[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 759 Introduced in House (IH)]

111th CONGRESS
  1st Session
                                H. R. 759

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            January 28, 2009

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

_______________________________________________________________________

                                 A BILL


 
To amend the Federal Food, Drug, and Cosmetic Act to improve the safety 
 of food, drugs, devices, and cosmetics 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; REFERENCES; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Food and Drug 
Administration Globalization Act of 2009''.
    (b) References to the Federal Food, Drug, and Cosmetic Act.--Except 
as otherwise specified, whenever in this Act an amendment is expressed 
in terms of an amendment to a section or other provision, the reference 
shall be considered to be made to a section or other provision of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
    (c) Table of Contents.--The table of contents of this Act is as 
follows:

Sec. 1. Short title; references; table of contents.
Sec. 2. Relationship to State law.
                          TITLE I--FOOD SAFETY

                         Subtitle A--Prevention

Sec. 101. Changes in registration of food facilities.
Sec. 102. Hazard analysis, risk-based preventive controls, and food 
                            safety plan.
Sec. 103. Performance standards.
Sec. 104. Safety standards for fresh produce.
Sec. 105. Risk-based inspection.
Sec. 106. Access to records.
Sec. 107. Traceability of food.
Sec. 108. Reinspection fee applicable to facilities.
Sec. 109. Certification of food facilities.
Sec. 110. Safe and secure food importation program.
                        Subtitle B--Intervention

Sec. 111. Public health assessment system.
Sec. 112. Public education and advisory system.
Sec. 113. Research.
Sec. 114. Notification, nondistribution, and recall of adulterated or 
                            misbranded articles of food.
                          Subtitle C--Response

Sec. 121. Administrative detention.
Sec. 122. Civil penalties relating to food.
Sec. 123. Failure to consent to investigation.
                       Subtitle D--Miscellaneous

Sec. 131.  Labeling requirement for meat, poultry products, and seafood 
                            that contain carbon monoxide.
Sec. 132.  Food substances generally recognized as safe.
Sec. 133.  Country of origin labeling; disclosure of source of 
                            ingredients.
Sec. 134. New food and animal feed export certification fee to improve 
                            the ability of United States firms to 
                            export their products.
                    TITLE II--DRUG AND DEVICE SAFETY

Sec. 201. Registration of producers of drugs and devices; applicable 
                            fee.
Sec. 202. Inspection of producers of drugs and active pharmaceutical 
                            ingredients.
Sec. 203. Documentation for admissibility of drug imports.
Sec. 204. Drug supply quality and safety.
Sec. 205. Delay, limitation, or denial of inspection.
Sec. 206. Country of origin labeling.
Sec. 207. Nondistribution and recall of adulterated or misbranded 
                            drugs.
Sec. 208. Destruction of adulterated, misbranded or counterfeit 
                            articles offered for import.
Sec. 209. Administrative detention of drugs that appear to violate the 
                            law.
Sec. 210. Penalties regarding counterfeit drugs.
Sec. 211. Civil money penalties for violative drugs and devices and 
                            improper import entry filings.
Sec. 212. Human generic drug application and supplement fees to cover 
                            pre-approval inspection costs.
                       TITLE III--COSMETIC SAFETY

Sec. 301. Registration of cosmetic establishments.
Sec. 302. Cosmetic and ingredient statements.
Sec. 303. Serious and unexpected adverse event reports for cosmetics.
Sec. 304. Good manufacturing practices for cosmetics.
Sec. 305. Authorization of appropriations.
Sec. 306. Effective date.
                        TITLE IV--MISCELLANEOUS

Sec. 401. Registration for commercial importers of food, drugs, 
                            devices, and cosmetics; fee.
Sec. 402. Unique identification number for food, drug, and device 
                            facilities and establishments.
Sec. 403. Prohibition against delaying or limiting inspection.
Sec. 404. Dedicated foreign inspectorate.
Sec. 405. Continued operation of field laboratories.
Sec. 406. False or misleading reporting to FDA.
Sec. 407. Subpoena authority.
Sec. 408. Whistleblower protections.

SEC. 2. RELATIONSHIP TO STATE LAW.

    This Act and the amendments made by this Act may not be construed 
as modifying or otherwise affecting any action or the liability of any 
person (as defined in section 201 of the Federal Food, Drug, and 
Cosmetic Act) under the law of any State.

                          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 or is in 
violation of section 741 (requiring payment of a fee for such 
registration).''.
    (b) Annual Registration and Payment of Registration Fee.--
            (1) In general.--Section 415(a) (21 U.S.C. 350d(a)) is 
        amended--
                    (A) in the first sentence of paragraph (1), by 
                inserting ``annually'' after ``be registered'';
                    (B) in paragraph (1), by inserting ``and pay the 
                registration fee required under section 741'' after 
                ``submit a registration to the Secretary'' each place 
                it appears in subparagraphs (A) and (B); and
                    (C) 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 and shall 
                treat such removal as a suspension of the facility's 
                registration.''.
            (2) Registration fee.--Chapter VII (21 U.S.C. 371 et seq.) 
        is amended--
                    (A) by redesignating sections 741 and 742 as 
                sections 744 and 745, respectively; and
                    (B) by adding at the end of subchapter C the 
                following:

                    ``PART 5--FEES RELATING TO FOOD

``SEC. 741. FACILITY REGISTRATION FEE.

    ``(a) In General.--The Secretary shall assess and collect a fee for 
a facility registration under section 415 to defray increases (as 
described in subsection (f)(2)(A)(ii)) in the costs of inspecting 
establishments registered under section 415 and for related activities 
to ensure compliance by such establishments with the requirements of 
this Act relating to food (including increases in such costs for 
management of information, and the acquisition, maintenance, and repair 
of information technology resources).
    ``(b) Fee Revenue Amounts.--
            ``(1) In general.--For each of fiscal years 2010 through 
        2014, fees under subsection (a) shall, except as provided in 
        subsections (c), (e), and (f), be established to generate a 
        total revenue amount under subsection (a).
            ``(2) Total revenue amount.--Not later than September 1, 
        2009, the Secretary shall transmit to the Congress the total 
        revenue amount under paragraph (1) and how such amount was 
        calculated.
            ``(3) Annual fee setting.--The Secretary shall, not later 
        than 60 days before the start of each fiscal year that begins 
        after September 30, 2009, establish, for the next fiscal year, 
        registration fees under subsection (a) based on the total 
        revenue amount applicable under paragraph (1).
    ``(c) Adjustments.--
            ``(1) Inflation adjustment.--For fiscal year 2011 and 
        subsequent fiscal years, the revenues established under 
        subsection (b)(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; U.S. 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.
        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 2009 under 
        this subsection.
            ``(2) Workload adjustment.--For fiscal year 2011 and 
        subsequent fiscal years, after the fee revenues established 
        under subsection (b)(1) are adjusted for a fiscal year for 
        inflation in accordance with paragraph (1), the fee revenues 
        shall be adjusted further for such fiscal year to reflect 
        changes in the workload of the Secretary for inspections and 
        related activities described in subsection (a). With respect to 
        such adjustment:
                    ``(A) The adjustment shall be determined by the 
                Secretary based on a weighted average of the change in 
                the total amount of inspections and related activities 
                described in subsection (a). The Secretary shall 
                publish in the Federal Register the fee revenues and 
                fees resulting from the adjustment and the supporting 
                methodologies.
                    ``(B) Under no circumstances shall the adjustment 
                result in fee revenues for a fiscal year that are less 
                than the fee revenues for the fiscal year established 
                under subsection (b)(1), as adjusted for inflation 
                under paragraph (1). Any adjustment for changes in 
                inspections and related activities described in 
                subsection (a) made in setting fees and revenue amounts 
                for fiscal year 2011 or any subsequent year may not 
                result in the total workload adjustment being more than 
                2 percentage points higher than it would have been in 
                the absence of the adjustment for changes in 
                inspections and related activities.
                    ``(C) The Secretary shall contract with an 
                independent accounting firm to study the adjustment for 
                changes in inspections and related activities described 
                in subsection (a) applied in setting fees and revenue 
                amounts for fiscal year 2011 and to make 
                recommendations, if warranted, for future changes in 
                the methodology for calculating the adjustment. After 
                review of the recommendations, the Secretary shall, if 
                warranted, make appropriate changes to the methodology, 
                and the changes shall be effective for each of fiscal 
                years 2012 through 2014. The Secretary shall not make 
                any adjustment for changes in inspections and related 
                activities described in subsection (a) for any fiscal 
                year after 2011 unless such study has been completed.
            ``(3) Rent and rent-related cost adjustment.--For fiscal 
        year 2012 and each subsequent fiscal year, the Secretary shall, 
        before making adjustments under paragraphs (1) and (2), 
        decrease the fee revenue amount established under subsection 
        (b)(1) if actual costs paid for rent and rent-related expenses 
        for the preceding fiscal year are less than estimates made for 
        such year in fiscal year 2008. Any reduction made under this 
        paragraph shall not exceed the amount by which such costs fall 
        below the estimates made in fiscal year 2008 for such fiscal 
        year, and shall not exceed $11,721,000 for any fiscal year.
            ``(4) Final year adjustment.--For fiscal year 2014, the 
        Secretary may, in addition to adjustments under paragraphs (1), 
        (2), (3), and (5), further increase the fee revenues and fees 
        established in subsection (b) if such an adjustment is 
        necessary to provide for not more than 3 months of operating 
        reserves of carryover user fees for inspections described in 
        subsection (a) for the first 3 months of fiscal year 2015. If 
        such an adjustment is necessary, the rationale for the amount 
        of the increase shall be contained in the annual notice 
        establishing fee revenues and fees for fiscal year 2014. If the 
        Secretary has carryover balances for such inspections in excess 
        of 3 months of such operating reserves, the adjustment under 
        this paragraph shall not be made.
            ``(5) Cost estimate adjustment.--For fiscal year 2011 and 
        subsequent fiscal years, the Secretary by notice, published in 
        the Federal Register, shall--
                    ``(A) provide an estimate of the amount of the 
                total increases described in subsection (a) for such 
                fiscal year; and
                    ``(B) after making adjustments under paragraphs 
                (1), (2), and (3), adjust the revenues established 
                under subsection (b)(1) to be equal to such amount.
            ``(6) Limit.--The total amount of fees charged, as adjusted 
        under this subsection, for a fiscal year may not exceed the 
        total increases described in subsection (a) for such fiscal 
        year.
    ``(d) Waivers.--The Secretary shall waive the fee under this 
section with respect to any facility that is a small business, as 
defined by the Secretary.
    ``(e) 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 the 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.
    ``(f) 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 appropriation acts.--
                    ``(A) In general.--The fees authorized by this 
                section--
                            ``(i) 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
                            ``(ii) shall only be collected and 
                        available to defray increases in the costs of 
                        inspecting establishments registered under 
                        section 415 and related activities to ensure 
                        compliance by such establishments with the 
                        requirements of this Act relating to food 
                        (including increases in such costs for an 
                        additional number of full-time equivalent 
                        positions in the Department of Health and Human 
                        Services to be engaged in such inspections and 
                        for management of information, and the 
                        acquisition, maintenance, and repair of 
                        information technology resources) over such 
                        costs, excluding costs paid from fees collected 
                        under this section, for fiscal year 2009 
                        multiplied by the adjustment factor.
                    ``(B) Compliance.--The Secretary shall be 
                considered to have met the requirements of subparagraph 
                (A)(ii) in any fiscal year if the costs funded by 
                appropriations and allocated for inspections described 
                in subsection (a)--
                            ``(i) are not more than 3 percent below the 
                        level specified in subparagraph (A)(ii); or
                            ``(ii)(I) are more than 3 percent below the 
                        level specified in subparagraph (A)(ii), and 
                        fees assessed for the fiscal year following the 
                        subsequent fiscal year are decreased by the 
                        amount in excess of 3 percent by which such 
                        costs fell below the level specified in such 
                        subparagraph; and
                            ``(II) such costs are not more than 5 
                        percent below the level specified in such 
                        subparagraph.
            ``(3) Authorization of appropriations.--For each of the 
        fiscal years 2010 through 2014, there is authorized to be 
        appropriated for fees under this section an amount equal to the 
        total revenue amount determined under subsection (b)(1) for the 
        fiscal year, as adjusted or otherwise affected under subsection 
        (c) and paragraph (4) of this subsection.
            ``(4) Offset.--If the sum of the cumulative amount of fees 
        collected under this section for the fiscal years 2010 through 
        2013 and the amount of fees estimated to be collected under 
        this section for fiscal year 2014 exceeds the cumulative amount 
        appropriated under paragraph (3) for the fiscal years 2010 
        through 2013, the excess shall be credited to the appropriation 
        account of the Food and Drug Administration as provided in 
        paragraph (1), and shall be subtracted from the amount of fees 
        that would otherwise be authorized to be collected under this 
        section for fiscal year 2014.
    ``(g) 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.
    ``(h) 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, employers, and advisory 
committees not engaged in inspections described in subsection (a), be 
reduced to offset the number of officers, employees, and advisory 
committees so engaged.
    ``(i) 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.
    ``(j) Definition.--In this section, 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.''.
    (c) Contents of Registration.--Paragraph (2) of section 415(a) (21 
U.S.C. 350d(a)) 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 each facility engaged in manufacturing, 
                processing, packing, or holding food for consumption in 
                the United States that the registrant operates.
                    ``(B) The primary purpose and business activity of 
                each such facility, including the dates of operation if 
                the facility is seasonal.
                    ``(C) The general food category (as listed under 
                section 170.3(n) of title 21, Code of Federal 
                Regulations, or as the Secretary may otherwise 
                designate for purposes of evaluating potential threats 
                to food protection) of any food manufactured, 
                processed, packed, or held at each such facility.
                    ``(D) All trade names under which each such 
                facility conducts business related to food.
                    ``(E) The name, address, and 24-hour emergency 
                contact information of the United States distribution 
                agent for each such facility, which agent shall 
                maintain information on the wholesale and retail 
                distribution of food.
        The registrant shall notify the Secretary of any change in the 
        products, function, or legal status of each such facility 
        (including cessation of business activities) not later than 30 
        days after the date of such change.''.
    (d) Suspension Authority.--Section 415(a) (21 U.S.C. 350d(a)), as 
amended by subsection (c), 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, including the facility of an importer--
                            ``(i) for violation of this Act that could 
                        result in serious adverse health consequences 
                        or death to humans or animals; or
                            ``(ii) if the facility, or an employee of 
                        the facility, delays or limits an inspection, 
                        or refuses to permit entry or inspection, by 
                        the Secretary under this Act.
                    ``(B) Notice and opportunity for hearing.--Before 
                suspending the registration of a facility under this 
                paragraph, the Secretary shall provide notice to a 
                registrant of an intent to suspend the registration and 
                provide the registrant with an opportunity for an 
                informal hearing. The Secretary may issue a written 
                order of suspension following the hearing, if the 
                Secretary finds that a violation described in 
                subparagraph (A) has occurred.
                    ``(C) Reinstatement.--A registration that is 
                suspended under this section may be reinstated pursuant 
                to criteria published by the Secretary in the Federal 
                Register and on a public website of the Food and Drug 
                Administration.
                    ``(D) Appeal.--Any registrant whose registration is 
                suspended under this section may appeal that action in 
                any appropriate district court of the United States.''.
    (e) Effective Dates.--
            (1) Fees.--
                    (A) Effective date.--The Secretary of Health and 
                Human Services shall first impose the fee established 
                under section 741 of the Federal Food, Drug, and 
                Cosmetic Act, as added by subsection (b)(2), for fiscal 
                years beginning with fiscal year 2010.
                    (B) Sunset date.--Section 741 of the Federal Food, 
                Drug, and Cosmetic Act, as added by subsection (b)(2), 
                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.
            (2) Modification of registration form.--Not later than 30 
        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 
        subsection (c).
            (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 60 days 
        after the date of the enactment of this Act.

