[House Report 111-234]
[From the U.S. Government Publishing Office]


111th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES
 1st Session                                                    111-234

======================================================================



 
                  FOOD SAFETY ENHANCEMENT ACT OF 2009

                                _______
                                

 July 29, 2009.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

 Mr. Waxman, from the Committee on Energy and Commerce, submitted the 
                               following

                              R E P O R T

                        [To accompany H.R. 2749]

      [Including cost estimate of the Congressional Budget Office]

  The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 2749) to amend the Federal Food, Drug, and 
Cosmetic Act to improve the safety of food in the global 
market, and for other purposes, having considered the same, 
report favorably thereon with an amendment and recommend that 
the bill as amended do pass.

                                CONTENTS

                                                                   Page
Purpose and Summary..............................................    35
Background and Need for Legislation..............................    36
Legislative History..............................................    36
Committee Consideration..........................................    36
Committee Votes..................................................    37
Committee Oversight Findings and Recommendations.................    37
New Budget Authority, Entitlement Authority, and Tax Expenditures    37
Statement of General Performance Goals and Objectives............    37
Constitutional Authority Statement...............................    37
Earmarks and Tax and Tariff Benefits.............................    37
Advisory Committee Statement.....................................    38
Applicability of Law to Legislative Branch.......................    38
Federal Mandates Statement.......................................    38
Committee Cost Estimate..........................................    38
Congressional Budget Office Estimate.............................    38
Section-by-Section Analysis of the Legislation...................    43
Explanation of Amendments........................................    57
Changes in Existing Law Made by the Bill, as Reported............    58

    The amendment is as follows:
    Strike all after the enacting clause and insert the 
following:

SECTION 1. SHORT TITLE.

  This Act may be cited as the ``Food Safety Enhancement Act of 2009''.

SEC. 2. TABLE OF CONTENTS.

  The table of contents of this Act is as follows:

Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. References.
Sec. 4. Rules of construction.
Sec. 5. USDA exemptions.
Sec. 6. Alcohol-related facilities.

                          TITLE I--FOOD SAFETY

                         Subtitle A--Prevention

Sec. 101. Changes in registration of food facilities.
Sec. 102. Hazard analysis, risk-based preventive controls, food safety 
plan, finished product test results from category 1 facilities.
Sec. 103. Performance standards.
Sec. 104. Safety standards for produce and certain other raw 
agricultural commodities.
Sec. 105. Risk-based inspection schedule.
Sec. 106. Access to records.
Sec. 107. Traceability of food.
Sec. 108. Reinspection and food recall fees applicable to facilities.
Sec. 109. Certification and accreditation.
Sec. 110. Testing by accredited laboratories.
Sec. 111. Notification, nondistribution, and recall of adulterated or 
misbranded food.
Sec. 112. Reportable food registry; exchange of information.
Sec. 113. Safe and secure food importation program.
Sec. 114. Infant formula.

                        Subtitle B--Intervention

Sec. 121. Surveillance.
Sec. 122. Public education and advisory system.
Sec. 123. Research.

                          Subtitle C--Response

Sec. 131. Procedures for seizure.
Sec. 132. Administrative detention.
Sec. 133. Quarantine authority for foods.
Sec. 134. Criminal penalties.
Sec. 135. Civil penalties for violations relating to food.
Sec. 136. Improper import entry filings.

                        TITLE II--MISCELLANEOUS

Sec. 201. Food substances generally recognized as safe.
Sec. 202. Country of origin labeling; disclosure of source of 
ingredients.
Sec. 203. Exportation certificate program.
Sec. 204. Registration for commercial importers of food; fee.
Sec. 205. Registration for customs brokers and filers; fee.
Sec. 206. Unique identification number for food facilities, importers, 
custom brokers, and filers.
Sec. 207. Prohibition against delaying, limiting, or refusing 
inspection.
Sec. 208. Dedicated foreign inspectorate.
Sec. 209. Plan and review of continued operation of field laboratories.
Sec. 210. False or misleading reporting to FDA.
Sec. 211. Subpoena authority.
Sec. 212. Whistleblower protections.
Sec. 213. Extraterritorial jurisdiction.
Sec. 214. Support for training institutes.
Sec. 215. Bisphenol A in food and beverage containers.

SEC. 3. 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.).

SEC. 4. RULES OF CONSTRUCTION.

  (a) Nothing in this Act or any amendment made by this Act shall be 
construed to prohibit or limit--
          (1) any cause of action under State law; or
          (2) the introduction of evidence of compliance or 
        noncompliance with the requirements of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 301 et seq.).
  (b) Nothing in this Act or any amendment made by this Act shall be 
construed to--
          (1) alter the jurisdiction between the Secretary of 
        Agriculture and the Secretary of Health and Human Services, 
        under applicable statutes and regulations;
          (2) limit the authority of the Secretary of Health and Human 
        Services to issue regulations related to the safety of food 
        under--
                  (A) the Federal Food, Drug, and Cosmetic Act (21 
                U.S.C. 301 et seq.) as in effect on the day before the 
                date of the 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 the 
                enactment of this Act; or
          (3) impede, minimize, or affect the authority of the 
        Secretary of Agriculture to prevent, control, or mitigate a 
        plant or animal health emergency, or a food emergency involving 
        products regulated under the Federal Meat Inspection Act (21 
        U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 
        U.S.C. 451 et seq.), or the Egg Products Inspection Act (21 
        U.S.C. 1031 et seq.).

SEC. 5. USDA EXEMPTIONS.

  (a) USDA-regulated Products.--Food is exempt from the requirements of 
this Act if such food is regulated by the Secretary of Agriculture 
under the Federal Meat Inspection Act, the Poultry Products Inspection 
Act, or the Egg Products Inspection Act.
  (b) USDA-regulated Facilities.--A facility is exempt from the 
requirements of this Act if such facility is regulated exclusively as 
an official establishment by the Secretary of Agriculture under the 
Federal Meat Inspection Act, the Poultry Products Inspection Act, or 
the Egg Products Inspection Act.
  (c) Farms.--A farm is exempt from the requirements of this Act to the 
extent such farm raises animals from which food is derived that is 
regulated under the Federal Meat Inspection Act, the Poultry Products 
Inspection Act, or the Egg Products Inspection Act.

SEC. 6. ALCOHOL-RELATED FACILITIES.

  (a) In General.--With the exception of the amendments made by section 
101(a) and (b) and section 113 of this Act, 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 or chapter 
        51 of subtitle E of the Internal Revenue Code, 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, as amended by this Act, is required to register as a 
        facility solely because such facility is engaged in 
        manufacturing, processing, packing, or holding 1 or more 
        alcoholic beverages.
  (b) Rule of Construction.--This section shall not be construed to 
exempt any food, apart from distilled spirits, wine, and malt 
beverages, as defined in section 211 of the Federal Alcohol 
Administration Act, from the requirements of this Act and the 
amendments made by this Act.

                          TITLE I--FOOD SAFETY

                         Subtitle A--Prevention

SEC. 101. CHANGES IN REGISTRATION OF FOOD FACILITIES.

  (a) Misbranding.--Section 403 (21 U.S.C. 343) is amended by adding at 
the end the following:
  ``(z) If it was manufactured, processed, packed, or held in a 
facility that is not duly registered under section 415, including a 
facility whose registration is canceled or suspended under such 
section.''.
  (b) Annual Registration.--
          (1) In general.--Section 415(a) (21 U.S.C. 350d(a)) is 
        amended--
                  (A) in the first sentence of paragraph (1)--
                          (i) by striking ``require that'' and 
                        inserting ``require that, on or before December 
                        31 of each year,''; and
                          (ii) by striking ``food for consumption in 
                        the United States'' and inserting ``food for 
                        consumption in the United States or for export 
                        from the United States'';
                  (B) in subparagraphs (A) and (B) of paragraph (1), by 
                inserting ``and pay the registration fee required under 
                section 743'' after ``submit a registration to the 
                Secretary'' each place it appears;
                  (C) in the first sentence of paragraph (2), by 
                inserting ``in electronic format'' after ``submit''; 
                and
                  (D) in paragraph (4), by inserting after the first 
                sentence the following: ``The Secretary shall remove 
                from such list the name of any facility that fails to 
                reregister in accordance with this section, that fails 
                to pay the registration fee required under section 743, 
                or whose registration is canceled by the registrant, 
                canceled by the Secretary in accordance with this 
                section, or suspended by the Secretary in accordance 
                with this section.''.
          (2) Contents of registration.--Paragraph (2) of section 
        415(a) (21 U.S.C. 350d(a)), as amended by paragraph (1), is 
        amended by striking ``containing information'' and all that 
        follows and inserting the following: ``containing information 
        that identifies the following:
                  ``(A) The name, address, and emergency contact 
                information of the facility being registered.
                  ``(B) The primary purpose and business activity of 
                the facility, including the dates of operation if the 
                facility is seasonal.
                  ``(C) The general food category (as defined by the 
                Secretary by guidance) of each food manufactured, 
                processed, packed, or held at the facility.
                  ``(D) All trade names under which the facility 
                conducts business related to food.
                  ``(E) The name, address, and 24-hour emergency 
                contact information of the United States distribution 
                agent for the facility, which agent shall have access 
                to the information required to be maintained under 
                section 414(d) for food that is manufactured, 
                processed, packed, or held at the facility.
                  ``(F) If the facility is located outside of the 
                United States, the name, address, and emergency contact 
                information for a United States agent.
                  ``(G) The unique facility identifier of the facility, 
                as specified under section 911.
                  ``(H) Such additional information pertaining to the 
                facility as the Secretary may require by regulation.
        The registrant shall notify the Secretary of any change in the 
        submitted information not later than 30 days after the date of 
        such change, unless otherwise specified by the Secretary.''.
          (3) Suspension and cancellation authority.--Section 415(a) 
        (21 U.S.C. 350d(a)), as amended by paragraphs (1) and (2), is 
        further amended by adding at the end the following:
          ``(5) Suspension of registration.--
                  ``(A) In general.--The Secretary may suspend the 
                registration of any facility registered under this 
                section for a violation of this Act that could result 
                in serious adverse health consequences or death to 
                humans or animals.
                  ``(B) Notice of suspension.--Suspension of a 
                registration shall be preceded by--
                          ``(i) notice to the facility of the intent to 
                        suspend the registration; and
                          ``(ii) an opportunity for an informal 
                        hearing, as defined in guidance or regulations 
                        issued by the Secretary, concerning the 
                        suspension of such registration for such 
                        facility.
                  ``(C) Request.--The owner, operator, or agent in 
                charge of a facility whose registration is suspended 
                may request that the Secretary vacate the suspension of 
                registration when such owner, operator, or agent has 
                corrected the violation that is the basis for such 
                suspension.
                  ``(D) Vacating of suspension.--If, based on an 
                inspection of the facility or other information, the 
                Secretary determines that adequate reasons do not exist 
                to continue the suspension of a registration, the 
                Secretary shall vacate such suspension.
          ``(6) Cancellation of registration.--
                  ``(A) In general.--Not earlier than 10 days after 
                providing the notice under subparagraph (B), the 
                Secretary may cancel a registration if the Secretary 
                determines that--
                          ``(i) the registration was not updated in 
                        accordance with this section or otherwise 
                        contains false, incomplete, or inaccurate 
                        information; or
                          ``(ii) the required registration fee has not 
                        been paid within 30 days after the date due.
                  ``(B) Notice of cancellation.--Cancellation shall be 
                preceded by notice to the facility of the intent to 
                cancel the registration and the basis for such 
                cancellation.
                  ``(C) Timely update or correction.--If the 
                registration for the facility is updated or corrected 
                no later than 7 days after notice is provided under 
                subparagraph (B), the Secretary shall not cancel such 
                registration.
          ``(7) Report to congress.--Not later than March 30th of each 
        year, the Secretary shall submit to the Congress a report, 
        based on the registrations on or before December 31 of the 
        previous year, on the following:
                  ``(A) The number of facilities registered under this 
                section.
                  ``(B) The number of such facilities that are 
                domestic.
                  ``(C) The number of such facilities that are foreign.
                  ``(D) The number of such facilities that are high-
                risk.
                  ``(E) The number of such facilities that are low-
                risk.
                  ``(F) The number of such facilities that hold food.
          ``(8) Limitation on delegation.--The authority conferred by 
        this subsection to issue an order to suspend a registration or 
        cancel a registration shall not be delegated to any officer or 
        employee other than the Commissioner of Food and Drugs, the 
        Principal Deputy Commissioner, the Associate Commissioner for 
        Regulatory Affairs, or the Director for the Center for Food 
        Safety and Applied Nutrition, of the Food and Drug 
        Administration.''.
  (c) Registration Fee.--Chapter VII (21 U.S.C. 371 et seq.) is amended 
by adding at the end of subchapter C the following:

                    ``PART 6--FEES RELATING TO FOOD

``SEC. 743. FACILITY REGISTRATION FEE.

  ``(a) In General.--
          ``(1) Assessment and collection.--Beginning in fiscal year 
        2010, the Secretary shall assess and collect an annual fee for 
        the registration of a facility under section 415.
          ``(2) Payable date.--A fee under this section shall be 
        payable--
                  ``(A) for a facility that was not registered under 
                section 415 for the preceding fiscal year, on the date 
                of registration; and
                  ``(B) for any other facility--
                          ``(i) for fiscal year 2010, not later than 
                        the sooner of 90 days after the date of the 
                        enactment of this part or December 31, 2009; 
                        and
                          ``(ii) for a subsequent fiscal year, not 
                        later than December 31 of such fiscal year.
  ``(b) Fee Amounts.--
          ``(1) In general.--The registration fee under subsection (a) 
        shall be--
                  ``(A) for fiscal year 2010, $500; and
                  ``(B) for fiscal year 2011 and each subsequent fiscal 
                year, the fee for fiscal year 2010 as adjusted under 
                subsection (c).
          ``(2) Annual fee setting.--The Secretary shall, not later 
        than 60 days before the start of fiscal year 2011 and each 
        subsequent fiscal year, establish, for the next fiscal year, 
        registration fees under subsection (a), as described in 
        paragraph (1).
          ``(3) Maximum amount.--Notwithstanding paragraph (1), a 
        person who owns or operates multiple facilities for which a fee 
        must be paid under this section for a fiscal year shall be 
        liable for not more than $175,000 in aggregate fees under this 
        section for such fiscal year.
  ``(c) Inflation Adjustment.--For fiscal year 2011 and each subsequent 
fiscal year, the fee amount under subsection (b)(1) shall be adjusted 
by the Secretary by notice, published in the Federal Register, to 
reflect the greater of--
          ``(1) the total percentage change that occurred in the 
        Consumer Price Index for all urban consumers (all items; U.S. 
        city average) for the 12-month period ending June 30 preceding 
        the fiscal year for which fees are being established;
          ``(2) the total percentage change for the previous fiscal 
        year in basic pay under the General Schedule in accordance with 
        section 5332 of title 5, United States Code, as adjusted by any 
        locality-based comparability payment pursuant to section 5304 
        of such title for Federal employees stationed in the District 
        of Columbia; or
          ``(3) the average annual change in the cost, per full-time 
        equivalent position of the Food and Drug Administration, of all 
        personnel compensation and benefits paid with respect to such 
        positions for the first 5 years of the preceding 6 fiscal 
        years.
The adjustment made each fiscal year under this subsection shall be 
added on a compounded basis to the sum of all adjustments made each 
fiscal year after fiscal year 2010 under this subsection.
  ``(d) Limitations.--
          ``(1) In general.--Fees under subsection (a) shall be 
        refunded for a fiscal year beginning after fiscal year 2010 
        unless appropriations for salaries and expenses of the Food and 
        Drug Administration for such fiscal year (excluding the amount 
        of fees appropriated for such fiscal year) are equal to or 
        greater than the amount of appropriations for the salaries and 
        expenses of the Food and Drug Administration for fiscal year 
        2010 (excluding the amount of fees appropriated for such fiscal 
        year) multiplied by the adjustment factor applicable to the 
        fiscal year involved.
          ``(2) Authority.--If the Secretary does not assess fees under 
        subsection (a) during any portion of a fiscal year because of 
        paragraph (1) and if at a later date in such fiscal year the 
        Secretary may assess such fees, the Secretary may assess and 
        collect such fees, without any modification in the rate, for 
        registration under section 415 at any time in such fiscal year.
          ``(3) Adjustment factor.--In this subsection, the term 
        `adjustment factor' applicable to a fiscal year is the Consumer 
        Price Index for all urban consumers (all items; United States 
        city average) for October of the preceding fiscal year divided 
        by such Index for October 2009.
  ``(e) Crediting and Availability of Fees.--
          ``(1) In general.--Fees authorized under subsection (a) shall 
        be collected and available for obligation only to the extent 
        and in the amount provided in advance 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 appropriation 
        account without fiscal year limitation to such appropriation 
        account for salaries and expenses with such fiscal year 
        limitation.
          ``(2) Collections and appropriations acts.--The fees 
        authorized by this section--
                  ``(A) shall be retained in each fiscal year in an 
                amount not to exceed the amount specified in 
                appropriation Acts, or otherwise made available for 
                obligation, for such fiscal year; and
                  ``(B) shall only be collected and available to defray 
                the costs of food safety activities.
          ``(3) Authorization of appropriations.--For each of fiscal 
        years 2010 through 2014, there are authorized to be 
        appropriated for fees under this section such sums as may be 
        necessary.
          ``(4) Public meetings.--For each fiscal year, the Secretary 
        shall hold a public meeting on how fees collected under this 
        section will be used to defray the costs of food safety 
        activities in order to solicit the views of the regulated 
        industry, consumers, and other interested stakeholders.
  ``(f) Collection of Unpaid Fees.--In any case where the Secretary 
does not receive payment of a fee assessed under subsection (a) within 
30 days after it is due, such fee shall be treated as a claim of the 
United States Government subject to subchapter II of chapter 37 of 
title 31, United States Code.
  ``(g) Construction.--This section may not be construed to require 
that the number of full-time equivalent positions in the Department of 
Health and Human Services, for officers, employees, and advisory 
committees not engaged in food safety activities, be reduced to offset 
the number of officers, employees, and advisory committees so engaged.
  ``(h) Annual Fiscal Reports.--Beginning with fiscal year 2011, not 
later than 120 days after the end of each fiscal year for which fees 
are collected under this section, the Secretary shall prepare and 
submit to the Committee on Energy and Commerce of the House of 
Representatives and the Committee on Health, Education, Labor, and 
Pensions of the Senate a report on the implementation of the authority 
for such fees during such fiscal year and the use, by the Food and Drug 
Administration, of the fees collected for such fiscal year.
  ``(i) Definitions.--In this section:
          ``(1) The term `costs of food safety activities' means the 
        expenses incurred in connection with food safety activities 
        for--
                  ``(A) officers and employees of the Food and Drug 
                Administration, contractors of the Food and Drug 
                Administration, advisory committees, and costs related 
                to such officers, employees, and committees and to 
                contracts with such contractors;
                  ``(B) laboratory capacity;
                  ``(C) management of information, and the acquisition, 
                maintenance, and repair of technology resources;
                  ``(D) leasing, maintenance, renovation, and repair of 
                facilities and acquisition, maintenance, and repair of 
                fixtures, furniture, scientific equipment, and other 
                necessary materials and supplies; and
                  ``(E) collecting fees under this section and 
                accounting for resources allocated for food safety 
                activities.
          ``(2) The term `food safety activities' means activities 
        related to compliance by facilities registered under section 
        415 with the requirements of this Act relating to food 
        (including research related to and the development of standards 
        (such as performance standards and preventive controls), risk 
        assessments, hazard analyses, inspection planning and 
        inspections, third-party inspections, compliance review and 
        enforcement, import review, information technology support, 
        test development, product sampling, risk communication, and 
        administrative detention).''.
  (d) Transitional Provisions.--
          (1) Fees.--The Secretary of Health and Human Services shall 
        first impose the fee established under section 743 of the 
        Federal Food, Drug, and Cosmetic Act, as added by subsection 
        (c), for fiscal years beginning with fiscal year 2010.
          (2) Modification of registration form.--Not later than 180 
        days after the date of the enactment of this Act, the Secretary 
        of Health and Human Services shall modify the registration form 
        under section 415 of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 350d) to comply with the amendments made by this 
        section.
          (3) Application.--The amendments made by this section, other 
        than subsections (b)(2) and (c), shall take effect on the date 
        that is 30 days after the date on which such modified 
        registration form takes effect, but not later than 210 days 
        after the date of the enactment of this Act.
          (4) Sunset date.--Section 743 of the Federal Food, Drug, and 
        Cosmetic Act, as added by subsection (c), does not authorize 
        the assessment or collection of a fee for registration under 
        section 415 of such Act (21 U.S.C. 360) occurring after fiscal 
        year 2014.

SEC. 102. HAZARD ANALYSIS, RISK-BASED PREVENTIVE CONTROLS, FOOD SAFETY 
                    PLAN, FINISHED PRODUCT TEST RESULTS FROM CATEGORY 1 
                    FACILITIES.

  (a) Hazard Analysis, Risk-based Preventive Controls, Food Safety 
Plan.--
          (1) Adulterated food.--Section 402 (21 U.S.C. 342) is amended 
        by adding at the end the following:
  ``(j) If it has been manufactured, processed, packed, transported, or 
held under conditions that do not meet the requirements of sections 418 
and 418A.''.
          (2) Requirements.--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 of a facility shall, 
in accordance with this section--
          ``(1) conduct a hazard analysis (or more than one if 
        appropriate);
          ``(2) identify, implement, and validate effective preventive 
        controls;
          ``(3) monitor preventive controls;
          ``(4) institute corrective actions when--
                  ``(A) monitoring shows that preventive controls have 
                not been properly implemented; or
                  ``(B) monitoring and verification show that such 
                controls were ineffective;
          ``(5) conduct verification activities;
          ``(6) maintain records of monitoring, corrective action, and 
        verification; and
          ``(7) reanalyze for hazards.
  ``(b) Identification of Hazards.--
          ``(1) In general.--The owner, operator, or agent of a 
        facility shall evaluate whether there are any hazards, 
        including hazards due to the source of the ingredients, that 
        are reasonably likely to occur in the absence of preventive 
        controls that may affect the safety, wholesomeness, or 
        sanitation of the food manufactured, processed, packed, 
        transported, or held by the facility, including--
                  ``(A) biological, chemical, physical, and 
                radiological hazards, natural toxins, pesticides, drug 
                residues, filth, decomposition, parasites, allergens, 
                and unapproved food and color additives; and
                  ``(B) hazards that occur naturally, may be 
                unintentionally introduced, or may be intentionally 
                introduced, including by acts of terrorism.
          ``(2) Identified by the secretary.--The Secretary may, by 
        regulation or guidance, identify hazards that are reasonably 
        likely to occur in the absence of preventive controls.
          ``(3) Hazard analysis.--The owner, operator, or agent of a 
        facility shall identify and describe the hazards evaluated 
        under paragraph (1) or identified under paragraph (2), to the 
        extent applicable to the facility, in a hazard analysis.
  ``(c) Preventive Controls.--
          ``(1) In general.--The owner, operator, or agent of a 
        facility shall identify, implement, and validate effective 
        preventive controls to prevent, eliminate, or reduce to 
        acceptable levels the occurrence of any hazards identified in 
        the hazard analysis under subsection (b)(3).
          ``(2) Identified by the secretary.--
                  ``(A) Establishment.--The Secretary may establish by 
                regulation or guidance preventive controls for specific 
                product types to prevent intentional or unintentional 
                contamination throughout the supply chain. The owner, 
                operator, or agent of a facility shall implement any 
                preventive controls identified by the Secretary under 
                this paragraph.
                  ``(B) Alternative controls.--Such regulation or 
                guidance shall allow the owner, operator, or agent of a 
                facility to implement an alternative preventive control 
                to one established by the Secretary, provided that, in 
                response to a request by the Secretary, the owner, 
                operator, or agent can present to the Secretary data or 
                other information sufficient to demonstrate that the 
                alternative control effectively addresses the hazard, 
                including meeting any applicable performance standard.
                  ``(C) Limitation.--Subparagraph (B) shall not apply 
                to any preventive control described in subparagraph 
                (A), (B), or (E) of subsection (i)(2).
  ``(d) Monitoring.--The owner, operator, or agent of a facility shall 
monitor the implementation of preventive controls under subsection (c) 
to identify any circumstances in which the preventive controls are not 
fully implemented or verification shows that such controls were 
ineffective.
  ``(e) Corrective Actions.--The owner, operator, or agent of a 
facility shall establish and implement procedures to ensure that, if 
the preventive controls under subsection (c) are not fully implemented 
or are not effective--
          ``(1) no product from such facility enters commerce; and
          ``(2) appropriate action is taken to reduce the likelihood of 
        recurrence of the implementation failure.
  ``(f) Verification.--The owner, operator, or agent of a facility 
shall ensure that--
          ``(1) the preventive controls identified under subsection (c) 
        have been validated as adequate to control the hazards 
        identified in the hazard analysis under subsection (b)(3);
          ``(2) the facility is conducting monitoring in accordance 
        with subsection (d);
          ``(3) the facility is taking effective corrective actions 
        under subsection (e); and
          ``(4) the preventive controls are effectively preventing, 
        eliminating, or reducing to an acceptable level the occurrence 
        of identified hazards, including through the use of 
        environmental and product testing programs and other 
        appropriate means.
  ``(g) Requirement to Reanalyze and Revise.--
          ``(1) Requirement.--The owner, operator, or agent of a 
        facility shall--
                  ``(A) review the evaluation under subsection (b) for 
                the facility and, as necessary, revise the hazard 
                analysis under subsection (b)(3) for the facility--
                          ``(i) not less than every 2 years;
                          ``(ii) if there is a change in the process or 
                        product that could affect the hazard analysis; 
                        and
                          ``(iii) if the Secretary determines that it 
                        is appropriate to protect public health; and
                  ``(B) whenever there is a change in the hazard 
                analysis, revise the preventive controls under 
                subsection (c) for the facility as necessary to ensure 
                that all hazards that are reasonably likely to occur 
                are prevented, eliminated, or reduced to an acceptable 
                level, or document the basis for the conclusion that no 
                such revision is needed.
          ``(2) Nondelegation.--Any revisions ordered by the Secretary 
        under this subsection shall be ordered by the Secretary or an 
        official designated by the Secretary. An official may not be so 
        designated unless the official is the director of the district 
        under this Act in which the article involved is located, or is 
        an official senior to such director.
  ``(h) Recordkeeping.--The owner, operator, or agent of a facility 
shall maintain, for not less than 2 years, records documenting the 
activities described in subsections (a) through (g).
  ``(i) Definitions.--For purposes of this section:
          ``(1) Facility.--The term `facility' means a domestic 
        facility or a foreign facility that is required to be 
        registered under section 415.
          ``(2) Preventive controls.--The term `preventive controls' 
        means those risk-based procedures, practices, and processes 
        that a person knowledgeable about the safe manufacturing, 
        processing, packing, transporting, or holding of food would 
        employ to prevent, eliminate, or reduce to an acceptable level 
        the hazards identified in the hazard analysis under subsection 
        (b)(3) and that are consistent with the current scientific 
        understanding of safe food manufacturing, processing, packing, 
        transporting, or holding at the time of the analysis. Those 
        procedures, practices, and processes shall include the 
        following, as appropriate:
                  ``(A) Sanitation procedures and practices.
                  ``(B) Supervisor, manager, and employee hygiene 
                training.
                  ``(C) Process controls.
                  ``(D) An allergen control program to minimize 
                potential allergic reactions in humans from ingestion 
                of, or contact with, human and animal food.
                  ``(E) Good manufacturing practices.
                  ``(F) Verification procedures, practices, and 
                processes for suppliers and incoming ingredients, which 
                may include onsite auditing of suppliers and testing of 
                incoming ingredients.
                  ``(G) Other procedures, practices, and processes 
                established by the Secretary under subsection (c)(2).
          ``(3) Hazard that is reasonably likely to occur.--A food 
        safety hazard that is reasonably likely to occur is one for 
        which a prudent person who, as applicable, manufactures, 
        processes, packs, transports, or holds food, would establish 
        controls because experience, illness data, scientific reports, 
        or other information provides a basis to conclude that there is 
        a reasonable possibility that the hazard will occur in the type 
        of food being manufactured, processed, packed, transported, or 
        held in the absence of those controls.

``SEC. 418A. FOOD SAFETY PLAN.

  ``(a) In General.--Before a facility (as defined in section 418(i)) 
introduces or delivers for introduction into interstate commerce any 
shipment of food, the owner, operator, or agent of the facility shall 
develop and implement a written food safety plan (in this section 
referred to as a `food safety plan').
  ``(b) Contents.--The food safety plan shall include each of the 
following elements:
          ``(1) The hazard analysis and any reanalysis conducted under 
        section 418.
          ``(2) A description of the preventive controls being 
        implemented under subsection 418(c), including those to address 
        hazards or conditions identified by the Secretary under 
        subsection 418(b)(2).
          ``(3) A description of the procedures for monitoring 
        preventive controls.
          ``(4) A description of the procedures for taking corrective 
        actions.
          ``(5) A description of verification activities for the 
        preventive controls, including validation, review of monitoring 
        and corrective action records, and procedures for determining 
        whether the preventive controls are effectively preventing, 
        eliminating, or reducing to an acceptable level the occurrence 
        of identified hazards or conditions, including the use of 
        environmental and product testing programs.
          ``(6) A description of the facility's recordkeeping 
        procedures.
          ``(7) A description of the facility's procedures for the 
        recall of articles of food, whether voluntarily or when 
        required under section 422.
          ``(8) A description of the facility's procedures for tracing 
        the distribution history of articles of food, whether 
        voluntarily or when required under section 414.
          ``(9) A description of the facility's procedures to ensure a 
        safe and secure supply chain for the ingredients or components 
        used in making the food manufactured, processed, packed, 
        transported, or held by such facility.
          ``(10) A description of the facility's procedures to 
        implement the science-based performance standards issued under 
        section 419.''.
          (3) Guidance or regulations.--
                  (A) In general.--The Secretary of Health and Human 
                Services (referred to in this subsection as the 
                ``Secretary'') shall issue guidance or promulgate 
                regulations to establish science-based standards for 
                conducting a hazard analysis, documenting hazards, 
                identifying and implementing preventive controls, and 
                documenting the implementation of the preventive 
                controls, including verification and corrective actions 
                under sections 418 and 418A of the Federal Food, Drug, 
                and Cosmetic Act (as added by paragraph (2)).
                  (B) International standards.--In issuing guidance or 
                regulations under subparagraph (A), the Secretary shall 
                review international hazard analysis and preventive 
                control standards that are in existence on the date of 
                the enactment of this Act and relevant to such 
                guidelines or regulations to ensure that the programs 
                under sections 418 and 418A of the Federal Food, Drug, 
                and Cosmetic Act (as added by paragraph (2)) are 
                consistent, to the extent the Secretary determines 
                practicable and appropriate, with such standards.
                  (C) Authority with respect to certain facilities.--
                The Secretary may, by regulation, exempt or modify the 
                requirements for compliance under this section and the 
                amendments made by this section with respect to 
                facilities that are solely engaged in--
                          (i) the production of food for animals other 
                        than man or the storage of packaged foods that 
                        are not exposed to the environment; or
                          (ii) the storage of raw agricultural 
                        commodities for further processing.
                  (D) Small businesses.--The Secretary--
                          (i) shall consider the impact of any guidance 
                        or regulations under this section on small 
                        businesses; and
                          (ii) shall issue guidance to assist small 
                        businesses in complying with the requirements 
                        of this section and the amendments made by this 
                        section.
          (4) No effect on existing haccp authorities.--Nothing in this 
        section or 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.), as in effect on the day 
        before the date of the enactment of this Act, 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.
          (5) Consideration.--When implementing sections 418 and 418A 
        of the Federal Food, Drug, and Cosmetic Act, as added by 
        paragraph (2), the Secretary may take into account differences 
        between food intended for human consumption and food intended 
        for consumption by animals other than man.
          (6) Effective date.--
                  (A) General rule.--The amendments made by subsection 
                (a) and this subsection shall take effect 18 months 
                after the date of the enactment of this Act.
                  (B) Exceptions.--Notwithstanding subparagraph (A)--
                          (i) the amendments made by subsection (a) and 
                        this subsection shall apply to a small business 
                        (as defined by the Secretary) after the date 
                        that is 2 years after the date of the enactment 
                        of this Act; and
                          (ii) the amendments made by subsection (a) 
                        and this subsection shall apply to a very small 
                        business (as defined by the Secretary) after 
                        the date that is 3 years after the date of the 
                        enactment of this Act.
  (b) Finished Product Test Results From Category 1 Facilities.--
          (1) Adulteration.--Section 402 (21 U.S.C. 342), as amended by 
        subsection (a), is amended by adding at the end the following:
  ``(k) If it is manufactured or processed in a facility that is in 
violation of section 418B.''.
          (2) Requirements.--Chapter IV (21 U.S.C. 341 et seq.) is 
        amended by adding at the end the following:

``SEC. 418B. FINISHED PRODUCT TEST RESULTS FROM CATEGORY 1 FACILITIES.

  ``(a) Authority.--Beginning on the date specified in subsection (c), 
the Secretary shall require, after public notice and an opportunity for 
comment, the submission to the Secretary of finished product test 
results by the owner, operator, or agent of each category 1 facility 
subject to good manufacturing practices regulations documenting the 
presence of contaminants in food in the possession or control of such 
facility posing a risk of severe adverse health consequences or death.
  ``(b) Considerations.--The Secretary shall require submissions under 
subsection (a)--
          ``(1) as the Secretary determines feasible and appropriate; 
        and
          ``(2) taking into consideration available data and 
        information on the potential risks posed by the facility.
  ``(c) Beginning Date.--The date specified in this subsection is the 
sooner of--
          ``(1) the date of completion of the pilot projects and 
        feasibility study under subsections (d) and (e); and
          ``(2) the date that is 2 years after the date of the 
        enactment of this section.
  ``(d) Pilot Projects.--The Secretary shall conduct 2 or more pilot 
projects to evaluate the feasibility of collecting positive finished 
product testing results from category 1 facilities, including the value 
and feasibility of reporting corrective actions taken when positive 
finished product test results are reported to the Secretary.
  ``(e) Feasibility Study.--The Secretary shall assess the feasibility 
and benefits of the reporting by facilities subject to good 
manufacturing practices regulations of appropriate finished product 
testing results from category 1 facilities to the Secretary, including 
the extent to which the collection of such finished product testing 
results will help the Secretary assess the risk presented by a facility 
or product category.
  ``(f) Limitations.--Nothing in this section shall be construed--
          ``(1) to require the Secretary to mandate testing or 
        submission of test results that the Secretary determines would 
        not provide useful information in assessing the potential risk 
        presented by a facility or product category; or
          ``(2) to limit the Secretary's authority under any other 
        provisions of law to require any person to provide access, or 
        to submit information or test results, to the Secretary, 
        including the ability of the Secretary to require field or 
        other testing and to obtain test results in the course of an 
        investigation of a potential food-borne illness or 
        contamination incident.
  ``(g) Definition.--In this section, the term `category 1 facility' 
means a category 1 facility within the meaning of section 704(h).''.

SEC. 103. PERFORMANCE STANDARDS.

  (a) Adulterated Food.--Section 402 (21 U.S.C. 342), as amended by 
section 102, is amended by adding at the end the following:
  ``(l) If it has been manufactured, processed, packed, transported, or 
held under conditions that do not meet the standards issued under 
section 419.''.
  (b) Requirements.--Chapter IV (21 U.S.C. 341 et seq.), as amended by 
section 102(b), is further amended by adding at the end the following:

``SEC. 419. PERFORMANCE STANDARDS.

