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

111th CONGRESS
  1st Session
                                 S. 510

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 3, 2009

 Mr. Durbin (for himself, Mr. Gregg, Mr. Kennedy, Mr. Burr, Mr. Dodd, 
 Mr. Alexander, and Mr. Isakson) introduced the following bill; which 
  was read twice and referred to the Committee on Health, Education, 
                          Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
 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. Final rule for prevention of Salmonella Enteritidis in shell 
                            eggs during production.
Sec. 112. Sanitary transportation of food.
Sec. 113. Food allergy and anaphylaxis management.
   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. Recognition of laboratory accreditation for analyses of 
                            foods.
Sec. 203. Integrated consortium of laboratory networks.
Sec. 204. Enhancing traceback and recordkeeping.
Sec. 205. Surveillance.
Sec. 206. Mandatory recall authority.
Sec. 207. Administrative detention of food.
Sec. 208. Decontamination and disposal standards and plans.
            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. Review of a regulatory authority of a foreign country.
Sec. 306. Building capacity of foreign governments with respect to 
                            food.
Sec. 307. Inspection of foreign food facilities.
Sec. 308. Accreditation of qualified third-party auditors and audit 
                            agents.
Sec. 309. Foreign offices of the Food and Drug Administration.
                   TITLE IV--MISCELLANEOUS PROVISIONS

Sec. 401. Funding for food safety.
Sec. 402. Jurisdiction; authorities.

      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 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 record 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, 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 the facility under this section in accordance with this 
        subsection.
            ``(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 days after the issuance of the 
        order, 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 in a timely manner.
                    ``(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 vacate the order or modify the order.
            ``(4) Effect of suspension.--If the registration of a 
        facility is suspended under this subsection, such facility 
        shall not import food or offer to import food into the United 
        States, or otherwise introduce food into interstate commerce in 
        the United States.
            ``(5) Regulations.--The Secretary shall promulgate 
        regulations that describe the standards officials will use in 
        making a determination to suspend a registration, and the 
        format such officials will use to explain to the registrant the 
        conditions found at the facility.
            ``(6) 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) 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) 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.--Each 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 their occurrence 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, may be 
                unintentionally introduced, or may be intentionally 
                introduced, including by acts of terrorism; and
            ``(2) 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) will be significantly minimized or 
        prevented; and
            ``(2) 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 that a facility will implement 
if the preventive controls implemented under subsection (c) are found 
to be ineffective through monitoring under subsection (d).
    ``(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); 
        and
            ``(4) there is documented, periodic reanalysis of the plan 
        under subsection (i) to ensure that the plan is still relevant 
        to the raw materials, as well as to conditions and processes in 
        the facility, and to 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, instances 
when corrective actions were implemented, and the efficacy of 
preventive controls and corrective actions.
    ``(h) Written Plan and Documentation.--Each 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 to 
address those hazards under subsection (c). Such written plan, together 
with documentation that the plan is being implemented, shall be made 
promptly available to a duly authorized representative of the Secretary 
upon oral or written request.
    ``(i) Requirement To Reanalyze.--Each 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 commenced. 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.
    ``(j) Deemed Compliance of Seafood, Juice, and Low-Acid Canned Food 
Facilities in Compliance With HACCP.--An owner, operator, or agent in 
charge of a facility required to comply with 1 of the following 
standards and regulations with respect to such facility shall be deemed 
to be in compliance with this section, 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).
    ``(k) Exception for Facilities in Compliance With Section 419.--
This section shall not apply to a facility that is subject to section 
419.
    ``(l) 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 or the storage of 
packaged foods that are not exposed to the environment.
    ``(m) 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 it 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 have employed to significantly minimize or prevent the 
        hazards identified under the hazard analysis conducted under 
        subsection (a) 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.
                    ``(D) An allergen control program.
                    ``(E) A recall contingency plan.
                    ``(F) Good Manufacturing Practices (GMPs).
                    ``(G) Supplier verification activities.''.
    (b) Regulations.--
            (1) In general.--The Secretary of Health and Human Services 
        (referred to in this Act as the ``Secretary'') shall promulgate 
        regulations 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 section 418 of the Federal Food, 
        Drug, and Cosmetic Act (as added by subsection (a)).
            (2) Content.--The regulations promulgated under paragraph 
        (1) shall provide sufficient flexibility to be applicable in 
        all situations, including in the operations of small 
        businesses.
            (3) Rule of construction.--Nothing in this subsection shall 
        be construed to provide the Secretary with the authority to 
        apply specific technologies, practices, or critical controls to 
        an individual facility.
            (4) Review.--In promulgating the regulations under 
        paragraph (1), the Secretary shall review regulatory hazard 
        analysis and preventive control programs in existence on the 
        date of enactment of this Act to ensure that the program under 
        such section 418 is consistent, to the extent practicable, with 
        applicable internationally recognized standards in existence on 
        such date.
    (c) Guidance Document.--The Secretary shall issue a guidance 
document related to hazard analysis and preventive controls required 
under section 418 of the Federal Food, Drug, and Cosmetic Act (as added 
by subsection (a)).
    (d) Prohibited Acts.--Section 301 (21 U.S.C. 331) is amended by 
adding at the end the following:
    ``(oo) The operation of a facility that manufacturers, 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.''.
    (e) 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.
    (f) Effective Date.--
            (1) General rule.--The amendments made by this section 
        shall take effect 18 months after the date of enactment of this 
        Act.
            (2) Exceptions.--Notwithstanding paragraph (1)--
                    (A) the amendments made by this section shall apply 
                to a small business (as defined by the Secretary) after 
                the date that is 2 years after the date of enactment of 
                this Act; and
                    (B) the amendments made by this section shall apply 
                to a very small business (as defined by the Secretary) 
                after the date that is 3 years after the date of 
                enactment of this Act.

