[Congressional Record (Bound Edition), Volume 156 (2010), Part 13]
[Senate]
[Pages 17971-17999]
[From the U.S. Government Publishing Office, www.gpo.gov]




                           TEXT OF AMENDMENTS

  SA 4708. Mr. PRYOR submitted an amendment intended to be proposed by 
him to the bill S. 510, to amend the Federal Food, Drug, and Cosmetic 
Act with respect to the safety of the food supply; which was ordered to 
lie on the table; as follows:

       At the end of title IV, add the following:

     SEC. 405. NANOTECHNOLOGY PROGRAM.

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

     ``SEC. 1012. NANOTECHNOLOGY PROGRAM.

       ``(a) In General.--Not later than 180 days after the date 
     of enactment of the FDA Food Safety Modernization Act, the 
     Secretary of Health and Human Services, in consultation with 
     the Secretary of Agriculture, shall establish within the Food 
     and Drug Administration a program for the scientific 
     investigation of nanoscale materials included or intended for 
     inclusion in FDA-regulated products, to address the potential 
     toxicology of such materials, the effects of such materials 
     on biological systems, and interaction of such materials with 
     biological systems.
       ``(b) Program Purposes.--The purposes of the program 
     established under subsection (a) shall be to--
       ``(1) assess scientific literature and data on general 
     nanoscale material interactions with biological systems and 
     on specific nanoscale materials of concern to Food and Drug 
     Administration;
       ``(2) develop and organize information using databases and 
     models that will enable the formulation of generalized 
     principles for the behavior of classes of nanoscale materials 
     with biological systems;
       ``(3) promote intramural Administration programs and 
     participate in collaborative efforts, to further the 
     understanding of the science of novel properties at the 
     nanoscale that might contribute to toxicity;
       ``(4) promote and participate in collaborative efforts to 
     further the understanding of measurement and detection 
     methods for nanoscale materials;
       ``(5) collect, synthesize, interpret, and disseminate 
     scientific information and data related to the interactions 
     of nanoscale materials with biological systems;
       ``(6) build scientific expertise on nanoscale materials 
     within such Administration;
       ``(7) ensure ongoing training, as well as dissemination of 
     new information within the centers of such Administration, 
     and more broadly across such Administration, to ensure 
     timely, informed consideration of the most current science;
       ``(8) encourage such Administration to participate in 
     international and national consensus standards activities; 
     and
       ``(9) carry out other activities that the Secretary 
     determines are necessary and consistent with the purposes 
     described in paragraphs (1) through (8).
       ``(c) Program Administration.--
       ``(1) Program manager.--In carrying out the program under 
     this section, the Secretary shall designate a program manager 
     who shall supervise the planning, management, and 
     coordination of the program.
       ``(2) Duties.--The program manager shall--
       ``(A) develop a detailed strategic plan for achieving 
     specific short- and long-term technical goals for the 
     program;
       ``(B) coordinate and integrate the strategic plan with 
     investments by the Food and Drug Administration and other 
     departments and agencies participating in the National 
     Nanotechnology Initiative; and
       ``(C) develop intramural Administration programs, 
     contracts, memoranda of agreement, joint funding agreements, 
     and other cooperative arrangements necessary for meeting the 
     long-term challenges and achieving the specific technical 
     goals of the program.
       ``(d) Reports.--The Secretary shall submit to the National 
     Science and Technology Council information on the program 
     under this section, including the information required to be 
     provided by the National Research Council in the annual 
     report described in section 2(d) of the 21st Century 
     Nanotechnology Research and Development Act (15 U.S.C. 
     7501(d)).
       ``(e) Authorization of Appropriations.--There are 
     authorized to be appropriated such sums as necessary to carry 
     out this section.''.
                                 ______
                                 
  SA 4709. Ms. LANDRIEU submitted an amendment intended to be proposed 
by her to the bill S. 510, to amend the Federal Food, Drug, and 
Cosmetic Act with respect to the safety of the food supply; which was 
ordered to lie on the table; as follows:

       At the end of title III, insert the following:

     SEC. 310. RESTRICTION ON PARTICIPATION IN VOLUNTARY QUALIFIED 
                   IMPORTER PROGRAM.

       Section 806 of the Federal Food, Drug, and Cosmetic Act (as 
     added by section 302), is amended--
       (1) by redesignating subsections (e) through (g) as 
     subsections (f) through (h), respectively; and
       (2) by inserting after subsection (d) the following:
       ``(e) Restriction on Participation.--Notwithstanding 
     section 307 of the Tariff Act of 1930, the Secretary shall 
     deny entry into the United States under the program described 
     in this section of any food exported from a country listed by 
     the Bureau of International Labor Affairs of the Department 
     of Labor in the `List of Goods Produced by Child Labor or 
     Forced Labor' for the most recent reporting period as a 
     country that produces food with the use of child or forced 
     labor.''.

     SEC. 311. IMPORTED SEAFOOD.

       (a) Penalties for the Import of Seafood Containing Banned 
     Substances.--Section 303 (21 U.S.C. 333) is amended by adding 
     at the end the following:
       ``(h) If the Secretary finds that seafood imported or 
     offered for import into the United States contains a 
     substance that has been banned by the Food and Drug 
     Administration for use in food in the United States, the 
     following shall apply to the importer of such seafood, 
     notwithstanding section 801:
       ``(1) In the case of a first such violation by an importer, 
     the Secretary shall impose a fine upon the importer, in an 
     amount determined by the Secretary.
       ``(2) In the case of a second such violation by an 
     importer, the Secretary shall ban such importer from 
     importing or offering for import into the United States 
     seafood until the importer provides substantiating evidence 
     that seafood imported or offered for import by such importer 
     does not contain any substance banned by the Food and Drug 
     Administration for use in food.
       ``(3) In the case of a third such violation, the Secretary 
     shall permanently ban the importer from importing or offering 
     for import into the United States seafood.''.
       (b) Inspection of Imported Seafood.--
       (1) In general.--Section 801 (21 U.S.C. 381), as amended by 
     section 303, is further amended by adding at the end the 
     following:
       ``(r) The Secretary shall inspect not less than 20 percent 
     of all seafood imported or offered for import into the United 
     States.''.
       (2) Effective date.--The amendment made by paragraph (1) 
     shall take effect on January 1, 2015.

     SEC. 312. REGISTRATION FOR COMMERCIAL IMPORTERS OF FOOD.

       (a) Prohibitions.--Section 301 (21 U.S.C. 331), as amended 
     by section 301(b) of this Act,

[[Page 17972]]

     is further amended by adding at the end the following:
       ``(aaa) the failure to register in accordance with section 
     801(s).''.
       (b) Misbranding.--Section 403 (21 U.S.C. 343) is amended by 
     adding at the end the following:
       ``(z) If it is imported or offered for import by an 
     importer not duly registered under section 801(s).''.
       (c) Registration.--Section 801 (21 U.S.C. 381), as amended 
     by section 310 of this Act, is further amended by adding at 
     the end the following:
       ``(s) Registration of Importers.--
       ``(1) In general.--The Secretary shall require an importer 
     of food to be registered with the Secretary in a form and 
     manner specified by the Secretary.
       ``(2) Conditions of registration.--As a condition of 
     registration under paragraph (1), an importer shall 
     demonstrate to the Secretary that:
       ``(A) the importer has fully disclosed to the Secretary all 
     ownership interests in the importer;
       ``(B) the importer has sufficiently complied with U.S. food 
     safety and trade laws;
       ``(C) the importer has submitted appropriate unique 
     facility identifiers required under section 1012;
       ``(D) there is no reason to believe that the importer is 
     not likely to engage in good importer practices described in 
     paragraph (3); and
       ``(E) the importer has sufficiently demonstrated or 
     provided information regarding any other requirement deemed 
     necessary for registration by the Secretary.''
       ``(3) Good importer practices.--The initial grant and 
     subsequent maintenance of registration under this subsection 
     is conditioned on compliance with good importer practices in 
     accordance with the following:
       ``(A) The Secretary, in consultation with Customs and 
     Border Protection, shall promulgate regulations to establish 
     good importer practices that specify the measures an importer 
     shall take to ensure imported food is in compliance with the 
     requirements of this Act.
       ``(B) The measures under subparagraph (A) shall ensure that 
     the importer of a food--
       ``(i) has adequate information about the food, hazards of 
     the food, and the requirements of this Act applicable to such 
     food;
       ``(ii) has adequate information or procedures in place to 
     verify that both the food and each person that produced, 
     manufactured, processed, packed, transported, or held the 
     food, including components of the food, are in compliance 
     with the requirements of this Act; and
       ``(iii) has adequate procedures in place to take corrective 
     action, such as the ability to appropriately trace, withhold, 
     and recall articles of food, if a food imported by the 
     importer is not in compliance with the requirements of this 
     Act.
       ``(4) Suspension of registration.--Registration under this 
     subsection is subject to suspension upon a finding by the 
     Secretary, after notice and an opportunity for an informal 
     hearing, of--
       ``(A) a violation of this Act; or
       ``(B) the knowing or repeated making of an inaccurate or 
     incomplete statement or submission of information relating to 
     the importation of food.''
       ``(5) Cancellation of registration.--
       ``(A) In general.--Not earlier than 10 days after providing 
     the notice under subparagraph (B), the Secretary shall cancel 
     a registration that the Secretary determines was not updated 
     in accordance with this section or otherwise contains false, 
     incomplete, or inaccurate information.
       ``(B) Notice of cancellation.--Cancellation shall be 
     preceded by notice to the importer of the intent to cancel 
     the registration and the basis for such cancellation.
       ``(C) Timely update or correction.--If the registration for 
     the importer is updated or corrected not later than 7 days 
     after notice is provided under subparagraph (B), the 
     Secretary shall not cancel such registration.
       ``(6) Exemptions.--The Secretary, by notice published in 
     the Federal Register--
       ``(A) shall establish an exemption from the requirements of 
     this subsection for importations for personal use; and
       ``(B) may establish other exemptions from the requirements 
     of this subsection.''
       (d) Unique Identification Number for Importers.--
       (1) In general.--Chapter X (21 U.S.C. 391 et seq) is 
     amended by adding at the end the following:

     ``SEC. 1012. UNIQUE FACILITY IDENTIFIER.

       ``(a) Registration of Importers.--A person required to 
     register pursuant to section 801(s) shall submit, at the time 
     of registration, a unique facility identifier for the 
     principal place of business for which such person is required 
     to register under section 801(s).
       ``(b) Guidance.--The Secretary may, by guidance, and in 
     consultation with the Commissioner responsible for Customs 
     and Border Protection, specify the unique numerical 
     identifier system to be used to meet the requirements of 
     subsection (a) and the form, manner, and timing of a 
     submission under such subsection. Development of such 
     guidelines shall take into account the utilization of 
     existing unique identification schemes and compatibility with 
     customs automated systems, such as integration with the 
     Automated Commercial Environment and the International Trade 
     Data System, and any successor systems.
       ``(c) Importation.--An article of food imported or offered 
     for import shall be refused admission unless the appropriate 
     unique facility identifiers, as specified by the Secretary, 
     are provided for such article.''.
       (e) Regulations.--Not later than 1 year after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services, in consultation with the Commissioner of Customs 
     and Border Protection, shall promulgate the regulations 
     required to carry out sections 801(s) and 1012 of the Federal 
     Food, Drug, and Cosmetic Act, as added by subsections (c) and 
     (d).
       (f) Effective Date.--The amendments made by this section 
     shall take effect on the date that is 180 days after the date 
     of enactment of this Act.
                                 ______
                                 
  SA 4710. Mr. CORKER submitted an amendment intended to be proposed by 
him to the bill S. 510, to amend the Federal Food, Drug, and Cosmetic 
Act with respect to the safety of the food supply; which was ordered to 
lie on the table; as follows:

       At the end of title IV, add the following:

     SEC. 405. RESCISSION OF UNSPENT FEDERAL FUNDS TO OFFSET NEW 
                   SPENDING.

       (a) In General.--Notwithstanding any other provision of 
     law, there are hereby rescinded from all available 
     unobligated funds, such appropriated discretionary funds as 
     may be necessary to offset amounts expended to carry out this 
     Act (including any amendments made by this Act).
       (b) Implementation.--The Director of the Office of 
     Management and Budget shall determine and identify from which 
     appropriation accounts the rescission under subsection (a) 
     shall apply and the amount of such rescission that shall 
     apply to each such account. Not later than 60 days after the 
     date of the enactment of this Act, the Director of the Office 
     of Management and Budget shall submit a report to the 
     Secretary of the Treasury and Congress of the accounts and 
     amounts determined and identified for rescission under the 
     preceding sentence.
       (c) Exception.--This section shall not apply to the 
     unobligated funds of the Department of Defense or the 
     Department of Veterans Affairs.   
                                 ______
                                 
  SA 4711. Mr. REID (for Mr. Baucus (for himself and Mr. Grassley)) 
proposed an amendment to the bill H.R. 5712, entitled ``The Physician 
Payment and Therapy Relief Act of 2010'', as follows:

       Strike all after the enacting clause and insert the 
     following:

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``The Physician Payment and 
     Therapy Relief Act of 2010''.

     SEC. 2. PHYSICIAN PAYMENT UPDATE.

       Section 1848(d)(11) of the Social Security Act (42 U.S.C. 
     1395w-4(d)(11)) is amended--
       (1) in the heading, by striking ``november'' and inserting 
     ``december'';
       (2) in subparagraph (A), by striking ``November 30'' and 
     inserting ``December 31''; and
       (3) in subparagraph (B)--
       (A) in the heading, by striking ``remaining portion of 
     2010'' and inserting ``2011''; and
       (B) by striking ``the period beginning on December 1, 2010, 
     and ending on December 31, 2010, and for''.

     SEC. 3. TREATMENT OF MULTIPLE SERVICE PAYMENT POLICIES FOR 
                   THERAPY SERVICES.

       (a) Smaller Payment Discount for Certain Multiple Therapy 
     Services.--Section 1848(b) of the Social Security Act (42 
     U.S.C. 1395w-4(b)) is amended by adding at the end the 
     following new paragraph:
       ``(7) Adjustment in discount for certain multiple therapy 
     services.--In the case of therapy services furnished on or 
     after January 1, 2011, and for which payment is made under 
     fee schedules established under this section, instead of the 
     25 percent multiple procedure payment reduction specified in 
     the final rule published by the Secretary in the Federal 
     Register on November 29, 2010, the reduction percentage shall 
     be 20 percent.''.
       (b) Exemption of Payment Reduction From Budget-
     neutrality.--Section 1848(c)(2)(B)(v) of the Social Security 
     Act (42 U.S.C. 1395w-4(c)(2)(B)(v)) is amended by adding at 
     the end the following new subclause:

       ``(VII) Reduced expenditures for multiple therapy 
     services.--Effective for fee schedules established beginning 
     with 2011, reduced expenditures attributable to the multiple 
     procedure payment reduction for therapy services (as 
     described in subsection (b)(7)).''.

     SEC. 4. DETERMINATION OF BUDGETARY EFFECTS.

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

[[Page 17973]]


                                 ______
                                 
  SA 4712. Mr. REID (for Mr. Baucus) proposed an amendment to the bill 
H.R. 5712, entitled ``The Physician Payment and Therapy Relief Act of 
2010''; as follows:

       Amend the title so as to read:
       An act entitled ``The Physician Payment and Therapy Relief 
     Act of 2010''.
                                 ______
                                 
  SA 4713. Mr. BAUCUS submitted an amendment intended to be proposed by 
him to the bill S. 510, to amend the Federal Food, Drug, and Cosmetic 
Act with respect to the safety of the food supply; which was ordered to 
lie on the table; as follows:

       Strike all after the enacting clause and insert the 
     following:

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Small Business Paperwork 
     Relief Act''.

     SEC. 2. REPEAL OF EXPANSION OF INFORMATION REPORTING 
                   REQUIREMENTS.

       (a) Repeal of Payments for Property and Other Gross 
     Proceeds.--Subsection (b) of section 9006 of the Patient 
     Protection and Affordable Care Act, and the amendments made 
     thereby, are hereby repealed; and the Internal Revenue Code 
     of 1986 shall be applied as if such subsection, and 
     amendments, had never been enacted.
       (b) Repeal of Application to Corporations; Application of 
     Regulatory Authority.--
       (1) In general.--Section 6041 of the Internal Revenue Code 
     of 1986, as amended by section 9006(a) of the Patient 
     Protection and Affordable Care Act and section 2101 of the 
     Small Business Jobs Act of 2010, is amended by striking 
     subsections (i) and (j) and inserting the following new 
     subsection:
       ``(i) Regulations.--The Secretary may prescribe such 
     regulations and other guidance as may be appropriate or 
     necessary to carry out the purposes of this section, 
     including rules to prevent duplicative reporting of 
     transactions.''.
       (2) Effective date.--The amendments made by this subsection 
     shall apply to payments made after December 31, 2010.
                                 ______
                                 
  SA 4714. Mr. REID submitted an amendment intended to be proposed by 
him to the bill S. 510, to amend the Federal Food, Drug, and Cosmetic 
Act with respect to the safety of the food supply; which was ordered to 
lie on the table; as follows:

       At the appropriate place, insert the following:

     SEC. _ FISCAL YEARS 2011 THROUGH 2013 EARMARK MORATORIUM.