  ``(a) Performance Standards.--The Secretary shall, not less 
frequently than every 2 years, review and evaluate epidemiological data 
and other appropriate sources of information, including research under 
section 123 of the Food Safety Enhancement Act of 2009, to identify the 
most significant food-borne contaminants and the most significant 
resulting hazards. The Secretary shall issue, as soon as practicable, 
through guidance or by regulation, science-based performance standards 
(which may include action levels) applicable to foods or food classes, 
as appropriate, to minimize to an acceptable level, prevent, or 
eliminate the occurrence of such hazards. Such standards shall be 
applicable to foods and food classes.
  ``(b) List of Contaminants.--Following each review under subsection 
(a), the Secretary shall publish in the Federal Register a list of 
food-borne contaminants that have the greatest adverse impact on public 
health. In determining whether a particular food-borne contaminant 
should be added to such list, the Secretary shall consider the number 
and severity of illnesses and the number of deaths associated with the 
foods associated with such contaminants.
  ``(c) Revocation by Secretary.--All performance standards of the Food 
and Drug Administration applicable to foods or food classes in effect 
on the date of the enactment of this section, or issued under this 
section, shall remain in effect until revised or revoked by the 
Secretary.''.
  (c) Report to Congress.--The Secretary of Health and Human Services 
shall submit to the Congress by March 30th of the year following each 
review under section 419 of the Federal Food, Drug, and Cosmetic Act, 
as added by subsection (b), a report on the results of such review and 
the Secretary's plans to address the significant food-borne hazards 
identified, or the basis for not addressing any significant food-borne 
hazards identified, including any resource limitations or limitations 
in data that preclude further action at that time.

SEC. 104. SAFETY STANDARDS FOR PRODUCE AND CERTAIN OTHER RAW 
                    AGRICULTURAL COMMODITIES.

  (a) Adulterated Food.--Section 402 (21 U.S.C. 342), as amended by 
sections 102 and 103(a), is amended by adding at the end the following:
  ``(m) If it has been grown, harvested, processed, packed, sorted, 
transported, or held under conditions that do not meet the standards 
established under section 419A.''.
  (b) Standards.--Chapter IV (21 U.S.C. 341 et seq.), as amended by 
sections 102(b) and 103(b), is amended by adding at the end the 
following:

``SEC. 419A. SAFETY STANDARDS FOR PRODUCE AND CERTAIN OTHER RAW 
                    AGRICULTURAL COMMODITIES.

  ``(a) Standards.--The Secretary shall establish by regulation 
scientific and risk-based standards for the safe growing, harvesting, 
processing, packing, sorting, transporting, and holding of those types 
of raw agricultural commodities--
          ``(1) that are from a plant or a fungus; and
          ``(2) for which the Secretary has determined that such 
        standards are reasonably necessary to minimize the risk of 
        serious adverse health consequences or death to humans or 
        animals.
  ``(b) Contents.--The regulations under subsection (a)--
          ``(1) may set forth such procedures, processes, and practices 
        as the Secretary determines to be reasonably necessary--
                  ``(A) 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 raw agricultural commodities that are 
                from a plant or a fungus; and
                  ``(B) to provide reasonable assurances that such 
                commodity is not adulterated under section 402;
          ``(2) may include, with respect to growing, harvesting, 
        processing, packing, sorting, transporting, and storage 
        operations, standards for safety as the Secretary determines to 
        be reasonably necessary;
          ``(3) may include standards addressing manure use, water 
        quality, employee hygiene, sanitation and animal control, and 
        temperature controls, as the Secretary determines to be 
        reasonably necessary;
          ``(4) may include standards for such other elements as the 
        Secretary determines necessary to carry out subsection (a);
          ``(5) shall provide a reasonable period of time for 
        compliance, taking into account the needs of small businesses 
        for additional time to comply;
          ``(6) may provide for coordination of education and 
        enforcement activities;
          ``(7) shall take into consideration, consistent with ensuring 
        enforceable public health protection, the impact on small-scale 
        and diversified farms, and on wildlife habitat, conservation 
        practices, watershed-protection efforts, and organic production 
        methods;
          ``(8) may provide for coordination of education and training 
        with other government agencies, universities, private entities, 
        and others with experience working directly with farmers; and
          ``(9) may provide for recognition through guidance of other 
        existing publicly available procedures, processes, and 
        practices that the Secretary determines to be equivalent to 
        those established under paragraph (1).
  ``(c) Enforcement.--The Secretary may coordinate with the Secretary 
of Agriculture and may contract and coordinate with the agency or 
department designated by the Governor of each State to perform 
activities to ensure compliance with this section.''.
  (c) Timing.--
          (1) Proposed rule.--Not later than 18 months after the date 
        of enactment of this Act, the Secretary of Health and Human 
        Services shall issue a proposed rule to carry out section 419A 
        of the Federal Food, Drug, and Cosmetic Act, as added by 
        subsection (b).
          (2) Final rule.--Not later than 3 years after such date, the 
        Secretary of Health and Human Services shall issue a final rule 
        under such section.
  (d) No Effect on Existing HACCP Authorities.--Nothing in this section 
or 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.), as 
in effect on the day before the date of the enactment of this Act, 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.
  (e) Update Existing Guidance.--Not later than 1 year after the date 
of the enactment of this Act, the Secretary of Health and Human 
Services shall update the guidance document entitled ``Guidance For 
Industry: Guide To Minimize Microbial Food Safety Hazards For Fresh 
Fruits And Vegetables'' (issued on October 26, 1998) in accordance with 
this section and the amendments made by this section.

SEC. 105. RISK-BASED INSPECTION SCHEDULE.

  (a) In General.--Section 704 (21 U.S.C. 374) is amended by adding at 
the end the following:
  ``(h)(1) Each facility registered under section 415 shall be 
inspected--
          ``(A)(i) by one or more officers duly designated under 
        section 702 or other statutory authority by the Secretary;
          ``(ii) for domestic facilities, by a Federal, State, or local 
        official recognized by the Secretary under paragraph (2); or
          ``(iii) for foreign facilities, by an agency or a 
        representative of a country that is recognized by the Secretary 
        under paragraph (2); and
          ``(B) at a frequency determined pursuant to a risk-based 
        schedule.
  ``(2) For purposes of paragraph (1)(A), the Secretary--
          ``(A) may recognize Federal, State, and local officials and 
        agencies and representatives of foreign countries as meeting 
        standards established by the Secretary for conducting 
        inspections under this Act; and
          ``(B) may limit such recognition to inspections of specific 
        commodities or food types.
  ``(3) The risk-based schedule under paragraph (1)(B) shall be 
implemented beginning not later than 18 months after the date of the 
enactment of this subsection.
  ``(4) Such risk-based schedule shall provide for a frequency of 
inspections commensurate with the risk presented by the facility and 
shall be based on the following categories and inspection frequencies:
          ``(A) Category 1.--A category 1 food facility is a high-risk 
        facility that manufactures or processes food. The Secretary 
        shall randomly inspect a category 1 food facility at least 
        every 6 to 12 months.
          ``(B) Category 2.--A category 2 food facility is a low-risk 
        facility that manufactures or processes food or a facility that 
        packs or labels food. The Secretary shall randomly inspect a 
        category 2 facility at least every 18 months to 3 years.
          ``(C) Category 3.--A category 3 food facility is a facility 
        that holds food. The Secretary shall randomly inspect a 
        category 3 facility at least every 5 years.
  ``(5) The Secretary--
          ``(A) may, by guidance, modify the types of food facilities 
        within a category under paragraph (4);
          ``(B) may alter the inspection frequencies specified in 
        paragraph (4) based on the need to respond to food-borne 
        illness outbreaks and food recalls; and
          ``(C) may inspect a facility more frequently than the 
        inspection frequency provided by paragraph (4);
          ``(D) beginning 6 months after submitting the report required 
        by section 105(b)(2) of the Food Safety Enhancement Act of 
        2009, may--
                  ``(i) publish in the Federal Register adjustments to 
                the inspection frequencies specified in subparagraphs 
                (B) and (C) of paragraph (4) for category 2 and 
                category 3 food facilities, which adjustments shall be 
                in accordance with the Secretary's recommendations in 
                such report; and
                  ``(ii) after such publication, implement the 
                adjustments; and
          ``(E) except as provided in subparagraphs (B) and (C), may 
        not alter the inspection frequency specified in paragraph 
        (4)(A) for category 1 food facilities.
  ``(6) In determining the appropriate frequency of inspection, the 
Secretary shall consider--
          ``(A) the type of food manufactured, processed, packed, or 
        held at the facility;
          ``(B) the compliance history of the facility;
          ``(C) whether the facility importing or offering for import 
        into the United States food is certified by a qualified 
        certifying entity in accordance with section 801(p); and
          ``(D) such other factors as the Secretary determines by 
        guidance to be relevant to assessing the risk presented by the 
        facility.''.
  (b) Reports on Risk-based Inspections of Food Facilities.--
          (1) Annual report.--Not later than December 31 of each year, 
        the Secretary of Health and Human Services shall submit a 
        report to the Committee on Energy and Commerce of the House of 
        Representatives and the Committee on Health, Education, Labor, 
        and Pensions of the Senate describing--
                  (A) the number of foreign and domestic facilities, by 
                risk category, inspected under the risk-based 
                inspection schedule established under section 704(h) of 
                the Federal Food, Drug, and Cosmetic Act, as added by 
                subsection (a), in the preceding fiscal year; and
                  (B) the costs of implementing the risk-based 
                inspection schedule for the preceding 12 months.
          (2) Third-year report.--Not later than 3 years after the date 
        of the enactment of this Act, the Secretary of Health and Human 
        Services shall submit a report to the Committee on Energy and 
        Commerce of the House of Representatives and the Committee on 
        Health, Education, Labor, and Pensions of the Senate describing 
        recommendations on the risk-based inspection schedule under 
        section 704(h) of the Federal Food, Drug, and Cosmetic Act, as 
        added by subsection (a), including recommendations for 
        adjustments to the timing of the schedule and other ways to 
        improve the risk-based allocation of resources by the Food and 
        Drug Administration. In making such recommendations, the 
        Secretary shall consider the following--
                  (A) the nature of the food products being processed, 
                stored, or transported;
                  (B) the manner in which food products are processed, 
                stored, or transported;
                  (C) the inherent likelihood that the products will 
                contribute to the risk of food-borne illness;
                  (D) the best available evidence concerning reported 
                illnesses associated with the foods processed, stored, 
                held, or transported in the category of facilities; and
                  (E) the overall record of compliance with food safety 
                law among facilities in the category, including 
                compliance with applicable performance standards and 
                the frequency of recalls.

SEC. 106. ACCESS TO RECORDS.

  (a) Records Access.--Subsection (a) of section 414 (21 U.S.C. 350c) 
is amended to read as follows:
  ``(a) Records Access.--
          ``(1) Records access during an inspection.--
                  ``(A) In general.--Each person who produces, 
                manufactures, processes, packs, transports, 
                distributes, receives, or holds an article of food in 
                the United States or for import into the United States 
                shall, at the request of an officer or employee duly 
                designated by the Secretary, permit such officer or 
                employee, upon presentation of appropriate credentials, 
                at reasonable times and within reasonable limits and in 
                a reasonable manner, to have access to and copy all 
                records relating to such article bearing on whether the 
                food may be adulterated, misbranded, or otherwise in 
                violation of this Act, including all records collected 
                or developed to comply with section 418 or 418A.
                  ``(B) Scope of records.--The requirement under 
                subparagraph (A) applies to all records relating to the 
                production, manufacture, processing, packing, 
                transporting, 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.
                  ``(C) Immediate availability with notice.--Records 
                not required to be made available immediately on 
                commencement of an inspection under subparagraph (A) 
                shall nonetheless be made available immediately on 
                commencement of such an inspection if, by a reasonable 
                time before such inspection, the Secretary by letter to 
                the person identifies the records to be made available 
                during such inspection.
          ``(2) Additional authorities to access records remotely; 
        submission of records to the secretary.--
                  ``(A) Remote access in emergencies.--If the Secretary 
                has a reasonable belief that an article of food 
                presents a threat of serious adverse health 
                consequences or death to humans or animals, the 
                Secretary may require each person who manufactures, 
                processes, packs, transports, distributes, receives, 
                holds, or imports such article of food, or any article 
                of food that the Secretary determines may be affected 
                in a similar manner, to submit to the Secretary all 
                records reasonably related to such article of food as 
                soon as is reasonably practicable, after receiving 
                written notice (including by notice served personally 
                and outside normal business hours to an agent 
                identified under subparagraph (E) or (F) of section 
                415(a)(2)) of such requirement.
                  ``(B) Remote access to records related to food safety 
                plans.--With respect to a facility subject to section 
                418 and 418A, the Secretary may require the owner, 
                operator, or agent of such facility to submit to the 
                Secretary, as soon as reasonably practicable after 
                receiving written notice of such requirement, the food 
                safety plan, supporting information relied on by the 
                facility to select the preventive controls to include 
                in its food safety plan, and documentation of 
                corrective actions, if any, taken under section 418(e) 
                within the preceding 2 years
                  ``(C) Electronic submission.--If the records required 
                to be submitted to the Secretary under subparagraph (A) 
                or (B) are available in electronic format, such records 
                shall be submitted electronically unless the Secretary 
                specifies otherwise in the notice under such 
                subparagraph.''.
  (b) Regulations Concerning Recordkeeping.--
          (1) Amendment.--Subsection (b) of section 414 (21 U.S.C. 
        350c) is amended to read as follows:
  ``(b) Regulations Concerning Recordkeeping.--The Secretary, in 
consultation and coordination, as appropriate, with other Federal 
departments and agencies with responsibilities for regulating food 
safety, may by regulation establish requirements regarding the 
establishment and maintenance, for not longer than 3 years, of records 
by persons who produce, manufacture, process, pack, transport, 
distribute, receive, or hold food in the United States or for import 
into the United States. The Secretary shall take into account the size 
of a business in promulgating regulations under this section. The only 
distribution records which may be required of restaurants under this 
subsection are those showing the restaurant's suppliers and subsequent 
distribution other than to consumers.''.
          (2) Application.--The Secretary of Health and Human Services 
        shall promulgate revised regulations to implement section 
        414(b) of the Federal Food, Drug, and Cosmetic Act, as amended 
        by this subsection. Section 414(b) of the Federal Food, Drug, 
        and Cosmetic Act and regulations thereunder, as in effect on 
        the day before the date of the enactment of this Act, shall 
        apply to acts and omissions occurring before the effective date 
        of such revised regulations.
  (c) Conforming Amendments.--Section 704(a)(1) (21 U.S.C. 374(a)(1)) 
is amended--
          (1) in the first sentence--
                  (A) by inserting ``farm,'' before ``factory'' each 
                place it appears; and
                  (B) by inserting ``produced,'' before 
                ``manufactured'';
          (2) in the second sentence--
                  (A) by striking ``(excluding farms and 
                restaurants)'';
                  (B) by inserting ``produces,'' before 
                ``manufactures'';
                  (C) by inserting ``receives,'' before ``holds'';
                  (D) by striking ``described in section 414'' and 
                inserting ``described in or required under section 
                414''; and
                  (E) by striking ``when the Secretary has a reasonable 
                belief that an article of food is adulterated and 
                presents a threat of serious adverse health 
                consequences or death to humans or animals'' and 
                inserting ``bearing on whether such food is 
                adulterated, misbranded, or otherwise in violation of 
                this Act, including all records collected or developed 
                to comply with section 418 or 418A''; and
          (3) in the fourth sentence--
                  (A) by striking ``the preceding sentence'' and 
                inserting ``either of the preceding two sentences''; 
                and
                  (B) by inserting ``recipes for food,'' before 
                ``financial data,''.

SEC. 107. TRACEABILITY OF FOOD.

  (a) Prohibited Act.--Section 301(e) (21 U.S.C. 331(e)) is amended by 
inserting ``, the violation of any requirement of the food tracing 
system under section 414(c);'' before ``or the refusal to permit access 
to or verification or copying of any such required record''.
  (b) Imports.--Section 801(a) (21 U.S.C. 381(a)) is amended by 
inserting ``or (4) the requirements of section 414 have not been 
complied with regarding such article,'' before ``then such article 
shall be refused admission''.
  (c) Product Tracing for Food.--Section 414 (21 U.S.C. 350c), as 
amended by section 106, is amended--
          (1) by redesignating subsections (c) and (d) as subsections 
        (d) and (e), respectively; and
          (2) by inserting after subsection (b) the following:
  ``(c) Tracing System for Food.--
          ``(1) In general.--The Secretary shall by regulation 
        establish a tracing system for food that is located in the 
        United States or is for import into the United States.
          ``(2) Information gathering.--
                  ``(A) Tracing technologies.--Before issuing a 
                proposed regulation under this subsection, the 
                Secretary shall--
                          ``(i) identify technologies and methodologies 
                        for tracing the distribution history of a food 
                        that are, or may be, used by members of 
                        different sectors of the food industry, 
                        including technologies and methodologies to 
                        enable each person who produces, manufactures, 
                        processes, pack, transports, or holds a food 
                        to--
                                  ``(I) maintain the full pedigree of 
                                the origin and previous distribution 
                                history of the food;
                                  ``(II) link that history with the 
                                subsequent distribution of the food;
                                  ``(III) establish and maintain a 
                                system for tracing the food that is 
                                interoperable with the systems 
                                established and maintained by other 
                                such persons; and
                                  ``(IV) use a unique identifier for 
                                each facility owned or operated by such 
                                person for such purpose, as specified 
                                under section 911; and
                          ``(ii) to the extent practicable, assess--
                                  ``(I) the costs and benefits 
                                associated with the adoption and use of 
                                such technologies;
                                  ``(II) the feasibility of such 
                                technologies for different sectors of 
                                the food industry; and
                                  ``(III) whether such technologies are 
                                compatible with the requirements of 
                                this subsection.
                  ``(B) Public meetings.--Before issuing a proposed 
                regulation under this subsection, the Secretary shall 
                conduct not less than 2 public meetings in diverse 
                geographical areas of the United States to provide 
                persons in different regions an opportunity to provide 
                input and information to the Secretary.
                  ``(C) Pilot projects.--Before issuing a proposed 
                regulation under this subsection, the Secretary shall 
                conduct 1 or more pilot projects in coordination with 1 
                or more sectors of the food industry to explore and 
                evaluate tracing systems for food.
          ``(3) Regulation.--Taking into account information obtained 
        through information gathering under paragraph (2), the 
        Secretary shall issue regulations establishing a tracing system 
        that enables the Secretary to identify each person who grows, 
        produces, manufactures, processes, packs, transports, holds, or 
        sells such food in as short a timeframe as practicable but no 
        longer than 2 business days. The Secretary may include in such 
        regulation--
                  ``(A) the establishment and maintenance of lot 
                numbers;
                  ``(B) a standardized format for pedigree information; 
                and
                  ``(C) the use of a common nomenclature for food.
          ``(4) Exemptions.--
                  ``(A) Direct sales by farms.--Food is exempt from the 
                requirements of this subsection if such food is--
                          ``(i) produced on a farm or fishery 
                        (including an oyster bed, a wild fishery, an 
                        aquaculture facility, a fresh water fishery, 
                        and a saltwater fishery); and
                          ``(ii) sold by the owner, operator, or agent 
                        in charge of such farm or fishery directly to a 
                        consumer or to a restaurant or grocery store.
                  ``(B) Other foods.--The Secretary may by notice in 
                the Federal Register exempt a food or a type of 
                facility, farm, or restaurant from, or modify the 
                requirements with respect to, the requirements of this 
                subsection if the Secretary determines that a tracing 
                system for such food or type of facility, farm, or 
                restaurant is not necessary to protect the public 
                health.
                  ``(C) Previous sources and subsequent recipients.--
                For a food covered by an exemption under subparagraph 
                (B), the Secretary shall require each person who 
                produces, manufactures, processes, packs, transports, 
                or holds such food to maintain records to identify the 
                immediate previous sources of such food and its 
                ingredients and the immediate subsequent recipients of 
                such food.
                  ``(D) Restaurants and grocery stores.--For a food 
                covered by an exemption under subparagraph (A), 
                restaurants and grocery stores shall keep records 
                documenting the farm that was the source of the food.
                  ``(E) Farms and fisheries.--For a food covered by an 
                exemption under subparagraph (A), farms and fisheries 
                shall keep records, in electronic or non-electronic 
                format, for at least 6 months documenting the 
                restaurant or grocery store to which the food was 
                sold.''.

SEC. 108. REINSPECTION AND FOOD RECALL FEES APPLICABLE TO FACILITIES.

  (a) In General.--Part 6 of subchapter C of chapter VII (21 U.S.C. 371 
et seq.), as added by section 101(c), is amended by adding at the end 
the following:

``SEC. 743A. REINSPECTION AND FOOD RECALL FEES APPLICABLE TO 
                    FACILITIES.

  ``(a) In General.--The Secretary shall assess and collect fees from 
each entity in a fiscal year--
          ``(1) that--
                  ``(A) during such fiscal year commits a violation of 
                any requirement of this Act relating to food, including 
                any such requirement relating to good manufacturing 
                practices; and
                  ``(B) because of such violation, undergoes additional 
                inspection by the Food and Drug Administration; or
          ``(2) during such fiscal year is subject to a food recall.
  ``(b) Amount of Fees.--The Secretary shall set the amount of the fees 
under this section to fully cover the costs of--
          ``(1) in the case of fees collected under subsection (a)(1), 
        conducting the additional inspections referred to in such 
        subsection; and
          ``(2) in the case of fees collected under subsection (a)(2), 
        conducting food recall activities, including technical 
        assistance, follow-up effectiveness checks, and public 
        notifications, during the fiscal year involved.
  ``(c) Crediting and Availability of Fees.--
          ``(1) In general.--Fees authorized under subsection (a) shall 
        be collected and available for obligation only to the extent 
        and in the amount provided in advance 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 appropriation 
        account without fiscal year limitation to such appropriation 
        account for salaries and expenses with such fiscal year 
        limitation.
          ``(2) Collections and appropriations acts.--The fees 
        authorized by this section--
                  ``(A) shall be retained in each fiscal year in an 
                amount not to exceed the amount specified in 
                appropriation Acts, or otherwise made available for 
                obligation, for such fiscal year; and
                  ``(B) shall only be collected and available to defray 
                the costs referred to in subsection (b).
          ``(3) Authorization of appropriations.--For each of fiscal 
        years 2010 through 2014, there are authorized to be 
        appropriated for fees under this section such sums as may be 
        necessary.
  ``(d) Waiver.--The Secretary shall waive and, if applicable, refund 
the amount of any fee collected under this section from an entity as a 
result of a food recall that the Secretary determines was 
inappropriately ordered.''.
  (b) Effective Date.--The amendment made by subsection (a) shall apply 
to additional inspections and food recall activities occurring after 
the date of the enactment of this Act.

SEC. 109. CERTIFICATION AND ACCREDITATION.

  (a) Misbranding.--
          (1) In general.--Section 403 (21 U.S.C. 343), as amended by 
        section 101(a), is amended by adding at the end the following:
  ``(aa) If it is part of a shipment offered for import into the United 
States and such shipment is in violation of section 801(p) (requiring a 
certification to accompany certain food shipments).''.
          (2) Effective date.--The amendment made by paragraph (1) 
        shall apply to shipments offered for import on or after the 
        date that is 3 years after the date of the enactment of this 
        Act.
  (b) Certification of Compliance for Imports.--Chapter VIII (21 U.S.C. 
381 et seq.) is amended--
          (1) in section 801(a), as amended by section 107(b), by 
        inserting after the third sentence the following: ``If an 
        article of food being imported or offered for import into the 
        United States is not in compliance with the requirement of 
        subsection (p) (relating to certifications of compliance with 
        this Act), then such article shall be refused admission.'';
          (2) in the second sentence of section 801(b), by striking 
        ``the fourth sentence'' and inserting ``the fifth sentence''; 
        and
          (3) by adding at the end of section 801 the following:
  ``(p) Certifications Concerning Imported Articles.--
          ``(1) In general.--
                  ``(A) Requirement.--The Secretary shall require, as 
                an additional condition of granting admission to an 
                article of food being imported or offered for import 
                into the United States, that a qualified certifying 
                entity provide a certification that the article 
                complies with specified requirements of this Act if--
                          ``(i) for food imported from a particular 
                        country or region, based on the adequacy of 
                        government controls in such country or region 
                        or other information relevant to such food, 
                        certification would assist the Secretary in 
                        determining whether to refuse to admit such 
                        article under subsection (a);
                          ``(ii) for a type of food that could pose a 
                        significant risk to health, certification would 
                        assist the Secretary in determining whether 
                        such article poses such risk; or
                          ``(iii) for an article imported from a 
                        particular country, there is an agreement 
                        between the Secretary and the government of 
                        such country providing for such certification.
                  ``(B) Contents of certification.--Such certification 
                shall include such information regarding compliance as 
                the Secretary may specify, and may be provided in the 
                form of shipment-specific certificates, a listing of 
                certified facilities or other entities, or in such 
                other form as the Secretary may specify.
                  ``(C) Notice of cancellation or suspension of 
                certification.--As a condition on acceptance of 
                certifications from a qualified certifying entity, the 
                Secretary shall require the qualified certifying entity 
                to notify the Secretary whenever the qualified 
                certifying entity cancels or suspends the certification 
                of any facility or other entity included in a listing 
                under subparagraph (B).
          ``(2) Qualified certifying entity.--For purposes of this 
        subsection, the term `qualified certifying entity' means--
                  ``(A) an agency or a representative of the government 
                of the country from which the article originated, as 
                designated by such government or the Secretary; or
                  ``(B) an individual or entity determined by the 
                Secretary or an accredited body recognized by the 
                Secretary to be qualified to provide a certification 
                under paragraph (1).
          ``(3) No conflicts of interest.--
                  ``(A) In general.--The Secretary shall issue 
                regulations to ensure that any qualified certifying 
                entity and its auditors are free from conflicts of 
                interest.
                  ``(B) Regulations.--Such regulations shall require 
                that--
                          ``(i) the qualified certifying entity shall 
                        have a committee or management structure for 
                        safeguarding impartiality;
                          ``(ii) conflict of interest policies for a 
                        qualified certifying entity and auditors acting 
                        for the qualified certifying entity shall be 
                        written;
                          ``(iii) the qualified certifying entity shall 
                        not be owned, operated, or controlled by a 
                        producer, manufacturer, processor, packer, 
                        holder, supplier, or vendor of any article of 
                        the type it certifies;
                          ``(iv) the qualified certifying entity shall 
                        not have any ownership or financial interest in 
                        any product, producer, manufacturer, processor, 
                        packer, holder, supplier or vendor of the type 
                        it certifies;
                          ``(v) no auditor acting for the qualified 
                        certifying entity (or spouse or minor children) 
                        shall have any significant ownership or other 
                        financial interest regarding any product of the 
                        type it certifies;
                          ``(vi) the qualified certifying entity shall 
                        maintain records pertaining to the financial 
                        interests of the personnel involved in audits;
                          ``(vii) neither the qualified certifying 
                        entity nor any of its auditors acting for the 
                        qualified certifying entity shall participate 
                        in the production, manufacture, processing, 
                        packing, holding, promotion, or sale of any 
                        product of the type it certifies;
                          ``(viii) neither the qualified certifying 
                        entity nor any of its auditors shall provide 
                        consultative services to any facility certified 
                        by the qualified certifying entity, or the 
                        owner, operator, or agent in charge of such a 
                        facility, unless the qualified certifying 
                        entity has procedures in place, approved by the 
                        Secretary, to ensure separation of functions 
                        between auditors providing consultative 
                        services and auditors providing certification 
                        services under this subsection;
                          ``(ix) no auditors acting for the qualified 
                        certifying entity shall participate in an audit 
                        of a facility they were employed by within the 
                        last 12 months;
                          ``(x) fees charged or accepted shall not be 
                        contingent or based upon the report made by the 
                        qualified certifying entity or any personnel 
                        involved in the audit process;
                          ``(xi) neither the qualified certifying 
                        entity nor any of its auditors shall accept 
                        anything of value from anyone in connection 
                        with the facility being audited other than the 
                        audit fee;
                          ``(xii) the qualified certifying entity shall 
                        not be owned, operated, or controlled by a 
                        trade association whose member companies 
                        operate facilities that it certifies;
                          ``(xiii) the qualified certifying entity and 
                        its auditors shall be free from any other 
                        conflicts of interest that threaten 
                        impartiality;
                          ``(xiv) the qualified certifying entity and 
                        its auditors shall sign a statement attesting 
                        to compliance with the conflict of interests 
                        requirements under this paragraph; and
                          ``(xv) the qualified certifying entity shall 
                        ensure that any subcontractors that might be 
                        used (such as laboratories and sampling 
                        services) provide similar assurances, except 
                        that it shall not be a violation of this 
                        subsection to the extent such subcontractors 
                        perform additional nutritional testing services 
                        unrelated to the testing under this subsection.
                  ``(C) Anything of value.--In this paragraph, the term 
                `anything of value' includes gifts, gratuities, 
                reimbursement of expenses, entertainment, loans, or any 
                other form of compensation in cash or in kind.
          ``(4) Renewal and refusal of certifications.--The Secretary 
        shall--
                  ``(A) require that, to the extent applicable, any 
                certification provided by a qualified certifying entity 
                be renewed by such entity at such times as the 
                Secretary determines appropriate; and
                  ``(B) refuse to accept any certification if the 
                Secretary determines that such certification is no 
                longer valid or reliable.
          ``(5) Electronic submission.--The Secretary shall provide for 
        the electronic submission of certifications under this 
        subsection.
          ``(6) No limit on authority.--This subsection shall not be 
        construed to limit the authority of the Secretary to conduct 
        random inspections of imported articles or facilities of 
        importers, issue import alerts for detention without physical 
        examination, require submission to the Secretary of 
        documentation or other information about an article imported or 
        offered for import, or to take such other steps as the 
        Secretary deems appropriate to determine the admissibility of 
        imported articles.''.

SEC. 110. TESTING BY ACCREDITED LABORATORIES.

  (a) Prohibited Act.--Section 301 (21 U.S.C. 331) is amended by adding 
at the end the following:
  ``(oo) The violation of any requirement of section 714 (relating to 
testing by accredited laboratories).''.
  (b) Laboratory Accreditation.--Subchapter A of chapter VII (21 U.S.C. 
371 et seq.) is amended by adding at the end the following:

``SEC. 714. TESTING BY ACCREDITED LABORATORIES.

  ``(a) In General.--
          ``(1) Requirement.--Whenever analytical testing of an article 
        of food is conducted as part of testimony for the purposes of 
        section 801(a), or for such other purposes as the Secretary 
        deems appropriate through regulation or guidance, such testing 
        shall be conducted by a laboratory that--
                  ``(A) is accredited, for the analytical method used, 
                by a laboratory accreditation body that has been 
                recognized by the Secretary; and
                  ``(B) samples such article with adequate controls for 
                ensuring the integrity of the samples analyzed.
          ``(2) Independence of laboratory.--
                  ``(A) Certain tests.--Tests required for purposes of 
                section 801(a) or in response to a finding of 
                noncompliance by the Secretary shall be conducted by a 
                laboratory independent of the person on whose behalf 
                such testing is conducted and analyzed.
                  ``(B) Certain products.--The Secretary may require 
                that testing for certain products under paragraph (1) 
                be conducted by a laboratory independent of the person 
                on whose behalf such testing is conducted.
  ``(b) Recognition of Laboratory Accreditation Bodies.--The Secretary 
shall establish and implement a program for the recognition, based on 
standards the Secretary deems appropriate, of laboratory accreditation 
bodies that accredit laboratories to perform analytical testing for the 
purposes of this section. The Secretary shall issue regulations or 
guidance to implement this program.
  ``(c) Onsite Audits.--In evaluating whether an accreditation body 
meets, or continues to meet, the standards for recognition under 
subsection (b), the Secretary may--
          ``(1) observe onsite audits of laboratories by such 
        accreditation bodies; or
          ``(2) for any laboratory that is accredited by such 
        accreditation body under this section, upon request of an 
        officer or employee designated by the Secretary and upon 
        presentation of appropriate credentials, at reasonable times 
        and within reasonable limits and in a reasonable manner, 
        conduct an onsite audit of the laboratory, which shall include 
        access to, and copying and verification of, any related 
        records.
  ``(d) Publication of List of Recognized Accreditation Bodies.--The 
Secretary shall publish and maintain on the public Web site of the Food 
and Drug Administration a list of accreditation bodies recognized by 
the Secretary under subsection (b).
  ``(e) Notification of Accreditation of Laboratory.--An accreditation 
body that has been recognized pursuant to this section shall promptly 
notify the Secretary whenever it accredits a laboratory for the 
purposes of this section and whenever it withdraws or suspends such 
accreditation.
  ``(f) Advance Notice.--Whenever analytical testing is conducted 
pursuant to subsection (a), the person on whose behalf the testing is 
conducted shall notify the Secretary before any sample of the article 
is collected. Such notice shall contain information the Secretary 
determines is appropriate to identify the article, the location of the 
article, and each laboratory that will analyze the sample on the 
person's behalf.
  ``(g) Contents of Laboratory Packages.--Whenever analytical testing 
is conducted pursuant to subsection (a), the laboratory conducting such 
testing shall submit, directly to the Secretary--
          ``(1) the results of all analyses conducted by the laboratory 
        on each sample of such article; and
          ``(2) all information the Secretary deems appropriate to--
                  ``(A) determine whether the laboratory is accredited 
                by a recognized laboratory accreditation body;
                  ``(B) identify the article tested;
                  ``(C) evaluate the analytical results; and
                  ``(D) determine whether the requirements of this 
                section have been met.
  ``(h) Exigent Circumstances.--The Secretary may waive the requirement 
of subsection (a)(1)(A) (relating to analytical methods) on a 
laboratory or method basis due to exigent or other circumstances.
  ``(i) No Limit on Authority.--Nothing in this section shall be 
construed to limit--
          ``(1) the ability of the Secretary to review and act upon 
        information from the analytical testing of food (including 
        under this section), including determining the sufficiency of 
        such information and testing; or
          ``(2) the authority of the Secretary to conduct, require, or 
        consider the results of analytical testing pursuant to any 
        other provision of law.''.

SEC. 111. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR 
                    MISBRANDED FOOD.

  (a) Prohibited Acts.--Section 301 (21 U.S.C. 331), as amended by 
section 110, is amended by adding at the end the following:
  ``(pp)(1) The failure to notify the Secretary in violation of section 
420(a).
  ``(2) The failure to comply with any order issued under section 
420.''.
  (b) Notification, Nondistribution, and Recall of Adulterated or 
Misbranded Food.--Chapter IV (21 U.S.C. 341 et seq.), as amended by 
sections 102, 103, and 104, is amended by adding at the end the 
following:

``SEC. 420. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR 
                    MISBRANDED FOOD.