SEC. 104. PERFORMANCE STANDARDS.

    The Secretary shall, 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, 
to determine the most significant food-borne contaminants and, when 
appropriate to reduce the risk of serious illness or death to humans or 
animals or to prevent the 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 of communicable disease under section 361 of the Public 
Health Service Act (42 U.S.C. 264), shall issue contaminant-specific 
and science-based guidance documents, actions levels, or regulations. 
Such guidance, action levels, or regulations shall apply to products or 
product classes and shall not be written to be facility-specific.

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.--Not later than 1 year after the date of 
        enactment of the FDA Food Safety Modernization Act, the 
        Secretary, in consultation with the Secretary of Agriculture 
        and representatives of State departments of agriculture, 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 that are raw 
        agricultural commodities for which the Secretary has determined 
        that such standards minimize the risk of serious adverse health 
        consequences or death.
            ``(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) include, with respect to growing, harvesting, 
                sorting, and storage operations, minimum standards 
                related to soil amendments, hygiene, packaging, 
                temperature controls, animal encroachment, and water; 
                and
                    ``(B) consider hazards that occur naturally, may be 
                unintentionally introduced, or may be intentionally 
                introduced, including by acts of terrorism.
            ``(4) Prioritization.--The Secretary shall prioritize the 
        implementation of the regulations for specific fruits and 
        vegetables that are raw agricultural commodities that have been 
        associated with food-borne 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 standards for those types 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.
            ``(2) Final regulation.--The final regulation shall--
                    ``(A) provide a reasonable period of time for 
                compliance, taking into account the needs of small 
                businesses for additional time to comply;
                    ``(B) provide for coordination of education and 
                enforcement activities by State and local officials, as 
                designated by the Governors of the respective States; 
                and
                    ``(C) include a description of the variance process 
                under subsection (c) and the types of permissible 
                variances the Secretary may grant.
    ``(c) Criteria.--
            ``(1) In general.--The regulations adopted under subsection 
        (b) shall--
                    ``(A) set forth those procedures, processes, and 
                practices as 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 that are raw 
                agricultural commodities and to provide reasonable 
                assurances that the produce is not adulterated under 
                section 402; and
                    ``(B) permit States and foreign countries from 
                which food is imported into the United States, subject 
                to paragraph (2), to request from the Secretary 
                variances from the requirements of the regulations, 
                where upon approval of the Secretary, the variance is 
                considered permissible under the requirements of the 
                regulations adopted under subsection (b)(2)(C) and 
                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 to the same extent as the 
                requirements of the regulation adopted under subsection 
                (b).
            ``(2) Approval of variances.--A State or foreign country 
        from which food is imported into the United States shall 
        request a variance from the Secretary in writing. The Secretary 
        may deny such a request as not reasonably likely to ensure that 
        the produce is not adulterated under section 402 to the same 
        extent as the requirements of the regulation adopted under 
        subsection (b).
    ``(d) Enforcement.--The Secretary may coordinate with the Secretary 
of Agriculture and 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.--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 and 
representatives of State departments of agriculture, updated good 
agricultural practices and guidance for the safe production and 
harvesting of specific types of fresh produce.
    ``(f) Exception for Facilities in Compliance With Section 418.--
This section shall not apply to a facility that is subject to section 
418.''.
    (b) Prohibited Acts.--Section 301 (21 U.S.C. 331), as amended by 
section 103, is amended by adding at the end the following:
    ``(pp) The production or harvesting of produce not in accordance 
with minimum standards as provided by regulation under section 419(b) 
or a variance issued under section 419(c).''.
    (c) 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) In General.--Not later than 24 months after the date of 
enactment of the FDA Food Safety Modernization Act, the Secretary, in 
consultation with the Secretary of Homeland Security and the Secretary 
of Agriculture, shall promulgate regulations to protect against the 
intentional adulteration of food subject to this Act.
    ``(b) Content of Regulations.--Regulations under subsection (a) 
shall only apply to food--
            ``(1) for which the Secretary has identified clear 
        vulnerabilities (such as short shelf-life or susceptibility to 
        intentional contamination at critical control points);
            ``(2) in bulk or batch form, prior to being packaged for 
        the final consumer; and
            ``(3) for which there is a high risk of intentional 
        contamination, as determined by the Secretary, that could cause 
        serious adverse health consequences or death to humans or 
        animals.
    ``(c) Determinations.--In making the determination under subsection 
(b)(3), the Secretary shall--
            ``(1) conduct vulnerability assessments of the food system;
            ``(2) consider the best available understanding of 
        uncertainties, risks, costs, and benefits associated with 
        guarding against intentional adulteration at vulnerable points; 
        and
            ``(3) determine the types of science-based mitigation 
        strategies or measures that are necessary to protect against 
        the intentional adulteration of food.
    ``(d) Exception.--This section shall not apply to food produced on 
farms, except for 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, 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 document issued under paragraph 
        (1) shall--
                    (A) 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;
                    (B) specify appropriate science-based mitigation 
                strategies or measures to prepare and protect the food 
                supply chain at specific vulnerable points, as 
                appropriate;
                    (C) include a model assessment for a person to use 
                under subparagraph (A);
                    (D) include examples of mitigation strategies or 
                measures described in subparagraph (B); and
                    (E) specify situations in which the examples of 
                mitigation strategies or measures described in 
                subparagraph (D) are appropriate.
            (3) Limited distribution.--In the interest of national 
        security, the Secretary, in consultation with the Secretary of 
        Homeland Security, may determine the time and manner 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 shall periodically review and, 
as appropriate, update the regulation under 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:
    ``(qq) 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 
inserting after section 740 the following:

