appropriate 
        decisions about corrective actions taken under subsection (e);
            ``(4) the preventive controls implemented under subsection 
        (c) are effectively and significantly minimizing or preventing 
        the occurrence of identified hazards, including through the use 
        of environmental and product testing programs and other 
        appropriate means; and
            ``(5) there is documented, periodic reanalysis of the plan 
        under subsection (i) to ensure that the plan is still relevant 
        to the raw materials, conditions and processes in the facility, 
        and new and emerging threats.
    ``(g) Recordkeeping.--The owner, operator, or agent in charge of a 
facility shall maintain, for not less than 2 years, records documenting 
the monitoring of the preventive controls implemented under subsection 
(c), instances of nonconformance material to food safety, the results 
of testing and other appropriate means of verification under subsection 
(f)(4), instances when corrective actions were implemented, and the 
efficacy of preventive controls and corrective actions.
    ``(h) Written Plan and Documentation.--The owner, operator, or 
agent in charge of a facility shall prepare a written plan that 
documents and describes the procedures used by the facility to comply 
with the requirements of this section, including analyzing the hazards 
under subsection (b) and identifying the preventive controls adopted 
under subsection (c) to address those hazards. Such written plan, 
together with the documentation described in subsection (g), shall be 
made promptly available to a duly authorized representative of the 
Secretary upon oral or written request.
    ``(i) Requirement To Reanalyze.--The owner, operator, or agent in 
charge of a facility shall conduct a reanalysis under subsection (b) 
whenever a significant change is made in the activities conducted at a 
facility operated by such owner, operator, or agent if the change 
creates a reasonable potential for a new hazard or a significant 
increase in a previously identified hazard or not less frequently than 
once every 3 years, whichever is earlier. Such reanalysis shall be 
completed and additional preventive controls needed to address the 
hazard identified, if any, shall be implemented before the change in 
activities at the facility is operative. Such owner, operator, or agent 
shall revise the written plan required under subsection (h) if such a 
significant change is made or document the basis for the conclusion 
that no additional or revised preventive controls are needed. The 
Secretary may require a reanalysis under this section to respond to new 
hazards and developments in scientific understanding, including, as 
appropriate, results from the Department of Homeland Security 
biological, chemical, radiological, or other terrorism risk assessment.
    ``(j) Exemption for Seafood, Juice, and Low-acid Canned Food 
Facilities Subject to HACCP.--
            ``(1) In general.--This section shall not apply to a 
        facility if the owner, operator, or agent in charge of such 
        facility is required to comply with, and is in compliance with, 
        1 of the following standards and regulations with respect to 
        such facility:
                    ``(A) The Seafood Hazard Analysis Critical Control 
                Points Program of the Food and Drug Administration.
                    ``(B) The Juice Hazard Analysis Critical Control 
                Points Program of the Food and Drug Administration.
                    ``(C) The Thermally Processed Low-Acid Foods 
                Packaged in Hermetically Sealed Containers standards of 
                the Food and Drug Administration (or any successor 
                standards).
            ``(2) Applicability.--The exemption under paragraph (1)(C) 
        shall apply only with respect to microbiological hazards that 
        are regulated under the standards for Thermally Processed Low-
        Acid Foods Packaged in Hermetically Sealed Containers under 
        part 113 of chapter 21, Code of Federal Regulations (or any 
        successor regulations).
    ``(k) Exception for Activities of Facilities Subject to Section 
419.--This section shall not apply to activities of a facility that are 
subject to section 419.
    ``(l) Modified Requirements for Qualified Facilities.--
            ``(1) Qualified facilities.--
                    ``(A) In general.--A facility is a qualified 
                facility for purposes of this subsection if the 
                facility meets the conditions under subparagraph (B) or 
                (C).
                    ``(B) Very small business.--A facility is a 
                qualified facility under this subparagraph--
                            ``(i) if the facility, including any 
                        subsidiary or affiliate of the facility, is, 
                        collectively, a very small business (as defined 
                        in the regulations promulgated under subsection 
                        (n)); and
                            ``(ii) in the case where the facility is a 
                        subsidiary or affiliate of an entity, if such 
                        subsidiaries or affiliates, are, collectively, 
                        a very small business (as so defined).
                    ``(C) Limited annual monetary value of sales.--
                            ``(i) In general.--A facility is a 
                        qualified facility under this subparagraph if 
                        clause (ii) applies--
                                    ``(I) to the facility, including 
                                any subsidiary or affiliate of the 
                                facility, collectively; and
                                    ``(II) to the subsidiaries or 
                                affiliates, collectively, of any entity 
                                of which the facility is a subsidiary 
                                or affiliate.
                            ``(ii) Average annual monetary value.--This 
                        clause applies if--
                                    ``(I) during the 3-year period 
                                preceding the applicable calendar year, 
                                the average annual monetary value of 
                                the food manufactured, processed, 
                                packed, or held at such facility (or 
                                the collective average annual monetary 
                                value of such food at any subsidiary or 
                                affiliate, as described in clause (i)) 
                                that is sold directly to qualified end-
                                users during such period exceeded the 
                                average annual monetary value of the 
                                food manufactured, processed, packed, 
                                or held at such facility (or the 
                                collective average annual monetary 
                                value of such food at any subsidiary or 
                                affiliate, as so described) sold by 
                                such facility (or collectively by any 
                                such subsidiary or affiliate) to all 
                                other purchasers during such period; 
                                and
                                    ``(II) the average annual monetary 
                                value of all food sold by such facility 
                                (or the collective average annual 
                                monetary value of such food sold by any 
                                subsidiary or affiliate, as described 
                                in clause (i)) during such period was 
                                less than $500,000, adjusted for 
                                inflation.
            ``(2) Exemption.--A qualified facility--
                    ``(A) shall not be subject to the requirements 
                under subsections (a) through (i) and subsection (n) in 
                an applicable calendar year; and
                    ``(B) shall submit to the Secretary--
                            ``(i)(I) documentation that demonstrates 
                        that the owner, operator, or agent in charge of 
                        the facility has identified potential hazards 
                        associated with the food being produced, is 
                        implementing preventive controls to address the 
                        hazards, and is monitoring the preventive 
                        controls to ensure that such controls are 
                        effective; or
                            ``(II) documentation (which may include 
                        licenses, inspection reports, certificates, 
                        permits, credentials, certification by an 
                        appropriate agency (such as a State department 
                        of agriculture), or other evidence of 
                        oversight), as specified by the Secretary, that 
                        the facility is in compliance with State, 
                        local, county, or other applicable non-Federal 
                        food safety law; and
                            ``(ii) documentation, as specified by the 
                        Secretary in a guidance document issued not 
                        later than 1 year after the date of enactment 
                        of this section, that the facility is a 
                        qualified facility under paragraph (1)(B) or 
                        (1)(C).
            ``(3) Withdrawal; rule of construction.--
                    ``(A) In general.--In the event of an active 
                investigation of a foodborne illness outbreak that is 
                directly linked to a qualified facility subject to an 
                exemption under this subsection, or if the Secretary 
                determines that it is necessary to protect the public 
                health and prevent or mitigate a foodborne illness 
                outbreak based on conduct or conditions associated with 
                a qualified facility that are material to the safety of 
                the food manufactured, processed, packed, or held at 
                such facility, the Secretary may withdraw the exemption 
                provided to such facility under this subsection.
                    ``(B) Rule of construction.--Nothing in this 
                subsection shall be construed to expand or limit the 
                inspection authority of the Secretary.
            ``(4) Definitions.--In this subsection:
                    ``(A) Affiliate.--The term `affiliate' means any 
                facility that controls, is controlled by, or is under 
                common control with another facility.
                    ``(B) Qualified end-user.--The term `qualified end-
                user', with respect to a food, means--
                            ``(i) the consumer of the food; or
                            ``(ii) a restaurant or retail food 
                        establishment (as those terms are defined by 
                        the Secretary for purposes of section 415) 
                        that--
                                    ``(I) is located--
                                            ``(aa) in the same State as 
                                        the qualified facility that 
                                        sold the food to such 
                                        restaurant or establishment; or
                                            ``(bb) not more than 275 
                                        miles from such facility; and
                                    ``(II) is purchasing the food for 
                                sale directly to consumers at such 
                                restaurant or retail food 
                                establishment.
                    ``(C) Consumer.--For purposes of subparagraph (B), 
                the term `consumer' does not include a business.
                    ``(D) Subsidiary.--The term `subsidiary' means any 
                company which is owned or controlled directly or 
                indirectly by another company.
            ``(5) Study.--
                    ``(A) In general.--The Secretary, in consultation 
                with the Secretary of Agriculture, shall conduct a 
                study of the food processing sector regulated by the 
                Secretary to determine--
                            ``(i) the distribution of food production 
                        by type and size of operation, including 
                        monetary value of food sold;
                            ``(ii) the proportion of food produced by 
                        each type and size of operation;
                            ``(iii) the number and types of food 
                        facilities co-located on farms, including the 
                        number and proportion by commodity and by 
                        manufacturing or processing activity;
                            ``(iv) the incidence of foodborne illness 
                        originating from each size and type of 
                        operation and the type of food facilities for 
                        which no reported or known hazard exists; and
                            ``(v) the effect on foodborne illness risk 
                        associated with commingling, processing, 
                        transporting, and storing food and raw 
                        agricultural commodities, including differences 
                        in risk based on the scale and duration of such 
                        activities.
                    ``(B) Size.--The results of the study conducted 
                under subparagraph (A) shall include the information 
                necessary to enable the Secretary to define the terms 
                `small business' and `very small business', for 
                purposes of promulgating the regulation under 
                subsection (n). In defining such terms, the Secretary 
                shall include consideration of harvestable acres, 
                income, the number of employees, and the volume of food 
                harvested.
                    ``(C) Submission of report.--Not later than 18 
                months after the date of enactment the FDA Food Safety 
                Modernization Act, the Secretary shall submit to 
                Congress a report that describes the results of the 
                study conducted under subparagraph (A).
            ``(6) No preemption.--Nothing in this subsection preempts 
        State, local, county, or other non-Federal law regarding the 
        safe production of food. Compliance with this subsection shall 
        not relieve any person from liability at common law or under 
        State statutory law.
            ``(7) Notification to consumers.--
                    ``(A) In general.--A qualified facility that is 
                exempt from the requirements under subsections (a) 
                through (i) and subsection (n) and does not prepare 
                documentation under paragraph (2)(B)(i)(I) shall--
                            ``(i) with respect to a food for which a 
                        food packaging label is required by the 
                        Secretary under any other provision of this 
                        Act, include prominently and conspicuously on 