  ``(a) Notification, Nondistribution, and Recall of Adulterated or 
Misbranded Food.--
          ``(1) In general.--A responsible party as that term is 
        defined in section 417(a)(1) or a person required to register 
        under section 801(r) that has reason to believe that an article 
        of food when introduced into or while in interstate commerce, 
        or while held for sale (regardless of whether the first sale) 
        after shipment in interstate commerce, is adulterated or 
        misbranded in a manner that presents a reasonable probability 
        that the use or consumption of, or exposure to, the article (or 
        an ingredient or component used in any such article) will cause 
        a threat of serious adverse health consequences or death to 
        humans or animals shall, as soon as practicable, notify the 
        Secretary of the identity and location of the article.
          ``(2) Manner of notification.--Notification under paragraph 
        (1) shall be made in such manner and by such means as the 
        Secretary may require by regulation or guidance.
  ``(b) Voluntary Recall.--The Secretary may request that any person 
who distributes an article of food that the Secretary has reason to 
believe is adulterated, misbranded, or otherwise in violation of this 
Act voluntarily--
          ``(1) recall such article; and
          ``(2) provide for notice, including to individuals as 
        appropriate, to persons who may be affected by the recall.
  ``(c) Order to Cease Distribution.--If the Secretary has reason to 
believe that the use or consumption of, or exposure to, an article of 
food may cause serious adverse health consequences or death to humans 
or animals, the Secretary shall have the authority to issue an order 
requiring any person who distributes such article to immediately cease 
distribution of such article.
  ``(d) Action Following Order.--Any person who is subject to an order 
under subsection (c) shall immediately cease distribution of such 
article and provide notification as required by such order, and may 
appeal within 24 hours of issuance such order to the Secretary. Such 
appeal may include a request for an informal hearing and a description 
of any efforts to recall such article undertaken voluntarily by the 
person, including after a request under subsection (b). Except as 
provided in subsection (f), an informal hearing shall be held within as 
soon as practicable, but not later than 5 calendar days, or less as 
determined by the Secretary, after such an appeal is filed, unless the 
parties jointly agree to an extension. After affording an opportunity 
for an informal hearing, the Secretary shall determine whether the 
order should be amended to require a recall of such article. If, after 
providing an opportunity for such a hearing, the Secretary determines 
that inadequate grounds exist to support the actions required by the 
order, the Secretary shall vacate the order.
  ``(e) Order to Recall.--
          ``(1) Amendment.--Except as provided under subsection (f), if 
        after providing an opportunity for an informal hearing under 
        subsection (d), the Secretary determines that the order should 
        be amended to include a recall of the article with respect to 
        which the order was issued, the Secretary shall amend the order 
        to require a recall.
          ``(2) Contents.--An amended order under paragraph (1) shall--
                  ``(A) specify a timetable in which the recall will 
                occur;
                  ``(B) require periodic reports to the Secretary 
                describing the progress of the recall; and
                  ``(C) provide for notice, including to individuals as 
                appropriate, to persons who may be affected by the 
                recall.
        In providing for such notice, the Secretary may allow for the 
        assistance of health professionals, State or local officials, 
        or other individuals designated by the Secretary.
          ``(3) Nondelegation.--An amended order under this subsection 
        shall be ordered by the Secretary or an official designated by 
        the Secretary. An official may not be so designated unless the 
        official is the director of the district under this Act in 
        which the article involved is located, or is an official senior 
        to such director.
  ``(f) Emergency Recall Order.--
          ``(1) In general.--If the Secretary has a reasonable belief 
        that an article of food subject to an order under subsection 
        (c) presents an imminent threat of serious adverse health 
        consequences or death to humans or animals, the Secretary may 
        issue an order requiring any person who distributes such 
        article--
                  ``(A) to immediately recall such article; and
                  ``(B) to provide for notice, including to individuals 
                as appropriate, to persons who may be affected by the 
                recall.
          ``(2) Action following order.--Any person who is subject to 
        an emergency recall order under this subsection shall 
        immediately recall such article and provide notification as 
        required by such order, and may appeal within 24 hours after 
        issuance such order to the Secretary. An informal hearing shall 
        be held within as soon as practicable but not later than 5 
        calendar days, or less as determined by the Secretary, after 
        such an appeal is filed, unless the parties jointly agree to an 
        extension. After affording an opportunity for an informal 
        hearing, the Secretary shall determine whether the order should 
        be amended pursuant to subsection (e)(1). If, after providing 
        an opportunity for such a hearing, the Secretary determines 
        that inadequate grounds exist to support the actions required 
        by the order, the Secretary shall vacate the order.
          ``(3) Nondelegation.--An order under this subsection shall be 
        issued by the Commissioner of Food and Drugs, the Principal 
        Deputy Commissioner, or the Associate Commissioner for 
        Regulatory Affairs of the Food and Drug Administration.
  ``(g) Notice to Consumers and Health Officials.--The Secretary shall, 
as the Secretary determines to be necessary, provide notice of a recall 
order under this section to consumers to whom the article was, or may 
have been, distributed and to appropriate State and local health 
officials.
  ``(h) Savings Clause.--Nothing contained in this section shall be 
construed as limiting--
          ``(1) the authority of the Secretary to issue an order to 
        cease distribution of, or to recall, an article under any other 
        provision of this Act or the Public Health Service Act; or
          ``(2) the ability of the Secretary to request any person to 
        perform a voluntary activity related to any article subject to 
        this Act or the Public Health Service Act.''.
  (c) Articles Subject to Refusal.--The third sentence of subsection 
(a) of section 801 (21 U.S.C. 381), as amended by section 107(b), is 
amended by inserting ``or (5) such article is subject to an order under 
section 420 to cease distribution of or recall the article,'' before 
``then such article shall be refused admission''.
  (d) Effective Date.--Sections 301(pp)(1) and 420 of the Federal Food, 
Drug, and Cosmetic Act, as added by subsections (a) and (b), shall 
apply with respect to articles of food as of such date, not later than 
1 year after the date of the enactment of this Act, as the Secretary of 
Health and Human Services shall specify.

SEC. 112. REPORTABLE FOOD REGISTRY; EXCHANGE OF INFORMATION.

  (a) Reportable Food Registry.--Section 417 (21 U.S.C. 350f) is 
amended--
          (1) in subsection (a)(1), by striking ``means a person'' and 
        all that follows through the end of paragraph (1) and inserting 
        the following: ``means--
                  ``(A) a person who submits the registration under 
                section 415(a) for a food facility that is required to 
                be registered under section 415(a), at which such food 
                is manufactured, processed, packed, or held;
                  ``(B) a person who owns, operates, is an agent of, or 
                is otherwise responsible for such food on a farm (as 
                such term is defined in section 1.227(b)(3) of title 
                21, Code of Federal Regulations, or successor 
                regulations) at which such food is produced for sale or 
                distribution in interstate commerce;
                  ``(C) a person who owns, operates, or is an agent of 
                a restaurant or other retail food establishment (as 
                such terms are defined in section 1.227(b)(11) and 
                (12), respectively, of title 21, Code of Federal 
                Regulations, or successor regulations) at which such 
                food is offered for sale; or
                  ``(D) a person that is required to register pursuant 
                to section 801(r) with respect to importation of such 
                food.'';
          (2) in subsection (b), by adding at the end the following:
          ``(3) Reporting by restaurants and retail food 
        establishments.--In addition to the electronic portal described 
        in paragraph (1), the Secretary shall make available 
        alternative means of reporting under this section with respect 
        to restaurants and other retail food establishments with 
        limited ability for such reporting.'';
          (3) in subsection (d)(1)--
                  (A) in the matter preceding subparagraph (A), by 
                inserting ``following a timely review of any reasonably 
                available data and information,'' after ``reportable 
                food,'';
                  (B) in subparagraph (A), by striking ``and'' at the 
                end;
                  (C) by redesignating subparagraph (B) as subparagraph 
                (C); and
                  (D) by inserting after subparagraph (A) the 
                following:
                  ``(B) submit, with such report, through the 
                electronic portal, documentation of results from any 
                sampling and testing of such article, including--
                          ``(i) analytical results from testing of such 
                        article conducted by or on behalf of the 
                        responsible party under section 418, 418A, 419, 
                        419A, or 714;
                          ``(ii) analytical results from testing 
                        conducted by or on behalf of such responsible 
                        party of a component of such article;
                          ``(iii) analytical results of environmental 
                        testing of any facility at which such article, 
                        or a component of such article, is 
                        manufactured, processed, packed, or held; and
                          ``(iv) any other information the Secretary 
                        determines is necessary to evaluate the 
                        adulteration of such article, any component of 
                        such article, any other article of food 
                        manufactured, processed, packed or held in the 
                        same manner as, or at the same facility as, 
                        such article, or any other article containing a 
                        component from the same source as a component 
                        of such article; and''; and
          (4) in subsection (e)--
                  (A) in paragraph (1), by inserting ``if the 
                responsible party is required to register'' after 
                ``415(a)(3)''; and
                  (B) by adding at the end the following:
          ``(12) Such additional information as the Secretary deems 
        appropriate.''.
  (b) Exchange of Information.--Section 708 (21 U.S.C. 379) is 
amended--
          (1) by striking ``The Secretary'' and inserting ``(a) The 
        Secretary''; and
          (2) by adding at the end the following:
  ``(b)(1)(A) The Secretary may provide to any Federal agency acting 
within the scope of its jurisdiction any information relating to food 
that is exempt from disclosure pursuant to subsection (a) of section 
552 of title 5, United States Code, by reason of subsection (b)(4) of 
such section, or that is referred to in section 301(j) or 415(a)(4).
  ``(B) Any such information provided to another Federal agency shall 
not be disclosed by such agency except in any action or proceeding 
under the laws of the United States to which the receiving agency or 
the United States is a party.
  ``(2)(A) In carrying out this Act, the Secretary may provide to a 
State or local government agency any information relating to food that 
is exempt from disclosure pursuant to section 552(a) of title 5, United 
States Code, by reason of subsection (b)(4) of such section, or that is 
referred to in section 301(j) or 415(a)(4).
  ``(B) Any such information provided to a State or local government 
agency shall not be disclosed by such agency.
  ``(3) In carrying out this Act, the Secretary may provide to any 
person any information relating to food that is exempt from disclosure 
pursuant to section 552(a) of title 5, United States Code, by reason of 
subsection (b)(4) of such section, if the Secretary determines that 
providing the information to the person is appropriate under the 
circumstances and the recipient provides adequate assurances to the 
Secretary that the recipient will preserve the confidentiality of the 
information.
  ``(4) In carrying out this Act, the Secretary may provide any 
information relating to food that is exempt from disclosure pursuant to 
section 552(a) of title 5, United States Code, by reason of subsection 
(b)(4) of such section, or that is referred to in section 301(j)--
          ``(A) to any foreign government agency; or
          ``(B) any international organization established by law, 
        treaty, or other governmental action and having 
        responsibility--
                  ``(i) to facilitate global or regional harmonization 
                of standards and requirements in an area of 
                responsibility of the Food and Drug Administration; or
                  ``(ii) to promote and coordinate public health 
                efforts,
        if the agency or organization provides adequate assurances to 
        the Secretary that the agency or organization will preserve the 
        confidentiality of the information.
  ``(c) Except where specifically prohibited by statute, the Secretary 
may disclose to the public any information relating to food that is 
exempt from disclosure pursuant to section 552(a) of title 5, United 
States Code, by reason of subsection (b)(4) of such section, if the 
Secretary determines that such disclosure is necessary to protect the 
public health.
  ``(d) Except as provided in subsection (e), the Secretary shall not 
be required to disclose under section 552 of title 5, United States 
Code, or any other provision of law any information relating to food 
obtained from a Federal, State, or local government agency, or from a 
foreign government agency, or from an international organization 
described in subsection (b)(4), if the agency or organization has 
requested that the information be kept confidential, or has precluded 
such disclosure under other use limitations, as a condition of 
providing the information.
  ``(e) Nothing in subsection (d) authorizes the Secretary to withhold 
information from the Congress or prevents the Secretary from complying 
with an order of a court of the United States.
  ``(f) This section shall not affect the authority of the Secretary to 
provide or disclose information under any other provision of law.''.
  (c) Conforming Amendment.--Section 301(j) (21 U.S.C. 331(j)) is 
amended by striking ``or to the courts when relevant in any judicial 
proceeding under this Act,'' and inserting ``to the courts when 
relevant in any judicial proceeding under this Act, or as specified in 
section 708,''.

SEC. 113. SAFE AND SECURE FOOD IMPORTATION PROGRAM.

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

``SEC. 805. SAFE AND SECURE FOOD IMPORTATION PROGRAM.

  ``(a) In General.--The Secretary may establish by regulation or 
guidance a program that facilitates the movement of food through the 
importation process under this Act if the importer of such food--
          ``(1) verifies that each facility involved in the production, 
        manufacture, processing, packaging, and holding of the food is 
        in compliance with the food safety and security guidelines 
        developed under subsection (b) with respect to such food;
          ``(2) ensures that appropriate safety and security controls 
        are in place throughout the supply chain for such food; and
          ``(3) provides supporting information to the Secretary.
  ``(b) Guidelines.--
          ``(1) Development.--For purposes of the program established 
        under subsection (a), the Secretary shall develop safety and 
        security guidelines applicable to the importation of food.
          ``(2) Factors.--Such guidelines shall take into account the 
        following factors:
                  ``(A) The personnel of the person importing the food.
                  ``(B) The physical and procedural safety and security 
                of such person's food supply chain.
                  ``(C) The sufficiency of preventive controls for food 
                and ingredients purchased by such person.
                  ``(D) Vendor and supplier information.
                  ``(E) Other programs for certification or 
                verification by a qualified certifying entity used by 
                the importer.
                  ``(F) Such other factors as the Secretary determines 
                necessary.''.

SEC. 114. INFANT FORMULA.

  (a) Misbranding.--Section 403 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 343) as amended by sections 101(a) and 109(a), is 
amended by adding at the end the following:
  ``(bb) If it is a new infant formula and it is not the subject of a 
letter from the Secretary provided pursuant to section 412(c)(1)(C).''.
  (b) Requirements.--Section 412 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 350a) is amended--
          (1) in subsection (b)(1), by adding at the end the following: 
        ``The quality factor requirements established under this 
        paragraph may include requirements for one or more clinical 
        studies to demonstrate that the new infant formula supports 
        normal physical growth of infants.'';
          (2) in subsection (b)(4), by amending subparagraph (B) to 
        read as follows:
  ``(B) Records required under subparagraph (A) with respect to an 
infant formula shall be retained for at least one year after the 
expiration of the shelf life of such infant formula. Such records shall 
be made available to the Secretary for review and duplication upon 
request of the Secretary.'';
          (3) in subsection (c)(1)--
                  (A) in subparagraph (A), by striking ``and'' at the 
                end;
                  (B) in subparagraph (B), by striking ``(c)(1).'' at 
                the end and inserting ``(d)(1), and''; and
                  (C) by adding at the end the following:
          ``(C) the Secretary has by letter informed such person that 
        the registration requirements and the requirements in 
        subsection (d)(1) have been satisfied.''; and
          (4) in subsection (d)(1), by striking subparagraphs (C) and 
        (D) and inserting the following:
          ``(C) scientific evidence and other evidence, as identified 
        in regulations promulgated by the Secretary, that demonstrates 
        that the infant formula satisfies the requirements of 
        subsection (b)(1), and, as demonstrated by the testing required 
        under subsection (b)(3), that it satisfies the requirements of 
        subsection (i), and
          ``(D) scientific evidence and other evidence, as identified 
        in regulations promulgated by the Secretary, that demonstrate 
        that the processing of the infant formula complies with the 
        requirements of subsection (b)(2).''.

                        Subtitle B--Intervention

SEC. 121. SURVEILLANCE.

  (a) Definition of Food-Borne Illness Outbreak.--In this section, the 
term ``food-borne illness outbreak'' means the occurrence of 2 or more 
cases of a similar illness resulting from the ingestion of a food.
  (b) Food-Borne Illness Surveillance Systems.--The Secretary, acting 
through the Director of the Centers for Disease Control and Prevention, 
shall enhance food-borne illness surveillance systems to improve the 
collection, analysis, reporting, and usefulness of data on food-borne 
illnesses by--
          (1) coordinating Federal, State, and local food-borne illness 
        surveillance systems, including complaint systems, and 
        increasing participation in national networks of public health 
        and food regulatory agencies and laboratories;
          (2) facilitating sharing of findings on a more timely basis 
        among governmental agencies, including the Food and Drug 
        Administration, the Department of Agriculture, and State and 
        local agencies, and with the public;
          (3) developing improved epidemiological tools for obtaining 
        quality exposure data, and microbiological methods for 
        classifying cases;
          (4) augmenting such systems to improve attribution of a food-
        borne illness outbreak to a specific food;
          (5) expanding capacity of such systems, including 
        fingerprinting and other detection strategies for food-borne 
        infectious agents, in order to identify new or rarely 
        documented causes of food-borne illness;
          (6) allowing timely public access to aggregated, de-
        identified surveillance data;
          (7) at least annually, publishing current reports on findings 
        from such systems;
          (8) establishing a flexible mechanism for rapidly initiating 
        scientific research by academic institutions;
          (9) integrating food-borne illness surveillance systems and 
        data with other biosurveillance and public health situational 
        awareness capabilities at the Federal, State, and local levels; 
        and
          (10) other activities as determined appropriate by the 
        Secretary.
  (c) Improving Food Safety and Defense Capacity at the State and Local 
Level.--
          (1) In general.--The Secretary shall develop and implement 
        strategies to leverage and enhance the food safety and defense 
        capacities of State and local agencies in order to achieve the 
        following goals:
                  (A) Improve food-borne illness outbreak response and 
                containment.
                  (B) Accelerate food-borne illness surveillance and 
                outbreak investigation, including rapid shipment of 
                clinical isolates from clinical laboratories to 
                appropriate State laboratories, and conducting more 
                standardized illness outbreak interviews.
                  (C) Strengthen the capacity of State and local 
                agencies to carry out inspections and enforce safety 
                standards.
                  (D) Improve the effectiveness of Federal, State, and 
                local partnerships to coordinate food safety and 
                defense resources and reduce the incidence of food-
                borne illness.
                  (E) Share information on a timely basis among public 
                health and food regulatory agencies, with the food 
                industry, with health care providers, and with the 
                public.
          (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 this 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.

SEC. 122. PUBLIC EDUCATION AND ADVISORY SYSTEM.

  (a) Public Education.--The Secretary, in cooperation with private and 
public organizations, including the appropriate State entities, shall 
design and implement a national public education program on food 
safety. The program shall provide--
          (1) information to the public so that individuals can 
        understand the potential impact and risk of food-borne illness, 
        take action to reduce their risk of food-borne illness and 
        injury, and make healthy dietary choices;
          (2) information to health professionals so that they may 
        improve diagnosis and treatment of food-related illness and 
        advise individuals whose health conditions place them in 
        particular risk; and
          (3) such other information or advice to consumers and other 
        persons as the Secretary determines will promote the purposes 
        of this Act.
  (b) Health Advisories.--The Secretary shall work with the States and 
other appropriate entities to--
          (1) develop and distribute regional and national advisories 
        concerning food safety;
          (2) develop standardized formats for written and broadcast 
        advisories; and
          (3) incorporate State and local advisories into the national 
        public education program required under subsection (a).

SEC. 123. RESEARCH.

  The Secretary shall conduct research to assist in the implementation 
of this Act, including studies to--
          (1) improve sanitation and food safety practices in the 
        production, harvesting, and processing of food products;
          (2) develop improved techniques for the monitoring of food 
        and inspection of food products;
          (3) develop efficient, rapid, and sensitive methods for 
        determining and detecting the presence of contaminants in food 
        products;
          (4) determine the sources of contamination of food and food 
        products, including critical points of risk for fresh produce 
        and other raw agricultural commodities;
          (5) develop consumption data with respect to food products;
          (6) draw upon research and educational programs that exist at 
        the State and local level;
          (7) utilize the DNA matching system and other processes to 
        identify and control pathogens;
          (8) address common and emerging zoonotic diseases;
          (9) develop methods to reduce or destroy pathogens before, 
        during, and after processing;
          (10) analyze the incidence of antibiotic resistance as it 
        pertains to the food supply and evaluate methods to reduce the 
        transfer of antibiotic resistance to humans; and
          (11) conduct other research that supports the purposes of 
        this Act.

                          Subtitle C--Response

SEC. 131. PROCEDURES FOR SEIZURE.

  Section 304(b) (21 U.S.C. 334(b)) is amended by inserting ``and 
except that, with respect to proceedings relating to food, Rule G of 
the Supplemental Rules of Admiralty or Maritime Claims and Asset 
Forfeiture Actions shall not apply in any such case, exigent 
circumstances shall be deemed to exist for all seizures brought under 
this section, and the summons and arrest warrant shall be issued by the 
clerk of the court without court review in any such case'' after ``in 
any such case shall be tried by jury''.

SEC. 132. ADMINISTRATIVE DETENTION.

  (a) Amendments.--Section 304(h) (21 U.S.C. 334(h)) is amended--
          (1) in paragraph (1)(A), by striking ``credible evidence or 
        information indicating'' and inserting ``reason to believe'';
          (2) in paragraph (1)(A), by striking ``presents a threat of 
        serious adverse health consequences or death to humans or 
        animals'' and inserting ``is adulterated, misbranded, or 
        otherwise in violation of this Act'';
          (3) in paragraph (2), by striking ``30'' and inserting 
        ``60'';
          (4) in paragraph (3), by striking the third sentence; and
          (5) in paragraph (4)(A) by striking the terms ``five'' and 
        ``five-day'' and inserting ``fifteen'' and ``fifteen-day'', 
        respectively.
  (b) Regulations.--The Secretary shall issue regulations or guidance 
to implement the amendments made by this section.
  (c) Effective Date.--The amendments made by this section shall take 
effect 180 days after the date of the enactment of this Act.

SEC. 133. QUARANTINE AUTHORITY FOR FOODS.

  (a) Prohibited Act.--Section 301 (21 U.S.C. 331), as amended by 
sections 110 and 111, is amended by adding at the end by adding the 
following:
  ``(qq) The violation of a quarantine under section 304(i).''.
  (b) In General.--Section 304 (21 U.S.C. 334) is amended by adding at 
the end the following:
  ``(i) Quarantine of Geographic Location.--
          ``(1) Authority to quarantine.--If the Secretary determines 
        that there is credible evidence or information that an article 
        of food presents an imminent threat of serious adverse health 
        consequences or death to humans or animals, the Secretary may 
        quarantine any geographic area within the United States where 
        the Secretary reasonably believes such food is located or from 
        which such food originated. The authority to quarantine 
        includes prohibiting or restricting the movement of food or of 
        any vehicle being used or that has been used to transport or 
        hold such food within the geographic area. Any quarantine under 
        this paragraph shall be no greater than is appropriate, as 
        determined by the Secretary, to protect the public health.
          ``(2) Notification procedures.--Before any quarantine action 
        is taken in any State under this subsection, the Secretary 
        shall notify an appropriate official of the State affected and 
        shall issue a public announcement of--
                  ``(A) the Secretary's findings that support the 
                quarantine action;
                  ``(B) the area affected by the intended quarantine 
                action;
                  ``(C) the reasons for the intended quarantine action; 
                and
                  ``(D) where practicable, an estimate of the 
                anticipated duration of the quarantine.
        The Secretary is not required to make such announcement by 
        publication in the Federal Register, but may use a newspaper, 
        radio or television, the Internet, or any reasonable means to 
        make such announcement.
          ``(3) Nondelegation.--The authority to quarantine under this 
        subsection is limited to the Commissioner of Food and Drugs, 
        the Principal Deputy Commissioner, and the Associate 
        Commissioner for Regulatory Affairs of the Food and Drug 
        Administration.''.

SEC. 134. CRIMINAL PENALTIES.

  Section 303(a) (21 U.S.C. 333) is amended--
          (1) in paragraph (1), by striking ``Any'' and inserting 
        ``Except as provided in paragraph (2) or (3), any''; and
          (2) by adding at the end the following:
  ``(3) Notwithstanding paragraph (1), any person who knowingly 
violates paragraph (a), (b), (c), (k), or (v) of section 301 with 
respect to any food that is misbranded or adulterated shall be 
imprisoned for not more than 10 years or fined in accordance with title 
18, United States Code, or both.''.

SEC. 135. CIVIL PENALTIES FOR VIOLATIONS RELATING TO FOOD.

  (a) In General.--Paragraph (2) of section 303(f) (21 U.S.C. 331 et 
seq.) is amended to read as follows:
  ``(2)(A) Any person who violates a provision of section 301 relating 
to food shall be subject to a civil penalty for each such violation of 
not more than--
          ``(i) $20,000 in the case of an individual, not to exceed 
        $50,000 in a single proceeding; and
          ``(ii) $250,000 in the case of any other person, not to 
        exceed $1,000,000 in a single proceeding.
  ``(B) Any person who knowingly violates a provision of section 301 
relating to food shall be subject to a civil penalty for each such 
violation of not more than--
          ``(i) $50,000 in the case of an individual, not to exceed 
        $100,000 in a single proceeding; and
          ``(ii) $500,000 in the case of any other person, not to 
        exceed $7,500,000 in a single proceeding.
  ``(C) Each violation described in subparagraph (A) or (B) and each 
day during which the violation continues shall be considered to be a 
separate offense.''.
  (b) Effective Date.--The amendment made by subsection (a) applies to 
violations committed on or after the date of the enactment of this Act.

SEC. 136. IMPROPER IMPORT ENTRY FILINGS.

  (a) Prohibited Acts.--Section 301 (21 U.S.C. 331), as amended by 
sections 110, 111, and 133, is amended by adding at the end the 
following:
  ``(rr) The submission of information relating to food that is 
required by or under section 801 that is inaccurate or incomplete.
  ``(ss) The failure to submit information relating to food that is 
required by or under section 801.''.
  (b) Documentation for Imports.--Section 801 (21 U.S.C. 381), as 
amended by section 109, is amended by adding at the end the following:
  ``(q) Documentation.--
          ``(1) Submission.--The Secretary may require by regulation or 
        guidance the submission of documentation or other information 
        for articles of food that are imported or offered for import 
        into the United States.
          ``(2) Format.--A regulation or guidance under paragraph (1) 
        may specify the format for submission of the documentation or 
        other information.''.

                        TITLE II--MISCELLANEOUS

SEC. 201. FOOD SUBSTANCES GENERALLY RECOGNIZED AS SAFE.

  Section 409 (21 U.S.C. 348) is amended by adding at the end the 
following:

               ``Substances Generally Recognized as Safe

  ``(k)(1) Not later than 60 days after the date of receipt by the 
Secretary, after the date of the enactment of this subsection, of a 
determination that a substance is a GRAS food substance, the Secretary 
shall post notice of such determination and the supporting scientific 
justifications on the Food and Drug Administration's public Web site.
  ``(2) Not later than 60 days after the date of receipt of a request 
under paragraph (1), the Secretary shall acknowledge receipt of such 
request by informing the requester in writing of the date on which the 
request was received.
  ``(3) In this subsection, the term `GRAS food substance' means a 
substance excluded from the definition of the term `food additive' in 
section 201(s) because such substance is generally recognized, among 
experts qualified by scientific training and experience to evaluate its 
safety, as having been adequately shown through scientific procedures 
(or, in the case of a substance used in food prior to January 1, 1958, 
through either scientific procedures or experience based on common use 
in food) to be safe under the conditions of its intended use.''.

SEC. 202. COUNTRY OF ORIGIN LABELING; DISCLOSURE OF SOURCE OF 
                    INGREDIENTS.

  (a) Misbranding.--Section 403 (21 U.S.C. 343), as amended by sections 
101(a), 109(a), and 114(a), is amended by adding at the end the 
following:
  ``(cc) In the case of a processed food, if the labeling of the food 
fails to identify the country in which the final processing of the food 
occurs.
  ``(dd) In the case of nonprocessed food, if the labeling of the food 
fails to identify the country of origin of the food.''.
  (b) Regulations.--
          (1) Promulgation.--Not later than 180 days after the date of 
        the enactment of this Act, the Secretary of Health and Human 
        Services shall promulgate final regulations to carry out 
        paragraphs (cc) and (dd) of section 403 of the Federal Food, 
        Drug, and Cosmetic Act, as added by subsection (a).
          (2) Relation to other requirements.--Regulations promulgated 
        under paragraph (1) shall provide that labeling meets the 
        requirements of paragraphs (cc) and (dd) of section 403 of the 
        Federal Food, Drug, and Cosmetic Act, as added by subsection 
        (a), if--
                  (A) in the case of a processed food, the label of the 
                food informs the consumer of the country where the 
                final processing of the food occurred in accordance 
                with labeling requirements of the United States Customs 
                and Border Protection; or
                  (B) in the case of a nonprocessed food, the label of 
                the food informs the consumer of the country of origin 
                of the food in accordance with labeling requirements of 
                the Department of Agriculture.
  (c) Effective Date.--The requirements of paragraphs (cc) and (dd) of 
section 403 of the Federal Food, Drug, and Cosmetic Act, as added by 
subsection (a), take effect on the date that is 2 years after the date 
of the enactment of this Act.

SEC. 203. EXPORTATION CERTIFICATE PROGRAM.

  Section 801(e)(4) (21 U.S.C. 381) is amended--
          (1) in the matter preceding clause (i) in subparagraph (A)--
                  (A) by inserting ``from the United States'' after 
                ``exports''; and
                  (B) by striking ``a drug, animal drug, or device'' 
                and inserting ``a food (including animal feed), drug, 
                animal drug, or device'';
          (2) in subparagraph (A)(i)--
                  (A) by striking ``in writing''; and
                  (B) by striking ``exported drug, animal drug, or 
                device'' and inserting ``exported food, drug, animal 
                drug, or device'';
          (3) in subparagraph (A)(ii)--
                  (A) by striking ``in writing'';
                  (B) by striking ``the drug, animal drug, or device'' 
                and inserting ``the food, drug, animal drug, or 
                device''; and
                  (C) by striking ``the drug or device'' and inserting 
                ``the food, drug, or device'';
          (4) by redesignating subparagraph (B) as subparagraph (C);
          (5) by inserting after subparagraph (A) the following:
  ``(B) For purposes of this paragraph, a certification by the 
Secretary shall be made on such basis and in such form (such as a 
publicly available listing) as the Secretary determines appropriate.''; 
and
          (6) by adding at the end the following:
  ``(D) Notwithstanding subparagraph (C), if the Secretary issues an 
export certification within the 20 days prescribed by subparagraph (A) 
with respect to the export of food, a fee for such certification shall 
not exceed such amount as the Secretary determines is reasonably 
related to the cost of issuing certificates under subparagraph (A) with 
respect to the export of food. The Secretary may adjust this fee 
annually to account for inflation and other cost adjustments. Fees 
collected for a fiscal year pursuant to this subparagraph shall be 
credited to the appropriation account for salaries and expenses of the 
Food and Drug Administration and shall be available in accordance with 
appropriations Acts until expended, without fiscal year limitation. 
Such fees shall be collected in each fiscal year in an amount equal to 
the amount specified in appropriations Acts for such fiscal year and 
shall only be collected and available for the costs of the Food and 
Drug Administration to cover the cost of issuing such certifications. 
Such sums as necessary may be transferred from such appropriation 
account for salaries and expenses of the Food and Drug Administration 
without fiscal year limitation to such appropriation account for 
salaries and expenses with fiscal year limitation.''.

SEC. 204. REGISTRATION FOR COMMERCIAL IMPORTERS OF FOOD; FEE.

  (a) Registration.--
          (1) Prohibitions.--Section 301 (21 U.S.C. 331), as amended by 
        sections 110, 111, 133, and 136, is amended by adding at the 
        end the following:
  ``(tt) The failure to register in accordance with section 801(r).''.
          (2) Misbranding.--Section 403 (21 U.S.C. 343) as amended by 
        sections 101(a), 109(a), 114(a), and 202(a), is amended by 
        adding at the end the following:
  ``(ee) If it is imported or offered for import by an importer not 
duly registered under section 801(r).''.
          (3) Registration.--Section 801, as amended by sections 109 
        and 136, is amended by adding at the end the following:
  ``(r) Registration of Importers.--
          ``(1) Registration.--The Secretary shall require an importer 
        of food--
                  ``(A) to be registered with the Secretary in a form 
                and manner specified by the Secretary; and
                  ``(B) consistent with section 911, to submit 
                appropriate unique facility identifiers as a condition 
                of registration.
          ``(2) Good importer practices.--The maintenance of 
        registration under this subsection is conditioned on compliance 
        with good importer practices. Good importer practices shall 
        include the verification of good manufacturing practices and 
        preventive controls of the importer's foreign suppliers, as 
        applicable.
          ``(3) Suspension of registration.--
                  ``(A) In general.--Registration under this subsection 
                is subject to suspension upon a finding by the 
                Secretary, after notice and an opportunity for an 
                informal hearing, of--
                          ``(i) a violation of this Act; or
                          ``(ii) the knowing or repeated making of an 
                        inaccurate or incomplete statement or 
                        submission of information relating to the 
                        importation of food.
                  ``(B) Request.--The importer whose registration is 
                suspended may request that the Secretary vacate the 
                suspension of registration when such importer has 
                corrected the violation that is the basis for such 
                suspension.
                  ``(C) Vacating of suspension.--If the Secretary 
                determines that adequate reasons do not exist to 
                continue the suspension of a registration, the 
                Secretary shall vacate such suspension.
          ``(4) Cancellation of registration.--
                  ``(A) In general.--Not earlier than 10 days after 
                providing the notice under subparagraph (B), the 
                Secretary may 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 
                no later than 7 days after notice is provided under 
                subparagraph (B), the Secretary shall not cancel such 
                registration.
          ``(5) 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.''.
          (4) Regulations.--Not later than 24 months after the date of 
        the enactment of this Act, the Secretary of Health and Human 
        Services shall promulgate the regulations required to carry out 
        section 801(r) of the Federal Food, Drug, and Cosmetic Act, as 
        added by paragraph (3).
          (5) Effective date.--The amendments made by this subsection 
        shall take effect on the date that is 24 months after the date 
        of enactment of this Act.
  (b) Fee.--Subchapter C of chapter VII (21 U.S.C. 379f et seq.) as 
added and amended by sections 101 and 108, is amended by adding at the 
end the following:

                      ``PART 7--IMPORTERS OF FOOD

``SEC. 744. IMPORTERS OF FOOD.

  ``(a) Importers.--The Secretary shall assess and collect an annual 
fee for the registration of an importer of food under section 801(r).
  ``(b) Amount of Fee.--
          ``(1) Base amounts.--The registration fee under subsection 
        (a) shall be--
                  ``(A) for fiscal year 2010, $500; and
                  ``(B) for fiscal year 2011 and each subsequent fiscal 
                year, the fee for fiscal year 2010 as adjusted under 
                paragraph (2).
          ``(2) Adjustment.--For fiscal year 2011 and subsequent fiscal 
        years, the fees established pursuant to paragraph (1) shall be 
        adjusted by the Secretary by notice, published in the Federal 
        Register, for a fiscal year to reflect the greater of--
                  ``(A) 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 for 
                which fees are being established;
                  ``(B) the total percentage change for the previous 
                fiscal year in basic pay under the General Schedule in 
                accordance with section 5332 of title 5, United States 
                Code, as adjusted by any locality-based comparability 
                payment pursuant to section 5304 of such title for 
                Federal employees stationed in the District of 
                Columbia; or
                  ``(C) the average annual change in the cost, per 
                full-time equivalent position of the Food and Drug 
                Administration, of all personnel compensation and 
                benefits paid with respect to such positions for the 
                first 5 years of the preceding 6 fiscal years.
          ``(3) Compounded basis.--The adjustment made each fiscal year 
        pursuant this subsection shall be added on a compounded basis 
        to the sum of all adjustments made each fiscal year after 
        fiscal year 2010 under this subsection.
          ``(4) Waiver for importers required to pay registration 
        fee.--In the case of a person who is required to pay both a fee 
        under section 743 for registration of one or more facilities 
        under section 415 and a fee under this section for registration 
        as an importer of food under section 801(r), the Secretary 
        shall waive the fees applicable to such person under section 
        743 or the fee applicable to such person under this section.
  ``(c) Crediting and Availability of Fees.--
          ``(1) In general.--Fees authorized under subsection (a) shall 
        be collected and available for obligation only to the extent 
        and in the amount provided in advance 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 appropriation 
        account without fiscal year limitation to such appropriation 
        account for salaries and expenses with such fiscal year 
        limitation.
          ``(2) Collections and appropriations acts.--The fees 
        authorized by this section--
                  ``(A) shall be retained in each fiscal year in an 
                amount not to exceed the amount specified in 
                appropriation Acts, or otherwise made available for 
                obligation, for such fiscal year; and
                  ``(B) shall only be collected and available to cover 
                the costs associated with registering importers under 
                section 801(r) and with ensuring compliance with good 
                importer practices respecting food.
          ``(3) Authorization of appropriations.--For each of fiscal 
        years 2010 through 2014, there are authorized to be 
        appropriated for fees under this section such sums as may be 
        necessary.''.
  (c) Inspection.--Section 704 (21 U.S.C. 374), as amended by section 
105, is amended by adding at the end the following:
  ``(i) Importers.--Every person engaged in the importing of any food 
shall, upon request of an officer or employee designated by the 
Secretary, permit such officer or employee at all reasonable times to 
inspect the facilities of such person and have access to, and to copy 
and verify, any related records.''.

SEC. 205. REGISTRATION FOR CUSTOMS BROKERS AND FILERS; FEE.