       (a) Bills and Joint Resolutions.--
       (1) Point of order.--It shall not be in order to--
       (A) consider a bill or joint resolution reported by any 
     committee or a bill or joint resolution reported by any 
     committee with a report that includes an earmark, limited tax 
     benefit, or limited tariff benefit; or
       (B) a Senate bill or joint resolution not reported by 
     committee that includes an earmark, limited tax benefit, or 
     limited tariff benefit.
       (2) Return to the calendar.--If a point of order is 
     sustained under this subsection, the bill or joint resolution 
     shall be returned to the calendar until compliance with this 
     subsection has been achieved.
       (b) Conference Report.--
       (1) Point of order.--It shall not be in order to vote on 
     the adoption of a report of a committee of conference if the 
     report includes an earmark, limited tax benefit, or limited 
     tariff benefit.
       (2) Return to the calendar.--If a point of order is 
     sustained under this subsection, the conference report shall 
     be returned to the calendar.
       (c) Floor Amendment.--It shall not be in order to consider 
     an amendment to a bill or joint resolution if the amendment 
     contains an earmark, limited tax benefit, or limited tariff 
     benefit.
       (d) Amendment Between the Houses.--
       (1) In general.--It shall not be in order to consider an 
     amendment between the Houses if that amendment includes an 
     earmark, limited tax benefit, or limited tariff benefit.
       (2) Return to the calendar.--If a point of order is 
     sustained under this subsection, the amendment between the 
     Houses shall be returned to the calendar until compliance 
     with this subsection has been achieved.
       (e) Waiver.--Any Senator may move to waive any or all 
     points of order under this section by an affirmative vote of 
     two-thirds of the Members, duly chosen and sworn.
       (f) Definitions.--For the purpose of this section--
       (1) the term ``earmark'' means a provision or report 
     language included primarily at the request of a Senator or 
     Member of the House of Representatives providing, 
     authorizing, or recommending a specific amount of 
     discretionary budget authority, credit authority, or other 
     spending authority for a contract, loan, loan guarantee, 
     grant, loan authority, or other expenditure with or to an 
     entity, or targeted to a specific State, locality or 
     Congressional district, other than through a statutory or 
     administrative formula-driven or competitive award process;
       (2) the term ``limited tax benefit'' means any revenue 
     provision that--
       (A) provides a Federal tax deduction, credit, exclusion, or 
     preference to a particular beneficiary or limited group of 
     beneficiaries under the Internal Revenue Code of 1986; and
       (B) contains eligibility criteria that are not uniform in 
     application with respect to potential beneficiaries of such 
     provision; and
       (3) the term ``limited tariff benefit'' means a provision 
     modifying the Harmonized Tariff Schedule of the United States 
     in a manner that benefits 10 or fewer entities.
       (g) Fiscal Years 2011 Through 2013.--The point of order 
     under this section shall only apply to legislation providing 
     or authorizing discretionary budget authority, credit 
     authority or other spending authority, providing a federal 
     tax deduction, credit, or exclusion, or modifying the 
     Harmonized Tariff Schedule in fiscal years 2011 through 2013.
       (h) Application.--This rule shall not apply to any 
     authorization of appropriations to a Federal entity if such 
     authorization is not specifically targeted to a State, 
     locality, or congressional district.
       (i) This rule shall not apply to any bill, conference 
     report or joint resolution in which the total funding 
     provided for earmarks do not exceed the amount provided for 
     such purposes in 2009.''
                                 ______
                                 
  SA 4715. Mr. REID (for Mr. Harkin) proposed an amendment to the bill 
S. 510, to amend the Federal Food, Drug, and Cosmetic Act with respect 
to the safety of the food supply; as follows:
       Strike all after the enacting clause and insert 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.
Sec. 113. New dietary ingredients.
Sec. 114. Requirement for guidance relating to post harvest processing 
              of raw oysters.
Sec. 115. Port shopping.
Sec. 116. Alcohol-related facilities.

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

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

            TITLE III--IMPROVING THE SAFETY OF IMPORTED FOOD

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

                   TITLE IV--MISCELLANEOUS PROVISIONS

Sec. 401. Funding for food safety.
Sec. 402. Employee protections.

[[Page 17974]]

Sec. 403. Jurisdiction; authorities.
Sec. 404. Compliance with international agreements.
Sec. 405. Determination of budgetary effects.

      TITLE I--IMPROVING CAPACITY TO PREVENT FOOD SAFETY PROBLEMS

     SEC. 101. INSPECTIONS OF RECORDS.

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

     SEC. 102. REGISTRATION OF FOOD FACILITIES.

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

[[Page 17975]]

       (2) Section 415(d), as redesignated by subsection (b), is 
     amended by adding at the end before the period ``for a 
     facility to be registered, except with respect to the 
     reinstatement of a registration that is suspended under 
     subsection (b)''.

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

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

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

       ``(a) In General.--The owner, operator, or agent in charge 
     of a facility shall, in accordance with this section, 
     evaluate the hazards that could affect food manufactured, 
     processed, packed, or held by such facility, identify and 
     implement preventive controls to significantly minimize or 
     prevent the occurrence of such hazards and provide assurances 
     that such food is not adulterated under section 402 or 
     misbranded under section 403(w), monitor the performance of 
     those controls, and maintain records of this monitoring as a 
     matter of routine practice.
       ``(b) Hazard Analysis.--The owner, operator, or agent in 
     charge of a facility shall--
       ``(1) identify and evaluate known or reasonably foreseeable 
     hazards that may be associated with the facility, including--
       ``(A) biological, chemical, physical, and radiological 
     hazards, natural toxins, pesticides, drug residues, 
     decomposition, parasites, allergens, and unapproved food and 
     color additives; and
       ``(B) hazards that occur naturally, or may be 
     unintentionally introduced; and
       ``(2) identify and evaluate hazards that may be 
     intentionally introduced, including by acts of terrorism; and
       ``(3) develop a written analysis of the hazards.
       ``(c) Preventive Controls.--The owner, operator, or agent 
     in charge of a facility shall identify and implement 
     preventive controls, including at critical control points, if 
     any, to provide assurances that--
       ``(1) hazards identified in the hazard analysis conducted 
     under subsection (b)(1) will be significantly minimized or 
     prevented;
       ``(2) any hazards identified in the hazard analysis 
     conducted under subsection (b)(2) will be significantly 
     minimized or prevented and addressed, consistent with section 
     420, as applicable; and
       ``(3) the food manufactured, processed, packed, or held by 
     such facility will not be adulterated under section 402 or 
     misbranded under section 403(w).
       ``(d) Monitoring of Effectiveness.--The owner, operator, or 
     agent in charge of a facility shall monitor the effectiveness 
     of the preventive controls implemented under subsection (c) 
     to provide assurances that the outcomes described in 
     subsection (c) shall be achieved.
       ``(e) Corrective Actions.--The owner, operator, or agent in 
     charge of a facility shall establish procedures to ensure 
     that, if the preventive controls implemented under subsection 
     (c) are not properly implemented or are found to be 
     ineffective--
       ``(1) appropriate action is taken to reduce the likelihood 
     of recurrence of the implementation failure;
       ``(2) all affected food is evaluated for safety; and
       ``(3) all affected food is prevented from entering into 
     commerce if the owner, operator or agent in charge of such 
     facility cannot ensure that the affected food is not 
     adulterated under section 402 or misbranded under section 
     403(w).
       ``(f) Verification.--The owner, operator, or agent in 
     charge of a facility shall verify that--
       ``(1) the preventive controls implemented under subsection 
     (c) are adequate to control the hazards identified under 
     subsection (b);
       ``(2) the owner, operator, or agent is conducting 
     monitoring in accordance with subsection (d);
       ``(3) the owner, operator, or agent is making appropriate 
     decisions about corrective actions taken under subsection 
     (e);
       ``(4) the preventive controls implemented under subsection 
     (c) are effectively and significantly minimizing or 
     preventing the occurrence of identified hazards, including 
     through the use of environmental and product testing programs 
     and other appropriate means; and
       ``(5) there is documented, periodic reanalysis of the plan 
     under subsection (i) to ensure that the plan is still 
     relevant to the raw materials, conditions and processes in 
     the facility, and new and emerging threats.
       ``(g) Recordkeeping.--The owner, operator, or agent in 
     charge of a facility shall maintain, for not less than 2 
     years, records documenting the monitoring of the preventive 
     controls implemented under subsection (c), instances of 
     nonconformance material to food safety, the results of 
     testing and other appropriate means of verification under 
     subsection (f)(4), instances when corrective actions were 
     implemented, and the efficacy of preventive controls and 
     corrective actions.
       ``(h) Written Plan and Documentation.--The owner, operator, 
     or agent in charge of a facility shall prepare a written plan 
     that documents and describes the procedures used by the 
     facility to comply with the requirements of this section, 
     including analyzing the hazards under subsection (b) and 
     identifying the preventive controls adopted under subsection 
     (c) to address those hazards. Such written plan, together 
     with the documentation described in subsection (g), shall be 
     made promptly available to a duly authorized representative 
     of the Secretary upon oral or written request.
       ``(i) Requirement To Reanalyze.--The owner, operator, or 
     agent in charge of a facility shall conduct a reanalysis 
     under subsection (b) whenever a significant change is made in 
     the activities conducted at a facility operated by such 
     owner, operator, or agent if the change creates a reasonable 
     potential for a new hazard or a significant increase in a 
     previously identified hazard or not less frequently than once 
     every 3 years, whichever is earlier. Such reanalysis shall be 
     completed and additional preventive controls needed to 
     address the hazard identified, if any, shall be implemented 
     before the change in activities at the facility is operative. 
     Such owner, operator, or agent shall revise the written plan 
     required under subsection (h) if such a significant change is 
     made or document the basis for the conclusion that no 
     additional or revised preventive controls are needed. The 
     Secretary may require a reanalysis under this section to 
     respond to new hazards and developments in scientific 
     understanding, including, as appropriate, results from the 
     Department of Homeland Security biological, chemical, 
     radiological, or other terrorism risk assessment.
       ``(j) Exemption for Seafood, Juice, and Low-acid Canned 
     Food Facilities Subject to HACCP.--
       ``(1) In general.--This section shall not apply to a 
     facility if the owner, operator, or agent in charge of such 
     facility is required to comply with, and is in compliance 
     with, 1 of the following standards and regulations with 
     respect to such facility:
       ``(A) The Seafood Hazard Analysis Critical Control Points 
     Program of the Food and Drug Administration.
       ``(B) The Juice Hazard Analysis Critical Control Points 
     Program of the Food and Drug Administration.
       ``(C) The Thermally Processed Low-Acid Foods Packaged in 
     Hermetically Sealed Containers standards of the Food and Drug 
     Administration (or any successor standards).
       ``(2) Applicability.--The exemption under paragraph (1)(C) 
     shall apply only with respect to microbiological hazards that 
     are regulated under the standards for Thermally Processed 
     Low-Acid Foods Packaged in Hermetically Sealed Containers 
     under part 113 of chapter 21, Code of Federal Regulations (or 
     any successor regulations).
       ``(k) Exception for Activities of Facilities Subject to 
     Section 419.--This section shall not apply to activities of a 
     facility that are subject to section 419.
       ``(l) Modified Requirements for Qualified Facilities.--
       ``(1) Qualified facilities.--
       ``(A) In general.--A facility is a qualified facility for 
     purposes of this subsection if the facility meets the 
     conditions under subparagraph (B) or (C).
       ``(B) Very small business.--A facility is a qualified 
     facility under this subparagraph--
       ``(i) if the facility, including any subsidiary or 
     affiliate of the facility, is, collectively, a very small 
     business (as defined in the regulations promulgated under 
     subsection (n)); and
       ``(ii) in the case where the facility is a subsidiary or 
     affiliate of an entity, if such subsidiaries or affiliates, 
     are, collectively, a very small business (as so defined).
       ``(C) Limited annual monetary value of sales.--
       ``(i) In general.--A facility is a qualified facility under 
     this subparagraph if clause (ii) applies--

       ``(I) to the facility, including any subsidiary or 
     affiliate of the facility, collectively; and
       ``(II) to the subsidiaries or affiliates, collectively, of 
     any entity of which the facility is a subsidiary or 
     affiliate.

       ``(ii) Average annual monetary value.--This clause applies 
     if--

       ``(I) during the 3-year period preceding the applicable 
     calendar year, the average annual monetary value of the food 
     manufactured, processed, packed, or held at such facility (or 
     the collective average annual monetary value of such food at 
     any subsidiary or affiliate, as described in clause (i)) that 
     is sold directly to qualified end-users during such period 
     exceeded the average annual monetary value of the food 
     manufactured, processed, packed, or held at such facility (or 
     the collective average annual monetary value of such food at 
     any subsidiary or affiliate, as so described) sold by such 
     facility (or collectively by any such subsidiary or 
     affiliate) to all other purchasers during such period; and
       ``(II) the average annual monetary value of all food sold 
     by such facility (or the collective average annual monetary 
     value of such food sold by any subsidiary or affiliate, as 
     described in clause (i)) during such period was less than 
     $500,000, adjusted for inflation.

       ``(2) Exemption.--A qualified facility--
       ``(A) shall not be subject to the requirements under 
     subsections (a) through (i) and subsection (n) in an 
     applicable calendar year; and
       ``(B) shall submit to the Secretary--
       ``(i)(I) documentation that demonstrates that the owner, 
     operator, or agent in charge of the facility has identified 
     potential hazards associated with the food being produced,

[[Page 17976]]

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

       ``(I) is located--

       ``(aa) in the same State as the qualified facility that 
     sold the food to such restaurant or establishment; or
       ``(bb) not more than 275 miles from such facility; and

       ``(II) is purchasing the food for sale directly to 
     consumers at such restaurant or retail food establishment.

       ``(C) Consumer.--For purposes of subparagraph (B), the term 
     `consumer' does not include a business.
       ``(D) Subsidiary.--The term `subsidiary' means any company 
     which is owned or controlled directly or indirectly by 
     another company.
       ``(5) Study.--
       ``(A) In general.--The Secretary, in consultation with the 
     Secretary of Agriculture, shall conduct a study of the food 
     processing sector regulated by the Secretary to determine--
       ``(i) the distribution of food production by type and size 
     of operation, including monetary value of food sold;
       ``(ii) the proportion of food produced by each type and 
     size of operation;
       ``(iii) the number and types of food facilities co-located 
     on farms, including the number and proportion by commodity 
     and by manufacturing or processing activity;
       ``(iv) the incidence of foodborne illness originating from 
     each size and type of operation and the type of food 
     facilities for which no reported or known hazard exists; and
       ``(v) the effect on foodborne illness risk associated with 
     commingling, processing, transporting, and storing food and 
     raw agricultural commodities, including differences in risk 
     based on the scale and duration of such activities.
       ``(B) Size.--The results of the study conducted under 
     subparagraph (A) shall include the information necessary to 
     enable the Secretary to define the terms `small business' and 
     `very small business', for purposes of promulgating the 
     regulation under subsection (n). In defining such terms, the 
     Secretary shall include consideration of harvestable acres, 
     income, the number of employees, and the volume of food 
     harvested.
       ``(C) Submission of report.--Not later than 18 months after 
     the date of enactment the FDA Food Safety Modernization Act, 
     the Secretary shall submit to Congress a report that 
     describes the results of the study conducted under 
     subparagraph (A).
       ``(6) No preemption.--Nothing in this subsection preempts 
     State, local, county, or other non-Federal law regarding the 
     safe production of food. Compliance with this subsection 
     shall not relieve any person from liability at common law or 
     under State statutory law.
       ``(7) Notification to consumers.--
       ``(A) In general.--A qualified facility that is exempt from 
     the requirements under subsections (a) through (i) and 
     subsection (n) and does not prepare documentation under 
     paragraph (2)(B)(i)(I) shall--
       ``(i) with respect to a food for which a food packaging 
     label is required by the Secretary under any other provision 
     of this Act, include prominently and conspicuously on such 
     label the name and business address of the facility where the 
     food was manufactured or processed; or
       ``(ii) with respect to a food for which a food packaging 
     label is not required by the Secretary under any other 
     provisions of this Act, prominently and conspicuously 
     display, at the point of purchase, the name and business 
     address of the facility where the food was manufactured or 
     processed, on a label, poster, sign, placard, or documents 
     delivered contemporaneously with the food in the normal 
     course of business, or, in the case of Internet sales, in an 
     electronic notice.
       ``(B) No additional label.--Subparagraph (A) does not 
     provide authority to the Secretary to require a label that is 
     in addition to any label required under any other provision 
     of this Act.
       ``(m) Authority With Respect to Certain Facilities.--The 
     Secretary may, by regulation, exempt or modify the 
     requirements for compliance under this section with respect 
     to facilities that are solely engaged in the production of 
     food for animals other than man, the storage of raw 
     agricultural commodities (other than fruits and vegetables) 
     intended for further distribution or processing, or the 
     storage of packaged foods that are not exposed to the 
     environment.
       ``(n) Regulations.--
       ``(1) In general.--Not later than 18 months after the date 
     of enactment of the FDA Food Safety Modernization Act, the 
     Secretary shall promulgate regulations--
       ``(A) to establish science-based minimum standards for 
     conducting a hazard analysis, documenting hazards, 
     implementing preventive controls, and documenting the 
     implementation of the preventive controls under this section; 
     and
       ``(B) to define, for purposes of this section, the terms 
     `small business' and `very small business', taking into 
     consideration the study described in subsection (l)(5).
       ``(2) Coordination.--In promulgating the regulations under 
     paragraph (1)(A), with regard to hazards that may be 
     intentionally introduced, including by acts of terrorism, the 
     Secretary shall coordinate with the Secretary of Homeland 
     Security, as appropriate.
       ``(3) Content.--The regulations promulgated under paragraph 
     (1)(A) shall--
       ``(A) provide sufficient flexibility to be practicable for 
     all sizes and types of facilities, including small businesses 
     such as a small food processing facility co-located on a 
     farm;
       ``(B) comply with chapter 35 of title 44, United States 
     Code (commonly known as the `Paperwork Reduction Act'), with 
     special attention to minimizing the burden (as defined in 
     section 3502(2) of such Act) on the facility, and collection 
     of information (as defined in section 3502(3) of such Act), 
     associated with such regulations;
       ``(C) acknowledge differences in risk and minimize, as 
     appropriate, the number of separate standards that apply to 
     separate foods; and
       ``(D) not require a facility to hire a consultant or other 
     third party to identify, implement, certify, or audit 
     preventative controls, except in the case of negotiated 
     enforcement resolutions that may require such a consultant or 
     third party.
       ``(4) Rule of construction.--Nothing in this subsection 
     shall be construed to provide the Secretary with the 
     authority to prescribe specific technologies, practices, or 
     critical controls for an individual facility.
       ``(5) Review.--In promulgating the regulations under 
     paragraph (1)(A), the Secretary shall review regulatory 
     hazard analysis and preventive control programs in existence 
     on the date of enactment of the FDA Food Safety Modernization 
     Act, including the Grade `A' Pasteurized Milk Ordinance to 
     ensure that such regulations are consistent, to the extent 
     practicable, with applicable domestic and internationally-
     recognized standards in existence on such date.
       ``(o) Definitions.--For purposes of this section:
       ``(1) Critical control point.--The term `critical control 
     point' means a point, step, or procedure in a food process at 
     which control can be applied and is essential to prevent or 
     eliminate a food safety hazard or reduce such hazard to an 
     acceptable level.
       ``(2) Facility.--The term `facility' means a domestic 
     facility or a foreign facility that is required to register 
     under section 415.
       ``(3) Preventive controls.--The term `preventive controls' 
     means those risk-based, reasonably appropriate procedures, 
     practices, and processes that a person knowledgeable about 
     the safe manufacturing, processing, packing, or holding of 
     food would employ to significantly minimize or prevent the 
     hazards identified under the hazard analysis conducted under 
     subsection (b) and that are consistent with the current 
     scientific understanding of safe food manufacturing, 
     processing, packing, or holding at the time of the analysis. 
     Those procedures, practices, and processes may include the 
     following:
       ``(A) Sanitation procedures for food contact surfaces and 
     utensils and food-contact surfaces of equipment.
       ``(B) Supervisor, manager, and employee hygiene training.
       ``(C) An environmental monitoring program to verify the 
     effectiveness of pathogen controls in processes where a food 
     is exposed to a potential contaminant in the environment.
       ``(D) A food allergen control program.
       ``(E) A recall plan.