SEC. 102. HAZARD ANALYSIS, RISK-BASED PREVENTIVE CONTROLS, AND FOOD 
              SAFETY PLAN.

    (a) Prohibited Act.--Section 301 (21 U.S.C. 331) is amended by 
adding at the end the following:
    ``(oo) The operation of a facility that manufactures, processes, 
packs, transports, or holds food for consumption in the United States 
if the owner, operator, or agent in charge of such facility is not in 
compliance with sections 418 and 418A.''.
    (b) 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 in charge of a 
facility shall, in accordance with this section, evaluate the hazards 
that could affect food manufactured, processed, packed, transported, or 
held by such facility, identify and implement preventive controls to 
significantly minimize, prevent, or eliminate the occurrence of such 
hazards, monitor the performance of such controls, and maintain records 
of such monitoring.
    ``(b) Hazard Analysis.--The owner, operator, or agent in charge of 
a facility shall identify and evaluate known or reasonably foreseeable 
hazards that may be associated with the facility, including--
            ``(1) biological, chemical, physical, and radiological 
        hazards, natural toxins, pesticides, drug residues, 
        decomposition, parasites, allergens, and unapproved food and 
        color additives;
            ``(2) hazards that occur naturally, may be unintentionally 
        introduced, or may be intentionally introduced, including by 
        acts of terrorism; and
            ``(3) relevant hazards identified under section 419.
    ``(c) Preventive Controls.--
            ``(1) In general.--The owner, operator, or agent in charge 
        of a facility shall identify, implement, and validate 
        preventive controls, including at critical control points, if 
        any, to significantly minimize, prevent, or eliminate hazards 
        identified in the hazard analysis conducted under subsection 
        (b).
            ``(2) Specific product types.--The Secretary may establish 
        by regulation or guidance additional preventive controls under 
        this section for specific product types to prevent intentional 
        or unintentional contamination throughout the supply chain.
    ``(d) Monitoring of Effectiveness.--The owner, operator, or agent 
in charge of a facility shall monitor the effectiveness of the 
preventive controls implemented under subsection (c).
    ``(e) Corrective Actions.--The owner, operator, or agent in charge 
of a facility shall establish procedures that the facility will 
implement if the preventive controls implemented under subsection (c) 
are found to be ineffective through monitoring under subsection (d).
    ``(f) Verification.--The owner, operator, or agent in charge of a 
facility shall verify that--
            ``(1) the preventive controls implemented under subsection 
        (c) have been validated as adequate to control the hazards 
        identified under subsection (b);
            ``(2) the owner, operator, or agent is conducting 
        monitoring in accordance with subsection (d); and
            ``(3) the owner, operator, or agent is taking effective 
        corrective actions under subsection (e).
    ``(g) Record Keeping.--The owner, operator, or agent in charge of a 
facility shall maintain, for not less than 2 years, records documenting 
the monitoring and verification of the effectiveness of the actions 
described in subsections (a) through (f).
    ``(h) Requirement To Reanalyze.--Each owner, operator, or agent in 
charge of a facility shall--
            ``(1) conduct a reanalysis under subsection (b)--
                    ``(A) whenever there is a reasonable potential for 
                a new hazard or a significant increase in a previously 
                identified hazard;
                    ``(B) not less frequently than once every 2 years; 
                and
                    ``(C) if the Secretary determines it to be 
                appropriate for the protection of the public health; 
                and
            ``(2) revise the preventive controls under subsection (c) 
        to significantly minimize, prevent, or eliminate such hazard or 
        document the basis for the conclusion that no such revision is 
        needed.
    ``(i) Definitions.--For purposes of this section:
            ``(1) Critical control point.--The term `critical control 
        point' means a point, step, or procedure in a food process at 
        which control can be applied and is essential to prevent or 
        eliminate a food safety hazard or reduce it to an acceptable 
        level.
            ``(2) Facility.--The term `facility' means a domestic 
        facility or a foreign facility that is required to register 
        under section 415.
            ``(3) Preventive controls.--The term `preventive controls' 
        means those risk-based procedures, practices, and processes 
        that a person knowledgeable about the safe manufacturing, 
        processing, packing, transporting, or holding of food would 
        have employed to significantly minimize, prevent, or eliminate 
        the hazards identified under the hazard analysis conducted 
        under subsection (a) and that are consistent with the current 
        scientific understanding of safe food manufacturing, 
        processing, packing, transporting, or holding at the time of 
        the analysis. Those procedures, practices, and processes may 
        include the following:
                    ``(A) Sanitation procedures for food contact 
                surfaces and utensils and food-contact surfaces of 
                equipment.
                    ``(B) Supervisor, manager, and employee hygiene 
                training.
                    ``(C) An environmental monitoring program to verify 
                the effectiveness of pathogen controls.
                    ``(D) An allergen control program.
                    ``(E) A recall contingency plan.
                    ``(F) Good manufacturing practices.
                    ``(G) Supplier verification activities.

``SEC. 418A. FOOD SAFETY PLAN.

    ``(a) Implementation of Food Safety Plan.--
            ``(1) 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 in 
        charge of the facility shall develop and implement a written 
        food safety plan (in this section referred to as a `food safety 
        plan').
            ``(2) Contents.--The food safety plan shall include each of 
        the following elements:
                    ``(A) The hazard analysis conducted under section 
                418.
                    ``(B) A description of the preventive controls 
                being implemented under section 418(c), including any 
                those for specific product types under section 
                418(c)(2).
                    ``(C) Validation that such preventive controls are 
                effective to reduce, control, or eliminate such hazard.
                    ``(D) A description of monitoring of such 
                preventive controls being implemented, including 
                sampling and testing relating to the control of hazards 
                where appropriate to verify that the controls are 
                effective.
                    ``(E) A description of the record keeping being 
                conducted, including evidence of corrective actions, 
                sampling and testing records, monitoring and 
                verification records, and validation records.
                    ``(F) A description of established procedures for 
                the recall of articles of food, whether voluntarily or 
                when required under section 422.
                    ``(G) A description of established procedures for 
                the trace back of articles of food, whether voluntarily 
                or when required under section 403(g).
                    ``(H) A description of established procedures to 
                ensure a safe and secure supply chain for the 
                ingredients or components used in making the food 
                produced, processed, packed, transported, or held by 
                such facility.
                    ``(I) A description of established procedures to 
                implement the science-based performance standards 
                issued under section 419.
    ``(b) Inspection of Food Safety Plan in Course of Facility 
Inspection.--In the course of a facility inspection under section 704, 
the Secretary shall conduct a review of the food safety plan to ensure 
the plan meets relevant requirements of section 418, this section, and 
section 419 and is adequate to protect the public health.''.
    (c) Guidance or Regulations.--
            (1) 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 minimum standards for conducting a hazard analysis, 
        documenting hazards, implementing preventive controls, and 
        documenting the implementation of the preventive controls under 
        sections 418 and 418A of the Federal Food, Drug, and Cosmetic 
        Act (as added by subsection (b)).
            (2) Consideration.--In issuing guidance or promulgating 
        regulations under this section, the Secretary shall consider 
        the capacity of small businesses.
    (d) No Effect on HACCP Authorities.--Nothing in the amendments made 
by this section limits the authority of the Secretary under the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or the Public 
Health Service Act (42 U.S.C. 201 et seq.) to revise, issue, or enforce 
product and category-specific regulations, such as the Seafood Hazard 
Analysis Critical Controls Points Program, the Juice Hazard Analysis 
Critical Control Program, and the Thermally Processed Low-Acid Foods 
Packaged in Hermetically Sealed Containers standards.
    (e) Effective Date.--
            (1) General rule.--The amendments made by this section 
        shall take effect 18 months after the date of the enactment of 
        this Act.
            (2) Exceptions.--Notwithstanding paragraph (1)--
                    (A) the amendments made by this section shall apply 
                to a small business (as defined by the Secretary) after 
                the date that is 2 years after the date of the 
                enactment of this Act; and
                    (B) the amendments made by this section shall apply 
                to a very small business (as defined by the Secretary) 
                after the date that is 3 years after the date of the 
                enactment of this Act.

SEC. 103. PERFORMANCE STANDARDS.

    Chapter IV (21 U.S.C. 341 et seq.), as amended by section 102, is 
further amended by adding at the end the following:

``SEC. 419. 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 113 of the Food and 
Drug Administration Globalization Act of 2009, to identify the most 
significant food-borne contaminants and the most significant resulting 
hazards, and shall issue, through guidance or by regulation, science-
based performance standards (which may include action levels) to 
significantly minimize, prevent, or eliminate the occurrence of such 
hazards. Such standards shall be applicable to products and product 
classes and shall not be specific to an individual facility.''.

SEC. 104. SAFETY STANDARDS FOR FRESH PRODUCE.

    (a) Prohibited Act.--Section 301 (21 U.S.C. 331), as amended by 
sections 102 and 103, is amended by adding at the end the following:
    ``(pp) The production or harvesting of produce not in accordance 
with minimum standards as provided by regulation under section 419A(a) 
or a variance issued under section 419A(e).''.
    (b) Standards.--Chapter IV (21 U.S.C. 341 et seq.), as amended by 
sections 102 and 103, is amended by adding at the end the following:

``SEC. 419A. STANDARDS FOR PRODUCE SAFETY.