  (a) Registration.--
          (1) Prohibitions.--Section 301(tt) (21 U.S.C. 331), as added 
        by section 204, is amended by inserting ``or 801(s)'' after 
        ``801(r)''.
          (2) Misbranding.--Section 403(ee) (21 U.S.C. 343), as added 
        by section 204, is amended--
                  (A) by inserting ``or a customs broker or filer'' 
                after ``by an importer''; and
                  (B) by inserting ``or 801(s)'' after ``801(r)''.
          (3) Registration.--Section 801, as amended by sections 109, 
        136, and 204, is amended by adding at the end the following:
  ``(s) Registration of Customs Brokers and Filers.--
          ``(1) Registration.--The Secretary shall require a customs 
        broker or filer, with respect to the importation of food--
                  ``(A) to be registered with the Secretary in a form 
                and manner specified by the Secretary; and
                  ``(B) consistent with section 911, to submit 
                appropriate unique facility identifiers as a condition 
                of registration.
          ``(2) Suspension of registration.--
                  ``(A) In general.--Registration under this subsection 
                is subject to suspension upon a finding by the 
                Secretary, after notice and an opportunity for an 
                informal hearing, of--
                          ``(i) a violation of this Act; or
                          ``(ii) the knowing or repeated making of an 
                        inaccurate or incomplete statement or 
                        submission of information relating to the 
                        importation of food.
                  ``(B) Request.--The customs broker or filer whose 
                registration is suspended may request that the 
                Secretary vacate the suspension of registration when 
                such customs broker or filer has corrected the 
                violation that is the basis for such suspension.
                  ``(C) Vacating of suspension.--If the Secretary 
                determines that adequate reasons do not exist to 
                continue the suspension of a registration, the 
                Secretary shall vacate such suspension.
          ``(3) Cancellation of registration.--
                  ``(A) In general.--Not earlier than 10 days after 
                providing the notice under subparagraph (B), the 
                Secretary may 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 customs broker or filer of 
                the intent to cancel the registration and the basis for 
                such cancellation.
                  ``(C) Timely update or correction.--If the 
                registration for the customs broker or filer is updated 
                or corrected no later than 7 days after notice is 
                provided under subparagraph (B), the Secretary shall 
                not cancel such registration.
          ``(4) 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.''.
          (4) Regulations.--Not later than 24 months after the date of 
        the enactment of this Act, the Secretary of Health and Human 
        Services shall promulgate the regulations required to carry out 
        section 801(s) of the Federal Food, Drug, and Cosmetic Act, as 
        added by paragraph (3).
          (5) Effective date.--The amendments made by this subsection 
        shall take effect on the date that is 24 months after the date 
        of enactment of this Act.
  (b) Inspection.--Section 704 (21 U.S.C. 374), as amended by sections 
105 and 204, is amended by adding at the end the following:
  ``(j) Brokers and Filers.--Every person engaged in the brokering for 
import or filing for import of any food shall, upon request of an 
officer or employee designated by the Secretary, permit such officer or 
employee at all reasonable times to inspect the facilities of such 
person and have access to, and to copy and verify, any related 
records.''.

SEC. 206. UNIQUE IDENTIFICATION NUMBER FOR FOOD FACILITIES, IMPORTERS, 
                    CUSTOM BROKERS, AND FILERS.

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

``SEC. 911. UNIQUE FACILITY IDENTIFIER.

  ``(a) Registration of Facility or Establishment.--A person required 
to register a facility pursuant to section 415 shall submit, at the 
time of registration, a unique facility identifier for the facility or 
establishment.
  ``(b) Registration of Importers, Custom Brokers, and Filers.--A 
person required to register pursuant to section 801(r) or 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(r) or 801(s).
  ``(c) Guidance.--The Secretary may, by guidance, specify the unique 
numerical identifier system to be used to meet the requirements of 
subsections (a) and (b) and the form, manner, and timing of a 
submission under such subsections.
  ``(d)  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.''.

SEC. 207. PROHIBITION AGAINST DELAYING, LIMITING, OR REFUSING 
                    INSPECTION.

  (a) Adulteration.--Section 402 (21 U.S.C. 342), as amended by 
sections 102, 103(a), and 104(a), is amended by adding at the end the 
following:
  ``(n) If it has been produced, manufactured, processed, packed, or 
held in any farm, factory, warehouse, or establishment and the owner, 
operator, or agent of such farm, factory, warehouse, or establishment, 
or any agent of a governmental authority in the foreign country within 
which such farm, factory, warehouse, or establishment is located, 
delays or limits an inspection, or refuses to permit entry or 
inspection, under section 414 or 704.''.
  (b) Foreign Inspections.--Section 704(a)(1) (21 U.S.C. 374(a)(1)), as 
amended by section 106(c), is amended--
          (1) in the first sentence, by inserting ``, including any 
        such food factory, warehouse, or establishment whether foreign 
        or domestic,'' after ``factory, warehouse, or establishment''; 
        and
          (2) in the third sentence, by inserting ``, including any 
        food factory, warehouse, establishment, or consulting 
        laboratory whether foreign or domestic,'' after ``factory, 
        warehouse, establishment, or consulting laboratory''.

SEC. 208. DEDICATED FOREIGN INSPECTORATE.

  Section 704 (21 U.S.C. 374), as amended by sections 105, 204, and 
205, is amended by adding at the end the following:
  ``(k) Dedicated Foreign Inspectorate.--The Secretary shall establish 
and maintain a corps of inspectors dedicated to inspections of foreign 
food facilities. This corps shall be staffed and funded by the 
Secretary at a level sufficient to enable it to assist the Secretary in 
achieving the frequency of inspections for food facilities as described 
in this Act.''.

SEC. 209. PLAN AND REVIEW OF CONTINUED OPERATION OF FIELD LABORATORIES.

  (a) Submission of Plan.--Not later than 90 days before the Secretary 
terminates or consolidates any laboratory, district office, or the 
functions (including the inspection and compliance functions) of any 
such laboratory or district office, specified in subsection (b), the 
Secretary shall submit a reorganization plan to the Comptroller General 
of the United States, the Committee on Energy and Commerce of the House 
of Representatives, and the Committee on Health, Education, Labor, and 
Pensions of the Senate.
  (b) Specified Laboratories and Offices.--The laboratories and offices 
specified in this subsection are the following:
          (1) Any of the 13 field laboratories responsible for 
        analyzing food that were operated by the Office of Regulatory 
        Affairs of the Food and Drug Administration as of January 1, 
        2007.
          (2) Any of the 20 district offices of the Food and Drug 
        Administration with responsibility for food safety functioning 
        as of January 1, 2007.
  (c) Congressional Review.--A reorganization plan described in 
subsection (a) is deemed to be a major rule (as defined in section 
804(2) of title 5, United States Code) for purposes of chapter 8 of 
such title.

SEC. 210. FALSE OR MISLEADING REPORTING TO FDA.

  (a) In General.--Section 301(q)(2) (21 U.S.C. 331(q)(2)) is amended 
by inserting after ``device'' the following: ``or food''.
  (b) Effective Date.--The amendment made by subsection (a) shall apply 
to submissions made on or after the date of the enactment of this Act.

SEC. 211. SUBPOENA AUTHORITY.

  (a) Prohibited Act.--Section 301(f) is amended by inserting before 
the period the following: ``or the failure or refusal to obey a 
subpoena issued pursuant to section 311''.
  (b) Amendment.--Chapter III (21 U.S.C. 331 et seq.) is amended by 
adding at the end the following:

``SEC. 311. EXERCISE OF SUBPOENA AUTHORITY.

  ``(a) In General.--For the purpose of--
          ``(1) any hearing, investigation, or other proceeding 
        respecting a violation of a provision of this Act, the Public 
        Health Service Act, or the Federal Anti-Tampering Act, relating 
        to food; or
          ``(2) any hearing, investigation, or other proceeding to 
        determine if a person is in violation of a specific provision 
        of this Act, the Public Health Service Act, or the Federal 
        Anti-Tampering Act, relating to food,
the Commissioner may issue subpoenas requiring the attendance and 
testimony of witnesses and the production of records and other things.
  ``(b) Timing of Compliance.--When the Commissioner deems that 
immediate compliance with a subpoena issued under this section is 
necessary to address a threat of serious adverse health consequences or 
death, the subpoena may require immediate production.
  ``(c) Service of Subpoena.--
          ``(1) In general.--Subpoenas of the Commissioner shall be 
        served by a person authorized by the Commissioner by delivering 
        a copy thereof to the person named therein or by certified mail 
        addressed to such person at such person's last known dwelling 
        place or principal place of business.
          ``(2) Corporations and other entities.--Service on a domestic 
        or foreign corporation, partnership, unincorporated 
        association, or other entity that is subject to suit under a 
        common name may be made by delivering the subpoena to an 
        officer, a managing or general agent, or any other agent 
        authorized by appointment or by law to receive service of 
        process.
          ``(3) Person outside u.s. jurisdiction.--Service on any 
        person not found within the territorial jurisdiction of any 
        court of the United States may be made in any manner as the 
        Federal Rules of Civil Procedure prescribe for service in a 
        foreign nation.
          ``(4) Proof of service.--A verified return by the person so 
        serving the subpoena setting forth the manner of service, or, 
        in the case of service by certified mail, the return post 
        office receipt therefor signed by the person so served, shall 
        be proof of service.
  ``(d) Payment of Witnesses.--Witnesses subpoenaed under subsection 
(a) shall be paid the same fees and mileage as are paid witnesses in 
the district courts of the United States.
  ``(e) Enforcement.--In the case of a refusal to obey a subpoena duly 
served upon any person under subsection (a), any district court of the 
United States for the judicial district in which such person charged 
with refusal to obey is found, resides, or transacts business, upon 
application by the Commissioner, shall have jurisdiction to issue an 
order compelling compliance with the subpoena and requiring such person 
to appear and give testimony or to appear and produce records and other 
things, or both. The failure to obey such order of the court may be 
punished by the court as contempt thereof. If the person charged with 
failure or refusal to obey is not found within the territorial 
jurisdiction of the United States, the United States District Court for 
the District of Columbia shall have the same jurisdiction, consistent 
with due process, to take any action respecting compliance with the 
subpoena by such person that such district court would have if such 
person were personally within the jurisdiction of such district court.
  ``(f) Nondisclosure.--A United States district court for the district 
in which the subpoena is or will be served, upon application of the 
Commissioner, may issue an ex parte order that no person or entity 
disclose to any other person or entity (other than to an attorney to 
obtain legal advice) the existence of such subpoena for a period of up 
to 90 days. Such order may be issued on a showing that the records or 
things being sought may be relevant to the hearing, investigation, 
proceeding, or other matter and that there is reason to believe that 
such disclosure may result in--
          ``(1) furtherance of a potential violation under 
        investigation;
          ``(2) endangerment to the life or physical safety of any 
        person;
          ``(3) flight or other action to avoid prosecution or other 
        enforcement remedies;
          ``(4) destruction of or tampering with evidence; or
          ``(5) intimidation of potential witnesses.
An order under this subsection may be renewed for additional periods of 
up to 90 days upon a showing that any of the circumstances described in 
paragraphs (1) through (5) continue to exist.
  ``(g) Relation to Other Provisions.--The subpoena authority vested in 
the Commissioner and the district courts of the United States by this 
section is in addition to any such authority vested in the Commissioner 
or such courts by other provisions of law.
  ``(h) Nondelegation.--The authority to issue a subpoena under this 
section is limited to the Secretary or an official designated by the 
Secretary. An official may not be so designated unless the official is 
the director of the district under this Act in which the article 
involved is located, or is an official senior to such director.''.

SEC. 212. WHISTLEBLOWER PROTECTIONS.

  Chapter IX (21 U.S.C. 391 et seq.), as amended by section 206, is 
amended by adding at the end the following:

``SEC. 912. PROTECTIONS FOR EMPLOYEES WHO REFUSE TO VIOLATE, OR WHO 
                    DISCLOSE VIOLATIONS OF, THIS ACT OR SECTION 351 OF 
                    THE PUBLIC HEALTH SERVICE ACT.

  ``(a) In General.--No person who submits or is required under this 
Act or the Public Health Service Act to submit any information related 
to a food, or any officer, employee, contractor, subcontractor, or 
agent of such person may discharge, demote, suspend, threaten, harass, 
or in any other manner discriminate against an employee in the terms 
and conditions of employment because of any lawful act done by the 
employee, including within the ordinary course of the job duties of 
such employee--
          ``(1) to provide information, cause information to be 
        provided, or otherwise assist in any investigation regarding 
        any conduct which the employee reasonably believes constitutes 
        a violation of this Act, or any other provision of Federal law 
        relating to the safety of a food, if the information or 
        assistance is provided to, or an investigation stemming from 
        the provided information is conducted by--
                  ``(A) a Federal regulatory or law enforcement agency;
                  ``(B) any Member of Congress or any committee of 
                Congress; or
                  ``(C) a person with supervisory authority over the 
                employee (or such other person working for the employer 
                who has the authority to investigate, discover, or 
                terminate the misconduct);
          ``(2) to file, cause to be filed, testify, participate in, or 
        otherwise assist in a proceeding filed, or about to be filed 
        (with any knowledge of the employer), in any court or 
        administrative forum relating to any such alleged violation; or
          ``(3) to refuse to commit or assist in any such violation.
  ``(b) Enforcement Action.--
          ``(1) In general.--An employee who alleges discharge or other 
        discrimination in violation of subsection (a) may seek relief 
        in accordance with the provisions of subsection (c) by--
                  ``(A) filing a complaint with the Secretary of Labor; 
                or
                  ``(B) if the Secretary of Labor has not issued a 
                final decision within 210 days of the filing of the 
                complaint and there is no showing that such delay is 
                due to the bad faith of the claimant, or within 90 days 
                after receiving a final decision or order from the 
                Secretary, bringing an action at law or equity for de 
                novo review in the appropriate district court of the 
                United States, which court shall have jurisdiction over 
                such 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.
          ``(2) Procedure.--
                  ``(A) In general.--Any action under paragraph (1) 
                shall be governed under the rules and procedures set 
                forth in section 42121(b) of title 49, United States 
                Code.
                  ``(B) Exception.--Notification in an action under 
                paragraph (1) shall be made in accordance with section 
                42121(b)(1) of title 49, United States Code, except 
                that such notification shall be made to the person 
                named in the complaint and to the employer.
                  ``(C) Burdens of proof.--An action brought under 
                paragraph (1)(B) shall be governed by the legal burdens 
                of proof set forth in section 42121(b) of title 49, 
                United States Code.
                  ``(D) Statute of limitations.--An action under 
                paragraph (1) shall be commenced not later than 180 
                days after the date on which the violation occurs.
  ``(c) Remedies.--
          ``(1) In general.--An employee prevailing in any action under 
        subsection (b)(1) shall be entitled to all relief necessary to 
        make the employee whole.
          ``(2) Issuance of order.--If, in response to a complaint 
        filed under subsection (b)(1), the Secretary of Labor or the 
        district court, as applicable, determines that a violation of 
        subsection (a) has occurred, the Secretary or the court shall 
        order the person who committed such violation--
                  ``(A) to take affirmative action to abate the 
                violation;
                  ``(B) to--
                          ``(i) reinstate the complainant to his or her 
                        former position together with compensation 
                        (including backpay); and
                          ``(ii) restore the terms, conditions, and 
                        privileges associated with his or her 
                        employment; and
                  ``(C) to provide compensatory damages to the 
                complainant.
        If such an order is issued under this paragraph, the Secretary 
        or the court, 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 
        attorney 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) Rights Retained by Employee.--Nothing in this section shall be 
deemed 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.''.

SEC. 213. EXTRATERRITORIAL JURISDICTION.

  (a) Prohibited Act.--Section 301 (21 U.S.C. 331), as amended by 
sections 110, 111, 133, 136, and 204, is amended by adding at the end 
the following:
  ``(uu) The production, manufacture, processing, preparation, packing, 
holding, or distribution of an adulterated or misbranded food with the 
knowledge or intent that such article will be imported into the United 
States.''.
  (b) Jurisdiction.--Chapter III (21 U.S.C. 331 et seq.), as amended by 
section 211, is amended by adding at the end the following:

``SEC. 312. EXTRATERRITORIAL JURISDICTION.

  ``There is extraterritorial Federal jurisdiction over any violation 
of this Act relating to any article of food if such article was 
intended for import into the United States or if any act in furtherance 
of the violation was committed in the United States.''.

SEC. 214. SUPPORT FOR TRAINING INSTITUTES.

  The Secretary of Health and Human Services, acting through the 
Commissioner of Food and Drugs, shall provide financial and other 
assistance to appropriate entities to establish and maintain one or 
more university-affiliated food protection training institutes that--
          (1) conduct training related to food protection activities 
        for Federal, State, local, territorial, and tribal officials; 
        and
          (2) meet standards developed by the Secretary.

SEC. 215. BISPHENOL A IN FOOD AND BEVERAGE CONTAINERS.

  (a) Notice of Determination.--No later than December 31, 2009, the 
Secretary of Health and Human Services shall notify the Congress 
whether the available scientific data support a determination that 
there is a reasonable certainty of no harm, for infants, young 
children, pregnant women, and adults, for approved uses of 
polycarbonate plastic and epoxy resin made with bisphenol A in food and 
beverage containers, including reusable food and beverage containers, 
under the conditions of use prescribed in current Food and Drug 
Administration regulations.
  (b) Notice of Actions to Be Taken.--If the Secretary concludes that 
such a determination cannot be made for any approved use, the Secretary 
shall notify the Congress of the actions the Secretary intends to take 
under the Secretary's authority to regulate food additives to protect 
the public health, which may include--
          (1) revoking or modifying any of the approved uses of 
        bisphenol A in food and beverage containers, including reusable 
        food and beverage containers; and
          (2) ensuring that the public is sufficiently informed of such 
        determination and the steps the public may take in response to 
        such determination.
  (c) Rule of Construction.--Nothing herein is intended or shall be 
construed to modify existing Food and Drug Administration authority, 
procedures, or policies for assessing scientific data, making safety 
determinations, or regulating the safe use of food additives.

                          Purpose and Summary

    H.R. 2749, the Food Safety Enhancement Act of 2009, is to 
amend the Federal Food, Drug, and Cosmetic Act to improve the 
safety of food, and for other purposes.
    A primary focus of H.R. 2749 is preventing food safety 
problems before they occur. Under the legislation, food 
facilities must implement preventive food safety plans in order 
to identify potential food hazards and take steps to prevent 
them from occurring. H.R. 2749 grants the Secretary the 
authority to issue mandatory performance standards for reducing 
hazards. The legislation also requires the Secretary to conduct 
more frequent risk-based inspections and expands the 
Secretary's access to food safety records. H.R. 2749 increases 
the Secretary's ability to oversee the safety of imported food 
by permitting the Secretary to require safety-related 
documentation for potentially unsafe imported food as a 
condition of import.
    H.R. 2749 provides the Secretary with enhanced tools to 
address food-borne illness outbreaks when they do occur. H.R. 
2749 requires the Secretary to establish, by regulation after a 
public input process, a system for the rapid tracing of the 
origin of food. The legislation also grants the Secretary the 
authority to mandate recalls of contaminated food and to 
quarantine geographic areas of the United States from which the 
Secretary reasonably believes contaminated food originated.
    To enable the Secretary to better account for entities 
involved in the manufacture, processing, packing, holding, and 
import of food, H.R. 2749 requires food facilities, importers, 
custom brokers, and filers to register with the Secretary 
annually and to provide certain information related to the 
entity. Facilities and importers are also required to pay an 
annual registration fee in the amount of $500.
    To increase the development and dissemination of food 
safety information, H.R. 2749 requires the Secretary to enhance 
food-borne illness surveillance systems, to design and 
implement a national public education program on food safety, 
and to conduct extensive food safety-related research.
    H.R. 2749 provides the Secretary with enhanced enforcement 
tools for food-related violations, including civil monetary 
penalties, increased criminal penalties, and subpoena 
authority.

                  Background and Need for Legislation

    There is substantial evidence that the nation's food safety 
system could be improved to better address potential food 
safety threats. There has been a string of food-borne illness 
outbreaks in recent years in foods consumed by millions of 
Americans each day such as pistachios, peanuts, and spinach. As 
numerous reports and congressional hearings have shown, the 
ability of the Food and Drug Administration (FDA) to oversee 
the safety of our food supply is compromised by inadequate 
authorities and insufficient resources.\1\
---------------------------------------------------------------------------
    \1\See, e.g., Food and Drug Administration, Science and Mission at 
Risk, Report of the Subcommittee on Science and Technology (Nov. 2007) 
(online at www.fda.gov/ohrms/dockets/ac/07/briefing/2007-
4329b_02_01_FDA%20Report%20on%20 Science%20and%20Technology.pdf); U.S. 
Government Accountability Office, High Risk Series: An Update (Jan. 
2009) (online at www.gao.gov/new.items/d09271.pdf); U.S. Government 
Accountability Office, Food Safety: Improvements Needed in FDA 
Oversight of Fresh Produce (Sept. 26, 2008) (online at www.gao.gov/
new.items/d081047.pdf); House Committee on Energy and Commerce, 
Subcommittee on Oversight and Investigations, The Salmonella Outbreak: 
The Continued Failure to Protect the Food Supply, 111th Cong. (Feb. 11, 
2009) (online at http://energycommerce.house.gov/
index.php?option=com_content&task=view&id=1492&Itemid=95); House 
Committee on Energy and Commerce, Subcommittee on Oversight and 
Investigations, The Recent Salmonella Outbreak: Lessons Learned and 
Consequences to Industry and Public Health (July 31, 2008); House 
Committee on Energy and Commerce, Subcommittee on Oversight and 
Investigations, American Lives Still at Risk: When Will FDA's Food 
Protection Plan Be Fully Funded and Implemented? (June 12, 2008) 
(online at http://energycommerce.house.gov/
index.php?option=com_content&task=view&id=1392&Itemid=106); House 
Committee on Energy and Commerce, Subcommittee on Health, Discussion 
Draft of the `Food and Drug Administration Globalization Act' 
Legislation: Food Provisions (Apr. 24, 2008) (online at http://
energycommerce.house.gov/
index.php?option=com_content&task=view&id=655&Itemid=106).
---------------------------------------------------------------------------

                          Legislative History

    H.R. 2749 was introduced on June 8, 2009, by Chairman 
Emeritus Dingell, Chairman Waxman, Subcommittee on Health 
Chairman Pallone, and Reps. DeGette and Sutton. H.R. 2749 
builds upon the food-related provisions in H.R. 759, the Food 
and Drug Administration Globalization Act of 2009, introduced 
by Chairmen Dingell, Pallone, and Stupak on January 28, 2009. 
Prior to the bill's introduction, the Subcommittee on Health 
held a legislative hearing on the discussion draft of the Food 
Safety Enhancement Act of 2009 on June 3, 2009. There were 
three hearings on food safety held in the 111th Congress by the 
Subcommittee on Oversight and Investigations (February 11, 
2009, and March 19, 2009) and by the Subcommittee on Health 
(March 11, 2009). These hearings built upon the hearings held 
in the 110th Congress on the safety of the nation's food 
supply.

                        Committee Consideration

    The Subcommittee on Health met in open markup session on 
Wednesday, June 10, 2009, to consider H.R. 2749. An amendment 
in the nature of a substitute, offered as a manager's amendment 
by Chairman Pallone to H.R. 2749, made substantive changes to 
the bill as introduced. The Pallone manager's amendment was 
adopted by a voice vote. The Subcommittee favorably forwarded 
H.R. 2749, amended, to the full Committee by a voice vote.
    The Committee on Energy and Commerce met in open markup 
session on Wednesday, June 17, 2009, to consider H.R. 2749, as 
amended by the Subcommittee on Health on June 10, 2009. An 
amendment in the nature of a substitute, offered by Mr. Waxman 
as a manager's amendment, to the bill as forwarded by the 
Subcommittee on Health, was adopted by a voice vote. H.R. 2749 
was then ordered favorably reported to the House, amended, by a 
voice vote.

                            Committee Votes

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list the record votes 
on the motion to report legislation and amendments thereto. The 
Committee agreed to a motion by Mr. Waxman to order H.R. 2749 
favorably reported to the House, amended, by a voice vote. 
There were no record votes during consideration of the 
legislation.

            Committee Oversight Findings and Recommendations

    In compliance with clause 3(c)(1) of rule XIII and clause 
2(b)(1) of rule X of the Rules of the House of Representatives, 
the oversight findings and recommendations of the Committee are 
reflected in the descriptive portions of this report.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    Regarding compliance with clause 3(c)(2) of rule XIII of 
the Rules of the House of Representatives, the Committee adopts 
as its own the estimate prepared on H.R. 2749 by the Director 
of the Congressional Budget Office pursuant to section 402 of 
the Congressional Budget Act of 1974.

         Statement of General Performance Goals and Objectives

    In accordance with clause 3(c)(4) of rule XIII of the Rules 
of the House of Representatives, the performance goals and 
objectives of the Committee are reflected in the descriptive 
portions of this report.

                   Constitutional Authority Statement

    Pursuant to clause 3(d)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee finds that the 
constitutional authority for this legislation is provided in 
Article I, section 8, clause 18 of the Constitution of the 
United States.

                  Earmarks and Tax and Tariff Benefits

    H.R. 2749 does not include any congressional earmarks, 
limited tax benefits, or limited tariff benefits as defined in 
clause 9(e), 9(f), or 9(g) of rule XXI of the Rules of the 
House of Representatives.

                      Advisory Committee Statement

    The Committee finds that the legislation does not establish 
or authorize the establishment of advisory committees within 
the definition of section 5 U.S.C. App., section 5(b) of the 
Federal Advisory Committee Act.

             Applicability of Law to the Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act of 1985.

                       Federal Mandates Statement

    The Committee adopts as its own the estimates of federal 
mandates on H.R. 2749 prepared by the Director of the 
Congressional Budget Office pursuant to section 423 of the 
Unfunded Mandates Reform Act.

                        Committee Cost Estimate

    The Committee adopts as its own the cost estimate on H.R. 
2749 prepared by the Director of the Congressional Budget 
Office pursuant to section 402 of the Congressional Budget Act.

                  Congressional Budget Office Estimate

    Pursuant to clause 3(c)(3) of rule XIII of the Rules of the 
House of Representatives, the following is the cost estimate on 
H.R. 2749 provided by the Congressional Budget Office pursuant 
to section 402 of the Congressional Budget Act of 1974:

                                     U.S. Congress,
                               Congressional Budget Office,
                                     Washington, DC, July 24, 2009.
Hon. Henry A. Waxman,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for H.R. 2749, the Food 
Safety Enhancement Act of 2009.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Ellen Werble.
            Sincerely,
                                              Douglas W. Elmendorf.
    Enclosure.

H.R. 2749--Food Safety Enhancement Act of 2009

    Summary: H.R. 2749 would require the Department of Health 
and Human Services (HHS) to strengthen federal efforts related 
to ensuring the safety of commercially distributed food. H.R. 
2749 would also broaden the Food and Drug Administration's 
(FDA's) authority to regulate food products, and would require 
the agency to assess fees on food facilities, as well as 
importers and exporters of food products to cover the costs of 
registering and inspecting facilities authorized in the bill. 
Such fees could be collected and made available for obligation 
only to the extent and in the amounts provided in advance in 
appropriations acts.
    CBO estimates that:
           Implementing the bill would increase 
        spending subject to appropriation, on net, by about 
        $2.0 billion over the 2010-2014 period, assuming annual 
        appropriation action consistent with the bill; and
           Federal revenues from civil penalties for 
        food related violations of the Federal Food, Drug, and 
        Cosmetic Act would increase by $10 million over the 
        2010-2014 period and by $20 million over the 2010-2019 
        period.
    H.R. 2749 would impose a number of mandates, as defined in 
the Unfunded Mandates Reform Act (UMRA), on individuals and 
entities involved in producing, manufacturing, processing, 
packing, transporting, distributing, receiving, holding, 
importing, or exporting articles of food. CBO estimates that 
the total cost of those mandates would exceed the threshold 
established in UMRA for private-sector entities ($139 million 
in 2009, adjusted annually for inflation) in each year, 
beginning with 2010. Given the limited number of public 
entities affected by the requirements, CBO estimates that the 
costs of intergovernmental mandates would fall below the 
threshold established in UMRA ($69 million in 2009, adjusted 
annually for inflation).
    Estimated cost to the Federal Government: The estimated 
budgetary impact of H.R. 2749 is shown in the following table. 
The costs of this legislation fall within budget function 550 
(health).

----------------------------------------------------------------------------------------------------------------
                                                              By fiscal year, in millions of dollars--
                                                   -------------------------------------------------------------
                                                      2010      2011      2012      2013      2014     2010-2014
----------------------------------------------------------------------------------------------------------------
                                  CHANGES IN SPENDING SUBJECT TO APPROPRIATION

Food and Drug Administration (FDA):
    Collection of New Fees:
        Estimated Authorization Level.............      -209      -241      -290      -333      -368      -1,441
        Estimated Outlays.........................      -209      -241      -290      -333      -368      -1,441
    Spending of New Fees:
        Estimated Authorization Level.............       209       241       290       333       368       1,441
        Estimated Outlays.........................        66       199       309       352       372       1,298
    Net Changes from Fee Authority:
        Estimated Authorization Level.............         0         0         0         0         0           0
        Estimated Outlays.........................      -143       -43        19        19         4        -144
FDA Activities Not Supported by Fees:
    Estimated Authorization Level.................       -35         4       459       777     1,109       2,314
    Estimated Outlays.............................       -35        -9       368       749     1,084       2,157
Total Changes in Spending Subject to
 Appropriation:
    Estimated Authorization Level.................       -35         4       459       777     1,109       2,314
    Estimated Outlays.............................      -178       -51       387       768     1,088       2,014

                                               CHANGES IN REVENUES

Estimated Revenues from Civil Penalties...........         2         2         2         2         2          10
----------------------------------------------------------------------------------------------------------------
Note: Components may not sum to totals because of rounding.

    Basis of estimate: For this estimate, CBO assumes that H.R. 
2749 will be enacted near the start of fiscal year 2010, that 
the full amounts authorized will be collected (starting in 
fiscal year 2010) to fund FDA's regulatory activities 
authorized under the bill, and that outlays will follow 
historical patterns for similar activities.
    H.R. 2749 would broaden the FDA's authority to regulate 
food facilities. Such authority would include:
           Mandating the annual registration of all 
        establishments that import, export, manufacture, 
        process, pack, or hold food for consumption in the 
        United States, and specifying certain inspection, 
        recordkeeping, and reporting requirements for such 
        facilities;
           Requiring any person who produces, 
        manufactures, processes, packs, transports, 
        distributes, receives, imports, or holds an article of 
        food to permit an officer or employee designated by the 
        Secretary of HHS to have access to their records 
        relating to articles of food that may be adulterated, 
        misbranded, or otherwise in violation of the Federal 
        Food, Drug, and Cosmetic Act;
           Requiring any food facility that violates a 
        food-related requirement of the Federal Food, Drug, and 
        Cosmetic Act that consequently requires a reinspection 
        or food recall shall pay a fee to cover the costs of 
        the reinspection or food recall; and
           Reviewing and evaluating epidemiological 
        data every two years to identify the most significant 
        food-borne contaminants and resulting hazards, and 
        setting national performance standards to minimize the 
        occurrence of such hazards, and establishing national 
        standards for risk-based preventive controls, hazard 
        analysis, safe growing, harvesting, processing, 
        packing, sorting, transporting, and holding of raw 
        agricultural products.
    H.R. 2749 also would require the FDA to inspect registered 
food facilities on a risk-based schedule beginning no later 
than 18 months after enactment. The Secretary of Health and 
Human Services may recognize federal, state, and local 
officials, and agencies and representatives of foreign 
countries to conduct inspections. The frequency of the 
inspections shall be determined by the category of the 
facility:
           A category 1 facility is a high-risk 
        facility that manufactures or processes food and must 
        be inspected at least once every 6 to 12 months;
           A category 2 facility is a low-risk facility 
        that manufactures or processes food and must be 
        inspected at least every 18 months to 3 years; and
           A category 3 facility is a facility that 
        holds food and must be inspected at least every 5 
        years.
    Based on information from the FDA, CBO estimates this bill 
would require about 360,000 domestic and foreign food 
facilities be inspected on a risk-based frequency schedule. 
This estimate assumes the magnitude of the inspections required 
in the risk-based inspection schedule will lead the FDA to 
recognize agencies and representatives of foreign countries to 
help fulfill the bill's requirements for inspection frequency.
    The bill also would require the Secretary of HHS to design 
and implement a tracing system for food located in the United 
States or for import into the country. The bill would 
explicitly exempt all food products and facilities regulated by 
the Secretary of Agriculture under the Federal Meat Inspection 
Act, the Poultry Products Inspection Act, or the Egg Products 
Inspection Act from the requirements in H.R. 2749.

Spending subject to appropriation

    CBO estimates that implementing H.R. 2749 would increase 
spending subject to appropriation, on net, by $2.0 billion over 
the 2010-2014 period, assuming appropriation action consistent 
with the bill. The effect on discretionary spending by federal 
programs reflects the authorized funding relating to the 
federal regulation of food products.
    The gross costs for FDA to administer the new regulatory 
activities authorized under the legislation--about $3.5 billion 
over the 2010-2014 period--would be partially covered by fees 
assessed on registered food facilities, importers, and 
exporters.

Collection of new fees

    H.R. 2749 would amend and modify the Federal Food, Drug, 
and Cosmetic Act to authorize the FDA to collect fees to help 
defray some of FDA's costs of performing food safety 
activities. The bill would create two new fee programs: a 
facility reinspection and recall fee program, and an importer 
registration fee program. The bill also would amend two current 
categories of fees: food facility registration fees, and export 
certification fees.
    Under current law, both domestic and foreign food 
facilities are required to register with the FDA; however, 
periodic renewal is not required and the FDA does not have 
authority to collect fees. The bill would mandate annual 
registration for all food facilities and require an annual fee 
of $500 adjusted for inflation. The legislation also would 
authorize the FDA to collect fees for food (including animal 
feed) export certificates under the current export 
certification program. Fees authorized by the bill would be 
collected and made available for obligation only to the extent 
and in the amounts provided in advance in appropriations acts. 
As a result, those collections would be credited as an offset 
to discretionary spending.

Spending of fees by FDA to regulate food products

    Spending of the new fees assessed by FDA to regulate food 
products would be classified as discretionary spending because 
the authorized amounts would be available for obligation 
subject to appropriation action. Amounts collected would be 
available to cover FDA's administrative costs to regulate food 
products at any point in the future.
    Importer registration fees could only be collected and made 
available to defray the costs of registering importers and 
enforcing compliance with good importer practices. Export 
certification fees could only be collected and made available 
to cover the cost of issuing such certifications. Reinspection 
and recall fees could also only be collected and made available 
to cover the costs of such activities. The fees program for 
food facility registration could be collected and made 
available to defray the costs of food safety activities, which 
are defined in the bill as expenses incurred in connection with 
food safety activities.
    Assuming appropriation action consistent with the bill, CBO 
estimates that implementing the program to assess fees to cover 
new FDA costs associated with regulating food products would 
increase collections and subsequent spending of those fees by 
about $1.4 billion over five years, and would result in a net 
decrease in discretionary outlays of about $140 million over 
the 2010-2014 period. (Spending of fees would lag slightly 
behind their collection.)

FDA activities not supported by fees

    Because of the magnitude of the inspections required under 
the bill, CBO estimates the fees collected would not offset all 
of the costs of the new requirements. The net additional 
inspections and administrative activities not covered by fees 
would increase discretionary outlays, on net, by $2.2 billion 
over five years. This amount incorporates savings to the FDA 
for food safety activities conducted under current law that 
would be replaced by fees in the bill. For example, in 2010, 
CBO anticipates the FDA will save $35 million relative to its 
current appropriation level for activities that would be funded 
through new fees.