                        such label the name and business address of the 
                        facility where the food was manufactured or 
                        processed; or
                            ``(ii) with respect to a food for which a 
                        food packaging label is not required by the 
                        Secretary under any other provisions of this 
                        Act, prominently and conspicuously display, at 
                        the point of purchase, the name and business 
                        address of the facility where the food was 
                        manufactured or processed, on a label, poster, 
                        sign, placard, or documents delivered 
                        contemporaneously with the food in the normal 
                        course of business, or, in the case of Internet 
                        sales, in an electronic notice.
                    ``(B) No additional label.--Subparagraph (A) does 
                not provide authority to the Secretary to require a 
                label that is in addition to any label required under 
                any other provision of this Act.
    ``(m) Authority With Respect to Certain Facilities.--The Secretary 
may, by regulation, exempt or modify the requirements for compliance 
under this section with respect to facilities that are solely engaged 
in the production of food for animals other than man, the storage of 
raw agricultural commodities (other than fruits and vegetables) 
intended for further distribution or processing, or the storage of 
packaged foods that are not exposed to the environment.
    ``(n) Regulations.--
            ``(1) In general.--Not later than 18 months after the date 
        of enactment of the FDA Food Safety Modernization Act, the 
        Secretary shall promulgate regulations--
                    ``(A) to establish science-based minimum standards 
                for conducting a hazard analysis, documenting hazards, 
                implementing preventive controls, and documenting the 
                implementation of the preventive controls under this 
                section; and
                    ``(B) to define, for purposes of this section, the 
                terms `small business' and `very small business', 
                taking into consideration the study described in 
                subsection (l)(5).
            ``(2) Coordination.--In promulgating the regulations under 
        paragraph (1)(A), with regard to hazards that may be 
        intentionally introduced, including by acts of terrorism, the 
        Secretary shall coordinate with the Secretary of Homeland 
        Security, as appropriate.
            ``(3) Content.--The regulations promulgated under paragraph 
        (1)(A) shall--
                    ``(A) provide sufficient flexibility to be 
                practicable for all sizes and types of facilities, 
                including small businesses such as a small food 
                processing facility co-located on a farm;
                    ``(B) comply with chapter 35 of title 44, United 
                States Code (commonly known as the `Paperwork Reduction 
                Act'), with special attention to minimizing the burden 
                (as defined in section 3502(2) of such Act) on the 
                facility, and collection of information (as defined in 
                section 3502(3) of such Act), associated with such 
                regulations;
                    ``(C) acknowledge differences in risk and minimize, 
                as appropriate, the number of separate standards that 
                apply to separate foods; and
                    ``(D) not require a facility to hire a consultant 
                or other third party to identify, implement, certify, 
                or audit preventative controls, except in the case of 
                negotiated enforcement resolutions that may require 
                such a consultant or third party.
            ``(4) Rule of construction.--Nothing in this subsection 
        shall be construed to provide the Secretary with the authority 
        to prescribe specific technologies, practices, or critical 
        controls for an individual facility.
            ``(5) Review.--In promulgating the regulations under 
        paragraph (1)(A), the Secretary shall review regulatory hazard 
        analysis and preventive control programs in existence on the 
        date of enactment of the FDA Food Safety Modernization Act, 
        including the Grade `A' Pasteurized Milk Ordinance to ensure 
        that such regulations are consistent, to the extent 
        practicable, with applicable domestic and internationally-
        recognized standards in existence on such date.
    ``(o) Definitions.--For purposes of this section:
            ``(1) Critical control point.--The term `critical control 
        point' means a point, step, or procedure in a food process at 
        which control can be applied and is essential to prevent or 
        eliminate a food safety hazard or reduce such hazard to an 
        acceptable level.
            ``(2) Facility.--The term `facility' means a domestic 
        facility or a foreign facility that is required to register 
        under section 415.
            ``(3) Preventive controls.--The term `preventive controls' 
        means those risk-based, reasonably appropriate procedures, 
        practices, and processes that a person knowledgeable about the 
        safe manufacturing, processing, packing, or holding of food 
        would employ to significantly minimize or prevent the hazards 
        identified under the hazard analysis conducted under subsection 
        (b) and that are consistent with the current scientific 
        understanding of safe food manufacturing, processing, packing, 
        or holding at the time of the analysis. Those procedures, 
        practices, and processes may include the following:
                    ``(A) Sanitation procedures for food contact 
                surfaces and utensils and food-contact surfaces of 
                equipment.
                    ``(B) Supervisor, manager, and employee hygiene 
                training.
                    ``(C) An environmental monitoring program to verify 
                the effectiveness of pathogen controls in processes 
                where a food is exposed to a potential contaminant in 
                the environment.
                    ``(D) A food allergen control program.
                    ``(E) A recall plan.
                    ``(F) Current Good Manufacturing Practices (cGMPs) 
                under part 110 of title 21, Code of Federal Regulations 
                (or any successor regulations).
                    ``(G) Supplier verification activities that relate 
                to the safety of food.''.
    (b) Guidance Document.--The Secretary shall issue a guidance 
document related to the regulations promulgated under subsection (b)(1) 
with respect to the hazard analysis and preventive controls under 
section 418 of the Federal Food, Drug, and Cosmetic Act (as added by 
subsection (a)).
    (c) Rulemaking.--
            (1) Proposed rulemaking.--
                    (A) In general.--Not later than 9 months after the 
                date of enactment of this Act, the Secretary of Health 
                and Human Services (referred to in this subsection as 
                the ``Secretary'') shall publish a notice of proposed 
                rulemaking in the Federal Register to promulgate 
                regulations with respect to--
                            (i) activities that constitute on-farm 
                        packing or holding of food that is not grown, 
                        raised, or consumed on such farm or another 
                        farm under the same ownership for purposes of 
                        section 415 of the Federal Food, Drug, and 
                        Cosmetic Act (21 U.S.C. 350d), as amended by 
                        this Act; and
                            (ii) activities that constitute on-farm 
                        manufacturing or processing of food that is not 
                        consumed on that farm or on another farm under 
                        common ownership for purposes of such section 
                        415.
                    (B) Clarification.--The rulemaking described under 
                subparagraph (A) shall enhance the implementation of 
                such section 415 and clarify the activities that are 
                included as part of the definition of the term 
                ``facility'' under such section 415. Nothing in this 
                Act authorizes the Secretary to modify the definition 
                of the term ``facility'' under such section.
                    (C) Science-based risk analysis.--In promulgating 
                regulations under subparagraph (A), the Secretary shall 
                conduct a science-based risk analysis of--
                            (i) specific types of on-farm packing or 
                        holding of food that is not grown, raised, or 
                        consumed on such farm or another farm under the 
                        same ownership, as such packing and holding 
                        relates to specific foods; and
                            (ii) specific on-farm manufacturing and 
                        processing activities as such activities relate 
                        to specific foods that are not consumed on that 
                        farm or on another farm under common ownership.
                    (D) Authority with respect to certain facilities.--
                            (i) In general.--In promulgating the 
                        regulations under subparagraph (A), the 
                        Secretary shall consider the results of the 
                        science-based risk analysis conducted under 
                        subparagraph (C), and shall exempt certain 
                        facilities from the requirements in section 418 
                        of the Federal Food, Drug, and Cosmetic Act (as 
                        added by this section), including hazard 
                        analysis and preventive controls, and the 
                        mandatory inspection frequency in section 421 
                        of such Act (as added by section 201), or 
                        modify the requirements in such sections 418 or 
                        421, as the Secretary determines appropriate, 
                        if such facilities are engaged only in specific 
                        types of on-farm manufacturing, processing, 
                        packing, or holding activities that the 
                        Secretary determines to be low risk involving 
                        specific foods the Secretary determines to be 
                        low risk.
                            (ii) Limitation.--The exemptions or 
                        modifications under clause (i) shall not 
                        include an exemption from the requirement to 
                        register under section 415 of the Federal Food, 
                        Drug, and Cosmetic Act (21 U.S.C. 350d), as 
                        amended by this Act, if applicable, and shall 
                        apply only to small businesses and very small 
                        businesses, as defined in the regulation 
                        promulgated under section 418(n) of the Federal 
                        Food, Drug, and Cosmetic Act (as added under 
                        subsection (a)).
            (2) Final regulations.--Not later than 9 months after the 
        close of the comment period for the proposed rulemaking under 
        paragraph (1), the Secretary shall adopt final rules with 
        respect to--
                    (A) activities that constitute on-farm packing or 
                holding of food that is not grown, raised, or consumed 
                on such farm or another farm under the same ownership 
                for purposes of section 415 of the Federal Food, Drug, 
                and Cosmetic Act (21 U.S.C. 350d), as amended by this 
                Act;
                    (B) activities that constitute on-farm 
                manufacturing or processing of food that is not 
                consumed on that farm or on another farm under common 
                ownership for purposes of such section 415; and
                    (C) the requirements under sections 418 and 421 of 
                the Federal Food, Drug, and Cosmetic Act, as added by 
                this Act, from which the Secretary may issue exemptions 
                or modifications of the requirements for certain types 
                of facilities.
    (d) Small Entity Compliance Policy Guide.--Not later than 180 days 
after the issuance of the regulations promulgated under subsection (n) 
of section 418 of the Federal Food, Drug, and Cosmetic Act (as added by 
subsection (a)), the Secretary shall issue a small entity compliance 
policy guide setting forth in plain language the requirements of such 
section 418 and this section to assist small entities in complying with 
the hazard analysis and other activities required under such section 
418 and this section.
    (e) Prohibited Acts.--Section 301 (21 U.S.C. 331) is amended by 
adding at the end the following:
    ``(uu) The operation of a facility that manufactures, processes, 
packs, or holds food for sale in the United States if the owner, 
operator, or agent in charge of such facility is not in compliance with 
section 418.''.
    (f) No Effect on HACCP Authorities.--Nothing in the amendments made 
by this section limits the authority of the Secretary under the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or the Public 
Health Service Act (42 U.S.C. 201 et seq.) to revise, issue, or enforce 
Hazard Analysis Critical Control programs and the Thermally Processed 
Low-Acid Foods Packaged in Hermetically Sealed Containers standards.
    (g) Dietary Supplements.--Nothing in the amendments made by this 
section shall apply to any facility with regard to the manufacturing, 
processing, packing, or holding of a dietary supplement that is in 
compliance with the requirements of sections 402(g)(2) and 761 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(g)(2), 379aa-1).
    (h) Updating Guidance Relating to Fish and Fisheries Products 
Hazards and Controls.--The Secretary shall, not later than 180 days 
after the date of enactment of this Act, update the Fish and Fisheries 
Products Hazards and Control Guidance to take into account advances in 
technology that have occurred since the previous publication of such 
Guidance by the Secretary.
    (i) Effective Dates.--
            (1) General rule.--The amendments made by this section 
        shall take effect 18 months after the date of enactment of this 
        Act.
            (2) Flexibility for small businesses.--Notwithstanding 
        paragraph (1)--
                    (A) the amendments made by this section shall apply 
                to a small business (as defined in the regulations 
                promulgated under section 418(n) of the Federal Food, 
                Drug, and Cosmetic Act (as added by this section)) 
                beginning on the date that is 6 months after the 
                effective date of such regulations; and
                    (B) the amendments made by this section shall apply 
                to a very small business (as defined in such 
                regulations) beginning on the date that is 18 months 
                after the effective date of such regulations.

