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

                                                       Calendar No. 247
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, Mr. Isakson, Ms. Klobuchar, Mr. Chambliss, Mr. Burris, 
Mr. Udall of New Mexico, Mrs. Gillibrand, Mr. Hatch, Mr. Bingaman, Mr. 
  Harkin, and Mr. Enzi) introduced the following bill; which was read 
 twice and referred to the Committee on Health, Education, Labor, and 
                                Pensions

                           December 18, 2009

               Reported by Mr. Harkin, with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 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,

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

<DELETED>    (a) Short Title.--This Act may be cited as the ``FDA Food 
Safety Modernization Act''.</DELETED>
<DELETED>    (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.).</DELETED>
<DELETED>    (c) Table of Contents.--The table of contents for this Act 
is as follows:</DELETED>

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

<DELETED>Sec. 101. Inspections of records.
<DELETED>Sec. 102. Registration of food facilities.
<DELETED>Sec. 103. Hazard analysis and risk-based preventive controls.
<DELETED>Sec. 104. Performance standards.
<DELETED>Sec. 105. Standards for produce safety.
<DELETED>Sec. 106. Protection against intentional adulteration.
<DELETED>Sec. 107. Authority to collect fees.
<DELETED>Sec. 108. National agriculture and food defense strategy.
<DELETED>Sec. 109. Food and Agriculture Coordinating Councils.
<DELETED>Sec. 110. Building domestic capacity.
<DELETED>Sec. 111. Final rule for prevention of Salmonella Enteritidis 
                            in shell eggs during production.
<DELETED>Sec. 112. Sanitary transportation of food.
<DELETED>Sec. 113. Food allergy and anaphylaxis management.
  <DELETED>TITLE II--IMPROVING CAPACITY TO DETECT AND RESPOND TO FOOD 
                            SAFETY PROBLEMS

<DELETED>Sec. 201. Targeting of inspection resources for domestic 
                            facilities, foreign facilities, and ports 
                            of entry; annual report.
<DELETED>Sec. 202. Recognition of laboratory accreditation for analyses 
                            of foods.
<DELETED>Sec. 203. Integrated consortium of laboratory networks.
<DELETED>Sec. 204. Enhancing traceback and recordkeeping.
<DELETED>Sec. 205. Surveillance.
<DELETED>Sec. 206. Mandatory recall authority.
<DELETED>Sec. 207. Administrative detention of food.
<DELETED>Sec. 208. Decontamination and disposal standards and plans.
       <DELETED>TITLE III--IMPROVING THE SAFETY OF IMPORTED FOOD

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

<DELETED>Sec. 401. Funding for food safety.
<DELETED>Sec. 402. Jurisdiction; authorities.

      <DELETED>TITLE I--IMPROVING CAPACITY TO PREVENT FOOD SAFETY 
                           PROBLEMS</DELETED>

<DELETED>SEC. 101. INSPECTIONS OF RECORDS.</DELETED>

<DELETED>    (a) In General.--Section 414(a) (21 U.S.C. 350c(a)) is 
amended--</DELETED>
        <DELETED>    (1) by striking the heading and all follows 
        through ``of food is'' and inserting the following: ``Records 
        Inspection.--</DELETED>
        <DELETED>    ``(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'';</DELETED>
        <DELETED>    (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'';</DELETED>
        <DELETED>    (3) by striking the last sentence; and</DELETED>
        <DELETED>    (4) by inserting at the end the 
        following:</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.''.</DELETED>
<DELETED>    (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''.</DELETED>

<DELETED>SEC. 102. REGISTRATION OF FOOD FACILITIES.</DELETED>

<DELETED>    (a) Updating of Food Category Regulations; Biennial 
Registration Renewal.--Section 415(a) (21 U.S.C. 350d(a)) is amended--
</DELETED>
        <DELETED>    (1) in paragraph (2), by--</DELETED>
                <DELETED>    (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</DELETED>
                <DELETED>    (B) inserting ``, or any other food 
                categories as determined appropriate by the Secretary, 
                including by guidance)'' after ``Code of Federal 
                Regulations'';</DELETED>
        <DELETED>    (2) by redesignating paragraphs (3) and (4) as 
        paragraphs (4) and (5), respectively; and</DELETED>
        <DELETED>    (3) by inserting after paragraph (2) the 
        following:</DELETED>
        <DELETED>    ``(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.''.</DELETED>
<DELETED>    (b) Suspension of Registration.--</DELETED>
        <DELETED>    (1) In general.--Section 415 (21 U.S.C. 350d) is 
        amended--</DELETED>
                <DELETED>    (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.'';</DELETED>
                <DELETED>    (B) by redesignating subsections (b) and 
                (c) as subsections (c) and (d), respectively; 
                and</DELETED>
                <DELETED>    (C) by inserting after subsection (a) the 
                following:</DELETED>
<DELETED>    ``(b) Suspension of Registration.--</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(3) Post-hearing corrective action plan; 
        vacating of order.--</DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.''.</DELETED>
        <DELETED>    (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''.</DELETED>
<DELETED>    (c) Conforming Amendments.--</DELETED>
        <DELETED>    (1) Section 301(d) (21 U.S.C. 331(d)) is amended 
        by inserting ``415,'' after ``404,''.</DELETED>
        <DELETED>    (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)''.</DELETED>

<DELETED>SEC. 103. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE 
              CONTROLS.</DELETED>

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

<DELETED>``SEC. 418. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE 
              CONTROLS.</DELETED>

<DELETED>    ``(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.</DELETED>
<DELETED>    ``(b) Hazard Analysis.--The owner, operator, or agent in 
charge of a facility shall--</DELETED>
        <DELETED>    ``(1) identify and evaluate known or reasonably 
        foreseeable hazards that may be associated with the facility, 
        including--</DELETED>
                <DELETED>    ``(A) biological, chemical, physical, and 
                radiological hazards, natural toxins, pesticides, drug 
                residues, decomposition, parasites, allergens, and 
                unapproved food and color additives; and</DELETED>
                <DELETED>    ``(B) hazards that occur naturally, may be 
                unintentionally introduced, or may be intentionally 
                introduced, including by acts of terrorism; 
                and</DELETED>
        <DELETED>    ``(2) develop a written analysis of the 
        hazards.</DELETED>
<DELETED>    ``(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--</DELETED>
        <DELETED>    ``(1) hazards identified in the hazard analysis 
        conducted under subsection (b) will be significantly minimized 
        or prevented; and</DELETED>
        <DELETED>    ``(2) the food manufactured, processed, packed, or 
        held by such facility will not be adulterated under section 402 
        or misbranded under section 403(w).</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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).</DELETED>
<DELETED>    ``(f) Verification.--The owner, operator, or agent in 
charge of a facility shall verify that--</DELETED>
        <DELETED>    ``(1) the preventive controls implemented under 
        subsection (c) are adequate to control the hazards identified 
        under subsection (b);</DELETED>
        <DELETED>    ``(2) the owner, operator, or agent is conducting 
        monitoring in accordance with subsection (d);</DELETED>
        <DELETED>    ``(3) the owner, operator, or agent is making 
        appropriate decisions about corrective actions taken under 
        subsection (e); and</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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:</DELETED>
        <DELETED>    ``(1) The Seafood Hazard Analysis Critical Control 
        Points Program of the Food and Drug Administration.</DELETED>
        <DELETED>    ``(2) The Juice Hazard Analysis Critical Control 
        Points Program of the Food and Drug Administration.</DELETED>
        <DELETED>    ``(3) The Thermally Processed Low-Acid Foods 
        Packaged in Hermetically Sealed Containers standards of the 
        Food and Drug Administration (or any successor 
        standards).</DELETED>
<DELETED>    ``(k) Exception for Facilities in Compliance With Section 
419.--This section shall not apply to a facility that is subject to 
section 419.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(m) Definitions.--For purposes of this 
section:</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(2) Facility.--The term `facility' means a 
        domestic facility or a foreign facility that is required to 
        register under section 415.</DELETED>
        <DELETED>    ``(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:</DELETED>
                <DELETED>    ``(A) Sanitation procedures for food 
                contact surfaces and utensils and food-contact surfaces 
                of equipment.</DELETED>
                <DELETED>    ``(B) Supervisor, manager, and employee 
                hygiene training.</DELETED>
                <DELETED>    ``(C) An environmental monitoring program 
                to verify the effectiveness of pathogen 
                controls.</DELETED>
                <DELETED>    ``(D) An allergen control 
                program.</DELETED>
                <DELETED>    ``(E) A recall contingency plan.</DELETED>
                <DELETED>    ``(F) Good Manufacturing Practices 
                (GMPs).</DELETED>
                <DELETED>    ``(G) Supplier verification 
                activities.''.</DELETED>
<DELETED>    (b) Regulations.--</DELETED>
        <DELETED>    (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)).</DELETED>
        <DELETED>    (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.</DELETED>
        <DELETED>    (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.</DELETED>
        <DELETED>    (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.</DELETED>
<DELETED>    (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)).</DELETED>
<DELETED>    (d) Prohibited Acts.--Section 301 (21 U.S.C. 331) is 
amended by adding at the end the following:</DELETED>
<DELETED>    ``(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.''.</DELETED>
<DELETED>    (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.</DELETED>
<DELETED>    (f) Effective Date.--</DELETED>
        <DELETED>    (1) General rule.--The amendments made by this 
        section shall take effect 18 months after the date of enactment 
        of this Act.</DELETED>
        <DELETED>    (2) Exceptions.--Notwithstanding paragraph (1)--
        </DELETED>
                <DELETED>    (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</DELETED>
                <DELETED>    (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.</DELETED>

<DELETED>SEC. 104. PERFORMANCE STANDARDS.</DELETED>

<DELETED>    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.</DELETED>

<DELETED>SEC. 105. STANDARDS FOR PRODUCE SAFETY.</DELETED>

<DELETED>    (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:</DELETED>

<DELETED>``SEC. 419. STANDARDS FOR PRODUCE SAFETY.</DELETED>

<DELETED>    ``(a) Proposed Rulemaking.--</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(3) Content.--The proposed rulemaking under 
        paragraph (1) shall--</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(B) consider hazards that occur 
                naturally, may be unintentionally introduced, or may be 
                intentionally introduced, including by acts of 
                terrorism.</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(b) Final Regulation.--</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(2) Final regulation.--The final regulation 
        shall--</DELETED>
                <DELETED>    ``(A) provide a reasonable period of time 
                for compliance, taking into account the needs of small 
                businesses for additional time to comply;</DELETED>
                <DELETED>    ``(B) provide for coordination of 
                education and enforcement activities by State and local 
                officials, as designated by the Governors of the 
                respective States; and</DELETED>
                <DELETED>    ``(C) include a description of the 
                variance process under subsection (c) and the types of 
                permissible variances the Secretary may 
                grant.</DELETED>
<DELETED>    ``(c) Criteria.--</DELETED>
        <DELETED>    ``(1) In general.--The regulations adopted under 
        subsection (b) shall--</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(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).</DELETED>
        <DELETED>    ``(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).</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(f) Exception for Facilities in Compliance With Section 
418.--This section shall not apply to a facility that is subject to 
section 418.''.</DELETED>
<DELETED>    (b) Prohibited Acts.--Section 301 (21 U.S.C. 331), as 
amended by section 103, is amended by adding at the end the 
following:</DELETED>
<DELETED>    ``(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).''.</DELETED>
<DELETED>    (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.</DELETED>

<DELETED>SEC. 106. PROTECTION AGAINST INTENTIONAL 
              ADULTERATION.</DELETED>

<DELETED>    (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:</DELETED>

<DELETED>``SEC. 420. PROTECTION AGAINST INTENTIONAL 
              ADULTERATION.</DELETED>

<DELETED>    ``(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.</DELETED>
<DELETED>    ``(b) Content of Regulations.--Regulations under 
subsection (a) shall only apply to food--</DELETED>
        <DELETED>    ``(1) for which the Secretary has identified clear 
        vulnerabilities (such as short shelf-life or susceptibility to 
        intentional contamination at critical control 
        points);</DELETED>
        <DELETED>    ``(2) in bulk or batch form, prior to being 
        packaged for the final consumer; and</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(c) Determinations.--In making the determination under 
subsection (b)(3), the Secretary shall--</DELETED>
        <DELETED>    ``(1) conduct vulnerability assessments of the 
        food system;</DELETED>
        <DELETED>    ``(2) consider the best available understanding of 
        uncertainties, risks, costs, and benefits associated with 
        guarding against intentional adulteration at vulnerable points; 
        and</DELETED>
        <DELETED>    ``(3) determine the types of science-based 
        mitigation strategies or measures that are necessary to protect 
        against the intentional adulteration of food.</DELETED>
<DELETED>    ``(d) Exception.--This section shall not apply to food 
produced on farms, except for milk.</DELETED>
<DELETED>    ``(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).''.</DELETED>
<DELETED>    (b) Guidance Documents.--</DELETED>
        <DELETED>    (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).</DELETED>
        <DELETED>    (2) Content.--The guidance document issued under 
        paragraph (1) shall--</DELETED>
                <DELETED>    (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;</DELETED>
                <DELETED>    (B) specify appropriate science-based 
                mitigation strategies or measures to prepare and 
                protect the food supply chain at specific vulnerable 
                points, as appropriate;</DELETED>
                <DELETED>    (C) include a model assessment for a 
                person to use under subparagraph (A);</DELETED>
                <DELETED>    (D) include examples of mitigation 
                strategies or measures described in subparagraph (B); 
                and</DELETED>
                <DELETED>    (E) specify situations in which the 
                examples of mitigation strategies or measures described 
                in subparagraph (D) are appropriate.</DELETED>
        <DELETED>    (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.</DELETED>
<DELETED>    (c) Periodic Review.--The Secretary shall periodically 
review and, as appropriate, update the regulation under subsection (a) 
and the guidance documents under subsection (b).</DELETED>
<DELETED>    (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:</DELETED>
<DELETED>    ``(qq) The failure to comply with section 
420.''.</DELETED>