[[Page 17977]]

       ``(F) Current Good Manufacturing Practices (cGMPs) under 
     part 110 of title 21, Code of Federal Regulations (or any 
     successor regulations).
       ``(G) Supplier verification activities that relate to the 
     safety of food.''.
       (b) Guidance Document.--The Secretary shall issue a 
     guidance document related to the regulations promulgated 
     under subsection (b)(1) with respect to the hazard analysis 
     and preventive controls under section 418 of the Federal 
     Food, Drug, and Cosmetic Act (as added by subsection (a)).
       (c) Rulemaking.--
       (1) Proposed rulemaking.--
       (A) In general.--Not later than 9 months after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services (referred to in this subsection as the 
     ``Secretary'') shall publish a notice of proposed rulemaking 
     in the Federal Register to promulgate regulations with 
     respect to--
       (i) activities that constitute on-farm packing or holding 
     of food that is not grown, raised, or consumed on such farm 
     or another farm under the same ownership for purposes of 
     section 415 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 350d), as amended by this Act; and
       (ii) activities that constitute on-farm manufacturing or 
     processing of food that is not consumed on that farm or on 
     another farm under common ownership for purposes of such 
     section 415.
       (B) Clarification.--The rulemaking described under 
     subparagraph (A) shall enhance the implementation of such 
     section 415 and clarify the activities that are included as 
     part of the definition of the term ``facility'' under such 
     section 415. Nothing in this Act authorizes the Secretary to 
     modify the definition of the term ``facility'' under such 
     section.
       (C) Science-based risk analysis.--In promulgating 
     regulations under subparagraph (A), the Secretary shall 
     conduct a science-based risk analysis of--
       (i) specific types of on-farm packing or holding of food 
     that is not grown, raised, or consumed on such farm or 
     another farm under the same ownership, as such packing and 
     holding relates to specific foods; and
       (ii) specific on-farm manufacturing and processing 
     activities as such activities relate to specific foods that 
     are not consumed on that farm or on another farm under common 
     ownership.
       (D) Authority with respect to certain facilities.--
       (i) In general.--In promulgating the regulations under 
     subparagraph (A), the Secretary shall consider the results of 
     the science-based risk analysis conducted under subparagraph 
     (C), and shall exempt certain facilities from the 
     requirements in section 418 of the Federal Food, Drug, and 
     Cosmetic Act (as added by this section), including hazard 
     analysis and preventive controls, and the mandatory 
     inspection frequency in section 421 of such Act (as added by 
     section 201), or modify the requirements in such sections 418 
     or 421, as the Secretary determines appropriate, if such 
     facilities are engaged only in specific types of on-farm 
     manufacturing, processing, packing, or holding activities 
     that the Secretary determines to be low risk involving 
     specific foods the Secretary determines to be low risk.
       (ii) Limitation.--The exemptions or modifications under 
     clause (i) shall not include an exemption from the 
     requirement to register under section 415 of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 350d), as amended by 
     this Act, if applicable, and shall apply only to small 
     businesses and very small businesses, as defined in the 
     regulation promulgated under section 418(n) of the Federal 
     Food, Drug, and Cosmetic Act (as added under subsection (a)).
       (2) Final regulations.--Not later than 9 months after the 
     close of the comment period for the proposed rulemaking under 
     paragraph (1), the Secretary shall adopt final rules with 
     respect to--
       (A) activities that constitute on-farm packing or holding 
     of food that is not grown, raised, or consumed on such farm 
     or another farm under the same ownership for purposes of 
     section 415 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 350d), as amended by this Act;
       (B) activities that constitute on-farm manufacturing or 
     processing of food that is not consumed on that farm or on 
     another farm under common ownership for purposes of such 
     section 415; and
       (C) the requirements under sections 418 and 421 of the 
     Federal Food, Drug, and Cosmetic Act, as added by this Act, 
     from which the Secretary may issue exemptions or 
     modifications of the requirements for certain types of 
     facilities.
       (d) Small Entity Compliance Policy Guide.--Not later than 
     180 days after the issuance of the regulations promulgated 
     under subsection (n) of section 418 of the Federal Food, 
     Drug, and Cosmetic Act (as added by subsection (a)), the 
     Secretary shall issue a small entity compliance policy guide 
     setting forth in plain language the requirements of such 
     section 418 and this section to assist small entities in 
     complying with the hazard analysis and other activities 
     required under such section 418 and this section.
       (e) Prohibited Acts.--Section 301 (21 U.S.C. 331) is 
     amended by adding at the end the following:
       ``(uu) The operation of a facility that manufactures, 
     processes, packs, or holds food for sale in the United States 
     if the owner, operator, or agent in charge of such facility 
     is not in compliance with section 418.''.
       (f) No Effect on HACCP Authorities.--Nothing in the 
     amendments made by this section limits the authority of the 
     Secretary under the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 301 et seq.) or the Public Health Service Act (42 
     U.S.C. 201 et seq.) to revise, issue, or enforce Hazard 
     Analysis Critical Control programs and the Thermally 
     Processed Low-Acid Foods Packaged in Hermetically Sealed 
     Containers standards.
       (g) Dietary Supplements.--Nothing in the amendments made by 
     this section shall apply to any facility with regard to the 
     manufacturing, processing, packing, or holding of a dietary 
     supplement that is in compliance with the requirements of 
     sections 402(g)(2) and 761 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 342(g)(2), 379aa-1).
       (h) Updating Guidance Relating to Fish and Fisheries 
     Products Hazards and Controls.--The Secretary shall, not 
     later than 180 days after the date of enactment of this Act, 
     update the Fish and Fisheries Products Hazards and Control 
     Guidance to take into account advances in technology that 
     have occurred since the previous publication of such Guidance 
     by the Secretary.
       (i) Effective Dates.--
       (1) General rule.--The amendments made by this section 
     shall take effect 18 months after the date of enactment of 
     this Act.
       (2) Flexibility for small businesses.--Notwithstanding 
     paragraph (1)--
       (A) the amendments made by this section shall apply to a 
     small business (as defined in the regulations promulgated 
     under section 418(n) of the Federal Food, Drug, and Cosmetic 
     Act (as added by this section)) beginning on the date that is 
     6 months after the effective date of such regulations; and
       (B) the amendments made by this section shall apply to a 
     very small business (as defined in such regulations) 
     beginning on the date that is 18 months after the effective 
     date of such regulations.

     SEC. 104. PERFORMANCE STANDARDS.

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

     SEC. 105. STANDARDS FOR PRODUCE SAFETY.

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

     ``SEC. 419. STANDARDS FOR PRODUCE SAFETY.

       ``(a) Proposed Rulemaking.--
       ``(1) In general.--
       ``(A) Rulemaking.--Not later than 1 year after the date of 
     enactment of the FDA Food Safety Modernization Act, the 
     Secretary, in coordination with the Secretary of Agriculture 
     and representatives of State departments of agriculture 
     (including with regard to the national organic program 
     established under the Organic Foods Production Act of 1990), 
     and in consultation with the Secretary of Homeland Security, 
     shall publish a notice of proposed rulemaking to establish 
     science-based minimum standards for the safe production and 
     harvesting of those types of fruits and vegetables, including 
     specific mixes or categories of fruits and vegetables, that 
     are raw agricultural commodities for which the Secretary has 
     determined that such standards minimize the risk of serious 
     adverse health consequences or death.
       ``(B) Determination by secretary.--With respect to small 
     businesses and very small

[[Page 17978]]

     businesses (as such terms are defined in the regulation 
     promulgated under subparagraph (A)) that produce and harvest 
     those types of fruits and vegetables that are raw 
     agricultural commodities that the Secretary has determined 
     are low risk and do not present a risk of serious adverse 
     health consequences or death, the Secretary may determine not 
     to include production and harvesting of such fruits and 
     vegetables in such rulemaking, or may modify the applicable 
     requirements of regulations promulgated pursuant to this 
     section.
       ``(2) Public input.--During the comment period on the 
     notice of proposed rulemaking under paragraph (1), the 
     Secretary shall conduct not less than 3 public meetings in 
     diverse geographical areas of the United States to provide 
     persons in different regions an opportunity to comment.
       ``(3) Content.--The proposed rulemaking under paragraph (1) 
     shall--
       ``(A) provide sufficient flexibility to be applicable to 
     various types of entities engaged in the production and 
     harvesting of fruits and vegetables that are raw agricultural 
     commodities, including small businesses and entities that 
     sell directly to consumers, and be appropriate to the scale 
     and diversity of the production and harvesting of such 
     commodities;
       ``(B) include, with respect to growing, harvesting, 
     sorting, packing, and storage operations, science-based 
     minimum standards related to soil amendments, hygiene, 
     packaging, temperature controls, animals in the growing area, 
     and water;
       ``(C) consider hazards that occur naturally, may be 
     unintentionally introduced, or may be intentionally 
     introduced, including by acts of terrorism;
       ``(D) take into consideration, consistent with ensuring 
     enforceable public health protection, conservation and 
     environmental practice standards and policies established by 
     Federal natural resource conservation, wildlife conservation, 
     and environmental agencies;
       ``(E) in the case of production that is certified organic, 
     not include any requirements that conflict with or duplicate 
     the requirements of the national organic program established 
     under the Organic Foods Production of 1990, while providing 
     the same level of public health protection as the 
     requirements under guidance documents, including guidance 
     documents regarding action levels, and regulations under the 
     FDA Food Safety Modernization Act; and
       ``(F) define, for purposes of this section, the terms 
     `small business' and `very small business'
       ``(4) Prioritization.--The Secretary shall prioritize the 
     implementation of the regulations under this section for 
     specific fruits and vegetables that are raw agricultural 
     commodities based on known risks which may include a history 
     and severity of foodborne illness outbreaks.
       ``(b) Final Regulation.--
       ``(1) In general.--Not later than 1 year after the close of 
     the comment period for the proposed rulemaking under 
     subsection (a), the Secretary shall adopt a final regulation 
     to provide for minimum science-based standards for those 
     types of fruits and vegetables, including specific mixes or 
     categories of fruits or vegetables, that are raw agricultural 
     commodities, based on known safety risks, which may include a 
     history of foodborne illness outbreaks.
       ``(2) Final regulation.--The final regulation shall--
       ``(A) provide for coordination of education and enforcement 
     activities by State and local officials, as designated by the 
     Governors of the respective States or the appropriate elected 
     State official as recognized by State statute; and
       ``(B) include a description of the variance process under 
     subsection (c) and the types of permissible variances the 
     Secretary may grant.
       ``(3) Flexibility for small businesses.--Notwithstanding 
     paragraph (1)--
       ``(A) the regulations promulgated under this section shall 
     apply to a small business (as defined in the regulation 
     promulgated under subsection (a)(1)) after the date that is 1 
     year after the effective date of the final regulation under 
     paragraph (1); and
       ``(B) the regulations promulgated under this section shall 
     apply to a very small business (as defined in the regulation 
     promulgated under subsection (a)(1)) after the date that is 2 
     years after the effective date of the final regulation under 
     paragraph (1).
       ``(c) Criteria.--
       ``(1) In general.--The regulations adopted under subsection 
     (b) shall--
       ``(A) set forth those procedures, processes, and practices 
     that the Secretary determines to minimize the risk of serious 
     adverse health consequences or death, including procedures, 
     processes, and practices that the Secretary determines to be 
     reasonably necessary to prevent the introduction of known or 
     reasonably foreseeable biological, chemical, and physical 
     hazards, including hazards that occur naturally, may be 
     unintentionally introduced, or may be intentionally 
     introduced, including by acts of terrorism, into fruits and 
     vegetables, including specific mixes or categories of fruits 
     and vegetables, that are raw agricultural commodities and to 
     provide reasonable assurances that the produce is not 
     adulterated under section 402;
       ``(B) provide sufficient flexibility to be practicable for 
     all sizes and types of businesses, including small businesses 
     such as a small food processing facility co-located on a 
     farm;
       ``(C) comply with chapter 35 of title 44, United States 
     Code (commonly known as the `Paperwork Reduction Act'), with 
     special attention to minimizing the burden (as defined in 
     section 3502(2) of such Act) on the business, and collection 
     of information (as defined in section 3502(3) of such Act), 
     associated with such regulations;
       ``(D) acknowledge differences in risk and minimize, as 
     appropriate, the number of separate standards that apply to 
     separate foods; and
       ``(E) not require a business to hire a consultant or other 
     third party to identify, implement, certify, compliance with 
     these procedures, processes, and practices, except in the 
     case of negotiated enforcement resolutions that may require 
     such a consultant or third party; and
       ``(F) permit States and foreign countries from which food 
     is imported into the United States to request from the 
     Secretary variances from the requirements of the regulations, 
     subject to paragraph (2), where the State or foreign country 
     determines that the variance is necessary in light of local 
     growing conditions and that the procedures, processes, and 
     practices to be followed under the variance are reasonably 
     likely to ensure that the produce is not adulterated under 
     section 402 and to provide the same level of public health 
     protection as the requirements of the regulations adopted 
     under subsection (b).
       ``(2) Variances.--
       ``(A) Requests for variances.--A State or foreign country 
     from which food is imported into the United States may in 
     writing request a variance from the Secretary. Such request 
     shall describe the variance requested and present information 
     demonstrating that the variance does not increase the 
     likelihood that the food for which the variance is requested 
     will be adulterated under section 402, and that the variance 
     provides the same level of public health protection as the 
     requirements of the regulations adopted under subsection (b). 
     The Secretary shall review such requests in a reasonable 
     timeframe.
       ``(B) Approval of variances.--The Secretary may approve a 
     variance in whole or in part, as appropriate, and may specify 
     the scope of applicability of a variance to other similarly 
     situated persons.
       ``(C) Denial of variances.--The Secretary may deny a 
     variance request if the Secretary determines that such 
     variance is not reasonably likely to ensure that the food is 
     not adulterated under section 402 and is not reasonably 
     likely to provide the same level of public health protection 
     as the requirements of the regulation adopted under 
     subsection (b). The Secretary shall notify the person 
     requesting such variance of the reasons for the denial.
       ``(D) Modification or revocation of a variance.--The 
     Secretary, after notice and an opportunity for a hearing, may 
     modify or revoke a variance if the Secretary determines that 
     such variance is not reasonably likely to ensure that the 
     food is not adulterated under section 402 and is not 
     reasonably likely to provide the same level of public health 
     protection as the requirements of the regulations adopted 
     under subsection (b).
       ``(d) Enforcement.--The Secretary may coordinate with the 
     Secretary of Agriculture and, as appropriate, shall contract 
     and coordinate with the agency or department designated by 
     the Governor of each State to perform activities to ensure 
     compliance with this section.
       ``(e) Guidance.--
       ``(1) In general.--Not later than 1 year after the date of 
     enactment of the FDA Food Safety Modernization Act, the 
     Secretary shall publish, after consultation with the 
     Secretary of Agriculture, representatives of State 
     departments of agriculture, farmer representatives, and 
     various types of entities engaged in the production and 
     harvesting or importing of fruits and vegetables that are raw 
     agricultural commodities, including small businesses, updated 
     good agricultural practices and guidance for the safe 
     production and harvesting of specific types of fresh produce 
     under this section.
       ``(2) Public meetings.--The Secretary shall conduct not 
     fewer than 3 public meetings in diverse geographical areas of 
     the United States as part of an effort to conduct education 
     and outreach regarding the guidance described in paragraph 
     (1) for persons in different regions who are involved in the 
     production and harvesting of fruits and vegetables that are 
     raw agricultural commodities, including persons that sell 
     directly to consumers and farmer representatives, and for 
     importers of fruits and vegetables that are raw agricultural 
     commodities.
       ``(3) Paperwork reduction.--The Secretary shall ensure that 
     any updated guidance under this section will--
       ``(A) provide sufficient flexibility to be practicable for 
     all sizes and types of facilities, including small businesses 
     such as a small food processing facility co-located on a 
     farm; and
       ``(B) acknowledge differences in risk and minimize, as 
     appropriate, the number of separate standards that apply to 
     separate foods.
       ``(f) Exemption for Direct Farm Marketing.--

[[Page 17979]]

       ``(1) In general.--A farm shall be exempt from the 
     requirements under this section in a calendar year if--
       ``(A) during the previous 3-year period, the average annual 
     monetary value of the food sold by such farm directly to 
     qualified end-users during such period exceeded the average 
     annual monetary value of the food sold by such farm to all 
     other buyers during such period; and
       ``(B) the average annual monetary value of all food sold 
     during such period was less than $500,000, adjusted for 
     inflation.
       ``(2) Notification to consumers.--
       ``(A) In general.--A farm that is exempt from the 
     requirements under this section shall--
       ``(i) with respect to a food for which a food packaging 
     label is required by the Secretary under any other provision 
     of this Act, include prominently and conspicuously on such 
     label the name and business address of the farm where the 
     produce was grown; or
       ``(ii) with respect to a food for which a food packaging 
     label is not required by the Secretary under any other 
     provision of this Act, prominently and conspicuously display, 
     at the point of purchase, the name and business address of 
     the farm where the produce was grown, on a label, poster, 
     sign, placard, or documents delivered contemporaneously with 
     the food in the normal course of business, or, in the case of 
     Internet sales, in an electronic notice.
       ``(B) No additional label.--Subparagraph (A) does not 
     provide authority to the Secretary to require a label that is 
     in addition to any label required under any other provision 
     of this Act.
       ``(3) Withdrawal; rule of construction.--
       ``(A) In general.--In the event of an active investigation 
     of a foodborne illness outbreak that is directly linked to a 
     farm subject to an exemption under this subsection, or if the 
     Secretary determines that it is necessary to protect the 
     public health and prevent or mitigate a foodborne illness 
     outbreak based on conduct or conditions associated with a 
     farm that are material to the safety of the food produced or 
     harvested at such farm, the Secretary may withdraw the 
     exemption provided to such farm under this subsection.
       ``(B) Rule of construction.--Nothing in this subsection 
     shall be construed to expand or limit the inspection 
     authority of the Secretary.
       ``(4) Definitions.--
       ``(A) Qualified end-user.--In this subsection, the term 
     `qualified end-user', with respect to a food means--
       ``(i) the consumer of the food; or
       ``(ii) a restaurant or retail food establishment (as those 
     terms are defined by the Secretary for purposes of section 
     415) that is located--

       ``(I) in the same State as the farm that produced the food; 
     or
       ``(II) not more than 275 miles from such farm.