    ``(a) Standards.--The Secretary shall establish by regulation 
science-based minimum standards for the safe production and harvesting 
of those types of fruits and vegetables that are raw agricultural 
commodities for which the Secretary has determined that such standards 
minimize the risk of serious adverse health consequences or death.
    ``(b) Contents.--The regulations under subsection (a)--
            ``(1) shall 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 fruits and vegetables that are raw 
                agricultural commodities; and
                    ``(B) to provide reasonable assurances that the 
                produce is not adulterated under section 402;
            ``(2) shall include, with respect to growing, harvesting, 
        packing, sorting, and storage operations, minimum standards for 
        safety;
            ``(3) shall include standards addressing manure use, water 
        quality, employee hygiene, sanitation and animal control, 
        temperature controls, and nutrients;
            ``(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; and
            ``(6) shall provide for coordination of education and 
        enforcement activities by State and local officials, as 
        designated by the Governors of the respective States.
    ``(c) Prioritization.--The Secretary shall prioritize the 
implementation of the regulations under subsection (a) for specific 
fruits and vegetables that are raw agricultural commodities and have 
been associated with food-borne illness outbreaks.
    ``(d) Enforcement.--The Secretary may coordinate with the Secretary 
of Agriculture and shall contract and coordinate with the agency or 
department designated by the Governor of each State to perform 
activities to ensure compliance with this section.''.
    (c) Guidance; Rulemaking.--
            (1) Guidance.--Not later than 1 year after the date of 
        enactment of this Act, the Secretary shall publish, after 
        consultation with the Secretary of Agriculture and 
        representatives of State departments of agriculture, updated 
        good agricultural practices and guidance for the safe 
        production and harvesting of specific types of fresh produce.
            (2) Proposed rulemaking.--
                    (A) In general.--Not later than 1 year after the 
                date of the enactment of this Act, the Secretary, in 
                consultation with the Secretary of Agriculture and 
                representatives of State departments of agriculture, 
                shall publish a notice of proposed rulemaking under 
                section 419A of the Federal Food, Drug, and Cosmetic 
                Act, as added by subsection (b).
                    (B) Public input.--During the comment period on the 
                notice of proposed rulemaking under subparagraph (A), 
                the Secretary shall conduct not less than 3 public 
                meetings in diverse geographical areas of the United 
                States to provide persons in different regions an 
                opportunity to comment.
            (3) Final regulation.--Not later than 1 year after the 
        close of the comment period for the proposed rulemaking under 
        paragraph (2), the Secretary shall adopt a final regulation 
        under section 419A of the Federal Food, Drug, and Cosmetic Act, 
        as added by subsection (b).
    (d) No Effect on HACCP Authorities.--Nothing in the amendments made 
by this section limits the authority of the Secretary under the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or the Public 
Health Service Act (42 U.S.C. 201 et seq.) to revise, issue, or enforce 
product and category-specific regulations, such as the Seafood Hazard 
Analysis Critical Controls Points Program, the Juice Hazard Analysis 
Critical Control Program, and the Thermally Processed Low-Acid Foods 
Packaged in Hermetically Sealed Containers standards.

SEC. 105. RISK-BASED INSPECTION.

    (a) Risk-Based Inspection Schedule.--
            (1) 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 by one or more officers duly designated by the Secretary at a 
frequency determined pursuant to a risk-based schedule.
    ``(2) The Secretary shall establish such risk-based schedule not 
later than 18 months after the date of the enactment of this subsection 
and may subsequently revise such schedule in accordance with this 
section.
    ``(3) Such risk-based schedule shall provide for a frequency of 
inspections commensurate with the risk presented by the facility, but 
in no case shall inspections of a facility occur less than once every 4 
years beginning on the date of the facility's initial registration 
pursuant to section 415.
    ``(4) 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 is certified by a certifying 
        agent accredited pursuant to section 420(a); and
            ``(D) such other factors as the Secretary determines by 
        guidance to be relevant to assessing the risk presented by the 
        facility.''.
            (2) Facilities already registered.--In section 704(h)(3) of 
        the Federal Food, Drug, and Cosmetic Act, as added by paragraph 
        (1), the term ``initial registration pursuant to section 415'' 
        means, with respect to a facility that is registered pursuant 
        to section 415 of such Act as of the date of the enactment of 
        this Act, the first annual registration of the facility 
        pursuant to such section 415 that occurs on or after such date 
        of enactment.
            (3) Reports on risk-based inspections of food facilities.--
                    (A) Initial report.--Not later than 18 months 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 the risk-
                based inspection schedule established under section 
                704(h)(2) of the Federal Food, Drug, and Cosmetic Act, 
                as added by paragraph (1). Such report shall include a 
                description of the frequency of inspections for 
                different classes of risk, the number of facilities in 
                each class, and an estimate of the projected 5-year 
                costs of implementing such inspection schedule.
                    (B) Subsequent reports.--Annually after the 
                submission of the report required by subparagraph (A), 
                the Secretary shall submit a report to the Congress 
                on--
                            (i) the number of foreign and domestic 
                        facilities inspected under the risk-based 
                        inspection schedule established under section 
                        704(h)(2) of the Federal Food, Drug, and 
                        Cosmetic Act, as added by paragraph (1), in the 
                        preceding 12 months; and
                            (ii) the costs of implementing the risk-
                        based inspection schedule for the preceding 12 
                        months.
    (b) Food Offered for Import.--The third sentence of subsection (a) 
of section 801 (21 U.S.C. 381) is amended by inserting ``or (4) such 
article is food that has been processed, packed, or held at a facility 
that is in violation of section 301(f) (prohibiting the delay or 
limitation of an inspection, or the refusal to permit entry or 
inspection, under section 704),'' before ``then such article shall be 
refused admission''.

SEC. 106. ACCESS TO RECORDS.

    (a) Records Inspection.--Section 414(a) (21 U.S.C. 350c) is 
amended--
            (1) by striking ``If the Secretary has a reasonable belief 
        that an article of food is adulterated and presents a threat of 
        serious adverse health consequences or death to humans or 
        animals, each'' and inserting ``Each'';
            (2) by striking the term ``such article'' the first place 
        such term appears and inserting ``an article of food'';
            (3) by striking ``and a written notice to such person''; 
        and
            (4) by striking ``and presents a threat of serious adverse 
        health consequences or death to humans or animals'' and 
        inserting ``, misbranded, or otherwise in violation of this 
        Act''; and
    (b) Conforming Amendment.--Section 704(a)(1) (21 U.S.C. 374(a)(1)) 
is amended 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''.

SEC. 107. TRACEABILITY OF FOOD.

    (a) Farm and Restaurant Records.--
            (1) Inspection.--Section 414(a) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 350c(a)), as amended by section 
        106, is amended by striking ``(excluding farms and 
        restaurants)''.
            (2) Maintenance of records.--Section 414(b) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 350c(b)), as amended by 
        section 106, is amended by striking ``(excluding farms and 
        restaurants)''.
    (b) Standardized Electronic Format.--Section 414 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 350c(a)), as amended by section 
106 and subsection (a), is amended--
            (1) in subsection (a), by striking ``in any format 
        (including paper and electronic formats) and''; and
            (2) in subsection (b), by adding at the end the following: 
        ``The Secretary shall require such persons to maintain such 
        records in a standardized electronic format.''.
    (c) Identification of Source of Raw Agricultural Products.--Section 
403 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343) is 
amended by adding at the end the following:
    ``(z) If it is a raw agricultural product, unless each commercial 
shipment of the product contains information enabling the Secretary to 
identify--
            ``(1) the grower of the product;
            ``(2) the lot on which the product was produced;
            ``(3) the harvesting and packing dates of the product; and
            ``(4) any other information determined appropriate by the 
        Secretary to facilitate identification of the source of raw 
        agricultural products.''.
    (d) Study.--Not later than 2 years after the date of the enactment 
of this Act, the Commissioner of Food and Drugs shall--
            (1) complete a study on the effectiveness of technologies 
        for determining the source of raw agricultural products; and
            (2) submit a report to the Congress on the results of such 
        study.

SEC. 108. REINSPECTION FEE APPLICABLE TO FACILITIES.

    (a) In General.--Part 5 of subchapter C of chapter VII (21 U.S.C. 
371 et seq.), as added by section 101(b)(2), is further amended by 
adding at the end the following:

``SEC. 741A. REINSPECTION FEE APPLICABLE TO FACILITIES.

    ``(a) In General.--The Secretary shall assess and collect fees from 
each facility (as defined in section 415(b)) that--
            ``(1) 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
            ``(2) because of such violation, undergoes additional 
        inspection by the Food and Drug Administration.
    ``(b) Amount of Fees.--The Secretary shall set the amount of the 
fees under this section to fully defray the costs of conducting the 
additional inspections referred to in subsection (a)(2).
    ``(c) Use of Fees.--The Secretary shall make all of the fees 
collected pursuant to this section available solely to pay for the 
costs of additional inspections referred to in subsection (a)(2).''.
    (b) Effective Date.--The amendment made by subsection (a) shall 
apply to additional inspections occurring after the date of the 
enactment of this Act.

SEC. 109. CERTIFICATION OF FOOD FACILITIES.

    (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 420(b)(5) 
(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) Accreditation of Certifying Agents; Certification of 
Laboratories and Accreditation of Laboratory Certifying Agents.--
Chapter IV (21 U.S.C. 341 et seq.), as amended by sections 102(b), 103, 
and 104, is amended by adding at the end the following:

``SEC. 420. ACCREDITATION OF CERTIFYING AGENTS.

    ``(a) Accreditation as Certifying Agent.--
            ``(1) In general.--Beginning not later than 2 years after 
        the date of the enactment of this section, the Secretary shall 
        establish and implement an accreditation system under which a 
        foreign government, a State or regional food authority, a 
        foreign or domestic cooperative that aggregates the products of 
        growers or processors, and any other third party that the 
        Secretary determines appropriate, may request to be accredited 
        as a certifying agent to certify facilities as meeting the 
        applicable requirements of this Act.
            ``(2) Qualifications of certifying agents.--Prior to 
        accrediting an third party as a certifying agent under 
        paragraph (1), the Secretary shall perform such reviews and 
        audits of the training and qualifications of auditors used by 
        the third party, and conduct such reviews of internal systems 
        and such other investigation of the third party, as the 
        Secretary deems necessary to determine whether the third 
        party--
                    ``(A) meets the requirements of this section; and
                    ``(B) is qualified to evaluate the compliance of a 
                facility with the applicable requirements of this Act.
            ``(3) Limitation of accreditation.--The Secretary may limit 
        the accreditation under paragraph (1) of a certifying agent to 
        the certification of facilities that produce, manufacture, 
        process, or hold only specified food products (or categories of 
        food products).
            ``(4) Performance of audits and renewal of accreditation.--
        The Secretary shall audit the performance of certifying agents 
        on a periodic basis, but not less than every 4 years, for the 
        purpose of renewing the accreditation of such agents.
            ``(5) Withdrawal of accreditation.--The Secretary--
                    ``(A) may withdraw accreditation under paragraph 
                (1) from a certifying agent if--
                            ``(i) a facility certified by the agent is 
                        linked to an outbreak of human or animal 
                        illness; or
                            ``(ii) the Secretary finds that the agent 
                        no longer meets the requirements for 
                        accreditation; and
                    ``(B) shall withdraw accreditation under paragraph 
                (1) from a certifying agent if the Secretary finds that 
                the certifying agent has refused to allow the Secretary 
                to conduct such audits and investigations as may be 
                necessary to ensure continued compliance with the 
                requirements of this section.
            ``(6) Publication of list of certifying agents.--The 
        Secretary shall publish and maintain on the website of the Food 
        and Drug Administration a current list of certifying agents 
        accredited under this section, including--
                    ``(A) each such agent's name and location; and
                    ``(B) any other information deemed necessary by the 
                Secretary.
    ``(b) Additional Requirements Applicable to Certifying Agents.--As 
conditions of accreditation under subsection (a), a certifying agent 
shall agree to the following:
            ``(1) Audit requirements.--A certifying agent shall not 
        certify a facility unless the certifying agent has--
                    ``(A) conducted an on-site audit of the facility, 
                which shall be unannounced for a domestic facility;
                    ``(B) reviewed the facility's food safety plan 
                under section 418A to ensure the plan meets applicable 
                requirements of this Act and is adequate to protect the 
                public health;
                    ``(C) prepared an audit report in a form and manner 
                designated by the Secretary; and
                    ``(D) conducted any other review, analysis, or 
                testing determined by the Secretary to be appropriate 
                for determining such facility's compliance with the 
                applicable requirements of this Act.
            ``(2) Access to reports and records.--A certifying agent 
        shall provide to the Secretary, upon request--
                    ``(A) a copy of any audit report prepared under 
                paragraph (1)(C);
                    ``(B) any records relating to corrective actions 
                planned or taken by the audited facility; and
                    ``(C) any other records related to--
                            ``(i) the certification or decertification 
                        of a facility;
                            ``(ii) compliance of a facility with the 
                        requirements of this Act; or
                            ``(iii) the accreditation of the certifying 
                        agent.
            ``(3) Conflicts of interest.--
                    ``(A) In general.--A certifying agent shall--
                            ``(i) not have an ownership, management, or 
                        other financial interest in any facility to be 
                        certified by the certifying agent or in such 
                        facility's suppliers or vendors;
                            ``(ii) have procedures to ensure against 
                        the use, in carrying out audits of a facility 
                        under this section, of any officer or employee 
                        who has a financial conflict of interest 
                        regarding such facility; and
                            ``(iii) have written conflict of interest 
                        policies that include prompt disclosure to the 
                        Secretary of all conflicts or potential 
                        conflicts of interest.
                    ``(B) Regulations.--Not later than 18 months after 
                the date of the enactment of this section, the 
                Secretary shall promulgate regulations to implement the 
                requirements of subparagraph (A). Such regulations 
                shall include a structure, including timing and public 
                disclosure, for fees paid by facilities to certifying 
                agents.
            ``(4) Decertification of facilities.--A certifying agent 
        shall decertify a facility if the certifying agent, after 
        providing a reasonable opportunity for corrective action, finds 
        that the facility no longer meets the applicable requirements 
        of this Act.
            ``(5) Required certification of imports.--A certifying 
        agent shall issue a written and electronic certification to 
        accompany each shipment offered for import into the United 
        States containing food that was manufactured, processed, 
        packed, or held by a facility certified by the agent, subject 
        to requirements set forth by the Secretary.
            ``(6) Risks to public health.--If, at any time during an 
        audit, an auditor of a certifying agent finds a condition at a 
        facility that could cause or contribute to illness or injury to 
        an individual consuming an article of food manufactured, 
        processed, packed, or held by the facility, the certifying 
        agent shall immediately notify the Secretary of the identity of 
        the facility and such condition.
    ``(c) False or Misleading Statements.--For purposes of section 
301(q)(2), any statement or representation made by an employee or agent 
of a facility to an auditor of a certifying agent or a certifying agent 
is deemed to be a report required by or under this Act.
    ``(d) Definitions.--In this section:
            ``(1) The term `certifying agent' means a third party 
        accredited as a certifying agent pursuant to subsection (a)(1).
            ``(2) The term `facility' means a facility required to be 
        registered under section 415.