<DELETED>SEC. 107. AUTHORITY TO COLLECT FEES.</DELETED>

<DELETED>    (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:</DELETED>

           <DELETED>``PART 5--FEES RELATED TO FOOD</DELETED>

<DELETED>``SEC. 740A. AUTHORITY TO COLLECT AND USE FEES.</DELETED>

<DELETED>    ``(a) In General.--</DELETED>
        <DELETED>    ``(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--
        </DELETED>
                <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(2) Definitions.--For purposes of this section--
        </DELETED>
                <DELETED>    ``(A) the term `reinspection' means--
                </DELETED>
                        <DELETED>    ``(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</DELETED>
                        <DELETED>    ``(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</DELETED>
                <DELETED>    ``(B) the term `reinspection-related 
                costs' means all expenses, including administrative 
                expenses, incurred in connection with--</DELETED>
                        <DELETED>    ``(i) arranging, conducting, and 
                        evaluating the results of reinspections; 
                        and</DELETED>
                        <DELETED>    ``(ii) assessing and collecting 
                        reinspection fees under this section.</DELETED>
<DELETED>    ``(b) Establishment of Fees.--</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(2) Fee methodology.--</DELETED>
                <DELETED>    ``(A) Fees.--Fees amounts established for 
                collection--</DELETED>
                        <DELETED>    ``(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;</DELETED>
                        <DELETED>    ``(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;</DELETED>
                        <DELETED>    ``(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</DELETED>
                        <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(B) Other considerations.--</DELETED>
                        <DELETED>    ``(i) Voluntary qualified importer 
                        program.--</DELETED>
                                <DELETED>    ``(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.</DELETED>
                                <DELETED>    ``(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.</DELETED>
                        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(c) Limitations.--</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(3) Limitation on amount of certain fees.--
        </DELETED>
                <DELETED>    ``(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--
                </DELETED>
                        <DELETED>    ``(i) under subparagraph (B) of 
                        subsection (a)(1) exceeds $20,000,000; 
                        and</DELETED>
                        <DELETED>    ``(ii) under subparagraphs (A) and 
                        (D) of subsection (a)(1) exceeds $25,000,000 
                        combined.</DELETED>
                <DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(e) Collection of Fees.--</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.''.</DELETED>
<DELETED>    (b) Export Certification Fees for Foods and Animal Feed.--
</DELETED>
        <DELETED>    (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--</DELETED>
                <DELETED>    (A) in the matter preceding clause (i), by 
                striking ``a drug'' and inserting ``a food, 
                drug'';</DELETED>
                <DELETED>    (B) in clause (i) by striking ``exported 
                drug'' and inserting ``exported food, drug''; 
                and</DELETED>
                <DELETED>    (C) in clause (ii) by striking ``the 
                drug'' each place it appears and inserting ``the food, 
                drug''.</DELETED>
        <DELETED>    (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:</DELETED>
                <DELETED>    ``(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.''.</DELETED>

<DELETED>SEC. 108. NATIONAL AGRICULTURE AND FOOD DEFENSE 
              STRATEGY.</DELETED>

<DELETED>    (a) Development and Submission of Strategy.--</DELETED>
        <DELETED>    (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.</DELETED>
        <DELETED>    (2) Implementation plan.--The strategy shall 
        include an implementation plan for use by the Secretaries 
        described under paragraph (1) in carrying out the 
        strategy.</DELETED>
        <DELETED>    (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).</DELETED>
        <DELETED>    (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.</DELETED>
        <DELETED>    (5) Consistency with existing plans.--The strategy 
        described in paragraph (1) shall be consistent with--</DELETED>
                <DELETED>    (A) the National Incident Management 
                System;</DELETED>
                <DELETED>    (B) the National Response 
                Framework;</DELETED>
                <DELETED>    (C) the National Infrastructure Protection 
                Plan;</DELETED>
                <DELETED>    (D) the National Preparedness Goals; 
                and</DELETED>
                <DELETED>    (E) other relevant national 
                strategies.</DELETED>
<DELETED>    (b) Components.--</DELETED>
        <DELETED>    (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--</DELETED>
                <DELETED>    (A) to achieve each goal described in 
                paragraph (2); and</DELETED>
                <DELETED>    (B) to evaluate the progress made by 
                Federal, State, local, and tribal governments towards 
                the achievement of each goal described in paragraph 
                (2).</DELETED>
        <DELETED>    (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:</DELETED>
                <DELETED>    (A) Preparedness goal.--Enhance the 
                preparedness of the agriculture and food system by--
                </DELETED>
                        <DELETED>    (i) conducting vulnerability 
                        assessments of the agriculture and food 
                        system;</DELETED>
                        <DELETED>    (ii) mitigating vulnerabilities of 
                        the system;</DELETED>
                        <DELETED>    (iii) improving communication and 
                        training relating to the system;</DELETED>
                        <DELETED>    (iv) developing and conducting 
                        exercises to test decontamination and disposal 
                        plans;</DELETED>
                        <DELETED>    (v) developing modeling tools to 
                        improve event consequence assessment and 
                        decision support; and</DELETED>
                        <DELETED>    (vi) preparing risk communication 
                        tools and enhancing public awareness through 
                        outreach.</DELETED>
                <DELETED>    (B) Detection goal.--Improve agriculture 
                and food system detection capabilities by--</DELETED>
                        <DELETED>    (i) identifying contamination in 
                        food products at the earliest possible time; 
                        and</DELETED>
                        <DELETED>    (ii) conducting surveillance to 
                        prevent the spread of diseases.</DELETED>
                <DELETED>    (C) Emergency response goal.--Ensure an 
                efficient response to agriculture and food emergencies 
                by--</DELETED>
                        <DELETED>    (i) immediately investigating 
                        animal disease outbreaks and suspected food 
                        contamination;</DELETED>
                        <DELETED>    (ii) preventing additional human 
                        illnesses;</DELETED>
                        <DELETED>    (iii) organizing, training, and 
                        equipping animal, plant, and food emergency 
                        response teams of--</DELETED>
                                <DELETED>    (I) the Federal 
                                Government; and</DELETED>
                                <DELETED>    (II) State, local, and 
                                tribal governments;</DELETED>
                        <DELETED>    (iv) designing, developing, and 
                        evaluating training and exercises carried out 
                        under agriculture and food defense plans; 
                        and</DELETED>
                        <DELETED>    (v) ensuring consistent and 
                        organized risk communication to the public by--
                        </DELETED>
                                <DELETED>    (I) the Federal 
                                Government;</DELETED>
                                <DELETED>    (II) State, local, and 
                                tribal governments; and</DELETED>
                                <DELETED>    (III) the private 
                                sector.</DELETED>
                <DELETED>    (D) Recovery goal.--Secure agriculture and 
                food production after an agriculture or food emergency 
                by--</DELETED>
                        <DELETED>    (i) working with the private 
                        sector to develop business recovery plans to 
                        rapidly resume agriculture and food 
                        production;</DELETED>
                        <DELETED>    (ii) conducting exercises of the 
                        plans described in subparagraph (C) with the 
                        goal of long-term recovery results;</DELETED>
                        <DELETED>    (iii) rapidly removing, and 
                        effectively disposing of--</DELETED>
                                <DELETED>    (I) contaminated 
                                agriculture and food products; 
                                and</DELETED>
                                <DELETED>    (II) infected plants and 
                                animals; and</DELETED>
                        <DELETED>    (iv) decontaminating and restoring 
                        areas affected by an agriculture or food 
                        emergency.</DELETED>

<DELETED>SEC. 109. FOOD AND AGRICULTURE COORDINATING 
              COUNCILS.</DELETED>

<DELETED>    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--</DELETED>
        <DELETED>    (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;</DELETED>
        <DELETED>    (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);</DELETED>
        <DELETED>    (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</DELETED>
        <DELETED>    (4) recommending methods by which to protect the 
        economy and the public health of the United States from the 
        effects of--</DELETED>
                <DELETED>    (A) animal or plant disease 
                outbreaks;</DELETED>
                <DELETED>    (B) food contamination; and</DELETED>
                <DELETED>    (C) natural disasters affecting 
                agriculture and food.</DELETED>

<DELETED>SEC. 110. BUILDING DOMESTIC CAPACITY.</DELETED>

<DELETED>    (a) In General.--</DELETED>
        <DELETED>    (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:</DELETED>
                <DELETED>    (A) Analysis of the need for regulations 
                or guidance to industry.</DELETED>
                <DELETED>    (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.</DELETED>
                <DELETED>    (C) Systems to ensure the prompt 
                distribution to the food industry of information and 
                technical assistance concerning preventive 
                strategies.</DELETED>
                <DELETED>    (D) Communication systems to ensure that 
                information about specific threats to the safety and 
                security of the food supply are rapidly and effectively 
                disseminated.</DELETED>
                <DELETED>    (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.</DELETED>
                <DELETED>    (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.</DELETED>
                <DELETED>    (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.</DELETED>
        <DELETED>    (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--</DELETED>
                <DELETED>    (A) reviews previous food safety programs 
                and practices;</DELETED>
                <DELETED>    (B) outlines the success of those programs 
                and practices;</DELETED>
                <DELETED>    (C) identifies future programs and 
                practices; and</DELETED>
                <DELETED>    (D) includes information related to any 
                matter described in subparagraphs (A) through (G) of 
                paragraph (1), as necessary.</DELETED>
<DELETED>    (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.</DELETED>
<DELETED>    (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.</DELETED>
<DELETED>    (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.</DELETED>
<DELETED>    (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.</DELETED>
<DELETED>    (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.</DELETED>
<DELETED>    (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.</DELETED>

<DELETED>SEC. 111. FINAL RULE FOR PREVENTION OF SALMONELLA ENTERITIDIS 
              IN SHELL EGGS DURING PRODUCTION.</DELETED>

<DELETED>    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).</DELETED>

<DELETED>SEC. 112. SANITARY TRANSPORTATION OF FOOD.</DELETED>

<DELETED>    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)).</DELETED>

<DELETED>SEC. 113. FOOD ALLERGY AND ANAPHYLAXIS MANAGEMENT.</DELETED>

<DELETED>    (a) Definitions.--In this section:</DELETED>
        <DELETED>    (1) Early childhood education program.--The term 
        ``early childhood education program'' means--</DELETED>
                <DELETED>    (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.);</DELETED>
                <DELETED>    (B) a State licensed or regulated child 
                care program or school; or</DELETED>
                <DELETED>    (C) a State prekindergarten program that 
                serves children from birth through 
                kindergarten.</DELETED>
        <DELETED>    (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).</DELETED>
        <DELETED>    (3) School.--The term ``school'' includes public--
        </DELETED>
                <DELETED>    (A) kindergartens;</DELETED>
                <DELETED>    (B) elementary schools; and</DELETED>
                <DELETED>    (C) secondary schools.</DELETED>
        <DELETED>    (4) Secretary.--The term ``Secretary'' means the 
        Secretary of Health and Human Services.</DELETED>
<DELETED>    (b) Establishment of Voluntary Food Allergy and 
Anaphylaxis Management Guidelines.--</DELETED>
        <DELETED>    (1) Establishment.--</DELETED>
                <DELETED>    (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--</DELETED>
                        <DELETED>    (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</DELETED>
                        <DELETED>    (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.</DELETED>
                <DELETED>    (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).</DELETED>
        <DELETED>    (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:</DELETED>
                <DELETED>    (A) Parental obligation to provide the 
                school or early childhood education program, prior to 
                the start of every school year, with--</DELETED>
                        <DELETED>    (i) documentation from their 
                        child's physician or nurse--</DELETED>
                                <DELETED>    (I) supporting a diagnosis 
                                of food allergy, and any risk of 
                                anaphylaxis, if applicable;</DELETED>
                                <DELETED>    (II) identifying any food 
                                to which the child is 
                                allergic;</DELETED>
                                <DELETED>    (III) describing, if 
                                appropriate, any prior history of 
                                anaphylaxis;</DELETED>
                                <DELETED>    (IV) listing any 
                                medication prescribed for the child for 
                                the treatment of anaphylaxis;</DELETED>
                                <DELETED>    (V) detailing emergency 
                                treatment procedures in the event of a 
                                reaction;</DELETED>
                                <DELETED>    (VI) listing the signs and 
                                symptoms of a reaction; and</DELETED>
                                <DELETED>    (VII) assessing the 
                                child's readiness for self-
                                administration of prescription 
                                medication; and</DELETED>
                        <DELETED>    (ii) a list of substitute meals 
                        that may be offered to the child by school or 
                        early childhood education program food service 
                        personnel.</DELETED>
                <DELETED>    (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--
                </DELETED>
                        <DELETED>    (i) the children are capable of 
                        self-administering medication; and</DELETED>
                        <DELETED>    (ii) such administration is not 
                        prohibited by State law.</DELETED>
                <DELETED>    (C) Communication strategies between 
                individual schools or early childhood education 
                programs and providers of emergency medical services, 
                including appropriate instructions for emergency 
                medical response.</DELETED>
                <DELETED>    (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.</DELETED>
                <DELETED>    (E) The dissemination of general 
                information on life-threatening food allergies to 
                school or early childhood education program staff, 
                parents, and children.</DELETED>
                <DELETED>    (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.</DELETED>
                <DELETED>    (G) The authorization and training of 
                school or early childhood education program personnel 
                to administer epinephrine when the nurse is not 
                immediately available.</DELETED>
                <DELETED>    (H) The timely accessibility of 
                epinephrine by school or early childhood education 
                program personnel when the nurse is not immediately 
                available.</DELETED>
                <DELETED>    (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.</DELETED>
                <DELETED>    (J) Maintenance of information for each 
                administration of epinephrine to a child at risk for 
                anaphylaxis and prompt notification to 
                parents.</DELETED>
                <DELETED>    (K) Other elements the Secretary 
                determines necessary for the management of food 
                allergies and anaphylaxis in schools and early 
                childhood education programs.</DELETED>
        <DELETED>    (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.</DELETED>
<DELETED>    (c) School-based Food Allergy Management Grants.--
</DELETED>
        <DELETED>    (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).</DELETED>
        <DELETED>    (2) Application.--</DELETED>
                <DELETED>    (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.</DELETED>
                <DELETED>    (B) Contents.--Each application submitted 
                under subparagraph (A) shall include--</DELETED>
                        <DELETED>    (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);</DELETED>
                        <DELETED>    (ii) a description of the 
                        activities to be funded by the grant in 
                        carrying out the food allergy and anaphylaxis 
                        management guidelines, including--</DELETED>
                                <DELETED>    (I) how the guidelines 
                                will be carried out at individual 
                                schools served by the local educational 
                                agency;</DELETED>
                                <DELETED>    (II) how the local 
                                educational agency will inform parents 
                                and students of the guidelines in 
                                place;</DELETED>
                                <DELETED>    (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</DELETED>
                                <DELETED>    (IV) any other activities 
                                that the Secretary determines 
                                appropriate;</DELETED>
                        <DELETED>    (iii) an itemization of how grant 
                        funds received under this subsection will be 
                        expended;</DELETED>
                        <DELETED>    (iv) a description of how adoption 
                        of the guidelines and implementation of grant 
                        activities will be monitored; and</DELETED>
                        <DELETED>    (v) an agreement by the local 
                        educational agency to report information 
                        required by the Secretary to conduct 
                        evaluations under this subsection.</DELETED>
        <DELETED>    (3) Use of funds.--Each local educational agency 
        that receives a grant under this subsection may use the grant 
        funds for the following:</DELETED>
                <DELETED>    (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).</DELETED>
                <DELETED>    (B) In partnership with local health 
                departments, school nurse, teacher, and personnel 
                training for food allergy management.</DELETED>
                <DELETED>    (C) Programs that educate students as to 
                the presence of, and policies and procedures in place 
                related to, food allergies and anaphylactic 
                shock.</DELETED>
                <DELETED>    (D) Outreach to parents.</DELETED>
                <DELETED>    (E) Any other activities consistent with 
                the guidelines described in subsection (b).</DELETED>
        <DELETED>    (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.</DELETED>
        <DELETED>    (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.</DELETED>
        <DELETED>    (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.</DELETED>
        <DELETED>    (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)).</DELETED>
        <DELETED>    (8) Matching funds.--</DELETED>
                <DELETED>    (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.</DELETED>
                <DELETED>    (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.</DELETED>
        <DELETED>    (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.</DELETED>
        <DELETED>    (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).</DELETED>
        <DELETED>    (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.</DELETED>
        <DELETED>    (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.</DELETED>
<DELETED>    (d) Voluntary Nature of Guidelines.--</DELETED>
        <DELETED>    (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.</DELETED>
        <DELETED>    (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).</DELETED>