SEC. 104. PERFORMANCE STANDARDS.

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

SEC. 105. STANDARDS FOR PRODUCE SAFETY.

    (a) In General.--Chapter IV (21 U.S.C. 341 et seq.), as amended by 
section 103, is amended by adding at the end the following:

``SEC. 419. STANDARDS FOR PRODUCE SAFETY.

    ``(a) Proposed Rulemaking.--
            ``(1) In general.--
                    ``(A) Rulemaking.--Not later than 1 year after the 
                date of enactment of the FDA Food Safety Modernization 
                Act, the Secretary, in coordination with the Secretary 
                of Agriculture and representatives of State departments 
                of agriculture (including with regard to the national 
                organic program established under the Organic Foods 
                Production Act of 1990), and in consultation with the 
                Secretary of Homeland Security, shall publish a notice 
                of proposed rulemaking to establish science-based 
                minimum standards for the safe production and 
                harvesting of those types of fruits and vegetables, 
                including specific mixes or categories of fruits and 
                vegetables, that are raw agricultural commodities for 
                which the Secretary has determined that such standards 
                minimize the risk of serious adverse health 
                consequences or death.
                    ``(B) Determination by secretary.--With respect to 
                small businesses and very small businesses (as such 
                terms are defined in the regulation promulgated under 
                subparagraph (A)) that produce and harvest those types 
                of fruits and vegetables that are raw agricultural 
                commodities that the Secretary has determined are low 
                risk and do not present a risk of serious adverse 
                health consequences or death, the Secretary may 
                determine not to include production and harvesting of 
                such fruits and vegetables in such rulemaking, or may 
                modify the applicable requirements of regulations 
                promulgated pursuant to this section.
            ``(2) Public input.--During the comment period on the 
        notice of proposed rulemaking under paragraph (1), the 
        Secretary shall conduct not less than 3 public meetings in 
        diverse geographical areas of the United States to provide 
        persons in different regions an opportunity to comment.
            ``(3) Content.--The proposed rulemaking under paragraph (1) 
        shall--
                    ``(A) provide sufficient flexibility to be 
                applicable to various types of entities engaged in the 
                production and harvesting of fruits and vegetables that 
                are raw agricultural commodities, including small 
                businesses and entities that sell directly to 
                consumers, and be appropriate to the scale and 
                diversity of the production and harvesting of such 
                commodities;
                    ``(B) include, with respect to growing, harvesting, 
                sorting, packing, and storage operations, science-based 
                minimum standards related to soil amendments, hygiene, 
                packaging, temperature controls, animals in the growing 
                area, and water;
                    ``(C) consider hazards that occur naturally, may be 
                unintentionally introduced, or may be intentionally 
                introduced, including by acts of terrorism;
                    ``(D) take into consideration, consistent with 
                ensuring enforceable public health protection, 
                conservation and environmental practice standards and 
                policies established by Federal natural resource 
                conservation, wildlife conservation, and environmental 
                agencies;
                    ``(E) in the case of production that is certified 
                organic, not include any requirements that conflict 
                with or duplicate the requirements of the national 
                organic program established under the Organic Foods 
                Production Act of 1990, while providing the same level 
                of public health protection as the requirements under 
                guidance documents, including guidance documents 
                regarding action levels, and regulations under the FDA 
                Food Safety Modernization Act; and
                    ``(F) define, for purposes of this section, the 
                terms `small business' and `very small business'
            ``(4) Prioritization.--The Secretary shall prioritize the 
        implementation of the regulations under this section for 
        specific fruits and vegetables that are raw agricultural 
        commodities based on known risks which may include a history 
        and severity of foodborne illness outbreaks.
    ``(b) Final Regulation.--
            ``(1) In general.--Not later than 1 year after the close of 
        the comment period for the proposed rulemaking under subsection 
        (a), the Secretary shall adopt a final regulation to provide 
        for minimum science-based standards for those types of fruits 
        and vegetables, including specific mixes or categories of 
        fruits or vegetables, that are raw agricultural commodities, 
        based on known safety risks, which may include a history of 
        foodborne illness outbreaks.
            ``(2) Final regulation.--The final regulation shall--
                    ``(A) provide for coordination of education and 
                enforcement activities by State and local officials, as 
                designated by the Governors of the respective States or 
                the appropriate elected State official as recognized by 
                State statute; and
                    ``(B) include a description of the variance process 
                under subsection (c) and the types of permissible 
                variances the Secretary may grant.
            ``(3) Flexibility for small businesses.--Notwithstanding 
        paragraph (1)--
                    ``(A) the regulations promulgated under this 
                section shall apply to a small business (as defined in 
                the regulation promulgated under subsection (a)(1)) 
                after the date that is 1 year after the effective date 
                of the final regulation under paragraph (1); and
                    ``(B) the regulations promulgated under this 
                section shall apply to a very small business (as 
                defined in the regulation promulgated under subsection 
                (a)(1)) after the date that is 2 years after the 
                effective date of the final regulation under paragraph 
                (1).
    ``(c) Criteria.--
            ``(1) In general.--The regulations adopted under subsection 
        (b) shall--
                    ``(A) set forth those procedures, processes, and 
                practices that the Secretary determines to minimize the 
                risk of serious adverse health consequences or death, 
                including procedures, processes, and practices that the 
                Secretary determines to be reasonably necessary to 
                prevent the introduction of known or reasonably 
                foreseeable biological, chemical, and physical hazards, 
                including hazards that occur naturally, may be 
                unintentionally introduced, or may be intentionally 
                introduced, including by acts of terrorism, into fruits 
                and vegetables, including specific mixes or categories 
                of fruits and vegetables, that are raw agricultural 
                commodities and to provide reasonable assurances that 
                the produce is not adulterated under section 402;
                    ``(B) provide sufficient flexibility to be 
                practicable for all sizes and types of businesses, 
                including small businesses such as a small food 
                processing facility co-located on a farm;
                    ``(C) comply with chapter 35 of title 44, United 
                States Code (commonly known as the `Paperwork Reduction 
                Act'), with special attention to minimizing the burden 
                (as defined in section 3502(2) of such Act) on the 
                business, and collection of information (as defined in 
                section 3502(3) of such Act), associated with such 
                regulations;
                    ``(D) acknowledge differences in risk and minimize, 
                as appropriate, the number of separate standards that 
                apply to separate foods; and
                    ``(E) not require a business to hire a consultant 
                or other third party to identify, implement, certify, 
                compliance with these procedures, processes, and 
                practices, except in the case of negotiated enforcement 
                resolutions that may require such a consultant or third 
                party; and
                    ``(F) permit States and foreign countries from 
                which food is imported into the United States to 
                request from the Secretary variances from the 
                requirements of the regulations, subject to paragraph 
                (2), where the State or foreign country determines that 
                the variance is necessary in light of local growing 
                conditions and that the procedures, processes, and 
                practices to be followed under the variance are 
                reasonably likely to ensure that the produce is not 
                adulterated under section 402 and to provide the same 
                level of public health protection as the requirements 
                of the regulations adopted under subsection (b).
            ``(2) Variances.--
                    ``(A) Requests for variances.--A State or foreign 
                country from which food is imported into the United 
                States may in writing request a variance from the 
                Secretary. Such request shall describe the variance 
                requested and present information demonstrating that 
                the variance does not increase the likelihood that the 
                food for which the variance is requested will be 
                adulterated under section 402, and that the variance 
                provides the same level of public health protection as 
                the requirements of the regulations adopted under 
                subsection (b). The Secretary shall review such 
                requests in a reasonable timeframe.
                    ``(B) Approval of variances.--The Secretary may 
                approve a variance in whole or in part, as appropriate, 
                and may specify the scope of applicability of a 
                variance to other similarly situated persons.
                    ``(C) Denial of variances.--The Secretary may deny 
                a variance request if the Secretary determines that 
                such variance is not reasonably likely to ensure that 
                the food is not adulterated under section 402 and is 
                not reasonably likely to provide the same level of 
                public health protection as the requirements of the 
                regulation adopted under subsection (b). The Secretary 
                shall notify the person requesting such variance of the 
                reasons for the denial.
                    ``(D) Modification or revocation of a variance.--
                The Secretary, after notice and an opportunity for a 
                hearing, may modify or revoke a variance if the 
                Secretary determines that such variance is not 
                reasonably likely to ensure that the food is not 
                adulterated under section 402 and is not reasonably 
                likely to provide the same level of public health 
                protection as the requirements of the regulations 
                adopted under subsection (b).
    ``(d) Enforcement.--The Secretary may coordinate with the Secretary 
of Agriculture and, as appropriate, shall contract and coordinate with 
the agency or department designated by the Governor of each State to 
perform activities to ensure compliance with this section.
    ``(e) Guidance.--
            ``(1) In general.--Not later than 1 year after the date of 
        enactment of the FDA Food Safety Modernization Act, the 
        Secretary shall publish, after consultation with the Secretary 
        of Agriculture, representatives of State departments of 
        agriculture, farmer representatives, and various types of 
        entities engaged in the production and harvesting or importing 
        of fruits and vegetables that are raw agricultural commodities, 
        including small businesses, updated good agricultural practices 
        and guidance for the safe production and harvesting of specific 
        types of fresh produce under this section.
            ``(2) Public meetings.--The Secretary shall conduct not 
        fewer than 3 public meetings in diverse geographical areas of 
        the United States as part of an effort to conduct education and 
        outreach regarding the guidance described in paragraph (1) for 
        persons in different regions who are involved in the production 
        and harvesting of fruits and vegetables that are raw 
        agricultural commodities, including persons that sell directly 
        to consumers and farmer representatives, and for importers of 
        fruits and vegetables that are raw agricultural commodities.
            ``(3) Paperwork reduction.--The Secretary shall ensure that 
        any updated guidance under this section will--
                    ``(A) provide sufficient flexibility to be 
                practicable for all sizes and types of facilities, 
                including small businesses such as a small food 
                processing facility co-located on a farm; and
                    ``(B) acknowledge differences in risk and minimize, 
                as appropriate, the number of separate standards that 
                apply to separate foods.
    ``(f) Exemption for Direct Farm Marketing.--
            ``(1) In general.--A farm shall be exempt from the 
        requirements under this section in a calendar year if--
                    ``(A) during the previous 3-year period, the 
                average annual monetary value of the food sold by such 
                farm directly to qualified end-users during such period 
                exceeded the average annual monetary value of the food 
                sold by such farm to all other buyers during such 
                period; and
                    ``(B) the average annual monetary value of all food 
                sold during such period was less than $500,000, 
                adjusted for inflation.
            ``(2) Notification to consumers.--
                    ``(A) In general.--A farm that is exempt from the 
                requirements under this section shall--
                            ``(i) with respect to a food for which a 
                        food packaging label is required by the 
                        Secretary under any other provision of this 
                        Act, include prominently and conspicuously on 
                        such label the name and business address of the 
                        farm where the produce was grown; or
                            ``(ii) with respect to a food for which a 
                        food packaging label is not required by the 
                        Secretary under any other provision of this 
                        Act, prominently and conspicuously display, at 
                        the point of purchase, the name and business 
                        address of the farm where the produce was 
                        grown, on a label, poster, sign, placard, or 
                        documents delivered contemporaneously with the 
                        food in the normal course of business, or, in 
                        the case of Internet sales, in an electronic 
                        notice.
                    ``(B) No additional label.--Subparagraph (A) does 
                not provide authority to the Secretary to require a 
                label that is in addition to any label required under 
                any other provision of this Act.
            ``(3) Withdrawal; rule of construction.--
                    ``(A) In general.--In the event of an active 
                investigation of a foodborne illness outbreak that is 
                directly linked to a farm subject to an exemption under 
                this subsection, or if the Secretary determines that it 
                is necessary to protect the public health and prevent 
                or mitigate a foodborne illness outbreak based on 
                conduct or conditions associated with a farm that are 
                material to the safety of the food produced or 
                harvested at such farm, the Secretary may withdraw the 
                exemption provided to such farm under this subsection.
                    ``(B) Rule of construction.--Nothing in this 
                subsection shall be construed to expand or limit the 
                inspection authority of the Secretary.
            ``(4) Definitions.--
                    ``(A) Qualified end-user.--In this subsection, the 
                term `qualified end-user', with respect to a food 
                means--
                            ``(i) the consumer of the food; or
                            ``(ii) a restaurant or retail food 
                        establishment (as those terms are defined by 
                        the Secretary for purposes of section 415) that 
                        is located--
                                    ``(I) in the same State as the farm 
                                that produced the food; or
                                    ``(II) not more than 275 miles from 
                                such farm.
                    ``(B) Consumer.--For purposes of subparagraph (A), 
                the term `consumer' does not include a business.
            ``(5) No preemption.--Nothing in this subsection preempts 
        State, local, county, or other non-Federal law regarding the 
        safe production, harvesting, holding, transportation, and sale 
        of fresh fruits and vegetables. Compliance with this subsection 
        shall not relieve any person from liability at common law or 
        under State statutory law.
            ``(6) Limitation of effect.--Nothing in this subsection 
        shall prevent the Secretary from exercising any authority 
        granted in the other sections of this Act.
    ``(g) Clarification.--This section shall not apply to produce that 
is produced by an individual for personal consumption.
    ``(h) Exception for Activities of Facilities Subject to Section 
418.--This section shall not apply to activities of a facility that are 
subject to section 418.''.
    (b) Small Entity Compliance Policy Guide.--Not later than 180 days 
after the issuance of regulations under section 419 of the Federal 
Food, Drug, and Cosmetic Act (as added by subsection (a)), the 
Secretary of Health and Human Services shall issue a small entity 
compliance policy guide setting forth in plain language the 
requirements of such section 419 and to assist small entities in 
complying with standards for safe production and harvesting and other 
activities required under such section.
    (c) Prohibited Acts.--Section 301 (21 U.S.C. 331), as amended by 
section 103, is amended by adding at the end the following:
    ``(vv) The failure to comply with the requirements under section 
419.''.
    (d) No Effect on HACCP Authorities.--Nothing in the amendments made 
by this section limits the authority of the Secretary under the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or the Public 
Health Service Act (42 U.S.C. 201 et seq.) to revise, issue, or enforce 
product and category-specific regulations, such as the Seafood Hazard 
Analysis Critical Controls Points Program, the Juice Hazard Analysis 
Critical Control Program, and the Thermally Processed Low-Acid Foods 
Packaged in Hermetically Sealed Containers standards.