``SEC. 421. CERTIFICATION OF LABORATORIES; ACCREDITATION OF LABORATORY 
              CERTIFYING AGENTS.

    ``(a) In General.--Not later than 2 years after the date of the 
enactment of this section, the Secretary shall establish a program for 
the certification of laboratories for the purpose of conducting 
sampling and testing of food to ensure compliance with the requirements 
of this Act.
    ``(b) Standards.--Not later than 18 months after the date of the 
enactment of this section, the Secretary shall develop standards to 
certify laboratories under this section. Such standards shall include--
            ``(1) standards for sampling and analytical procedures;
            ``(2) training and qualification levels for individuals who 
        conduct the analyses;
            ``(3) standards for internal quality systems; and
            ``(4) any other standards determined appropriate by the 
        Secretary.
    ``(c) Accreditation of Third Parties as Laboratory Certifying 
Agents.--
            ``(1) In general.--The Secretary may establish an 
        accreditation system under which third parties, as determined 
        appropriate by the Secretary, may request to be accredited as a 
        laboratory certifying agent to certify laboratories as meeting 
        the applicable requirements of this Act.
            ``(2) Application of requirements relating to 
        qualifications of agents, performance of audits and renewal of 
        accreditation, and withdrawal of accreditation.--The provisions 
        of paragraphs (2), (4), and (5), other than paragraph 
        (5)(A)(i), of section 420(a) shall apply to the accreditation 
        of laboratory certifying agents with respect to laboratories in 
        the same manner as such provisions apply to the accreditation 
        of certifying agents with respect to facilities.
            ``(3) Application of additional requirements.--The 
        provisions of paragraphs (1) (other than subparagraph (B) and 
        other than the requirement under subparagraph (A) that an audit 
        be unannounced), (2), (3), and (4) of section 420(b) shall 
        apply to laboratory certifying agents under this subsection 
        with respect to laboratories in the same manner as such 
        provisions apply to the certifying agents with respect to 
        facilities.
            ``(4) Laboratory certifying agent defined.--In this 
        section, the term `laboratory certifying agent' means a third 
        party accredited as a laboratory certifying agent under this 
        subsection.
    ``(d) Publication of List of Certifying Agents and Certified 
Laboratories.--The provisions of paragraph (6) of section 420(a) shall 
apply to third parties accredited as laboratory certifying agents under 
subsection (c) and to laboratories certified under subsection (a) in 
the same manner as such provisions apply to third parties accredited as 
certifying agents under such section.
    ``(e) Food Testing by Certified Laboratories.--
            ``(1) In general.--Beginning 3 years after the date of the 
        enactment of this section, testing of food described in 
        paragraph (2) shall be conducted only by Federal laboratories 
        or by laboratories certified under subsection (a).
            ``(2) Testing of food covered.--The testing of food 
        described in this paragraph is testing of food--
                    ``(A) conducted in support of an admission of an 
                article of food under section 801;
                    ``(B) conducted in support of a reoffer of food 
                previously denied admission under section 402(h);
                    ``(C) conducted under an import alert that requires 
                successive consecutive tests;
                    ``(D) conducted to show compliance with an order of 
                the Secretary;
                    ``(E) conducted in support of an appeal of an order 
                of the Secretary; or
                    ``(F) as otherwise required to be conducted by the 
                Secretary, as the Secretary deems appropriate.
            ``(3) Access to testing results.--The results of any 
        testing of food described in paragraph (2) by a laboratory 
        certified under this section shall be promptly transmitted by 
        such laboratory in electronic format to the Secretary.
    ``(f) False or Misleading Statements.--For purposes of section 
301(q)(2), as amended by section 406, any statement or representation 
made by an employee or agent of a laboratory to a laboratory certifying 
agent is deemed to be a report required by or under this Act.''.
    (c) Fees.--Part 5 of subchapter C of chapter VII, as added by 
section 101(b) and amended by section 108(a), is amended by adding at 
the end the following:

``SEC. 741B. CERTIFYING AGENT FEE.

    ``(a) In General.--The Secretary shall assess and collect a fee for 
the accreditation of an entity as a certifying agent under section 
420(a) for the purpose of defraying the costs of implementing the 
system established for such accreditation.
    ``(b) Amount of Fee.--The amount of a fee under this section shall 
be as determined by the Secretary.

``SEC. 741C. LABORATORY CERTIFYING AGENT ACCREDITATION FEE.

    ``The Secretary shall assess and collect an annual fee, specified 
by the Secretary, for accreditation of laboratory certifying agents 
under section 421 for the purpose of defraying the costs of the 
accreditation activities under such section.''.

SEC. 110. 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.--Beginning not later than 2 years after the date 
of the enactment of this section, the Secretary shall establish by 
regulation and carry out a program under which the Secretary expedites 
the movement of food through the importation process under this Act if 
each facility involved in the production, manufacture, processing, 
packaging, and holding of the food--
            ``(1) is certified by a certifying agent accredited 
        pursuant to section 420(a)(1); and
            ``(2) has agreed to abide by, and has been determined by 
        the Secretary to be in compliance with, the food safety and 
        security guidelines developed under subsection (b) with respect 
        to such food.
    ``(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 access controls for food 
                and ingredients purchased by such person.
                    ``(D) Vendor and supplier information.
                    ``(E) Such other factors as the Secretary 
                determines necessary.''.

                        Subtitle B--Intervention

SEC. 111. PUBLIC HEALTH ASSESSMENT SYSTEM.

    (a) Active Surveillance System.--The Secretary of Health and Human 
Services (in this subtitle referred to as the ``Secretary''), acting 
through the Centers for Disease Control and Prevention, shall establish 
and implement an active surveillance system for food, based on a 
representative proportion of the population of the United States, to 
assess more accurately the frequency and sources of human illness in 
the United States associated with the consumption of food.
    (b) Sampling System.--
            (1) In general.--The Secretary shall establish and 
        implement a sampling system under which the Secretary takes and 
        analyzes samples of food products--
                    (A) to assist the Secretary in carrying out this 
                Act and the Federal Food, Drug, and Cosmetic Act (21 
                U.S.C. 301 et seq.); and
                    (B) to more accurately assess the nature, frequency 
                of occurrence, and amounts of contaminants in food 
                products.
            (2) Requirements.--Such sampling system shall provide--
                    (A) statistically valid monitoring, including 
                market-basket studies, on the nature, frequency of 
                occurrence, and amounts of contaminants in food 
                products available to consumers; and
                    (B) at the request of the Secretary, such other 
                information, including analysis of monitoring and 
                verification samples, as the Secretary determines may 
                be useful in assessing the occurrence of contaminants 
                in food products.
            (3) Guidelines.--Within 12 months after the date of the 
        enactment of this Act, the Secretary shall establish guidelines 
        for the sampling system under this subsection.
    (c) Assessment of Health Hazards.--Through the surveillance system 
under subsection (a) and the sampling system under subsection (b), the 
Secretary shall rank food categories based on their hazard to human 
health and identify appropriate industry and regulatory approaches to 
minimize hazards in the food supply. Such analysis may include--
            (1) the safety of commercial harvesting and processing, as 
        compared with the health hazards associated with food products 
        that are harvested for recreational or subsistence purposes and 
        prepared noncommercially;
            (2) the safety of food products that are domestically 
        harvested and processed, as compared with the health hazards 
        associated with food products that are harvested or processed 
        outside the United States;
            (3) contamination originating from handling practices that 
        occur prior to or after sale of food products to consumers; and
            (4) use of comparative risk assessments.

SEC. 112. 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 regarding Federal standards 
        and good practice requirements and promotion of public 
        awareness, understanding, and acceptance of such standards and 
        requirements;
            (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. 113. RESEARCH.

    (a) In General.--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 
        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 with contaminants;
            (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 develop new methods to reduce 
        the transfer of antibiotic resistance to humans; and
            (11) conduct other research that supports the purposes of 
        this Act.
    (b) Contract Authority.--The Secretary is authorized to enter into 
contracts and agreements with any State, university, government agency, 
or other person to carry out this section.

SEC. 114. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR 
              MISBRANDED ARTICLES OF FOOD.

    (a) Prohibited Acts.--Section 301 (21 U.S.C. 331), as amended by 
sections 102 and 104, is amended by adding at the end the following:
    ``(qq)(1) The failure to notify the Secretary in violation of 
section 422(a).
    ``(2) The failure to comply with--
            ``(A) an order issued under section 422(b) following any 
        hearing requested under section 422(c); or
            ``(B) an amended order issued under section 422(d)(1).''.
    (b) Notification, Nondistribution, and Recall of Adulterated or 
Misbranded Articles of Food.--Chapter IV (21 U.S.C. 341 et seq.), as 
amended by sections 102(b), 104, and 108(c), is amended by adding at 
the end the following:

``SEC. 422. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR 
              MISBRANDED ARTICLES OF FOOD.

    ``(a) Notification to Secretary of Violation.--
            ``(1) In general.--A person (other than a household 
        consumer or other individual who is the intended consumer of an 
        article of food) 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, if consumed, may result in illness 
        or injury 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.
    ``(b) Recall and Consumer Notification.--
            ``(1) Voluntary actions.--On receiving notification under 
        subsection (a) or by other means of a suspected adulteration or 
        misbranding of food, if the Secretary finds 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, if consumed, may result in illness 
        or injury (as determined by the Secretary), the Secretary shall 
        provide all appropriate persons (including the manufacturer, 
        importer, distributor, or retailer of the article) with an 
        opportunity (as determined by the Secretary)--
                    ``(A) to cease distribution of the article;
                    ``(B) to notify all persons--
                            ``(i) that produce, manufacture, pack, 
                        process, prepare, treat, package, distribute, 
                        or hold the article, to cease immediately those 
                        activities with respect to the article; or
                            ``(ii) to which the article has been 
                        distributed, transported, or sold, to cease 
                        immediately distribution of the article;
                    ``(C) to recall the article;
                    ``(D) in consultation with the Secretary, to 
                provide notice of the finding of the Secretary to all 
                consumers to which the article was, or may have been, 
                distributed and to appropriate State and local health 
                officials; and
                    ``(E) to notify State and local public health 
                officials.
            ``(2) Mandatory actions.--If the appropriate person 
        referred to in paragraph (1) does not carry out the actions 
        described in that paragraph with respect to an article within 
        the time period and in the manner prescribed by the Secretary, 
        the Secretary--
                    ``(A) shall issue an order requiring the person--
                            ``(i) to immediately cease distribution of 
                        the article; and
                            ``(ii) to immediately make the notification 
                        described in paragraph (1)(B); and
                    ``(B) may take control or possession of the 
                article.
            ``(3) Notice to consumers and health officials.--The 
        Secretary shall, as the Secretary determines to be necessary, 
        provide notice of the finding of the Secretary under paragraph 
        (1) to consumers to which the article was, or may have been, 
        distributed and to appropriate State and local health 
        officials.
    ``(c) Hearings on Orders.--
            ``(1) In general.--The Secretary shall provide a person 
        subject to an order under subsection (b)(2) with an opportunity 
        for a hearing on--
                    ``(A) the actions required by the order; and
                    ``(B) any reasons why the article of food that is 
                the subject of the order should not be recalled.
            ``(2) Timing of hearings.--If a hearing is requested under 
        paragraph (1) with respect to an order, the Secretary shall 
        hold the hearing as soon as practicable, but not later than 2 
        business days, after the date of issuance of the order.
    ``(d) Post-Hearing Recall Orders.--
            ``(1) Amendment of orders.--If, after providing an 
        opportunity for a hearing (and a hearing if requested) under 
        subsection (c), the Secretary determines 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, if consumed, may result in illness 
        or injury, the Secretary may, as the Secretary determines to be 
        necessary--
                    ``(A) amend the order under subsection (b)(2)--
                            ``(i) to require recall of the article or 
                        other appropriate action; and
                            ``(ii) to specify a timetable during which 
                        the recall shall occur;
                    ``(B) require periodic reports to the Secretary 
                describing the progress of any such recall; and
                    ``(C) provide notice of such a recall to consumers 
                to which the article was, or may have been, 
                distributed.
            ``(2) Vacation of orders.--If, after providing an 
        opportunity for a hearing (and a hearing if requested) under 
        subsection (c), the Secretary determines that adequate grounds 
        do not exist to continue the actions required by the order, the 
        Secretary shall vacate the order.
    ``(e) Remedies Not Exclusive.--The remedies authorized by this 
section shall be in addition to any other remedies that may be 
available.''.
    (c) Effective Date.--Sections 301(qq)(1) and 422 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.