       ``(B) Consumer.--For purposes of subparagraph (A), the term 
     `consumer' does not include a business.
       ``(5) No preemption.--Nothing in this subsection preempts 
     State, local, county, or other non-Federal law regarding the 
     safe production, harvesting, holding, transportation, and 
     sale of fresh fruits and vegetables. Compliance with this 
     subsection shall not relieve any person from liability at 
     common law or under State statutory law.
       ``(6) Limitation of effect.--Nothing in this subsection 
     shall prevent the Secretary from exercising any authority 
     granted in the other sections of this Act.
       ``(g) Clarification.--This section shall not apply to 
     produce that is produced by an individual for personal 
     consumption.
       ``(h) Exception for Activities of Facilities Subject to 
     Section 418.--This section shall not apply to activities of a 
     facility that are subject to section 418.''.
       (b) Small Entity Compliance Policy Guide.--Not later than 
     180 days after the issuance of regulations under section 419 
     of the Federal Food, Drug, and Cosmetic Act (as added by 
     subsection (a)), the Secretary of Health and Human Services 
     shall issue a small entity compliance policy guide setting 
     forth in plain language the requirements of such section 419 
     and to assist small entities in complying with standards for 
     safe production and harvesting and other activities required 
     under such section.
       (c) Prohibited Acts.--Section 301 (21 U.S.C. 331), as 
     amended by section 103, is amended by adding at the end the 
     following:
       ``(vv) The failure to comply with the requirements under 
     section 419.''.
       (d) No Effect on HACCP Authorities.--Nothing in the 
     amendments made by this section limits the authority of the 
     Secretary under the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 301 et seq.) or the Public Health Service Act (42 
     U.S.C. 201 et seq.) to revise, issue, or enforce product and 
     category-specific regulations, such as the Seafood Hazard 
     Analysis Critical Controls Points Program, the Juice Hazard 
     Analysis Critical Control Program, and the Thermally 
     Processed Low-Acid Foods Packaged in Hermetically Sealed 
     Containers standards.

     SEC. 106. PROTECTION AGAINST INTENTIONAL ADULTERATION.

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

     ``SEC. 420. PROTECTION AGAINST INTENTIONAL ADULTERATION.

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

     SEC. 107. AUTHORITY TO COLLECT FEES.

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

                     ``PART 6--FEES RELATED TO FOOD

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

       ``(a) In General.--
       ``(1) Purpose and authority.--For fiscal year 2010 and each 
     subsequent fiscal year, the Secretary shall, in accordance 
     with this section, assess and collect fees from--

[[Page 17980]]

       ``(A) the responsible party for each domestic facility (as 
     defined in section 415(b)) and the United States agent for 
     each foreign facility subject to a reinspection in such 
     fiscal year, to cover reinspection-related costs for such 
     year;
       ``(B) the responsible party for a domestic facility (as 
     defined in section 415(b)) and an importer who does not 
     comply with a recall order under section 423 or under section 
     412(f) in such fiscal year, to cover food recall activities 
     associated with such order performed by the Secretary, 
     including technical assistance, follow-up effectiveness 
     checks, and public notifications, for such year;
       ``(C) each importer participating in the voluntary 
     qualified importer program under section 806 in such year, to 
     cover the administrative costs of such program for such year; 
     and
       ``(D) each importer subject to a reinspection in such 
     fiscal year, to cover reinspection-related costs for such 
     year.
       ``(2) Definitions.--For purposes of this section--
       ``(A) the term `reinspection' means--
       ``(i) with respect to domestic facilities (as defined in 
     section 415(b)), 1 or more inspections conducted under 
     section 704 subsequent to an inspection conducted under such 
     provision which identified noncompliance materially related 
     to a food safety requirement of this Act, specifically to 
     determine whether compliance has been achieved to the 
     Secretary's satisfaction; and
       ``(ii) with respect to importers, 1 or more examinations 
     conducted under section 801 subsequent to an examination 
     conducted under such provision which identified noncompliance 
     materially related to a food safety requirement of this Act, 
     specifically to determine whether compliance has been 
     achieved to the Secretary's satisfaction;
       ``(B) the term `reinspection-related costs' means all 
     expenses, including administrative expenses, incurred in 
     connection with--
       ``(i) arranging, conducting, and evaluating the results of 
     reinspections; and
       ``(ii) assessing and collecting reinspection fees under 
     this section; and
       ``(C) the term `responsible party' has the meaning given 
     such term in section 417(a)(1).
       ``(b) Establishment of Fees.--
       ``(1) In general.--Subject to subsections (c) and (d), the 
     Secretary shall establish the fees to be collected under this 
     section for each fiscal year specified in subsection (a)(1), 
     based on the methodology described under paragraph (2), and 
     shall publish such fees in a Federal Register notice not 
     later than 60 days before the start of each such year.
       ``(2) Fee methodology.--
       ``(A) Fees.--Fees amounts established for collection--
       ``(i) under subparagraph (A) of subsection (a)(1) for a 
     fiscal year shall be based on the Secretary's estimate of 100 
     percent of the costs of the reinspection-related activities 
     (including by type or level of reinspection activity, as the 
     Secretary determines applicable) described in such 
     subparagraph (A) for such year;
       ``(ii) under subparagraph (B) of subsection (a)(1) for a 
     fiscal year shall be based on the Secretary's estimate of 100 
     percent of the costs of the activities described in such 
     subparagraph (B) for such year;
       ``(iii) under subparagraph (C) of subsection (a)(1) for a 
     fiscal year shall be based on the Secretary's estimate of 100 
     percent of the costs of the activities described in such 
     subparagraph (C) for such year; and
       ``(iv) under subparagraph (D) of subsection (a)(1) for a 
     fiscal year shall be based on the Secretary's estimate of 100 
     percent of the costs of the activities described in such 
     subparagraph (D) for such year.
       ``(B) Other considerations.--
       ``(i) Voluntary qualified importer program.--

       ``(I) Participation.--In establishing the fee amounts under 
     subparagraph (A)(iii) for a fiscal year, the Secretary shall 
     provide for the number of importers who have submitted to the 
     Secretary a notice under section 806(c) informing the 
     Secretary of the intent of such importer to participate in 
     the program under section 806 in such fiscal year.
       ``(II) Recoupment.--In establishing the fee amounts under 
     subparagraph (A)(iii) for the first 5 fiscal years after the 
     date of enactment of this section, the Secretary shall 
     include in such fee a reasonable surcharge that provides a 
     recoupment of the costs expended by the Secretary to 
     establish and implement the first year of the program under 
     section 806.

       ``(ii) Crediting of fees.--In establishing the fee amounts 
     under subparagraph (A) for a fiscal year, the Secretary shall 
     provide for the crediting of fees from the previous year to 
     the next year if the Secretary overestimated the amount of 
     fees needed to carry out such activities, and consider the 
     need to account for any adjustment of fees and such other 
     factors as the Secretary determines appropriate.
       ``(iii) Published guidelines.--Not later than 180 days 
     after the date of enactment of the FDA Food Safety 
     Modernization Act, the Secretary shall publish in the Federal 
     Register a proposed set of guidelines in consideration of the 
     burden of fee amounts on small business. Such consideration 
     may include reduced fee amounts for small businesses. The 
     Secretary shall provide for a period of public comment on 
     such guidelines. The Secretary shall adjust the fee schedule 
     for small businesses subject to such fees only through notice 
     and comment rulemaking.
       ``(3) Use of fees.--The Secretary shall make all of the 
     fees collected pursuant to clause (i), (ii), (iii), and (iv) 
     of paragraph (2)(A) available solely to pay for the costs 
     referred to in such clause (i), (ii), (iii), and (iv) of 
     paragraph (2)(A), respectively.
       ``(c) Limitations.--
       ``(1) In general.--Fees under subsection (a) shall be 
     refunded for a fiscal year beginning after fiscal year 2010 
     unless the amount of the total appropriations for food safety 
     activities at the Food and Drug Administration for such 
     fiscal year (excluding the amount of fees appropriated for 
     such fiscal year) is equal to or greater than the amount of 
     appropriations for food safety activities at the Food and 
     Drug Administration for fiscal year 2009 (excluding the 
     amount of fees appropriated for such fiscal year), multiplied 
     by the adjustment factor under paragraph (3).
       ``(2) Authority.--If--
       ``(A) the Secretary does not assess fees under subsection 
     (a) for a portion of a fiscal year because paragraph (1) 
     applies; and
       ``(B) at a later date in such fiscal year, such paragraph 
     (1) ceases to apply,
     the Secretary may assess and collect such fees under 
     subsection (a), without any modification to the rate of such 
     fees, notwithstanding the provisions of subsection (a) 
     relating to the date fees are to be paid.
       ``(3) Adjustment factor.--
       ``(A) In general.--The adjustment factor described in 
     paragraph (1) shall be the total percentage change that 
     occurred in the Consumer Price Index for all urban consumers 
     (all items; United States city average) for the 12-month 
     period ending June 30 preceding the fiscal year, but in no 
     case shall such adjustment factor be negative.
       ``(B) Compounded basis.--The adjustment under subparagraph 
     (A) made each fiscal year shall be added on a compounded 
     basis to the sum of all adjustments made each fiscal year 
     after fiscal year 2009.
       ``(4) Limitation on amount of certain fees.--
       ``(A) In general.--Notwithstanding any other provision of 
     this section and subject to subparagraph (B), the Secretary 
     may not collect fees in a fiscal year such that the amount 
     collected--
       ``(i) under subparagraph (B) of subsection (a)(1) exceeds 
     $20,000,000; and
       ``(ii) under subparagraphs (A) and (D) of subsection (a)(1) 
     exceeds $25,000,000 combined.
       ``(B) Exception.--If a domestic facility (as defined in 
     section 415(b)) or an importer becomes subject to a fee 
     described in subparagraph (A), (B), or (D) of subsection 
     (a)(1) after the maximum amount of fees has been collected by 
     the Secretary under subparagraph (A), the Secretary may 
     collect a fee from such facility or importer.
       ``(d) Crediting and Availability of Fees.--Fees authorized 
     under subsection (a) shall be collected and available for 
     obligation only to the extent and in the amount provided in 
     appropriations Acts. Such fees are authorized to remain 
     available until expended. Such sums as may be necessary may 
     be transferred from the Food and Drug Administration salaries 
     and expenses account without fiscal year limitation to such 
     appropriation account for salaries and expenses with such 
     fiscal year limitation. The sums transferred shall be 
     available solely for the purpose of paying the operating 
     expenses of the Food and Drug Administration employees and 
     contractors performing activities associated with these food 
     safety fees.
       ``(e) Collection of Fees.--
       ``(1) In general.--The Secretary shall specify in the 
     Federal Register notice described in subsection (b)(1) the 
     time and manner in which fees assessed under this section 
     shall be collected.
       ``(2) Collection of unpaid fees.--In any case where the 
     Secretary does not receive payment of a fee assessed under 
     this section within 30 days after it is due, such fee shall 
     be treated as a claim of the United States Government subject 
     to provisions of subchapter II of chapter 37 of title 31, 
     United States Code.
       ``(f) Annual Report to Congress.--Not later than 120 days 
     after each fiscal year for which fees are assessed under this 
     section, the Secretary shall submit a report to the Committee 
     on Health, Education, Labor, and Pensions of the Senate and 
     the Committee on Energy and Commerce of the House of 
     Representatives, to include a description of fees assessed 
     and collected for each such year and a summary description of 
     the entities paying such fees and the types of business in 
     which such entities engage.
       ``(g) Authorization of Appropriations.--For fiscal year 
     2010 and each fiscal year thereafter, there is authorized to 
     be appropriated for fees under this section an amount equal 
     to the total revenue amount determined under subsection (b) 
     for the fiscal year, as adjusted or otherwise affected under 
     the other provisions of this section.''.
       (b) Export Certification Fees for Foods and Animal Feed.--
       (1) Authority for export certifications for food, including 
     animal feed.--Section 801(e)(4)(A) (21 U.S.C. 381(e)(4)(A)) 
     is amended--

[[Page 17981]]

       (A) in the matter preceding clause (i), by striking ``a 
     drug'' and inserting ``a food, drug'';
       (B) in clause (i) by striking ``exported drug'' and 
     inserting ``exported food, drug''; and
       (C) in clause (ii) by striking ``the drug'' each place it 
     appears and inserting ``the food, drug''.
       (2) Clarification of certification.--Section 801(e)(4) (21 
     U.S.C. 381(e)(4)) is amended by inserting after subparagraph 
     (B) the following new subparagraph:
       ``(C) For purposes of this paragraph, a certification by 
     the Secretary shall be made on such basis, and in such form 
     (including a publicly available listing) as the Secretary 
     determines appropriate.''.

     SEC. 108. NATIONAL AGRICULTURE AND FOOD DEFENSE STRATEGY.

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

       (I) the Federal Government; and
       (II) State, local, and tribal governments;

       (iv) designing, developing, and evaluating training and 
     exercises carried out under agriculture and food defense 
     plans; and
       (v) ensuring consistent and organized risk communication to 
     the public by--

       (I) the Federal Government;
       (II) State, local, and tribal governments; and
       (III) the private sector.

       (D) Recovery goal.--Secure agriculture and food production 
     after an agriculture or food emergency by--
       (i) working with the private sector to develop business 
     recovery plans to rapidly resume agriculture, food 
     production, and international trade;
       (ii) conducting exercises of the plans described in 
     subparagraph (C) with the goal of long-term recovery results;
       (iii) rapidly removing, and effectively disposing of--

       (I) contaminated agriculture and food products; and
       (II) infected plants and animals; and

       (iv) decontaminating and restoring areas affected by an 
     agriculture or food emergency.
       (3) Evaluation.--The Secretary, in coordination with the 
     Secretary of Agriculture and the Secretary of Homeland 
     Security, shall--
       (A) develop metrics to measure progress for the evaluation 
     process described in paragraph (1)(B); and
       (B) report on the progress measured in subparagraph (A) as 
     part of the National Agriculture and Food Defense strategy 
     described in subsection (a)(1).
       (c) Limited Distribution.--In the interest of national 
     security, the Secretary of Health and Human Services and the 
     Secretary of Agriculture, in coordination with the Secretary 
     of Homeland Security, may determine the manner and format in 
     which the National Agriculture and Food Defense strategy 
     established under this section is made publicly available on 
     the Internet Web sites of the Department of Health and Human 
     Services, the Department of Homeland Security, and the 
     Department of Agriculture, as described in subsection (a)(1).

     SEC. 109. FOOD AND AGRICULTURE COORDINATING COUNCILS.

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

     SEC. 110. BUILDING DOMESTIC CAPACITY.

       (a) In General.--
       (1) Initial report.--The Secretary, in coordination with 
     the Secretary of Agriculture and the Secretary of Homeland 
     Security, shall, not later than 2 years after the date of 
     enactment of this Act, submit to Congress a comprehensive 
     report that identifies programs and practices that are 
     intended to promote the safety and supply chain security of 
     food and to prevent outbreaks of foodborne illness and other 
     food-related hazards that can be addressed through preventive 
     activities. Such report shall include a description of the 
     following:
       (A) Analysis of the need for further regulations or 
     guidance to industry.
       (B) Outreach to food industry sectors, including through 
     the Food and Agriculture Coordinating Councils referred to in 
     section 109, to identify potential sources of emerging 
     threats to the safety and security of the food supply and 
     preventive strategies to address those threats.
       (C) Systems to ensure the prompt distribution to the food 
     industry of information and technical assistance concerning 
     preventive strategies.
       (D) Communication systems to ensure that information about 
     specific threats to the safety and security of the food 
     supply are rapidly and effectively disseminated.
       (E) Surveillance systems and laboratory networks to rapidly 
     detect and respond to foodborne illness outbreaks and other 
     food-related hazards, including how such systems and networks 
     are integrated.
       (F) Outreach, education, and training provided to States 
     and local governments to build State and local food safety 
     and food defense capabilities, including progress 
     implementing strategies developed under sections 108 and 205.
       (G) The estimated resources needed to effectively implement 
     the programs and practices identified in the report developed 
     in this section over a 5-year period.
       (H) The impact of requirements under this Act (including 
     amendments made by this

[[Page 17982]]

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

     SEC. 111. SANITARY TRANSPORTATION OF FOOD.

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

     SEC. 112. FOOD ALLERGY AND ANAPHYLAXIS MANAGEMENT.