  <DELETED>TITLE II--IMPROVING CAPACITY TO DETECT AND RESPOND TO FOOD 
                       SAFETY PROBLEMS</DELETED>

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

<DELETED>    (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:</DELETED>

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

<DELETED>    ``(a) Identification and Inspection of Facilities.--
</DELETED>
        <DELETED>    ``(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:</DELETED>
                <DELETED>    ``(A) The risk profile of the food 
                manufactured, processed, packed, or held at the 
                facility.</DELETED>
                <DELETED>    ``(B) The facility's history of food 
                recalls, outbreaks, and violations of food safety 
                standards.</DELETED>
                <DELETED>    ``(C) The rigor of the facility's hazard 
                analysis and risk-based preventive controls.</DELETED>
                <DELETED>    ``(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).</DELETED>
                <DELETED>    ``(E) Whether the facility has received a 
                certificate as described in section 809(b).</DELETED>
                <DELETED>    ``(F) Any other criteria deemed necessary 
                and appropriate by the Secretary for purposes of 
                allocating inspection resources.</DELETED>
        <DELETED>    ``(2) Inspections.--</DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(B) High-risk facilities.--The Secretary 
                shall increase the frequency of inspection of 
                facilities identified under paragraph (1) as high-risk 
                facilities such that--</DELETED>
                        <DELETED>    ``(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</DELETED>
                        <DELETED>    ``(ii) for each succeeding year, 
                        each high-risk facility is inspected not less 
                        often than once each year.</DELETED>
                <DELETED>    ``(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.</DELETED>
<DELETED>    ``(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:</DELETED>
        <DELETED>    ``(1) The risk profile of the food 
        imported.</DELETED>
        <DELETED>    ``(2) The risk profile of the countries of origin 
        and countries of transport of the food imported.</DELETED>
        <DELETED>    ``(3) The history of food recalls, outbreaks, and 
        violations of food safety standards of the food 
        importer.</DELETED>
        <DELETED>    ``(4) The rigor of the foreign supplier 
        verification program under section 805.</DELETED>
        <DELETED>    ``(5) Whether the food importer participates in 
        the voluntary qualified importer program under section 
        806.</DELETED>
        <DELETED>    ``(6) Whether the food meets the criteria for 
        priority under section 801(h)(1).</DELETED>
        <DELETED>    ``(7) Whether the food is from a facility that has 
        received a certificate as described in section 
        809(b).</DELETED>
        <DELETED>    ``(8) Any other criteria deemed appropriate by the 
        Secretary for purposes of allocating inspection 
        resources.</DELETED>
<DELETED>    ``(c) Coordination.--The Secretary shall improve 
coordination and cooperation with the Secretary of Agriculture to 
target food inspection resources.</DELETED>
<DELETED>    ``(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.''.</DELETED>
<DELETED>    (b) Annual Report.--Section 903 (21 U.S.C. 393) is amended 
by adding at the end the following:</DELETED>
<DELETED>    ``(h) Annual Report Regarding Food.--Not later than 
February 1 of each year, the Secretary shall submit to Congress a 
report regarding--</DELETED>
        <DELETED>    ``(1) information about food facilities 
        including--</DELETED>
                <DELETED>    ``(A) the appropriations used to inspect 
                facilities registered pursuant to section 415 in the 
                previous fiscal year;</DELETED>
                <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(E) the number of high-risk facilities 
                identified pursuant to section 421 that the Secretary 
                inspected in the previous fiscal year; and</DELETED>
                <DELETED>    ``(F) the number of high-risk facilities 
                identified pursuant to section 421 that the Secretary 
                did not inspect in the previous fiscal year;</DELETED>
        <DELETED>    ``(2) information about food imports including--
        </DELETED>
                <DELETED>    ``(A) the number of lines of food imported 
                into the United States that the Secretary physically 
                inspected or sampled in the previous fiscal 
                year;</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(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</DELETED>
        <DELETED>    ``(3) information on the foreign offices 
        established under section 309 of the FDA Food Safety 
        Modernization Act including--</DELETED>
                <DELETED>    ``(A) the number of foreign offices 
                established; and</DELETED>
                <DELETED>    ``(B) the number of personnel permanently 
                stationed in each foreign office.</DELETED>
<DELETED>    ``(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.''.</DELETED>

<DELETED>SEC. 202. RECOGNITION OF LABORATORY ACCREDITATION FOR ANALYSES 
              OF FOODS.</DELETED>

<DELETED>    (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:</DELETED>

<DELETED>``SEC. 422. RECOGNITION OF LABORATORY ACCREDITATION FOR 
              ANALYSES OF FOODS.</DELETED>

<DELETED>    ``(a) Recognition of Laboratory Accreditation.--</DELETED>
        <DELETED>    ``(1) In general.--Not later than 2 years after 
        the date of enactment of the FDA Food Safety Modernization Act, 
        the Secretary shall--</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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--</DELETED>
                <DELETED>    ``(A) appropriate sampling and analytical 
                procedures are followed and reports of analyses are 
                certified as true and accurate;</DELETED>
                <DELETED>    ``(B) internal quality systems are 
                established and maintained;</DELETED>
                <DELETED>    ``(C) procedures exist to evaluate and 
                respond promptly to complaints regarding analyses and 
                other activities for which the laboratory is 
                recognized;</DELETED>
                <DELETED>    ``(D) individuals who conduct the analyses 
                are qualified by training and experience to do so; 
                and</DELETED>
                <DELETED>    ``(E) any other criteria determined 
                appropriate by the Secretary.</DELETED>
        <DELETED>    ``(4) Review of accreditation.--To assure 
        compliance with the requirements of this section, the Secretary 
        shall--</DELETED>
                <DELETED>    ``(A) periodically, or at least every 5 
                years, reevaluate accreditation bodies recognized under 
                paragraph (1); and</DELETED>
                <DELETED>    ``(B) promptly revoke the recognition of 
                any accreditation body found not to be in compliance 
                with the requirements of this section.</DELETED>
<DELETED>    ``(b) Testing Procedures.--</DELETED>
        <DELETED>    ``(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--</DELETED>
                <DELETED>    ``(A) in support of admission of an 
                article of food under section 801(a);</DELETED>
                <DELETED>    ``(B) due to a specific testing 
                requirement in this Act or implementing regulations, 
                when applied to address an identified or suspected food 
                safety problem;</DELETED>
                <DELETED>    ``(C) under an Import Alert that requires 
                successful consecutive tests; or</DELETED>
                <DELETED>    ``(D) is so required by the Secretary as 
                the Secretary deems appropriate to address an 
                identified or suspected food safety problem.</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.''.</DELETED>
<DELETED>    (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--</DELETED>
        <DELETED>    (1) provides ongoing surveillance, rapid 
        detection, and surge capacity for large-scale food-related 
        emergencies, including intentional adulteration of the food 
        supply;</DELETED>
        <DELETED>    (2) coordinates the food laboratory capacities of 
        State food laboratories, including the sharing of data between 
        State laboratories to develop national situational 
        awareness;</DELETED>
        <DELETED>    (3) provides accessible, timely, accurate, and 
        consistent food laboratory services throughout the United 
        States;</DELETED>
        <DELETED>    (4) develops and implements a methods repository 
        for use by Federal, State, and local officials;</DELETED>
        <DELETED>    (5) responds to food-related emergencies; 
        and</DELETED>
        <DELETED>    (6) is integrated with relevant laboratory 
        networks administered by other Federal agencies.</DELETED>

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

<DELETED>    (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--</DELETED>
        <DELETED>    (1) agree on common laboratory methods in order to 
        facilitate the sharing of knowledge and information relating to 
        animal health, agriculture, and human health;</DELETED>
        <DELETED>    (2) identify the means by which each laboratory 
        network member could work cooperatively--</DELETED>
                <DELETED>    (A) to optimize national laboratory 
                preparedness; and</DELETED>
                <DELETED>    (B) to provide surge capacity during 
                emergencies; and</DELETED>
        <DELETED>    (3) engage in ongoing dialogue and build 
        relationships that will support a more effective and integrated 
        response during emergencies.</DELETED>
<DELETED>    (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.</DELETED>

<DELETED>SEC. 204. ENHANCING TRACEBACK AND RECORDKEEPING.</DELETED>

<DELETED>    (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.</DELETED>
<DELETED>    (b) Pilot Project.--</DELETED>
        <DELETED>    (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.</DELETED>
        <DELETED>    (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--
        </DELETED>
                <DELETED>    (A) methods that are applicable and 
                appropriate for small businesses; and</DELETED>
                <DELETED>    (B) technologies, including existing 
                technologies, that enhance traceback and trace 
                forward.</DELETED>
<DELETED>    (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.</DELETED>
<DELETED>    (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.</DELETED>
<DELETED>    (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.</DELETED>
<DELETED>    (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)).</DELETED>

<DELETED>SEC. 205. SURVEILLANCE.</DELETED>

<DELETED>    (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.</DELETED>
<DELETED>    (b) Food-borne Illness Surveillance Systems.--</DELETED>
        <DELETED>    (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--</DELETED>
                <DELETED>    (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;</DELETED>
                <DELETED>    (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;</DELETED>
                <DELETED>    (C) developing improved epidemiological 
                tools for obtaining quality exposure data, and 
                microbiological methods for classifying 
                cases;</DELETED>
                <DELETED>    (D) augmenting such systems to improve 
                attribution of a food-borne illness outbreak to a 
                specific food;</DELETED>
                <DELETED>    (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;</DELETED>
                <DELETED>    (F) allowing timely public access to 
                aggregated, de-identified surveillance data;</DELETED>
                <DELETED>    (G) at least annually, publishing current 
                reports on findings from such systems;</DELETED>
                <DELETED>    (H) establishing a flexible mechanism for 
                rapidly initiating scientific research by academic 
                institutions;</DELETED>
                <DELETED>    (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</DELETED>
                <DELETED>    (J) other activities as determined 
                appropriate by the Secretary.</DELETED>
        <DELETED>    (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--</DELETED>
                <DELETED>    (A) the priority needs of regulatory 
                agencies, the food industry, and consumers for 
                information and analysis on food-borne illness and its 
                causes;</DELETED>
                <DELETED>    (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;</DELETED>
                <DELETED>    (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;</DELETED>
                <DELETED>    (D) key barriers to improvement in food-
                borne illness surveillance and its utility for 
                preventing food-borne illness at Federal, State, and 
                local levels;</DELETED>
                <DELETED>    (E) the capabilities needed for 
                establishing automatic electronic searches of 
                surveillance data; and</DELETED>
                <DELETED>    (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.</DELETED>
<DELETED>    (c) Improving Food Safety and Defense Capacity at the 
State and Local Level.--</DELETED>
        <DELETED>    (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:</DELETED>
                <DELETED>    (A) Improve food-borne illness outbreak 
                response and containment.</DELETED>
                <DELETED>    (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.</DELETED>
                <DELETED>    (C) Strengthen the capacity of State and 
                local agencies to carry out inspections and enforce 
                safety standards.</DELETED>
                <DELETED>    (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.</DELETED>
                <DELETED>    (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.</DELETED>
                <DELETED>    (F) Strengthen the capacity of State and 
                local agencies to achieve the goals described in 
                section 108.</DELETED>
        <DELETED>    (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--</DELETED>
                <DELETED>    (A) staffing levels and expertise 
                available to perform food safety and defense 
                functions;</DELETED>
                <DELETED>    (B) laboratory capacity to support 
                surveillance, outbreak response, inspection, and 
                enforcement activities;</DELETED>
                <DELETED>    (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</DELETED>
                <DELETED>    (D) other State and local activities and 
                needs as determined appropriate by the 
                Secretary.</DELETED>
<DELETED>    (d) Food Safety Capacity Building Grants.--Section 317R(b) 
of the Public Health Service Act (42 U.S.C. 247b-20(b)) is amended--
</DELETED>
        <DELETED>    (1) by striking ``2002'' and inserting ``2010''; 
        and</DELETED>
        <DELETED>    (2) by striking ``2003 through 2006'' and 
        inserting ``2011 through 2014''.</DELETED>

<DELETED>SEC. 206. MANDATORY RECALL AUTHORITY.</DELETED>

<DELETED>    (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:</DELETED>

<DELETED>``SEC. 423. MANDATORY RECALL AUTHORITY.</DELETED>

<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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--</DELETED>
        <DELETED>    ``(1) immediately cease distribution of such 
        article; or</DELETED>
        <DELETED>    ``(2) immediately notify all persons--</DELETED>
                <DELETED>    ``(A) manufacturing, processing, packing, 
                transporting, distributing, receiving, holding, or 
                importing and selling such article; and</DELETED>
                <DELETED>    ``(B) to which such article has been 
                distributed, transported, or sold, to immediately cease 
                distribution of such article.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(d) Post-hearing Recall Order and Modification of 
Order.--</DELETED>
        <DELETED>    ``(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--</DELETED>
                <DELETED>    ``(A) amend the order to require recall of 
                such article or other appropriate action;</DELETED>
                <DELETED>    ``(B) specify a timetable in which the 
                recall shall occur;</DELETED>
                <DELETED>    ``(C) require periodic reports to the 
                Secretary describing the progress of the recall; 
                and</DELETED>
                <DELETED>    ``(D) provide notice to consumers to whom 
                such article was, or may have been, 
                distributed.</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(e) Cooperation and Consultation.--The Secretary shall 
work with State and local public health officials in carrying out this 
section, as appropriate.</DELETED>
<DELETED>    ``(f) Public Notification.--In conducting a recall under 
this section, the Secretary shall--</DELETED>
        <DELETED>    ``(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--</DELETED>
                <DELETED>    ``(A) of the recall to consumers and 
                retailers to whom such article was, or may have been, 
                distributed; and</DELETED>
                <DELETED>    ``(B) that includes, at a minimum--
                </DELETED>
                        <DELETED>    ``(i) the name of the article of 
                        food subject to the recall; and</DELETED>
                        <DELETED>    ``(ii) a description of the risk 
                        associated with such article; and</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(h) Effect.--Nothing in this section shall affect the 
authority of the Secretary to request or participate in a voluntary 
recall.''.</DELETED>
<DELETED>    (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)''.</DELETED>
<DELETED>    (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:</DELETED>
<DELETED>    ``(rr) The refusal or failure to follow an order under 
section 423.''.</DELETED>

