`[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2749 Reported in House (RH)]

                                                 Union Calendar No. 130
111th CONGRESS
  1st Session
                                H. R. 2749

                          [Report No. 111-234]

To amend the Federal Food, Drug, and Cosmetic Act to improve the safety 
         of food in the global market, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              June 8, 2009

  Mr. Dingell (for himself, Mr. Waxman, Mr. Pallone, Mr. Stupak, Ms. 
   DeGette, and Ms. Sutton) introduced the following bill; which was 
            referred to the Committee on Energy and Commerce

                             July 29, 2009

  Reported with an amendment, committed to the Committee of the Whole 
       House on the State of the Union, and ordered to be printed
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]
[For text of introduced bill, see copy of bill as introduced on June 8, 
                                 2009]





_______________________________________________________________________

                                 A BILL


 
To amend the Federal Food, Drug, and Cosmetic Act to improve the safety 
         of food in the global market, and for other purposes.


 


    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

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;
            ``(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.
                                                 Union Calendar No. 130

111th CONGRESS

  1st Session

                               H. R. 2749

                          [Report No. 111-234]

_______________________________________________________________________

                                 A BILL

To amend the Federal Food, Drug, and Cosmetic Act to improve the safety 
         of food in the global market, and for other purposes.

_______________________________________________________________________

                             July 29, 2009

  Reported with an amendment, committed to the Committee of the Whole 
       House on the State of the Union, and ordered to be printed`