                     ``PART 5--FEES RELATED TO FOOD

``SEC. 740A. 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) each domestic facility (as defined in section 
                415(b)) subject to a reinspection in such fiscal year, 
                to cover reinspection-related costs for such year;
                    ``(B) each domestic facility (as defined in section 
                415(b)) and importer subject to a food recall in such 
                fiscal year, to cover food recall activities 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 such program 
                for such year; and
                    ``(D) each importer subject to a reinspection in 
                such fiscal year at a port of entry, to cover 
                reinspection-related costs at ports of entry 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; and
                    ``(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.
    ``(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(e) 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.
            ``(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.
            ``(4) Compliance with international agreements.--Nothing in 
        this section shall be construed to authorize the assessment of 
        any fee inconsistent with the agreement establishing the World 
        Trade Organization or any other treaty or international 
        agreement to which the United States is a party.
    ``(c) Limitations.--
            ``(1) In general.--Fees under subsection (a) shall be 
        refunded for a fiscal year beginning after fiscal year 2010 
        unless appropriations for the Center for Food Safety and 
        Applied Nutrition and the Center for Veterinary Medicine and 
        related activities of the Office of Regulatory Affairs at the 
        Food and Drug Administration for such fiscal year (excluding 
        the amount of fees appropriated for such fiscal year) are equal 
        to or greater than the amount of appropriations for the Center 
        for Food Safety and Applied Nutrition and the Center for 
        Veterinary Medicine and related activities of the Office of 
        Regulatory Affairs at the Food and Drug Administration for the 
        preceding fiscal year (excluding the amount of fees 
        appropriated for such fiscal year) multiplied by 1 plus 4.5 
        percent.
            ``(2) Authority.--If the Secretary does not assess fees 
        under subsection (a) during any portion of a fiscal year 
        because of paragraph (1) and if at a later date in such fiscal 
        year the Secretary may assess such fees, the Secretary may 
        assess and collect such fees, without any modification in the 
        rate, under subsection (a), notwithstanding the provisions of 
        subsection (a) relating to the date fees are to be paid.
            ``(3) 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 United States Senate and the Committee on 
Energy and Commerce of the United States 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 submit to 
        the relevant committees of Congress, and make publicly 
        available on the Internet Web site 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 and food production;
                            (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.

SEC. 109. FOOD AND AGRICULTURE COORDINATING COUNCILS.

    The Secretary of Homeland Security, in consultation 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 unify 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 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 security 
        of food and to prevent outbreaks of food-borne 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 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 food-borne 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.
            (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 (G) 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 techniques that can be employed at ports of entry 
and through Food Emergency Response Network laboratories, and to 
provide for well-equipped and staffed laboratory facilities.
    (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 food-borne 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) of the Federal Food, Drug, and Cosmetic 
Act (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, outbreak identification, and 
traceback.
    (g) Biennial Food Safety and Food Defense Research Plan.--The 
Secretary and the Secretary of Agriculture 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 food-borne 
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 following 2-year period.

SEC. 111. FINAL RULE FOR PREVENTION OF SALMONELLA ENTERITIDIS IN SHELL 
              EGGS DURING PRODUCTION.