<DELETED>SEC. 207. ADMINISTRATIVE DETENTION OF FOOD.</DELETED>

<DELETED>    (a) In General.--Section 304(h)(1)(A) (21 U.S.C. 
334(h)(1)(A)) is amended by--</DELETED>
        <DELETED>    (1) striking ``credible evidence or information 
        indicating'' and inserting ``reason to believe''; and</DELETED>
        <DELETED>    (2) striking ``presents a threat of serious 
        adverse health consequences or death to humans or animals'' and 
        inserting ``is adulterated or misbranded''.</DELETED>
<DELETED>    (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.</DELETED>
<DELETED>    (c) Effective Date.--The amendment made by this section 
shall take effect 180 days after the date of enactment of this 
Act.</DELETED>

<DELETED>SEC. 208. DECONTAMINATION AND DISPOSAL STANDARDS AND 
              PLANS.</DELETED>

<DELETED>    (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.</DELETED>
<DELETED>    (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.</DELETED>
<DELETED>    (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--</DELETED>
        <DELETED>    (1) the decontamination of individuals, equipment, 
        and facilities following an intentional contamination of 
        agriculture or food; and</DELETED>
        <DELETED>    (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.</DELETED>
<DELETED>    (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)).</DELETED>
<DELETED>    (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.</DELETED>
<DELETED>    (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--</DELETED>
        <DELETED>    (1) highest-risk biological, chemical, and 
        radiological threat agents;</DELETED>
        <DELETED>    (2) agents that could cause the greatest economic 
        devastation to the agriculture and food system; and</DELETED>
        <DELETED>    (3) agents that are most difficult to clean or 
        remediate.</DELETED>

  <DELETED>TITLE III--IMPROVING THE SAFETY OF IMPORTED FOOD</DELETED>

<DELETED>SEC. 301. FOREIGN SUPPLIER VERIFICATION PROGRAM.</DELETED>

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

<DELETED>``SEC. 805. FOREIGN SUPPLIER VERIFICATION PROGRAM.</DELETED>

<DELETED>    ``(a) In General.--</DELETED>
        <DELETED>    ``(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--
        </DELETED>
                <DELETED>    ``(A) produced in compliance with the 
                requirements of section 418 or 419, as appropriate; 
                and</DELETED>
                <DELETED>    ``(B) is not adulterated under section 402 
                or misbranded under section 403(w).</DELETED>
        <DELETED>    ``(2) Importer defined.--For purposes of this 
        section, the term `importer' means, with respect to an article 
        of food--</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(c) Regulations.--</DELETED>
        <DELETED>    ``(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).</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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:</DELETED>
        <DELETED>    ``(1) The Seafood Hazard Analysis Critical Control 
        Points Program of the Food and Drug Administration.</DELETED>
        <DELETED>    ``(2) The Juice Hazard Analysis Critical Control 
        Points Program of the Food and Drug Administration.</DELETED>
        <DELETED>    ``(3) The Thermally Processed Low-Acid Foods 
        Packaged in Hermetically Sealed Containers standards of the 
        Food and Drug Administration (or any successor 
        standards).</DELETED>
<DELETED>    ``(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.''.</DELETED>
<DELETED>    (b) Prohibited Act.--Section 301 (21 U.S.C. 331), as 
amended by section 206, is amended by adding at the end the 
following:</DELETED>
<DELETED>    ``(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.''.</DELETED>
<DELETED>    (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''.</DELETED>
<DELETED>    (d) Effective Date.--The amendments made by this section 
shall take effect 2 years after the date of enactment of this 
Act.</DELETED>

<DELETED>SEC. 302. VOLUNTARY QUALIFIED IMPORTER PROGRAM.</DELETED>

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

<DELETED>``SEC. 806. VOLUNTARY QUALIFIED IMPORTER PROGRAM.</DELETED>

<DELETED>    ``(a) In General.--Beginning not later than 1 year after 
the date of enactment of the FDA Food Safety Modernization Act, the 
Secretary shall--</DELETED>
        <DELETED>    ``(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</DELETED>
        <DELETED>    ``(2) issue a guidance document related to 
        participation and compliance with such program.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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:</DELETED>
        <DELETED>    ``(1) The nature of the food to be 
        imported.</DELETED>
        <DELETED>    ``(2) The compliance history of the foreign 
        supplier.</DELETED>
        <DELETED>    ``(3) The capability of the regulatory system of 
        the country of export to ensure compliance with United States 
        food safety standards.</DELETED>
        <DELETED>    ``(4) The compliance of the importer with the 
        requirements of section 805.</DELETED>
        <DELETED>    ``(5) The recordkeeping, testing, inspections and 
        audits of facilities, traceability of articles of food, 
        temperature controls, and sourcing practices of the 
        importer.</DELETED>
        <DELETED>    ``(6) The potential risk for intentional 
        adulteration of the food.</DELETED>
        <DELETED>    ``(7) Any other factor that the Secretary 
        determines appropriate.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.''.</DELETED>

<DELETED>SEC. 303. AUTHORITY TO REQUIRE IMPORT CERTIFICATIONS FOR 
              FOOD.</DELETED>

<DELETED>    (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.''.</DELETED>
<DELETED>    (b) Addition of Certification Requirement.--Section 801 
(21 U.S.C. 381) is amended by adding at the end the following new 
subsection:</DELETED>
<DELETED>    ``(p) Certifications Concerning Imported Foods.--
</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(2) Certifying entities.--For purposes of 
        paragraph (1), entities that shall provide the certification or 
        assurances described in such paragraph are--</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(B) such other persons or entities 
                accredited pursuant to section 809 to provide such 
                certification or assurance.</DELETED>
        <DELETED>    ``(3) Renewal and refusal of certifications.--The 
        Secretary may--</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(B) refuse to accept any certification 
                or assurance if the Secretary determines that such 
                certification or assurance is no longer valid or 
                reliable.</DELETED>
        <DELETED>    ``(4) Electronic submission.--The Secretary shall 
        provide for the electronic submission of certifications under 
        this subsection.</DELETED>
        <DELETED>    ``(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.''.</DELETED>
<DELETED>    (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,''.</DELETED>
<DELETED>    (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.</DELETED>

<DELETED>SEC. 304. PRIOR NOTICE OF IMPORTED FOOD SHIPMENTS.</DELETED>

<DELETED>    (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;''.</DELETED>
<DELETED>    (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.</DELETED>
<DELETED>    (c) Effective Date.--The amendment made by this section 
shall take effect 180 days after the date of enactment of this 
Act.</DELETED>

<DELETED>SEC. 305. REVIEW OF A REGULATORY AUTHORITY OF A FOREIGN 
              COUNTRY.</DELETED>

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

<DELETED>``SEC. 807. REVIEW OF A REGULATORY AUTHORITY OF A FOREIGN 
              COUNTRY.</DELETED>

<DELETED>    ``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.''.</DELETED>

<DELETED>SEC. 306. BUILDING CAPACITY OF FOREIGN GOVERNMENTS WITH 
              RESPECT TO FOOD.</DELETED>

<DELETED>    (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.</DELETED>
<DELETED>    (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.</DELETED>
<DELETED>    (c) Plan.--The plan developed under subsection (a) shall 
include, as appropriate, the following:</DELETED>
        <DELETED>    (1) Recommendations for bilateral and multilateral 
        arrangements and agreements, including provisions to provide 
        for responsibility of exporting countries to ensure the safety 
        of food.</DELETED>
        <DELETED>    (2) Provisions for electronic data 
        sharing.</DELETED>
        <DELETED>    (3) Provisions for mutual recognition of 
        inspection reports.</DELETED>
        <DELETED>    (4) Training of foreign governments and food 
        producers on United States requirements for safe 
        food.</DELETED>
        <DELETED>    (5) Recommendations to harmonize requirements 
        under the Codex Alimentarius.</DELETED>
        <DELETED>    (6) Provisions for the multilateral acceptance of 
        laboratory methods and detection techniques.</DELETED>

<DELETED>SEC. 307. INSPECTION OF FOREIGN FOOD FACILITIES.</DELETED>

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

<DELETED>``SEC. 808. INSPECTION OF FOREIGN FOOD FACILITIES.</DELETED>

<DELETED>    ``(a) Inspection.--The Secretary--</DELETED>
        <DELETED>    ``(1) may enter into arrangements and agreements 
        with foreign governments to facilitate the inspection of 
        foreign facilities registered under section 415; and</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.''.</DELETED>

<DELETED>SEC. 308. ACCREDITATION OF THIRD-PARTY AUDITORS AND AUDIT 
              AGENTS.</DELETED>

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

<DELETED>``SEC. 809. ACCREDITATION OF THIRD-PARTY AUDITORS AND AUDIT 
              AGENTS.</DELETED>

<DELETED>    ``(a) Definitions.--In this section:</DELETED>
        <DELETED>    ``(1) Accredited audit agent.--The term 
        `accredited audit agent' means an audit agent accredited by an 
        accreditation body under this section.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(3) Accreditation body.--The term `accreditation 
        body' means a recognized authority that performs accreditation 
        of third-party auditors and audit agents.</DELETED>
        <DELETED>    ``(4) Accredited third-party auditor.--The term 
        `accredited third-party auditor' means a third-party auditor 
        accredited by an accreditation body under this 
        section.</DELETED>
        <DELETED>    ``(5) Consultative audit.--The term `consultative 
        audit' means an audit of an eligible entity--</DELETED>
                <DELETED>    ``(A) to determine whether such entity is 
                in compliance with the provisions of this Act and with 
                applicable industry standards and practices; 
                and</DELETED>
                <DELETED>    ``(B) the results of which are for 
                internal facility purposes only.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(7) Regulatory audit.--The term `regulatory 
        audit' means an audit of an eligible entity--</DELETED>
                <DELETED>    ``(A) to determine whether such entity is 
                in compliance with the provisions of this Act; 
                and</DELETED>
                <DELETED>    ``(B) the results of which determine--
                </DELETED>
                        <DELETED>    ``(i) whether an entity is 
                        eligible to receive a certification under 
                        section 801(p); and</DELETED>
                        <DELETED>    ``(ii) whether the entity is 
                        eligible to participate in the voluntary 
                        qualified importer program under section 
                        806.</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(b) Accreditation System.--</DELETED>
        <DELETED>    ``(1) Accreditation bodies.--</DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(c) Third-party Auditors and Audit Agencies.--</DELETED>
        <DELETED>    ``(1) Requirements for accreditation as a third-
        party auditor or audit agent.--</DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(2) Requirement to issue certification of 
        eligible entities.--</DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(B) Purpose of certification.--The 
                Secretary shall use evidence of certification provided 
                by accredited third-party auditors and audit agents--
                </DELETED>
                        <DELETED>    ``(i) to determined the 
                        eligibility of an importer to receive a 
                        certification under section 801(p); 
                        and</DELETED>
                        <DELETED>    ``(ii) determine the eligibility 
                        of an importer to participate in the voluntary 
                        qualified importer program under section 
                        806.</DELETED>
        <DELETED>    ``(3) Audit report requirements.--</DELETED>
                <DELETED>    ``(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--</DELETED>
                        <DELETED>    ``(i) the identity of the persons 
                        at the audited eligible entity responsible for 
                        compliance with food safety 
                        requirements;</DELETED>
                        <DELETED>    ``(ii) the dates of the 
                        audit;</DELETED>
                        <DELETED>    ``(iii) the scope of the audit; 
                        and</DELETED>
                        <DELETED>    ``(iv) any other info required by 
                        the Secretary that relate to or may influence 
                        an assessment of compliance with this 
                        Act.</DELETED>
                <DELETED>    ``(B) Submission of reports to the 
                secretary.--</DELETED>
                        <DELETED>    ``(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.</DELETED>
                        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(4) Requirements of audit agents.--</DELETED>
                <DELETED>    ``(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--</DELETED>
                        <DELETED>    ``(i) the identification of the 
                        eligible entity subject to the audit; 
                        and</DELETED>
                        <DELETED>    ``(ii) such condition.</DELETED>
                <DELETED>    ``(B) Types of audits.--An accredited 
                audit agent may perform consultative and regulatory 
                audits of eligible entities.</DELETED>
                <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(5) Conflicts of interest.--</DELETED>
                <DELETED>    ``(A) Third-party auditors.--An accredited 
                third-party auditor shall--</DELETED>
                        <DELETED>    ``(i) not be owned, managed, or 
                        controlled by any person that owns or operates 
                        an eligible entity to be certified by such 
                        auditor;</DELETED>
                        <DELETED>    ``(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</DELETED>
                        <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(B) Audit agents.--An accredited audit 
                agent shall--</DELETED>
                        <DELETED>    ``(i) not own or operate an 
                        eligible entity to be certified by such 
                        agent;</DELETED>
                        <DELETED>    ``(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</DELETED>
                        <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(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--</DELETED>
                        <DELETED>    ``(i) requiring that audits 
                        performed under this section be 
                        unannounced;</DELETED>
                        <DELETED>    ``(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</DELETED>
                        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(6) Withdrawal of accreditation.--The Secretary 
        shall withdraw accreditation from an accredited third-party 
        auditor or audit agent--</DELETED>
                <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(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--</DELETED>
        <DELETED>    ``(1) intends to participate in voluntary 
        qualified importer program under section 806; or</DELETED>
        <DELETED>    ``(2) must provide to the Secretary a 
        certification under section 801(p) for any food from such 
        entity.</DELETED>
<DELETED>    ``(e) False Statements.--Any statement or representation 
made--</DELETED>
        <DELETED>    ``(1) by an employee or agent of an eligible 
        entity to an accredited third-party auditor or audit agent; 
        or</DELETED>
        <DELETED>    ``(2) by an accredited third-party auditor or an 
        audit agent to the Secretary,</DELETED>
<DELETED>shall be subject to section 1001 of title 18, United States 
Code.</DELETED>
<DELETED>    ``(f) Monitoring.--To ensure compliance with the 
requirements of this section, the Secretary shall--</DELETED>
        <DELETED>    ``(1) periodically, or at least once every 4 
        years, reevaluate the accreditation bodies described in 
        subsection (b)(1);</DELETED>
        <DELETED>    ``(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;</DELETED>
        <DELETED>    ``(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</DELETED>
        <DELETED>    ``(4) take any other measures deemed necessary by 
        the Secretary.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(h) Limitations.--</DELETED>
        <DELETED>    ``(1) No effect on section 704 inspections.--The 
        audits performed under this section shall not be considered 
        inspections under section 704.</DELETED>
        <DELETED>    ``(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.''.</DELETED>

<DELETED>SEC. 309. FOREIGN OFFICES OF THE FOOD AND DRUG 
              ADMINISTRATION.</DELETED>

<DELETED>    (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.</DELETED>
<DELETED>    (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.</DELETED>
<DELETED>    (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.</DELETED>

         <DELETED>TITLE IV--MISCELLANEOUS PROVISIONS</DELETED>

<DELETED>SEC. 401. FUNDING FOR FOOD SAFETY.</DELETED>

<DELETED>    (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--</DELETED>
        <DELETED>    (1) $825,000,000 for fiscal year 2010; 
        and</DELETED>
        <DELETED>    (2) such sums as may be necessary for fiscal years 
        2011 through 2014.</DELETED>
<DELETED>    (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--</DELETED>
        <DELETED>    (1) 3,800 staff members in fiscal year 
        2010;</DELETED>
        <DELETED>    (2) 4,000 staff members in fiscal year 
        2011;</DELETED>
        <DELETED>    (3) 4,200 staff members in fiscal year 
        2012;</DELETED>
        <DELETED>    (4) 4,600 staff members in fiscal year 2013; 
        and</DELETED>
        <DELETED>    (5) 5,000 staff members in fiscal year 
        2014.</DELETED>

<DELETED>SEC. 402. JURISDICTION; AUTHORITIES.</DELETED>

<DELETED>    Nothing in this Act, or an amendment made by this Act, 
shall be construed to--</DELETED>
        <DELETED>    (1) alter the jurisdiction between the Secretary 
        of Agriculture and the Secretary of Health and Human Services, 
        under applicable statutes and regulations;</DELETED>
        <DELETED>    (2) limit the authority of the Secretary of Health 
        and Human Services to issue regulations related to the safety 
        of food under--</DELETED>
                <DELETED>    (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</DELETED>
                <DELETED>    (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</DELETED>
        <DELETED>    (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.</DELETED>

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

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

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

      TITLE I--IMPROVING CAPACITY TO PREVENT FOOD SAFETY PROBLEMS

Sec. 101. Inspections of records.
Sec. 102. Registration of food facilities.
Sec. 103. Hazard analysis and risk-based preventive controls.
Sec. 104. Performance standards.
Sec. 105. Standards for produce safety.
Sec. 106. Protection against intentional adulteration.
Sec. 107. Authority to collect fees.
Sec. 108. National agriculture and food defense strategy.
Sec. 109. Food and Agriculture Coordinating Councils.
Sec. 110. Building domestic capacity.
Sec. 111. Sanitary transportation of food.
Sec. 112. Food allergy and anaphylaxis management.