Revenues

    The bill would expand the FDA's authority to assess civil 
penalties for food related violations of the Federal Food, 
Drug, and Cosmetic Act. Such violations include the 
introduction into interstate commerce of certain adulterated or 
misbranded foods. Based on information provided by the FDA 
regarding recent enforcement activity, CBO estimates that the 
bill would increase revenues from civil penalties by $20 
million over the 2010-2019 period.
    The bill could also increase revenues from criminal 
penalties, which are recorded as revenues, deposited in the 
Crime Victims Fund, and later spent. CBO expects that any 
additional revenues from criminal penalties would not be 
significant.
    Intergovernmental and Private-Sector Impact: H.R. 2749 
would impose a number of mandates, as defined in the UMRA, on 
individuals and entities involved in producing, manufacturing, 
processing, packing, transporting, distributing, receiving, 
holding, importing, or exporting articles of food. CBO 
estimates that the total cost of those mandates would exceed 
the threshold established in UMRA for private-sector entities 
($139 million in 2009, adjusted annually for inflation) in each 
year, beginning with 2010. Given the limited number of public 
entities affected by the requirements, CBO estimates that the 
costs of intergovernmental mandates would fall below the 
threshold established in UMRA ($69 million in 2009, adjusted 
annually for inflation).
    The bill would require facilities engaged in manufacturing, 
processing, packing, or holding food for consumption in the 
United States or export to other countries to register with the 
Secretary of HHS and pay an annual fee. Under current law, all 
of those facilities are required to register with the Secretary 
except for facilities holding food for export, but the annual 
fee would be a new requirement. CBO estimates fees would total 
almost $210 million in 2010 and rise to almost $370 million by 
2014. The costs of those payments alone would exceed the 
threshold established by UMRA.
    The bill also would place new requirements on entities 
involved in producing, manufacturing, processing, packing, 
transporting, distributing, receiving, holding, importing, or 
exporting articles of food. In general, the costs of those 
mandates on the private sector would depend on future guidance 
and regulations established by the Secretary. For example, the 
Secretary would be required to develop science- and risk-based 
standards, to establish a tracing system for food located in 
the United States or for import into the country, and to 
develop safety and security guidelines for the importation of 
food. It is unclear how those requirements would be implemented 
and how they would affect the food industry. Therefore, CBO 
cannot estimate the cost to private entities of those 
provisions.
    The bill would require owners, operators, and agents of 
facilities to conduct hazard analyses, implement and monitor 
preventive controls, institute corrective actions when 
necessary, repeat hazard analyses at least every two years, and 
maintain records of these activities. They also would have to 
develop food safety plans that outline how facilities would 
meet these requirements. High-risk facilities that manufacture 
or process food, also referred to as ``category 1 facilities,'' 
would be required to test finished products for the presence of 
contaminants and submit the results of the tests to the 
Secretary. The Secretary would have the option to establish 
guidance or regulations, which would determine the extent of 
the requirements for complying with these provisions of the 
legislation.
    The bill also would require entities, among other things, 
to be prepared to present all records related to the 
production, manufacture, processing, packing, transporting, 
distribution, receipt, holding or importation of an article of 
food; to report to a food registry; to use accredited 
laboratories recognized by the Secretary for analytical testing 
of an article of food; to notify the Secretary of the identity 
and location of an article of food that is believed to be 
adulterated or misbranded; to maintain records with respect to 
infant formula for at least one year after the expiration of 
the shelf life; and to identify the country in which the final 
processing occurred and for unprocessed food to identify the 
country of origin of the food. Under current law, many entities 
may already have the capability to meet some of those 
requirements, but entities such as farms and restaurants that 
are not currently subject to any of those requirements 
previously could incur significant costs to comply with their 
respective mandates.
    Mandates in the bill would extend to some public entities, 
including public colleges and universities that operate farms 
and a limited number of tribal entities that produce and 
package food items for resale. Given the limited number of 
public entities affected, however, CBO estimates that the costs 
of the mandates would fall below the intergovernmental 
threshold ($69 million in 2009, adjusted annually for 
inflation).
    Estimate prepared by: Federal Spending: Ellen Werble, 
Rebecca Yip; Federal Revenues: Zachary Epstein; Impact on 
State, Local, and Tribal Governments: Leo Lex; Impact on the 
Private Sector: Keisuke Nakagawa.
    Estimate approved by: Peter H. Fontaine, Assistant Director 
for Budget Analysis.

             Section-by-Section Analysis of the Legislation


Section 1. Short title

    The short title is designated as the ``Food Safety 
Enhancement Act of 2009''.

Section 2. Table of contents

    Section 2 provides the table of contents.

Section 3. References

    Section 3 establishes that unless otherwise specified, 
amendments made to a section or other provisions are considered 
to be made to a section or provision of the Federal Food, Drug, 
and Cosmetic Act (FFDCA).

Section 4. Rules of construction

    Section 4 establishes that the Food Safety Enhancement Act 
of 2009 shall not be construed as modifying or otherwise 
affecting any action or the liability of any person under the 
law of any State.
    Section 4 further establishes that the Food Safety 
Enhancement Act of 2009 shall not be construed to alter the 
jurisdiction between the Secretary of Agriculture and the 
Secretary of Health and Human Services; to limit the authority 
of the Secretary of Health and Human Services to issue 
regulations related to the safety of food under the Federal 
Food, Drug, and Cosmetic Act or the Public Health Service Act; 
or to impede, minimize, or affect the authority of the 
Secretary of Agriculture to prevent, control, or mitigate a 
plant or animal health emergency, or a food emergency involving 
products regulated under the Federal Meat Inspection Act, the 
Poultry Products Inspection Act, or the Egg Products Inspection 
Act.

Section 5. USDA exemptions

    Section 5 clarifies the effect of the Food Safety 
Enhancement Act of 2009 on USDA-regulated foods, farms, and 
facilities.
    A food is exempt from the requirements of the Food Safety 
Enhancement Act of 2009 if such food is regulated by the 
Secretary of Agriculture under the Federal Meat Inspection Act, 
the Poultry Products Inspection Act, or the Egg Products 
Inspection Act.
    A facility is exempt from the requirements of this Act if 
such facility is regulated exclusively as an official 
establishment by the Secretary of Agriculture under the Federal 
Meat Inspection Act, the Poultry Products Inspection Act, or 
the Egg Products Inspection Act.
    A farm is exempt from the requirements of this Act to the 
extent that such farm raises animals from which food is derived 
that is regulated by the Secretary of Agriculture under the 
Federal Meat Inspection Act, the Poultry Products Inspection 
Act, or the Egg Products Inspection Act. The portions of a farm 
that produce FDA-regulated foods are covered by the provisions 
of the bill.

Section 6. Alcohol-related facilities

    Section 6 establishes that an alcohol-related facility that 
is required to register as a facility under section 415 of the 
Federal Food, Drug, and Cosmetic Act, as amended by this Act, 
solely because such facility is engaged in manufacturing, 
processing, packing, or holding one or more alcoholic 
beverages, is not subject to the requirements of the Food 
Safety Enhancement Act of 2009 if such facility is required to 
obtain a permit or to register with the Secretary of the 
Treasury as a condition of doing business. Such facility is, 
however, still subject to the registration requirements set 
forth in section 101 (a) and (b) of the Food Safety Enhancement 
Act of 2009 and may participate in the Safe and Secure Food 
Importation Program established under section 113 of the Act.
    Section 6 shall not be construed to exempt any food, apart 
from alcoholic beverages, from the requirements of the FSEA.

                          TITLE I--FOOD SAFETY


                         Subtitle A--Prevention


Section 101. Changes in registration of food facilities

    Section 101 amends section 415 of the FFDCA to require 
annual facility registration. Registrants are required to 
provide additional information pertaining to the facility, 
including contact information, the primary purpose and business 
activity of the facility, all trade names under which the 
facility conducts business related to food, and for foreign 
facilities, the United States agent for the facility. The 
registrant is required to notify the Secretary of any change in 
the submitted information no later than 30 days after the date 
of such change.
    The Committee does not intend to alter FDA's current 
regulatory definition of ``facility'' governing which entities 
must register. For example, the Committee believes that any 
storage facility located on a farm does not need to be 
registered with the FDA if the commodities stored in such 
facility originate on that farm or another farm under the same 
ownership.
    The Secretary is authorized to suspend the registration of 
a facility for a violation of the Act that could result in 
serious adverse health consequences or death. The Secretary is 
also granted authority to cancel a registration that the 
Secretary determines was not updated or otherwise contains 
false, incomplete, or inaccurate information, or if the 
required registration fee has not been paid within 30 days 
after the due date. However, an order to suspend or cancel a 
registration shall not be delegated to any officer or employee 
other than the Commissioner, the Principal Deputy Commissioner, 
the Associate Commissioner for Regulatory Affairs, or the 
Director for the Center for Food Safety and Applied Nutrition.
    The Secretary is required to provide a report to Congress 
annually detailing the number and type of facilities registered 
under this section.
    Section 101 requires the Secretary to assess and collect an 
annual fee of $500 for the registration of a facility under 
section 415 of the FFDCA. The fee shall be collected and 
available to defray the costs of food safety activities 
(activities related to compliance by facilities registered 
under section 415 with the requirements of this Act relating to 
food). The registration fee shall not exceed $175,000 for an 
individual company. The Secretary is required to hold a public 
meeting to allow stakeholders to provide input into how the fee 
revenue will be allocated.
    The bill provides that revenues generated by new 
registration fees be directed to specified food safety 
activities. Because an effective food safety program must be a 
combined effort of the scientific and regulatory food safety 
activities of the Center for Food Safety and Applied Nutrition 
(CFSAN) and support for the food safety inspection-related 
activities of the Office of Regulatory Affairs (ORA), the 
Committee expresses its intent that the agency give highest 
priority for use of these funds to activities that directly 
support implementation of this bill, including: (1) regulations 
and guidance, particularly with respect to hazard analyses, 
preventive controls, and food safety plans, both with respect 
to packaged food and to fresh produce; (2) risk assessment 
activities underlying development of performance standards; (3) 
information gathering steps prior to developing regulations on 
traceability and reporting results of finished product testing, 
including required pilot projects, technology assessments, and 
feasibility studies; (4) maintenance of an enhanced 
registration system; (5) maintenance of an up-to-date 
reportable food registry; (6) information technology systems to 
support domestic and import inspectional activities; (7) 
scientific equipment to conduct needed research and perform 
product sampling; (8) training of agency and state officials in 
the proper conduct of inspectional activities; (9) development 
of an expedited safe and secure importation program; (10) 
surveillance, public education, and research activities in 
support of improving food safety; (11) review of infant formula 
and GRAS submissions; and (12) creation and implementation of a 
risk-based inspection schedule.
    The bill seeks to ensure that the revenues collected from 
registration fees be additive to the existing FDA appropriated 
resource base for food safety activities, adjusted for 
inflation in future years, and that funds from food safety-
related activities not be redirected to meet responsibilities 
of other FDA programs. The bill seeks to accomplish this by 
stating that user fees may not be collected in any fiscal year 
in which the salaries and expenses for the Food and Drug 
Administration do not equal that for fiscal year 2010, adjusted 
for inflation.

Section 102. Hazard analysis, risk-based preventive controls, food 
        safety plan, finished product test results from category 1 
        facilities

    Section 102 requires the owner, operator, or agent of a 
facility to develop and implement a written food safety plan. 
As part of this food safety plan, the owner, operator, or agent 
shall conduct a hazard analysis; identify and implement 
effective preventive controls; monitor preventive controls; 
institute corrective actions when monitoring shows that 
preventive controls have not been properly implemented or were 
ineffective; conduct verification activities; maintain records 
of monitoring, corrective action, and verification; and 
reanalyze for hazards. The food safety plan shall also include 
a description of the facility's procedures for recordkeeping; 
recall; trace back; supply chain safety; and science-based 
performance standards. When developing food safety plans under 
Section 102, facilities should evaluate whether there are 
hazards that could affect the safety, sanitation, or 
wholesomeness of the food manufactured, processed, packed, 
transported, or held by the facility. This analysis should 
include consideration of biological, chemical, physical, and 
radiological hazards, natural toxins, pesticides, drug 
residues, filth, decomposition, parasites, allergens, and 
unapproved food and color additives, and should include 
consideration of such contamination on surfaces or in the air 
or from other possible vectors.
    The requirements of this section shall take effect 18 
months after the date of enactment. Small businesses and very 
small businesses will have 2 years and 3 years, respectively, 
to comply.
    Section 102 also requires certain high-risk facilities to 
submit finished product test results documenting the presence 
of contaminants in food posing a risk of severe adverse health 
consequences or death. Before requiring the reporting of such 
test results, the Secretary must conduct two or more pilot 
projects and a study to evaluate the feasibility of such a 
reporting system.

Section 103. Performance standards

    Section 103 requires the Secretary, not less frequently 
than every 2 years, to identify the most significant food-borne 
contaminants and the most significant resulting hazards. The 
Secretary shall issue science-based performance standards, as 
appropriate, to minimize to an acceptable level, prevent, or 
eliminate the occurrence of such hazards.
    Section 103 also requires the Secretary to publish in the 
Federal Register a list of food-borne contaminants that have 
the greatest adverse impact on public health. In determining 
whether a particular food-borne contaminant should be added to 
such list, the Secretary is required to consider the number and 
severity of illnesses and the number of deaths associated with 
the foods associated with such contaminants.

Section 104. Safety standards for produce and certain other raw 
        agricultural commodities

    Section 104 requires the Secretary to establish by 
regulation science-based standards for the safe growing, 
harvesting, packing, sorting, transporting, and holding of raw 
agricultural commodities for which the Secretary has determined 
that such standards minimize the risk of serious adverse health 
consequences or death to humans or animals. The Secretary shall 
provide a reasonable period of time for compliance, taking into 
account the needs of small business for additional time to 
comply.
    Section 104 requires the Secretary, in issuing the 
regulations under this section, to take into consideration, 
consistent with ensuring enforceable public health protection, 
the impact of any regulations issued under this section on 
small-scale and diversified farms, and on wildlife habitat, 
conservation practices, water-shed protection efforts, and 
organic production methods. The Secretary is permitted to 
provide for coordination with other entities and provide for 
recognition through guidance of other existing publicly 
available procedures, processes, and practices that the 
Secretary determines to be equivalent to the goals established 
under this section.
    Section 104 requires the Secretary to update the guidance 
document entitled ''Guidance for Industry: Guide to Minimize 
Microbial Food Safety Hazards for Fresh Fruits and 
Vegetables.''

Section 105. Risk-based inspection schedule

    Section 105 requires that each facility registered under 
section 415 be inspected by the Secretary, by a federal, state, 
or local official in the case of a domestic facility, or by an 
agency or representative of a country in the case of a foreign 
facility, according to a risk-based schedule. The risk-based 
schedule shall be implemented not later than 18 months after 
enactment and shall provide for a frequency of inspections 
commensurate with the risk presented by the facility and shall 
be based on the following categories and inspection 
frequencies:

    Category 1 (high-risk)--the Secretary shall randomly 
inspect a category 1 food facility at least every 6 to 12 
months.
    Category 2 (low-risk)--the Secretary shall randomly inspect 
a category 2 facility at least every 18 months to 3 years.
    Category 3 (facility that holds food)--the Secretary shall 
randomly inspect a category 3 facility at least every 5 years.

    Section 105 requires the Secretary to provide an annual 
report to Congress on the number of facilities inspected and 
the costs of implementing the risk-based inspection schedule 
for the preceding 12 months. In the third year after enactment, 
the Secretary is also required to submit to Congress a report 
describing recommendations on the risk-based inspection 
schedule, including recommendations for adjustments to the 
timing of the schedule. In making recommendations to change the 
inspection schedule, the Secretary shall consider the nature of 
the food products being processed, stored, or transported; the 
manner in which food products are processed, stored, or 
transported; the inherent likelihood that the products will 
contribute to the risk of food-borne illness; the best 
available evidence concerning reported illnesses associated 
with the foods processed, stored, held, or transported in the 
category of facilities; and the overall record of compliance 
with food safety law among facilities in the category, 
including compliance with applicable performance standards and 
the frequency of recalls.
    Six months after submitting the Third-Year Report, the 
Secretary may implement the adjustments to the inspection 
schedule recommended in the Third-Year Report with respect to 
category 2 and category 3 facilities only. The new inspection 
schedule and a justification for the changes must be published 
in the Federal Register.

Section 106. Access to records

    Section 106 requires each person who produces, 
manufactures, processes, packs, transports, distributes, 
receives, or holds an article of food in the United States or 
for import into the United States to permit an officer or 
employee duly designated by the Secretary to have access to and 
copy all records relating to such article bearing on whether 
the food may be adulterated, misbranded, or otherwise in 
violation of this Act during an inspection.
    If the Secretary has a reasonable belief that an article of 
food presents a threat of serious adverse health consequences 
of death to human or animals, the Secretary is authorized to 
remotely access records reasonably related to that food. The 
Secretary may also remotely access records related to the food 
safety plan, supporting information relied on by the facility 
to select the preventive controls to include in its food safety 
plan, and documentation of corrective actions, if any, taken 
within the preceding two years. The Committee expects FDA, when 
notifying the company of the need for such ``remote access'' to 
records, to specify which types of food safety records FDA 
seeks, including for what product(s) and over what time frame. 
This will ensure that the records collection process is 
properly tailored to assist FDA in its investigation and that 
the agency will not waste time sorting through a broader array 
of records that are not pertinent to its investigation.
    This authority is intended to provide FDA with a mechanism 
to gain a better understanding of a facility's food safety 
program, but it is not intended as a substitute for an on-site 
inspection. The Committee expects that FDA would use this 
authority as an initial survey and triage tool, to help the 
agency prioritize which facilities to inspect and where to 
focus the inspection, when conducted. The Committee underscores 
the importance of on-site inspections for FDA to have a clear 
and complete understanding of the facility's food safety 
program.
    The Committee recognizes that large document productions 
are not the most efficient way to provide FDA with information, 
and that additional mechanisms are needed if FDA is to 
accomplish its public health goal in a timely way. Therefore, 
it is the Committee's view that when FDA believes it can 
accomplish its goal of conducting smarter investigations by 
first sending a food company written questions for the company 
to answer, with a request for supporting documentation, as 
needed, it should do so. The Committee expects companies to 
respond in a timely manner to FDA's questions by providing 
information reasonably known at the time. The Committee expects 
companies to supply such information as soon as reasonably 
possible. The Committee's goal is to facilitate good 
communication between FDA and the company to help FDA determine 
whether appropriate preventive controls are in place, whether 
there is a need for additional preventive controls, guidance, 
or regulations, and what circumstances caused food 
contamination. This provision should be applied by FDA with 
that goal in mind.
    Section 106 allows the Secretary to establish requirements 
regarding the establishment and maintenance, for not longer 
than three years, of records by persons who produce, 
manufacture, process, pack, transport, distribute, receive, or 
hold food in the United States or for import into the United 
States. The Secretary shall take into account the size of a 
business in promulgating regulations under this section. The 
Secretary is only authorized to require restaurants to maintain 
distribution records showing their suppliers, and subsequent 
distribution other than to consumers.

Section 107. Traceability of food

    Section 107 requires the Secretary to establish, by 
regulation, a tracing system for food that is located in the 
United States or is for import into the United States. Before 
issuing a proposed regulation, the Secretary shall conduct 
information gathering to (1) identify technologies and 
methodologies for tracing to enable each person who produces, 
manufactures, processes, packs, transports, or holds a food to 
maintain the full pedigree of the origin and previous 
distribution history of the food, link that history with the 
subsequent distribution of the food, establish and maintain a 
system for tracing the food that is interoperable with the 
systems established and maintained by other such persons, and 
to use a unique identifier; and (2) to the extent practicable, 
assess the costs and benefits associated with the adoption of 
such technologies, the feasibility of such technologies for 
different sectors for the food industry, and whether such 
technologies are compatible with the requirements of this 
subsection.
    Section 107 requires the Secretary to take into account 
information obtained through the information gathering process, 
and to conduct at least two public meetings and one or more 
pilot projects. After completing this public input process, the 
Secretary shall issue proposed regulations establishing a 
tracing system that enables the Secretary to identify each 
person who grows, produces, manufacturers, processes, packs, 
transports, holds or sells such food in as short a timeframe as 
practicable, but in no longer than two business days. The 
Secretary may include in such regulation: the establishment and 
maintenance of lot numbers; a standardized format for pedigree 
information; and the use of a common nomenclature for food.
    Food produced on a farm or a fishery and sold directly to a 
consumer, restaurant, or grocery store is exempt from the 
tracing system requirements, although restaurants and grocery 
stores must keep records documenting the farm that was the 
source of the food. The Secretary is also granted authority to 
exempt a food or type of facility from the tracing system 
requirements if the Secretary determines application of these 
requirements is not necessary to protect the public health. For 
a food so exempted, each person who produces, manufactures, 
processes, packs, transports, or holds such food is required to 
maintain records to identify the immediate previous sources of 
such food and its ingredients and the immediate subsequent 
recipients of such food.

Section 108. Reinspection and food recall fees applicable to facilities

    Section 108 requires the Secretary to assess and collect 
fees from each facility in a fiscal year that undergoes 
additional inspection by the FDA due to a violation of any 
requirement of the Federal Food, Drug, and Cosmetic Act or is 
subject to a recall.
    Section 108 establishes that there will be an exemption 
from the fees for a recall that FDA inappropriately ordered.

Section 109. Certification and accreditation

    Section 109 establishes that certain imported foods be 
accompanied by a certification that the food complies with 
specified requirements of the Federal Food, Drug, and Cosmetic 
Act. The Secretary shall require certification for food 
imported from a particular country or region if certification 
would assist the Secretary in determining whether to refuse to 
admit such article; for a type of food that could pose a 
significant risk to health, certification would assist the 
Secretary in determining whether such article poses such risk; 
or for an article imported from a particular country, there is 
an agreement between the Secretary and the government of such 
country providing for such certification. Certifications under 
this section must be provided by a ``qualified certifying 
entity.'' A qualified certifying entity may be an agency or a 
representative of the government of the country from which the 
article originated, an individual or entity determined by the 
Secretary, or an accredited body recognized by the Secretary. 
The Secretary is required to issue regulations to ensure that 
any qualified certifying entity and its auditors are free from 
conflicts of interest.

Section 110. Testing by accredited laboratories

    Section 110 requires that whenever analytical testing of an 
article of food is conducted as part of testimony in a food 
import detention hearing or for other purposes as the Secretary 
deems appropriate, such testing shall be conducted by a 
laboratory that is accredited for the analytical method used, 
by a laboratory accreditation body that has been recognized by 
the Secretary; and samples such article with adequate controls 
for ensuring the integrity of the samples analyzed. When 
testing is required for purposes of a food import detention 
hearing, in response to a finding of non-compliance by the 
Secretary, or for certain products designated by the Secretary, 
the test must be conducted by an accredited, independent 
laboratory that is independent of the person on whose behalf 
such testing is being conducted.
    The Secretary shall establish and implement a program for 
the recognition of laboratory accreditation bodies that 
accredit laboratories to perform analytical testing for the 
purposes of this section.
    Whenever such analytical testing is conducted, the 
laboratory conducting such testing shall submit, directly to 
the Secretary the results of all analyses conducted by the 
laboratory on each sample of such article; and all information 
the Secretary deems appropriate to determine whether the 
laboratory is accredited by a recognized laboratory 
accreditation body, identify the article tested, evaluate the 
analytical results, and determine whether the requirements of 
this section have been met.

Section 111. Notification, nondistribution, and recall of adulterated 
        or misbranded food

    Section 111 requires food facilities, importers, customs 
brokers, and filers that have reason to believe that an article 
of food is adulterated or misbranded in a manner that presents 
a reasonable probability that the use or consumption of, or 
exposure to, the article will cause a threat of serious adverse 
health consequences or death to humans or animals to notify the 
Secretary of the identity and location of the article as soon 
as practicable.
    The Secretary may request that any person who distributes 
an article of food that the Secretary has reason to believe is 
adulterated, misbranded, or otherwise in violation of this Act 
voluntarily recall such article.
    The Secretary shall have the authority to issue an order 
requiring any person who distributes an article of food to 
immediately cease distribution of such article if the Secretary 
has reason to believe that the use or consumption of, or 
exposure to, the article of food may cause serious adverse 
health consequences or death to humans or animals. The person 
subject to the order may appeal the order and request an 
informal hearing. If after providing an opportunity for an 
informal hearing under subsection (d), the Secretary determines 
that the order should be amended to include a recall of the 
article with respect to which the order was issued, the 
Secretary shall amend the order to require a recall. Only the 
Secretary or an official designated by the Secretary may order 
the recall. An official may not be so designated unless the 
official is the director of the district under this Act in 
which the article involved is located, nor is an official 
senior to such director.
    If the Secretary has a reasonable belief that an article of 
food subject to an order to cease distribution presents an 
imminent threat of serious health consequences or death to 
humans or animals, the Secretary may issue an emergency recall 
order requiring any person who distributes such article to 
immediately recall such article. An informal hearing shall be 
granted following the cease distribution and emergency recall. 
Section 111 requires that an emergency recall order come from 
the FDA Commissioner, Principal Deputy Commissioner or 
Associate Commissioner for Regulatory Affairs.

Section 112. Reportable food registry; exchange of information

    Section 112 amends section 417 of the Federal Food, Drug, 
and Cosmetic Act to require an owner of a food facility, farm, 
or restaurant to submit a report to FDA following a timely 
review of any reasonably available data and information and a 
determination that there is a reasonable probability that use 
of, or exposure to, a particular article of food will cause 
serious adverse health consequences or death to humans or 
animals. Section 112 requires the report to also include 
analytical results from testing of such article and such 
additional information as the Secretary deems appropriate. 
Section 112 requires the Secretary to make available other 
means of reporting for restaurants and other retail food 
establishments that have limited ability to report via 
electronic means.
    Section 112 authorizes the Secretary to share certain 
confidential information relating to food with any federal 
agency, state, local, or foreign government, or any person. 
This information shall not be publicly disclosed.

Section 113. Safe and secure food importation program

    Section 113 permits the Secretary to establish by 
regulation or guidance a program to facilitate the movement of 
food through the importation process if the importer of such 
food verifies that each facility involved in the production, 
manufacture, processing, packaging, and holding of the food has 
been determined to be in compliance with food safety and 
security guidelines developed by the Secretary.

Section 114. Infant formula

    Section 114 requires that no person shall introduce or 
deliver for introduction into interstate commerce infant 
formula prior to receiving a letter from the Secretary 
informing such person that the following have been satisfied: 
(1) the registration requirement and (2) a demonstration that 
the infant formula satisfies the quality factor requirements 
established by the Secretary. The Committee anticipates that 
the language of this section will change as this legislation 
moves through the legislative process.

                        Subtitle B--Intervention


Section 121. Surveillance

    Section 121 requires the Secretary to enhance the current 
food safety surveillance systems to include the collection, 
analysis, reporting, and usefulness of data on food-borne 
illnesses by coordinating federal, state, and local 
surveillance systems, and increasing participation in national 
networks of public health and food regulatory agencies and 
laboratories; facilitating the timely sharing of food safety 
findings and data with the public; developing improved 
epidemiological tools for obtaining better data; improving 
attribution of a food-borne illness outbreak to a specific 
food; expanding capacity of surveillance systems to identify 
new or rarely documented causes of food-borne illness; and 
other activities deemed appropriate by the Secretary. Section 
121 requires the Secretary to develop and implement strategies 
to leverage and enhance the food safety and defense capacities 
of State and local agencies.

Section 122. Public education and advisory system

    Section 122 requires the Secretary, in collaboration with 
private and public organizations, to design and implement a 
national public education program on food safety that would 
educate the public on how to reduce their risk of food-borne 
illness and injury and provide information to health care 
professionals to improve diagnosis and treatment of food-borne 
illnesses. This section also directs the Secretary to work with 
the states and other entities to develop and distribute 
regional and national advisories concerning food safety; 
develop standardized formats for written and broadcast 
advisories; and incorporate State and local advisories into the 
national public education program.

Section 123. Research

    Section 123 requires the Secretary to conduct research to 
assist in the implementation of the Food Safety Enhancement Act 
of 2009, including studies to improve sanitation and food 
safety practices; develop improved monitoring and inspection 
techniques; develop rapid and sensitive food testing methods; 
determine the sources of food contamination, including critical 
points of risk for fresh produce and other raw agricultural 
commodities; develop consumption data for food products; 
utilize DNA matching systems to identify and control pathogens; 
address common and emerging zoonotic diseases; develop methods 
to destroy pathogens before, during, and after processing; and 
analyze the incidence of antibiotic resistance as it pertains 
to the food supply and evaluate methods to reduce the transfer 
of antibiotic resistance to humans.

                          Subtitle C--Response


Section 131. Procedures for seizure

    Section 131 amends section 304 of the FFDCA to stipulate 
that with respect to seizure proceedings relating to food, Rule 
G of the Supplemental Rules of Admiralty or Maritime Claims and 
Asset Forfeiture Actions shall not apply.

Section 132. Administrative detention

    Section 132 amends section 304 of the Federal Food, Drug, 
and Cosmetic Act to allow an official or qualified employee of 
the FDA to order the detention of any article of food if they 
have reason to believe that such article is adulterated, 
misbranded, or otherwise in violation of this Act.
    Section 132 extends the time period during which a food may 
be detained from 30 to 60 days, and extends from 5 to 15 days 
the deadline for an informal hearing when such detention is 
challenged.

Section 133. Quarantine authority for foods

    Section 133 permits the Secretary authority to quarantine 
any geographic area within the United States if the Secretary 
determines that there is credible evidence or information that 
an article of food that is located in such area presents an 
imminent threat of serious adverse health consequences or death 
to humans or animals. The authority to quarantine includes 
prohibiting or restricting the movement of food or of any 
vehicle being used to hold such food.
    Before exercising authority to quarantine a geographic 
area, the Secretary is required to notify an appropriate 
official of the state affected and to issue a public 
announcement of the Secretary's findings that support the 
action; the area affected by the intended quarantine; the 
reasons for the quarantine; and where practicable, an estimate 
of the anticipated duration of the quarantine.
    Section 133 requires that a quarantine order must come from 
the FDA Commissioner, Principal Deputy Commissioner, or 
Associate Commissioner for Regulatory Affairs.

Section 134. Criminal penalties

    Section 134 amends section 303 of the Federal Food, Drug, 
and Cosmetic Act to require that any person who knowingly 
violates section 301 of the FFDCA with respect to any food that 
is misbranded or adulterated shall be imprisoned for not more 
than 10 years or fined in accordance with title 18, United 
States Code, or both.

Section 135. Civil penalties for violations relating to food

    Section 135 amends section 303 of the FFDCA to require that 
any person who violates a provision of section 301 relating to 
food shall be subject to a civil penalty for each such 
violation of not more than $20,000 in the case of an 
individual, not to exceed $50,000 in a single proceeding; 
$250,000 in the case of any other person, not to exceed 
$1,000,000 in a single proceeding. Any person who knowingly 
violates a provision of section 301 relating to food shall be 
subject to a civil penalty for each such violation of not more 
than $50,000 in the case of an individual, not to exceed 
$100,000 in a single proceeding; and $500,000 in the case of 
any other person, not to exceed $7,500,000 in a single 
proceeding.

Section 136. Improper import entry filings

    Section 136 makes the submission of information relating to 
imported food that is inaccurate or incomplete, or the failure 
to submit information that is required to be submitted related 
to imported food a prohibited act. Section 136 allows the 
Secretary to require the submission of documentation or other 
information for articles of food that are imported or offered 
for import into the United States.

                        TITLE II--MISCELLANEOUS


Section 201. Food substances generally recognized as safe

    Section 201 requires the Secretary to post on FDA's website 
a ``generally recognized as safe'' (GRAS) determination as well 
as the supporting scientific justifications no later than 60 
days after receipt by the Secretary of such determination.

Section 202. Country of origin labeling; disclosure of source of 
        ingredients

    Section 202 requires that all processed food labels 
identify the country in which the final processing occurred. If 
the label of a processed food is already in compliance with 
country of origin requirements from the U.S. Customs and Border 
Protection, the food will be deemed in compliance with this 
section. All non-processed foods must be labeled with the 
country of origin of the food. If a non-processed food already 
lists the country of origin pursuant to farm bill requirements, 
the food will be deemed in compliance with this section.

Section 203. Exportation certificate program

    Section 203 authorizes the Secretary to impose a fee for 
the issuance of export certificates for foods and animal feeds. 
Such fee shall not exceed such amount as the Secretary 
determines is reasonably related to the cost of issuing 
certificates with respect to the export of food and animal 
feed.

Section 204. Registration for commercial importers of food; fee

    Section 204 requires all importers of foods to register 
with the FDA annually and to pay a registration fee in the 
amount of $500. An importer that is also a registered facility 
under section 101 is subject to only one fee. Each registered 
importer must comply with good importer practices, which the 
Secretary must establish through regulation. The Secretary may 
suspend an importer's registration, after notice and 
opportunity for an informal hearing, if the importer is found 
in violation of the Federal Food, Drug, and Cosmetic Act, or 
found to have knowingly or repeatedly made inaccurate or 
incomplete statements or submissions of information related to 
the importation of food. The Secretary may cancel an importer's 
registration if, after notice, the Secretary determines that 
the registration was not updated correctly or otherwise 
contains false, incomplete, or inaccurate information. If the 
importer's registration is updated or corrected no later than 7 
days after notice is provided, the Secretary shall not cancel 
the importer's registration.

Section 205. Registration for customs brokers and filers

    Section 205 requires all customs brokers or filers with 
respect to the importation of foods to register with the FDA in 
a form and manner specified by the Secretary and to submit 
appropriate unique facility identifiers as a condition of 
registration. The Secretary may suspend an importer's 
registration, after notice and opportunity for an informal 
hearing, if the customs broker or filer is found in violation 
of Federal Food, Drug, and Cosmetic Act, or found to have 
knowingly or repeatedly made inaccurate or incomplete 
statements or submissions of information related to the 
importation of food. The Secretary may cancel an importer's 
registration if, after notice, the Secretary determines that 
the registration was not updated correctly or otherwise 
contains false, incomplete, or inaccurate information.

Section 206. Unique identification number for food facilities, 
        importers, custom brokers, and filers

    Section 206 requires that a person required to register a 
facility under section 415 or importers, custom brokers, and 
filers required to register pursuant to section 801 submit, at 
the time of registration, a unique facility identifier. Section 
206 requires the Secretary to refuse admission of an imported 
food into the U.S. for interstate commerce unless the unique 
facility identifiers are provided for such article.

Section 207. Prohibition against delaying, limiting, or refusing 
        inspection

    Section 207 makes it unlawful for the owner, operator, or 
agent of a farm, factory, warehouse, or establishment to delay 
or limit an inspection, or refuse to permit entry or 
inspection. In addition, Section 207 makes it unlawful for an 
agent of a governmental authority in the foreign country within 
which the farm, factory, warehouse, or establishment is located 
to delay, limit, or refuses to permit entry or inspection.

Section 208. Dedicated foreign inspectorate

    Section 208 requires the Secretary to establish and 
maintain inspectors dedicated to inspections of foreign food 
facilities.

Section 209. Plan and review of continued operation of field 
        laboratories

    Section 209 requires the Secretary, no later than 90 days 
before the Secretary terminates or consolidates any laboratory 
responsible for analyzing food, district office with 
responsibility for food safety, or the functions of any such 
laboratory or district office, to submit a reorganization plan 
to the Comptroller General of the U.S., the Committee on Energy 
and Commerce of the House of Representatives, and the Committee 
on Health, Education, Labor, and Pensions of the Senate.

Section 210. False or misleading reporting to FDA

    Section 210 amends Section 301 of the Federal Food, Drug, 
and Cosmetic Act to establish that the submission of any report 
relating to food that is required by or under the Act that is 
false or misleading in any material respect is a prohibited 
act.

Section 211. Subpoena authority

    Section 211 grants the Commissioner the power to issue 
subpoenas for the purpose of any hearing, investigation, or 
other proceeding respecting a violation of the Federal Food, 
Drug, and Cosmetic Act, the Public Health Service Act, or the 
Federal Anti-Tampering Act relating to food; or to determine if 
a person is in violation of a specific provision of the Federal 
Food, Drug, and Cosmetic Act, the Public Health Service Act, or 
the Federal Anti-Tampering Act relating to food. A subpoena may 
be issued only by a district director or an individual senior 
to the district director.

Section 212. Whistleblower protections

    Section 212 grants protections for employees who refuse to 
violate, or who disclose violations of this Act, or Section 351 
of the Public Health Service Act. No person who submits any 
information related to a food, or any officer, employee, 
contractor, subcontractor, or agent may discharge, demote, 
suspend, threaten, harass or in any other manner discriminate 
against an employee in retaliation for assisting in any 
investigation regarding any conduct which the employee 
reasonably believes constitutes a violation of federal law. 
Section 212 ensures an employee shall be entitled to all relief 
necessary against retaliation by an employer.

Section 213. Extraterritorial jurisdiction

    Section 213 establishes that there is extraterritorial 
federal jurisdiction over any violation of this Act relating to 
any article of food intended for import into the United States 
or if any act in furtherance of the violation was committed in 
the United States.

Section 214. Support for training institutes

    Section 214 requires the Secretary, acting through the 
Commissioner, to provide financial and other assistance to 
appropriate entities to establish and maintain one or more 
university-affiliated food protection training institutes in 
order to conduct training related to food protection activities 
for Federal, State, local, territorial, and tribal officials; 
and meet standards developed by the Secretary.