                          Subtitle C--Response

SEC. 121. ADMINISTRATIVE DETENTION.

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

SEC. 122. CIVIL PENALTIES RELATING TO FOOD.

    (a) In General.--Chapter III (21 U.S.C. 331 et seq.) is amended by 
adding after section 303 the following:

``SEC. 303A. CIVIL PENALTIES RELATING TO FOODS.

    ``(a) In General.--
            ``(1) Assessment.--The Secretary may assess against a 
        person that commits an act prohibited by section 301 with 
        respect to an article of food a civil penalty for each such act 
        of not more than--
                    ``(A) $100,000, in the case of an individual; and
                    ``(B) $500,000, in the case of any other person.
            ``(2) Separate offenses.--Each prohibited act described in 
        paragraph (1) and each day during which the act continues shall 
        be considered to be a separate offense.
            ``(3) Notice and opportunity for hearing.--The Secretary 
        shall not assess a civil penalty under this section against a 
        person unless the person is given notice and opportunity for a 
        hearing on the record before the Secretary in accordance with 
        sections 554 and 556 of title 5, United States Code.
            ``(4) Determination of civil penalty amount.--The amount of 
        a civil penalty under this section--
                    ``(A) shall be assessed by the Secretary by written 
                order, taking into account--
                            ``(i) the gravity of the violation;
                            ``(ii) the degree of culpability of the 
                        person;
                            ``(iii) the size and type of the business 
                        of the person; and
                            ``(iv) any history of prior offenses by the 
                        person; and
                    ``(B) shall be reviewed only in accordance with 
                subsection (b).
    ``(b) Judicial Review.--
            ``(1) In general.--An order assessing a civil penalty 
        against a person under subsection (a) shall be final unless the 
        person--
                    ``(A) not later than 30 days after the effective 
                date of the order, files a petition for judicial review 
                of the order in--
                            ``(i) the United States court of appeals 
                        for the circuit in which the person resides or 
                        has its principal place of business; or
                            ``(ii) the United States Court of Appeals 
                        for the District of Columbia Circuit; and
                    ``(B) simultaneously sends a copy of the petition 
                by certified mail to the Secretary.
            ``(2) Filing of copy of record.--The Secretary shall 
        promptly file in the court a certified copy of the record on 
        which the order was issued.
            ``(3) Standard of review.--The findings of the Secretary 
        relating to the order shall be set aside only if the findings 
        are found to be unsupported by substantial evidence on the 
        record as a whole.
    ``(c) Collection Actions for Failure To Pay Assessment.--
            ``(1) Referral to attorney general.--If a person fails to 
        pay a civil penalty assessed under subsection (a) after the 
        order assessing the civil penalty has become a final order, or 
        after the court of appeals has entered final judgment in favor 
        of the Secretary, the Secretary may refer the matter to the 
        Attorney General.
            ``(2) Action by attorney general.--The Attorney General 
        shall bring a civil action to recover the amount of the civil 
        penalty in United States district court.
            ``(3) Scope of review.--In a civil action under paragraph 
        (2), the validity and appropriateness of the order of the 
        Secretary assessing the civil penalty shall not be subject to 
        review.
    ``(d) Penalties Deposited in Treasury.--All amounts collected as 
civil penalties under this section shall be deposited in the Treasury 
of the United States and shall be available to cover costs of the 
Administration in carrying out food safety activities under this Act.
    ``(e) Penalties in Lieu of Other Actions.--Nothing in this Act 
requires the Secretary to report for prosecution, or for the 
commencement of any libel or injunction proceeding, any violation of 
this Act in any case in which the Secretary believes that the public 
interest will be adequately served by the assessment of a civil penalty 
under this section.
    ``(f) Remedies Not Exclusive.--The remedies authorized by this 
section shall be in addition to any other remedies that may be 
available.''.
    (b) Effective Date.--The amendment made by subsection (a) shall 
apply to prohibited acts committed on or after the date of the 
enactment of this Act .

SEC. 123. FAILURE TO CONSENT TO INVESTIGATION.

    Section 801 (21 U.S.C. 381) is amended by adding at the end the 
following:
    ``(p) The Secretary may deny importation of food, other than only 
for personal use, from any foreign country, or which is manufactured, 
processed, packed, or held by a facility (as defined in section 415), 
if the government of such country, or such facility, respectively, does 
not timely consent to an investigation by the Administration when food 
from that country or facility is linked to a food-borne illness 
outbreak or is otherwise found to be adulterated or mislabeled.''.

                       Subtitle D--Miscellaneous

SEC. 131. LABELING REQUIREMENT FOR MEAT, POULTRY PRODUCTS, AND SEAFOOD 
              THAT CONTAIN CARBON MONOXIDE.

    (a) Labeling Requirement.--
            (1) In general.--Paragraph (t) of section 201 (21 U.S.C. 
        321) is amended by adding at the end the following:
    ``(4) In the case of food that is meat within the meaning of the 
Federal Meat Inspection Act, a poultry product within the meaning of 
the Poultry Products Inspection Act, or seafood (including all fresh or 
saltwater fish, molluscan shellfish, crustaceans, and other forms of 
aquatic animal life) intended for human consumption as food within the 
meaning of section 201(f) (referred to collectively in this paragraph 
as `seafood'), the term `color additive' shall include carbon monoxide 
under conditions of use that may impart, maintain, preserve, stabilize, 
fix, or otherwise affect the color of fresh meat, poultry products, or 
seafood, unless the label of such food bears, prominently and 
conspicuously in such place and in such manner as to render it likely 
to be read and understood by the ordinary person, the following 
statement to prevent consumer deception and serious risks to the public 
health: `CONSUMER NOTICE: Carbon monoxide has been used to preserve the 
color of this product. Do not rely on color or the ``use or freeze by'' 
date alone to judge the freshness of the product.'''.
            (2) Effective date.--The amendment made by this subsection 
        shall apply to food labeled on or after the date that is 30 
        days after the date of the enactment of this Act.
    (b) Discretionary Authority.--If, not earlier than 5 years after 
the effective date described in subsection (a)(2), the Secretary of 
Health and Human Services finds, based on competent and reliable 
scientific evidence, that the statement prescribed in section 201(t)(4) 
of the Federal Food, Drug, and Cosmetic Act is no longer required to 
prevent consumer deception and other harms, then the Secretary is 
authorized to issue regulations establishing alternative labeling 
requirements that are shown to be adequate and effective in preventing 
consumer deception and other harms related to the conditions of use of 
carbon monoxide, including with respect to preventing any consumer 
deception or other harm that may result from the actual conditions of 
carbon monoxide use and its potential to impart a persistent color to 
meat, poultry products, or seafood described in such section through a 
reaction with natural pigment.

SEC. 132. 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 
request for a substance to be determined by the Secretary to be a GRAS 
food substance, the Secretary shall publish notice of such request in 
the Federal Register.
    ``(2) Not later than 90 days after the date of publication of a 
notice under paragraph (1), the Secretary shall determine whether the 
substance is a GRAS food substance.
    ``(3) A determination by the Secretary of whether a substance is a 
GRAS food substance shall be published in the Federal Register.
    ``(4) 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 substances 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. 133. COUNTRY OF ORIGIN LABELING; DISCLOSURE OF SOURCE OF 
              INGREDIENTS.

    (a) Food.--Section 403 (21 U.S.C. 343), as amended by sections 
101(a) and 108(b), is amended by adding at the end the following:
    ``(bb) In the case of a processed food if--
            ``(1) the labeling of the food fails to identify the 
        country in which the final processing of the food occurs; and
            ``(2) the website for the manufacturer of the food fails to 
        identify the country (or countries) of origin for each 
        ingredient in the food.
    ``(cc) In the case of non-processed food if--
            ``(1) the labeling of the food fails to identify the 
        country of origin of the food; and
            ``(2) the website for the original packer of the food fails 
        to identify the country of origin for the food.''.
    (b) Regulations.--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 (bb) and (cc) of 
section 403 of the Federal Food, Drug, and Cosmetic Act, as added by 
subsection (a).
    (c) Effective Date.--The requirements of paragraphs (bb) and (cc) 
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. 134. NEW FOOD AND ANIMAL FEED EXPORT CERTIFICATION FEE TO IMPROVE 
              THE ABILITY OF UNITED STATES FIRMS TO EXPORT THEIR 
              PRODUCTS.

    Part 5 of subchapter C of chapter VII (21 U.S.C. 371 et seq.), as 
added by section 101(b) and amended by sections 108 and 109, is further 
amended by adding at the end the following:

``SEC. 741D. NEW FOOD AND ANIMAL FEED EXPORT CERTIFICATION FEE TO 
              IMPROVE THE ABILITY OF UNITED STATES FIRMS TO EXPORT 
              THEIR PRODUCTS.

    ``(a) In General.--If the Secretary provides for the issuance of 
export certificates for foods and animal feeds in cases where 
exportation is restricted without such a certificate, the Secretary may 
impose a fee for the issuance of such a certificate.
    ``(b) Amount.--The amount of the fee under this section shall be an 
amount that is reasonably related to the cost of issuing such 
certificates.
    ``(c) Use of Fees.--The Secretary shall make all of the fees 
collected pursuant to this section available solely to pay for the 
costs of issuance of such certificates.''.

                    TITLE II--DRUG AND DEVICE SAFETY

SEC. 201. REGISTRATION OF PRODUCERS OF DRUGS AND DEVICES; APPLICABLE 
              FEE.

    (a) Registration.--
            (1) Misbranding.--Paragraph (o) of section 502 (21 U.S.C. 
        352) is amended by striking ``in any State''.
            (2) Effective date.--The amendment made by paragraph (1) 
        applies only with respect to registration under section 510 of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360) 
        occurring on or after the date of the enactment of this Act.
    (b) Registration Fee.--
            (1) Misbranding.--Paragraph (o) of section 502 (21 U.S.C. 
        352), as amended by subsection (a)(2), is further amended by 
        inserting after ``not duly registered under section 510'' the 
        following: ``or in violation of section 736C for failure to pay 
        a fee''.
            (2) Establishment.--Part 2 of subchapter C of chapter VII 
        (21 U.S.C. 379g et seq.) is amended by adding at the end the 
        following:

``SEC. 736C. REGISTRATION FEE.