   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. Pilot project to enhance traceback and recordkeeping with 
                            respect to processed food.
Sec. 206. Surveillance.
Sec. 207. Mandatory recall authority.
Sec. 208. Administrative detention of food.
Sec. 209. Decontamination and disposal standards and plans.
Sec. 210. Improving the training of State, local, territorial, and 
                            tribal food safety officials.
Sec. 211. Grants to enhance food safety.

            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 third-party auditors and audit agents.
Sec. 309. Foreign offices of the Food and Drug Administration.
Sec. 310. Smuggled food.

                   TITLE IV--MISCELLANEOUS PROVISIONS

Sec. 401. Funding for food safety.
Sec. 402. Whistleblower protections.
Sec. 403. Jurisdiction; authorities.
Sec. 404. Compliance with international agreements.

      TITLE I--IMPROVING CAPACITY TO PREVENT FOOD SAFETY PROBLEMS

SEC. 101. INSPECTIONS OF RECORDS.

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

SEC. 102. REGISTRATION OF FOOD FACILITIES.

    (a) Updating of Food Category Regulations; Biennial Registration 
Renewal.--Section 415(a) (21 U.S.C. 350d(a)) is amended--
            (1) in paragraph (2), by--
                    (A) striking ``conducts business and'' and 
                inserting ``conducts business, the e-mail address for 
                the contact person of the facility or, in the case of a 
                foreign facility, the United States agent for the 
                facility, and''; and
                    (B) inserting ``, or any other food categories as 
                determined appropriate by the Secretary, including by 
                guidance'' after ``Code of Federal Regulations'';
            (2) by redesignating paragraphs (3) and (4) as paragraphs 
        (4) and (5), respectively; and
            (3) by inserting after paragraph (2) the following:
            ``(3) Biennial registration renewal.--During the period 
        beginning on October 1 and ending on December 31 of each even-
        numbered year, a registrant that has submitted a registration 
        under paragraph (1) shall submit to the Secretary a renewal 
        registration containing the information described in paragraph 
        (2). The Secretary shall provide for an abbreviated 
        registration renewal process for any registrant that has not 
        had any changes to such information since the registrant 
        submitted the preceding registration or registration renewal 
        for the facility involved.''.
    (b) Suspension of Registration.--
            (1) In general.--Section 415 (21 U.S.C. 350d) is amended--
                    (A) in subsection (a)(2), by inserting after the 
                first sentence the following: ``The registration shall 
                contain an assurance that the Secretary will be 
                permitted to inspect such facility at the times and in 
                the manner permitted by this Act.'';
                    (B) by redesignating subsections (b) and (c) as 
                subsections (c) and (d), respectively; and
                    (C) by inserting after subsection (a) the 
                following:
    ``(b) Suspension of Registration.--
            ``(1) In general.--If the Secretary determines that food 
        manufactured, processed, packed, 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 business days after the issuance 
        of the order or such other time period, as agreed upon by the 
        Secretary and the registrant, on the actions required for 
        reinstatement of registration and why the registration that is 
        subject to suspension should be reinstated. The Secretary shall 
        reinstate a registration if the Secretary determines, based on 
        evidence presented, that adequate grounds do not exist to 
        continue the suspension of the registration.
            ``(3) Post-hearing corrective action plan; vacating of 
        order.--
                    ``(A) Corrective action plan.--If, after providing 
                opportunity for an informal hearing under paragraph 
                (2), the Secretary determines that the suspension of 
                registration remains necessary, the Secretary shall 
                require the registrant to submit a corrective action 
                plan to demonstrate how the registrant plans to correct 
                the conditions found by the Secretary. The Secretary 
                shall review such plan 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 or 
        intrastate commerce in the United States.
            ``(5) Regulations.--The Secretary shall promulgate 
        regulations that describe the standards the Commissioner will 
        use in making a determination to suspend a registration, and 
        the format the Commissioner will use to explain to the 
        registrant the conditions found at the facility. The Secretary 
        may promulgate such regulations on an interim final basis.
            ``(6) Application date.--Facilities shall be subject to the 
        requirements of this subsection beginning on the earlier of--
                    ``(A) the date on which the Secretary issues 
                regulations under paragraph (5); or
                    ``(B) 180 days after the date of enactment of the 
                FDA Food Safety Modernization Act.
            ``(7) No delegation.--The authority conferred by this 
        subsection to issue an order to suspend a registration or 
        vacate an order of suspension shall not be delegated to any 
        officer or employee other than the Commissioner.''.
            (2) 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.--The owner, operator, or agent in charge of a 
facility shall, in accordance with this section, evaluate the hazards 
that could affect food manufactured, processed, packed, or held by such 
facility, identify and implement preventive controls to significantly 
minimize or prevent the occurrence of such hazards and provide 
assurances that such food is not adulterated under section 402 or 
misbranded under section 403(w), monitor the performance of those 
controls, and maintain records of this monitoring as a matter of 
routine practice.
    ``(b) Hazard Analysis.--The owner, operator, or agent in charge of 
a facility shall--
            ``(1) identify and evaluate known or reasonably foreseeable 
        hazards that may be associated with the facility, including--
                    ``(A) biological, chemical, physical, and 
                radiological hazards, natural toxins, pesticides, drug 
                residues, decomposition, parasites, allergens, and 
                unapproved food and color additives; and
                    ``(B) hazards that occur naturally, 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);
            ``(4) the preventive controls implemented under subsection 
        (c) are effectively and significantly minimizing or preventing 
        the occurrence of identified hazards, including through the use 
        of environmental and product testing programs and other 
        appropriate means; and
            ``(5) there is documented, periodic reanalysis of the plan 
        under subsection (i) to ensure that the plan is still relevant 
        to the raw materials, conditions and processes in the facility, 
        and new and emerging threats.
    ``(g) Recordkeeping.--The owner, operator, or agent in charge of a 
facility shall maintain, for not less than 2 years, records documenting 
the monitoring of the preventive controls implemented under subsection 
(c), instances of nonconformance material to food safety, the results 
of testing and other appropriate means of verification under subsection 
(f)(4), instances when corrective actions were implemented, and the 
efficacy of preventive controls and corrective actions.
    ``(h) Written Plan and Documentation.--The owner, operator, or 
agent in charge of a facility shall prepare a written plan that 
documents and describes the procedures used by the facility to comply 
with the requirements of this section, including analyzing the hazards 
under subsection (b) and identifying the preventive controls adopted 
under subsection (c) to address those hazards. Such written plan, 
together with the documentation described in subsection (g), shall be 
made promptly available to a duly authorized representative of the 
Secretary upon oral or written request.
    ``(i) Requirement To Reanalyze.--The owner, operator, or agent in 
charge of a facility shall conduct a reanalysis under subsection (b) 
whenever a significant change is made in the activities conducted at a 
facility operated by such owner, operator, or agent if the change 
creates a reasonable potential for a new hazard or a significant 
increase in a previously identified hazard or not less frequently than 
once every 3 years, whichever is earlier. Such reanalysis shall be 
completed and additional preventive controls needed to address the 
hazard identified, if any, shall be implemented before the change in 
activities at the facility is operative. Such owner, operator, or agent 
shall revise the written plan required under subsection (h) if such a 
significant change is made or document the basis for the conclusion 
that no additional or revised preventive controls are needed. The 
Secretary may require a reanalysis under this section to respond to new 
hazards and developments in scientific understanding.
    ``(j) Deemed Compliance of Seafood, Juice, and Low-acid Canned Food 
Facilities Subject to HACCP.--The 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 Subject to 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, the storage of 
raw agricultural commodities (other than fruits and vegetables) 
intended for further distribution or processing, or the storage of 
packaged foods that are not exposed to the environment.
    ``(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 such hazard to an 
        acceptable level.
            ``(2) Facility.--The term `facility' means a domestic 
        facility or a foreign facility that is required to register 
        under section 415.
            ``(3) Preventive controls.--The term `preventive controls' 
        means those risk-based, reasonably appropriate procedures, 
        practices, and processes that a person knowledgeable about the 
        safe manufacturing, processing, packing, or holding of food 
        would employ to significantly minimize or prevent the hazards 
        identified under the hazard analysis conducted under subsection 
        (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 in processes 
                where a food is exposed to a potential contaminant in 
                the environment.
                    ``(D) A food allergen control program.
                    ``(E) A recall plan.
                    ``(F) Good Manufacturing Practices (GMPs).
                    ``(G) Supplier verification activities.''.
    (b) Regulations.--
            (1) In general.--Not later than 18 months after the date of 
        enactment of this Act, 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 domestic and 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 related to 
the regulations promulgated 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:
    ``(uu) 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) Dietary Supplements.--Nothing in the amendments made by this 
section shall apply to any dietary supplement that is in compliance 
with the requirements of sections 402(g)(2) and 761 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 342(g)(2), 379aa-1).
    (g) No Effect on Alcohol-related Facilities.--
            (1) In general.--Nothing in the amendments made by this 
        section shall apply to a facility that--
                    (A) under the Federal Alcohol Administration Act 
                (27 U.S.C. 201 et seq.) or chapter 51 of subtitle E of 
                the Internal Revenue Code of 1986 (26 U.S.C. 5291 et 
                seq.) is required to obtain a permit or to register 
                with the Secretary of the Treasury as a condition of 
                doing business in the United States; and
                    (B) is required to register as a facility under 
                section 415 of the Federal Food, Drug, and Cosmetic Act 
                (21 U.S.C. 350d) because such facility is engaged in 
                manufacturing, processing, packing, or holding 1 or 
                more alcoholic beverages,
        with respect to the activities of such facility that relate to 
        the manufacturing, processing, packing, or holding of alcoholic 
        beverages.
            (2) Limited receipt and distribution of non-alcohol food.--
        Paragraph (1) shall not apply to a facility engaged in the 
        receipt or distribution of any non-alcohol food, except that 
        such paragraph shall apply to a facility described in such 
        paragraph that receives and distributes non-alcohol food, 
        provided such food is received and distributed--
                    (A) in a prepackaged form that prevents any direct 
                human contact with such food; and
                    (B) in amounts that constitute not more than 5 
                percent of the overall sales of such facility, as 
                determined by the Secretary of the Treasury.
            (3) Rule of construction.--Except as provided in paragraphs 
        (1) and (2), this subsection shall not be construed to exempt 
        any food, other than distilled spirits, wine, and malt 
        beverages, as defined in section 211 of the Federal Alcohol 
        Administration Act (27 U.S.C. 211), from the requirements of 
        this Act (including the amendments made by this Act).
    (h) 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 for 
                purposes of this section, not later than 90 days after 
                the date of enactment of this Act) 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 
                for purposes of this section, not later than 90 days 
                after the date of enactment of this Act) 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 foodborne contaminants. Based on such 
review and evaluation, and when appropriate to reduce the risk of 
serious illness or death to humans or animals or to prevent 
adulteration of the food under section 402 of the Federal Food, Drug, 
or Cosmetic Act (21 U.S.C. 342) or to prevent the spread of 
communicable disease under section 361 of the Public Health Service Act 
(42 U.S.C. 264), the Secretary shall issue contaminant-specific and 
science-based guidance documents, action 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 coordination with the Secretary of Agriculture 
        and representatives of State departments of agriculture 
        (including with regard to the national organic program 
        established under the Organic Foods Production Act of 1990 (7 
        U.S.C. 6501 et seq.)), 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) provide sufficient flexibility to be 
                applicable to various types of entities engaged in the 
                production and harvesting of raw agricultural 
                commodities, including small businesses and entities 
                that sell directly to consumers, and be appropriate to 
                the scale and diversity of the production and 
                harvesting of such commodities;
                    ``(B) include, with respect to growing, harvesting, 
                sorting, packing, and storage operations, minimum 
                standards related to soil amendments, hygiene, 
                packaging, temperature controls, animal encroachment, 
                and water;
                    ``(C) consider hazards that occur naturally, may be 
                unintentionally introduced, or may be intentionally 
                introduced, including by acts of terrorism;
                    ``(D) take into consideration, consistent with 
                ensuring enforceable public health protection, 
                conservation and environmental practice standards and 
                policies established by Federal natural resource 
                conservation, wildlife conservation, and environmental 
                agencies; and
                    ``(E) in the case of production that is certified 
                organic, not include any requirements that conflict 
                with or duplicate the requirements of the national 
                organic program established under the Organic Foods 
                Production Act of 1990 (7 U.S.C. 6501 et seq.), while 
                providing for public health protection consistent with 
                the requirements of this Act.
            ``(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 foodborne illness outbreaks.
    ``(b) Final Regulation.--
            ``(1) In general.--Not later than 1 year after the close of 
        the comment period for the proposed rulemaking under subsection 
        (a), the Secretary shall adopt a final regulation to provide 
        for minimum 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, as appropriate, shall contract and coordinate with 
the agency or department designated by the Governor of each State to 
perform activities to ensure compliance with this section.
    ``(e) Guidance.--
            ``(1) In general.--Not later than 1 year after the date of 
        enactment of the FDA Food Safety Modernization Act, the 
        Secretary shall publish, after consultation with the Secretary 
        of Agriculture, representatives of State departments of 
        agriculture, farmer representatives, and various types of 
        entities engaged in the production and harvesting of fruits and 
        vegetables that are raw agricultural commodities, including 
        small businesses, updated good agricultural practices and 
        guidance for the safe production and harvesting of specific 
        types of fresh produce.
            ``(2) Public meetings.--The Secretary shall conduct not 
        fewer than 3 public meetings in diverse geographical areas of 
        the United States as part of an effort to conduct education and 
        outreach regarding the guidance described in paragraph (1) for 
        persons in different regions who are involved in the production 
        and harvesting of fruits and vegetables that are raw 
        agricultural commodities, including persons that sell directly 
        to consumers and farmer representatives.
    ``(f) Exception for Facilities Subject to 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:
    ``(vv) The failure to comply with the requirements under section 
419.''.
    (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 2 years 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) Applicability.--Regulations under subsection (a) shall apply 
only to food--
            ``(1) for which the Secretary has identified clear 
        vulnerabilities (including 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) Content of Regulations.--Regulations under subsection (a) 
shall--
            ``(1) specify how a person shall assess whether the person 
        is required to implement mitigation strategies or measures 
        intended to protect against the intentional adulteration of 
        food; and
            ``(2) specify appropriate science-based mitigation 
        strategies or measures to prepare and protect the food supply 
        chain at specific vulnerable points, as appropriate.
    ``(e) Exception.--This section shall not apply to farms, except for 
those that produce milk.
    ``(f) Definition.--For purposes of this section, the term `farm' 
has the meaning given that term in section 1.227 of title 21, Code of 
Federal Regulations (or any successor regulation).''.
    (b) Guidance Documents.--
            (1) In general.--Not later than 1 year after the date of 
        enactment of this Act, the Secretary of Health and Human 
        Services, in consultation with the Secretary of Homeland 
        Security and the Secretary of Agriculture, shall issue guidance 
        documents related to protection against the intentional 
        adulteration of food, including mitigation strategies or 
        measures to guard against such adulteration as required under 
        section 420 of the Federal Food, Drug, and Cosmetic Act, as 
        added by subsection (a).
            (2) Content.--The guidance documents issued under paragraph 
        (1) shall--
                    (A) include a model assessment for a person to use 
                under subsection (d)(1) of section 420 of the Federal 
                Food, Drug, and Cosmetic Act, as added by subsection 
                (a);
                    (B) include examples of mitigation strategies or 
                measures described in subsection (d)(2) of such 
                section; and
                    (C) specify situations in which the examples of 
                mitigation strategies or measures described in 
                subsection (d)(2) of such section are appropriate.
            (3) Limited distribution.--In the interest of national 
        security, the Secretary of Health and Human Services, in 
        consultation with the Secretary of Homeland Security, may 
        determine the time 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 of Health and Human Services 
shall periodically review and, as appropriate, update the regulations 
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:
    ``(ww) The failure to comply with section 420.''.