       (a) Definitions.--In this section:
       (1) Early childhood education program.--The term ``early 
     childhood education program'' means--
       (A) a Head Start program or an Early Head Start program 
     carried out under the Head Start Act (42 U.S.C. 9831 et 
     seq.);
       (B) a State licensed or regulated child care program or 
     school; or
       (C) a State prekindergarten program that serves children 
     from birth through kindergarten.
       (2) ESEA definitions.--The terms ``local educational 
     agency'', ``secondary school'', ``elementary school'', and 
     ``parent'' have the meanings given the terms in section 9101 
     of the Elementary and Secondary Education Act of 1965 (20 
     U.S.C. 7801).
       (3) School.--The term ``school'' includes public--
       (A) kindergartens;
       (B) elementary schools; and
       (C) secondary schools.
       (4) Secretary.--The term ``Secretary'' means the Secretary 
     of Health and Human Services.
       (b) Establishment of Voluntary Food Allergy and Anaphylaxis 
     Management Guidelines.--
       (1) Establishment.--
       (A) In general.--Not later than 1 year after the date of 
     enactment of this Act, the Secretary, in consultation with 
     the Secretary of Education, shall--
       (i) develop guidelines to be used on a voluntary basis to 
     develop plans for individuals to manage the risk of food 
     allergy and anaphylaxis in schools and early childhood 
     education programs; and
       (ii) make such guidelines available to local educational 
     agencies, schools, early childhood education programs, and 
     other interested entities and individuals to be implemented 
     on a voluntary basis only.
       (B) Applicability of ferpa.--Each plan described in 
     subparagraph (A) that is developed for an individual shall be 
     considered an education record for the purpose of section 444 
     of the General Education Provisions Act (commonly referred to 
     as the ``Family Educational Rights and Privacy Act of 1974'') 
     (20 U.S.C. 1232g).
       (2) Contents.--The voluntary guidelines developed by the 
     Secretary under paragraph (1) shall address each of the 
     following and may be updated as the Secretary determines 
     necessary:
       (A) Parental obligation to provide the school or early 
     childhood education program, prior to the start of every 
     school year, with--
       (i) documentation from their child's physician or nurse--

       (I) supporting a diagnosis of food allergy, and any risk of 
     anaphylaxis, if applicable;
       (II) identifying any food to which the child is allergic;
       (III) describing, if appropriate, any prior history of 
     anaphylaxis;
       (IV) listing any medication prescribed for the child for 
     the treatment of anaphylaxis;
       (V) detailing emergency treatment procedures in the event 
     of a reaction;

[[Page 17983]]

       (VI) listing the signs and symptoms of a reaction; and
       (VII) assessing the child's readiness for self-
     administration of prescription medication; and

       (ii) a list of substitute meals that may be offered to the 
     child by school or early childhood education program food 
     service personnel.
       (B) The creation and maintenance of an individual plan for 
     food allergy management, in consultation with the parent, 
     tailored to the needs of each child with a documented risk 
     for anaphylaxis, including any procedures for the self-
     administration of medication by such children in instances 
     where--
       (i) the children are capable of self-administering 
     medication; and
       (ii) such administration is not prohibited by State law.
       (C) Communication strategies between individual schools or 
     early childhood education programs and providers of emergency 
     medical services, including appropriate instructions for 
     emergency medical response.
       (D) Strategies to reduce the risk of exposure to 
     anaphylactic causative agents in classrooms and common school 
     or early childhood education program areas such as 
     cafeterias.
       (E) The dissemination of general information on life-
     threatening food allergies to school or early childhood 
     education program staff, parents, and children.
       (F) Food allergy management training of school or early 
     childhood education program personnel who regularly come into 
     contact with children with life-threatening food allergies.
       (G) The authorization and training of school or early 
     childhood education program personnel to administer 
     epinephrine when the nurse is not immediately available.
       (H) The timely accessibility of epinephrine by school or 
     early childhood education program personnel when the nurse is 
     not immediately available.
       (I) The creation of a plan contained in each individual 
     plan for food allergy management that addresses the 
     appropriate response to an incident of anaphylaxis of a child 
     while such child is engaged in extracurricular programs of a 
     school or early childhood education program, such as non-
     academic outings and field trips, before- and after-school 
     programs or before- and after-early child education program 
     programs, and school-sponsored or early childhood education 
     program-sponsored programs held on weekends.
       (J) Maintenance of information for each administration of 
     epinephrine to a child at risk for anaphylaxis and prompt 
     notification to parents.
       (K) Other elements the Secretary determines necessary for 
     the management of food allergies and anaphylaxis in schools 
     and early childhood education programs.
       (3) Relation to state law.--Nothing in this section or the 
     guidelines developed by the Secretary under paragraph (1) 
     shall be construed to preempt State law, including any State 
     law regarding whether students at risk for anaphylaxis may 
     self-administer medication.
       (c) School-based Food Allergy Management Grants.--
       (1) In general.--The Secretary may award grants to local 
     educational agencies to assist such agencies with 
     implementing voluntary food allergy and anaphylaxis 
     management guidelines described in subsection (b).
       (2) Application.--
       (A) In general.--To be eligible to receive a grant under 
     this subsection, a local educational agency shall submit an 
     application to the Secretary at such time, in such manner, 
     and including such information as the Secretary may 
     reasonably require.
       (B) Contents.--Each application submitted under 
     subparagraph (A) shall include--
       (i) an assurance that the local educational agency has 
     developed plans in accordance with the food allergy and 
     anaphylaxis management guidelines described in subsection 
     (b);
       (ii) a description of the activities to be funded by the 
     grant in carrying out the food allergy and anaphylaxis 
     management guidelines, including--

       (I) how the guidelines will be carried out at individual 
     schools served by the local educational agency;
       (II) how the local educational agency will inform parents 
     and students of the guidelines in place;
       (III) how school nurses, teachers, administrators, and 
     other school-based staff will be made aware of, and given 
     training on, when applicable, the guidelines in place; and
       (IV) any other activities that the Secretary determines 
     appropriate;

       (iii) an itemization of how grant funds received under this 
     subsection will be expended;
       (iv) a description of how adoption of the guidelines and 
     implementation of grant activities will be monitored; and
       (v) an agreement by the local educational agency to report 
     information required by the Secretary to conduct evaluations 
     under this subsection.
       (3) Use of funds.--Each local educational agency that 
     receives a grant under this subsection may use the grant 
     funds for the following:
       (A) Purchase of materials and supplies, including limited 
     medical supplies such as epinephrine and disposable wet 
     wipes, to support carrying out the food allergy and 
     anaphylaxis management guidelines described in subsection 
     (b).
       (B) In partnership with local health departments, school 
     nurse, teacher, and personnel training for food allergy 
     management.
       (C) Programs that educate students as to the presence of, 
     and policies and procedures in place related to, food 
     allergies and anaphylactic shock.
       (D) Outreach to parents.
       (E) Any other activities consistent with the guidelines 
     described in subsection (b).
       (4) Duration of awards.--The Secretary may award grants 
     under this subsection for a period of not more than 2 years. 
     In the event the Secretary conducts a program evaluation 
     under this subsection, funding in the second year of the 
     grant, where applicable, shall be contingent on a successful 
     program evaluation by the Secretary after the first year.
       (5) Limitation on grant funding.--The Secretary may not 
     provide grant funding to a local educational agency under 
     this subsection after such local educational agency has 
     received 2 years of grant funding under this subsection.
       (6) Maximum amount of annual awards.--A grant awarded under 
     this subsection may not be made in an amount that is more 
     than $50,000 annually.
       (7) Priority.--In awarding grants under this subsection, 
     the Secretary shall give priority to local educational 
     agencies with the highest percentages of children who are 
     counted under section 1124(c) of the Elementary and Secondary 
     Education Act of 1965 (20 U.S.C. 6333(c)).
       (8) Matching funds.--
       (A) In general.--The Secretary may not award a grant under 
     this subsection unless the local educational agency agrees 
     that, with respect to the costs to be incurred by such local 
     educational agency in carrying out the grant activities, the 
     local educational agency shall make available (directly or 
     through donations from public or private entities) non-
     Federal funds toward such costs in an amount equal to not 
     less than 25 percent of the amount of the grant.
       (B) Determination of amount of non-federal contribution.--
     Non-Federal funds required under subparagraph (A) may be cash 
     or in kind, including plant, equipment, or services. Amounts 
     provided by the Federal Government, and any portion of any 
     service subsidized by the Federal Government, may not be 
     included in determining the amount of such non-Federal funds.
       (9) Administrative funds.--A local educational agency that 
     receives a grant under this subsection may use not more than 
     2 percent of the grant amount for administrative costs 
     related to carrying out this subsection.
       (10) Progress and evaluations.--At the completion of the 
     grant period referred to in paragraph (4), a local 
     educational agency shall provide the Secretary with 
     information on how grant funds were spent and the status of 
     implementation of the food allergy and anaphylaxis management 
     guidelines described in subsection (b).
       (11) Supplement, not supplant.--Grant funds received under 
     this subsection shall be used to supplement, and not 
     supplant, non-Federal funds and any other Federal funds 
     available to carry out the activities described in this 
     subsection.
       (12) Authorization of appropriations.--There is authorized 
     to be appropriated to carry out this subsection $30,000,000 
     for fiscal year 2011 and such sums as may be necessary for 
     each of the 4 succeeding fiscal years.
       (d) Voluntary Nature of Guidelines.--
       (1) In general.--The food allergy and anaphylaxis 
     management guidelines developed by the Secretary under 
     subsection (b) are voluntary. Nothing in this section or the 
     guidelines developed by the Secretary under subsection (b) 
     shall be construed to require a local educational agency to 
     implement such guidelines.
       (2) Exception.--Notwithstanding paragraph (1), the 
     Secretary may enforce an agreement by a local educational 
     agency to implement food allergy and anaphylaxis management 
     guidelines as a condition of the receipt of a grant under 
     subsection (c).

     SEC. 113. NEW DIETARY INGREDIENTS.

       (a) In General.--Section 413 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 350b) is amended--
       (1) by redesignating subsection (c) as subsection (d); and
       (2) by inserting after subsection (b) the following:
       ``(c) Notification.--
       ``(1) In general.--If the Secretary determines that the 
     information in a new dietary ingredient notification 
     submitted under this section for an article purported to be a 
     new dietary ingredient is inadequate to establish that a 
     dietary supplement containing such article will reasonably be 
     expected to be safe because the article may be, or may 
     contain, an anabolic steroid or an analogue of an anabolic 
     steroid, the Secretary shall notify the Drug Enforcement 
     Administration of such determination. Such notification by 
     the Secretary shall include, at a minimum, the name of the 
     dietary supplement or article, the name of the person or 
     persons who marketed the product or made the submission of

[[Page 17984]]

     information regarding the article to the Secretary under this 
     section, and any contact information for such person or 
     persons that the Secretary has.
       ``(2) Definitions.--For purposes of this subsection--
       ``(A) the term `anabolic steroid' has the meaning given 
     such term in section 102(41) of the Controlled Substances 
     Act; and
       ``(B) the term `analogue of an anabolic steroid' means a 
     substance whose chemical structure is substantially similar 
     to the chemical structure of an anabolic steroid.''.
       (b) Guidance.--Not later than 180 days after the date of 
     enactment of this Act, the Secretary shall publish guidance 
     that clarifies when a dietary supplement ingredient is a new 
     dietary ingredient, when the manufacturer or distributor of a 
     dietary ingredient or dietary supplement should provide the 
     Secretary with information as described in section 413(a)(2) 
     of the Federal Food, Drug, and Cosmetic Act, the evidence 
     needed to document the safety of new dietary ingredients, and 
     appropriate methods for establishing the identify of a new 
     dietary ingredient.

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

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

     SEC. 115. PORT SHOPPING.

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

     SEC. 116. ALCOHOL-RELATED FACILITIES.

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

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

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

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

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

       ``(a) Identification and Inspection of Facilities.--
       ``(1) Identification.--The Secretary shall identify high-
     risk facilities and shall allocate resources to inspect 
     facilities according to the known safety risks of the 
     facilities, which shall be based on the following factors:
       ``(A) The known safety risks of the food manufactured, 
     processed, packed, or held at the facility.
       ``(B) The compliance history of a facility, including with 
     regard to food recalls, outbreaks of foodborne illness, and 
     violations of food safety standards.
       ``(C) The rigor and effectiveness of the facility's hazard 
     analysis and risk-based preventive controls.
       ``(D) Whether the food manufactured, processed, packed, or 
     held at the facility meets the criteria for priority under 
     section 801(h)(1).
       ``(E) Whether the food or the facility that manufactured, 
     processed, packed, or held such food has received a 
     certification as described in section 801(q) or 806, as 
     appropriate.
       ``(F) Any other criteria deemed necessary and appropriate 
     by the Secretary for purposes of allocating inspection 
     resources.
       ``(2) Inspections.--
       ``(A) In general.--Beginning on the date of enactment of 
     the FDA Food Safety Modernization Act, the Secretary shall 
     increase the frequency of inspection of all facilities.
       ``(B) Domestic high-risk facilities.--The Secretary shall 
     increase the frequency of inspection of domestic facilities 
     identified under paragraph (1) as high-risk facilities such 
     that each such facility is inspected--
       ``(i) not less often than once in the 5-year period 
     following the date of enactment of the FDA Food Safety 
     Modernization Act; and
       ``(ii) not less often than once every 3 years thereafter.
       ``(C) Domestic non-high-risk facilities.--The Secretary 
     shall ensure that each domestic facility that is not 
     identified under paragraph (1) as a high-risk facility is 
     inspected--
       ``(i) not less often than once in the 7-year period 
     following the date of enactment of the FDA Food Safety 
     Modernization Act; and
       ``(ii) not less often than once every 5 years thereafter.
       ``(D) Foreign facilities.--
       ``(i) Year 1.--In the 1-year period following the date of 
     enactment of the FDA Food Safety Modernization Act, the 
     Secretary shall inspect not fewer than 600 foreign 
     facilities.
       ``(ii) Subsequent years.--In each of the 5 years following 
     the 1-year period described in clause (i), the Secretary 
     shall inspect not fewer than twice the number of foreign 
     facilities inspected by the Secretary during the previous 
     year.

[[Page 17985]]

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

     SEC. 202. LABORATORY ACCREDITATION FOR ANALYSES OF FOODS.

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

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

       ``(a) Recognition of Laboratory Accreditation.--
       ``(1) In general.--Not later than 2 years after the date of 
     enactment of the FDA Food Safety Modernization Act, the 
     Secretary shall--
       ``(A) establish a program for the testing of food by 
     accredited laboratories;
       ``(B) establish a publicly available registry of 
     accreditation bodies recognized by the Secretary and 
     laboratories accredited by a recognized accreditation body, 
     including the name of, contact information for, and other 
     information deemed appropriate by the Secretary about such 
     bodies and laboratories; and
       ``(C) require, as a condition of recognition or 
     accreditation, as appropriate, that recognized accreditation 
     bodies and accredited laboratories report to the Secretary 
     any changes that would affect the recognition of such 
     accreditation body or the accreditation of such laboratory.
       ``(2) Program requirements.--The program established under 
     paragraph (1)(A) shall provide for the recognition of 
     laboratory accreditation bodies that meet criteria 
     established by the Secretary for accreditation of 
     laboratories, including independent private laboratories and 
     laboratories run and operated by a Federal agency (including 
     the Department of Commerce), State, or locality with a 
     demonstrated capability to conduct 1 or more sampling and 
     analytical testing methodologies for food.
       ``(3) Increasing the number of qualified laboratories.--The 
     Secretary shall work with the laboratory accreditation bodies 
     recognized under paragraph (1), as appropriate, to increase 
     the number of qualified laboratories that are eligible to 
     perform testing under subparagraph (b) beyond the number so 
     qualified on the date of enactment of the FDA Food Safety 
     Modernization Act.
       ``(4) Limited distribution.--In the interest of national 
     security, the Secretary, in coordination with the Secretary 
     of Homeland Security, may determine the time, manner, and 
     form in which the registry established under paragraph (1)(B) 
     is made publicly available.
       ``(5) Foreign laboratories.--Accreditation bodies 
     recognized by the Secretary under paragraph (1) may accredit 
     laboratories that operate outside the United States, so long 
     as such laboratories meet the accreditation standards 
     applicable to domestic laboratories accredited under this 
     section.
       ``(6) Model laboratory standards.--The Secretary shall 
     develop model standards that a laboratory shall meet to be 
     accredited by a recognized accreditation body for a specified 
     sampling or analytical testing methodology and included in 
     the registry provided for under paragraph (1). In developing 
     the model standards, the Secretary shall consult existing 
     standards for guidance. The model standards shall include--
       ``(A) methods to ensure that--
       ``(i) appropriate sampling, analytical procedures 
     (including rapid analytical procedures), and commercially 
     available techniques are followed and reports of analyses are 
     certified as true and accurate;

[[Page 17986]]

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

     SEC. 203. INTEGRATED CONSORTIUM OF LABORATORY NETWORKS.

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

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

       (a) Pilot Projects.--
       (1) In general.--Not later than 270 days after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services (referred to in this section as the ``Secretary''), 
     taking into account recommendations from the Secretary of 
     Agriculture and representatives of State departments of 
     health and agriculture, shall establish pilot projects in 
     coordination with the food industry to explore and evaluate 
     methods to rapidly and effectively identify recipients of 
     food to prevent or mitigate a foodborne illness outbreak and 
     to address credible threats of serious adverse health 
     consequences or death to humans or animals as a result of 
     such food being adulterated under section 402 of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 342) or misbranded 
     under section 403(w) of such Act (21 U.S.C. 343(w)).
       (2) Content.--The Secretary shall conduct 1 or more pilot 
     projects under paragraph (1) in coordination with the 
     processed food sector and 1 or more such pilot projects in 
     coordination with processors or distributors of fruits and 
     vegetables that are raw agricultural commodities. The 
     Secretary shall ensure that the pilot projects under 
     paragraph (1) reflect the diversity of the food supply and 
     include at least 3 different types of foods that have been 
     the subject of significant outbreaks during the 5-year period 
     preceding the date of enactment of this Act, and are selected 
     in order to--
       (A) develop and demonstrate methods for rapid and effective 
     tracking and tracing of foods in a manner that is practicable 
     for facilities of varying sizes, including small businesses;
       (B) develop and demonstrate appropriate technologies, 
     including technologies existing on the date of enactment of 
     this Act, that enhance the tracking and tracing of food; and
       (C) inform the promulgation of regulations under subsection 
     (d).
       (3) Report.--Not later than 18 months after the date of 
     enactment of this Act, the Secretary shall report to Congress 
     on the findings of the pilot projects under this subsection 
     together with recommendations for improving the tracking and 
     tracing of food.
       (b) Additional Data Gathering.--
       (1) In general.--The Secretary, in coordination with the 
     Secretary of Agriculture and multiple representatives of 
     State departments of health and agriculture, shall assess--
       (A) the costs and benefits associated with the adoption and 
     use of several product tracing technologies, including 
     technologies used in the pilot projects under subsection (a);
       (B) the feasibility of such technologies for different 
     sectors of the food industry, including small businesses; and
       (C) whether such technologies are compatible with the 
     requirements of this subsection.
       (2) Requirements.--To the extent practicable, in carrying 
     out paragraph (1), the Secretary shall--
       (A) evaluate domestic and international product tracing 
     practices in commercial use;
       (B) consider international efforts, including an assessment 
     of whether product tracing requirements developed under this 
     section are compatible with global tracing systems, as 
     appropriate; and
       (C) consult with a diverse and broad range of experts and 
     stakeholders, including representatives of the food industry, 
     agricultural producers, and nongovernmental organizations 
     that represent the interests of consumers.
       (c) Product Tracing System.--The Secretary, in consultation 
     with the Secretary of

[[Page 17987]]