SEC. 106. PROTECTION AGAINST INTENTIONAL ADULTERATION.

    (a) In General.--Chapter IV (21 U.S.C. 341 et seq.), as amended by 
section 105, is amended by adding at the end the following:

``SEC. 420. PROTECTION AGAINST INTENTIONAL ADULTERATION.

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

SEC. 107. AUTHORITY TO COLLECT FEES.

    (a) Fees for Reinspection, Recall, and Importation Activities.--
Subchapter C of chapter VII (21 U.S.C. 379f et seq.) is amended by 
adding at the end the following:

                     ``PART 6--FEES RELATED TO FOOD

``SEC. 743. AUTHORITY TO COLLECT AND USE FEES.

    ``(a) In General.--
            ``(1) Purpose and authority.--For fiscal year 2010 and each 
        subsequent fiscal year, the Secretary shall, in accordance with 
        this section, assess and collect fees from--
                    ``(A) the responsible party for each domestic 
                facility (as defined in section 415(b)) and the United 
                States agent for each foreign facility subject to a 
                reinspection in such fiscal year, to cover 
                reinspection-related costs for such year;
                    ``(B) the responsible party for a domestic facility 
                (as defined in section 415(b)) and an importer who does 
                not comply with a recall order under section 423 or 
                under section 412(f) in such fiscal year, to cover food 
                recall activities associated with such order performed 
                by the Secretary, including technical assistance, 
                follow-up effectiveness checks, and public 
                notifications, for such year;
                    ``(C) each importer participating in the voluntary 
                qualified importer program under section 806 in such 
                year, to cover the administrative costs of such program 
                for such year; and
                    ``(D) each importer subject to a reinspection in 
                such fiscal year, to cover reinspection-related costs 
                for such year.
            ``(2) Definitions.--For purposes of this section--
                    ``(A) the term `reinspection' means--
                            ``(i) with respect to domestic facilities 
                        (as defined in section 415(b)), 1 or more 
                        inspections conducted under section 704 
                        subsequent to an inspection conducted under 
                        such provision which identified noncompliance 
                        materially related to a food safety requirement 
                        of this Act, specifically to determine whether 
                        compliance has been achieved to the Secretary's 
                        satisfaction; and
                            ``(ii) with respect to importers, 1 or more 
                        examinations conducted under section 801 
                        subsequent to an examination conducted under 
                        such provision which identified noncompliance 
                        materially related to a food safety requirement 
                        of this Act, specifically to determine whether 
                        compliance has been achieved to the Secretary's 
                        satisfaction;
                    ``(B) the term `reinspection-related costs' means 
                all expenses, including administrative expenses, 
                incurred in connection with--
                            ``(i) arranging, conducting, and evaluating 
                        the results of reinspections; and
                            ``(ii) assessing and collecting 
                        reinspection fees under this section; and
                    ``(C) the term `responsible party' has the meaning 
                given such term in section 417(a)(1).
    ``(b) Establishment of Fees.--
            ``(1) In general.--Subject to subsections (c) and (d), the 
        Secretary shall establish the fees to be collected under this 
        section for each fiscal year specified in subsection (a)(1), 
        based on the methodology described under paragraph (2), and 
        shall publish such fees in a Federal Register notice not later 
        than 60 days before the start of each such year.
            ``(2) Fee methodology.--
                    ``(A) Fees.--Fees amounts established for 
                collection--
                            ``(i) under subparagraph (A) of subsection 
                        (a)(1) for a fiscal year shall be based on the 
                        Secretary's estimate of 100 percent of the 
                        costs of the reinspection-related activities 
                        (including by type or level of reinspection 
                        activity, as the Secretary determines 
                        applicable) described in such subparagraph (A) 
                        for such year;
                            ``(ii) under subparagraph (B) of subsection 
                        (a)(1) for a fiscal year shall be based on the 
                        Secretary's estimate of 100 percent of the 
                        costs of the activities described in such 
                        subparagraph (B) for such year;
                            ``(iii) under subparagraph (C) of 
                        subsection (a)(1) for a fiscal year shall be 
                        based on the Secretary's estimate of 100 
                        percent of the costs of the activities 
                        described in such subparagraph (C) for such 
                        year; and
                            ``(iv) under subparagraph (D) of subsection 
                        (a)(1) for a fiscal year shall be based on the 
                        Secretary's estimate of 100 percent of the 
                        costs of the activities described in such 
                        subparagraph (D) for such year.
                    ``(B) Other considerations.--
                            ``(i) Voluntary qualified importer 
                        program.--
                                    ``(I) Participation.--In 
                                establishing the fee amounts under 
                                subparagraph (A)(iii) for a fiscal 
                                year, the Secretary shall provide for 
                                the number of importers who have 
                                submitted to the Secretary a notice 
                                under section 806(c) informing the 
                                Secretary of the intent of such 
                                importer to participate in the program 
                                under section 806 in such fiscal year.
                                    ``(II) Recoupment.--In establishing 
                                the fee amounts under subparagraph 
                                (A)(iii) for the first 5 fiscal years 
                                after the date of enactment of this 
                                section, the Secretary shall include in 
                                such fee a reasonable surcharge that 
                                provides a recoupment of the costs 
                                expended by the Secretary to establish 
                                and implement the first year of the 
                                program under section 806.
                            ``(ii) Crediting of fees.--In establishing 
                        the fee amounts under subparagraph (A) for a 
                        fiscal year, the Secretary shall provide for 
                        the crediting of fees from the previous year to 
                        the next year if the Secretary overestimated 
                        the amount of fees needed to carry out such 
                        activities, and consider the need to account 
                        for any adjustment of fees and such other 
                        factors as the Secretary determines 
                        appropriate.
                            ``(iii) Published guidelines.--Not later 
                        than 180 days after the date of enactment of 
                        the FDA Food Safety Modernization Act, the 
                        Secretary shall publish in the Federal Register 
                        a proposed set of guidelines in consideration 
                        of the burden of fee amounts on small business. 
                        Such consideration may include reduced fee 
                        amounts for small businesses. The Secretary 
                        shall provide for a period of public comment on 
                        such guidelines. The Secretary shall adjust the 
                        fee schedule for small businesses subject to 
                        such fees only through notice and comment 
                        rulemaking.
            ``(3) Use of fees.--The Secretary shall make all of the 
        fees collected pursuant to clause (i), (ii), (iii), and (iv) of 
        paragraph (2)(A) available solely to pay for the costs referred 
        to in such clause (i), (ii), (iii), and (iv) of paragraph 
        (2)(A), respectively.
    ``(c) Limitations.--
            ``(1) In general.--Fees under subsection (a) shall be 
        refunded for a fiscal year beginning after fiscal year 2010 
        unless the amount of the total appropriations for food safety 
        activities at the Food and Drug Administration for such fiscal 
        year (excluding the amount of fees appropriated for such fiscal 
        year) is equal to or greater than the amount of appropriations 
        for food safety activities at the Food and Drug Administration 
        for fiscal year 2009 (excluding the amount of fees appropriated 
        for such fiscal year), multiplied by the adjustment factor 
        under paragraph (3).
            ``(2) Authority.--If--
                    ``(A) the Secretary does not assess fees under 
                subsection (a) for a portion of a fiscal year because 
                paragraph (1) applies; and
                    ``(B) at a later date in such fiscal year, such 
                paragraph (1) ceases to apply,
        the Secretary may assess and collect such fees under subsection 
        (a), without any modification to the rate of such fees, 
        notwithstanding the provisions of subsection (a) relating to 
        the date fees are to be paid.
            ``(3) Adjustment factor.--
                    ``(A) In general.--The adjustment factor described 
                in paragraph (1) shall be the total percentage change 
                that occurred in the Consumer Price Index for all urban 
                consumers (all items; United States city average) for 
                the 12-month period ending June 30 preceding the fiscal 
                year, but in no case shall such adjustment factor be 
                negative.
                    ``(B) Compounded basis.--The adjustment under 
                subparagraph (A) made each fiscal year shall be added 
                on a compounded basis to the sum of all adjustments 
                made each fiscal year after fiscal year 2009.
            ``(4) Limitation on amount of certain fees.--
                    ``(A) In general.--Notwithstanding any other 
                provision of this section and subject to subparagraph 
                (B), the Secretary may not collect fees in a fiscal 
                year such that the amount collected--
                            ``(i) under subparagraph (B) of subsection 
                        (a)(1) exceeds $20,000,000; and
                            ``(ii) under subparagraphs (A) and (D) of 
                        subsection (a)(1) exceeds $25,000,000 combined.
                    ``(B) Exception.--If a domestic facility (as 
                defined in section 415(b)) or an importer becomes 
                subject to a fee described in subparagraph (A), (B), or 
                (D) of subsection (a)(1) after the maximum amount of 
                fees has been collected by the Secretary under 
                subparagraph (A), the Secretary may collect a fee from 
                such facility or importer.
    ``(d) Crediting and Availability of Fees.--Fees authorized under 
subsection (a) shall be collected and available for obligation only to 
the extent and in the amount provided in appropriations Acts. Such fees 
are authorized to remain available until expended. Such sums as may be 
necessary may be transferred from the Food and Drug Administration 
salaries and expenses account without fiscal year limitation to such 
appropriation account for salaries and expenses with such fiscal year 
limitation. The sums transferred shall be available solely for the 
purpose of paying the operating expenses of the Food and Drug 
Administration employees and contractors performing activities 
associated with these food safety fees.
    ``(e) Collection of Fees.--
            ``(1) In general.--The Secretary shall specify in the 
        Federal Register notice described in subsection (b)(1) the time 
        and manner in which fees assessed under this section shall be 
        collected.
            ``(2) Collection of unpaid fees.--In any case where the 
        Secretary does not receive payment of a fee assessed under this 
        section within 30 days after it is due, such fee shall be 
        treated as a claim of the United States Government subject to 
        provisions of subchapter II of chapter 37 of title 31, United 
        States Code.
    ``(f) Annual Report to Congress.--Not later than 120 days after 
each fiscal year for which fees are assessed under this section, the 
Secretary shall submit a report to the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Committee on Energy and 
Commerce of the House of Representatives, to include a description of 
fees assessed and collected for each such year and a summary 
description of the entities paying such fees and the types of business 
in which such entities engage.
    ``(g) Authorization of Appropriations.--For fiscal year 2010 and 
each fiscal year thereafter, there is authorized to be appropriated for 
fees under this section an amount equal to the total revenue amount 
determined under subsection (b) for the fiscal year, as adjusted or 
otherwise affected under the other provisions of this section.''.
    (b) Export Certification Fees for Foods and Animal Feed.--
            (1) Authority for export certifications for food, including 
        animal feed.--Section 801(e)(4)(A) (21 U.S.C. 381(e)(4)(A)) is 
        amended--
                    (A) in the matter preceding clause (i), by striking 
                ``a drug'' and inserting ``a food, drug'';
                    (B) in clause (i) by striking ``exported drug'' and 
                inserting ``exported food, drug''; and
                    (C) in clause (ii) by striking ``the drug'' each 
                place it appears and inserting ``the food, drug''.
            (2) Clarification of certification.--Section 801(e)(4) (21 
        U.S.C. 381(e)(4)) is amended by inserting after subparagraph 
        (B) the following new subparagraph:
                    ``(C) For purposes of this paragraph, a 
                certification by the Secretary shall be made on such 
                basis, and in such form (including a publicly available 
                listing) as the Secretary determines appropriate.''.

SEC. 108. NATIONAL AGRICULTURE AND FOOD DEFENSE STRATEGY.

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

SEC. 109. FOOD AND AGRICULTURE COORDINATING COUNCILS.