SEC. 107. AUTHORITY TO COLLECT FEES.

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

                     ``PART 6--FEES RELATED TO FOOD

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

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

SEC. 108. NATIONAL AGRICULTURE AND FOOD DEFENSE STRATEGY.

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

SEC. 109. FOOD AND AGRICULTURE COORDINATING COUNCILS.

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

SEC. 110. BUILDING DOMESTIC CAPACITY.

    (a) In General.--
            (1) Initial report.--The Secretary shall, not later than 2 
        years after the date of enactment of this Act, submit to 
        Congress a comprehensive report that identifies programs and 
        practices that are intended to promote the safety and supply 
        chain security of food and to prevent outbreaks of foodborne 
        illness and other food-related hazards that can be addressed 
        through preventive activities. Such report shall include a 
        description of the following:
                    (A) Analysis of the need for further regulations or 
                guidance to industry.
                    (B) Outreach to food industry sectors, including 
                through the Food and Agriculture Coordinating Councils 
                referred to in section 109, to identify potential 
                sources of emerging threats to the safety and security 
                of the food supply and preventive strategies to address 
                those threats.
                    (C) Systems to ensure the prompt distribution to 
                the food industry of information and technical 
                assistance concerning preventive strategies.
                    (D) Communication systems to ensure that 
                information about specific threats to the safety and 
                security of the food supply are rapidly and effectively 
                disseminated.
                    (E) Surveillance systems and laboratory networks to 
                rapidly detect and respond to foodborne illness 
                outbreaks and other food-related hazards, including how 
                such systems and networks are integrated.
                    (F) Outreach, education, and training provided to 
                States and local governments to build State and local 
                food safety and food defense capabilities, including 
                progress implementing strategies developed under 
                sections 108 and 206.
                    (G) The estimated resources needed to effectively 
                implement the programs and practices identified in the 
                report developed in this section over a 5-year period.
                    (H) The impact of requirements under this Act 
                (including amendments made by this Act) on certified 
                organic farms and facilities (as defined in section 415 
                (21 U.S.C. 350d).
            (2) Biennial reports.--On a biennial basis following the 
        submission of the report under paragraph (1), the Secretary 
        shall submit to Congress a report that--
                    (A) reviews previous food safety programs and 
                practices;
                    (B) outlines the success of those programs and 
                practices;
                    (C) identifies future programs and practices; and
                    (D) includes information related to any matter 
                described in subparagraphs (A) through (H) of paragraph 
                (1), as necessary.
    (b) Risk-based Activities.--The report developed under subsection 
(a)(1) shall describe methods that seek to ensure that resources 
available to the Secretary for food safety-related activities are 
directed at those actions most likely to reduce risks from food, 
including the use of preventive strategies and allocation of inspection 
resources. The Secretary shall promptly undertake those risk-based 
actions that are identified during the development of the report as 
likely to contribute to the safety and security of the food supply.
    (c) Capability for Laboratory Analyses; Research.--The report 
developed under subsection (a)(1) shall provide a description of 
methods to increase capacity to undertake analyses of food samples 
promptly after collection, to identify new and rapid analytical 
techniques, including commercially-available techniques that can be 
employed at ports of entry and by Food Emergency Response Network 
laboratories, and to provide for well-equipped and staffed laboratory 
facilities.
    (d) Information Technology.--The report developed under subsection 
(a)(1) shall include a description of such information technology 
systems as may be needed to identify risks and receive data from 
multiple sources, including foreign governments, State, local, and 
tribal governments, other Federal agencies, the food industry, 
laboratories, laboratory networks, and consumers. The information 
technology systems that the Secretary describes shall also provide for 
the integration of the facility registration system under section 415 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d), and the 
prior notice system under section 801(m) of such Act (21 U.S.C. 381(m)) 
with other information technology systems that are used by the Federal 
Government for the processing of food offered for import into the 
United States.
    (e) Automated Risk Assessment.--The report developed under 
subsection (a)(1) shall include a description of progress toward 
developing and improving an automated risk assessment system for food 
safety surveillance and allocation of resources.
    (f) Traceback and Surveillance Report.--The Secretary shall include 
in the report developed under subsection (a)(1) an analysis of the Food 
and Drug Administration's performance in foodborne illness outbreaks 
during the 5-year period preceding the date of enactment of this Act 
involving fruits and vegetables that are raw agricultural commodities 
(as defined in section 201(r) (21 U.S.C. 321(r)) and recommendations 
for enhanced surveillance, outbreak response, and traceability. Such 
findings and recommendations shall address communication and 
coordination with the public, industry, and State and local 
governments, as such communication and coordination relates to outbreak 
identification and traceback.
    (g) Biennial Food Safety and Food Defense Research Plan.--The 
Secretary 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 foodborne 
illness. Such biennial plan shall include a list and description of 
projects conducted during the previous 2-year period and the plan for 
projects to be conducted during the subsequent 2-year period.

SEC. 111. 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. 112. FOOD ALLERGY AND ANAPHYLAXIS MANAGEMENT.

    (a) Definitions.--In this section:
            (1) Early childhood education program.--The term ``early 
        childhood education program'' means--
                    (A) a Head Start program or an Early Head Start 
                program carried out under the Head Start Act (42 U.S.C. 
                9831 et seq.);
                    (B) a State licensed or regulated child care 
                program or school; or
                    (C) a State prekindergarten program that serves 
                children from birth through kindergarten.
            (2) ESEA definitions.--The terms ``local educational 
        agency'', ``secondary school'', ``elementary school'', and 
        ``parent'' have the meanings given the terms in section 9101 of 
        the Elementary and Secondary Education Act of 1965 (20 U.S.C. 
        7801).
            (3) School.--The term ``school'' includes public--
                    (A) kindergartens;
                    (B) elementary schools; and
                    (C) secondary schools.
            (4) Secretary.--The term ``Secretary'' means the Secretary 
        of Health and Human Services.
    (b) Establishment of Voluntary Food Allergy and Anaphylaxis 
Management Guidelines.--
            (1) Establishment.--
                    (A) In general.--Not later than 1 year after the 
                date of enactment of this Act, the Secretary, in 
                consultation with the Secretary of Education, shall--
                            (i) develop guidelines to be used on a 
                        voluntary basis to develop plans for 
                        individuals to manage the risk of food allergy 
                        and anaphylaxis in schools and early childhood 
                        education programs; and
                            (ii) make such guidelines available to 
                        local educational agencies, schools, early 
                        childhood education programs, and other 
                        interested entities and individuals to be 
                        implemented on a voluntary basis only.
                    (B) Applicability of ferpa.--Each plan described in 
                subparagraph (A) that is developed for an individual 
                shall be considered an education record for the purpose 
                of section 444 of the General Education Provisions Act 
                (commonly referred to as the ``Family Educational 
                Rights and Privacy Act of 1974'') (20 U.S.C. 1232g).
            (2) Contents.--The voluntary guidelines developed by the 
        Secretary under paragraph (1) shall address each of the 
        following and may be updated as the Secretary determines 
        necessary:
                    (A) Parental obligation to provide the school or 
                early childhood education program, prior to the start 
                of every school year, with--
                            (i) documentation from their child's 
                        physician or nurse--
                                    (I) supporting a diagnosis of food 
                                allergy, and any risk of anaphylaxis, 
                                if applicable;
                                    (II) identifying any food to which 
                                the child is allergic;
                                    (III) describing, if appropriate, 
                                any prior history of anaphylaxis;
                                    (IV) listing any medication 
                                prescribed for the child for the 
                                treatment of anaphylaxis;
                                    (V) detailing emergency treatment 
                                procedures in the event of a reaction;
                                    (VI) listing the signs and symptoms 
                                of a reaction; and
                                    (VII) assessing the child's 
                                readiness for self-administration of 
                                prescription medication; and
                            (ii) a list of substitute meals that may be 
                        offered to the child by school or early 
                        childhood education program food service 
                        personnel.
                    (B) The creation and maintenance of an individual 
                plan for food allergy management, in consultation with 
                the parent, tailored to the needs of each child with a 
                documented risk for anaphylaxis, including any 
                procedures for the self-administration of medication by 
                such children in instances where--
                            (i) the children are capable of self-
                        administering medication; and
                            (ii) such administration is not prohibited 
                        by State law.
                    (C) Communication strategies between individual 
                schools or early childhood education programs and 
                providers of emergency medical services, including 
                appropriate instructions for emergency medical 
                response.
                    (D) Strategies to reduce the risk of exposure to 
                anaphylactic causative agents in classrooms and common 
                school or early childhood education program areas such 
                as cafeterias.
                    (E) The dissemination of general information on 
                life-threatening food allergies to school or early 
                childhood education program staff, parents, and 
                children.
                    (F) Food allergy management training of school or 
                early childhood education program personnel who 
                regularly come into contact with children with life-
                threatening food allergies.
                    (G) The authorization and training of school or 
                early childhood education program personnel to 
                administer epinephrine when the nurse is not 
                immediately available.
                    (H) The timely accessibility of epinephrine by 
                school or early childhood education program personnel 
                when the nurse is not immediately available.
                    (I) The creation of a plan contained in each 
                individual plan for food allergy management that 
                addresses the appropriate response to an incident of 
                anaphylaxis of a child while such child is engaged in 
                extracurricular programs of a school or early childhood 
                education program, such as non-academic outings and 
                field trips, before- and after-school programs or 
                before- and after-early child education program 
                programs, and school-sponsored or early childhood 
                education program-sponsored programs held on weekends.
                    (J) Maintenance of information for each 
                administration of epinephrine to a child at risk for 
                anaphylaxis and prompt notification to parents.
                    (K) Other elements the Secretary determines 
                necessary for the management of food allergies and 
                anaphylaxis in schools and early childhood education 
                programs.
            (3) Relation to state law.--Nothing in this section or the 
        guidelines developed by the Secretary under paragraph (1) shall 
        be construed to preempt State law, including any State law 
        regarding whether students at risk for anaphylaxis may self-
        administer medication.
    (c) School-based Food Allergy Management Grants.--
            (1) In general.--The Secretary may award grants to local 
        educational agencies to assist such agencies with implementing 
        voluntary food allergy and anaphylaxis management guidelines 
        described in subsection (b).
            (2) Application.--
                    (A) In general.--To be eligible to receive a grant 
                under this subsection, a local educational agency shall 
                submit an application to the Secretary at such time, in 
                such manner, and including such information as the 
                Secretary may reasonably require.
                    (B) Contents.--Each application submitted under 
                subparagraph (A) shall include--
                            (i) an assurance that the local educational 
                        agency has developed plans in accordance with 
                        the food allergy and anaphylaxis management 
                        guidelines described in subsection (b);
                            (ii) a description of the activities to be 
                        funded by the grant in carrying out the food 
                        allergy and anaphylaxis management guidelines, 
                        including--
                                    (I) how the guidelines will be 
                                carried out at individual schools 
                                served by the local educational agency;
                                    (II) how the local educational 
                                agency will inform parents and students 
                                of the guidelines in place;
                                    (III) how school nurses, teachers, 
                                administrators, and other school-based 
                                staff will be made aware of, and given 
                                training on, when applicable, the 
                                guidelines in place; and
                                    (IV) any other activities that the 
                                Secretary determines appropriate;
                            (iii) an itemization of how grant funds 
                        received under this subsection will be 
                        expended;
                            (iv) a description of how adoption of the 
                        guidelines and implementation of grant 
                        activities will be monitored; and
                            (v) an agreement by the local educational 
                        agency to report information required by the 
                        Secretary to conduct evaluations under this 
                        subsection.
            (3) Use of funds.--Each local educational agency that 
        receives a grant under this subsection may use the grant funds 
        for the following:
                    (A) Purchase of materials and supplies, including 
                limited medical supplies such as epinephrine and 
                disposable wet wipes, to support carrying out the food 
                allergy and anaphylaxis management guidelines described 
                in subsection (b).
                    (B) In partnership with local health departments, 
                school nurse, teacher, and personnel training for food 
                allergy management.
                    (C) Programs that educate students as to the 
                presence of, and policies and procedures in place 
                related to, food allergies and anaphylactic shock.
                    (D) Outreach to parents.
                    (E) Any other activities consistent with the 
                guidelines described in subsection (b).
            (4) Duration of awards.--The Secretary may award grants 
        under this subsection for a period of not more than 2 years. In 
        the event the Secretary conducts a program evaluation under 
        this subsection, funding in the second year of the grant, where 
        applicable, shall be contingent on a successful program 
        evaluation by the Secretary after the first year.
            (5) Limitation on grant funding.--The Secretary may not 
        provide grant funding to a local educational agency under this 
        subsection after such local educational agency has received 2 
        years of grant funding under this subsection.
            (6) Maximum amount of annual awards.--A grant awarded under 
        this subsection may not be made in an amount that is more than 
        $50,000 annually.
            (7) Priority.--In awarding grants under this subsection, 
        the Secretary shall give priority to local educational agencies 
        with the highest percentages of children who are counted under 
        section 1124(c) of the Elementary and Secondary Education Act 
        of 1965 (20 U.S.C. 6333(c)).
            (8) Matching funds.--
                    (A) In general.--The Secretary may not award a 
                grant under this subsection unless the local 
                educational agency agrees that, with respect to the 
                costs to be incurred by such local educational agency 
                in carrying out the grant activities, the local 
                educational agency shall make available (directly or 
                through donations from public or private entities) non-
                Federal funds toward such costs in an amount equal to 
                not less than 25 percent of the amount of the grant.
                    (B) Determination of amount of non-federal 
                contribution.--Non-Federal funds required under 
                subparagraph (A) may be cash or in kind, including 
                plant, equipment, or services. Amounts provided by the 
                Federal Government, and any portion of any service 
                subsidized by the Federal Government, may not be 
                included in determining the amount of such non-Federal 
                funds.
            (9) Administrative funds.--A local educational agency that 
        receives a grant under this subsection may use not more than 2 
        percent of the grant amount for administrative costs related to 
        carrying out this subsection.
            (10) Progress and evaluations.--At the completion of the 
        grant period referred to in paragraph (4), a local educational 
        agency shall provide the Secretary with information on how 
        grant funds were spent and the status of implementation of the 
        food allergy and anaphylaxis management guidelines described in 
        subsection (b).
            (11) Supplement, not supplant.--Grant funds received under 
        this subsection shall be used to supplement, and not supplant, 
        non-Federal funds and any other Federal funds available to 
        carry out the activities described in this subsection.
            (12) Authorization of appropriations.--There is authorized 
        to be appropriated to carry out this subsection $30,000,000 for 
        fiscal year 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 compliance history, including 
                with regard to food recalls, outbreaks, and violations 
                of food safety standards.
                    ``(C) The rigor and effectiveness of the facility's 
                hazard analysis and risk-based preventive controls.
                    ``(D) Whether the food manufactured, processed, 
                packed, 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 or regions of 
        origin and countries of transport of the food imported.
            ``(3) The compliance history of the importer, including 
        with regard to food recalls, outbreaks, and violations of food 
        safety standards.
            ``(4) The rigor and effectiveness 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 1003 (21 U.S.C. 393) is amended by 
adding at the end the following:
    ``(h) Annual Report Regarding Food.--Not later than February 1 of 
each year, the Secretary shall submit to Congress a report regarding--
            ``(1) information about food facilities including--
                    ``(A) the appropriations used to inspect facilities 
                registered pursuant to section 415 in the previous 
                fiscal year;
                    ``(B) the average cost of both a non-high-risk food 
                facility inspection and a high-risk food facility 
                inspection, if such a difference exists, in the 
                previous fiscal year;
                    ``(C) the number of domestic facilities and the 
                number of foreign facilities registered pursuant to 
                section 415 that the Secretary inspected in the 
                previous fiscal year;
                    ``(D) the number of domestic facilities and the 
                number of foreign facilities registered pursuant to 
                section 415 that were scheduled for inspection in the 
                previous fiscal year and which the Secretary did not 
                inspect in such year;
                    ``(E) the number of high-risk facilities identified 
                pursuant to section 421 that the Secretary inspected in 
                the previous fiscal year; and
                    ``(F) the number of high-risk facilities identified 
                pursuant to section 421 that were scheduled for 
                inspection in the previous fiscal year and which the 
                Secretary did not inspect in such year.
            ``(2) information about food imports including--
                    ``(A) the number of lines of food imported into the 
                United States that the Secretary physically inspected 
                or sampled in the previous fiscal year;
                    ``(B) the number of lines of food imported into the 
                United States that the Secretary did not physically 
                inspect or sample in the previous fiscal year; and
                    ``(C) the average cost of physically inspecting or 
                sampling a food line subject to this Act that is 
                imported or offered for import into the United States; 
                and
            ``(3) information on the foreign offices of the Food and 
        Drug Administration including--
                    ``(A) the number of foreign offices established; 
                and
                    ``(B) the number of personnel permanently stationed 
                in each foreign office.
    ``(i) Public Availability of Annual Food Reports.--The Secretary 
shall make the reports required under subsection (h) available to the 
public on the Internet Web site of the Food and Drug Administration.''.