Section 215. Bisphenol A in food and beverage containers

    Section 215 requires the Secretary to notify Congress no 
later than December 31, 2009, whether the available scientific 
data support a determination that there is a reasonable 
certainty of no harm, for infants, young children, pregnant 
women, and adults, for approved uses of polycarbonate plastic 
and epoxy resin made with bisphenol A in food and beverage 
containers. If the Secretary is unable to make such a 
determination, the Secretary must notify Congress of the 
actions the Secretary intends to take to protect the public 
health.

                       Explanation of Amendments

    During full Committee markup, the Chairman offered a 
manager's amendment (amendment in the nature of a substitute) 
making several changes to the bill, which was adopted by the 
Committee on a voice vote. The manager's amendment clarifies 
that the bill applies to FDA-regulated farms and facilities and 
delineates the ways in which the bill applies--and does not 
apply--to facilities manufacturing alcoholic beverages.
    In the area of preventive food safety plans, the manager's 
amendment clarifies that the Secretary must permit the use of 
alternative preventive controls which have sufficiently 
demonstrated to effectively address the hazard. The manager's 
amendment clarifies that the Secretary may require finished 
product testing at high-risk facilities if such testing or 
reporting would provide useful risk information. Before doing 
so, the Secretary must complete two or more pilot projects and 
a feasibility study.
    The manager's amendment clarifies the circumstances under 
which the Secretary may access food records remotely.
    The manager's amendment specifies that importers must pay a 
$500 annual registration fee as other registered facilities are 
required to do in the bill.
    The manager's amendment revises section 205 to require 
customs brokers to register with the Secretary but removes the 
requirement that customs brokers pay a fee.
    The manager's amendment adds two new sections. Section 214 
requires the Secretary to support and provide assistance to 
establish and maintain one or more university-affiliated food 
protection training institutes that conduct training related to 
food protection activities for Federal, State, local, 
territorial, and tribal officials. Section 215 requires the 
Secretary to assess the risks associated with bisphenol A in 
food and beverage containers, to report back to Congress on the 
findings, and to take appropriate actions to address any risks 
identified.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italic, existing law in which no change is 
proposed is shown in roman):

FEDERAL FOOD, DRUG, AND COSMETIC ACT

           *       *       *       *       *       *       *


               CHAPTER III--PROHIBITED ACTS AND PENALTIES

                            PROHIBITED ACTS

  Sec. 301. The following acts and the causing thereof are 
hereby prohibited:
  (a) * * *

           *       *       *       *       *       *       *

  (e) The refusal to permit access to or copying of any record 
as required by section 412, 414, 417(g), 416, 504, 564, 703, 
704(a), 760, or 761; or the failure to establish or maintain 
any record, or make any report, required under section 412, 
414(b), 417, 416, 504, 505 (i) or (k), 512(a)(4)(C), 512 (j), 
(l) or (m), 572(i), 515(f), 519, 564, 760, or 761, the 
violation of any requirement of the food tracing system under 
section 414(c); or the refusal to permit access to or 
verification or copying of any such required record.
  (f) The refusal to permit entry or inspection as authorized 
by section 704 or the failure or refusal to obey a subpoena 
issued pursuant to section 311.

           *       *       *       *       *       *       *

  (j) The using by any person to his own advantage, or 
revealing, other than to the Secretary or officers or employees 
of the Department, [or to the courts when relevant in any 
judicial proceeding under this Act,] to the courts when 
relevant in any judicial proceeding under this Act, or as 
specified in section 708, any information acquired under 
authority of section 404, 409, 412, 414, 505, 510, 512, 513, 
514, 515, 516, 518, 519, 520, 571, 572, 573., 704, 708, or 721 
concerning any method or process which as a trade secret is 
entitled to protection; or the violating of section 408(i)(2) 
or any regulation issued under that section.. This paragraph 
does not authorize the withholding of information from either 
House of Congress or from, to the extent of matter within its 
jurisdiction, any committee or subcommittee of such committee 
or any joint committee of Congress or any subcommittee of such 
joint committee.

           *       *       *       *       *       *       *

  (q)(1) * * *
  (2) With respect to any device or food, the submission of any 
report that is required by or under this Act that is false or 
misleading in any material respect.

           *       *       *       *       *       *       *

  (oo) The violation of any requirement of section 714 
(relating to testing by accredited laboratories).
  (pp)(1) The failure to notify the Secretary in violation of 
section 420(a).
  (2) The failure to comply with any order issued under section 
420.
  (qq) The violation of a quarantine under section 304(i).
  (rr) The submission of information relating to food that is 
required by or under section 801 that is inaccurate or 
incomplete.
  (ss) The failure to submit information relating to food that 
is required by or under section 801.
  (tt) The failure to register in accordance with section 
801(r) or 801(s).
  (uu) The production, manufacture, processing, preparation, 
packing, holding, or distribution of an adulterated or 
misbranded food with the knowledge or intent that such article 
will be imported into the United States.

           *       *       *       *       *       *       *


                               PENALTIES

  Sec. 303. (a)(1) [Any] Except as provided in paragraph (2) or 
(3), any person who violates a provision of section 301 shall 
be imprisoned for not more than one year or fined not more than 
$1,000, or both.

           *       *       *       *       *       *       *

  (3) Notwithstanding paragraph (1), any person who knowingly 
violates paragraph (a), (b), (c), (k), or (v) of section 301 
with respect to any food that is misbranded or adulterated 
shall be imprisoned for not more than 10 years or fined in 
accordance with title 18, United States Code, or both.

           *       *       *       *       *       *       *

  (f)(1) * * *
  [(2)(A) Any person who introduces into interstate commerce or 
delivers for introduction into interstate commerce an article 
of food that is adulterated within the meaning of section 
402(a)(2)(B) shall be subject to a civil money penalty of not 
more than $50,000 in the case of an individual and $250,000 in 
the case of any other person for such introduction or delivery, 
not to exceed $500,000 for all such violations adjudicated in a 
single proceeding.
  [(B) This paragraph shall not apply to any person who grew 
the article of food that is adulterated. If the Secretary 
assesses a civil penalty against any person under this 
paragraph, the Secretary may not use the criminal authorities 
under this section to sanction such person for the introduction 
or delivery for introduction into interstate commerce of the 
article of food that is adulterated. If the Secretary assesses 
a civil penalty against any person under this paragraph, the 
Secretary may not use the seizure authorities of section 304 or 
the injunction authorities of section 302 with respect to the 
article of food that is adulterated.
  [(C) In a hearing to assess a civil penalty under this 
paragraph, the presiding officer shall have the same authority 
with regard to compelling testimony or production of documents 
as a presiding officer has under section 408(g)(2)(B). The 
third sentence of paragraph (5)(A) shall not apply to any 
investigation under this paragraph.]
  (2)(A) Any person who violates a provision of section 301 
relating to food shall be subject to a civil penalty for each 
such violation of not more than--
          (i) $20,000 in the case of an individual, not to 
        exceed $50,000 in a single proceeding; and
          (ii) $250,000 in the case of any other person, not to 
        exceed $1,000,000 in a single proceeding.
  (B) Any person who knowingly violates a provision of section 
301 relating to food shall be subject to a civil penalty for 
each such violation of not more than--
          (i) $50,000 in the case of an individual, not to 
        exceed $100,000 in a single proceeding; and
          (ii) $500,000 in the case of any other person, not to 
        exceed $7,500,000 in a single proceeding.
  (C) Each violation described in subparagraph (A) or (B) and 
each day during which the violation continues shall be 
considered to be a separate offense.

           *       *       *       *       *       *       *


                                SEIZURE

  Sec. 304. (a) * * *
  (b) The article, equipment, or other thing proceeded against 
shall be liable to seizure by process pursuant to the libel, 
and the procedure in cases under this section shall conform, as 
nearly as may be, to the procedure in admiralty; except that on 
demand of either party any issue of fact joined in any such 
case shall be tried by jury and except that, with respect to 
proceedings relating to food, Rule G of the Supplemental Rules 
of Admiralty or Maritime Claims and Asset Forfeiture Actions 
shall not apply in any such case, exigent circumstances shall 
be deemed to exist for all seizures brought under this section, 
and the summons and arrest warrant shall be issued by the clerk 
of the court without court review in any such case. When libel 
for condemnation proceedings under this section, involving the 
same claimant and the same issues of adulteration or 
misbranding, are pending in two or more jurisdictions, such 
pending proceedings, upon application of the claimant 
seasonably made to the court of one such jurisdiction, shall be 
consolidated for trial by order of such court, and tried in (1) 
any district selected by the claimant where one of such 
proceedings is pending; or (2) a district agreed upon by 
stipulation between the parties. If no order for consolidation 
is so made within a reasonable time, the claimant may apply to 
the court of one such jurisdiction, and such court (after 
giving the United States attorney for such district reasonable 
notice and opportunity to be heard) shall by order, unless good 
cause to the contrary is shown, specify a district of 
reasonable proximity to the claimant's principal place of 
business, in which all such pending proceedings shall be 
consolidated for trial and tried. Such order of consolidation 
shall not apply so as to require the removal of any case the 
date for trial of which has been fixed. The court granting such 
order shall give prompt notification thereof to the other 
courts having jurisdiction of the cases covered thereby.

           *       *       *       *       *       *       *

  (h) Administrative Detention of Foods.--
          (1) Detention authority.--
                  (A) In general.--An officer or qualified 
                employee of the Food and Drug Administration 
                may order the detention, in accordance with 
                this subsection, of any article of food that is 
                found during an inspection, examination, or 
                investigation under this Act conducted by such 
                officer or qualified employee, if the officer 
                or qualified employee has [credible evidence or 
                information indicating] reason to believe that 
                such article [presents a threat of serious 
                adverse health consequences or death to humans 
                or animals] is adulterated, misbranded, or 
                otherwise in violation of this Act.

           *       *       *       *       *       *       *

          (2) Period of detention.--An article of food may be 
        detained under paragraph (1) for a reasonable period, 
        not to exceed 20 days, unless a greater period, not to 
        exceed [30] 60 days, is necessary, to enable the 
        Secretary to institute an action under subsection (a) 
        or section 302. The Secretary shall by regulation 
        provide for procedures for instituting such action on 
        an expedited basis with respect to perishable foods.
          (3) Security of detained article.--An order under 
        paragraph (1) with respect to an article of food may 
        require that such article be labeled or marked as 
        detained, and shall require that the article be removed 
        to a secure facility, as appropriate. An article 
        subject to such an order shall not be transferred by 
        any person from the place at which the article is 
        ordered detained, or from the place to which the 
        article is so removed, as the case may be, until 
        released by the Secretary or until the expiration of 
        the detention period applicable under such order, 
        whichever occurs first. [This subsection may not be 
        construed as authorizing the delivery of the article 
        pursuant to the execution of a bond while the article 
        is subject to the order, and section 801(b) does not 
        authorize the delivery of the article pursuant to the 
        execution of a bond while the article is subject to the 
        order.]
          (4) Appeal of detention order.--
                  (A) In general.--With respect to an article 
                of food ordered detained under paragraph (1), 
                any person who would be entitled to be a 
                claimant for such article if the article were 
                seized under subsection (a) may appeal the 
                order to the Secretary. Within [five] fifteen 
                days after such an appeal is filed, the 
                Secretary, after providing opportunity for an 
                informal hearing, shall confirm or terminate 
                the order involved, and such confirmation by 
                the Secretary shall be considered a final 
                agency action for purposes of section 702 of 
                title 5, United States Code. If during such 
                [five-day] fifteen-day period the Secretary 
                fails to provide such an opportunity, or to 
                confirm or terminate such order, the order is 
                deemed to be terminated.

           *       *       *       *       *       *       *

  (i) Quarantine of Geographic Location.--
          (1) Authority to quarantine.--If the Secretary 
        determines that there is credible evidence or 
        information that an article of food presents an 
        imminent threat of serious adverse health consequences 
        or death to humans or animals, the Secretary may 
        quarantine any geographic area within the United States 
        where the Secretary reasonably believes such food is 
        located or from which such food originated. The 
        authority to quarantine includes prohibiting or 
        restricting the movement of food or of any vehicle 
        being used or that has been used to transport or hold 
        such food within the geographic area. Any quarantine 
        under this paragraph shall be no greater than is 
        appropriate, as determined by the Secretary, to protect 
        the public health.
          (2) Notification procedures.--Before any quarantine 
        action is taken in any State under this subsection, the 
        Secretary shall notify an appropriate official of the 
        State affected and shall issue a public announcement 
        of--
                  (A) the Secretary's findings that support the 
                quarantine action;
                  (B) the area affected by the intended 
                quarantine action;
                  (C) the reasons for the intended quarantine 
                action; and
                  (D) where practicable, an estimate of the 
                anticipated duration of the quarantine.
        The Secretary is not required to make such announcement 
        by publication in the Federal Register, but may use a 
        newspaper, radio or television, the Internet, or any 
        reasonable means to make such announcement.
          (3) Nondelegation.--The authority to quarantine under 
        this subsection is limited to the Commissioner of Food 
        and Drugs, the Principal Deputy Commissioner, and the 
        Associate Commissioner for Regulatory Affairs of the 
        Food and Drug Administration.

           *       *       *       *       *       *       *


SEC. 311. EXERCISE OF SUBPOENA AUTHORITY.

  (a) In General.--For the purpose of--
          (1) any hearing, investigation, or other proceeding 
        respecting a violation of a provision of this Act, the 
        Public Health Service Act, or the Federal Anti-
        Tampering Act, relating to food; or
          (2) any hearing, investigation, or other proceeding 
        to determine if a person is in violation of a specific 
        provision of this Act, the Public Health Service Act, 
        or the Federal Anti-Tampering Act, relating to food,
the Commissioner may issue subpoenas requiring the attendance 
and testimony of witnesses and the production of records and 
other things.
  (b) Timing of Compliance.--When the Commissioner deems that 
immediate compliance with a subpoena issued under this section 
is necessary to address a threat of serious adverse health 
consequences or death, the subpoena may require immediate 
production.
  (c) Service of Subpoena.--
          (1) In general.--Subpoenas of the Commissioner shall 
        be served by a person authorized by the Commissioner by 
        delivering a copy thereof to the person named therein 
        or by certified mail addressed to such person at such 
        person's last known dwelling place or principal place 
        of business.
          (2) Corporations and other entities.--Service on a 
        domestic or foreign corporation, partnership, 
        unincorporated association, or other entity that is 
        subject to suit under a common name may be made by 
        delivering the subpoena to an officer, a managing or 
        general agent, or any other agent authorized by 
        appointment or by law to receive service of process.
          (3) Person outside u.s. jurisdiction.--Service on any 
        person not found within the territorial jurisdiction of 
        any court of the United States may be made in any 
        manner as the Federal Rules of Civil Procedure 
        prescribe for service in a foreign nation.
          (4) Proof of service.--A verified return by the 
        person so serving the subpoena setting forth the manner 
        of service, or, in the case of service by certified 
        mail, the return post office receipt therefor signed by 
        the person so served, shall be proof of service.
  (d) Payment of Witnesses.--Witnesses subpoenaed under 
subsection (a) shall be paid the same fees and mileage as are 
paid witnesses in the district courts of the United States.
  (e) Enforcement.--In the case of a refusal to obey a subpoena 
duly served upon any person under subsection (a), any district 
court of the United States for the judicial district in which 
such person charged with refusal to obey is found, resides, or 
transacts business, upon application by the Commissioner, shall 
have jurisdiction to issue an order compelling compliance with 
the subpoena and requiring such person to appear and give 
testimony or to appear and produce records and other things, or 
both. The failure to obey such order of the court may be 
punished by the court as contempt thereof. If the person 
charged with failure or refusal to obey is not found within the 
territorial jurisdiction of the United States, the United 
States District Court for the District of Columbia shall have 
the same jurisdiction, consistent with due process, to take any 
action respecting compliance with the subpoena by such person 
that such district court would have if such person were 
personally within the jurisdiction of such district court.
  (f) Nondisclosure.--A United States district court for the 
district in which the subpoena is or will be served, upon 
application of the Commissioner, may issue an ex parte order 
that no person or entity disclose to any other person or entity 
(other than to an attorney to obtain legal advice) the 
existence of such subpoena for a period of up to 90 days. Such 
order may be issued on a showing that the records or things 
being sought may be relevant to the hearing, investigation, 
proceeding, or other matter and that there is reason to believe 
that such disclosure may result in--
          (1) furtherance of a potential violation under 
        investigation;
          (2) endangerment to the life or physical safety of 
        any person;
          (3) flight or other action to avoid prosecution or 
        other enforcement remedies;
          (4) destruction of or tampering with evidence; or
          (5) intimidation of potential witnesses.
An order under this subsection may be renewed for additional 
periods of up to 90 days upon a showing that any of the 
circumstances described in paragraphs (1) through (5) continue 
to exist.
  (g) Relation to Other Provisions.--The subpoena authority 
vested in the Commissioner and the district courts of the 
United States by this section is in addition to any such 
authority vested in the Commissioner or such courts by other 
provisions of law.
  (h) Nondelegation.--The authority to issue a subpoena under 
this section is limited to the Secretary or an official 
designated by the Secretary. An official may not be so 
designated unless the official is the director of the district 
under this Act in which the article involved is located, or is 
an official senior to such director.

SEC. 312. EXTRATERRITORIAL JURISDICTION.

  There is extraterritorial Federal jurisdiction over any 
violation of this Act relating to any article of food if such 
article was intended for import into the United States or if 
any act in furtherance of the violation was committed in the 
United States.

CHAPTER IV--FOOD

           *       *       *       *       *       *       *


                            ADULTERATED FOOD

  Sec. 402. A food shall be deemed to be adulterated--
  (a) * * *

           *       *       *       *       *       *       *

  (j) If it has been manufactured, processed, packed, 
transported, or held under conditions that do not meet the 
requirements of sections 418 and 418A.
  (k) If it is manufactured or processed in a facility that is 
in violation of section 418B.
  (l) If it has been manufactured, processed, packed, 
transported, or held under conditions that do not meet the 
standards issued under section 419.
  (m) If it has been grown, harvested, processed, packed, 
sorted, transported, or held under conditions that do not meet 
the standards established under section 419A.
  (n) If it has been produced, manufactured, processed, packed, 
or held in any farm, factory, warehouse, or establishment and 
the owner, operator, or agent of such farm, factory, warehouse, 
or establishment, or any agent of a governmental authority in 
the foreign country within which such farm, factory, warehouse, 
or establishment is located, delays or limits an inspection, or 
refuses to permit entry or inspection, under section 414 or 
704.

                            MISBRANDED FOOD

  Sec. 403. A food shall be deemed to be misbranded--
  (a) * * *

           *       *       *       *       *       *       *

  (z) If it was manufactured, processed, packed, or held in a 
facility that is not duly registered under section 415, 
including a facility whose registration is canceled or 
suspended under such section.
  (aa) If it is part of a shipment offered for import into the 
United States and such shipment is in violation of section 
801(p) (requiring a certification to accompany certain food 
shipments).
  (bb) If it is a new infant formula and it is not the subject 
of a letter from the Secretary provided pursuant to section 
412(c)(1)(C).
  (cc) In the case of a processed food, if the labeling of the 
food fails to identify the country in which the final 
processing of the food occurs.
  (dd) In the case of nonprocessed food, if the labeling of the 
food fails to identify the country of origin of the food.
  (ee) If it is imported or offered for import by an importer 
or a customs broker or filer not duly registered under section 
801(r) or 801(s).

           *       *       *       *       *       *       *


                             FOOD ADDITIVES

  Sec. 409. (a) * * *

           *       *       *       *       *       *       *


                Substances Generally Recognized as Safe

  (k)(1) Not later than 60 days after the date of receipt by 
the Secretary, after the date of the enactment of this 
subsection, of a determination that a substance is a GRAS food 
substance, the Secretary shall post notice of such 
determination and the supporting scientific justifications on 
the Food and Drug Administration's public Web site.
  (2) Not later than 60 days after the date of receipt of a 
request under paragraph (1), the Secretary shall acknowledge 
receipt of such request by informing the requester in writing 
of the date on which the request was received.
  (3) In this subsection, the term ``GRAS food substance'' 
means a substance excluded from the definition of the term 
``food additive'' in section 201(s) because such substance is 
generally recognized, among experts qualified by scientific 
training and experience to evaluate its safety, as having been 
adequately shown through scientific procedures (or, in the case 
of a substance used in food prior to January 1, 1958, through 
either scientific procedures or experience based on common use 
in food) to be safe under the conditions of its intended use.

           *       *       *       *       *       *       *


                    REQUIREMENTS FOR INFANT FORMULAS

  Sec. 412. (a) * * *
  (b)(1) The Secretary shall by regulation establish 
requirements for quality factors for infant formulas to the 
extent possible consistent with current scientific knowledge, 
including quality factor requirements for the nutrients 
required by subsection (i). The quality factor requirements 
established under this paragraph may include requirements for 
one or more clinical studies to demonstrate that the new infant 
formula supports normal physical growth of infants.

           *       *       *       *       *       *       *

  (4)(A) * * *
  [(B)(i) Records required under subparagraph (A) with respect 
to an infant formula shall be retained for at least one year 
after the expiration of the shelf life of such infant formula. 
Except as provided in clause (ii), such records shall be made 
available to the Secretary for review and duplication upon 
request of the Secretary.
  [(ii) A manufacturer need only provide written assurances to 
the Secretary that the regularly scheduled audits required by 
paragraph (2)(B)(iv) are being conducted by the manufacturer, 
and need not make available to the Secretary the actual written 
reports of such audits.]
  (B) Records required under subparagraph (A) with respect to 
an infant formula shall be retained for at least one year after 
the expiration of the shelf life of such infant formula. Such 
records shall be made available to the Secretary for review and 
duplication upon request of the Secretary.
  (c)(1) No person shall introduce or deliver for introduction 
into interstate commerce any new infant formula unless--
          (A) such person has, before introducing such new 
        infant formula, or delivering such new infant formula 
        for introduction, into interstate commerce, registered 
        with the Secretary the name of such person, the place 
        of business of such person, and all establishments at 
        which such person intends to manufacture such new 
        infant formula, [and]
          (B) such person has at least 90 days before marketing 
        such new infant formula, made the submission to the 
        Secretary required by subsection [(c)(1).] (d)(1), and
          (C) the Secretary has by letter informed such person 
        that the registration requirements and the requirements 
        in subsection (d)(1) have been satisfied.

           *       *       *       *       *       *       *

  (d)(1) A person shall, with respect to any infant formula 
subject to subsection (c), make a submission to the Secretary 
which shall include--
          (A) * * *

           *       *       *       *       *       *       *

          [(C) assurances that the infant formula will not be 
        marketed unless it meets the requirements of 
        subsections (b)(1) and (i), as demonstrated by the 
        testing required under subsection (b)(3), and
          [(D) assurances that the processing of the infant 
        formula complies with subsection (b)(2).]
          (C) scientific evidence and other evidence, as 
        identified in regulations promulgated by the Secretary, 
        that demonstrates that the infant formula satisfies the 
        requirements of subsection (b)(1), and, as demonstrated 
        by the testing required under subsection (b)(3), that 
        it satisfies the requirements of subsection (i), and
          (D) scientific evidence and other evidence, as 
        identified in regulations promulgated by the Secretary, 
        that demonstrate that the processing of the infant 
        formula complies with the requirements of subsection 
        (b)(2).

           *       *       *       *       *       *       *


SEC. 414. MAINTENANCE AND INSPECTION OF RECORDS.

  [(a) Records Inspection.--If the Secretary has a reasonable 
belief that an article of food is adulterated and presents a 
threat of 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 that are needed to assist the 
Secretary in determining whether the food is adulterated and 
presents a threat of serious adverse health consequences or 
death to humans or animals. The requirement under the preceding 
sentence 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) Regulations Concerning Recordkeeping.--The Secretary, in 
consultation and coordination, as appropriate, with other 
Federal departments and agencies with responsibilities for 
regulating food safety, may by regulation establish 
requirements regarding the establishment and maintenance, for 
not longer than two years, of records by persons (excluding 
farms and restaurants) who manufacture, process, pack, 
transport, distribute, receive, hold, or import food, which 
records are needed by the Secretary for inspection to allow the 
Secretary to identify the immediate previous sources and the 
immediate subsequent recipients of food, including its 
packaging, in order to address credible threats of serious 
adverse health consequences or death to humans or animals. The 
Secretary shall take into account the size of a business in 
promulgating regulations under this section.]
  (a) Records Access.--
          (1) Records access during an inspection.--
                  (A) In general.--Each person who produces, 
                manufactures, processes, packs, transports, 
                distributes, receives, or holds an article of 
                food in the United States or for import into 
                the United States shall, at the request of an 
                officer or employee duly designated by the 
                Secretary, permit such officer or employee, 
                upon presentation of appropriate credentials, 
                at reasonable times and within reasonable 
                limits and in a reasonable manner, to have 
                access to and copy all records relating to such 
                article bearing on whether the food may be 
                adulterated, misbranded, or otherwise in 
                violation of this Act, including all records 
                collected or developed to comply with section 
                418 or 418A.
                  (B) Scope of records.--The requirement under 
                subparagraph (A) applies to all records 
                relating to the production, manufacture, 
                processing, packing, transporting, 
                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.
                  (C) Immediate availability with notice.--
                Records not required to be made available 
                immediately on commencement of an inspection 
                under subparagraph (A) shall nonetheless be 
                made available immediately on commencement of 
                such an inspection if, by a reasonable time 
                before such inspection, the Secretary by letter 
                to the person identifies the records to be made 
                available during such inspection.
          (2) Additional authorities to access records 
        remotely; submission of records to the secretary.--
                  (A) Remote access in emergencies.--If the 
                Secretary has a reasonable belief that an 
                article of food presents a threat of serious 
                adverse health consequences or death to humans 
                or animals, the Secretary may require each 
                person who manufactures, processes, packs, 
                transports, distributes, receives, holds, or 
                imports such article of food, or any article of 
                food that the Secretary determines may be 
                affected in a similar manner, to submit to the 
                Secretary all records reasonably related to 
                such article of food as soon as is reasonably 
                practicable, after receiving written notice 
                (including by notice served personally and 
                outside normal business hours to an agent 
                identified under subparagraph (E) or (F) of 
                section 415(a)(2)) of such requirement.
                  (B) Remote access to records related to food 
                safety plans.--With respect to a facility 
                subject to section 418 and 418A, the Secretary 
                may require the owner, operator, or agent of 
                such facility to submit to the Secretary, as 
                soon as reasonably practicable after receiving 
                written notice of such requirement, the food 
                safety plan, supporting information relied on 
                by the facility to select the preventive 
                controls to include in its food safety plan, 
                and documentation of corrective actions, if 
                any, taken under section 418(e) within the 
                preceding 2 years
                  (C) Electronic submission.--If the records 
                required to be submitted to the Secretary under 
                subparagraph (A) or (B) are available in 
                electronic format, such records shall be 
                submitted electronically unless the Secretary 
                specifies otherwise in the notice under such 
                subparagraph.
  (b) Regulations Concerning Recordkeeping.--The Secretary, in 
consultation and coordination, as appropriate, with other 
Federal departments and agencies with responsibilities for 
regulating food safety, may by regulation establish 
requirements regarding the establishment and maintenance, for 
not longer than 3 years, of records by persons who produce, 
manufacture, process, pack, transport, distribute, receive, or 
hold food in the United States or for import into the United 
States. The Secretary shall take into account the size of a 
business in promulgating regulations under this section. The 
only distribution records which may be required of restaurants 
under this subsection are those showing the restaurant's 
suppliers and subsequent distribution other than to consumers.
  (c) Tracing System for Food.--
          (1) In general.--The Secretary shall by regulation 
        establish a tracing system for food that is located in 
        the United States or is for import into the United 
        States.
          (2) Information gathering.--
                  (A) Tracing technologies.--Before issuing a 
                proposed regulation under this subsection, the 
                Secretary shall--
                          (i) identify technologies and 
                        methodologies for tracing the 
                        distribution history of a food that 
                        are, or may be, used by members of 
                        different sectors of the food industry, 
                        including technologies and 
                        methodologies to enable each person who 
                        produces, manufactures, processes, 
                        pack, transports, or holds a food to--
                                  (I) maintain the full 
                                pedigree of the origin and 
                                previous distribution history 
                                of the food;
                                  (II) link that history with 
                                the subsequent distribution of 
                                the food;
                                  (III) establish and maintain 
                                a system for tracing the food 
                                that is interoperable with the 
                                systems established and 
                                maintained by other such 
                                persons; and
                                  (IV) use a unique identifier 
                                for each facility owned or 
                                operated by such person for 
                                such purpose, as specified 
                                under section 911; and
                          (ii) to the extent practicable, 
                        assess--
                                  (I) the costs and benefits 
                                associated with the adoption 
                                and use of such technologies;
                                  (II) the feasibility of such 
                                technologies for different 
                                sectors of the food industry; 
                                and
                                  (III) whether such 
                                technologies are compatible 
                                with the requirements of this 
                                subsection.
                  (B) Public meetings.--Before issuing a 
                proposed regulation under this subsection, the 
                Secretary shall conduct not less than 2 public 
                meetings in diverse geographical areas of the 
                United States to provide persons in different 
                regions an opportunity to provide input and 
                information to the Secretary.
                  (C) Pilot projects.--Before issuing a 
                proposed regulation under this subsection, the 
                Secretary shall conduct 1 or more pilot 
                projects in coordination with 1 or more sectors 
                of the food industry to explore and evaluate 
                tracing systems for food.
          (3) Regulation.--Taking into account information 
        obtained through information gathering under paragraph 
        (2), the Secretary shall issue regulations establishing 
        a tracing system that enables the Secretary to identify 
        each person who grows, produces, manufactures, 
        processes, packs, transports, holds, or sells such food 
        in as short a timeframe as practicable but no longer 
        than 2 business days. The Secretary may include in such 
        regulation--
                  (A) the establishment and maintenance of lot 
                numbers;
                  (B) a standardized format for pedigree 
                information; and
                  (C) the use of a common nomenclature for 
                food.
          (4) Exemptions.--
                  (A) Direct sales by farms.--Food is exempt 
                from the requirements of this subsection if 
                such food is--
                          (i) produced on a farm or fishery 
                        (including an oyster bed, a wild 
                        fishery, an aquaculture facility, a 
                        fresh water fishery, and a saltwater 
                        fishery); and
                          (ii) sold by the owner, operator, or 
                        agent in charge of such farm or fishery 
                        directly to a consumer or to a 
                        restaurant or grocery store.
                  (B) Other foods.--The Secretary may by notice 
                in the Federal Register exempt a food or a type 
                of facility, farm, or restaurant from, or 
                modify the requirements with respect to, the 
                requirements of this subsection if the 
                Secretary determines that a tracing system for 
                such food or type of facility, farm, or 
                restaurant is not necessary to protect the 
                public health.
                  (C) Previous sources and subsequent 
                recipients.--For a food covered by an exemption 
                under subparagraph (B), the Secretary shall 
                require each person who produces, manufactures, 
                processes, packs, transports, or holds such 
                food to maintain records to identify the 
                immediate previous sources of such food and its 
                ingredients and the immediate subsequent 
                recipients of such food.
                  (D) Restaurants and grocery stores.--For a 
                food covered by an exemption under subparagraph 
                (A), restaurants and grocery stores shall keep 
                records documenting the farm that was the 
                source of the food.
                  (E) Farms and fisheries.--For a food covered 
                by an exemption under subparagraph (A), farms 
                and fisheries shall keep records, in electronic 
                or non-electronic format, for at least 6 months 
                documenting the restaurant or grocery store to 
                which the food was sold.
  [(c)] (d) Protection of Sensitive Information.--The Secretary 
shall take appropriate measures to ensure that there are in 
effect effective procedures to prevent the unauthorized 
disclosure of any trade secret or confidential information that 
is obtained by the Secretary pursuant to this section.
  [(d)] (e) Limitations.--This section shall not be construed--
          (1) * * *

           *       *       *       *       *       *       *


SEC. 415. REGISTRATION OF FOOD FACILITIES.

  (a) Registration.--
          (1) In general.--The Secretary shall by regulation 
        [require that] require that, on or before December 31 
        of each year, any facility engaged in manufacturing, 
        processing, packing, or holding [food for consumption 
        in the United States] food for consumption in the 
        United States or for export from the United States be 
        registered with the Secretary. To be registered--
                  (A) for a domestic facility, the owner, 
                operator, or agent in charge of the facility 
                shall submit a registration to the Secretary 
                and pay the registration fee required under 
                section 743; and
                  (B) for a foreign facility, the owner, 
                operator, or agent in charge of the facility 
                shall submit a registration to the Secretary 
                and pay the registration fee required under 
                section 743 and shall include with the 
                registration the name of the United States 
                agent for the facility.
          (2) Registration.--An entity (referred to in this 
        section as the ``registrant'') shall submit in 
        electronic format a registration under paragraph (1) to 
        the Secretary [containing information necessary to 
        notify the Secretary of the name and address of each 
        facility at which, and all trade names under which, the 
        registrant conducts business and, when determined 
        necessary by the Secretary through guidance, the 
        general food category (as identified under section 
        170.3 of title 21, Code of Federal Regulations) of any 
        food manufactured, processed, packed, or held at such 
        facility. The registrant shall notify the Secretary in 
        a timely manner of changes to such information.] 
        containing information that identifies the following:
                  (A) The name, address, and emergency contact 
                information of the facility being registered.
                  (B) The primary purpose and business activity 
                of the facility, including the dates of 
                operation if the facility is seasonal.
                  (C) The general food category (as defined by 
                the Secretary by guidance) of each food 
                manufactured, processed, packed, or held at the 
                facility.
                  (D) All trade names under which the facility 
                conducts business related to food.
                  (E) The name, address, and 24-hour emergency 
                contact information of the United States 
                distribution agent for the facility, which 
                agent shall have access to the information 
                required to be maintained under section 414(d) 
                for food that is manufactured, processed, 
                packed, or held at the facility.
                  (F) If the facility is located outside of the 
                United States, the name, address, and emergency 
                contact information for a United States agent.
                  (G) The unique facility identifier of the 
                facility, as specified under section 911.
                  (H) Such additional information pertaining to 
                the facility as the Secretary may require by 
                regulation.
        The registrant shall notify the Secretary of any change 
        in the submitted information not later than 30 days 
        after the date of such change, unless otherwise 
        specified by the Secretary.

           *       *       *       *       *       *       *

          (4) List.--The Secretary shall compile and maintain 
        an up-to-date list of facilities that are registered 
        under this section. The Secretary shall remove from 
        such list the name of any facility that fails to 
        reregister in accordance with this section, that fails 
        to pay the registration fee required under section 743, 
        or whose registration is canceled by the registrant, 
        canceled by the Secretary in accordance with this 
        section, or suspended by the Secretary in accordance 
        with this section. Such list and any registration 
        documents submitted pursuant to this subsection shall 
        not be subject to disclosure under section 552 of title 
        5, United States Code. Information derived from such 
        list or registration documents shall not be subject to 
        disclosure under section 552 of title 5, United States 
        Code, to the extent that it discloses the identity or 
        location of a specific registered person.
          (5) Suspension of registration.--
                  (A) In general.--The Secretary may suspend 
                the registration of any facility registered 
                under this section for a violation of this Act 
                that could result in serious adverse health 
                consequences or death to humans or animals.
                  (B) Notice of suspension.--Suspension of a 
                registration shall be preceded by--
                          (i) notice to the facility of the 
                        intent to suspend the registration; and
                          (ii) an opportunity for an informal 
                        hearing, as defined in guidance or 
                        regulations issued by the Secretary, 
                        concerning the suspension of such 
                        registration for such facility.
                  (C) Request.--The owner, operator, or agent 
                in charge of a facility whose registration is 
                suspended may request that the Secretary vacate 
                the suspension of registration when such owner, 
                operator, or agent has corrected the violation 
                that is the basis for such suspension.
                  (D) Vacating of suspension.--If, based on an 
                inspection of the facility or other 
                information, the Secretary determines that 
                adequate reasons do not exist to continue the 
                suspension of a registration, the Secretary 
                shall vacate such suspension.
          (6) Cancellation of registration.--
                  (A) In general.--Not earlier than 10 days 
                after providing the notice under subparagraph 
                (B), the Secretary may cancel a registration if 
                the Secretary determines that--
                          (i) the registration was not updated 
                        in accordance with this section or 
                        otherwise contains false, incomplete, 
                        or inaccurate information; or
                          (ii) the required registration fee 
                        has not been paid within 30 days after 
                        the date due.
                  (B) Notice of cancellation.--Cancellation 
                shall be preceded by notice to the facility of 
                the intent to cancel the registration and the 
                basis for such cancellation.
                  (C) Timely update or correction.--If the 
                registration for the facility is updated or 
                corrected no later than 7 days after notice is 
                provided under subparagraph (B), the Secretary 
                shall not cancel such registration.
          (7) Report to congress.--Not later than March 30th of 
        each year, the Secretary shall submit to the Congress a 
        report, based on the registrations on or before 
        December 31 of the previous year, on the following:
                  (A) The number of facilities registered under 
                this section.
                  (B) The number of such facilities that are 
                domestic.
                  (C) The number of such facilities that are 
                foreign.
                  (D) The number of such facilities that are 
                high-risk.
                  (E) The number of such facilities that are 
                low-risk.
                  (F) The number of such facilities that hold 
                food.
          (8) Limitation on delegation.--The authority 
        conferred by this subsection to issue an order to 
        suspend a registration or cancel a registration shall 
        not be delegated to any officer or employee other than 
        the Commissioner of Food and Drugs, the Principal 
        Deputy Commissioner, the Associate Commissioner for 
        Regulatory Affairs, or the Director for the Center for 
        Food Safety and Applied Nutrition, of the Food and Drug 
        Administration.

