[Congressional Record Volume 156, Number 151 (Thursday, November 18, 2010)]
[Senate]
[Pages S8031-S8046]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                   FDA FOOD SAFETY MODERNIZATION ACT

  The PRESIDING OFFICER. The clerk will report the bill by title.
  The assistant legislative clerk read as follows:

       A bill (S. 510) to amend the Federal Food, Drug, and 
     Cosmetic Act with respect to the safety of the food supply.

  The Senate proceeded to consider the bill, which had been reported 
from the Committee on Health, Education, Labor, and Pensions, with an 
amendment to strike all after the enacting clause and insert in lieu 
thereof the following:

     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.

[[Page S8032]]

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);

[[Page S8033]]

       ``(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

[[Page S8034]]

     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

[[Page S8035]]

     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

[[Page S8036]]

     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

[[Page S8037]]

     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.

[[Page S8038]]

       (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.

[[Page S8039]]

       ``(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

[[Page S8040]]

     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

[[Page S8041]]

     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

[[Page S8042]]

     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

[[Page S8043]]

       ``(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

[[Page S8044]]

     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

[[Page S8045]]

     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

[[Page S8046]]

     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.

  Mr. REID. Mr. President, are we on the bill now?
  The PRESIDING OFFICER. Yes, we are.

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