     Agriculture, shall, as appropriate, establish within the Food 
     and Drug Administration a product tracing system to receive 
     information that improves the capacity of the Secretary to 
     effectively and rapidly track and trace food that is in the 
     United States or offered for import into the United States. 
     Prior to the establishment of such product tracing system, 
     the Secretary shall examine the results of applicable pilot 
     projects and shall ensure that the activities of such system 
     are adequately supported by the results of such pilot 
     projects.
       (d) Additional Recordkeeping Requirements for High Risk 
     Foods.--
       (1) In general.--In order to rapidly and effectively 
     identify recipients of a food to prevent or mitigate a 
     foodborne illness outbreak and to address credible threats of 
     serious adverse health consequences or death to humans or 
     animals as a result of such food being adulterated under 
     section 402 of the Federal Food, Drug, and Cosmetic Act or 
     misbranded under section 403(w) of such Act, not later than 2 
     years after the date of enactment of this Act, the Secretary 
     shall publish a notice of proposed rulemaking to establish 
     recordkeeping requirements, in addition to the requirements 
     under section 414 of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 350c) and subpart J of part 1 of title 21, Code of 
     Federal Regulations (or any successor regulations), for 
     facilities that manufacture, process, pack, or hold foods 
     that the Secretary designates under paragraph (2) as high-
     risk foods. The Secretary shall set an appropriate effective 
     date of such additional requirements for foods designated as 
     high risk that takes into account the length of time 
     necessary to comply with such requirements. Such requirements 
     shall--
       (A) relate only to information that is reasonably available 
     and appropriate;
       (B) be science-based;
       (C) not prescribe specific technologies for the maintenance 
     of records;
       (D) ensure that the public health benefits of imposing 
     additional recordkeeping requirements outweigh the cost of 
     compliance with such requirements;
       (E) be scale-appropriate and practicable for facilities of 
     varying sizes and capabilities with respect to costs and 
     recordkeeping burdens, and not require the creation and 
     maintenance of duplicate records where the information is 
     contained in other company records kept in the normal course 
     of business;
       (F) minimize the number of different recordkeeping 
     requirements for facilities that handle more than 1 type of 
     food;
       (G) to the extent practicable, not require a facility to 
     change business systems to comply with such requirements;
       (H) allow any person subject to this subsection to maintain 
     records required under this subsection at a central or 
     reasonably accessible location provided that such records can 
     be made available to the Secretary not later than 24 hours 
     after the Secretary requests such records;
       (I) include a process by which the Secretary may issue a 
     waiver of the requirements under this subsection if the 
     Secretary determines that such requirements would result in 
     an economic hardship for an individual facility or a type of 
     facility;
       (J) be commensurate with the known safety risks of the 
     designated food;
       (K) take into account international trade obligations;
       (L) not require--
       (i) a full pedigree, or a record of the complete previous 
     distribution history of the food from the point of origin of 
     such food;
       (ii) records of recipients of a food beyond the immediate 
     subsequent recipient of such food; or
       (iii) product tracking to the case level by persons subject 
     to such requirements; and
       (M) include a process by which the Secretary may remove a 
     high-risk food designation developed under paragraph (2) for 
     a food or type of food.
       (2) Designation of high-risk foods.--
       (A) In general.--Not later than 1 year after the date of 
     enactment of this Act, and thereafter as the Secretary 
     determines necessary, the Secretary shall designate high-risk 
     foods for which the additional recordkeeping requirements 
     described in paragraph (1) are appropriate and necessary to 
     protect the public health. Each such designation shall be 
     based on--
       (i) the known safety risks of a particular food, including 
     the history and severity of foodborne illness outbreaks 
     attributed to such food, taking into consideration foodborne 
     illness data collected by the Centers for Disease Control and 
     Prevention;
       (ii) the likelihood that a particular food has a high 
     potential risk for microbiological or chemical contamination 
     or would support the growth of pathogenic microorganisms due 
     to the nature of the food or the processes used to produce 
     such food;
       (iii) the point in the manufacturing process of the food 
     where contamination is most likely to occur;
       (iv) the likelihood of contamination and steps taken during 
     the manufacturing process to reduce the possibility of 
     contamination;
       (v) the likelihood that consuming a particular food will 
     result in a foodborne illness due to contamination of the 
     food; and
       (vi) the likely or known severity, including health and 
     economic impacts, of a foodborne illness attributed to a 
     particular food.
       (B) List of high-risk foods.--At the time the Secretary 
     promulgates the final rules under paragraph (1), the 
     Secretary shall publish the list of the foods designated 
     under subparagraph (A) as high-risk foods on the Internet 
     website of the Food and Drug Administration. The Secretary 
     may update the list to designate new high-risk foods and to 
     remove foods that are no longer deemed to be high-risk foods, 
     provided that each such update to the list is consistent with 
     the requirements of this subsection and notice of such update 
     is published in the Federal Register.
       (3) Protection of sensitive information.--In promulgating 
     regulations under this subsection, the Secretary shall take 
     appropriate measures to ensure that there are effective 
     procedures to prevent the unauthorized disclosure of any 
     trade secret or confidential information that is obtained by 
     the Secretary pursuant to this section, including periodic 
     risk assessment and planning to prevent unauthorized release 
     and controls to--
       (A) prevent unauthorized reproduction of trade secret or 
     confidential information;
       (B) prevent unauthorized access to trade secret or 
     confidential information; and
       (C) maintain records with respect to access by any person 
     to trade secret or confidential information maintained by the 
     agency.
       (4) Public input.--During the comment period in the notice 
     of proposed rulemaking under paragraph (1), the Secretary 
     shall conduct not less than 3 public meetings in diverse 
     geographical areas of the United States to provide persons in 
     different regions an opportunity to comment.
       (5) Retention of records.--Except as otherwise provided in 
     this subsection, the Secretary may require that a facility 
     retain records under this subsection for not more than 2 
     years, taking into consideration the risk of spoilage, loss 
     of value, or loss of palatability of the applicable food when 
     determining the appropriate timeframes.
       (6) Limitations.--
       (A) Farm to school programs.--In establishing requirements 
     under this subsection, the Secretary shall, in consultation 
     with the Secretary of Agriculture, consider the impact of 
     requirements on farm to school or farm to institution 
     programs of the Department of Agriculture and other farm to 
     school and farm to institution programs outside such agency, 
     and shall modify the requirements under this subsection, as 
     appropriate, with respect to such programs so that the 
     requirements do not place undue burdens on farm to school or 
     farm to institution programs.
       (B) Identity-preserved labels with respect to farm sales of 
     food that is produced and packaged on a farm.--The 
     requirements under this subsection shall not apply to a food 
     that is produced and packaged on a farm if--
       (i) the packaging of the food maintains the integrity of 
     the product and prevents subsequent contamination or 
     alteration of the product; and
       (ii) the labeling of the food includes the name, complete 
     address (street address, town, State, country, and zip or 
     other postal code), and business phone number of the farm, 
     unless the Secretary waives the requirement to include a 
     business phone number of the farm, as appropriate, in order 
     to accommodate a religious belief of the individual in charge 
     of such farm.
       (C) Fishing vessels.--The requirements under this 
     subsection with respect to a food that is produced through 
     the use of a fishing vessel (as defined in section 3(18) of 
     the Magnuson-Stevens Fishery Conservation and Management Act 
     (16 U.S.C. 1802(18))) shall be limited to the requirements 
     under subparagraph (F) until such time as the food is sold by 
     the owner, operator, or agent in charge of such fishing 
     vessel.
       (D) Commingled raw agricultural commodities.--
       (i) Limitation on extent of tracing.--Recordkeeping 
     requirements under this subsection with regard to any 
     commingled raw agricultural commodity shall be limited to the 
     requirements under subparagraph (F).
       (ii) Definitions.--For the purposes of this subparagraph--

       (I) the term ``commingled raw agricultural commodity'' 
     means any commodity that is combined or mixed after 
     harvesting, but before processing;
       (II) the term ``commingled raw agricultural commodity'' 
     shall not include types of fruits and vegetables that are raw 
     agricultural commodities for which the Secretary has 
     determined that standards promulgated under section 419 of 
     the Federal Food, Drug, and Cosmetic Act (as added by section 
     105) would minimize the risk of serious adverse health 
     consequences or death; and
       (III) the term ``processing'' means operations that alter 
     the general state of the commodity, such as canning, cooking, 
     freezing, dehydration, milling, grinding, pasteurization, or 
     homogenization.

       (E) Exemption of other foods.--The Secretary may, by notice 
     in the Federal Register, modify the requirements under this 
     subsection with respect to, or exempt a food or a type of 
     facility from, the requirements of this subsection (other 
     than the requirements under subparagraph (F), if applicable)

[[Page 17988]]

     if the Secretary determines that product tracing requirements 
     for such food (such as bulk or commingled ingredients that 
     are intended to be processed to destroy pathogens) or type of 
     facility is not necessary to protect the public health.
       (F) Recordkeeping regarding previous sources and subsequent 
     recipients.--In the case of a person or food to which a 
     limitation or exemption under subparagraph (C), (D), or (E) 
     applies, if such person, or a person who manufactures, 
     processes, packs, or holds such food, is required to register 
     with the Secretary under section 415 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 350d) with respect to the 
     manufacturing, processing, packing, or holding of the 
     applicable food, the Secretary shall require such person to 
     maintain records that identify the immediate previous source 
     of such food and the immediate subsequent recipient of such 
     food.
       (G) Grocery stores.--With respect to a sale of a food 
     described in subparagraph (H) to a grocery store, the 
     Secretary shall not require such grocery store to maintain 
     records under this subsection other than records documenting 
     the farm that was the source of such food. The Secretary 
     shall not require that such records be kept for more than 180 
     days.
       (H) Farm sales to consumers.--The Secretary shall not 
     require a farm to maintain any distribution records under 
     this subsection with respect to a sale of a food described in 
     subparagraph (I) (including a sale of a food that is produced 
     and packaged on such farm), if such sale is made by the farm 
     directly to a consumer.
       (I) Sale of a food.--A sale of a food described in this 
     subparagraph is a sale of a food in which--
       (i) the food is produced on a farm; and
       (ii) the sale is made by the owner, operator, or agent in 
     charge of such farm directly to a consumer or grocery store.
       (7) No impact on non-high-risk foods.--The recordkeeping 
     requirements established under paragraph (1) shall have no 
     effect on foods that are not designated by the Secretary 
     under paragraph (2) as high-risk foods. Foods described in 
     the preceding sentence shall be subject solely to the 
     recordkeeping requirements under section 414 of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 350c) and subpart J 
     of part 1 of title 21, Code of Federal Regulations (or any 
     successor regulations).
       (e) Evaluation and Recommendations.--
       (1) Report.--Not later than 1 year after the effective date 
     of the final rule promulgated under subsection (d)(1), the 
     Comptroller General of the United States shall submit to 
     Congress a report, taking into consideration the costs of 
     compliance and other regulatory burdens on small businesses 
     and Federal, State, and local food safety practices and 
     requirements, that evaluates the public health benefits and 
     risks, if any, of limiting--
       (A) the product tracing requirements under subsection (d) 
     to foods identified under paragraph (2) of such subsection, 
     including whether such requirements provide adequate 
     assurance of traceability in the event of intentional 
     adulteration, including by acts of terrorism; and
       (B) the participation of restaurants in the recordkeeping 
     requirements.
       (2) Determination and recommendations.--In conducting the 
     evaluation and report under paragraph (1), if the Comptroller 
     General of the United States determines that the limitations 
     described in such paragraph do not adequately protect the 
     public health, the Comptroller General shall submit to 
     Congress recommendations, if appropriate, regarding 
     recordkeeping requirements for restaurants and additional 
     foods, in order to protect the public health.
       (f) Farms.--
       (1) Request for information.--Notwithstanding subsection 
     (d), during an active investigation of a foodborne illness 
     outbreak, or if the Secretary determines it is necessary to 
     protect the public health and prevent or mitigate a foodborne 
     illness outbreak, the Secretary, in consultation and 
     coordination with State and local agencies responsible for 
     food safety, as appropriate, may request that the owner, 
     operator, or agent of a farm identify potential immediate 
     recipients, other than consumers, of an article of the food 
     that is the subject of such investigation if the Secretary 
     reasonably believes such article of food--
       (A) is adulterated under section 402 of the Federal Food, 
     Drug, and Cosmetic Act;
       (B) presents a threat of serious adverse health 
     consequences or death to humans or animals; and
       (C) was adulterated as described in subparagraph (A) on a 
     particular farm (as defined in section 1.227 of chapter 21, 
     Code of Federal Regulations (or any successor regulation)).
       (2) Manner of request.--In making a request under paragraph 
     (1), the Secretary, in consultation and coordination with 
     State and local agencies responsible for food safety, as 
     appropriate, shall issue a written notice to the owner, 
     operator, or agent of the farm to which the article of food 
     has been traced. The individual providing such notice shall 
     present to such owner, operator, or agent appropriate 
     credentials and shall deliver such notice at reasonable times 
     and within reasonable limits and in a reasonable manner.
       (3) Delivery of information requested.--The owner, 
     operator, or agent of a farm shall deliver the information 
     requested under paragraph (1) in a prompt and reasonable 
     manner. Such information may consist of records kept in the 
     normal course of business, and may be in electronic or non-
     electronic format.
       (4) Limitation.--A request made under paragraph (1) shall 
     not include a request for information relating to the 
     finances, pricing of commodities produced, personnel, 
     research, sales (other than information relating to 
     shipping), or other disclosures that may reveal trade secrets 
     or confidential information from the farm to which the 
     article of food has been traced, other than information 
     necessary to identify potential immediate recipients of such 
     food. Section 301(j) of the Federal Food, Drug, and Cosmetic 
     Act and the Freedom of Information Act shall apply with 
     respect to any confidential commercial information that is 
     disclosed to the Food and Drug Administration in the course 
     of responding to a request under paragraph (1).
       (5) Records.--Except with respect to identifying potential 
     immediate recipients in response to a request under this 
     subsection, nothing in this subsection shall require the 
     establishment or maintenance by farms of new records.
       (g) No Limitation on Commingling of Food.--Nothing in this 
     section shall be construed to authorize the Secretary to 
     impose any limitation on the commingling of food.
       (h) Small Entity Compliance Guide.--Not later than 180 days 
     after promulgation of a final rule under subsection (d), the 
     Secretary shall issue a small entity compliance guide setting 
     forth in plain language the requirements of the regulations 
     under such subsection in order to assist small entities, 
     including farms and small businesses, in complying with the 
     recordkeeping requirements under such subsection.
       (i) Flexibility for Small Businesses.--Notwithstanding any 
     other provision of law, the regulations promulgated under 
     subsection (d) shall apply--
       (1) to small businesses (as defined by the Secretary in 
     section 103, not later than 90 days after the date of 
     enactment of this Act) beginning on the date that is 1 year 
     after the effective date of the final regulations promulgated 
     under subsection (d); and
       (2) to very small businesses (as defined by the Secretary 
     in section 103, not later than 90 days after the date of 
     enactment of this Act) beginning on the date that is 2 years 
     after the effective date of the final regulations promulgated 
     under subsection (d).
       (j) Enforcement.--
       (1) Prohibited acts.--Section 301(e) (21 U.S.C. 331(e)) is 
     amended by inserting ``; or the violation of any 
     recordkeeping requirement under section 204 of the FDA Food 
     Safety Modernization Act (except when such violation is 
     committed by a farm)'' before the period at the end.
       (2) Imports.--Section 801(a) (21 U.S.C. 381(a)) is amended 
     by inserting ``or (4) the recordkeeping requirements under 
     section 204 of the FDA Food Safety Modernization Act (other 
     than the requirements under subsection (f) of such section) 
     have not been complied with regarding such article,'' in the 
     third sentence before ``then such article shall be refused 
     admission''.

     SEC. 205. SURVEILLANCE.

       (a) Definition of Foodborne Illness Outbreak.--In this Act, 
     the term ``foodborne illness outbreak'' means the occurrence 
     of 2 or more cases of a similar illness resulting from the 
     ingestion of a certain food.
       (b) Foodborne Illness Surveillance Systems.--
       (1) In general.--The Secretary, acting through the Director 
     of the Centers for Disease Control and Prevention, shall 
     enhance foodborne illness surveillance systems to improve the 
     collection, analysis, reporting, and usefulness of data on 
     foodborne illnesses by--
       (A) coordinating Federal, State and local foodborne illness 
     surveillance systems, including complaint systems, and 
     increasing participation in national networks of public 
     health and food regulatory agencies and laboratories;
       (B) facilitating sharing of surveillance information on a 
     more timely basis among governmental agencies, including the 
     Food and Drug Administration, the Department of Agriculture, 
     the Department of Homeland Security, and State and local 
     agencies, and with the public;
       (C) developing improved epidemiological tools for obtaining 
     quality exposure data and microbiological methods for 
     classifying cases;
       (D) augmenting such systems to improve attribution of a 
     foodborne illness outbreak to a specific food;
       (E) expanding capacity of such systems, including working 
     toward automatic electronic searches, for implementation of 
     identification practices, including fingerprinting 
     strategies, for foodborne infectious agents, in order to 
     identify new or rarely documented causes of foodborne illness 
     and submit standardized information to a centralized 
     database;
       (F) allowing timely public access to aggregated, de-
     identified surveillance data;

[[Page 17989]]

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

     SEC. 206. MANDATORY RECALL AUTHORITY.

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

     ``SEC. 423. MANDATORY RECALL AUTHORITY.