           *       *       *       *       *       *       *


SEC. 417. REPORTABLE FOOD REGISTRY.

  (a) Definitions.--In this section:
          (1) Responsible party.--The term ``responsible 
        party'', with respect to an article of food, [means a 
        person that submits the registration under section 
        415(a) for a food facility that is required to register 
        under section 415(a), at which such article of food is 
        manufactured, processed, packed, or held.] means--
                  (A) a person who submits the registration 
                under section 415(a) for a food facility that 
                is required to be registered under section 
                415(a), at which such food is manufactured, 
                processed, packed, or held;
                  (B) a person who owns, operates, is an agent 
                of, or is otherwise responsible for such food 
                on a farm (as such term is defined in section 
                1.227(b)(3) of title 21, Code of Federal 
                Regulations, or successor regulations) at which 
                such food is produced for sale or distribution 
                in interstate commerce;
                  (C) a person who owns, operates, or is an 
                agent of a restaurant or other retail food 
                establishment (as such terms are defined in 
                section 1.227(b)(11) and (12), respectively, of 
                title 21, Code of Federal Regulations, or 
                successor regulations) at which such food is 
                offered for sale; or
                  (D) a person that is required to register 
                pursuant to section 801(r) with respect to 
                importation of such food.

           *       *       *       *       *       *       *

  (b) Establishment.--
          (1) * * *

           *       *       *       *       *       *       *

          (3) Reporting by restaurants and retail food 
        establishments.--In addition to the electronic portal 
        described in paragraph (1), the Secretary shall make 
        available alternative means of reporting under this 
        section with respect to restaurants and other retail 
        food establishments with limited ability for such 
        reporting.

           *       *       *       *       *       *       *

  (d) Reporting and Notification.--
          (1) In general.--Except as provided in paragraph (2), 
        as soon as practicable, but in no case later than 24 
        hours after a responsible party determines that an 
        article of food is a reportable food, following a 
        timely review of any reasonably available data and 
        information, the responsible party shall--
                  (A) submit a report to the Food and Drug 
                Administration through the electronic portal 
                established under subsection (b) that includes 
                the data elements described in subsection (e) 
                (except the elements described in paragraphs 
                (8), (9), and (10) of such subsection); [and]
                  (B) submit, with such report, through the 
                electronic portal, documentation of results 
                from any sampling and testing of such article, 
                including--
                          (i) analytical results from testing 
                        of such article conducted by or on 
                        behalf of the responsible party under 
                        section 418, 418A, 419, 419A, or 714;
                          (ii) analytical results from testing 
                        conducted by or on behalf of such 
                        responsible party of a component of 
                        such article;
                          (iii) analytical results of 
                        environmental testing of any facility 
                        at which such article, or a component 
                        of such article, is manufactured, 
                        processed, packed, or held; and
                          (iv) any other information the 
                        Secretary determines is necessary to 
                        evaluate the adulteration of such 
                        article, any component of such article, 
                        any other article of food manufactured, 
                        processed, packed or held in the same 
                        manner as, or at the same facility as, 
                        such article, or any other article 
                        containing a component from the same 
                        source as a component of such article; 
                        and
                  [(B)] (C) investigate the cause of the 
                adulteration if the adulteration of the article 
                of food may have originated with the 
                responsible party.

           *       *       *       *       *       *       *

  (e) Data Elements.--The data elements described in this 
subsection are the following:
          (1) The registration numbers of the responsible party 
        under section 415(a)(3) if the responsible party is 
        required to register.

           *       *       *       *       *       *       *

          (12) Such additional information as the Secretary 
        deems appropriate.

           *       *       *       *       *       *       *


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

  (a) In General.--The owner, operator, or agent of a facility 
shall, in accordance with this section--
          (1) conduct a hazard analysis (or more than one if 
        appropriate);
          (2) identify, implement, and validate effective 
        preventive controls;
          (3) monitor preventive controls;
          (4) institute corrective actions when--
                  (A) monitoring shows that preventive controls 
                have not been properly implemented; or
                  (B) monitoring and verification show that 
                such controls were ineffective;
          (5) conduct verification activities;
          (6) maintain records of monitoring, corrective 
        action, and verification; and
          (7) reanalyze for hazards.
  (b) Identification of Hazards.--
          (1) In general.--The owner, operator, or agent of a 
        facility shall evaluate whether there are any hazards, 
        including hazards due to the source of the ingredients, 
        that are reasonably likely to occur in the absence of 
        preventive controls that may affect the safety, 
        wholesomeness, or sanitation of the food manufactured, 
        processed, packed, transported, or held by the 
        facility, including--
                  (A) biological, chemical, physical, and 
                radiological hazards, natural toxins, 
                pesticides, drug residues, filth, 
                decomposition, parasites, allergens, and 
                unapproved food and color additives; and
                  (B) hazards that occur naturally, may be 
                unintentionally introduced, or may be 
                intentionally introduced, including by acts of 
                terrorism.
          (2) Identified by the secretary.--The Secretary may, 
        by regulation or guidance, identify hazards that are 
        reasonably likely to occur in the absence of preventive 
        controls.
          (3) Hazard analysis.--The owner, operator, or agent 
        of a facility shall identify and describe the hazards 
        evaluated under paragraph (1) or identified under 
        paragraph (2), to the extent applicable to the 
        facility, in a hazard analysis.
  (c) Preventive Controls.--
          (1) In general.--The owner, operator, or agent of a 
        facility shall identify, implement, and validate 
        effective preventive controls to prevent, eliminate, or 
        reduce to acceptable levels the occurrence of any 
        hazards identified in the hazard analysis under 
        subsection (b)(3).
          (2) Identified by the secretary.--
                  (A) Establishment.--The Secretary may 
                establish by regulation or guidance preventive 
                controls for specific product types to prevent 
                intentional or unintentional contamination 
                throughout the supply chain. The owner, 
                operator, or agent of a facility shall 
                implement any preventive controls identified by 
                the Secretary under this paragraph.
                  (B) Alternative controls.--Such regulation or 
                guidance shall allow the owner, operator, or 
                agent of a facility to implement an alternative 
                preventive control to one established by the 
                Secretary, provided that, in response to a 
                request by the Secretary, the owner, operator, 
                or agent can present to the Secretary data or 
                other information sufficient to demonstrate 
                that the alternative control effectively 
                addresses the hazard, including meeting any 
                applicable performance standard.
                  (C) Limitation.--Subparagraph (B) shall not 
                apply to any preventive control described in 
                subparagraph (A), (B), or (E) of subsection 
                (i)(2).
  (d) Monitoring.--The owner, operator, or agent of a facility 
shall monitor the implementation of preventive controls under 
subsection (c) to identify any circumstances in which the 
preventive controls are not fully implemented or verification 
shows that such controls were ineffective.
  (e) Corrective Actions.--The owner, operator, or agent of a 
facility shall establish and implement procedures to ensure 
that, if the preventive controls under subsection (c) are not 
fully implemented or are not effective--
          (1) no product from such facility enters commerce; 
        and
          (2) appropriate action is taken to reduce the 
        likelihood of recurrence of the implementation failure.
  (f) Verification.--The owner, operator, or agent of a 
facility shall ensure that--
          (1) the preventive controls identified under 
        subsection (c) have been validated as adequate to 
        control the hazards identified in the hazard analysis 
        under subsection (b)(3);
          (2) the facility is conducting monitoring in 
        accordance with subsection (d);
          (3) the facility is taking effective corrective 
        actions under subsection (e); and
          (4) the preventive controls are effectively 
        preventing, eliminating, or reducing to an acceptable 
        level the occurrence of identified hazards, including 
        through the use of environmental and product testing 
        programs and other appropriate means.
  (g) Requirement to Reanalyze and Revise.--
          (1) Requirement.--The owner, operator, or agent of a 
        facility shall--
                  (A) review the evaluation under subsection 
                (b) for the facility and, as necessary, revise 
                the hazard analysis under subsection (b)(3) for 
                the facility--
                          (i) not less than every 2 years;
                          (ii) if there is a change in the 
                        process or product that could affect 
                        the hazard analysis; and
                          (iii) if the Secretary determines 
                        that it is appropriate to protect 
                        public health; and
                  (B) whenever there is a change in the hazard 
                analysis, revise the preventive controls under 
                subsection (c) for the facility as necessary to 
                ensure that all hazards that are reasonably 
                likely to occur are prevented, eliminated, or 
                reduced to an acceptable level, or document the 
                basis for the conclusion that no such revision 
                is needed.
          (2) Nondelegation.--Any revisions ordered by the 
        Secretary under this subsection shall be ordered by the 
        Secretary or an official designated by the Secretary. 
        An official may not be so designated unless the 
        official is the director of the district under this Act 
        in which the article involved is located, or is an 
        official senior to such director.
  (h) Recordkeeping.--The owner, operator, or agent of a 
facility shall maintain, for not less than 2 years, records 
documenting the activities described in subsections (a) through 
(g).
  (i) Definitions.--For purposes of this section:
          (1) Facility.--The term ``facility'' means a domestic 
        facility or a foreign facility that is required to be 
        registered under section 415.
          (2) Preventive controls.--The term ``preventive 
        controls'' means those risk-based procedures, 
        practices, and processes that a person knowledgeable 
        about the safe manufacturing, processing, packing, 
        transporting, or holding of food would employ to 
        prevent, eliminate, or reduce to an acceptable level 
        the hazards identified in the hazard analysis under 
        subsection (b)(3) and that are consistent with the 
        current scientific understanding of safe food 
        manufacturing, processing, packing, transporting, or 
        holding at the time of the analysis. Those procedures, 
        practices, and processes shall include the following, 
        as appropriate:
                  (A) Sanitation procedures and practices.
                  (B) Supervisor, manager, and employee hygiene 
                training.
                  (C) Process controls.
                  (D) An allergen control program to minimize 
                potential allergic reactions in humans from 
                ingestion of, or contact with, human and animal 
                food.
                  (E) Good manufacturing practices.
                  (F) Verification procedures, practices, and 
                processes for suppliers and incoming 
                ingredients, which may include onsite auditing 
                of suppliers and testing of incoming 
                ingredients.
                  (G) Other procedures, practices, and 
                processes established by the Secretary under 
                subsection (c)(2).
          (3) Hazard that is reasonably likely to occur.--A 
        food safety hazard that is reasonably likely to occur 
        is one for which a prudent person who, as applicable, 
        manufactures, processes, packs, transports, or holds 
        food, would establish controls because experience, 
        illness data, scientific reports, or other information 
        provides a basis to conclude that there is a reasonable 
        possibility that the hazard will occur in the type of 
        food being manufactured, processed, packed, 
        transported, or held in the absence of those controls.

SEC. 418A. FOOD SAFETY PLAN.

  (a) In General.--Before a facility (as defined in section 
418(i)) introduces or delivers for introduction into interstate 
commerce any shipment of food, the owner, operator, or agent of 
the facility shall develop and implement a written food safety 
plan (in this section referred to as a ``food safety plan'').
  (b) Contents.--The food safety plan shall include each of the 
following elements:
          (1) The hazard analysis and any reanalysis conducted 
        under section 418.
          (2) A description of the preventive controls being 
        implemented under subsection 418(c), including those to 
        address hazards or conditions identified by the 
        Secretary under subsection 418(b)(2).
          (3) A description of the procedures for monitoring 
        preventive controls.
          (4) A description of the procedures for taking 
        corrective actions.
          (5) A description of verification activities for the 
        preventive controls, including validation, review of 
        monitoring and corrective action records, and 
        procedures for determining whether the preventive 
        controls are effectively preventing, eliminating, or 
        reducing to an acceptable level the occurrence of 
        identified hazards or conditions, including the use of 
        environmental and product testing programs.
          (6) A description of the facility's recordkeeping 
        procedures.
          (7) A description of the facility's procedures for 
        the recall of articles of food, whether voluntarily or 
        when required under section 422.
          (8) A description of the facility's procedures for 
        tracing the distribution history of articles of food, 
        whether voluntarily or when required under section 414.
          (9) A description of the facility's procedures to 
        ensure a safe and secure supply chain for the 
        ingredients or components used in making the food 
        manufactured, processed, packed, transported, or held 
        by such facility.
          (10) A description of the facility's procedures to 
        implement the science-based performance standards 
        issued under section 419.

SEC. 418B. FINISHED PRODUCT TEST RESULTS FROM CATEGORY 1 FACILITIES.

  (a) Authority.--Beginning on the date specified in subsection 
(c), the Secretary shall require, after public notice and an 
opportunity for comment, the submission to the Secretary of 
finished product test results by the owner, operator, or agent 
of each category 1 facility subject to good manufacturing 
practices regulations documenting the presence of contaminants 
in food in the possession or control of such facility posing a 
risk of severe adverse health consequences or death.
  (b) Considerations.--The Secretary shall require submissions 
under subsection (a)--
          (1) as the Secretary determines feasible and 
        appropriate; and
          (2) taking into consideration available data and 
        information on the potential risks posed by the 
        facility.
  (c) Beginning Date.--The date specified in this subsection is 
the sooner of--
          (1) the date of completion of the pilot projects and 
        feasibility study under subsections (d) and (e); and
          (2) the date that is 2 years after the date of the 
        enactment of this section.
  (d) Pilot Projects.--The Secretary shall conduct 2 or more 
pilot projects to evaluate the feasibility of collecting 
positive finished product testing results from category 1 
facilities, including the value and feasibility of reporting 
corrective actions taken when positive finished product test 
results are reported to the Secretary.
  (e) Feasibility Study.--The Secretary shall assess the 
feasibility and benefits of the reporting by facilities subject 
to good manufacturing practices regulations of appropriate 
finished product testing results from category 1 facilities to 
the Secretary, including the extent to which the collection of 
such finished product testing results will help the Secretary 
assess the risk presented by a facility or product category.
  (f) Limitations.--Nothing in this section shall be 
construed--
          (1) to require the Secretary to mandate testing or 
        submission of test results that the Secretary 
        determines would not provide useful information in 
        assessing the potential risk presented by a facility or 
        product category; or
          (2) to limit the Secretary's authority under any 
        other provisions of law to require any person to 
        provide access, or to submit information or test 
        results, to the Secretary, including the ability of the 
        Secretary to require field or other testing and to 
        obtain test results in the course of an investigation 
        of a potential food-borne illness or contamination 
        incident.
  (g) Definition.--In this section, the term ``category 1 
facility'' means a category 1 facility within the meaning of 
section 704(h).

SEC. 419. PERFORMANCE STANDARDS.

  (a) Performance Standards.--The Secretary shall, not less 
frequently than every 2 years, review and evaluate 
epidemiological data and other appropriate sources of 
information, including research under section 123 of the Food 
Safety Enhancement Act of 2009, to identify the most 
significant food-borne contaminants and the most significant 
resulting hazards. The Secretary shall issue, as soon as 
practicable, through guidance or by regulation, science-based 
performance standards (which may include action levels) 
applicable to foods or food classes, as appropriate, to 
minimize to an acceptable level, prevent, or eliminate the 
occurrence of such hazards. Such standards shall be applicable 
to foods and food classes.
  (b) List of Contaminants.--Following each review under 
subsection (a), the Secretary shall publish in the Federal 
Register a list of food-borne contaminants that have the 
greatest adverse impact on public health. In determining 
whether a particular food-borne contaminant should be added to 
such list, the Secretary shall consider the number and severity 
of illnesses and the number of deaths associated with the foods 
associated with such contaminants.
  (c) Revocation by Secretary.--All performance standards of 
the Food and Drug Administration applicable to foods or food 
classes in effect on the date of the enactment of this section, 
or issued under this section, shall remain in effect until 
revised or revoked by the Secretary.

SEC. 419A. SAFETY STANDARDS FOR PRODUCE AND CERTAIN OTHER RAW 
                    AGRICULTURAL COMMODITIES.

  (a) Standards.--The Secretary shall establish by regulation 
scientific and risk-based standards for the safe growing, 
harvesting, processing, packing, sorting, transporting, and 
holding of those types of raw agricultural commodities--
          (1) that are from a plant or a fungus; and
          (2) for which the Secretary has determined that such 
        standards are reasonably necessary to minimize the risk 
        of serious adverse health consequences or death to 
        humans or animals.
  (b) Contents.--The regulations under subsection (a)--
          (1) may set forth such procedures, processes, and 
        practices as the Secretary determines to be reasonably 
        necessary--
                  (A) 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 raw 
                agricultural commodities that are from a plant 
                or a fungus; and
                  (B) to provide reasonable assurances that 
                such commodity is not adulterated under section 
                402;
          (2) may include, with respect to growing, harvesting, 
        processing, packing, sorting, transporting, and storage 
        operations, standards for safety as the Secretary 
        determines to be reasonably necessary;
          (3) may include standards addressing manure use, 
        water quality, employee hygiene, sanitation and animal 
        control, and temperature controls, as the Secretary 
        determines to be reasonably necessary;
          (4) may include standards for such other elements as 
        the Secretary determines necessary to carry out 
        subsection (a);
          (5) shall provide a reasonable period of time for 
        compliance, taking into account the needs of small 
        businesses for additional time to comply;
          (6) may provide for coordination of education and 
        enforcement activities;
          (7) shall take into consideration, consistent with 
        ensuring enforceable public health protection, the 
        impact on small-scale and diversified farms, and on 
        wildlife habitat, conservation practices, watershed-
        protection efforts, and organic production methods;
          (8) may provide for coordination of education and 
        training with other government agencies, universities, 
        private entities, and others with experience working 
        directly with farmers; and
          (9) may provide for recognition through guidance of 
        other existing publicly available procedures, 
        processes, and practices that the Secretary determines 
        to be equivalent to those established under paragraph 
        (1).
  (c) Enforcement.--The Secretary may coordinate with the 
Secretary of Agriculture and may contract and coordinate with 
the agency or department designated by the Governor of each 
State to perform activities to ensure compliance with this 
section.

SEC. 420. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR 
                    MISBRANDED FOOD.

  (a) Notification, Nondistribution, and Recall of Adulterated 
or Misbranded Food.--
          (1) In general.--A responsible party as that term is 
        defined in section 417(a)(1) or a person required to 
        register under section 801(r) that has reason to 
        believe that an article of food when introduced into or 
        while in interstate commerce, or while held for sale 
        (regardless of whether the first sale) after shipment 
        in interstate commerce, is adulterated or misbranded in 
        a manner that presents a reasonable probability that 
        the use or consumption of, or exposure to, the article 
        (or an ingredient or component used in any such 
        article) will cause a threat of serious adverse health 
        consequences or death to humans or animals shall, as 
        soon as practicable, notify the Secretary of the 
        identity and location of the article.
          (2) Manner of notification.--Notification under 
        paragraph (1) shall be made in such manner and by such 
        means as the Secretary may require by regulation or 
        guidance.
  (b) Voluntary Recall.--The Secretary may request that any 
person who distributes an article of food that the Secretary 
has reason to believe is adulterated, misbranded, or otherwise 
in violation of this Act voluntarily--
          (1) recall such article; and
          (2) provide for notice, including to individuals as 
        appropriate, to persons who may be affected by the 
        recall.
  (c) Order to Cease Distribution.--If the Secretary has reason 
to believe that the use or consumption of, or exposure to, an 
article of food may cause serious adverse health consequences 
or death to humans or animals, the Secretary shall have the 
authority to issue an order requiring any person who 
distributes such article to immediately cease distribution of 
such article.
  (d) Action Following Order.--Any person who is subject to an 
order under subsection (c) shall immediately cease distribution 
of such article and provide notification as required by such 
order, and may appeal within 24 hours of issuance such order to 
the Secretary. Such appeal may include a request for an 
informal hearing and a description of any efforts to recall 
such article undertaken voluntarily by the person, including 
after a request under subsection (b). Except as provided in 
subsection (f), an informal hearing shall be held within as 
soon as practicable, but not later than 5 calendar days, or 
less as determined by the Secretary, after such an appeal is 
filed, unless the parties jointly agree to an extension. After 
affording an opportunity for an informal hearing, the Secretary 
shall determine whether the order should be amended to require 
a recall of such article. If, after providing an opportunity 
for such a hearing, the Secretary determines that inadequate 
grounds exist to support the actions required by the order, the 
Secretary shall vacate the order.
  (e) Order to Recall.--
          (1) Amendment.--Except as provided under subsection 
        (f), if after providing an opportunity for an informal 
        hearing under subsection (d), the Secretary determines 
        that the order should be amended to include a recall of 
        the article with respect to which the order was issued, 
        the Secretary shall amend the order to require a 
        recall.
          (2) Contents.--An amended order under paragraph (1) 
        shall--
                  (A) specify a timetable in which the recall 
                will occur;
                  (B) require periodic reports to the Secretary 
                describing the progress of the recall; and
                  (C) provide for notice, including to 
                individuals as appropriate, to persons who may 
                be affected by the recall.
        In providing for such notice, the Secretary may allow 
        for the assistance of health professionals, State or 
        local officials, or other individuals designated by the 
        Secretary.
          (3) Nondelegation.--An amended order under this 
        subsection shall be ordered by the Secretary or an 
        official designated by the Secretary. An official may 
        not be so designated unless the official is the 
        director of the district under this Act in which the 
        article involved is located, or is an official senior 
        to such director.
  (f) Emergency Recall Order.--
          (1) In general.--If the Secretary has a reasonable 
        belief that an article of food subject to an order 
        under subsection (c) presents an imminent threat of 
        serious adverse health consequences or death to humans 
        or animals, the Secretary may issue an order requiring 
        any person who distributes such article--
                  (A) to immediately recall such article; and
                  (B) to provide for notice, including to 
                individuals as appropriate, to persons who may 
                be affected by the recall.
          (2) Action following order.--Any person who is 
        subject to an emergency recall order under this 
        subsection shall immediately recall such article and 
        provide notification as required by such order, and may 
        appeal within 24 hours after issuance such order to the 
        Secretary. An informal hearing shall be held within as 
        soon as practicable but not later than 5 calendar days, 
        or less as determined by the Secretary, after such an 
        appeal is filed, unless the parties jointly agree to an 
        extension. After affording an opportunity for an 
        informal hearing, the Secretary shall determine whether 
        the order should be amended pursuant to subsection 
        (e)(1). If, after providing an opportunity for such a 
        hearing, the Secretary determines that inadequate 
        grounds exist to support the actions required by the 
        order, the Secretary shall vacate the order.
          (3) Nondelegation.--An order under this subsection 
        shall be issued by the Commissioner of Food and Drugs, 
        the Principal Deputy Commissioner, or the Associate 
        Commissioner for Regulatory Affairs of the Food and 
        Drug Administration.
  (g) Notice to Consumers and Health Officials.--The Secretary 
shall, as the Secretary determines to be necessary, provide 
notice of a recall order under this section to consumers to 
whom the article was, or may have been, distributed and to 
appropriate State and local health officials.
  (h) Savings Clause.--Nothing contained in this section shall 
be construed as limiting--
          (1) the authority of the Secretary to issue an order 
        to cease distribution of, or to recall, an article 
        under any other provision of this Act or the Public 
        Health Service Act; or
          (2) the ability of the Secretary to request any 
        person to perform a voluntary activity related to any 
        article subject to this Act or the Public Health 
        Service Act.

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                     CHAPTER VII--GENERAL AUTHORITY

Subchapter A--General Administrative Provisions

           *       *       *       *       *       *       *


                           FACTORY INSPECTION

  Sec. 704. (a)(1) For purposes of enforcement of this Act, 
officers or employees duly designated by the Secretary, upon 
presenting appropriate credentials and a written notice to the 
owner, operator, or agent in charge, are authorized (A) to 
enter, at reasonable times, any farm, factory, warehouse, or 
establishment, including any such food factory, warehouse, or 
establishment whether foreign or domestic, in which food, 
drugs, devices, or cosmetics are produced, manufactured, 
processed, packed, or held, for introduction into interstate 
commerce or after such introduction, or to enter any vehicle, 
being used to transport or hold such food, drugs, devices, or 
cosmetics in interstate commerce; and (B) to inspect, at 
reasonable times and within reasonable limits and in a 
reasonable manner, such farm, factory, warehouse, 
establishment, or vehicle and all pertinent equipment, finished 
and unfinished materials, containers, and labeling therein. In 
the case of any person [(excluding farms and restaurants)] who 
produces, manufactures, processes, packs, transports, 
distributes, receives, holds, or imports foods, the inspection 
shall extend to all records and other information [described in 
section 414 when the Secretary has a reasonable belief that an 
article of food is adulterated and presents a threat of serious 
adverse health consequences or death to humans or animals] 
described in or required under section 414 bearing on whether 
such food is adulterated, misbranded, or otherwise in violation 
of this Act, including all records collected or developed to 
comply with section 418 or 418A, subject to the limitations 
established in section 414(d). In the case of any farm, 
factory, warehouse, establishment, or consulting laboratory, 
including any food factory, warehouse, establishment, or 
consulting laboratory whether foreign or domestic, in which 
prescription drugs, nonprescription drugs intended for human 
use, or restricted devices are manufactured, processed, packed, 
or held, inspection shall extend to all things therein 
(including records, files, papers, processes, controls, and 
facilities) bearing on whether prescription drugs, 
nonprescription drugs intended for human use, or restricted 
devices which are adulterated or misbranded within the meaning 
of this Act, or which may not be manufactured, introduced into 
interstate commerce, or sold, or offered for sale by reason of 
any provision of this Act, have been or are being manufactured, 
processed, packed, transported, or held in any such place, or 
otherwise bearing on violation of this Act. No inspection 
authorized by [the preceding sentence] either of the preceding 
two sentences or by paragraph (3) shall extend to recipes for 
food, financial data, sales data other than shipment data, 
pricing data, personnel data (other than data as to 
qualifications of technical and professional personnel 
performing functions subject to this Act), and research data 
(other than data relating to new drugs, antibiotic drugs, and 
devices and subject to reporting and inspection under 
regulations lawfully issued pursuant to section 505(i) or (k) 
section 519, or 520(g), and data relating to other drugs or 
devices which in the case of a new drug would be subject to 
reporting or inspection under lawful regulations issued 
pursuant to section 505(j)). A separate notice shall be given 
for each such inspection, but a notice shall not be required 
for each entry made during the period covered by the 
inspection. Each such inspection shall be commenced and 
completed with reasonable promptness.

           *       *       *       *       *       *       *

  (h)(1) Each facility registered under section 415 shall be 
inspected--
          (A)(i) by one or more officers duly designated under 
        section 702 or other statutory authority by the 
        Secretary;
          (ii) for domestic facilities, by a Federal, State, or 
        local official recognized by the Secretary under 
        paragraph (2); or
          (iii) for foreign facilities, by an agency or a 
        representative of a country that is recognized by the 
        Secretary under paragraph (2); and
          (B) at a frequency determined pursuant to a risk-
        based schedule.
  (2) For purposes of paragraph (1)(A), the Secretary--
          (A) may recognize Federal, State, and local officials 
        and agencies and representatives of foreign countries 
        as meeting standards established by the Secretary for 
        conducting inspections under this Act; and
          (B) may limit such recognition to inspections of 
        specific commodities or food types.
  (3) The risk-based schedule under paragraph (1)(B) shall be 
implemented beginning not later than 18 months after the date 
of the enactment of this subsection.
  (4) Such risk-based schedule shall provide for a frequency of 
inspections commensurate with the risk presented by the 
facility and shall be based on the following categories and 
inspection frequencies:
          (A) Category 1.--A category 1 food facility is a 
        high-risk facility that manufactures or processes food. 
        The Secretary shall randomly inspect a category 1 food 
        facility at least every 6 to 12 months.
          (B) Category 2.--A category 2 food facility is a low-
        risk facility that manufactures or processes food or a 
        facility that packs or labels food. The Secretary shall 
        randomly inspect a category 2 facility at least every 
        18 months to 3 years.
          (C) Category 3.--A category 3 food facility is a 
        facility that holds food. The Secretary shall randomly 
        inspect a category 3 facility at least every 5 years.
  (5) The Secretary--
          (A) may, by guidance, modify the types of food 
        facilities within a category under paragraph (4);
          (B) may alter the inspection frequencies specified in 
        paragraph (4) based on the need to respond to food-
        borne illness outbreaks and food recalls; and
          (C) may inspect a facility more frequently than the 
        inspection frequency provided by paragraph (4);
          (D) beginning 6 months after submitting the report 
        required by section 105(b)(2) of the Food Safety 
        Enhancement Act of 2009, may--
                  (i) publish in the Federal Register 
                adjustments to the inspection frequencies 
                specified in subparagraphs (B) and (C) of 
                paragraph (4) for category 2 and category 3 
                food facilities, which adjustments shall be in 
                accordance with the Secretary's recommendations 
                in such report; and
                  (ii) after such publication, implement the 
                adjustments; and
          (E) except as provided in subparagraphs (B) and (C), 
        may not alter the inspection frequency specified in 
        paragraph (4)(A) for category 1 food facilities.
  (6) In determining the appropriate frequency of inspection, 
the Secretary shall consider--
          (A) the type of food manufactured, processed, packed, 
        or held at the facility;
          (B) the compliance history of the facility;
          (C) whether the facility importing or offering for 
        import into the United States food is certified by a 
        qualified certifying entity in accordance with section 
        801(p); and
          (D) such other factors as the Secretary determines by 
        guidance to be relevant to assessing the risk presented 
        by the facility.
  (i) Importers.--Every person engaged in the importing of any 
food shall, upon request of an officer or employee designated 
by the Secretary, permit such officer or employee at all 
reasonable times to inspect the facilities of such person and 
have access to, and to copy and verify, any related records.
  (j) Brokers and Filers.--Every person engaged in the 
brokering for import or filing for import of any food shall, 
upon request of an officer or employee designated by the 
Secretary, permit such officer or employee at all reasonable 
times to inspect the facilities of such person and have access 
to, and to copy and verify, any related records.
  (k) Dedicated Foreign Inspectorate.--The Secretary shall 
establish and maintain a corps of inspectors dedicated to 
inspections of foreign food facilities. This corps shall be 
staffed and funded by the Secretary at a level sufficient to 
enable it to assist the Secretary in achieving the frequency of 
inspections for food facilities as described in this Act.

           *       *       *       *       *       *       *


                        CONFIDENTIAL INFORMATION

  Sec. 708. [The Secretary] (a) The Secretary may provide any 
information which is exempt from disclosure pursuant to 
subsection (a) of section 552 of title 5, United States Code, 
by reason of subsection (b)(4) of such section to a person 
other than an officer or employee of the Department if the 
Secretary determines such other person requires the information 
in connection with an activity which is undertaken under 
contract with the Secretary, which relates to the 
administration of this Act, and with respect to which the 
Secretary (or an officer or employee of the Department) is not 
prohibited from using such information. The Secretary shall 
require as a condition to the provision of information under 
this section that the person receiving it take such security 
precautions respecting the information as the Secretary may by 
regulation prescribe.
  (b)(1)(A) The Secretary may provide to any Federal agency 
acting within the scope of its jurisdiction any information 
relating to food that is exempt from disclosure pursuant to 
subsection (a) of section 552 of title 5, United States Code, 
by reason of subsection (b)(4) of such section, or that is 
referred to in section 301(j) or 415(a)(4).
  (B) Any such information provided to another Federal agency 
shall not be disclosed by such agency except in any action or 
proceeding under the laws of the United States to which the 
receiving agency or the United States is a party.
  (2)(A) In carrying out this Act, the Secretary may provide to 
a State or local government agency any information relating to 
food that is exempt from disclosure pursuant to section 552(a) 
of title 5, United States Code, by reason of subsection (b)(4) 
of such section, or that is referred to in section 301(j) or 
415(a)(4).
  (B) Any such information provided to a State or local 
government agency shall not be disclosed by such agency.
  (3) In carrying out this Act, the Secretary may provide to 
any person any information relating to food that is exempt from 
disclosure pursuant to section 552(a) of title 5, United States 
Code, by reason of subsection (b)(4) of such section, if the 
Secretary determines that providing the information to the 
person is appropriate under the circumstances and the recipient 
provides adequate assurances to the Secretary that the 
recipient will preserve the confidentiality of the information.
  (4) In carrying out this Act, the Secretary may provide any 
information relating to food that is exempt from disclosure 
pursuant to section 552(a) of title 5, United States Code, by 
reason of subsection (b)(4) of such section, or that is 
referred to in section 301(j)--
          (A) to any foreign government agency; or
          (B) any international organization established by 
        law, treaty, or other governmental action and having 
        responsibility--
                  (i) to facilitate global or regional 
                harmonization of standards and requirements in 
                an area of responsibility of the Food and Drug 
                Administration; or
                  (ii) to promote and coordinate public health 
                efforts,
        if the agency or organization provides adequate 
        assurances to the Secretary that the agency or 
        organization will preserve the confidentiality of the 
        information.
  (c) Except where specifically prohibited by statute, the 
Secretary may disclose to the public any information relating 
to food that is exempt from disclosure pursuant to section 
552(a) of title 5, United States Code, by reason of subsection 
(b)(4) of such section, if the Secretary determines that such 
disclosure is necessary to protect the public health.
  (d) Except as provided in subsection (e), the Secretary shall 
not be required to disclose under section 552 of title 5, 
United States Code, or any other provision of law any 
information relating to food obtained from a Federal, State, or 
local government agency, or from a foreign government agency, 
or from an international organization described in subsection 
(b)(4), if the agency or organization has requested that the 
information be kept confidential, or has precluded such 
disclosure under other use limitations, as a condition of 
providing the information.
  (e) Nothing in subsection (d) authorizes the Secretary to 
withhold information from the Congress or prevents the 
Secretary from complying with an order of a court of the United 
States.
  (f) This section shall not affect the authority of the 
Secretary to provide or disclose information under any other 
provision of law.

           *       *       *       *       *       *       *


SEC. 714. TESTING BY ACCREDITED LABORATORIES.