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

SEC. 110. BUILDING DOMESTIC CAPACITY.

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

SEC. 111. SANITARY TRANSPORTATION OF FOOD.

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

SEC. 112. FOOD ALLERGY AND ANAPHYLAXIS MANAGEMENT.

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

SEC. 113. NEW DIETARY INGREDIENTS.

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

SEC. 114. REQUIREMENT FOR GUIDANCE RELATING TO POST HARVEST PROCESSING 
              OF RAW OYSTERS.

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

SEC. 115. PORT SHOPPING.

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

SEC. 116. ALCOHOL-RELATED FACILITIES.

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

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

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

    (a) Targeting of Inspection Resources for Domestic Facilities, 
Foreign Facilities, and Ports of Entry.--Chapter IV (21 U.S.C. 341 et 
seq.), as amended by section 106, is amended by adding at the end the 
following:

``SEC. 421. TARGETING OF INSPECTION RESOURCES FOR DOMESTIC FACILITIES, 
              FOREIGN FACILITIES, AND PORTS OF ENTRY; ANNUAL REPORT.

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

SEC. 202. LABORATORY ACCREDITATION FOR ANALYSES OF FOODS.

    (a) In General.--Chapter IV (21 U.S.C. 341 et seq.), as amended by 
section 201, is amended by adding at the end the following:

``SEC. 422. LABORATORY ACCREDITATION FOR ANALYSES OF FOODS.

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

SEC. 203. INTEGRATED CONSORTIUM OF LABORATORY NETWORKS.

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

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

    (a) Pilot Projects.--
            (1) In general.--Not later than 270 days after the date of 
        enactment of this Act, the Secretary of Health and Human 
        Services (referred to in this section as the ``Secretary''), 
        taking into account recommendations from the Secretary of 
        Agriculture and representatives of State departments of health 
        and agriculture, shall establish pilot projects in coordination 
        with the food industry to explore and evaluate methods to 
        rapidly and effectively identify recipients of food to prevent 
        or mitigate a foodborne illness outbreak and to address 
        credible threats of serious adverse health consequences or 
        death to humans or animals as a result of such food being 
        adulterated under section 402 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 342) or misbranded under section 403(w) 
        of such Act (21 U.S.C. 343(w)).
            (2) Content.--The Secretary shall conduct 1 or more pilot 
        projects under paragraph (1) in coordination with the processed 
        food sector and 1 or more such pilot projects in coordination 
        with processors or distributors of fruits and vegetables that 
        are raw agricultural commodities. The Secretary shall ensure 
        that the pilot projects under paragraph (1) reflect the 
        diversity of the food supply and include at least 3 different 
        types of foods that have been the subject of significant 
        outbreaks during the 5-year period preceding the date of 
        enactment of this Act, and are selected in order to--
                    (A) develop and demonstrate methods for rapid and 
                effective tracking and tracing of foods in a manner 
                that is practicable for facilities of varying sizes, 
                including small businesses;
                    (B) develop and demonstrate appropriate 
                technologies, including technologies existing on the 
                date of enactment of this Act, that enhance the 
                tracking and tracing of food; and
                    (C) inform the promulgation of regulations under 
                subsection (d).
            (3) Report.--Not later than 18 months after the date of 
        enactment of this Act, the Secretary shall report to Congress 
        on the findings of the pilot projects under this subsection 
        together with recommendations for improving the tracking and 
        tracing of food.
    (b) Additional Data Gathering.--
            (1) In general.--The Secretary, in coordination with the 
        Secretary of Agriculture and multiple representatives of State 
        departments of health and agriculture, shall assess--
                    (A) the costs and benefits associated with the 
                adoption and use of several product tracing 
                technologies, including technologies used in the pilot 
                projects under subsection (a);
                    (B) the feasibility of such technologies for 
                different sectors of the food industry, including small 
                businesses; and
                    (C) whether such technologies are compatible with 
                the requirements of this subsection.
            (2) Requirements.--To the extent practicable, in carrying 
        out paragraph (1), the Secretary shall--
                    (A) evaluate domestic and international product 
                tracing practices in commercial use;
                    (B) consider international efforts, including an 
                assessment of whether product tracing requirements 
                developed under this section are compatible with global 
                tracing systems, as appropriate; and
                    (C) consult with a diverse and broad range of 
                experts and stakeholders, including representatives of 
                the food industry, agricultural producers, and 
                nongovernmental organizations that represent the 
                interests of consumers.
    (c) Product Tracing System.--The Secretary, in consultation with 
the Secretary of Agriculture, shall, as appropriate, establish within 
the Food and Drug Administration a product tracing system to receive 
information that improves the capacity of the Secretary to effectively 
and rapidly track and trace food that is in the United States or 
offered for import into the United States. Prior to the establishment 
of such product tracing system, the Secretary shall examine the results 
of applicable pilot projects and shall ensure that the activities of 
such system are adequately supported by the results of such pilot 
projects.
    (d) Additional Recordkeeping Requirements for High Risk Foods.--
            (1) In general.--In order to rapidly and effectively 
        identify recipients of a food to prevent or mitigate a 
        foodborne illness outbreak and to address credible threats of 
        serious adverse health consequences or death to humans or 
        animals as a result of such food being adulterated under 
        section 402 of the Federal Food, Drug, and Cosmetic Act or 
        misbranded under section 403(w) of such Act, not later than 2 
        years after the date of enactment of this Act, the Secretary 
        shall publish a notice of proposed rulemaking to establish 
        recordkeeping requirements, in addition to the requirements 
        under section 414 of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 350c) and subpart J of part 1 of title 21, Code of 
        Federal Regulations (or any successor regulations), for 
        facilities that manufacture, process, pack, or hold foods that 
        the Secretary designates under paragraph (2) as high-risk 
        foods. The Secretary shall set an appropriate effective date of 
        such additional requirements for foods designated as high risk 
        that takes into account the length of time necessary to comply 
        with such requirements. Such requirements shall--
                    (A) relate only to information that is reasonably 
                available and appropriate;
                    (B) be science-based;
                    (C) not prescribe specific technologies for the 
                maintenance of records;
                    (D) ensure that the public health benefits of 
                imposing additional recordkeeping requirements outweigh 
                the cost of compliance with such requirements;
                    (E) be scale-appropriate and practicable for 
                facilities of varying sizes and capabilities with 
                respect to costs and recordkeeping burdens, and not 
                require the creation and maintenance of duplicate 
                records where the information is contained in other 
                company records kept in the normal course of business;
                    (F) minimize the number of different recordkeeping 
                requirements for facilities that handle more than 1 
                type of food;
                    (G) to the extent practicable, not require a 
                facility to change business systems to comply with such 
                requirements;
                    (H) allow any person subject to this subsection to 
                maintain records required under this subsection at a 
                central or reasonably accessible location provided that 
                such records can be made available to the Secretary not 
                later than 24 hours after the Secretary requests such 
                records; and
                    (I) include a process by which the Secretary may 
                issue a waiver of the requirements under this 
                subsection if the Secretary determines that such 
                requirements would result in an economic hardship for 
                an individual facility or a type of facility;
                    (J) be commensurate with the known safety risks of 
                the designated food;
                    (K) take into account international trade 
                obligations;
                    (L) not require--
                            (i) a full pedigree, or a record of the 
                        complete previous distribution history of the 
                        food from the point of origin of such food;
                            (ii) records of recipients of a food beyond 
                        the immediate subsequent recipient of such 
                        food; or
                            (iii) product tracking to the case level by 
                        persons subject to such requirements; and
                    (M) include a process by which the Secretary may 
                remove a high-risk food designation developed under 
                paragraph (2) for a food or type of food.
            (2) Designation of high-risk foods.--
                    (A) In general.--Not later than 1 year after the 
                date of enactment of this Act, and thereafter as the 
                Secretary determines necessary, the Secretary shall 
                designate high-risk foods for which the additional 
                recordkeeping requirements described in paragraph (1) 
                are appropriate and necessary to protect the public 
                health. Each such designation shall be based on--
                            (i) the known safety risks of a particular 
                        food, including the history and severity of 
                        foodborne illness outbreaks attributed to such 
                        food, taking into consideration foodborne 
                        illness data collected by the Centers for 
                        Disease Control and Prevention;
                            (ii) the likelihood that a particular food 
                        has a high potential risk for microbiological 
                        or chemical contamination or would support the 
                        growth of pathogenic microorganisms due to the 
                        nature of the food or the processes used to 
                        produce such food;
                            (iii) the point in the manufacturing 
                        process of the food where contamination is most 
                        likely to occur;
                            (iv) the likelihood of contamination and 
                        steps taken during the manufacturing process to 
                        reduce the possibility of contamination;
                            (v) the likelihood that consuming a 
                        particular food will result in a foodborne 
                        illness due to contamination of the food; and
                            (vi) the likely or known severity, 
                        including health and economic impacts, of a 
                        foodborne illness attributed to a particular 
                        food.
                    (B) List of high-risk foods.--At the time the 
                Secretary promulgates the final rules under paragraph 
                (1), the Secretary shall publish the list of the foods 
                designated under subparagraph (A) as high-risk foods on 
                the Internet website of the Food and Drug 
                Administration. The Secretary may update the list to 
                designate new high-risk foods and to remove foods that 
                are no longer deemed to be high-risk foods, provided 
                that each such update to the list is consistent with 
                the requirements of this subsection and notice of such 
                update is published in the Federal Register.
            (3) Protection of sensitive information.--In promulgating 
        regulations under this subsection, the Secretary shall take 
        appropriate measures to ensure that there are effective 
        procedures to prevent the unauthorized disclosure of any trade 
        secret or confidential information that is obtained by the 
        Secretary pursuant to this section, including periodic risk 
        assessment and planning to prevent unauthorized release and 
        controls to--
                    (A) prevent unauthorized reproduction of trade 
                secret or confidential information;
                    (B) prevent unauthorized access to trade secret or 
                confidential information; and
                    (C) maintain records with respect to access by any 
                person to trade secret or confidential information 
                maintained by the agency.
            (4) Public input.--During the comment period in the notice 
        of proposed rulemaking under paragraph (1), the Secretary shall 
        conduct not less than 3 public meetings in diverse geographical 
        areas of the United States to provide persons in different 
        regions an opportunity to comment.
            (5) Retention of records.--Except as otherwise provided in 
        this subsection, the Secretary may require that a facility 
        retain records under this subsection for not more than 2 years, 
        taking into consideration the risk of spoilage, loss of value, 
        or loss of palatability of the applicable food when determining 
        the appropriate timeframes.
            (6) Limitations.--
                    (A) Farm to school programs.--In establishing 
                requirements under this subsection, the Secretary 
                shall, in consultation with the Secretary of 
                Agriculture, consider the impact of requirements on 
                farm to school or farm to institution programs of the 
                Department of Agriculture and other farm to school and 
                farm to institution programs outside such agency, and 
                shall modify the requirements under this subsection, as 
                appropriate, with respect to such programs so that the 
                requirements do not place undue burdens on farm to 
                school or farm to institution programs.
                    (B) Identity-preserved labels with respect to farm 
                sales of food that is produced and packaged on a 
                farm.--The requirements under this subsection shall not 
                apply to a food that is produced and packaged on a farm 
                if--
                            (i) the packaging of the food maintains the 
                        integrity of the product and prevents 
                        subsequent contamination or alteration of the 
                        product; and
                            (ii) the labeling of the food includes the 
                        name, complete address (street address, town, 
                        State, country, and zip or other postal code), 
                        and business phone number of the farm, unless 
                        the Secretary waives the requirement to include 
                        a business phone number of the farm, as 
                        appropriate, in order to accommodate a 
                        religious belief of the individual in charge of 
                        such farm.
                    (C) Fishing vessels.--The requirements under this 
                subsection with respect to a food that is produced 
                through the use of a fishing vessel (as defined in 
                section 3(18) of the Magnuson-Stevens Fishery 
                Conservation and Management Act (16 U.S.C. 1802(18))) 
                shall be limited to the requirements under subparagraph 
                (F) until such time as the food is sold by the owner, 
                operator, or agent in charge of such fishing vessel.
                    (D) Commingled raw agricultural commodities.--
                            (i) Limitation on extent of tracing.--
                        Recordkeeping requirements under this 
                        subsection with regard to any commingled raw 
                        agricultural commodity shall be limited to the 
                        requirements under subparagraph (F).
                            (ii) Definitions.--For the purposes of this 
                        subparagraph--
                                    (I) the term ``commingled raw 
                                agricultural commodity'' means any 
                                commodity that is combined or mixed 
                                after harvesting, but before 
                                processing;
                                    (II) the term ``commingled raw 
                                agricultural commodity'' shall not 
                                include types of fruits and vegetables 
                                that are raw agricultural commodities 
                                for which the Secretary has determined 
                                that standards promulgated under 
                                section 419 of the Federal Food, Drug, 
                                and Cosmetic Act (as added by section 
                                105) would minimize the risk of serious 
                                adverse health consequences or death; 
                                and
                                    (III) the term ``processing'' means 
                                operations that alter the general state 
                                of the commodity, such as canning, 
                                cooking, freezing, dehydration, 
                                milling, grinding, pasteurization, or 
                                homogenization.
                    (E) Exemption of other foods.--The Secretary may, 
                by notice in the Federal Register, modify the 
                requirements under this subsection with respect to, or 
                exempt a food or a type of facility from, the 
                requirements of this subsection (other than the 
                requirements under subparagraph (F), if applicable) if 
                the Secretary determines that product tracing 
                requirements for such food (such as bulk or commingled 
                ingredients that are intended to be processed to 
                destroy pathogens) or type of facility is not necessary 
                to protect the public health.
                    (F) Recordkeeping regarding previous sources and 
                subsequent recipients.--In the case of a person or food 
                to which a limitation or exemption under subparagraph 
                (C), (D), or (E) applies, if such person, or a person 
                who manufactures, processes, packs, or holds such food, 
                is required to register with the Secretary under 
                section 415 of the Federal Food, Drug, and Cosmetic Act 
                (21 U.S.C. 350d) with respect to the manufacturing, 
                processing, packing, or holding of the applicable food, 
                the Secretary shall require such person to maintain 
                records that identify the immediate previous source of 
                such food and the immediate subsequent recipient of 
                such food.
                    (G) Grocery stores.--With respect to a sale of a 
                food described in subparagraph (H) to a grocery store, 
                the Secretary shall not require such grocery store to 
                maintain records under this subsection other than 
                records documenting the farm that was the source of 
                such food. The Secretary shall not require that such 
                records be kept for more than 180 days.
                    (H) Farm sales to consumers.--The Secretary shall 
                not require a farm to maintain any distribution records 
                under this subsection with respect to a sale of a food 
                described in subparagraph (I) (including a sale of a 
                food that is produced and packaged on such farm), if 
                such sale is made by the farm directly to a consumer.
                    (I) Sale of a food.--A sale of a food described in 
                this subparagraph is a sale of a food in which--
                            (i) the food is produced on a farm; and
                            (ii) the sale is made by the owner, 
                        operator, or agent in charge of such farm 
                        directly to a consumer or grocery store.
            (7) No impact on non-high-risk foods.--The recordkeeping 
        requirements established under paragraph (1) shall have no 
        effect on foods that are not designated by the Secretary under 
        paragraph (2) as high-risk foods. Foods described in the 
        preceding sentence shall be subject solely to the recordkeeping 
        requirements under section 414 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 350c) and subpart J of part 1 of title 
        21, Code of Federal Regulations (or any successor regulations).
    (e) Evaluation and Recommendations.--
            (1) Report.--Not later than 1 year after the effective date 
        of the final rule promulgated under subsection (d)(1), the 
        Comptroller General of the United States shall submit to 
        Congress a report, taking into consideration the costs of 
        compliance and other regulatory burdens on small businesses and 
        Federal, State, and local food safety practices and 
        requirements, that evaluates the public health benefits and 
        risks, if any, of limiting--
                    (A) the product tracing requirements under 
                subsection (d) to foods identified under paragraph (2) 
                of such subsection, including whether such requirements 
                provide adequate assurance of traceability in the event 
                of intentional adulteration, including by acts of 
                terrorism; and
                    (B) the participation of restaurants in the 
                recordkeeping requirements.
            (2) Determination and recommendations.--In conducting the 
        evaluation and report under paragraph (1), if the Comptroller 
        General of the United States determines that the limitations 
        described in such paragraph do not adequately protect the 
        public health, the Comptroller General shall submit to Congress 
        recommendations, if appropriate, regarding recordkeeping 
        requirements for restaurants and additional foods, in order to 
        protect the public health.
    (f) Farms.--
            (1) Request for information.--Notwithstanding subsection 
        (d), during an active investigation of a foodborne illness 
        outbreak, or if the Secretary determines it is necessary to 
        protect the public health and prevent or mitigate a foodborne 
        illness outbreak, the Secretary, in consultation and 
        coordination with State and local agencies responsible for food 
        safety, as appropriate, may request that the owner, operator, 
        or agent of a farm identify potential immediate recipients, 
        other than consumers, of an article of the food that is the 
        subject of such investigation if the Secretary reasonably 
        believes such article of food--
                    (A) is adulterated under section 402 of the Federal 
                Food, Drug, and Cosmetic Act;
                    (B) presents a threat of serious adverse health 
                consequences or death to humans or animals; and
                    (C) was adulterated as described in subparagraph 
                (A) on a particular farm (as defined in section 1.227 
                of chapter 21, Code of Federal Regulations (or any 
                successor regulation)).
            (2) Manner of request.--In making a request under paragraph 
        (1), the Secretary, in consultation and coordination with State 
        and local agencies responsible for food safety, as appropriate, 
        shall issue a written notice to the owner, operator, or agent 
        of the farm to which the article of food has been traced. The 
        individual providing such notice shall present to such owner, 
        operator, or agent appropriate credentials and shall deliver 
        such notice at reasonable times and within reasonable limits 
        and in a reasonable manner.
            (3) Delivery of information requested.--The owner, 
        operator, or agent of a farm shall deliver the information 
        requested under paragraph (1) in a prompt and reasonable 
        manner. Such information may consist of records kept in the 
        normal course of business, and may be in electronic or non-
        electronic format.
            (4) Limitation.--A request made under paragraph (1) shall 
        not include a request for information relating to the finances, 
        pricing of commodities produced, personnel, research, sales 
        (other than information relating to shipping), or other 
        disclosures that may reveal trade secrets or confidential 
        information from the farm to which the article of food has been 
        traced, other than information necessary to identify potential 
        immediate recipients of such food. Section 301(j) of the 
        Federal Food, Drug, and Cosmetic Act and the Freedom of 
        Information Act shall apply with respect to any confidential 
        commercial information that is disclosed to the Food and Drug 
        Administration in the course of responding to a request under 
        paragraph (1).
            (5) Records.--Except with respect to identifying potential 
        immediate recipients in response to a request under this 
        subsection, nothing in this subsection shall require the 
        establishment or maintenance by farms of new records.
    (g) No Limitation on Commingling of Food.--Nothing in this section 
shall be construed to authorize the Secretary to impose any limitation 
on the commingling of food.
    (h) Small Entity Compliance Guide.--Not later than 180 days after 
promulgation of a final rule under subsection (d), the Secretary shall 
issue a small entity compliance guide setting forth in plain language 
the requirements of the regulations under such subsection in order to 
assist small entities, including farms and small businesses, in 
complying with the recordkeeping requirements under such subsection.
    (i) Flexibility for Small Businesses.--Notwithstanding any other 
provision of law, the regulations promulgated under subsection (d) 
shall apply--
            (1) to small businesses (as defined by the Secretary in 
        section 103, not later than 90 days after the date of enactment 
        of this Act) beginning on the date that is 1 year after the 
        effective date of the final regulations promulgated under 
        subsection (d); and
            (2) to very small businesses (as defined by the Secretary 
        in section 103, not later than 90 days after the date of 
        enactment of this Act) beginning on the date that is 2 years 
        after the effective date of the final regulations promulgated 
        under subsection (d).
    (j) Enforcement.--
            (1) Prohibited acts.--Section 301(e) (21 U.S.C. 331(e)) is 
        amended by inserting ``; or the violation of any recordkeeping 
        requirement under section 204 of the FDA Food Safety 
        Modernization Act (except when such violation is committed by a 
        farm)'' before the period at the end.
            (2) Imports.--Section 801(a) (21 U.S.C. 381(a)) is amended 
        by inserting ``or (4) the recordkeeping requirements under 
        section 204 of the FDA Food Safety Modernization Act (other 
        than the requirements under subsection (f) of such section) 
        have not been complied with regarding such article,'' in the 
        third sentence before ``then such article shall be refused 
        admission''.