       ``(a) Voluntary Procedures.--If the Secretary determines, 
     based on information gathered through the reportable food 
     registry under section 417 or through any other means, that 
     there is a reasonable probability that an article of food 
     (other than infant formula) is adulterated under section 402 
     or misbranded under section 403(w) and the use of or exposure 
     to such article will cause serious adverse health 
     consequences or death to humans or animals, the Secretary 
     shall provide the responsible party (as defined in section 
     417) with an opportunity to cease distribution and recall 
     such article.
       ``(b) Prehearing Order To Cease Distribution and Give 
     Notice.--
       ``(1) In general.--If the responsible party refuses to or 
     does not voluntarily cease distribution or recall such 
     article within the time and in the manner prescribed by the 
     Secretary (if so prescribed), the Secretary may, by order 
     require, as the Secretary deems necessary, such person to--
       ``(A) immediately cease distribution of such article; and
       ``(B) as applicable, immediately notify all persons--
       ``(i) manufacturing, processing, packing, transporting, 
     distributing, receiving, holding, or importing and selling 
     such article; and
       ``(ii) to which such article has been distributed, 
     transported, or sold, to immediately cease distribution of 
     such article.
       ``(2) Required additional information.--
       ``(A) In general.--If an article of food covered by a 
     recall order issued under paragraph (1)(B) has been 
     distributed to a warehouse-based third party logistics 
     provider without providing such provider sufficient 
     information to know or reasonably determine the precise 
     identity of the article of food covered by a recall order 
     that is in its possession, the notice provided by the 
     responsible party subject to the order issued under paragraph 
     (1)(B) shall include such information as is necessary for the 
     warehouse-based third party logistics provider to identify 
     the food.
       ``(B) Rules of construction.--Nothing in this paragraph 
     shall be construed--
       ``(i) to exempt a warehouse-based third party logistics 
     provider from the requirements of this Act, including the 
     requirements in this section and section 414; or
       ``(ii) to exempt a warehouse-based third party logistics 
     provider from being the subject of a mandatory recall order.
       ``(3) Determination to limit areas affected.--If the 
     Secretary requires a responsible party to cease distribution 
     under paragraph (1)(A) of an article of food identified in 
     subsection (a), the Secretary may limit the size of the 
     geographic area and the markets affected by such cessation if 
     such limitation would not compromise the public health.
       ``(c) Hearing on Order.--The Secretary shall provide the 
     responsible party subject to an order under subsection (b) 
     with an opportunity for an informal hearing, to be held as 
     soon as possible, but not later than 2 days after the 
     issuance of the order, on the actions required by the order 
     and on why the article that is the subject of the order 
     should not be recalled.
       ``(d) Post-hearing Recall Order and Modification of 
     Order.--
       ``(1) Amendment of order.--If, after providing opportunity 
     for an informal hearing under subsection (c), the Secretary 
     determines that removal of the article from commerce is 
     necessary, the Secretary shall, as appropriate--
       ``(A) amend the order to require recall of such article or 
     other appropriate action;
       ``(B) specify a timetable in which the recall shall occur;
       ``(C) require periodic reports to the Secretary describing 
     the progress of the recall; and
       ``(D) provide notice to consumers to whom such article was, 
     or may have been, distributed.
       ``(2) Vacating of order.--If, after such hearing, the 
     Secretary determines that adequate grounds do not exist to 
     continue the actions required by the order, or that such 
     actions should be modified, the Secretary shall vacate the 
     order or modify the order.
       ``(e) Rule Regarding Alcoholic Beverages.--The Secretary 
     shall not initiate a mandatory recall or take any other 
     action under this section with respect to any alcohol 
     beverage until the Secretary has provided the Alcohol and 
     Tobacco Tax and Trade Bureau with a reasonable opportunity to 
     cease distribution and recall such article under the Alcohol 
     and Tobacco Tax and Trade Bureau authority.
       ``(f) Cooperation and Consultation.--The Secretary shall 
     work with State and local public health officials in carrying 
     out this section, as appropriate.
       ``(g) Public Notification.--In conducting a recall under 
     this section, the Secretary shall--
       ``(1) ensure that a press release is published regarding 
     the recall, as well as alerts and public notices, as 
     appropriate, in order to provide notification--
       ``(A) of the recall to consumers and retailers to whom such 
     article was, or may have been, distributed; and
       ``(B) that includes, at a minimum--
       ``(i) the name of the article of food subject to the 
     recall;

[[Page 17990]]

       ``(ii) a description of the risk associated with such 
     article; and
       ``(iii) to the extent practicable, information for 
     consumers about similar articles of food that are not 
     affected by the recall;
       ``(2) consult the policies of the Department of Agriculture 
     regarding providing to the public a list of retail consignees 
     receiving products involved in a Class I recall and shall 
     consider providing such a list to the public, as determined 
     appropriate by the Secretary; and
       ``(3) if available, publish on the Internet Web site of the 
     Food and Drug Administration an image of the article that is 
     the subject of the press release described in (1).
       ``(h) No Delegation.--The authority conferred by this 
     section to order a recall or vacate a recall order shall not 
     be delegated to any officer or employee other than the 
     Commissioner.
       ``(i) Effect.--Nothing in this section shall affect the 
     authority of the Secretary to request or participate in a 
     voluntary recall, or to issue an order to cease distribution 
     or to recall under any other provision of this Act or under 
     the Public Health Service Act.
       ``(j) Coordinated Communication.--
       ``(1) In general.--To assist in carrying out the 
     requirements of this subsection, the Secretary shall 
     establish an incident command operation or a similar 
     operation within the Department of Health and Human Services 
     that will operate not later than 24 hours after the 
     initiation of a mandatory recall or the recall of an article 
     of food for which the use of, or exposure to, such article 
     will cause serious adverse health consequences or death to 
     humans or animals.
       ``(2) Requirements.--To reduce the potential for 
     miscommunication during recalls or regarding investigations 
     of a food borne illness outbreak associated with a food that 
     is subject to a recall, each incident command operation or 
     similar operation under paragraph (1) shall use regular staff 
     and resources of the Department of Health and Human Services 
     to--
       ``(A) ensure timely and coordinated communication within 
     the Department, including enhanced communication and 
     coordination between different agencies and organizations 
     within the Department;
       ``(B) ensure timely and coordinated communication from the 
     Department, including public statements, throughout the 
     duration of the investigation and related foodborne illness 
     outbreak;
       ``(C) identify a single point of contact within the 
     Department for public inquiries regarding any actions by the 
     Secretary related to a recall;
       ``(D) coordinate with Federal, State, local, and tribal 
     authorities, as appropriate, that have responsibilities 
     related to the recall of a food or a foodborne illness 
     outbreak associated with a food that is subject to the 
     recall, including notification of the Secretary of 
     Agriculture and the Secretary of Education in the event such 
     recalled food is a commodity intended for use in a child 
     nutrition program (as identified in section 25(b) of the 
     Richard B. Russell National School Lunch Act (42 U.S.C. 
     1769f(b)); and
       ``(E) conclude operations at such time as the Secretary 
     determines appropriate.
       ``(3) Multiple recalls.--The Secretary may establish 
     multiple or concurrent incident command operations or similar 
     operations in the event of multiple recalls or foodborne 
     illness outbreaks necessitating such action by the Department 
     of Health and Human Services.''.
       (b) Search Engine.--Not later than 90 days after the date 
     of enactment of this Act, the Secretary shall modify the 
     Internet Web site of the Food and Drug Administration to 
     include a search engine that--
       (1) is consumer-friendly, as determined by the Secretary; 
     and
       (2) provides a means by which an individual may locate 
     relevant information regarding each article of food subject 
     to a recall under section 423 of the Federal Food, Drug, and 
     Cosmetic Act and the status of such recall (such as whether a 
     recall is ongoing or has been completed).
       (c) Civil Penalty.--Section 303(f)(2)(A) (21 U.S.C. 
     333(f)(2)(A)) is amended by inserting ``or any person who 
     does not comply with a recall order under section 423'' after 
     ``section 402(a)(2)(B)''.
       (d) Prohibited Acts.--Section 301 (21 U.S.C. 331 et seq.), 
     as amended by section 106, is amended by adding at the end 
     the following:
       ``(xx) The refusal or failure to follow an order under 
     section 423.''.
       (e) GAO Review.--
       (1) In general.--Not later than 90 days after the date of 
     enactment of this Act, the Comptroller General of the United 
     States shall submit to Congress a report that--
       (A) identifies State and local agencies with the authority 
     to require the mandatory recall of food, and evaluates use of 
     such authority with regard to frequency, effectiveness, and 
     appropriateness, including consideration of any new or 
     existing mechanisms available to compensate persons for 
     general and specific recall-related costs when a recall is 
     subsequently determined by the relevant authority to have 
     been an error;
       (B) identifies Federal agencies, other than the Department 
     of Health and Human Services, with mandatory recall authority 
     and examines use of that authority with regard to frequency, 
     effectiveness, and appropriateness, including any new or 
     existing mechanisms available to compensate persons for 
     general and specific recall-related costs when a recall is 
     subsequently determined by the relevant agency to have been 
     an error;
       (C) considers models for farmer restitution implemented in 
     other nations in cases of erroneous recalls; and
       (D) makes recommendations to the Secretary regarding use of 
     the authority under section 423 of the Federal Food, Drug, 
     and Cosmetic Act (as added by this section) to protect the 
     public health while seeking to minimize unnecessary economic 
     costs.
       (2) Effect of review.--If the Comptroller General of the 
     United States finds, after the review conducted under 
     paragraph (1), that the mechanisms described in such 
     paragraph do not exist or are inadequate, then, not later 
     than 90 days after the conclusion of such review, the 
     Secretary of Agriculture shall conduct a study of the 
     feasibility of implementing a farmer indemnification program 
     to provide restitution to agricultural producers for losses 
     sustained as a result of a mandatory recall of an 
     agricultural commodity by a Federal or State regulatory 
     agency that is subsequently determined to be in error. The 
     Secretary of Agriculture shall submit to the Committee on 
     Agriculture of the House of Representatives and the Committee 
     on Agriculture, Nutrition, and Forestry of the Senate a 
     report that describes the results of the study, including any 
     recommendations.
       (f) Annual Report to Congress.--
       (1) In general.--Not later than 2 years after the date of 
     enactment of this Act and annually thereafter, the Secretary 
     of Health and Human Services (referred to in this subsection 
     as the ``Secretary'') shall submit a report to the Committee 
     on Health, Education, Labor, and Pensions of the Senate and 
     the Committee on Energy and Commerce of the House of 
     Representatives on the use of recall authority under section 
     423 of the Federal Food, Drug, and Cosmetic Act (as added by 
     subsection (a)) and any public health advisories issued by 
     the Secretary that advise against the consumption of an 
     article of food on the ground that the article of food is 
     adulterated and poses an imminent danger to health.
       (2) Content.--The report under paragraph (1) shall include, 
     with respect to the report year--
       (A) the identity of each article of food that was the 
     subject of a public health advisory described in paragraph 
     (1), an opportunity to cease distribution and recall under 
     subsection (a) of section 423 of the Federal Food, Drug, and 
     Cosmetic Act, or a mandatory recall order under subsection 
     (b) of such section;
       (B) the number of responsible parties, as defined in 
     section 417 of the Federal Food, Drug, and Cosmetic Act, 
     formally given the opportunity to cease distribution of an 
     article of food and recall such article, as described in 
     section 423(a) of such Act;
       (C) the number of responsible parties described in 
     subparagraph (B) who did not cease distribution of or recall 
     an article of food after given the opportunity to cease 
     distribution or recall under section 423(a) of the Federal 
     Food, Drug, and Cosmetic Act;
       (D) the number of recall orders issued under section 423(b) 
     of the Federal Food, Drug, and Cosmetic Act; and
       (E) a description of any instances in which there was no 
     testing that confirmed adulteration of an article of food 
     that was the subject of a recall under section 423(b) of the 
     Federal Food, Drug, and Cosmetic Act or a public health 
     advisory described in paragraph (1).

     SEC. 207. ADMINISTRATIVE DETENTION OF FOOD.

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

     SEC. 208. DECONTAMINATION AND DISPOSAL STANDARDS AND PLANS.

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

[[Page 17991]]

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

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

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

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

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

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

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

[[Page 17992]]

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

     SEC. 210. ENHANCING FOOD SAFETY.

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

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

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

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

       ``(a) In General.--Not later than 1 year after the date of 
     enactment of the FDA Food Safety Modernization Act, the 
     Secretary, acting through the Director of the Centers for 
     Disease Control and Prevention and in consultation with the 
     working group described in subsection (b)(2), shall designate 
     5 Integrated Food Safety Centers of Excellence (referred to 
     in this section as the `Centers of Excellence') to serve as 
     resources for Federal, State, and local public health 
     professionals to respond to foodborne illness outbreaks. The 
     Centers of Excellence shall be headquartered at selected 
     State health departments.
       ``(b) Selection of Centers of Excellence.--
       ``(1) Eligible entities.--To be eligible to be designated 
     as a Center of Excellence under subsection (a), an entity 
     shall--
       ``(A) be a State health department;
       ``(B) partner with 1 or more institutions of higher 
     education that have demonstrated knowledge, expertise, and 
     meaningful experience with regional or national food 
     production, processing, and distribution, as well as 
     leadership in the laboratory, epidemiological, and 
     environmental detection and investigation of foodborne 
     illness; and
       ``(C) provide to the Secretary such information, at such 
     time, and in such manner, as the Secretary may require.
       ``(2) Working group.--Not later than 180 days after the 
     date of enactment of the FDA Food Safety Modernization Act, 
     the Secretary shall establish a diverse working group of 
     experts and stakeholders from Federal, State, and local food 
     safety and health agencies, the food industry, including food 
     retailers and food manufacturers, consumer organizations, and 
     academia to make recommendations to the Secretary regarding 
     designations of the Centers of Excellence.
       ``(3) Additional centers of excellence.--The Secretary may 
     designate eligible entities to be regional Food Safety 
     Centers of Excellence, in addition to the 5 Centers 
     designated under subsection (a).
       ``(c) Activities.--Under the leadership of the Director of 
     the Centers for Disease Control and Prevention, each Center 
     of Excellence shall be based out of a selected State health 
     department, which shall provide assistance to other regional, 
     State, and local departments of health through activities 
     that include--
       ``(1) providing resources, including timely information 
     concerning symptoms and tests, for frontline health 
     professionals interviewing individuals as part of routine 
     surveillance and outbreak investigations;
       ``(2) providing analysis of the timeliness and 
     effectiveness of foodborne disease surveillance and outbreak 
     response activities;
       ``(3) providing training for epidemiological and 
     environmental investigation of foodborne illness, including 
     suggestions for streamlining and standardizing the 
     investigation process;
       ``(4) establishing fellowships, stipends, and scholarships 
     to train future epidemiological and food-safety leaders and 
     to address critical workforce shortages;
       ``(5) training and coordinating State and local personnel;
       ``(6) strengthening capacity to participate in existing or 
     new foodborne illness surveillance and environmental 
     assessment information systems; and
       ``(7) conducting research and outreach activities focused 
     on increasing prevention, communication, and education 
     regarding food safety.
       ``(d) Report to Congress.--Not later than 2 years after the 
     date of enactment of the FDA Food Safety Modernization Act, 
     the Secretary shall submit to Congress a report that--
       ``(1) describes the effectiveness of the Centers of 
     Excellence; and
       ``(2) provides legislative recommendations or describes 
     additional resources required by the Centers of Excellence.

[[Page 17993]]

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

     SEC. 211. IMPROVING THE REPORTABLE FOOD REGISTRY.

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

            TITLE III--IMPROVING THE SAFETY OF IMPORTED FOOD

     SEC. 301. FOREIGN SUPPLIER VERIFICATION PROGRAM.

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

     ``SEC. 805. FOREIGN SUPPLIER VERIFICATION PROGRAM.

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

     SEC. 302. VOLUNTARY QUALIFIED IMPORTER PROGRAM.

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

[[Page 17994]]



     ``SEC. 806. VOLUNTARY QUALIFIED IMPORTER PROGRAM.

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

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

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

     SEC. 304. PRIOR NOTICE OF IMPORTED FOOD SHIPMENTS.

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

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

       (a) In General.--The Secretary shall, not later than 2 
     years of the date of enactment of this Act, develop a 
     comprehensive plan to expand the technical, scientific, and 
     regulatory food safety capacity of foreign governments, and 
     their respective food industries, from which foods are 
     exported to the United States.
       (b) Consultation.--In developing the plan under subsection 
     (a), the Secretary shall consult with the Secretary of 
     Agriculture, Secretary of State, Secretary of the Treasury, 
     the Secretary of Homeland Security, the United States Trade 
     Representative, and the Secretary of Commerce, 
     representatives of the food industry, appropriate foreign 
     government officials, nongovernmental organizations that 
     represent the interests of consumers, and other stakeholders.
       (c) Plan.--The plan developed under subsection (a) shall 
     include, as appropriate, the following:
       (1) Recommendations for bilateral and multilateral 
     arrangements and agreements, including provisions to provide 
     for responsibility of exporting countries to ensure the 
     safety of food.
       (2) Provisions for secure electronic data sharing.
       (3) Provisions for mutual recognition of inspection 
     reports.

[[Page 17995]]

       (4) Training of foreign governments and food producers on 
     United States requirements for safe food.
       (5) Recommendations on whether and how to harmonize 
     requirements under the Codex Alimentarius.
       (6) Provisions for the multilateral acceptance of 
     laboratory methods and testing and detection techniques.
       (d) Rule of Construction.--Nothing in this section shall be 
     construed to affect the regulation of dietary supplements 
     under the Dietary Supplement Health and Education Act of 1994 
     (Public Law 103-417).

     SEC. 306. INSPECTION OF FOREIGN FOOD FACILITIES.

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

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

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

     SEC. 307. ACCREDITATION OF THIRD-PARTY AUDITORS.