    Not later than 1 year after the date of enactment of this Act, the 
Secretary shall issue a final rule based on the proposed rule issued by 
the Commissioner of Food and Drugs entitled ``Prevention of Salmonella 
Enteritidis in Shell Eggs During Production'', 69 Fed. Reg. 56824, 
(September 22, 2004).

SEC. 112. SANITARY TRANSPORTATION OF FOOD.

    Not later than 1 year 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)).

SEC. 113. 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 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 2010 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).

   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 allocate 
        resources to inspect facilities according to the risk profile 
        of the facilities, which shall be based on the following 
        factors:
                    ``(A) The risk profile of the food manufactured, 
                processed, packed, or held at the facility.
                    ``(B) The facility's history of food recalls, 
                outbreaks, and violations of food safety standards.
                    ``(C) The rigor of the facility's hazard analysis 
                and risk-based preventive controls.
                    ``(D) Whether the food manufactured, processed, 
                packed, handled, prepared, treated, distributed, or 
                stored at the facility meets the criteria for priority 
                under section 801(h)(1).
                    ``(E) Whether the facility has received a 
                certificate as described in section 809(b).
                    ``(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) High-risk facilities.--The Secretary shall 
                increase the frequency of inspection of facilities 
                identified under paragraph (1) as high-risk facilities 
                such that--
                            ``(i) for the first 2 years after the date 
                        of enactment of the FDA Food Safety 
                        Modernization Act, each high-risk facility is 
                        inspected not less often than once every 2 
                        years; and
                            ``(ii) for each succeeding year, each high-
                        risk facility is inspected not less often than 
                        once each year.
                    ``(C) Non-high-risk facilities.--The Secretary 
                shall ensure that each facility that is not identified 
                under paragraph (1) as a high-risk facility is 
                inspected not less often than once every 4 years.
    ``(b) Identification and Inspection at Ports of Entry.--The 
Secretary, in consultation with the Secretary of Homeland Security, 
shall allocate resources to inspect articles of food imported into the 
United States according to the risk profile of the article of food, 
which shall be based on the following factors:
            ``(1) The risk profile of the food imported.
            ``(2) The risk profile of the countries of origin and 
        countries of transport of the food imported.
            ``(3) The history of food recalls, outbreaks, and 
        violations of food safety standards of the food importer.
            ``(4) The rigor 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 is from a facility that has received 
        a certificate as described in section 809(b).
            ``(8) Any other criteria deemed appropriate by the 
        Secretary for purposes of allocating inspection resources.
    ``(c) Coordination.--The Secretary shall improve coordination and 
cooperation with the Secretary of Agriculture to target food inspection 
resources.
    ``(d) 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 903 (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 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 the Secretary did not inspect in the 
                previous fiscal 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 the Secretary did not 
                inspect in the previous fiscal 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 food line subject to this Act that is 
                imported or offered for import into the United States; 
                and
            ``(3) information on the foreign offices established under 
        section 309 of the FDA Food Safety Modernization Act 
        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.''.

SEC. 202. RECOGNITION OF 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. RECOGNITION OF 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) provide for the recognition of accreditation 
                bodies that accredit laboratories, including 
                laboratories run and operated by a State or locality, 
                with a demonstrated capability to conduct analytical 
                testing of food products; and
                    ``(B) establish a publicly available registry of 
                accreditation bodies, including the name of, contact 
                information for, and other information deemed necessary 
                by the Secretary about such bodies.
            ``(2) Foreign laboratories.--Accreditation bodies 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.
            ``(3) Model accreditation standards.--The Secretary shall 
        develop model standards that an accreditation body shall 
        require laboratories to meet in order to be included in the 
        registry provided for under paragraph (1). In developing the 
        model standards, the Secretary shall look to existing standards 
        for guidance. The model standards shall include methods to 
        ensure that--
                    ``(A) appropriate sampling and analytical 
                procedures are followed and reports of analyses are 
                certified as true and accurate;
                    ``(B) internal quality systems are established and 
                maintained;
                    ``(C) procedures exist to evaluate and respond 
                promptly to complaints regarding analyses and other 
                activities for which the laboratory is recognized;
                    ``(D) individuals who conduct the analyses are 
                qualified by training and experience to do so; and
                    ``(E) any other criteria determined appropriate by 
                the Secretary.
            ``(4) Review of accreditation.--To assure compliance with 
        the requirements of this section, the Secretary shall--
                    ``(A) periodically, or at least every 5 years, 
                reevaluate accreditation bodies recognized under 
                paragraph (1); and
                    ``(B) promptly revoke the recognition of any 
                accreditation body found not to be in compliance with 
                the requirements of this section.
    ``(b) Testing Procedures.--
            ``(1) In general.--Food testing shall be conducted by 
        either Federal laboratories or non-Federal laboratories that 
        have been accredited by an accreditation body on the registry 
        established by the Secretary under subsection (a) whenever such 
        testing is either conducted by or on behalf of an owner or 
        consignee--
                    ``(A) in support of admission of an article of food 
                under section 801(a);
                    ``(B) due to a specific testing requirement in this 
                Act or implementing regulations, when applied to 
                address an identified or suspected food safety problem;
                    ``(C) under an Import Alert that requires 
                successful consecutive tests; or
                    ``(D) is so required by the Secretary as the 
                Secretary deems appropriate to address an identified or 
                suspected food safety problem.
            ``(2) Results of testing.--The results of any such testing 
        shall be sent directly to the Food and Drug Administration. 
        Such results may be submitted to the Food and Drug 
        Administration through electronic means.
    ``(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 an 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 
        food laboratories, including the sharing of data between 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 
consultation with the Secretary of Health and Human Services, the 
Secretary of Agriculture, 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 
        facilitate the sharing of knowledge and information relating to 
        animal health, agriculture, and human health;
            (2) identify the means by which each laboratory network 
        member 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 TRACEBACK AND RECORDKEEPING.