SEC. 205. SURVEILLANCE.

    (a) Definition of Foodborne Illness Outbreak.--In this Act, the 
term ``foodborne illness outbreak'' means the occurrence of 2 or more 
cases of a similar illness resulting from the ingestion of a certain 
food.
    (b) Foodborne Illness Surveillance Systems.--
            (1) In general.--The Secretary, acting through the Director 
        of the Centers for Disease Control and Prevention, shall 
        enhance foodborne illness surveillance systems to improve the 
        collection, analysis, reporting, and usefulness of data on 
        foodborne illnesses by--
                    (A) coordinating Federal, State and local foodborne 
                illness surveillance systems, including complaint 
                systems, and increasing participation in national 
                networks of public health and food regulatory agencies 
                and laboratories;
                    (B) facilitating sharing of surveillance 
                information on a more timely basis among governmental 
                agencies, including the Food and Drug Administration, 
                the Department of Agriculture, the Department of 
                Homeland Security, and State and local agencies, and 
                with the public;
                    (C) developing improved epidemiological tools for 
                obtaining quality exposure data and microbiological 
                methods for classifying cases;
                    (D) augmenting such systems to improve attribution 
                of a foodborne illness outbreak to a specific food;
                    (E) expanding capacity of such systems, including 
                working toward automatic electronic searches, for 
                implementation of identification practices, including 
                fingerprinting strategies, for foodborne infectious 
                agents, in order to identify new or rarely documented 
                causes of foodborne illness and submit standardized 
                information to a centralized database;
                    (F) allowing timely public access to aggregated, 
                de-identified surveillance data;
                    (G) at least annually, publishing current reports 
                on findings from such systems;
                    (H) establishing a flexible mechanism for rapidly 
                initiating scientific research by academic 
                institutions;
                    (I) integrating foodborne illness surveillance 
                systems and data with other biosurveillance and public 
                health situational awareness capabilities at the 
                Federal, State, and local levels, including by sharing 
                foodborne illness surveillance data with the National 
                Biosurveillance Integration Center; and
                    (J) other activities as determined appropriate by 
                the Secretary.
            (2) Working group.--The Secretary shall support and 
        maintain a diverse working group of experts and stakeholders 
        from Federal, State, and local food safety and health agencies, 
        the food and food testing industries, consumer organizations, 
        and academia. Such working group shall provide the Secretary, 
        through at least annual meetings of the working group and an 
        annual public report, advice and recommendations on an ongoing 
        and regular basis regarding the improvement of foodborne 
        illness surveillance and implementation of this section, 
        including advice and recommendations on--
                    (A) the priority needs of regulatory agencies, the 
                food industry, and consumers for information and 
                analysis on foodborne illness and its causes;
                    (B) opportunities to improve the effectiveness of 
                initiatives at the Federal, State, and local levels, 
                including coordination and integration of activities 
                among Federal agencies, and between the Federal, State, 
                and local levels of government;
                    (C) improvement in the timeliness and depth of 
                access by regulatory and health agencies, the food 
                industry, academic researchers, and consumers to 
                foodborne illness aggregated, de-identified 
                surveillance data collected by government agencies at 
                all levels, including data compiled by the Centers for 
                Disease Control and Prevention;
                    (D) key barriers at Federal, State, and local 
                levels to improving foodborne illness surveillance and 
                the utility of such surveillance for preventing 
                foodborne illness;
                    (E) the capabilities needed for establishing 
                automatic electronic searches of surveillance data; and
                    (F) specific actions to reduce barriers to 
                improvement, implement the working group's 
                recommendations, and achieve the purposes of this 
                section, with measurable objectives and timelines, and 
                identification of resource and staffing needs.
            (3) Authorization of appropriations.--To carry out the 
        activities described in paragraph (1), there is authorized to 
        be appropriated $24,000,000 for each fiscal years 2011 through 
        2015.
    (c) Improving Food Safety and Defense Capacity at the State and 
Local Level.--
            (1) In general.--The Secretary shall develop and implement 
        strategies to leverage and enhance the food safety and defense 
        capacities of State and local agencies in order to achieve the 
        following goals:
                    (A) Improve foodborne illness outbreak response and 
                containment.
                    (B) Accelerate foodborne illness surveillance and 
                outbreak investigation, including rapid shipment of 
                clinical isolates from clinical laboratories to 
                appropriate State laboratories, and conducting more 
                standardized illness outbreak interviews.
                    (C) Strengthen the capacity of State and local 
                agencies to carry out inspections and enforce safety 
                standards.
                    (D) Improve the effectiveness of Federal, State, 
                and local partnerships to coordinate food safety and 
                defense resources and reduce the incidence of foodborne 
                illness.
                    (E) Share information on a timely basis among 
                public health and food regulatory agencies, with the 
                food industry, with health care providers, and with the 
                public.
                    (F) Strengthen the capacity of State and local 
                agencies to achieve the goals described in section 108.
            (2) Review.--In developing of the strategies required by 
        paragraph (1), the Secretary shall, not later than 1 year after 
        the date of enactment of the FDA Food Safety Modernization Act, 
        complete a review of State and local capacities, and needs for 
        enhancement, which may include a survey with respect to--
                    (A) staffing levels and expertise available to 
                perform food safety and defense functions;
                    (B) laboratory capacity to support surveillance, 
                outbreak response, inspection, and enforcement 
                activities;
                    (C) information systems to support data management 
                and sharing of food safety and defense information 
                among State and local agencies and with counterparts at 
                the Federal level; and
                    (D) other State and local activities and needs as 
                determined appropriate by the Secretary.
    (d) Food Safety Capacity Building Grants.--Section 317R(b) of the 
Public Health Service Act (42 U.S.C. 247b-20(b)) is amended--
            (1) by striking ``2002'' and inserting ``2010''; and
            (2) by striking ``2003 through 2006'' and inserting ``2011 
        through 2015''.