  (a) In General.--
          (1) Requirement.--Whenever analytical testing of an 
        article of food is conducted as part of testimony for 
        the purposes of section 801(a), or for such other 
        purposes as the Secretary deems appropriate through 
        regulation or guidance, such testing shall be conducted 
        by a laboratory that--
                  (A) is accredited, for the analytical method 
                used, by a laboratory accreditation body that 
                has been recognized by the Secretary; and
                  (B) samples such article with adequate 
                controls for ensuring the integrity of the 
                samples analyzed.
          (2) Independence of laboratory.--
                  (A) Certain tests.--Tests required for 
                purposes of section 801(a) or in response to a 
                finding of noncompliance by the Secretary shall 
                be conducted by a laboratory independent of the 
                person on whose behalf such testing is 
                conducted and analyzed.
                  (B) Certain products.--The Secretary may 
                require that testing for certain products under 
                paragraph (1) be conducted by a laboratory 
                independent of the person on whose behalf such 
                testing is conducted.
  (b) Recognition of Laboratory Accreditation Bodies.--The 
Secretary shall establish and implement a program for the 
recognition, based on standards the Secretary deems 
appropriate, of laboratory accreditation bodies that accredit 
laboratories to perform analytical testing for the purposes of 
this section. The Secretary shall issue regulations or guidance 
to implement this program.
  (c) Onsite Audits.--In evaluating whether an accreditation 
body meets, or continues to meet, the standards for recognition 
under subsection (b), the Secretary may--
          (1) observe onsite audits of laboratories by such 
        accreditation bodies; or
          (2) for any laboratory that is accredited by such 
        accreditation body under this section, upon request of 
        an officer or employee designated by the Secretary and 
        upon presentation of appropriate credentials, at 
        reasonable times and within reasonable limits and in a 
        reasonable manner, conduct an onsite audit of the 
        laboratory, which shall include access to, and copying 
        and verification of, any related records.
  (d) Publication of List of Recognized Accreditation Bodies.--
The Secretary shall publish and maintain on the public Web site 
of the Food and Drug Administration a list of accreditation 
bodies recognized by the Secretary under subsection (b).
  (e) Notification of Accreditation of Laboratory.--An 
accreditation body that has been recognized pursuant to this 
section shall promptly notify the Secretary whenever it 
accredits a laboratory for the purposes of this section and 
whenever it withdraws or suspends such accreditation.
  (f) Advance Notice.--Whenever analytical testing is conducted 
pursuant to subsection (a), the person on whose behalf the 
testing is conducted shall notify the Secretary before any 
sample of the article is collected. Such notice shall contain 
information the Secretary determines is appropriate to identify 
the article, the location of the article, and each laboratory 
that will analyze the sample on the person's behalf.
  (g) Contents of Laboratory Packages.--Whenever analytical 
testing is conducted pursuant to subsection (a), the laboratory 
conducting such testing shall submit, directly to the 
Secretary--
          (1) the results of all analyses conducted by the 
        laboratory on each sample of such article; and
          (2) all information the Secretary deems appropriate 
        to--
                  (A) determine whether the laboratory is 
                accredited by a recognized laboratory 
                accreditation body;
                  (B) identify the article tested;
                  (C) evaluate the analytical results; and
                  (D) determine whether the requirements of 
                this section have been met.
  (h) Exigent Circumstances.--The Secretary may waive the 
requirement of subsection (a)(1)(A) (relating to analytical 
methods) on a laboratory or method basis due to exigent or 
other circumstances.
  (i) No Limit on Authority.--Nothing in this section shall be 
construed to limit--
          (1) the ability of the Secretary to review and act 
        upon information from the analytical testing of food 
        (including under this section), including determining 
        the sufficiency of such information and testing; or
          (2) the authority of the Secretary to conduct, 
        require, or consider the results of analytical testing 
        pursuant to any other provision of law.

           *       *       *       *       *       *       *


Subchapter C--Fees

           *       *       *       *       *       *       *


                     PART 6--FEES RELATING TO FOOD

SEC. 743. FACILITY REGISTRATION FEE.

  (a) In General.--
          (1) Assessment and collection.--Beginning in fiscal 
        year 2010, the Secretary shall assess and collect an 
        annual fee for the registration of a facility under 
        section 415.
          (2) Payable date.--A fee under this section shall be 
        payable--
                  (A) for a facility that was not registered 
                under section 415 for the preceding fiscal 
                year, on the date of registration; and
                  (B) for any other facility--
                          (i) for fiscal year 2010, not later 
                        than the sooner of 90 days after the 
                        date of the enactment of this part or 
                        December 31, 2009; and
                          (ii) for a subsequent fiscal year, 
                        not later than December 31 of such 
                        fiscal year.
  (b) Fee Amounts.--
          (1) In general.--The registration fee under 
        subsection (a) shall be--
                  (A) for fiscal year 2010, $500; and
                  (B) for fiscal year 2011 and each subsequent 
                fiscal year, the fee for fiscal year 2010 as 
                adjusted under subsection (c).
          (2) Annual fee setting.--The Secretary shall, not 
        later than 60 days before the start of fiscal year 2011 
        and each subsequent fiscal year, establish, for the 
        next fiscal year, registration fees under subsection 
        (a), as described in paragraph (1).
          (3) Maximum amount.--Notwithstanding paragraph (1), a 
        person who owns or operates multiple facilities for 
        which a fee must be paid under this section for a 
        fiscal year shall be liable for not more than $175,000 
        in aggregate fees under this section for such fiscal 
        year.
  (c) Inflation Adjustment.--For fiscal year 2011 and each 
subsequent fiscal year, the fee amount under subsection (b)(1) 
shall be adjusted by the Secretary by notice, published in the 
Federal Register, to reflect the greater of--
          (1) the total percentage change that occurred in the 
        Consumer Price Index for all urban consumers (all 
        items; U.S. city average) for the 12-month period 
        ending June 30 preceding the fiscal year for which fees 
        are being established;
          (2) the total percentage change for the previous 
        fiscal year in basic pay under the General Schedule in 
        accordance with section 5332 of title 5, United States 
        Code, as adjusted by any locality-based comparability 
        payment pursuant to section 5304 of such title for 
        Federal employees stationed in the District of 
        Columbia; or
          (3) the average annual change in the cost, per full-
        time equivalent position of the Food and Drug 
        Administration, of all personnel compensation and 
        benefits paid with respect to such positions for the 
        first 5 years of the preceding 6 fiscal years.
The adjustment made each fiscal year under this subsection 
shall be added on a compounded basis to the sum of all 
adjustments made each fiscal year after fiscal year 2010 under 
this subsection.
  (d) Limitations.--
          (1) In general.--Fees under subsection (a) shall be 
        refunded for a fiscal year beginning after fiscal year 
        2010 unless appropriations for salaries and expenses of 
        the Food and Drug Administration for such fiscal year 
        (excluding the amount of fees appropriated for such 
        fiscal year) are equal to or greater than the amount of 
        appropriations for the salaries and expenses of the 
        Food and Drug Administration for fiscal year 2010 
        (excluding the amount of fees appropriated for such 
        fiscal year) multiplied by the adjustment factor 
        applicable to the fiscal year involved.
          (2) Authority.--If the Secretary does not assess fees 
        under subsection (a) during any portion of a fiscal 
        year because of paragraph (1) and if at a later date in 
        such fiscal year the Secretary may assess such fees, 
        the Secretary may assess and collect such fees, without 
        any modification in the rate, for registration under 
        section 415 at any time in such fiscal year.
          (3) Adjustment factor.--In this subsection, the term 
        ``adjustment factor'' applicable to a fiscal year is 
        the Consumer Price Index for all urban consumers (all 
        items; United States city average) for October of the 
        preceding fiscal year divided by such Index for October 
        2009.
  (e) Crediting and Availability of Fees.--
          (1) In general.--Fees authorized under subsection (a) 
        shall be collected and available for obligation only to 
        the extent and in the amount provided in advance 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 appropriation 
        account without fiscal year limitation to such 
        appropriation account for salaries and expenses with 
        such fiscal year limitation.
          (2) Collections and appropriations acts.--The fees 
        authorized by this section--
                  (A) shall be retained in each fiscal year in 
                an amount not to exceed the amount specified in 
                appropriation Acts, or otherwise made available 
                for obligation, for such fiscal year; and
                  (B) shall only be collected and available to 
                defray the costs of food safety activities.
          (3) Authorization of appropriations.--For each of 
        fiscal years 2010 through 2014, there are authorized to 
        be appropriated for fees under this section such sums 
        as may be necessary.
          (4) Public meetings.--For each fiscal year, the 
        Secretary shall hold a public meeting on how fees 
        collected under this section will be used to defray the 
        costs of food safety activities in order to solicit the 
        views of the regulated industry, consumers, and other 
        interested stakeholders.
  (f) Collection of Unpaid Fees.--In any case where the 
Secretary does not receive payment of a fee assessed under 
subsection (a) within 30 days after it is due, such fee shall 
be treated as a claim of the United States Government subject 
to subchapter II of chapter 37 of title 31, United States Code.
  (g) Construction.--This section may not be construed to 
require that the number of full-time equivalent positions in 
the Department of Health and Human Services, for officers, 
employees, and advisory committees not engaged in food safety 
activities, be reduced to offset the number of officers, 
employees, and advisory committees so engaged.
  (h) Annual Fiscal Reports.--Beginning with fiscal year 2011, 
not later than 120 days after the end of each fiscal year for 
which fees are collected under this section, the Secretary 
shall prepare and submit to the Committee on Energy and 
Commerce of the House of Representatives and the Committee on 
Health, Education, Labor, and Pensions of the Senate a report 
on the implementation of the authority for such fees during 
such fiscal year and the use, by the Food and Drug 
Administration, of the fees collected for such fiscal year.
  (i) Definitions.--In this section:
          (1) The term ``costs of food safety activities'' 
        means the expenses incurred in connection with food 
        safety activities for--
                  (A) officers and employees of the Food and 
                Drug Administration, contractors of the Food 
                and Drug Administration, advisory committees, 
                and costs related to such officers, employees, 
                and committees and to contracts with such 
                contractors;
                  (B) laboratory capacity;
                  (C) management of information, and the 
                acquisition, maintenance, and repair of 
                technology resources;
                  (D) leasing, maintenance, renovation, and 
                repair of facilities and acquisition, 
                maintenance, and repair of fixtures, furniture, 
                scientific equipment, and other necessary 
                materials and supplies; and
                  (E) collecting fees under this section and 
                accounting for resources allocated for food 
                safety activities.
          (2) The term ``food safety activities'' means 
        activities related to compliance by facilities 
        registered under section 415 with the requirements of 
        this Act relating to food (including research related 
        to and the development of standards (such as 
        performance standards and preventive controls), risk 
        assessments, hazard analyses, inspection planning and 
        inspections, third-party inspections, compliance review 
        and enforcement, import review, information technology 
        support, test development, product sampling, risk 
        communication, and administrative detention).

SEC. 743A. REINSPECTION AND FOOD RECALL FEES APPLICABLE TO FACILITIES.

  (a) In General.--The Secretary shall assess and collect fees 
from each entity in a fiscal year--
          (1) that--
                  (A) during such fiscal year commits a 
                violation of any requirement of this Act 
                relating to food, including any such 
                requirement relating to good manufacturing 
                practices; and
                  (B) because of such violation, undergoes 
                additional inspection by the Food and Drug 
                Administration; or
          (2) during such fiscal year is subject to a food 
        recall.
  (b) Amount of Fees.--The Secretary shall set the amount of 
the fees under this section to fully cover the costs of--
          (1) in the case of fees collected under subsection 
        (a)(1), conducting the additional inspections referred 
        to in such subsection; and
          (2) in the case of fees collected under subsection 
        (a)(2), conducting food recall activities, including 
        technical assistance, follow-up effectiveness checks, 
        and public notifications, during the fiscal year 
        involved.
  (c) Crediting and Availability of Fees.--
          (1) In general.--Fees authorized under subsection (a) 
        shall be collected and available for obligation only to 
        the extent and in the amount provided in advance 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 appropriation 
        account without fiscal year limitation to such 
        appropriation account for salaries and expenses with 
        such fiscal year limitation.
          (2) Collections and appropriations acts.--The fees 
        authorized by this section--
                  (A) shall be retained in each fiscal year in 
                an amount not to exceed the amount specified in 
                appropriation Acts, or otherwise made available 
                for obligation, for such fiscal year; and
                  (B) shall only be collected and available to 
                defray the costs referred to in subsection (b).
          (3) Authorization of appropriations.--For each of 
        fiscal years 2010 through 2014, there are authorized to 
        be appropriated for fees under this section such sums 
        as may be necessary.
  (d) Waiver.--The Secretary shall waive and, if applicable, 
refund the amount of any fee collected under this section from 
an entity as a result of a food recall that the Secretary 
determines was inappropriately ordered.

                       PART 7--IMPORTERS OF FOOD

SEC. 744. IMPORTERS OF FOOD.

  (a) Importers.--The Secretary shall assess and collect an 
annual fee for the registration of an importer of food under 
section 801(r).
  (b) Amount of Fee.--
          (1) Base amounts.--The registration fee under 
        subsection (a) shall be--
                  (A) for fiscal year 2010, $500; and
                  (B) for fiscal year 2011 and each subsequent 
                fiscal year, the fee for fiscal year 2010 as 
                adjusted under paragraph (2).
          (2) Adjustment.--For fiscal year 2011 and subsequent 
        fiscal years, the fees established pursuant to 
        paragraph (1) shall be adjusted by the Secretary by 
        notice, published in the Federal Register, for a fiscal 
        year to reflect the greater of--
                  (A) 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 for which fees are 
                being established;
                  (B) the total percentage change for the 
                previous fiscal year in basic pay under the 
                General Schedule in accordance with section 
                5332 of title 5, United States Code, as 
                adjusted by any locality-based comparability 
                payment pursuant to section 5304 of such title 
                for Federal employees stationed in the District 
                of Columbia; or
                  (C) the average annual change in the cost, 
                per full-time equivalent position of the Food 
                and Drug Administration, of all personnel 
                compensation and benefits paid with respect to 
                such positions for the first 5 years of the 
                preceding 6 fiscal years.
          (3) Compounded basis.--The adjustment made each 
        fiscal year pursuant this subsection shall be added on 
        a compounded basis to the sum of all adjustments made 
        each fiscal year after fiscal year 2010 under this 
        subsection.
          (4) Waiver for importers required to pay registration 
        fee.--In the case of a person who is required to pay 
        both a fee under section 743 for registration of one or 
        more facilities under section 415 and a fee under this 
        section for registration as an importer of food under 
        section 801(r), the Secretary shall waive the fees 
        applicable to such person under section 743 or the fee 
        applicable to such person under this section.
  (c) Crediting and Availability of Fees.--
          (1) In general.--Fees authorized under subsection (a) 
        shall be collected and available for obligation only to 
        the extent and in the amount provided in advance 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 appropriation 
        account without fiscal year limitation to such 
        appropriation account for salaries and expenses with 
        such fiscal year limitation.
          (2) Collections and appropriations acts.--The fees 
        authorized by this section--
                  (A) shall be retained in each fiscal year in 
                an amount not to exceed the amount specified in 
                appropriation Acts, or otherwise made available 
                for obligation, for such fiscal year; and
                  (B) shall only be collected and available to 
                cover the costs associated with registering 
                importers under section 801(r) and with 
                ensuring compliance with good importer 
                practices respecting food.
          (3) Authorization of appropriations.--For each of 
        fiscal years 2010 through 2014, there are authorized to 
        be appropriated for fees under this section such sums 
        as may be necessary.

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                   CHAPTER VIII--IMPORTS AND EXPORTS

                          IMPORTS AND EXPORTS

  Sec. 801. (a) The Secretary of the Treasury shall deliver to 
the Secretary of Health and Human Services, upon his request, 
samples of food, drugs, devices, and cosmetics which are being 
imported or offered for import into the United States, giving 
notice thereof to the owner or consignee, who may appear before 
the Secretary of Health and Human Services and have the right 
to introduce testimony. The Secretary of Health and Human 
Services shall furnish to the Secretary of the Treasury a list 
of establishments registered pursuant to subsection (i) of 
section 510 and shall request that if any drugs or devices 
manufactured, prepared, propagated, compounded, or processed in 
an establishment not so registered are imported or offered for 
import into the United States, samples of such drugs or devices 
be delivered to the Secretary of Health and Human Services, 
with notice of such delivery to the owner or consignee, who may 
appear before the Secretary of Health and Human Services and 
have the right to introduce testimony. If it appears from the 
examination of such samples or otherwise that (1) such article 
has been manufactured, processed, or packed under insanitary 
conditions or, in the case of a device, the methods used in, or 
the facilities or controls used for, the manufacture, packing, 
storage, or installation of the device do not conform to the 
requirements of section 520(f), or (2) such article is 
forbidden or restricted in sale in the country in which it was 
produced or from which it was exported, or (3) such article is 
adulterated, misbranded, or in violation of section 505, or 
prohibited from introduction or delivery for introduction into 
interstate commerce under section 301(ll), or (4) the 
requirements of section 414 have not been complied with 
regarding such article, or (5) such article is subject to an 
order under section 420 to cease distribution of or recall the 
article, then such article shall be refused admission, except 
as provided in subsection (b) of this section. If an article of 
food being imported or offered for import into the United 
States is not in compliance with the requirement of subsection 
(p) (relating to certifications of compliance with this Act), 
then such article shall be refused admission. If such article 
is subject to a requirement under section 760 or 761 and if the 
Secretary has credible evidence or information indicating that 
the responsible person (as defined in such section 760 or 761) 
has not complied with a requirement of such section 760 or 761 
with respect to any such article, or has not allowed access to 
records described in such section 760 or 761, then such article 
shall be refused admission, except as provided in subsection 
(b) of this section. The Secretary of the Treasury shall cause 
the destruction of any such article refused admission unless 
such article is exported, under regulations prescribed by the 
Secretary of the Treasury, within ninety days of the date of 
notice of such refusal or within such additional time as may be 
permitted pursuant to such regulations. Clause (2) of the third 
sentence of this paragraph shall not be construed to prohibit 
the admission of narcotic drugs the importation of which is 
permitted under the Controlled Substances Import and Export 
Act.
  (b) Pending decision as to the admission of an article being 
imported or offered for import, the Secretary of the Treasury 
may authorize delivery of such article to the owner or 
consignee upon the execution by him of a good and sufficient 
bond providing for the payment of such liquidated damages in 
the event of default as may be required pursuant to regulations 
of the Secretary of the Treasury. If it appears to the 
Secretary of Health and Human Services that (1) an article 
included within the provisions of clause (3) of subsection (a) 
of this section can, by relabeling or other action, be brought 
into compliance with the Act or rendered other than a food, 
drug, device, or cosmetic, or (2) with respect to an article 
included within the provision of [the fourth sentence] the 
fifth sentence of subsection (a), the responsible person (as 
defined in section 760 or 761) can take action that would 
assure that the responsible person is in compliance with 
section 760 or 761, as the case may be, final determination as 
to admission of such article may be deferred and, upon filing 
of timely written application by the owner or consignee and the 
execution by him of a bond as provided in the preceding 
provisions of this subsection, the Secretary may, in accordance 
with regulations, authorize the applicant, or, with respect to 
clause (2), the responsible person, to perform such relabeling 
or other action specified in such authorization (including 
destruction or export of rejected articles or portions thereof, 
as may be specified in the Secretary's authorization). All such 
relabeling or other action pursuant to such authorization shall 
in accordance with regulations be under the supervision of an 
officer or employee of the Department of Health and Human 
Services designated by the Secretary, or an officer or employee 
of the Department of the Treasury designated by the Secretary 
of the Treasury.

           *       *       *       *       *       *       *

  (e)(1) * * *

           *       *       *       *       *       *       *

  (4)(A) Any person who exports [a drug, animal drug, or 
device] from the United States a food (including animal feed), 
drug, animal drug, or device may request that the Secretary--
          (i) certify [in writing] that the [exported drug, 
        animal drug, or device] exported food, drug, animal 
        drug, or device meets the requirements of paragraph (1) 
        or section 802; or
          (ii) certify [in writing] that [the drug, animal 
        drug, or device] the food, drug, animal drug, or device 
        being exported meets the applicable requirements of 
        this Act upon a showing that [the drug or device] the 
        food, drug, or device meets the applicable requirements 
        of this Act.
The Secretary shall issue such a certification within 20 days 
of the receipt of a request for such certification.
  (B) For purposes of this paragraph, a certification by the 
Secretary shall be made on such basis and in such form (such as 
a publicly available listing) as the Secretary determines 
appropriate.
  [(B)] (C) If the Secretary issues a written export 
certification within the 20 days prescribed by subparagraph 
(A), a fee for such certification may be charged but shall not 
exceed $175 for each certification. Fees collected for a fiscal 
year pursuant to this subparagraph shall be credited to the 
appropriation account for salaries and expenses of the Food and 
Drug Administration and shall be available in accordance with 
appropriations Acts until expended without fiscal year 
limitation. Such fees shall be collected in each fiscal year in 
an amount equal to the amount specified in appropriations Acts 
for such fiscal year and shall only be collected and available 
for the costs of the Food and Drug Administration.
  (D) Notwithstanding subparagraph (C), if the Secretary issues 
an export certification within the 20 days prescribed by 
subparagraph (A) with respect to the export of food, a fee for 
such certification shall not exceed such amount as the 
Secretary determines is reasonably related to the cost of 
issuing certificates under subparagraph (A) with respect to the 
export of food. The Secretary may adjust this fee annually to 
account for inflation and other cost adjustments. Fees 
collected for a fiscal year pursuant to this subparagraph shall 
be credited to the appropriation account for salaries and 
expenses of the Food and Drug Administration and shall be 
available in accordance with appropriations Acts until 
expended, without fiscal year limitation. Such fees shall be 
collected in each fiscal year in an amount equal to the amount 
specified in appropriations Acts for such fiscal year and shall 
only be collected and available for the costs of the Food and 
Drug Administration to cover the cost of issuing such 
certifications. Such sums as necessary may be transferred from 
such appropriation account for salaries and expenses of the 
Food and Drug Administration without fiscal year limitation to 
such appropriation account for salaries and expenses with 
fiscal year limitation.

           *       *       *       *       *       *       *

  (p) Certifications Concerning Imported Articles.--
          (1) In general.--
                  (A) Requirement.--The Secretary shall 
                require, as an additional condition of granting 
                admission to an article of food being imported 
                or offered for import into the United States, 
                that a qualified certifying entity provide a 
                certification that the article complies with 
                specified requirements of this Act if--
                          (i) for food imported from a 
                        particular country or region, based on 
                        the adequacy of government controls in 
                        such country or region or other 
                        information relevant to such food, 
                        certification would assist the 
                        Secretary in determining whether to 
                        refuse to admit such article under 
                        subsection (a);
                          (ii) for a type of food that could 
                        pose a significant risk to health, 
                        certification would assist the 
                        Secretary in determining whether such 
                        article poses such risk; or
                          (iii) for an article imported from a 
                        particular country, there is an 
                        agreement between the Secretary and the 
                        government of such country providing 
                        for such certification.
                  (B) Contents of certification.--Such 
                certification shall include such information 
                regarding compliance as the Secretary may 
                specify, and may be provided in the form of 
                shipment-specific certificates, a listing of 
                certified facilities or other entities, or in 
                such other form as the Secretary may specify.
                  (C) Notice of cancellation or suspension of 
                certification.--As a condition on acceptance of 
                certifications from a qualified certifying 
                entity, the Secretary shall require the 
                qualified certifying entity to notify the 
                Secretary whenever the qualified certifying 
                entity cancels or suspends the certification of 
                any facility or other entity included in a 
                listing under subparagraph (B).
          (2) Qualified certifying entity.--For purposes of 
        this subsection, the term ``qualified certifying 
        entity'' means--
                  (A) an agency or a representative of the 
                government of the country from which the 
                article originated, as designated by such 
                government or the Secretary; or
                  (B) an individual or entity determined by the 
                Secretary or an accredited body recognized by 
                the Secretary to be qualified to provide a 
                certification under paragraph (1).
          (3) No conflicts of interest.--
                  (A) In general.--The Secretary shall issue 
                regulations to ensure that any qualified 
                certifying entity and its auditors are free 
                from conflicts of interest.
                  (B) Regulations.--Such regulations shall 
                require that--
                          (i) the qualified certifying entity 
                        shall have a committee or management 
                        structure for safeguarding 
                        impartiality;
                          (ii) conflict of interest policies 
                        for a qualified certifying entity and 
                        auditors acting for the qualified 
                        certifying entity shall be written;
                          (iii) the qualified certifying entity 
                        shall not be owned, operated, or 
                        controlled by a producer, manufacturer, 
                        processor, packer, holder, supplier, or 
                        vendor of any article of the type it 
                        certifies;
                          (iv) the qualified certifying entity 
                        shall not have any ownership or 
                        financial interest in any product, 
                        producer, manufacturer, processor, 
                        packer, holder, supplier or vendor of 
                        the type it certifies;
                          (v) no auditor acting for the 
                        qualified certifying entity (or spouse 
                        or minor children) shall have any 
                        significant ownership or other 
                        financial interest regarding any 
                        product of the type it certifies;
                          (vi) the qualified certifying entity 
                        shall maintain records pertaining to 
                        the financial interests of the 
                        personnel involved in audits;
                          (vii) neither the qualified 
                        certifying entity nor any of its 
                        auditors acting for the qualified 
                        certifying entity shall participate in 
                        the production, manufacture, 
                        processing, packing, holding, 
                        promotion, or sale of any product of 
                        the type it certifies;
                          (viii) neither the qualified 
                        certifying entity nor any of its 
                        auditors shall provide consultative 
                        services to any facility certified by 
                        the qualified certifying entity, or the 
                        owner, operator, or agent in charge of 
                        such a facility, unless the qualified 
                        certifying entity has procedures in 
                        place, approved by the Secretary, to 
                        ensure separation of functions between 
                        auditors providing consultative 
                        services and auditors providing 
                        certification services under this 
                        subsection;
                          (ix) no auditors acting for the 
                        qualified certifying entity shall 
                        participate in an audit of a facility 
                        they were employed by within the last 
                        12 months;
                          (x) fees charged or accepted shall 
                        not be contingent or based upon the 
                        report made by the qualified certifying 
                        entity or any personnel involved in the 
                        audit process;
                          (xi) neither the qualified certifying 
                        entity nor any of its auditors shall 
                        accept anything of value from anyone in 
                        connection with the facility being 
                        audited other than the audit fee;
                          (xii) the qualified certifying entity 
                        shall not be owned, operated, or 
                        controlled by a trade association whose 
                        member companies operate facilities 
                        that it certifies;
                          (xiii) the qualified certifying 
                        entity and its auditors shall be free 
                        from any other conflicts of interest 
                        that threaten impartiality;
                          (xiv) the qualified certifying entity 
                        and its auditors shall sign a statement 
                        attesting to compliance with the 
                        conflict of interests requirements 
                        under this paragraph; and
                          (xv) the qualified certifying entity 
                        shall ensure that any subcontractors 
                        that might be used (such as 
                        laboratories and sampling services) 
                        provide similar assurances, except that 
                        it shall not be a violation of this 
                        subsection to the extent such 
                        subcontractors perform additional 
                        nutritional testing services unrelated 
                        to the testing under this subsection.
                  (C) Anything of value.--In this paragraph, 
                the term ``anything of value'' includes gifts, 
                gratuities, reimbursement of expenses, 
                entertainment, loans, or any other form of 
                compensation in cash or in kind.
          (4) Renewal and refusal of certifications.--The 
        Secretary shall--
                  (A) require that, to the extent applicable, 
                any certification provided by a qualified 
                certifying entity be renewed by such entity at 
                such times as the Secretary determines 
                appropriate; and
                  (B) refuse to accept any certification if the 
                Secretary determines that such certification is 
                no longer valid or reliable.
          (5) Electronic submission.--The Secretary shall 
        provide for the electronic submission of certifications 
        under this subsection.
          (6) No limit on authority.--This subsection shall not 
        be construed to limit the authority of the Secretary to 
        conduct random inspections of imported articles or 
        facilities of importers, issue import alerts for 
        detention without physical examination, require 
        submission to the Secretary of documentation or other 
        information about an article imported or offered for 
        import, or to take such other steps as the Secretary 
        deems appropriate to determine the admissibility of 
        imported articles.
  (q) Documentation.--
          (1) Submission.--The Secretary may require by 
        regulation or guidance the submission of documentation 
        or other information for articles of food that are 
        imported or offered for import into the United States.
          (2) Format.--A regulation or guidance under paragraph 
        (1) may specify the format for submission of the 
        documentation or other information.
  (r) Registration of Importers.--
          (1) Registration.--The Secretary shall require an 
        importer of food--
                  (A) to be registered with the Secretary in a 
                form and manner specified by the Secretary; and
                  (B) consistent with section 911, to submit 
                appropriate unique facility identifiers as a 
                condition of registration.
          (2) Good importer practices.--The maintenance of 
        registration under this subsection is conditioned on 
        compliance with good importer practices. Good importer 
        practices shall include the verification of good 
        manufacturing practices and preventive controls of the 
        importer's foreign suppliers, as applicable.
          (3) Suspension of registration.--
                  (A) In general.--Registration under this 
                subsection is subject to suspension upon a 
                finding by the Secretary, after notice and an 
                opportunity for an informal hearing, of--
                          (i) a violation of this Act; or
                          (ii) the knowing or repeated making 
                        of an inaccurate or incomplete 
                        statement or submission of information 
                        relating to the importation of food.
                  (B) Request.--The importer whose registration 
                is suspended may request that the Secretary 
                vacate the suspension of registration when such 
                importer has corrected the violation that is 
                the basis for such suspension.
                  (C) Vacating of suspension.--If the Secretary 
                determines that adequate reasons do not exist 
                to continue the suspension of a registration, 
                the Secretary shall vacate such suspension.
          (4) Cancellation of registration.--
                  (A) In general.--Not earlier than 10 days 
                after providing the notice under subparagraph 
                (B), the Secretary may 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 no later than 7 days after notice is 
                provided under subparagraph (B), the Secretary 
                shall not cancel such registration.
          (5) 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.
  (s) Registration of Customs Brokers and Filers.--
          (1) Registration.--The Secretary shall require a 
        customs broker or filer, with respect to the 
        importation of food--
                  (A) to be registered with the Secretary in a 
                form and manner specified by the Secretary; and
                  (B) consistent with section 911, to submit 
                appropriate unique facility identifiers as a 
                condition of registration.
          (2) Suspension of registration.--
                  (A) In general.--Registration under this 
                subsection is subject to suspension upon a 
                finding by the Secretary, after notice and an 
                opportunity for an informal hearing, of--
                          (i) a violation of this Act; or
                          (ii) the knowing or repeated making 
                        of an inaccurate or incomplete 
                        statement or submission of information 
                        relating to the importation of food.
                  (B) Request.--The customs broker or filer 
                whose registration is suspended may request 
                that the Secretary vacate the suspension of 
                registration when such customs broker or filer 
                has corrected the violation that is the basis 
                for such suspension.
                  (C) Vacating of suspension.--If the Secretary 
                determines that adequate reasons do not exist 
                to continue the suspension of a registration, 
                the Secretary shall vacate such suspension.
          (3) Cancellation of registration.--
                  (A) In general.--Not earlier than 10 days 
                after providing the notice under subparagraph 
                (B), the Secretary may 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 customs 
                broker or filer of the intent to cancel the 
                registration and the basis for such 
                cancellation.
                  (C) Timely update or correction.--If the 
                registration for the customs broker or filer is 
                updated or corrected no later than 7 days after 
                notice is provided under subparagraph (B), the 
                Secretary shall not cancel such registration.
          (4) 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.

           *       *       *       *       *       *       *


SEC. 805. SAFE AND SECURE FOOD IMPORTATION PROGRAM.

  (a) In General.--The Secretary may establish by regulation or 
guidance a program that facilitates the movement of food 
through the importation process under this Act if the importer 
of such food--
          (1) verifies that each facility involved in the 
        production, manufacture, processing, packaging, and 
        holding of the food is in compliance with the food 
        safety and security guidelines developed under 
        subsection (b) with respect to such food;
          (2) ensures that appropriate safety and security 
        controls are in place throughout the supply chain for 
        such food; and
          (3) provides supporting information to the Secretary.
  (b) Guidelines.--
          (1) Development.--For purposes of the program 
        established under subsection (a), the Secretary shall 
        develop safety and security guidelines applicable to 
        the importation of food.
          (2) Factors.--Such guidelines shall take into account 
        the following factors:
                  (A) The personnel of the person importing the 
                food.
                  (B) The physical and procedural safety and 
                security of such person's food supply chain.
                  (C) The sufficiency of preventive controls 
                for food and ingredients purchased by such 
                person.
                  (D) Vendor and supplier information.
                  (E) Other programs for certification or 
                verification by a qualified certifying entity 
                used by the importer.
                  (F) Such other factors as the Secretary 
                determines necessary.

CHAPTER IX--MISCELLANEOUS

           *       *       *       *       *       *       *


SEC. 911. UNIQUE FACILITY IDENTIFIER.

  (a) Registration of Facility or Establishment.--A person 
required to register a facility pursuant to section 415 shall 
submit, at the time of registration, a unique facility 
identifier for the facility or establishment.
  (b) Registration of Importers, Custom Brokers, and Filers.--A 
person required to register pursuant to section 801(r) or 
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(r) 
or 801(s).
  (c) Guidance.--The Secretary may, by guidance, specify the 
unique numerical identifier system to be used to meet the 
requirements of subsections (a) and (b) and the form, manner, 
and timing of a submission under such subsections.
  (d) 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.

SEC. 912. PROTECTIONS FOR EMPLOYEES WHO REFUSE TO VIOLATE, OR WHO 
                    DISCLOSE VIOLATIONS OF, THIS ACT OR SECTION 351 OF 
                    THE PUBLIC HEALTH SERVICE ACT.

  (a) In General.--No person who submits or is required under 
this Act or the Public Health Service Act to submit any 
information related to a food, or any officer, employee, 
contractor, subcontractor, or agent of such person may 
discharge, demote, suspend, threaten, harass, or in any other 
manner discriminate against an employee in the terms and 
conditions of employment because of any lawful act done by the 
employee, including within the ordinary course of the job 
duties of such employee--
          (1) to provide information, cause information to be 
        provided, or otherwise assist in any investigation 
        regarding any conduct which the employee reasonably 
        believes constitutes a violation of this Act, or any 
        other provision of Federal law relating to the safety 
        of a food, if the information or assistance is provided 
        to, or an investigation stemming from the provided 
        information is conducted by--
                  (A) a Federal regulatory or law enforcement 
                agency;
                  (B) any Member of Congress or any committee 
                of Congress; or
                  (C) a person with supervisory authority over 
                the employee (or such other person working for 
                the employer who has the authority to 
                investigate, discover, or terminate the 
                misconduct);
          (2) to file, cause to be filed, testify, participate 
        in, or otherwise assist in a proceeding filed, or about 
        to be filed (with any knowledge of the employer), in 
        any court or administrative forum relating to any such 
        alleged violation; or
          (3) to refuse to commit or assist in any such 
        violation.
  (b) Enforcement Action.--
          (1) In general.--An employee who alleges discharge or 
        other discrimination in violation of subsection (a) may 
        seek relief in accordance with the provisions of 
        subsection (c) by--
                  (A) filing a complaint with the Secretary of 
                Labor; or
                  (B) if the Secretary of Labor has not issued 
                a final decision within 210 days of the filing 
                of the complaint and there is no showing that 
                such delay is due to the bad faith of the 
                claimant, or within 90 days after receiving a 
                final decision or order from the Secretary, 
                bringing an action at law or equity for de novo 
                review in the appropriate district court of the 
                United States, which court shall have 
                jurisdiction over such 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.
          (2) Procedure.--
                  (A) In general.--Any action under paragraph 
                (1) shall be governed under the rules and 
                procedures set forth in section 42121(b) of 
                title 49, United States Code.
                  (B) Exception.--Notification in an action 
                under paragraph (1) shall be made in accordance 
                with section 42121(b)(1) of title 49, United 
                States Code, except that such notification 
                shall be made to the person named in the 
                complaint and to the employer.
                  (C) Burdens of proof.--An action brought 
                under paragraph (1)(B) shall be governed by the 
                legal burdens of proof set forth in section 
                42121(b) of title 49, United States Code.
                  (D) Statute of limitations.--An action under 
                paragraph (1) shall be commenced not later than 
                180 days after the date on which the violation 
                occurs.
  (c) Remedies.--
          (1) In general.--An employee prevailing in any action 
        under subsection (b)(1) shall be entitled to all relief 
        necessary to make the employee whole.
          (2) Issuance of order.--If, in response to a 
        complaint filed under subsection (b)(1), the Secretary 
        of Labor or the district court, as applicable, 
        determines that a violation of subsection (a) has 
        occurred, the Secretary or the court shall order the 
        person who committed such violation--
                  (A) to take affirmative action to abate the 
                violation;
                  (B) to--
                          (i) reinstate the complainant to his 
                        or her former position together with 
                        compensation (including backpay); and
                          (ii) restore the terms, conditions, 
                        and privileges associated with his or 
                        her employment; and
                  (C) to provide compensatory damages to the 
                complainant.
        If such an order is issued under this paragraph, the 
        Secretary or the court, 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 attorney 
        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) Rights Retained by Employee.--Nothing in this section 
shall be deemed 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.

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