    (a) In General.--The Secretary, in consultation with the Secretary 
of Agriculture and representatives of State departments of health and 
agriculture, shall improve the capacity of the Secretary to effectively 
and rapidly track and trace, in the event of an outbreak, fruits and 
vegetables that are raw agricultural commodities.
    (b) Pilot Project.--
            (1) In general.--Not later than 9 months after the date of 
        enactment of this Act, the Secretary shall establish a pilot 
        project in coordination with the produce industry to explore 
        and evaluate methods for rapidly and effectively tracking and 
        tracing fruits and vegetables that are raw agricultural 
        commodities so that, if an outbreak occurs involving such a 
        fruit or vegetable, the Secretary may quickly identify the 
        source of the outbreak and the recipients of the contaminated 
        food.
            (2) Content.--The Secretary shall select participants from 
        the produce industry to run projects which overall shall 
        include at least 3 different types of fruits or vegetables that 
        have been the subject of outbreaks during the 5-year period 
        preceding the date of enactment of this Act, and shall be 
        selected in order to develop and demonstrate--
                    (A) methods that are applicable and appropriate for 
                small businesses; and
                    (B) technologies, including existing technologies, 
                that enhance traceback and trace forward.
    (c) 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 project under subsection (b) together with recommendations 
for establishing more effective traceback and trace forward procedures 
for fruits and vegetables that are raw agricultural commodities.
    (d) Traceback Performance Requirements.--Not later than 24 months 
after the date of enactment of this Act, the Secretary shall publish a 
notice of proposed rulemaking to establish standards for the type of 
information, format, and timeframe for persons to submit records to aid 
the Secretary in effectively and rapidly tracking and tracing, in the 
event of an outbreak, fruits and vegetables that are raw agricultural 
commodities. Nothing in this section shall be construed as giving the 
Secretary the authority to prescribe specific technologies for the 
maintenance of records.
    (e) Public Input.--During the comment period in the notice of 
proposed rulemaking under subsection (d), 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.
    (f) Raw Agricultural Commodity.--In this section, the term ``raw 
agricultural commodity'' has the meaning given that term in section 
201(r) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(r)).

SEC. 205. SURVEILLANCE.

    (a) Definition of Food-Borne Illness Outbreak.--In this section, 
the term ``food-borne illness outbreak'' means the occurrence of 2 or 
more cases of a similar illness resulting from the ingestion of a food.
    (b) Food-Borne Illness Surveillance Systems.--
            (1) In general.--The Secretary, acting through the Director 
        of the Centers for Disease Control and Prevention, shall 
        enhance food-borne illness surveillance systems to improve the 
        collection, analysis, reporting, and usefulness of data on 
        food-borne illnesses by--
                    (A) coordinating Federal, State and local food-
                borne 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 findings on a more 
                timely basis among governmental agencies, including the 
                Food and Drug Administration, the Department of 
                Agriculture, 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 food-borne illness outbreak to a specific food;
                    (E) expanding capacity of such systems, including 
                working toward automatic electronic searches, for 
                implementation of fingerprinting strategies for food-
                borne infectious agents, in order to identify new or 
                rarely documented causes of food-borne 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 food-borne illness surveillance 
                systems and data with other biosurveillance and public 
                health situational awareness capabilities at the 
                Federal, State, and local levels; and
                    (J) other activities as determined appropriate by 
                the Secretary.
            (2) Partnerships.--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 industry, 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 food-borne 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 food-borne 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 food-
                borne illness surveillance data collected by government 
                agencies at all levels, including data compiled by the 
                Centers for Disease Control and Prevention;
                    (D) key barriers to improvement in food-borne 
                illness surveillance and its utility for preventing 
                food-borne illness at Federal, State, and local levels;
                    (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.
    (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 food-borne illness outbreak response 
                and containment.
                    (B) Accelerate food-borne 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 food-
                borne 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 2014''.