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 sampling and 
                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 
        recognized by the Secretary under paragraph (1) may accredit 
        laboratories that operate outside the United States, so long as 
        such laboratories meet the accreditation standards applicable 
        to domestic laboratories accredited under this section.
            ``(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 rapid analytical 
                procedures and commercially available techniques 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 sampling and 
                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 ensure 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, specifying, as 
                appropriate, any terms and conditions necessary for 
                laboratories accredited by such body to continue to 
                perform testing as described in this section.
    ``(b) Testing Procedures.--
            ``(1) In general.--Food testing shall be conducted by 
        Federal laboratories or non-Federal laboratories that have been 
        accredited by an accreditation body on the registry established 
        by the Secretary under subsection (a)(1)(B) whenever such 
        testing is conducted--
                    ``(A) by or on behalf of an owner or consignee--
                            ``(i) in response to a specific testing 
                        requirement under this Act or implementing 
                        regulations, when applied to address an 
                        identified or suspected food safety problem; 
                        and
                            ``(ii) as required by the Secretary, as the 
                        Secretary deems appropriate, to address an 
                        identified or suspected food safety problem; 
                        and
                    ``(B) on behalf of an owner or consignee--
                            ``(i) in support of admission of an article 
                        of food under section 801(a); and
                            ``(ii) under an Import Alert that requires 
                        successful consecutive tests.
            ``(2) Results of testing.--The results of any such testing 
        shall be sent directly to the Food and Drug Administration, 
        except the Secretary may by regulation exempt test results that 
        do not have to be so submitted if the Secretary determines that 
        such results do not contribute to the protection of public 
        health. Test results required to be submitted may be submitted 
        to the Food and Drug Administration through electronic means.
    ``(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, 
        local, and private 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 
coordination 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 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 Projects.--
            (1) In general.--Not later than 9 months after the date of 
        enactment of this Act, the Secretary shall establish at least 3 
        pilot projects 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, as soon as practicable, 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 projects 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.--
            (1) In general.--Not later than 3 years 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 a foodborne illness 
        outbreak, fruits and vegetables that are raw agricultural 
        commodities. In promulgating the regulations under this 
        paragraph, the Secretary shall consider--
                    (A) the impact of such regulations on farms and 
                small businesses;
                    (B) the findings in the report submitted under 
                subsection (c); and
                    (C) existing international trade obligations.
            (2) Limitations.--
                    (A) Type of records.--The Secretary shall not 
                require an entity that is subject to the requirements 
                of section 419 of the Federal Food, Drug, and Cosmetic 
                Act (as added by section 105), but which is not a 
                facility (as such term is defined by section 415 of 
                such Act), to submit to the Secretary distribution 
                records under this section other than distribution 
                records that are kept in the normal course of business 
                and that show the immediate subsequent recipient, other 
                than a consumer.
                    (B) Maintenance of records.--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. PILOT PROJECT TO ENHANCE TRACEBACK AND RECORDKEEPING WITH 
              RESPECT TO PROCESSED FOOD.

    (a) In General.--As soon as practicable after the date of enactment 
of this Act, the Secretary shall establish a pilot project to explore 
and evaluate methods for rapidly and effectively tracking and tracing 
processed food so that, if an outbreak occurs involving such a 
processed food, the Secretary may quickly identify the source of the 
outbreak and the recipients of the contaminated food.
    (b) Consultation.--In establishing the pilot project under 
subsection (a), the Secretary shall consult with food processors and 
relevant businesses of varying size.
    (c) Content.--The Secretary shall select participants from the 
processed food industry to run a project which overall shall include 1 
or more different types of processed food 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--
            (1) methods that are applicable and appropriate for small 
        businesses; and
            (2) technologies, including existing technologies, that 
        enhance traceback and trace forward.
    (d) Report.--The Secretary shall report to Congress on the findings 
of the pilot project under this section, together with recommendations 
for establishing more effective traceback and trace forward procedures 
for processed food.
    (e) Processed Food.--In this section, the term ``processed food'' 
has the meaning given such term in section 201(gg) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321(gg)).

SEC. 206. SURVEILLANCE.

    (a) Definition of Foodborne Illness Outbreak.--In this section, the 
term ``foodborne illness outbreak'' means the occurrence of 2 or more 
cases of a similar illness resulting from the ingestion of a food.
    (b) Foodborne Illness Surveillance Systems.--
            (1) In general.--The Secretary, acting through the Director 
        of the Centers for Disease Control and Prevention, shall 
        enhance foodborne illness surveillance systems to improve the 
        collection, analysis, reporting, and usefulness of data on 
        foodborne illnesses by--
                    (A) coordinating Federal, State and local foodborne 
                illness surveillance systems, including complaint 
                systems, and increasing participation in national 
                networks of public health and food regulatory agencies 
                and laboratories;
                    (B) facilitating sharing of 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 foodborne illness outbreak to a specific food;
                    (E) expanding capacity of such systems, including 
                working toward automatic electronic searches, for 
                implementation of identification practices, including 
                fingerprinting strategies, for foodborne infectious 
                agents, in order to identify new or rarely documented 
                causes of foodborne illness and submit standardized 
                information to a centralized database;
                    (F) allowing timely public access to aggregated, 
                de-identified surveillance data;
                    (G) at least annually, publishing current reports 
                on findings from such systems;
                    (H) establishing a flexible mechanism for rapidly 
                initiating scientific research by academic 
                institutions;
                    (I) integrating foodborne illness surveillance 
                systems and data with other biosurveillance and public 
                health situational awareness capabilities at the 
                Federal, State, and local levels; 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 and food testing industries, consumer organizations, and 
        academia. Such working group shall provide the Secretary, 
        through at least annual meetings of the working group and an 
        annual public report, advice and recommendations on an ongoing 
        and regular basis regarding the improvement of foodborne 
        illness surveillance and implementation of this section, 
        including advice and recommendations on--
                    (A) the priority needs of regulatory agencies, the 
                food industry, and consumers for information and 
                analysis on foodborne illness and its causes;
                    (B) opportunities to improve the effectiveness of 
                initiatives at the Federal, State, and local levels, 
                including coordination and integration of activities 
                among Federal agencies, and between the Federal, State, 
                and local levels of government;
                    (C) improvement in the timeliness and depth of 
                access by regulatory and health agencies, the food 
                industry, academic researchers, and consumers to 
                foodborne illness aggregated, de-identified 
                surveillance data collected by government agencies at 
                all levels, including data compiled by the Centers for 
                Disease Control and Prevention;
                    (D) key barriers to improvement in foodborne 
                illness surveillance and its utility for preventing 
                foodborne 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 foodborne illness outbreak response and 
                containment.
                    (B) Accelerate foodborne illness surveillance and 
                outbreak investigation, including rapid shipment of 
                clinical isolates from clinical laboratories to 
                appropriate State laboratories, and conducting more 
                standardized illness outbreak interviews.
                    (C) Strengthen the capacity of State and local 
                agencies to carry out inspections and enforce safety 
                standards.
                    (D) Improve the effectiveness of Federal, State, 
                and local partnerships to coordinate food safety and 
                defense resources and reduce the incidence of foodborne 
                illness.
                    (E) Share information on a timely basis among 
                public health and food regulatory agencies, with the 
                food industry, with health care providers, and with the 
                public.
                    (F) Strengthen the capacity of State and local 
                agencies to achieve the goals described in section 108.
            (2) Review.--In developing of the strategies required by 
        paragraph (1), the Secretary shall, not later than 1 year after 
        the date of enactment of the FDA Food Safety Modernization Act, 
        complete a review of State and local capacities, and needs for 
        enhancement, which may include a survey with respect to--
                    (A) staffing levels and expertise available to 
                perform food safety and defense functions;
                    (B) laboratory capacity to support surveillance, 
                outbreak response, inspection, and enforcement 
                activities;
                    (C) information systems to support data management 
                and sharing of food safety and defense information 
                among State and local agencies and with counterparts at 
                the Federal level; and
                    (D) other State and local activities and needs as 
                determined appropriate by the Secretary.
    (d) Food Safety Capacity Building Grants.--Section 317R(b) of the 
Public Health Service Act (42 U.S.C. 247b-20(b)) is amended--
            (1) by striking ``2002'' and inserting ``2010''; and
            (2) by striking ``2003 through 2006'' and inserting ``2011 
        through 2014''.

SEC. 207. 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; and
            ``(2) as applicable, 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;
            ``(2) consult the policies of the Department of Agriculture 
        regarding providing to the public a list of retail consignees 
        receiving products involved in a Class I recall and shall 
        consider providing such a list to the public, as determined 
        appropriate by the Secretary; and
            ``(3) if available, publish on the Internet Web site of the 
        Food and Drug Administration an image of the article that is 
        the subject of the press release described in (1).
    ``(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) Search Engine.--Not later than 90 days after the date of 
enactment of this Act, the Secretary shall modify the Internet Web site 
of the Food and Drug Administration to include a search engine that--
            (1) is consumer-friendly, as determined by the Secretary; 
        and
            (2) provides a means by which an individual may locate 
        relevant information regarding each article of food subject to 
        a recall under section 420 of the Federal Food, Drug, and 
        Cosmetic Act and the status of such recall (such as whether a 
        recall is ongoing or has been completed).
    (c) Civil Penalty.--Section 303(f)(2)(A) (21 U.S.C. 333(f)(2)(A)) 
is amended by inserting ``or any person who does not comply with a 
recall order under section 423'' after ``section 402(a)(2)(B)''.
    (d) Prohibited Acts.--Section 301 (21 U.S.C. 331 et seq.), as 
amended by section 106, is amended by adding at the end the following:
    ``(xx) The refusal or failure to follow an order under section 
423.''.

SEC. 208. 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. 209. DECONTAMINATION AND DISPOSAL STANDARDS AND PLANS.

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

SEC. 210. IMPROVING THE TRAINING OF STATE, LOCAL, TERRITORIAL, AND 
              TRIBAL FOOD SAFETY OFFICIALS.