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

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

       ``(a) Definitions.--In this section:
       ``(1) Audit agent.--The term `audit agent' means an 
     individual who is an employee or agent of an accredited 
     third-party auditor and, although not individually 
     accredited, is qualified to conduct food safety audits on 
     behalf of an accredited third-party auditor.
       ``(2) Accreditation body.--The term `accreditation body' 
     means an authority that performs accreditation of third-party 
     auditors.
       ``(3) Third-party auditor.--The term `third-party auditor' 
     means a foreign government, agency of a foreign government, 
     foreign cooperative, or any other third party, as the 
     Secretary determines appropriate in accordance with the model 
     standards described in subsection (b)(2), that is eligible to 
     be considered for accreditation to conduct food safety audits 
     to certify that eligible entities meet the applicable 
     requirements of this section. A third-party auditor may be a 
     single individual. A third-party auditor may employ or use 
     audit agents to help conduct consultative and regulatory 
     audits.
       ``(4) Accredited third-party auditor.--The term `accredited 
     third-party auditor' means a third-party auditor accredited 
     by an accreditation body to conduct audits of eligible 
     entities to certify that such eligible entities meet the 
     applicable requirements of this section. An accredited third-
     party auditor may be an individual who conducts food safety 
     audits to certify that eligible entities meet the applicable 
     requirements of this section.
       ``(5) Consultative audit.--The term `consultative audit' 
     means an audit of an eligible entity--
       ``(A) to determine whether such entity is in compliance 
     with the provisions of this Act and with applicable industry 
     standards and practices; and
       ``(B) the results of which are for internal purposes only.
       ``(6) Eligible entity.--The term `eligible entity' means a 
     foreign entity, including a foreign facility registered under 
     section 415, in the food import supply chain that chooses to 
     be audited by an accredited third-party auditor or the audit 
     agent of such accredited third-party auditor.
       ``(7) Regulatory audit.--The term `regulatory audit' means 
     an audit of an eligible entity--
       ``(A) to determine whether such entity is in compliance 
     with the provisions of this Act; and
       ``(B) the results of which determine--
       ``(i) whether an article of food manufactured, processed, 
     packed, or held by such entity is eligible to receive a food 
     certification under section 801(q); or
       ``(ii) whether a facility is eligible to receive a facility 
     certification under section 806(a) for purposes of 
     participating in the program under section 806.
       ``(b) Accreditation System.--
       ``(1) Accreditation bodies.--
       ``(A) Recognition of accreditation bodies.--
       ``(i) In general.--Not later than 2 years after the date of 
     enactment of the FDA Food Safety Modernization Act, the 
     Secretary shall establish a system for the recognition of 
     accreditation bodies that accredit third-party auditors to 
     certify that eligible entities meet the applicable 
     requirements of this section.
       ``(ii) Direct accreditation.--If, by the date that is 2 
     years after the date of establishment of the system described 
     in clause (i), the Secretary has not identified and 
     recognized an accreditation body to meet the requirements of 
     this section, the Secretary may directly accredit third-party 
     auditors.
       ``(B) Notification.--Each accreditation body recognized by 
     the Secretary shall submit to the Secretary a list of all 
     accredited third-party auditors accredited by such body and 
     the audit agents of such auditors.
       ``(C) Revocation of recognition as an accreditation body.--
     The Secretary shall promptly revoke the recognition of any 
     accreditation body found not to be in compliance with the 
     requirements of this section.
       ``(D) Reinstatement.--The Secretary shall establish 
     procedures to reinstate recognition of an accreditation body 
     if the Secretary determines, based on evidence presented by 
     such accreditation body, that revocation was inappropriate or 
     that the body meets the requirements for recognition under 
     this section.
       ``(2) Model accreditation standards.--Not later than 18 
     months after the date of enactment of the FDA Food Safety 
     Modernization Act, the Secretary shall develop model 
     standards, including requirements for regulatory audit 
     reports, and each recognized accreditation body shall ensure 
     that third-party auditors and audit agents of such auditors 
     meet such standards in order to qualify such third-party 
     auditors as accredited third-party auditors under this 
     section. In developing the model standards, the Secretary 
     shall look to standards in place on the date of the enactment 
     of this section for guidance, to avoid unnecessary 
     duplication of efforts and costs.
       ``(c) Third-party Auditors.--
       ``(1) Requirements for accreditation as a third-party 
     auditor.--
       ``(A) Foreign governments.--Prior to accrediting a foreign 
     government or an agency of a foreign government as an 
     accredited third-party auditor, the accreditation body (or, 
     in the case of direct accreditation under subsection 
     (b)(1)(A)(ii), the Secretary) shall perform such reviews and 
     audits of food safety programs, systems, and standards of the 
     government or agency of the government as the Secretary deems 
     necessary, including requirements under the model standards 
     developed under subsection (b)(2), to determine that the 
     foreign government or agency of the foreign government is 
     capable of adequately ensuring that eligible entities or 
     foods certified by such government or agency meet the 
     requirements of this Act with respect to food manufactured, 
     processed, packed, or held for import into the United States.
       ``(B) Foreign cooperatives and other third parties.--Prior 
     to accrediting a foreign cooperative that aggregates the 
     products of growers or processors, or any other third party 
     to be an accredited third-party auditor, the accreditation 
     body (or, in the case of direct accreditation under 
     subsection (b)(1)(A)(ii), the Secretary) shall perform such 
     reviews and audits of the training and qualifications of 
     audit agents used by that cooperative or party and conduct 
     such reviews of internal systems and such other investigation 
     of the cooperative or party as the Secretary deems necessary, 
     including requirements under the model standards developed 
     under subsection (b)(2), to determine

[[Page 17996]]

     that each eligible entity certified by the cooperative or 
     party has systems and standards in use to ensure that such 
     entity or food meets the requirements of this Act.
       ``(2) Requirement to issue certification of eligible 
     entities or foods.--
       ``(A) In general.--An accreditation body (or, in the case 
     of direct accreditation under subsection (b)(1)(A)(ii), the 
     Secretary) may not accredit a third-party auditor unless such 
     third-party auditor agrees to issue a written and, as 
     appropriate, electronic food certification, described in 
     section 801(q), or facility certification under section 
     806(a), as appropriate, to accompany each food shipment for 
     import into the United States from an eligible entity, 
     subject to requirements set forth by the Secretary. Such 
     written or electronic certification may be included with 
     other documentation regarding such food shipment. The 
     Secretary shall consider certifications under section 801(q) 
     and participation in the voluntary qualified importer program 
     described in section 806 when targeting inspection resources 
     under section 421.
       ``(B) Purpose of certification.--The Secretary shall use 
     certification provided by accredited third-party auditors 
     to--
       ``(i) determine, in conjunction with any other assurances 
     the Secretary may require under section 801(q), whether a 
     food satisfies the requirements of such section; and
       ``(ii) determine whether a facility is eligible to be a 
     facility from which food may be offered for import under the 
     voluntary qualified importer program under section 806.
       ``(C) Requirements for issuing certification.--
       ``(i) In general.--An accredited third-party auditor shall 
     issue a food certification under section 801(q) or a facility 
     certification described under subparagraph (B) only after 
     conducting a regulatory audit and such other activities that 
     may be necessary to establish compliance with the 
     requirements of such sections.
       ``(ii) Provision of certification.--Only an accredited 
     third-party auditor or the Secretary may provide a facility 
     certification under section 806(a). Only those parties 
     described in 801(q)(3) or the Secretary may provide a food 
     certification under 301(g).
       ``(3) Audit report submission requirements.--
       ``(A) Requirements in general.--As a condition of 
     accreditation, not later than 45 days after conducting an 
     audit, an accredited third-party auditor or audit agent of 
     such auditor shall prepare, and, in the case of a regulatory 
     audit, submit, the audit report for each audit conducted, in 
     a form and manner designated by the Secretary, which shall 
     include--
       ``(i) the identity of the persons at the audited eligible 
     entity responsible for compliance with food safety 
     requirements;
       ``(ii) the dates of the audit;
       ``(iii) the scope of the audit; and
       ``(iv) any other information required by the Secretary that 
     relates to or may influence an assessment of compliance with 
     this Act.
       ``(B) Records.--Following any accreditation of a third-
     party auditor, the Secretary may, at any time, require the 
     accredited third-party auditor to submit to the Secretary an 
     onsite audit report and such other reports or documents 
     required as part of the audit process, for any eligible 
     entity certified by the third-party auditor or audit agent of 
     such auditor. Such report may include documentation that the 
     eligible entity is in compliance with any applicable 
     registration requirements.
       ``(C) Limitation.--The requirement under subparagraph (B) 
     shall not include any report or other documents resulting 
     from a consultative audit by the accredited third-party 
     auditor, except that the Secretary may access the results of 
     a consultative audit in accordance with section 414.
       ``(4) Requirements of accredited third-party auditors and 
     audit agents of such auditors.--
       ``(A) Risks to public health.--If, at any time during an 
     audit, an accredited third-party auditor or audit agent of 
     such auditor discovers a condition that could cause or 
     contribute to a serious risk to the public health, such 
     auditor shall immediately notify the Secretary of--
       ``(i) the identification of the eligible entity subject to 
     the audit; and
       ``(ii) such condition.
       ``(B) Types of audits.--An accredited third-party auditor 
     or audit agent of such auditor may perform consultative and 
     regulatory audits of eligible entities.
       ``(C) Limitations.--
       ``(i) In general.--An accredited third party auditor may 
     not perform a regulatory audit of an eligible entity if such 
     agent has performed a consultative audit or a regulatory 
     audit of such eligible entity during the previous 13-month 
     period.
       ``(ii) Waiver.--The Secretary may waive the application of 
     clause (i) if the Secretary determines that there is 
     insufficient access to accredited third-party auditors in a 
     country or region.
       ``(5) Conflicts of interest.--
       ``(A) Third-party auditors.--An accredited third-party 
     auditor shall--
       ``(i) not be owned, managed, or controlled by any person 
     that owns or operates an eligible entity to be certified by 
     such auditor;
       ``(ii) in carrying out audits of eligible entities under 
     this section, have procedures to ensure against the use of 
     any officer or employee of such auditor that has a financial 
     conflict of interest regarding an eligible entity to be 
     certified by such auditor; and
       ``(iii) annually make available to the Secretary 
     disclosures of the extent to which such auditor and the 
     officers and employees of such auditor have maintained 
     compliance with clauses (i) and (ii) relating to financial 
     conflicts of interest.
       ``(B) Audit agents.--An audit agent shall--
       ``(i) not own or operate an eligible entity to be audited 
     by such agent;
       ``(ii) in carrying out audits of eligible entities under 
     this section, have procedures to ensure that such agent does 
     not have a financial conflict of interest regarding an 
     eligible entity to be audited by such agent; and
       ``(iii) annually make available to the Secretary 
     disclosures of the extent to which such agent has maintained 
     compliance with clauses (i) and (ii) relating to financial 
     conflicts of interest.
       ``(C) Regulations.--The Secretary shall promulgate 
     regulations not later than 18 months after the date of 
     enactment of the FDA Food Safety Modernization Act to 
     implement this section and to ensure that there are 
     protections against conflicts of interest between an 
     accredited third-party auditor and the eligible entity to be 
     certified by such auditor or audited by such audit agent. 
     Such regulations shall include--
       ``(i) requiring that audits performed under this section be 
     unannounced;
       ``(ii) a structure to decrease the potential for conflicts 
     of interest, including timing and public disclosure, for fees 
     paid by eligible entities to accredited third-party auditors; 
     and
       ``(iii) appropriate limits on financial affiliations 
     between an accredited third-party auditor or audit agents of 
     such auditor and any person that owns or operates an eligible 
     entity to be certified by such auditor, as described in 
     subparagraphs (A) and (B).
       ``(6) Withdrawal of accreditation.--
       ``(A) In general.--The Secretary shall withdraw 
     accreditation from an accredited third-party auditor--
       ``(i) if food certified under section 801(q) or from a 
     facility certified under paragraph (2)(B) by such third-party 
     auditor is linked to an outbreak of foodborne illness that 
     has a reasonable probability of causing serious adverse 
     health consequences or death in humans or animals;
       ``(ii) following an evaluation and finding by the Secretary 
     that the third-party auditor no longer meets the requirements 
     for accreditation; or
       ``(iii) following a refusal to allow United States 
     officials to conduct such audits and investigations as may be 
     necessary to ensure continued compliance with the 
     requirements set forth in this section.
       ``(B) Additional basis for withdrawal of accreditation.--
     The Secretary may withdraw accreditation from an accredited 
     third-party auditor in the case that such third-party auditor 
     is accredited by an accreditation body for which recognition 
     as an accreditation body under subsection (b)(1)(C) is 
     revoked, if the Secretary determines that there is good cause 
     for the withdrawal.
       ``(C) Exception.--The Secretary may waive the application 
     of subparagraph (A)(i) if the Secretary--
       ``(i) conducts an investigation of the material facts 
     related to the outbreak of human or animal illness; and
       ``(ii) reviews the steps or actions taken by the third 
     party auditor to justify the certification and determines 
     that the accredited third-party auditor satisfied the 
     requirements under section 801(q) of certifying the food, or 
     the requirements under paragraph (2)(B) of certifying the 
     entity.
       ``(7) Reaccreditation.--The Secretary shall establish 
     procedures to reinstate the accreditation of a third-party 
     auditor for which accreditation has been withdrawn under 
     paragraph (6)--
       ``(A) if the Secretary determines, based on evidence 
     presented, that the third-party auditor satisfies the 
     requirements of this section and adequate grounds for 
     revocation no longer exist; and
       ``(B) in the case of a third-party auditor accredited by an 
     accreditation body for which recognition as an accreditation 
     body under subsection (b)(1)(C) is revoked--
       ``(i) if the third-party auditor becomes accredited not 
     later than 1 year after revocation of accreditation under 
     paragraph (6)(A), through direct accreditation under 
     subsection (b)(1)(A)(ii) or by an accreditation body in good 
     standing; or
       ``(ii) under such conditions as the Secretary may require 
     for a third-party auditor under paragraph (6)(B).
       ``(8) Neutralizing costs.--The Secretary shall establish by 
     regulation a reimbursement (user fee) program, similar to the 
     method described in section 203(h) of the Agriculture 
     Marketing Act of 1946, by which the Secretary assesses fees 
     and requires accredited third-party auditors and audit agents 
     to reimburse the Food and Drug Administration for the work 
     performed to establish and administer the accreditation 
     system under this section. The Secretary shall make operating 
     this program revenue-neutral and shall not generate surplus 
     revenue

[[Page 17997]]

     from such a reimbursement mechanism. Fees authorized under 
     this paragraph shall be collected and available for 
     obligation only to the extent and in the amount provided in 
     advance in appropriation Acts. Such fees are authorized to 
     remain available until expended.
       ``(d) Recertification of Eligible Entities.--An eligible 
     entity shall apply for annual recertification by an 
     accredited third-party auditor if such entity--
       ``(1) intends to participate in voluntary qualified 
     importer program under section 806; or
       ``(2) is required to provide to the Secretary a 
     certification under section 801(q) for any food from such 
     entity.
       ``(e) False Statements.--Any statement or representation 
     made--
       ``(1) by an employee or agent of an eligible entity to an 
     accredited third-party auditor or audit agent; or
       ``(2) by an accredited third-party auditor to the 
     Secretary,

     shall be subject to section 1001 of title 18, United States 
     Code.
       ``(f) Monitoring.--To ensure compliance with the 
     requirements of this section, the Secretary shall--
       ``(1) periodically, or at least once every 4 years, 
     reevaluate the accreditation bodies described in subsection 
     (b)(1);
       ``(2) periodically, or at least once every 4 years, 
     evaluate the performance of each accredited third-party 
     auditor, through the review of regulatory audit reports by 
     such auditors, the compliance history as available of 
     eligible entities certified by such auditors, and any other 
     measures deemed necessary by the Secretary;
       ``(3) at any time, conduct an onsite audit of any eligible 
     entity certified by an accredited third-party auditor, with 
     or without the auditor present; and
       ``(4) take any other measures deemed necessary by the 
     Secretary.
       ``(g) Publicly Available Registry.--The Secretary shall 
     establish a publicly available registry of accreditation 
     bodies and of accredited third-party auditors, including the 
     name of, contact information for, and other information 
     deemed necessary by the Secretary about such bodies and 
     auditors.
       ``(h) Limitations.--
       ``(1) No effect on section 704 inspections.--The audits 
     performed under this section shall not be considered 
     inspections under section 704.
       ``(2) No effect on inspection authority.--Nothing in this 
     section affects the authority of the Secretary to inspect any 
     eligible entity pursuant to this Act.''.

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

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

     SEC. 309. SMUGGLED FOOD.

       (a) In General.--Not later than 180 days after the 
     enactment of this Act, the Secretary shall, in coordination 
     with the Secretary of Homeland Security, develop and 
     implement a strategy to better identify smuggled food and 
     prevent entry of such food into the United States.
       (b) Notification to Homeland Security.--Not later than 10 
     days after the Secretary identifies a smuggled food that the 
     Secretary believes would cause serious adverse health 
     consequences or death to humans or animals, the Secretary 
     shall provide to the Secretary of Homeland Security a 
     notification under section 417(n) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 350f(k)) describing the smuggled 
     food and, if available, the names of the individuals or 
     entities that attempted to import such food into the United 
     States.
       (c) Public Notification.--If the Secretary--
       (1) identifies a smuggled food;
       (2) reasonably believes exposure to the food would cause 
     serious adverse health consequences or death to humans or 
     animals; and
       (3) reasonably believes that the food has entered domestic 
     commerce and is likely to be consumed,

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

                   TITLE IV--MISCELLANEOUS PROVISIONS

     SEC. 401. FUNDING FOR FOOD SAFETY.

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

     SEC. 402. EMPLOYEE PROTECTIONS.

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

     ``SEC. 1012. EMPLOYEE PROTECTIONS.

       ``(a) In General.--No entity engaged in the manufacture, 
     processing, packing, transporting, distribution, reception, 
     holding, or importation of food may discharge an employee or 
     otherwise discriminate against an employee with respect to 
     compensation, terms, conditions, or privileges of employment 
     because the employee, whether at the employee's initiative or 
     in the ordinary course of the employee's duties (or any 
     person acting pursuant to a request of the employee)--
       ``(1) provided, caused to be provided, or is about to 
     provide or cause to be provided to the employer, the Federal 
     Government, or the attorney general of a State information 
     relating to any violation of, or any act or omission the 
     employee reasonably believes to be a violation of any 
     provision of this Act or any order, rule, regulation, 
     standard, or ban under this Act, or any order, rule, 
     regulation, standard, or ban under this Act;
       ``(2) testified or is about to testify in a proceeding 
     concerning such violation;
       ``(3) assisted or participated or is about to assist or 
     participate in such a proceeding; or
       ``(4) objected to, or refused to participate in, any 
     activity, policy, practice, or assigned task that the 
     employee (or other such person) reasonably believed to be in 
     violation of any provision of this Act, or any order, rule, 
     regulation, standard, or ban under this Act.
       ``(b) Process.--
       ``(1) In general.--A person who believes that he or she has 
     been discharged or otherwise discriminated against by any 
     person in violation of subsection (a) may, not later than 180 
     days after the date on which such violation occurs, file (or 
     have any person file on his or her behalf) a complaint with 
     the Secretary of Labor (referred to in this section as the 
     `Secretary') alleging such discharge or discrimination and 
     identifying the person responsible for such act. Upon receipt 
     of such a complaint, the Secretary shall notify, in writing, 
     the person named in the complaint of the filing of the 
     complaint, of the allegations contained in the complaint, of 
     the substance of evidence supporting the complaint, and of 
     the opportunities that will be afforded to such person under 
     paragraph (2).
       ``(2) Investigation.--
       ``(A) In general.--Not later than 60 days after the date of 
     receipt of a complaint filed under paragraph (1) and after 
     affording the complainant and the person named in the 
     complaint an opportunity to submit to the Secretary a written 
     response to the complaint and an opportunity to meet with a 
     representative of the Secretary to present statements from 
     witnesses, the Secretary shall initiate an investigation and 
     determine whether there is reasonable cause to believe that 
     the complaint has merit and notify, in writing, the 
     complainant and the person alleged to have committed a 
     violation of subsection (a) of the Secretary's findings.
       ``(B) Reasonable cause found; preliminary order.--If the 
     Secretary concludes that there is reasonable cause to believe 
     that

[[Page 17998]]

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

     SEC. 403. JURISDICTION; AUTHORITIES.

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

[[Page 17999]]

     amendments made by the Agricultural Marketing Agreement Act 
     of 1937; or
       (5) alter, impede, or affect the authority of the Secretary 
     of Homeland Security under the Homeland Security Act of 2002 
     (6 U.S.C. 101 et seq.) or any other statute, including any 
     authority related to securing the borders of the United 
     States, managing ports of entry, or agricultural import and 
     entry inspection activities.

     SEC. 404. COMPLIANCE WITH INTERNATIONAL AGREEMENTS.

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

     SEC. 405. DETERMINATION OF BUDGETARY EFFECTS.

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

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