    ``(a) In General.--Except as provided in subsection (b) of this 
section, the Secretary shall assess and collect an annual fee for 
registration under subsection (b), (c), (d), or (i) of section 510 to 
defray increases (as described in subsection (g)(2)(A)(ii)) in the 
costs of inspecting establishments registered under subsection (b), 
(c), (d), or (i) of section 510 to ensure compliance by such 
establishments with the requirements of this Act relating to drugs or 
devices.
    ``(b) Exception.--The Secretary shall not assess or collect a fee 
under this section for registration of an establishment under section 
510 on the basis of such establishment's manufacture, preparation, 
propagation, or processing of an excipient of a drug.
    ``(c) Fee Revenue Amounts.--
            ``(1) In general.--For each of fiscal years 2010 through 
        2014, fees under subsection (a) shall, except as provided in 
        subsections (d), (f), and (g), be established to generate a 
        total revenue amount under subsection (a).
            ``(2) Total revenue amount.--Not later than September 1, 
        2010, the Secretary shall transmit to the Congress the total 
        revenue amount under paragraph (1) and how such amount was 
        calculated.
            ``(3) Annual fee setting.--The Secretary shall, not later 
        than 60 days before the start of each fiscal year that begins 
        after September 30, 2009, establish, for the next fiscal year, 
        registration fees under subsection (a)--
                    ``(A) based on the total revenue amount applicable 
                under paragraph (1); and
                    ``(B) taking into consideration the difference in 
                costs of inspections between foreign and domestic 
                establishments.
    ``(d) Adjustments.--
            ``(1) Inflation adjustment.--For fiscal year 2011 and 
        subsequent fiscal years, the revenues established in subsection 
        (c)(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; U.S. 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.
        The adjustment made each fiscal year by this subsection will be 
        added on a compounded basis to the sum of all adjustments made 
        each fiscal year after fiscal year 2009 under this subsection.
            ``(2) Workload adjustment.--For fiscal year 2011 and 
        subsequent fiscal years, after the fee revenues established in 
        subsection (c)(1) are adjusted for a fiscal year for inflation 
        in accordance with paragraph (1), the fee revenues shall be 
        adjusted further for such fiscal year to reflect changes in the 
        workload of the Secretary for inspections described in 
        subsection (a). With respect to such adjustment:
                    ``(A) The adjustment shall be determined by the 
                Secretary based on a weighted average of the change in 
                the total amount of inspections described in subsection 
                (a). The Secretary shall publish in the Federal 
                Register the fee revenues and fees resulting from the 
                adjustment and the supporting methodologies.
                    ``(B) Under no circumstances shall the adjustment 
                result in fee revenues for a fiscal year that are less 
                than the fee revenues for the fiscal year established 
                in subsection (c)(1), as adjusted for inflation under 
                paragraph (1). Any adjustment for changes in inspection 
                activities made in setting fees and revenue amounts for 
                fiscal year 2011 may not result in the total workload 
                adjustment being more than 2 percentage points higher 
                than it would have been in the absence of the 
                adjustment for changes in inspection activities.
                    ``(C) The Secretary shall contract with an 
                independent accounting firm to study the adjustment for 
                changes in inspection activities applied in setting 
                fees and revenue amounts for fiscal year 2011 and to 
                make recommendations, if warranted, for future changes 
                in the methodology for calculating the adjustment. 
                After review of the recommendations, the Secretary 
                shall, if warranted, make appropriate changes to the 
                methodology, and the changes shall be effective for 
                each of the fiscal years 2012 through 2014. The 
                Secretary shall not make any adjustment for changes in 
                inspection activities for any fiscal year after 2011 
                unless such study has been completed.
            ``(3) Rent and rent-related cost adjustment.--For fiscal 
        year 2012 and each subsequent fiscal year, the Secretary shall, 
        before making adjustments under paragraphs (1) and (2), 
        decrease the fee revenue amount established in subsection 
        (c)(1) if actual costs paid for rent and rent-related expenses 
        for the preceding fiscal year are less than estimates made for 
        such year in fiscal year 2008. Any reduction made under this 
        paragraph shall not exceed the amount by which such costs fall 
        below the estimates made in fiscal year 2008 for such fiscal 
        year, and shall not exceed $11,721,000 for any fiscal year.
            ``(4) Final year adjustment.--For fiscal year 2014, the 
        Secretary may, in addition to adjustments under paragraphs (1), 
        (2), (3), and (5), further increase the fee revenues and fees 
        established in subsection (c) if such an adjustment is 
        necessary to provide for not more than 3 months of operating 
        reserves of carryover user fees for inspections described in 
        subsection (a) for the first 3 months of fiscal year 2015. If 
        such an adjustment is necessary, the rationale for the amount 
        of the increase shall be contained in the annual notice 
        establishing fee revenues and fees for fiscal year 2014. If the 
        Secretary has carryover balances for such inspections in excess 
        of 3 months of such operating reserves, the adjustment under 
        this paragraph shall not be made.
            ``(5) Cost estimate adjustment.--For fiscal year 2011 and 
        subsequent fiscal years, the Secretary by notice, published in 
        the Federal Register, shall--
                    ``(A) provide an estimate of the amount of the 
                total increases described in subsection (a) for such 
                fiscal year; and
                    ``(B) after making adjustments under paragraphs 
                (1), (2), and (3), adjust the revenues established in 
                subsection (c)(1) to be equal to such amount.
            ``(6) Limit.--The total amount of fees charged, as adjusted 
        under this subsection, for a fiscal year may not exceed the 
        total increases described in subsection (a) for such fiscal 
        year.
    ``(e) Fee Waiver or Reduction..--
            ``(1) In general.--The Secretary may grant to a person a 
        waiver from, or a reduction of, one or more fees under this 
        section if the Secretary finds that--
                    ``(A) such waiver or reduction is necessary to 
                protect the public health; or
                    ``(B) the assessment of the fee would impose 
                significant financial hardship because of limited 
                resources available to such person or other 
                circumstances.
            ``(2) Special rules for positron emission tomography 
        drugs.--
                    ``(A) In general.--Except as provided in 
                subparagraph (B), each person who is named as the 
                applicant in an approved human drug application for a 
                positron emission tomography drug shall be subject 
                under paragraph (a) to one-sixth of an annual 
                registration fee with respect to each establishment 
                identified in the application as producing positron 
                emission tomography drugs under the approved 
                application.
                    ``(B) Exception from annual registration fee.--Each 
                person who is named as the applicant in an application 
                described in subparagraph (A) shall be granted a waiver 
                under paragraph (1) from an annual registration fee 
                under subsection (a) for a fiscal year if the person 
                certifies to the Secretary, at a time specified by the 
                Secretary and using procedures specified by the 
                Secretary, that--
                            ``(i) the person is a not-for-profit 
                        medical center that has only 1 establishment 
                        for the production of positron emission 
                        tomography drugs; and
                            ``(ii) at least 95 percent of the total 
                        number of doses of each positron emission 
                        tomography drug produced by such establishment 
                        during such fiscal year will be used within the 
                        medical center.
            ``(3) Designated orphan drug.--An establishment registered 
        under section 510 shall, with respect to the manufacture, 
        preparation, propagation, compounding, or processing of drugs, 
        be granted a waiver under paragraph (1) from a fee under 
        subsection (a) if all drugs manufactured, prepared, propagated, 
        compounded, or processed by the establishment are designated as 
        a drug for a rare disease or condition pursuant to section 526. 
        The preceding sentence shall not apply if the application 
        approved under section 505 for any such drug includes an 
        indication for a disease or condition other than such a rare 
        disease or condition.
    ``(f) 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 the 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 subsection (b), (c), (d), or (i) 
        of section 510 at any time in such fiscal year.
    ``(g) 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 appropriation acts.--
                    ``(A) In general.--The fees authorized by this 
                section--
                            ``(i) 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
                            ``(ii) shall only be collected and 
                        available to defray increases in the costs of 
                        inspecting establishments registered under 
                        subsection (b), (c), (d), or (i) of section 510 
                        to ensure compliance by such establishments 
                        with the requirements of this Act relating to 
                        drugs and devices (including increases in such 
                        costs for an additional number of full-time 
                        equivalent positions in the Department of 
                        Health and Human Services to be engaged in such 
                        inspections) over such costs, excluding costs 
                        paid from fees collected under this section, 
                        for fiscal year 2009 multiplied by the 
                        adjustment factor.
                    ``(B) Compliance.--The Secretary shall be 
                considered to have met the requirements of subparagraph 
                (A)(ii) in any fiscal year if the costs funded by 
                appropriations and allocated for inspections described 
                in subsection (a)--
                            ``(i) are not more than 3 percent below the 
                        level specified in subparagraph (A)(ii); or
                            ``(ii)(I) are more than 3 percent below the 
                        level specified in subparagraph (A)(ii), and 
                        fees assessed for the fiscal year following the 
                        subsequent fiscal year are decreased by the 
                        amount in excess of 3 percent by which such 
                        costs fell below the level specified in such 
                        subparagraph; and
                            ``(II) such costs are not more than 5 
                        percent below the level specified in such 
                        subparagraph.
            ``(3) Authorization of appropriations.--For each of the 
        fiscal years 2010 through 2014, there is authorized to be 
        appropriated for fees under this section an amount equal to the 
        total revenue amount determined under subsection (c)(1) for the 
        fiscal year, as adjusted or otherwise affected under subsection 
        (d) and paragraph (4) of this subsection.
            ``(4) Offset.--If the sum of the cumulative amount of fees 
        collected under this section for the fiscal years 2010 through 
        2013 and the amount of fees estimated to be collected under 
        this section for fiscal year 2014 exceeds the cumulative amount 
        appropriated under paragraph (3) for the fiscal years 2010 
        through 2014, the excess shall be credited to the appropriation 
        account of the Food and Drug Administration as provided in 
        paragraph (1), and shall be subtracted from the amount of fees 
        that would otherwise be authorized to be collected under this 
        section for fiscal year 2014.
    ``(h) 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.
    ``(i) Written Requests for Waivers, Reductions, and Refunds.--To 
qualify for consideration for a waiver or reduction under subsection 
(e), or for a refund of any fee collected in accordance with subsection 
(a), a person shall submit to the Secretary a written request for such 
waiver, reduction, or refund not later than 180 days after such fee is 
due.
    ``(j) 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, employers, and advisory 
committees not engaged in inspections described in subsection (a), be 
reduced to offset the number of officers, employees, and advisory 
committees so engaged.
    ``(k) 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.
    ``(l) Definition.--The term `costs of inspecting establishments 
registered under subsection (b), (c), (d), or (i) of section 510 to 
ensure compliance by such establishments with the requirements of this 
Act relating to drugs and devices' means the expenses incurred, in 
connection with inspecting establishments registered under subsection 
(b), (c), (d), or (i) of section 510 to ensure compliance by such 
establishments with the requirements of this Act relating to drugs and 
devices, for--
            ``(1) officers and employees of the Food and Drug 
        Administration, contractors of the Food and Drug 
        Administration, and costs related to such officers and 
        employees and to contracts with such contractors;
            ``(2) management of information, and the acquisition, 
        maintenance, and repair of information technology resources;
            ``(3) leasing, maintenance, renovation, and repair of 
        facilities and acquisition, maintenance, and repair of 
        fixtures, furniture, scientific equipment, and other necessary 
        materials and supplies; and
            ``(4) collecting fees under this section and accounting for 
        resources allocated for such inspections.''.
            (3) Effective date.--The Secretary of Health and Human 
        Services shall first impose the fee established under section 
        736C of the Federal Food, Drug, and Cosmetic Act, as added by 
        paragraph (2), for fiscal years beginning with fiscal year 
        2010.
            (4) Sunset date.--Section 736C of the Federal Food, Drug, 
        and Cosmetic Act, as added by paragraph (2), does not authorize 
        the assessment or collection of a fee for registration under 
        section 510 of such Act (21 U.S.C. 360) occurring after fiscal 
        year 2014.

SEC. 202. INSPECTION OF PRODUCERS OF DRUGS AND ACTIVE PHARMACEUTICAL 
              INGREDIENTS.