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

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

    ``(a) Training.--The Secretary shall set standards and administer 
training and education programs for the employees of State, local, 
territorial, and tribal food safety officials relating to the 
regulatory responsibilities and policies established by this Act, 
including programs for--
            ``(1) scientific training;
            ``(2) training to improve the skill of officers and 
        employees authorized to conduct inspections under sections 702 
        and 704;
            ``(3) training to achieve advanced product or process 
        specialization in such inspections;
            ``(4) training that addresses best practices;
            ``(5) training in administrative process and procedure and 
        integrity issues;
            ``(6) training in appropriate sampling and laboratory 
        analysis methodology; and
            ``(7) training in building enforcement actions following 
        inspections, examinations, testing, and investigations.
    ``(b) Partnerships With State and Local Officials.--
            ``(1) In general.--The Secretary, pursuant to a contract or 
        memorandum of understanding between the Secretary and the head 
        of a State, local, territorial, or tribal department or agency, 
        is authorized and encouraged to conduct examinations, testing, 
        and investigations for the purposes of determining compliance 
        with the food safety provisions of this Act through the 
        officers and employees of such State, local, territorial, or 
        tribal department or agency.
            ``(2) Content.--A contract or memorandum described under 
        paragraph (1) shall include provisions to ensure adequate 
        training of such officers and employees to conduct such 
        examinations, testing, and investigations. The contract or 
        memorandum shall contain provisions regarding reimbursement. 
        Such provisions may, at the sole discretion of the head of the 
        other department or agency, require reimbursement, in whole or 
        in part, from the Secretary for the examinations, testing, or 
        investigations performed pursuant to this section by the 
        officers or employees of the State, territorial, or tribal 
        department or agency.
            ``(3) Effect.--Nothing in this subsection shall be 
        construed to limit the authority of the Secretary under section 
        702.
    ``(c) Extension Service.--The Secretary shall ensure coordination 
with the extension activities of the National Institute of Food and 
Agriculture of the Department of Agriculture in advising producers and 
small processors transitioning into new practices required as a result 
of the enactment of the FDA Food Safety Modernization Act and assisting 
regulated industry with compliance with such Act.
    ``(d) Authorization of Appropriations.--There are authorized to be 
appropriated such sums as may be necessary to carry out this section 
for fiscal years 2011 through 2015.''.

SEC. 211. GRANTS TO ENHANCE FOOD SAFETY.

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

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

    ``(a) In General.--The Secretary is authorized to make grants to 
States, localities, territories, and Indian tribes (as defined in 
section 4(e) of the Indian Self-Determination and Education Assistance 
Act (25 U.S.C. 450b(e))) to--
            ``(1) undertake examinations, inspections, and 
        investigations, and related food safety activities under 
        section 702;
            ``(2) train to the standards of the Secretary for the 
        examination, inspection, and investigation of food 
        manufacturing, processing, packing, holding, distribution, and 
        importation, including as such examination, inspection, and 
        investigation relate to retail food establishments;
            ``(3) build the capacity of the laboratories of such State, 
        locality, territory, or Indian tribe for food safety;
            ``(4) build the infrastructure and capacity of the food 
        safety programs of such State, locality, territory, or Indian 
        tribe to meet the standards as outlined in the grant 
        application; and
            ``(5) take appropriate action to protect the public health 
        in response to--
                    ``(A) a notification under section 1008, including 
                planning and otherwise preparing to take such action; 
                or
                    ``(B) a recall of food under this Act.
    ``(b) Application.--
            ``(1) In general.--To be eligible to receive a grant under 
        this section, a State, locality, territory, or Indian tribe 
        shall submit an application to the Secretary at such time, in 
        such manner, and including such information as the Secretary 
        may reasonably require.
            ``(2) Contents.--Each application submitted under paragraph 
        (1) shall include--
                    ``(A) an assurance that the State, locality, 
                territory, or Indian tribe has developed plans to 
                engage in the types of activities described in 
                subsection (a);
                    ``(B) a description of the types of activities to 
                be funded by the grant;
                    ``(C) an itemization of how grant funds received 
                under this section will be expended;
                    ``(D) a description of how grant activities will be 
                monitored; and
                    ``(E) an agreement by the State, locality, 
                territory, or Indian tribe to report information 
                required by the Secretary to conduct evaluations under 
                this section.
    ``(c) Limitations.--The funds provided under subsection (a) shall 
be available to a State, locality, territory, or Indian tribe only to 
the extent such State, locality, territory, or Indian tribe funds its 
food safety programs independently of any grant under this section in 
each year of the grant at a level equal to the level of such funding in 
the previous year, increased by the Consumer Price Index.
    ``(d) Additional Authority.--The Secretary may--
            ``(1) award a grant under this section in each subsequent 
        fiscal year without reapplication for a period of not more than 
        3 years, provided the requirements of subsection (c) are met 
        for the previous fiscal year; and
            ``(2) award a grant under this section in a fiscal year for 
        which the requirement of subsection (c) has not been met only 
        if such requirement was not met because such funding was 
        diverted for response to 1 or more natural disasters or in 
        other extenuating circumstances that the Secretary may 
        determine appropriate.
    ``(e) Duration of Awards.--The Secretary may award grants to an 
individual grant recipient under this section for a period of not more 
than 3 years. In the event the Secretary conducts a program evaluation, 
funding in the second year or third year of the grant, where 
applicable, shall be contingent on a successful program evaluation by 
the Secretary after the first year.
    ``(f) Progress and Evaluation.--A grant recipient shall at the end 
of each year provide the Secretary with information on how grant funds 
were spent and the status of the efforts by such recipient to enhance 
food safety.
    ``(g) Supplement Not Supplant.--Grant funds received under this 
section shall be used to supplement, and not supplant, non-Federal 
funds and any other Federal funds available to carry out the activities 
described in this section.
    ``(h) Authorization of Appropriations.--For the purpose of making 
grants under this section, there are authorized to be appropriated such 
sums as may be necessary for fiscal years 2011 through 2015.''.

            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 importer shall 
        perform risk-based foreign supplier verification activities 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 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 an 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 to 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 an importer 
related to a foreign supplier verification program shall be maintained 
for a period of not less than 2 years and shall be made available 
promptly to a duly authorized representative of the Secretary upon 
request.
    ``(e) Deemed Compliance of Seafood, Juice, and Low-acid Canned Food 
Facilities in Compliance With HACCP.--The 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 207, is amended by adding at the end the following:
    ``(yy) 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 
        Secretary of Homeland Security, to provide for the expedited 
        review and importation of food offered for importation by 
        importers who have voluntarily agreed to participate in such 
        program; and
            ``(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.--Eligibility shall be limited to an importer 
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 (q) 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:
    ``(q) 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 not 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 
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 meets or 
exceeds the safety of 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, the United States Trade 
Representative, and the Secretary of Commerce, representatives of the 
food industry, appropriate foreign government officials, 
nongovernmental organizations that represent the interests of 
consumers, and other stakeholders.
    (c) Plan.--The plan developed under subsection (a) shall include, 
as appropriate, the following:
            (1) Recommendations for bilateral and multilateral 
        arrangements and agreements, including provisions to provide 
        for responsibility of exporting countries to ensure the safety 
        of food.
            (2) Provisions for secure electronic data sharing.
            (3) Provisions for mutual recognition of inspection 
        reports.
            (4) Training of foreign governments and food producers on 
        United States requirements for safe food.
            (5) Recommendations on whether and how to harmonize 
        requirements under the Codex Alimentarius.
            (6) Provisions for the multilateral acceptance of 
        laboratory methods and detection techniques.
    (d) Rule of Construction.--Nothing in this section shall be 
construed to affect the regulation of dietary supplements under the 
Dietary Supplement Health and Education Act of 1994 (Public Law 103-
417).

SEC. 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 
2 business days 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 a foreign facility registered under 
        section 415, in the food import supply chain that chooses to be 
        audited by an accredited third-party auditor or 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(q); 
                        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.--
                            ``(i) In general.--Not later than 2 years 
                        after the date of enactment of the FDA Food 
                        Safety Modernization Act, the Secretary shall 
                        establish a system for the recognition of 
                        accreditation bodies that accredit third-party 
                        auditors and audit agents to certify that 
                        eligible entities meet the applicable 
                        requirements of this Act.
                            ``(ii) Direct accreditation.--If, by the 
                        date that is 1 year after the date of 
                        establishment of the system described in clause 
                        (i), the Secretary has not identified and 
                        recognized an accreditation body to meet the 
                        requirements of this section, the Secretary may 
                        directly accredit third-party auditors and 
                        audit agents.
                    ``(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 (or, in the case of 
                direct accreditation under subsection (b)(1)(A)(ii), 
                the Secretary) shall perform such reviews and audits of 
                food safety programs, systems, and standards of the 
                government 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 into the United States.
                    ``(B) Foreign cooperatives and other third 
                parties.--Prior to accrediting a foreign cooperative 
                that aggregates the products of growers or processors, 
                or any other third party that the Secretary determines 
                appropriate to be an accredited third-party auditor or 
                audit agent, the accreditation body (or, in the case of 
                direct accreditation under subsection (b)(1)(A)(ii), 
                the Secretary) shall perform such reviews and audits of 
                the training and qualifications of 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 (or, in 
                the case of direct accreditation under subsection 
                (b)(1)(A)(ii), the Secretary) 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. Such written certification may be included 
                with other documentation regarding such food shipment. 
                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 to--
                            ``(i) determine the eligibility of an 
                        importer to receive a certification under 
                        section 801(q); 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 information 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 to decrease the 
                        potential for conflicts of interest, including 
                        timing and public disclosure, for fees paid by 
                        eligible entities to accredited third-party 
                        auditors or audit agents; 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(q) for any food from such entity.
    ``(e) False Statements.--Any statement or representation made--
            ``(1) by an employee or agent of an eligible entity to an 
        accredited third-party auditor or audit agent; or
            ``(2) by an accredited third-party auditor 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 establish offices of the Food 
and Drug Administration in foreign countries selected by the Secretary, 
to provide assistance to the appropriate governmental entities of such 
countries with respect to measures to provide for the safety of 
articles of food and other products regulated by the Food and Drug 
Administration exported by such country to the United States, including 
by directly conducting risk-based inspections of such articles and 
supporting such inspections by such governmental entity.
    (b) Consultation.--In establishing the foreign offices described in 
subsection (a), the Secretary shall consult with the Secretary of State 
and the United States Trade Representative.
    (c) Report.--Not later than October 1, 2011, the Secretary shall 
submit to Congress a report on the basis for the selection by the 
Secretary of the foreign countries in which the Secretary established 
offices, the progress which such offices have made with respect to 
assisting the governments of such countries in providing for the safety 
of articles of food and other products regulated by the Food and Drug 
Administration exported to the United States, and the plans of the 
Secretary for establishing additional foreign offices of the Food and 
Drug Administration, as appropriate.

SEC. 310. SMUGGLED FOOD.

    (a) In General.--Not later than 180 days after the enactment of 
this Act, the Secretary shall, in consultation with the Secretary of 
Homeland Security, the Commissioner of Customs and Border Patrol, and 
the Assistant Secretary for Immigration and Customs Enforcement, 
develop and implement a strategy to better identify smuggled food and 
prevent entry of such food into the United States.
    (b) Notification to Homeland Security.--Not later than 10 days 
after the Secretary identifies a smuggled food that the Secretary 
believes would cause serious adverse health consequences or death to 
humans or animals, the Secretary shall provide to the Secretary of 
Homeland Security a notification under section 417(k) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 350f(k)) describing the 
smuggled food and, if available, the names of the individuals or 
entities that attempted to import such food into the United States.
    (c) Public Notification.--If the Secretary--
            (1) identifies a smuggled food;
            (2) reasonably believes exposure to the food would cause 
        serious adverse health consequences or death to humans or 
        animals; and
            (3) reasonably believes that the food has entered domestic 
        commerce and is likely to be consumed,
the Secretary shall promptly issue a press release describing that food 
and shall use other emergency communication or recall networks, as 
appropriate, to warn consumers and vendors about the potential threat.
    (d) Definition.--In this subsection, the term ``smuggled food'' 
means any food that a person introduces into the United States through 
fraudulent means or with the intent to defraud or mislead.

                   TITLE IV--MISCELLANEOUS PROVISIONS

SEC. 401. FUNDING FOR FOOD SAFETY.

    (a) In General.--There are authorized to be appropriated to carry 
out the activities of the Center for Food Safety and Applied Nutrition, 
the Center for Veterinary Medicine, and related field activities in the 
Office of Regulatory Affairs of the Food and Drug Administration--
            (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.--
            (1) In general.--To carry out the activities of the Center 
        for Food Safety and Applied Nutrition, the Center for 
        Veterinary Medicine, and related field activities of the Office 
        of Regulatory Affairs of the Food and Drug Administration, the 
        Secretary of Health and Human Services shall increase the field 
        staff of such Centers and Office with a goal of not fewer 
        than--
                    (A) 3,800 staff members in fiscal year 2010;
                    (B) 4,000 staff members in fiscal year 2011;
                    (C) 4,200 staff members in fiscal year 2012;
                    (D) 4,600 staff members in fiscal year 2013; and
                    (E) 5,000 staff members in fiscal year 2014.
            (2) Field staff for food defense.--The goal under paragraph 
        (1) shall include an increase of 150 employees by fiscal year 
        2011 to--
                    (A) provide additional detection of and response to 
                food defense threats; and
                    (B) detect, track, and remove smuggled food (as 
                defined in section 310) from commerce.

SEC. 402. WHISTLEBLOWER PROTECTIONS.

    Chapter X of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
391 et seq.), as amended by section 210, is further amended by adding 
at the end the following:

``SEC. 1012. WHISTLEBLOWER PROTECTIONS.

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

SEC. 403. JURISDICTION; AUTHORITIES.

    Nothing in this Act, or an amendment made by this Act, shall be 
construed to--
            (1) alter the jurisdiction between the Secretary of 
        Agriculture and the Secretary of Health and Human Services, 
        under applicable statutes, regulations, or agreements regarding 
        products eligible for voluntary inspection under the 
        Agricultural Marketing Act (7 U.S.C. 1621 et seq.);
            (2) alter the jurisdiction between the Administration of 
        the Alcohol and Tobacco Tax and Trade Bureau and the Secretary 
        of Health and Human Services, under applicable statutes and 
        regulations;
            (3) limit the authority of the Secretary of Health and 
        Human Services 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
            (4) 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 or 
        foodborne illness outbreak involving products regulated under 
        the Federal Meat Inspection Act, the Poultry Products 
        Inspection Act, the Egg Products Inspection Act, or agreements 
        regarding voluntary inspection under the Agricultural Marketing 
        Act (7 U.S.C. 1621 et seq.).

SEC. 404. COMPLIANCE WITH INTERNATIONAL AGREEMENTS.

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

SEC. 405. UPDATING GUIDANCE RELATING TO FISH AND FISHERIES PRODUCTS 
              HAZARDS AND CONTROLS.

    The Secretary shall, not later than 180 days after the date of 
enactment of this Act, update the Fish and Fisheries Products Hazards 
and Control Guidance to take into account advances in technology that 
have occurred since the previous publication of such Guidance by the 
Secretary.

SEC. 406. FOOD TRANSPORTATION STUDY.

    The Secretary of Health and Human Services, acting through the 
Commissioner of Food and Drugs, shall conduct a study of the 
transportation of food for consumption in the United States, including 
transportation by air, that includes an examination of the unique needs 
of rural and frontier areas with regard to the delivery of safe food.
                                                       Calendar No. 247

111th CONGRESS

  1st Session

                                 S. 510

_______________________________________________________________________

                                 A BILL

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

_______________________________________________________________________

                           December 18, 2009

                       Reported with an amendment