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.--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--
            ``(1) immediately cease distribution of such article; or
            ``(2) immediately notify all persons--
                    ``(A) manufacturing, processing, packing, 
                transporting, distributing, receiving, holding, or 
                importing and selling such article; and
                    ``(B) to which such article has been distributed, 
                transported, or sold, to immediately cease distribution 
                of such article.
    ``(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) Cooperation and Consultation.--The Secretary shall work with 
State and local public health officials in carrying out this section, 
as appropriate.
    ``(f) 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; and
                            ``(ii) a description of the risk associated 
                        with such article; and
            ``(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.
    ``(g) 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.
    ``(h) Effect.--Nothing in this section shall affect the authority 
of the Secretary to request or participate in a voluntary recall.''.
    (b) 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)''.
    (c) 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:
    ``(rr) The refusal or failure to follow an order under section 
423.''.

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.

            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.--Each United States 
        importer shall perform risk-based foreign supplier verification 
        activities in accordance with regulations promulgated under 
        subsection (c) for the purpose of verifying that the food 
        imported by the importer or its agent is--
                    ``(A) produced in compliance with the requirements 
                of section 418 or 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 United States 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). Such regulations shall, as 
        appropriate, include a process for verification by a United 
        States importer, with respect to each foreign supplier from 
        which it obtains food, that the imported food is produced in 
        compliance with the requirements of section 418 or 419, as 
        appropriate, and is not adulterated under section 402 or 
        misbranded under section 403(w).
            ``(2) Verification.--The regulations under paragraph (1) 
        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 
        employing processes and procedures, including risk-based 
        reasonably appropriate preventive controls, equivalent in 
        preventing adulteration and reducing hazards as those required 
        by section 418 or section 419, as appropriate.
            ``(3) 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 a United States 
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) Deemed Compliance of Seafood, Juice, and Low-Acid Canned Food 
Facilities in Compliance With HACCP.--An owner, operator, or agent in 
charge of a facility required to comply with 1 of the following 
standards and regulations with respect to such facility shall be deemed 
to be in compliance with this section 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).
    ``(f) 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 206, is amended by adding at the end the following:
    ``(ss) 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 1 year after the date 
of enactment of the FDA Food Safety Modernization Act, the Secretary 
shall--
            ``(1) establish a program, in consultation with the 
        Department of Homeland Security, to provide for the expedited 
        review and importation of food offered for importation by 
        United States importers who have voluntarily agreed to 
        participate in such program; and
            ``(2) issue a guidance document related to participation 
        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 procedures established 
by the Secretary.
    ``(c) Eligibility.--In order to be eligible, an importer shall be 
offering food for importation from a facility that has a certification 
described in section 809(b). In reviewing the applications and making 
determinations on such requests, the Secretary shall consider the risk 
of the food to be imported based on factors, such as the following:
            ``(1) The nature of the food to be imported.
            ``(2) The compliance history of the foreign supplier.
            ``(3) The capability of the regulatory system of the 
        country of export to ensure compliance with United States food 
        safety standards.
            ``(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.
    ``(d) 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.
    ``(e) 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 to the Secretary of such intent at time and in a manner 
established by the Secretary.
    ``(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 (p) that such food be 
accompanied by a certification or other assurance that the food meets 
some or all 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:
    ``(p) Certifications Concerning Imported Foods.--
            ``(1) In general.--The Secretary, based on public health 
        considerations, including risks associated with the food or its 
        place of origin, 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 specified in paragraph 
        (2) provide a certification or such other assurances as the 
        Secretary determines appropriate that the article of food 
        complies with some or all applicable requirements of this Act, 
        as specified by the Secretary. Such certification or assurances 
        may be provided in the form of shipment-specific certificates, 
        a listing of certified entities, or in such other form as the 
        Secretary may specify. Such certification shall be used for 
        designated food imported from countries with which the Food and 
        Drug Administration has an agreement to establish a 
        certification program.
            ``(2) 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 such 
                government or the Secretary; or
                    ``(B) such other persons or entities accredited 
                pursuant to section 809 to provide such certification 
                or assurance.
            ``(3) 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 no longer valid or 
                reliable.
            ``(4) Electronic submission.--The Secretary shall provide 
        for the electronic submission of certifications under this 
        subsection.
            ``(5) 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.''.
    (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 random 
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. REVIEW OF A REGULATORY AUTHORITY OF A FOREIGN COUNTRY.

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

``SEC. 807. REVIEW OF A REGULATORY AUTHORITY OF A FOREIGN COUNTRY.

    ``The Secretary may review information from a country outlining the 
statutes, regulations, standards, and controls of such country, and 
conduct on-site audits in such country to verify the implementation of 
those statutes, regulations, standards, and controls. Based on such 
review, the Secretary shall determine whether such country can provide 
reasonable assurances that the food supply of the country is equivalent 
in safety to food manufactured, processed, packed, or held in the 
United States.''.

SEC. 306. BUILDING CAPACITY OF FOREIGN GOVERNMENTS WITH RESPECT TO 
              FOOD.