    (a) Inspection.--Subsection (h) of section 510 (21 U.S.C. 351) is 
amended--
            (1) by striking ``(h)'' and inserting ``(h)(1)'';
            (2) by striking ``Every establishment in any State 
        registered with the Secretary pursuant to this section'' and 
        inserting ``Every establishment registered with the Secretary 
        pursuant to subsection (b), (c), (d), or (i)'';
            (3) by striking ``704(g), at least once'' and all that 
        follows and inserting the following: ``704(g)--
            ``(A) at least once in the 2-year period beginning with the 
        date of registration of such establishment pursuant to this 
        section and at least once in every successive 2-year period 
        thereafter; or
            ``(B) at least once in the 4-year period beginning with the 
        date of registration of such establishment pursuant to this 
        section and at least once in every successive 4-year period 
        thereafter, if the Secretary determines that sufficient 
        information about the type of product produced in the 
        establishment, inspection history, compliance history, and such 
        additional factors as the Secretary determines, by guidance, 
        exists to assess risk and to establish a risk-based inspection 
        schedule.''; and
            (4) by adding at the end the following:
    ``(2)(A) The Secretary shall conduct an inspection of a drug 
establishment when the establishment begins to manufacture, prepare, 
propagate, compound, or process a drug or active pharmaceutical 
ingredient of a drug before its introduction into interstate commerce 
if the drug or ingredient is new or has undergone a major change 
requiring prior approval by the Secretary of a supplement to an 
application submitted under section 505. Notwithstanding the preceding 
sentence, the Secretary may opt against conducting such an inspection 
if the Secretary determines, based on the inspection history of the 
establishment, that such an inspection is not necessary to verify the 
data contained in the application (or supplement to the application) 
submitted under section 505, ensure compliance with current good 
manufacturing practice, or otherwise ensure the safety of the drug or 
ingredient.
    ``(B) The Secretary shall annually submit a report to the Congress 
on each instance during the preceding year in which the Secretary 
determined under subparagraph (A) that an inspection was not necessary.
    ``(3) The Secretary may, by regulation, provide for a risk-based 
inspection schedule for establishments engaged in the manufacture, 
propagation, compounding, or processing of an excipient of a drug at a 
frequency different than the inspection schedule for an establishment 
under paragraph (1).
    ``(4) Nothing in this subsection shall be construed as limiting the 
authority of the Secretary to conduct inspections under any other 
provision of the Act.
    ``(5) With respect to fiscal year 2010 and each subsequent fiscal 
year, the Secretary shall submit an annual report to the Congress on--
            ``(A) funding dedicated to inspections under this 
        subsection; and
            ``(B) the number of establishments for which the frequency 
        of such inspections has been modified pursuant to paragraph 
        (1)(B).
    ``(6) For purposes of determining inspection frequency under 
subparagraphs (A) and (B) of paragraph (1), the Secretary shall 
establish information systems capacity sufficient to assess risk and 
shall develop and maintain a risk-based system for conducting 
surveillance of current good manufacturing practices by establishments 
registered with the Secretary pursuant to subsection (b), (c), (d), or 
(i). The Secretary shall have such capacity in place and begin 
implementation of such risk-based system not later than 3 years after 
the date of the enactment of the Food and Drug Administration 
Globalization Act of 2009. Such risk-based system shall include 
consideration of the class of the establishment's products and 
associated risks, the date the establishment was last inspected, the 
establishment's compliance and safety history, the establishment's 
shipping volume and history, and such other factors as the Secretary 
determines relevant to assessing the risk presented by the 
establishment.''.
    (b) GAO Report.--Not later than 3 years after the date of the 
enactment of this Act, the Comptroller General of the United States 
shall submit a report to the Congress on the risk-based process for 
conducting surveillance of current good manufacturing practices 
developed and implemented under section 510(h)(6) of the Federal Food, 
Drug, and Cosmetic Act, as added by subsection (a)(4) of this section.
    (c) Effective Date.--The amendments made by this section shall 
apply to drugs introduced or delivered for introduction into interstate 
commerce on or after the date of the enactment of this Act.

SEC. 203. DOCUMENTATION FOR ADMISSIBILITY OF DRUG IMPORTS.

    Section 801 (21 U.S.C. 381), as amended by section 123, is further 
amended by adding at the end the following:
    ``(q) Beginning 3 years after the date of the enactment of this 
subsection, a drug shall not enter the United States unless the party 
offering the drug for import provides the Secretary, at the time of 
offering the drug for import, information demonstrating compliance with 
applicable requirements pertaining to identity, strength, quality, 
purity, approval, listing, labeling, registration, and such additional 
categories as the Secretary, by guidance, determines are necessary for 
protection of the public health. The Secretary may allow that such 
compliance be demonstrated through verification by an accredited third 
party or through such other means as determined, by guidance, by the 
Secretary.''.

SEC. 204. DRUG SUPPLY QUALITY AND SAFETY.

    (a) Adulteration.--Section 501 (21 U.S.C. 351) is amended by adding 
at the end the following:
    ``(j) If it is drug that was manufactured, prepared, propagated, 
compounded, or processed by an establishment that is or was at the time 
of such manufacture, preparation, propagation, compounding, or 
processing in violation of section 505-2 because of--
            ``(1) the failure to have in effect and implement a quality 
        risk management plan in accordance with section 505-2; or
            ``(2) the failure to transmit information in electronic 
        form as requested by the Secretary under section 505-2(f).''.
    (b) Quality Risk Management Plans.--Chapter V (21 U.S.C. 351 et 
seq.) is amended by inserting after section 505-1 the following:

``SEC. 505-2. DRUG SUPPLY QUALITY AND SAFETY.

    ``(a) Implementation of Quality Risk Management Plan.--An 
establishment required to be registered with the Secretary pursuant to 
subsection (b), (c), (d), or (i) of section 510 for the manufacture, 
preparation, propagation, compounding, or processing of a drug shall 
have in effect and implement an adequate quality risk management plan 
that ensures the safety and quality of each such drug, including any 
ingredients produced, manufactured, processed, packed, or held by 
another person.
    ``(b) Plan Provisions.--A quality risk management plan required by 
subsection (a) shall address risk assessment, risk control, risk 
communication, and risk review and shall--
            ``(1) provide for an assessment, prior to contracting with 
        a person to supply raw materials or ingredients or to undertake 
        any aspect of the manufacturing of the drug, of the suitability 
        and competence of such person to carry out such activity, using 
        audits, material evaluations, or qualification, as appropriate;
            ``(2) define responsibilities and communication processes 
        for manufacturing, quality control, and quality assurance 
        activities of any person referred to in paragraph (1);
            ``(3) provide for the monitoring and review through 
        periodic on-site audits of the facility conditions, controls, 
        and practices of any person referred to in paragraph (1) and 
        ensure the implementation of appropriate measures to improve 
        such conditions, controls, and practices;
            ``(4) provide for the monitoring of incoming materials to 
        ensure they are from a person that meets the requirements in 
        paragraphs (1) through (3);
            ``(5) provide for implementation of effective systems, 
        including appropriate specifications and test methods and 
        verification of the drug ingredients' identity, quality, 
        strength, and purity, to detect any hazard that has been, or is 
        reasonably likely to be, present in or on the drug during 
        production, manufacturing, processing, packing, holding, or 
        transporting; and
            ``(6) be periodically reviewed and, as needed, updated.
    ``(c) Additional Provisions.--If the Secretary determines that 
provisions in addition to those described in subsections (a) and (b) 
would be appropriate to include in a quality risk management plan for 
protection of the public health, including provisions for the 
prevention of intentional adulteration of a drug or class of drugs, the 
Secretary may by regulation require the inclusion of such provisions in 
a quality risk management plan.
    ``(d) Application of Specifications or Test Methods by Order of the 
Secretary.--Upon a finding that there is a significant threat to public 
health, the Secretary may order an establishment--
            ``(1) to promptly revise its quality risk management plan 
        to include new or modified specifications or test methods for a 
        drug; and
            ``(2) to promptly implement such specifications or test 
        methods.
    ``(e) Inspection of Quality Risk Management Plan.--The Secretary 
shall, in the course of an inspection of an establishment subject to 
this section or upon request by the Secretary, conduct a review of the 
establishment's quality risk management plan.
    ``(f) Documentation of Supply Chain.--
            ``(1) In general.--Each establishment required to be 
        registered with the Secretary pursuant to subsection (b), (c), 
        (d), or (i) of Section 510 for the manufacture, preparation, 
        propagation, compounding, or processing of a drug, shall 
        provide to the Secretary, upon request, adequate information 
        transmitted in electronic form, establishing--
                    ``(A) where the drug, including its raw materials, 
                were produced, including all preceding producers, 
                manufacturers, distributors, and shippers; and
                    ``(B) that the drug, its ingredients and raw 
                materials were manufactured, prepared, propagated, 
                compounded, processed, distributed, shipped, 
                warehoused, brokered, imported, and conveyed under 
                conditions that ensure the identity, strength, quality, 
                and purity of the drug.
            ``(2) Repackagers.--For those establishments that are 
        repackagers, paragraph (1)(A) requires only information 
        regarding the immediately preceding establishment.''.
    (c) Effective Date.--
            (1) In general.--The requirements of sections 501(j) and 
        505-2 of the Federal Food, Drug, and Cosmetic Act, as added by 
        subsections (a) and (b), take effect 2 years after the date of 
        the enactment of this Act.
            (2) Exception.--Notwithstanding the effective date 
        specified in paragraph (1)--
                    (A) the authority of the Secretary to order an 
                establishment to promptly implement new or modified 
                specifications or test methods for a drug, as described 
                in section 505-2(d)(2) of the Federal Food, Drug, and 
                Cosmetic Act, as amended by subsection (b), shall take 
                effect on the date of the enactment of this Act;
                    (B) such authority shall apply irrespective of 
                whether the establishment has in effect a quality risk 
                management plan; and
                    (C) a civil penalty under section 303(f)(5) of the 
                Federal Food, Drug, and Cosmetic Act, as added by 
                section 211 of this Act, shall apply to a violation of 
                an order under this paragraph to the same extent and in 
                the same manner as such a penalty applies to a 
                violation of an order under such section 505-2(d)(2).

SEC. 205. DELAY, LIMITATION, OR DENIAL OF INSPECTION.

    (a) Requirement.--Subsection (h) of section 510 (21 U.S.C. 351), as 
amended by section 202(a), is further amended by adding at the end the 
following:
    ``(7) The person who owns or operates an establishment registered 
with the Secretary pursuant to subsection (b), (c), (d), or (i), any 
agent or employee of such person, and any agent of a governmental 
authority in the foreign country within which such establishment is 
located shall not delay or limit an inspection, or refuse to permit 
entry or inspection, authorized by this subsection.''.
    (b) Reference to Prohibited Act.--For provision making delay, 
limiting, or denying an inspection under section 510(h) of the Federal 
Food, Drug, and Cosmetic Act a prohibited act under section 301(f) of 
such Act, see the amendment made by section 403.
    (c) Drugs Offered for Import.--The third sentence of subsection (a) 
of section 801 (21 U.S.C. 381), as amended by section 105(b), is 
amended by inserting ``or (5) such article has been manufactured, 
prepared, propagated, compounded, or processed by an establishment 
required to be registered with the Secretary pursuant to subsection 
(b), (c), (d), or (i) of section 510 and such establishment is in 
violation of section 510(h)(7) (prohibiting the delay, limitation, or 
denial of an inspection under section 510(h)),'' before ``then such 
article shall be refused admission''.

SEC. 206. COUNTRY OF ORIGIN LABELING.

    (a) Misbranding.--Section 502 (21 U.S.C. 352) is amended by adding 
at the end the following:
    ``(aa) If it is a drug and the website of the manufacturer of the 
drug does not list the country of origin for each active pharmaceutical 
ingredient and finished dosage form of such drug.''.
    (b) Regulations.--Not later than 1 year after the date of the 
enactment of this Act, the Secretary shall promulgate final regulations 
to carry out section 502(aa) of the Federal Food, Drug, and Cosmetic 
Act, as added by subsection (a).
    (c) Effective Date.--The requirement of section 502(aa) of the 
Federal Food, Drug, and Cosmetic Act, as added by subsection (a), takes 
effect 2 years after the date of the enactment of this Act.

SEC. 207. NONDISTRIBUTION AND RECALL OF ADULTERATED OR MISBRANDED 
              DRUGS.

    (a) Prohibited Acts.--Section 301 (21 U.S.C. 331), as amended by 
sections 102, 104, and 112 of this Act, is amended by adding at the end 
the following:
    ``(rr) The failure to comply with--
            ``(1) an order issued under section 568(a) following any 
        hearing requested under section 568(b); or
            ``(2) an amended order issued under section 568(c)(1).''.
    (b) Nondistribution and Recall of Adulterated or Misbranded 
Drugs.--Subchapter E of chapter V (21 U.S.C. 360bb et seq.) is amended 
by adding at the end the following:

``SEC. 568. NONDISTRIBUTION AND RECALL OF ADULTERATED OR MISBRANDED 
              DRUGS.