SEC. 206. MANDATORY RECALL AUTHORITY.

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

``SEC. 423. MANDATORY RECALL AUTHORITY.

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

SEC. 207. ADMINISTRATIVE DETENTION OF FOOD.

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

SEC. 208. DECONTAMINATION AND DISPOSAL STANDARDS AND PLANS.

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

SEC. 209. IMPROVING THE TRAINING OF STATE, LOCAL, TERRITORIAL, AND 
              TRIBAL FOOD SAFETY OFFICIALS.

    (a) Improving Training.--Chapter X (21 U.S.C. 391 et seq.) is 
amended by adding at the end the following:

``SEC. 1011. IMPROVING THE TRAINING OF STATE, LOCAL, TERRITORIAL, AND 
              TRIBAL FOOD SAFETY OFFICIALS.

    ``(a) Training.--The Secretary shall set standards and administer 
training and education programs for the employees of State, local, 
territorial, and tribal food safety officials relating to the 
regulatory responsibilities and policies established by this Act, 
including programs for--
            ``(1) scientific training;
            ``(2) training to improve the skill of officers and 
        employees authorized to conduct inspections under sections 702 
        and 704;
            ``(3) training to achieve advanced product or process 
        specialization in such inspections;
            ``(4) training that addresses best practices;
            ``(5) training in administrative process and procedure and 
        integrity issues;
            ``(6) training in appropriate sampling and laboratory 
        analysis methodology; and
            ``(7) training in building enforcement actions following 
        inspections, examinations, testing, and investigations.
    ``(b) Partnerships With State and Local Officials.--
            ``(1) In general.--The Secretary, pursuant to a contract or 
        memorandum of understanding between the Secretary and the head 
        of a State, local, territorial, or tribal department or agency, 
        is authorized and encouraged to conduct examinations, testing, 
        and investigations for the purposes of determining compliance 
        with the food safety provisions of this Act through the 
        officers and employees of such State, local, territorial, or 
        tribal department or agency.
            ``(2) Content.--A contract or memorandum described under 
        paragraph (1) shall include provisions to ensure adequate 
        training of such officers and employees to conduct such 
        examinations, testing, and investigations. The contract or 
        memorandum shall contain provisions regarding reimbursement. 
        Such provisions may, at the sole discretion of the head of the 
        other department or agency, require reimbursement, in whole or 
        in part, from the Secretary for the examinations, testing, or 
        investigations performed pursuant to this section by the 
        officers or employees of the State, territorial, or tribal 
        department or agency.
            ``(3) Effect.--Nothing in this subsection shall be 
        construed to limit the authority of the Secretary under section 
        702.
    ``(c) Extension Service.--The Secretary shall ensure coordination 
with the extension activities of the National Institute of Food and 
Agriculture of the Department of Agriculture in advising producers and 
small processors transitioning into new practices required as a result 
of the enactment of the FDA Food Safety Modernization Act and assisting 
regulated industry with compliance with such Act.
    ``(d) National Food Safety Training, Education, Extension, Outreach 
and Technical Assistance Program.--
            ``(1) In general.--In order to improve food safety and 
        reduce the incidence of foodborne illness, the Secretary shall, 
        not later than 180 days after the date of enactment of the FDA 
        Food Safety Modernization Act, enter into one or more memoranda 
        of understanding, or enter into other cooperative agreements, 
        with the Secretary of Agriculture to establish a competitive 
        grant program within the National Institute for Food and 
        Agriculture to provide food safety training, education, 
        extension, outreach, and technical assistance to--
                    ``(A) owners and operators of farms;
                    ``(B) small food processors; and
                    ``(C) small fruit and vegetable merchant 
                wholesalers.
            ``(2) Implementation.--The competitive grant program 
        established under paragraph (1) shall be carried out in 
        accordance with section 405 of the Agricultural Research, 
        Extension, and Education Reform Act of 1998.
    ``(e) Authorization of Appropriations.--There are authorized to be 
appropriated such sums as may be necessary to carry out this section 
for fiscal years 2011 through 2015.''.
    (b) National Food Safety Training, Education, Extension, Outreach, 
and Technical Assistance Program.--Title IV of the Agricultural 
Research, Extension, and Education Reform Act of 1998 is amended by 
inserting after section 404 (7 U.S.C. 7624) the following:

``SEC. 405. NATIONAL FOOD SAFETY TRAINING, EDUCATION, EXTENSION, 
              OUTREACH, AND TECHNICAL ASSISTANCE PROGRAM.

    ``(a) In General.--The Secretary shall award grants under this 
section to carry out the competitive grant program established under 
section 1011(d) of the Federal Food, Drug, and Cosmetic Act, pursuant 
to any memoranda of understanding entered into under such section.
    ``(b) Integrated Approach.--The grant program described under 
subsection (a) shall be carried out under this section in a manner that 
facilitates the integration of food safety standards and guidance with 
the variety of agricultural production systems, encompassing 
conventional, sustainable, organic, and conservation and environmental 
practices.
    ``(c) Priority.--In awarding grants under this section, the 
Secretary shall give priority to projects that target small and medium-
sized farms, beginning farmers, socially disadvantaged farmers, small 
processors, or small fresh fruit and vegetable merchant wholesalers.
    ``(d) Program Coordination.--
            ``(1) In general.--The Secretary shall coordinate 
        implementation of the grant program under this section with the 
        National Integrated Food Safety Initiative.
            ``(2) Interaction.--The Secretary shall--
                    ``(A) in carrying out the grant program under this 
                section, take into consideration applied research, 
                education, and extension results obtained from the 
                National Integrated Food Safety Initiative; and
                    ``(B) in determining the applied research agenda 
                for the National Integrated Food Safety Initiative, 
                take into consideration the needs articulated by 
                participants in projects funded by the program under 
                this section.
    ``(e) Grants.--
            ``(1) In general.--In carrying out this section, the 
        Secretary shall make competitive grants to support training, 
        education, extension, outreach, and technical assistance 
        projects that will help improve public health by increasing the 
        understanding and adoption of established food safety 
        standards, guidance, and protocols.
            ``(2) Encouraged features.--The Secretary shall encourage 
        projects carried out using grant funds under this section to 
        include co-management of food safety, conservation systems, and 
        ecological health.
            ``(3) Maximum term and size of grant.--
                    ``(A) In general.--A grant under this section shall 
                have a term that is not more than 3 years.
                    ``(B) Limitation on grant funding.--The Secretary 
                may not provide grant funding to an entity under this 
                section after such entity has received 3 years of grant 
                funding under this section.
    ``(f) Grant Eligibility.--
            ``(1) In general.--To be eligible for a grant under this 
        section, an entity shall be--
                    ``(A) a State cooperative extension service;
                    ``(B) a Federal, State, local, or tribal agency, a 
                nonprofit community-based or non-governmental 
                organization, or an organization representing owners 
                and operators of farms, small food processors, or small 
                fruit and vegetable merchant wholesalers that has a 
                commitment to public health and expertise in 
                administering programs that contribute to food safety;
                    ``(C) an institution of higher education (as 
                defined in section 101(a) of the Higher Education Act 
                of 1965 (20 U.S.C. 1001(a))) or a foundation maintained 
                by an institution of higher education;
                    ``(D) a collaboration of 2 of more eligible 
                entities described in this subsection; or
                    ``(E) such other appropriate entity, as determined 
                by the Secretary.
            ``(2) Multistate partnerships.--Grants under this section 
        may be made for projects involving more than 1 State.
    ``(g) Regional Balance.--In making grants under this section, the 
Secretary shall, to the maximum extent practicable, ensure--
            ``(1) geographic diversity; and
            ``(2) diversity of types of agricultural production.
    ``(h) Technical Assistance.--The Secretary may use funds made 
available under this section to provide technical assistance to grant 
recipients to further the purposes of this section.
    ``(i) Best Practices and Model Programs.--Based on evaluations of, 
and responses arising from, projects funded under this section, the 
Secretary may issue a set of recommended best practices and models for 
food safety training programs for agricultural producers, small food 
processors, and small fresh fruit and vegetable merchant wholesalers.
    ``(j) Authorization of Appropriations.--For the purposes of making 
grants under this section, there are authorized to be appropriated such 
sums as may be necessary for fiscal years 2011 through 2015.''.

SEC. 210. ENHANCING FOOD SAFETY.

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

``SEC. 1009. GRANTS TO ENHANCE FOOD SAFETY.