    (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 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, and the Secretary of Commerce, 
representatives of the food industry, appropriate foreign government 
officials, and 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 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 to harmonize requirements under the 
        Codex Alimentarius.
            (6) Provisions for the multilateral acceptance of 
        laboratory methods and detection techniques.

SEC. 307. INSPECTION OF FOREIGN FOOD FACILITIES.

    Chapter VIII (21 U.S.C. 381 et seq.), as amended by section 305, is 
amended by inserting at the end the following:

``SEC. 808. 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 facility registered under section 415 of 
which the owner, operator, or agent in charge of the facility, or the 
government of the foreign country, refuses to permit entry of United 
States inspectors, upon request, to inspect such facility. 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 refuses such a request to inspect a facility more than 
48 hours after such request is submitted.''.

SEC. 308. ACCREDITATION OF THIRD-PARTY AUDITORS AND AUDIT AGENTS.

    Chapter VIII (21 U.S.C. 381 et seq.), as amended by section 307, is 
amended by adding at the end the following:

``SEC. 809. ACCREDITATION OF THIRD-PARTY AUDITORS AND AUDIT AGENTS.

    ``(a) Definitions.--In this section:
            ``(1) Accredited audit agent.--The term `accredited audit 
        agent' means an audit agent accredited by an accreditation body 
        under this section.
            ``(2) Audit agent.--The term `audit agent' means an 
        individual who is qualified to conduct food safety audits, and 
        who may be an employee or an agent of a third-party auditor.
            ``(3) Accreditation body.--The term `accreditation body' 
        means a recognized authority that performs accreditation of 
        third-party auditors and audit agents.
            ``(4) Accredited third-party auditor.--The term `accredited 
        third-party auditor' means a third-party auditor accredited by 
        an accreditation body under 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 
                facility purposes only.
            ``(6) Eligible entity.--The term `eligible entity' means a 
        foreign entity, including foreign facilities registered under 
        section 415, in the food import supply chain that chooses to be 
        audited by an accredited third-party auditor or audit agent.
            ``(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 entity is eligible to 
                        receive a certification under section 801(p); 
                        and
                            ``(ii) whether the entity is eligible to 
                        participate in the voluntary qualified importer 
                        program under section 806.
            ``(8) Third-party auditor.--The term `third-party auditor' 
        means a foreign government, foreign cooperative, or any other 
        qualified third party, as the Secretary determines appropriate, 
        that conducts audits of eligible entities to certify that such 
        eligible entities meet the applicable requirements of this 
        section.
    ``(b) Accreditation System.--
            ``(1) Accreditation bodies.--
                    ``(A) Recognition of accreditation bodies.--
                Beginning 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 and audit agents to certify that eligible 
                entities meet the applicable requirements of this Act.
                    ``(B) Notification.--Each accreditation body 
                recognized by the Secretary shall submit to the 
                Secretary a list of all accredited third-party auditors 
                and audit agents accredited by such body.
                    ``(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.
            ``(2) Model accreditation standards.--The Secretary shall 
        develop model standards, including audit report requirements, 
        and each recognized accreditation body shall ensure that third-
        party auditors and audit agents meet such standards in order to 
        qualify as an accredited third-party auditor or audit agent 
        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 and Audit Agencies.--
            ``(1) Requirements for accreditation as a third-party 
        auditor or audit agent.--
                    ``(A) Foreign governments.--Prior to accrediting a 
                foreign government as an accredited third-party 
                auditor, the accreditation body shall perform such 
                reviews and audits of food safety programs, systems, 
                and standards of the government as the Secretary deems 
                necessary to determine that the foreign government is 
                capable of adequately ensuring that eligible entities 
                certified by such government meet the requirements of 
                this Act with respect to food manufactured, processed, 
                packed, or held for import to 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 that the Secretary determines 
                appropriate to be an accredited third-party auditor or 
                audit agent, the accreditation body shall perform such 
                reviews and audits of the training and qualifications 
                of auditors 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 to determine that each 
                eligible entity certified by the cooperative or party 
                has systems and standards in use to ensure that such 
                entity meets the requirements of this Act.
            ``(2) Requirement to issue certification of eligible 
        entities.--
                    ``(A) In general.--An accreditation body may not 
                accredit a third-party auditor or audit agent unless 
                such third-party auditor or audit agent agrees to issue 
                a written and electronic certification to accompany 
                each food shipment for import into the United States 
                from an eligible entity certified by the third-party 
                auditor or audit agent, subject to requirements set 
                forth by the Secretary. The Secretary shall consider 
                such certificates when targeting inspection resources 
                under section 421.
                    ``(B) Purpose of certification.--The Secretary 
                shall use evidence of certification provided by 
                accredited third-party auditors and audit agents--
                            ``(i) to determined the eligibility of an 
                        importer to receive a certification under 
                        section 801(p); and
                            ``(ii) determine the eligibility of an 
                        importer to participate in the voluntary 
                        qualified importer program under section 806.
            ``(3) Audit report requirements.--
                    ``(A) Requirements in general.--As a condition of 
                accreditation, an accredited third-party auditor or 
                audit agent shall prepare the audit report for an 
                audit, 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 info required by the 
                        Secretary that relate to or may influence an 
                        assessment of compliance with this Act.
                    ``(B) Submission of reports to the secretary.--
                            ``(i) In general.--Following any 
                        accreditation of a third-party auditor or audit 
                        agent, the Secretary may, at any time, require 
                        the accredited third-party auditor or audit 
                        agent 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. Such 
                        report may include documentation that the 
                        eligible entity is in compliance with any 
                        applicable registration requirements.
                            ``(ii) Limitation.--The requirement under 
                        clause (i) shall not include any report or 
                        other documents resulting from a consultative 
                        audit by the accredited third-party auditor or 
                        audit agent, except that the Secretary may 
                        access the results of a consultative audit in 
                        accordance with section 414.
            ``(4) Requirements of audit agents.--
                    ``(A) Risks to public health.--If, at any time 
                during an audit, an accredited audit agent discovers a 
                condition that could cause or contribute to a serious 
                risk to the public health, the audit agent 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 audit agent 
                may perform consultative and regulatory audits of 
                eligible entities.
                    ``(C) Limitations.--An accredited audit agent 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 24-month period.
            ``(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 accredited audit agent 
                shall--
                            ``(i) not own or operate an eligible entity 
                        to be certified 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 certified 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 
                ensure that there are protections against conflicts of 
                interest between an accredited third-party auditor or 
                audit agent and the eligible entity to be certified by 
                such auditor or audit agent. Such regulations shall 
                include--
                            ``(i) requiring that audits performed under 
                        this section be unannounced;
                            ``(ii) a structure, including timing and 
                        public disclosure, for fees paid by eligible 
                        entities to accredited third-party auditors or 
                        audit agents to decrease the potential for 
                        conflicts of interest; and
                            ``(iii) appropriate limits on financial 
                        affiliations between an accredited third-party 
                        auditor or audit agent and any person that owns 
                        or operates an eligible entity to be certified 
                        by such auditor or audit agent.
            ``(6) Withdrawal of accreditation.--The Secretary shall 
        withdraw accreditation from an accredited third-party auditor 
        or audit agent--
                    ``(A) if food from an eligible entity certified by 
                such third-party auditor or audit agent is linked to an 
                outbreak of human or animal illness;
                    ``(B) following a performance audit and finding by 
                the Secretary that the third-party auditor or audit 
                agent no longer meets the requirements for 
                accreditation; or
                    ``(C) 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.
            ``(7) Neutralizing costs.--The Secretary shall establish a 
        method, similar to the method used by the Department of 
        Agriculture, by which accredited third-party auditors and audit 
        agents 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.
    ``(d) Recertification of Eligible Entities.--An eligible entity 
shall apply for annual recertification by an accredited third-party 
auditor or audit agent if such entity--
            ``(1) intends to participate in voluntary qualified 
        importer program under section 806; or
            ``(2) must provide to the Secretary a certification under 
        section 801(p) 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 or an audit 
        agent 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, audit 
        the performance of each accredited third-party auditor and 
        audit agent, through the review of audit reports by such 
        auditors and audit agents, the compliance history as available 
        of eligible entities certified by such auditors and audit 
        agents, 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 or audit 
        agent, with or without the auditor or audit agent 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 and audit agents, including the name of, contact 
information for, and other information deemed necessary by the 
Secretary about such bodies, auditors, and agents.
    ``(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. 309. FOREIGN OFFICES OF THE FOOD AND DRUG ADMINISTRATION.

    (a) In General.--The Secretary shall by October 1, 2010, establish 
an office of the Food and Drug Administration in not less than 5 
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 
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 under subsection (a), 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.

                   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--
            (1) $825,000,000 for fiscal year 2010; and
            (2) such sums as may be necessary for fiscal years 2011 
        through 2014.
    (b) Increased Number of Field Staff.--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--
            (1) 3,800 staff members in fiscal year 2010;
            (2) 4,000 staff members in fiscal year 2011;
            (3) 4,200 staff members in fiscal year 2012;
            (4) 4,600 staff members in fiscal year 2013; and
            (5) 5,000 staff members in fiscal year 2014.

SEC. 402. 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 and regulations;
            (2) limit the authority of the Secretary of Health and 
        Human Services to issue regulations related to the safety of 
        food 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; or
            (3) impede, minimize, or affect the authority of the 
        Secretary of Agriculture to prevent, control, or mitigate a 
        plant or animal health emergency, or a food emergency involving 
        products regulated under the Federal Meat Inspection Act, the 
        Poultry Products Inspection Act, or the Egg Products Inspection 
        Act.
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