    ``(a) In General.--The Secretary is authorized to make grants to 
eligible entities to--
            ``(1) undertake examinations, inspections, and 
        investigations, and related food safety activities under 
        section 702;
            ``(2) train to the standards of the Secretary for the 
        examination, inspection, and investigation of food 
        manufacturing, processing, packing, holding, distribution, and 
        importation, including as such examination, inspection, and 
        investigation relate to retail food establishments;
            ``(3) build the food safety capacity of the laboratories of 
        such eligible entity, including the detection of zoonotic 
        diseases;
            ``(4) build the infrastructure and capacity of the food 
        safety programs of such eligible entity to meet the standards 
        as outlined in the grant application; and
            ``(5) take appropriate action to protect the public health 
        in response to--
                    ``(A) a notification under section 1008, including 
                planning and otherwise preparing to take such action; 
                or
                    ``(B) a recall of food under this Act.
    ``(b) Eligible Entities; Application.--
            ``(1) In general.--In this section, the term `eligible 
        entity' means an entity--
                    ``(A) that is--
                            ``(i) a State;
                            ``(ii) a locality;
                            ``(iii) a territory;
                            ``(iv) an Indian tribe (as defined in 
                        section 4(e) of the Indian Self-Determination 
                        and Education Assistance Act); or
                            ``(v) a nonprofit food safety training 
                        entity that collaborates with 1 or more 
                        institutions of higher education; and
                    ``(B) that submits an application to the Secretary 
                at such time, in such manner, and including such 
                information as the Secretary may reasonably require.
            ``(2) Contents.--Each application submitted under paragraph 
        (1) shall include--
                    ``(A) an assurance that the eligible entity has 
                developed plans to engage in the types of activities 
                described in subsection (a);
                    ``(B) a description of the types of activities to 
                be funded by the grant;
                    ``(C) an itemization of how grant funds received 
                under this section will be expended;
                    ``(D) a description of how grant activities will be 
                monitored; and
                    ``(E) an agreement by the eligible entity to report 
                information required by the Secretary to conduct 
                evaluations under this section.
    ``(c) Limitations.--The funds provided under subsection (a) shall 
be available to an eligible entity that receives a grant under this 
section only to the extent such entity funds the food safety programs 
of such entity independently of any grant under this section in each 
year of the grant at a level equal to the level of such funding in the 
previous year, increased by the Consumer Price Index. Such non-Federal 
matching funds may be provided directly or through donations from 
public or private entities and may be in cash or in-kind, fairly 
evaluated, including plant, equipment, or services.
    ``(d) Additional Authority.--The Secretary may--
            ``(1) award a grant under this section in each subsequent 
        fiscal year without reapplication for a period of not more than 
        3 years, provided the requirements of subsection (c) are met 
        for the previous fiscal year; and
            ``(2) award a grant under this section in a fiscal year for 
        which the requirement of subsection (c) has not been met only 
        if such requirement was not met because such funding was 
        diverted for response to 1 or more natural disasters or in 
        other extenuating circumstances that the Secretary may 
        determine appropriate.
    ``(e) Duration of Awards.--The Secretary may award grants to an 
individual grant recipient under this section for periods of not more 
than 3 years. In the event the Secretary conducts a program evaluation, 
funding in the second year or third year of the grant, where 
applicable, shall be contingent on a successful program evaluation by 
the Secretary after the first year.
    ``(f) Progress and Evaluation.--
            ``(1) In general.--The Secretary shall measure the status 
        and success of each grant program authorized under the FDA Food 
        Safety Modernization Act (and any amendment made by such Act), 
        including the grant program under this section. A recipient of 
        a grant described in the preceding sentence shall, at the end 
        of each grant year, provide the Secretary with information on 
        how grant funds were spent and the status of the efforts by 
        such recipient to enhance food safety. To the extent 
        practicable, the Secretary shall take the performance of such a 
        grant recipient into account when determining whether to 
        continue funding for such recipient.
            ``(2) No duplication.--In carrying out paragraph (1), the 
        Secretary shall not duplicate the efforts of the Secretary 
        under other provisions of this Act or the FDA Food Safety 
        Modernization Act that require measurement and review of the 
        activities of grant recipients under either such Act.
    ``(g) Supplement Not Supplant.--Grant funds received under this 
section shall be used to supplement, and not supplant, non-Federal 
funds and any other Federal funds available to carry out the activities 
described in this section.
    ``(h) Authorization of Appropriations.--For the purpose of making 
grants under this section, there are authorized to be appropriated such 
sums as may be necessary for fiscal years 2011 through 2015.''.
    (b) Centers of Excellence.--Part P of the Public Health Service Act 
(42 U.S.C. 280g et seq.) is amended by adding at the end the following:

``SEC. 399V-5. FOOD SAFETY INTEGRATED CENTERS OF EXCELLENCE.

    ``(a) In General.--Not later than 1 year after the date of 
enactment of the FDA Food Safety Modernization Act, the Secretary, 
acting through the Director of the Centers for Disease Control and 
Prevention and in consultation with the working group described in 
subsection (b)(2), shall designate 5 Integrated Food Safety Centers of 
Excellence (referred to in this section as the `Centers of Excellence') 
to serve as resources for Federal, State, and local public health 
professionals to respond to foodborne illness outbreaks. The Centers of 
Excellence shall be headquartered at selected State health departments.
    ``(b) Selection of Centers of Excellence.--
            ``(1) Eligible entities.--To be eligible to be designated 
        as a Center of Excellence under subsection (a), an entity 
        shall--
                    ``(A) be a State health department;
                    ``(B) partner with 1 or more institutions of higher 
                education that have demonstrated knowledge, expertise, 
                and meaningful experience with regional or national 
                food production, processing, and distribution, as well 
                as leadership in the laboratory, epidemiological, and 
                environmental detection and investigation of foodborne 
                illness; and
                    ``(C) provide to the Secretary such information, at 
                such time, and in such manner, as the Secretary may 
                require.
            ``(2) Working group.--Not later than 180 days after the 
        date of enactment of the FDA Food Safety Modernization Act, the 
        Secretary shall establish a diverse working group of experts 
        and stakeholders from Federal, State, and local food safety and 
        health agencies, the food industry, including food retailers 
        and food manufacturers, consumer organizations, and academia to 
        make recommendations to the Secretary regarding designations of 
        the Centers of Excellence.
            ``(3) Additional centers of excellence.--The Secretary may 
        designate eligible entities to be regional Food Safety Centers 
        of Excellence, in addition to the 5 Centers designated under 
        subsection (a).
    ``(c) Activities.--Under the leadership of the Director of the 
Centers for Disease Control and Prevention, each Center of Excellence 
shall be based out of a selected State health department, which shall 
provide assistance to other regional, State, and local departments of 
health through activities that include--
            ``(1) providing resources, including timely information 
        concerning symptoms and tests, for frontline health 
        professionals interviewing individuals as part of routine 
        surveillance and outbreak investigations;
            ``(2) providing analysis of the timeliness and 
        effectiveness of foodborne disease surveillance and outbreak 
        response activities;
            ``(3) providing training for epidemiological and 
        environmental investigation of foodborne illness, including 
        suggestions for streamlining and standardizing the 
        investigation process;
            ``(4) establishing fellowships, stipends, and scholarships 
        to train future epidemiological and food-safety leaders and to 
        address critical workforce shortages;
            ``(5) training and coordinating State and local personnel;
            ``(6) strengthening capacity to participate in existing or 
        new foodborne illness surveillance and environmental assessment 
        information systems; and
            ``(7) conducting research and outreach activities focused 
        on increasing prevention, communication, and education 
        regarding food safety.
    ``(d) Report to Congress.--Not later than 2 years after the date of 
enactment of the FDA Food Safety Modernization Act, the Secretary shall 
submit to Congress a report that--
            ``(1) describes the effectiveness of the Centers of 
        Excellence; and
            ``(2) provides legislative recommendations or describes 
        additional resources required by the Centers of Excellence.
    ``(e) Authorization of Appropriations.--There is authorized to be 
appropriated such sums as may be necessary to carry out this section.
    ``(f) No Duplication of Effort.--In carrying out activities of the 
Centers of Excellence or other programs under this section, the 
Secretary shall not duplicate other Federal foodborne illness response 
efforts.''.

SEC. 211. IMPROVING THE REPORTABLE FOOD REGISTRY.

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

            TITLE III--IMPROVING THE SAFETY OF IMPORTED FOOD

SEC. 301. FOREIGN SUPPLIER VERIFICATION PROGRAM.

    (a) In General.--Chapter VIII (21 U.S.C. 381 et seq.) is amended by 
adding at the end the following:

``SEC. 805. FOREIGN SUPPLIER VERIFICATION PROGRAM.

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

SEC. 302. VOLUNTARY QUALIFIED IMPORTER PROGRAM.

    Chapter VIII (21 U.S.C. 381 et seq.), as amended by section 301, is 
amended by adding at the end the following:

``SEC. 806. VOLUNTARY QUALIFIED IMPORTER PROGRAM.

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

SEC. 303. AUTHORITY TO REQUIRE IMPORT CERTIFICATIONS FOR FOOD.

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

SEC. 304. PRIOR NOTICE OF IMPORTED FOOD SHIPMENTS.

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

SEC. 305. BUILDING CAPACITY OF FOREIGN GOVERNMENTS WITH RESPECT TO FOOD 
              SAFETY.

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

SEC. 306. INSPECTION OF FOREIGN FOOD FACILITIES.

    (a) In General.--Chapter VIII (21 U.S.C. 381 et seq.), as amended 
by section 302, is amended by inserting at the end the following:

``SEC. 807. INSPECTION OF FOREIGN FOOD FACILITIES.

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

SEC. 307. ACCREDITATION OF THIRD-PARTY AUDITORS.

    Chapter VIII (21 U.S.C. 381 et seq.), as amended by section 306, is 
amended by adding at the end the following:

``SEC. 808. ACCREDITATION OF THIRD-PARTY AUDITORS.

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

SEC. 308. FOREIGN OFFICES OF THE FOOD AND DRUG ADMINISTRATION.

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

SEC. 309. SMUGGLED FOOD.

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

                   TITLE IV--MISCELLANEOUS PROVISIONS

SEC. 401. FUNDING FOR FOOD SAFETY.

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

SEC. 402. EMPLOYEE PROTECTIONS.

    Chapter X of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
391 et seq.), as amended by section 209, is further amended by adding 
at the end the following:

``SEC. 1012. EMPLOYEE PROTECTIONS.

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

SEC. 403. JURISDICTION; AUTHORITIES.

    Nothing in this Act, or an amendment made by this Act, shall be 
construed to--
            (1) alter the jurisdiction between the Secretary of 
        Agriculture and the Secretary of Health and Human Services, 
        under applicable statutes, regulations, or agreements regarding 
        voluntary inspection of non-amenable species under the 
        Agricultural Marketing Act of 1946 (7 U.S.C. 1621 et seq.);
            (2) alter the jurisdiction between the Alcohol and Tobacco 
        Tax and Trade Bureau and the Secretary of Health and Human 
        Services, under applicable statutes and regulations;
            (3) limit the authority of the Secretary of Health and 
        Human Services under--
                    (A) the Federal Food, Drug, and Cosmetic Act (21 
                U.S.C. 301 et seq.) as in effect on the day before the 
                date of enactment of this Act; or
                    (B) the Public Health Service Act (42 U.S.C. 301 et 
                seq.) as in effect on the day before the date of 
                enactment of this Act;
            (4) alter or limit the authority of the Secretary of 
        Agriculture under the laws administered by such Secretary, 
        including--
                    (A) the Federal Meat Inspection Act (21 U.S.C. 601 
                et seq.);
                    (B) the Poultry Products Inspection Act (21 U.S.C. 
                451 et seq.);
                    (C) the Egg Products Inspection Act (21 U.S.C. 1031 
                et seq.);
                    (D) the United States Grain Standards Act (7 U.S.C. 
                71 et seq.);
                    (E) the Packers and Stockyards Act, 1921 (7 U.S.C. 
                181 et seq.);
                    (F) the United States Warehouse Act (7 U.S.C. 241 
                et seq.);
                    (G) the Agricultural Marketing Act of 1946 (7 
                U.S.C. 1621 et seq.); and
                    (H) the Agricultural Adjustment Act (7 U.S.C. 601 
                et seq.), reenacted with the amendments made by the 
                Agricultural Marketing Agreement Act of 1937; or
            (5) alter, impede, or affect the authority of the Secretary 
        of Homeland Security under the Homeland Security Act of 2002 (6 
        U.S.C. 101 et seq.) or any other statute, including any 
        authority related to securing the borders of the United States, 
        managing ports of entry, or agricultural import and entry 
        inspection activities.

SEC. 404. COMPLIANCE WITH INTERNATIONAL AGREEMENTS.

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

SEC. 405. DETERMINATION OF BUDGETARY EFFECTS.

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

            Passed the Senate November 30, 2010.

            Attest:

                                                             Secretary.
111th CONGRESS

  2d Session

                                 S. 510

_______________________________________________________________________

                                 AN ACT

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