    ``(a) Recall and Consumer Notification.--
            ``(1) Voluntary actions.--On receiving information of a 
        suspected adulteration or misbranding of a drug, if the 
        Secretary finds that there is a reasonable probability that a 
        drug intended for human use would cause serious, adverse health 
        consequences or death, the Secretary shall provide all persons 
        (including the manufacturer, importer, distributor, or retailer 
        of the drug) with an opportunity (as determined by the 
        Secretary)--
                    ``(A) to cease distribution of the drug;
                    ``(B) to notify all entities--
                            ``(i) that produce, manufacture, pack, 
                        process, prepare, treat, package, distribute, 
                        or hold the drug, to cease immediately those 
                        activities with respect to the drug; or
                            ``(ii) to which the drug has been 
                        distributed, transported, or sold, to cease 
                        immediately distribution of the drug;
                    ``(C) to recall the drug;
                    ``(D) in consultation with the Secretary, to 
                provide notice of the finding of the Secretary to all 
                consumers to which the drug was, or may have been, 
                distributed and to appropriate State and local health 
                officials; and
                    ``(E) to notify State and local public health 
                officials.
            ``(2) Mandatory actions.--If a person referred to in 
        paragraph (1) does not carry out the actions described in that 
        paragraph with respect to a drug within the time period and in 
        the manner prescribed by the Secretary, the Secretary shall 
        issue an order requiring such person--
                    ``(A) to immediately cease distribution of the 
                drug; and
                    ``(B) to immediately notify health professionals 
                and drug user facilities of the order and to instruct 
                such professionals and facilities to cease use of such 
                drug.
    ``(b) Hearings on Orders.--The Secretary shall provide a person 
subject to an order under subsection (a)(2) with an opportunity for an 
informal hearing, to be held not later than 10 days after the date of 
the issuance of the order, on--
            ``(1) the actions required by the order; and
            ``(2) any reasons why the drug that is the subject of the 
        order should not be recalled.
    ``(c) Post-Hearing Recall Orders.--
            ``(1) Amendment of orders.--If, after providing an 
        opportunity for an informal hearing under subsection (b), the 
        Secretary determines that an order under subsection (a)(2) with 
        respect to a drug should be amended to include a recall or 
        other appropriate action, the Secretary shall, except as 
        provided in paragraph (2)--
                    ``(A) amend the order--
                            ``(i) to require recall of the drug or 
                        other appropriate action; and
                            ``(ii) to specify a timetable during which 
                        any such recall shall occur; and
                    ``(B) require periodic reports to the Secretary 
                describing the progress of any such recall.
            ``(2) Contents of order.--
                    ``(A) Individuals and drug user facilities.--An 
                amended order under paragraph (1) shall not include--
                            ``(i) a recall of a drug from individuals; 
                        or
                            ``(ii) a recall of a drug from drug user 
                        facilities if the Secretary determines that the 
                        risk of recalling such drug from the facilities 
                        presents a greater health risk than the health 
                        risk of not recalling the drug from use.
                    ``(B) Notice to individuals subject to risks.--An 
                amended order under paragraph (1) shall provide for 
                notice to individuals subject to the risks associated 
                with the use of such drug. In providing the notice 
                required by this paragraph, the Secretary may use the 
                assistance of health professionals who prescribed or 
                dispensed such a drug for individuals. If a significant 
                number of such individuals cannot be identified, the 
                Secretary shall notify such individuals pursuant to 
                section 705(b).
            ``(3) Vacation of orders.--If, after providing an 
        opportunity for an informal hearing under subsection (b), the 
        Secretary determines that adequate grounds do not exist to 
        continue the actions required by the order, the Secretary shall 
        vacate the order.
    ``(d) Remedies Not Exclusive.--The remedies authorized by this 
section shall be in addition to any other remedies that may be 
available.''.

SEC. 208. DESTRUCTION OF ADULTERATED, MISBRANDED OR COUNTERFEIT 
              ARTICLES OFFERED FOR IMPORT.

    (a) In General.--The fifth sentence of subsection (a) of section 
801 (21 U.S.C. 381), as amended by sections 105(b) and 205(c), is 
further amended by inserting before the period at the end of the 
following: ``, except that any article that is refused admission may, 
at the discretion of the Secretary, be promptly (subject to the next 
sentence) destroyed and not exported if it appears to pose a risk of 
injury or death''.
    (b) Notice.--Subsection (a) of section 801 (21 U.S.C. 381), as 
amended by sections 105(b) and 205(c) and subsection (a) of this 
section, is amended by inserting after the fifth sentence the 
following: ``Before causing the destruction of an article with a value 
greater than $2,000 under the preceding sentence, the Secretary shall 
provide notice and an opportunity for an informal hearing to the owner 
or consignee.''.
    (c) Improper Destruction.--Section 801 (21 U.S.C. 381), as amended 
by sections 123 and 203, is amended by adding at the end the following:
    ``(r) Any person claiming any article which has been destroyed 
under subsection (a) may, at any time within 3 months after the date of 
destruction, apply to the Secretary for reimbursement of the value of 
the article as determined by the Secretary. Upon the production of 
satisfactory proof that the destruction of the article was not within 
the authority of the Secretary as provided in this section, the 
Secretary shall order the value of the article restored to the 
applicant.''.
    (d) Samples of Destroyed Articles.--Section 801 (21 U.S.C. 381), as 
amended by sections 123 and 203 and subsection (c) of this section, is 
amended by adding at the end the following:
    ``(s) Where an article is caused to be destroyed under subsection 
(a) the Secretary shall, upon request, provide a sample of the article 
to the owner of the article, the owner's attorney or agent, or if 
applicable any person named on the label of the article, except that 
the Secretary is authorized, by regulations, to make such reasonable 
exceptions from, and impose such reasonable terms and conditions 
relating to, the operation of this subsection as the Secretary finds 
necessary for the proper administration of the provisions of this 
Act.''.
    (e) Effective Date.--The amendments made by subsections (a), (b), 
(c), and (d) shall take effect 90 days after the date of the enactment 
of this Act.

SEC. 209. ADMINISTRATIVE DETENTION OF DRUGS THAT APPEAR TO VIOLATE THE 
              LAW.

    (a) In General.--Section 304(g) (21 U.S.C. 334(g)) is amended--
            (1) by inserting ``drug or'' before ``device'' each place 
        it appears; and
            (2) in paragraph (1), by inserting after ``adulterated or 
        misbranded'' the following: ``or, in the case of a drug, which 
        in the determination of the officer or employee making the 
        inspection appears to be in violation of section 505,''.
    (b) Effective Date.--The amendments made by subsection (a) shall 
take effect on a date, specified by the Secretary of Health and Human 
Services, not later than 1 year after the date of the enactment of this 
Act.

SEC. 210. PENALTIES REGARDING COUNTERFEIT DRUGS.

    Section 303(a) (21 U.S.C. 333(a)) is amended by adding at the end 
the following paragraph:
    ``(3) Notwithstanding paragraph (1) or (2), any person who engages 
in any conduct described in section 301(i)(2) knowing that the conduct 
concerns the rendering of a drug as a counterfeit drug, or who engages 
in conduct described in section 301(i)(3) knowing that the conduct will 
cause a drug to be a counterfeit drug or knowing that a drug held, 
sold, or dispensed is a counterfeit drug, shall be fined in accordance 
with title 18, United States Code, or imprisoned not more than 20 
years, or both, except that if the use of the counterfeit drug by a 
consumer is the proximate cause of the death of the consumer, the term 
of imprisonment shall be any term of years or for life.''.

SEC. 211. CIVIL MONEY PENALTIES FOR VIOLATIVE DRUGS AND DEVICES AND 
              IMPROPER IMPORT ENTRY FILINGS.

    (a) In General.--Section 303(f) (21 U.S.C. 333) is amended--
            (1) by redesignating paragraphs (5), (6), and (7) as 
        paragraphs (6), (7), and (8), respectively;
            (2) by inserting after paragraph (4) the following:
            ``(5)(A)(i) Any person that violates a requirement of this 
        Act that relates to drugs for human use (except a requirement 
        referred to in paragraph (4) or subsection (g)) shall be liable 
        to the United States for a civil penalty not to exceed--
                            ``(I) $100,000 for an initial violation of 
                        such a requirement; or
                            ``(II) $200,000 for a subsequent violation 
                        of the same requirement.
            ``(ii) In clause (i)(I), the term `initial violation' means 
        the first violation by a person of a requirement described in 
        clause (i) that occurs on or after the date of the enactment of 
        the Food and Drug Administration Globalization Act of 2009.
            ``(iii) Each day during which a violation continues shall 
        be considered a separate violation under clause (i), except 
        that a continuing initial violation shall not be treated as a 
        subsequent violation for purposes of clause (i)(II).
            ``(B)(i) Any person that knowingly reports or enters false 
        or misleading data on documents related to the importation of a 
        drug shall be liable to the United States for a civil penalty 
        not to exceed $200,000.
            ``(ii) Each act of reporting or entering false data shall 
        be considered a separate violation under clause (i).
            ``(C) Any manufacturer, importer, distributer, or retailer 
        who fails to comply with an order or an amended order issued 
        under section 568(a) or 568(c)(1), respectively, shall be 
        liable to the United States for a civil penalty not to exceed 
        $250,000 per day.''.
            (3) in paragraph (6), as so redesignated, by striking ``, 
        or (4)'' each place it appears and inserting ``(4), or (5)'';
            (4) in paragraph (7), as so redesignated, by striking 
        ``(5)(A)'' and inserting ``(6)(A)''; and
            (5) in paragraph (8), as so redesignated, by striking 
        ``paragraph (6)'' each place it appears and inserting 
        ``paragraph (7)''.
    (b) Applicability.--Section 303(f)(5) (as amended by subsection 
(a)), shall apply to violations described in such section that occur 
after the date of the enactment of this Act.

SEC. 212. HUMAN GENERIC DRUG APPLICATION AND SUPPLEMENT FEES TO COVER 
              PRE-APPROVAL INSPECTION COSTS.

    (a) Sense of Congress.--It is the sense of the Congress that the 
amount of additional revenues generated from fees under this section 
should be used to support pre-approval inspections of generic drug 
establishments, in accordance with performance goals to be developed by 
the Secretary of Health and Human Services in consultation with the 
entities listed in subparagraphs (A) through (F) of section 736B(d)(1) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h-2(d)(1)).
    (b) Fee.--
            (1) Misbranding.--Paragraph (o) of section 502 (21 U.S.C. 
        352), as amended by subsections (a) and (b) of section 501, is 
        further amended by striking ``736C'' and inserting ``736C or 
        736D''.
            (2) Establishment.--Part 2 of subchapter C of chapter VII 
        (21 U.S.C. 379g et seq.), as amended by section 201(b), is 
        amended by adding at the end the following:

``SEC. 736D. HUMAN GENERIC DRUG APPLICATION AND SUPPLEMENT FEES TO 
              COVER PRE-APPROVAL INSPECTION COSTS.

    ``(a) In General.--The Secretary shall assess and collect a fee 
upon submission of any human generic drug application or supplement to 
defray increases (as described in subsection (c)(2)(B)) in the costs of 
resources allocated for conducting inspections in connection with the 
review of human generic drug applications and supplements.
    ``(b) Fee Revenue Amounts.--For each of fiscal years 2010 through 
2014, fees under subsection (a) shall be established, subject to the 
provisions referred to in subsection (d), to generate a total revenue 
amount.
    ``(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 appropriation 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 increases in the costs of resources allocated 
                for conducting inspections in connection with the 
                review of human generic drug applications and 
                supplements (including increases in such costs for an 
                additional number of full-time equivalent positions in 
                the Department of Health and Human Services to be 
                engaged in such review) over such costs, excluding 
                costs paid from fees collected under this section, for 
                fiscal year 2009 multiplied by the adjustment factor.
    ``(d) Applicability of Certain Provisions.--To the extent 
determined by the Secretary to be consistent with this section, the 
provisions of section 736 apply with respect to human generic drug 
application fees and supplement fees under this section to the same 
extent and in the same manner as such provisions apply with respect to 
human drug application fees and supplement fees under section 736.
    ``(e) Definitions.--In this section:
            ``(1) The term `costs of resources allocated for conducting 
        inspections in connection with the review of human generic drug 
        applications and supplements' means the expenses that are--
                    ``(A) incurred in connection with inspections 
                undertaken as part of the Secretary's review of pending 
                human generic drug applications and supplements; and
                    ``(B) described in subparagraphs (A) through (D) of 
                section 735(7), except that the reference in section 
                735(7)(D) to section 736 is deemed to be a reference to 
                this section, and the reference is section 735(7)(D) to 
                human drug applications and supplements (as defined in 
                section 735(2)) is deemed to be a reference to human 
                generic drug applications and supplements (as defined 
                in this section).
            ``(2) The term `human generic drug application' means an 
        application for approval of a new drug submitted under section 
        505(j). Such term does not include an application or a 
        supplement to an application described in section 735(1).
            ``(3) Notwithstanding section 735(2), the term `supplement' 
        means a request to the Secretary to approve a change in a human 
        generic drug application which has been approved.''.
            (3) Effective date.--The Secretary of Health and Human 
        Services shall first impose the fee established under section 
        736D of the Federal Food, Drug, and Cosmetic Act, as added by 
        paragraph (2), for fiscal years beginning with fiscal year 
        2010.
            (4) Sunset date.--Section 736D, as added by paragraph (2), 
        does not authorize the assessment or collection of a fee for 
        submission of an application or supplement under section 505(j) 
        of such Act (21 U.S.C. 355(j)) occurring after fiscal year 
        2014.

                       TITLE III--COSMETIC SAFETY

SEC. 301. REGISTRATION OF COSMETIC ESTABLISHMENTS.

    (a) Misbranding.--Section 602 is amended by adding at the end the 
following:
    ``(g) If it was manufactured or packaged in an establishment that 
is not duly registered under section 604.''.
    (b) Annual Registration.--Chapter VI is amended by adding at the 
end the following:

``SEC. 604. REGISTRATION OF COSMETIC ESTABLISHMENTS.

    ``(a) Registration.--
            ``(1) In general.--The Secretary shall by regulation 
        require that any establishment engaged in manufacturing or 
        packaging cosmetics for use in the United States be registered 
        annually with the Secretary. To be registered--
                    ``(A) for a domestic establishment, the owner, 
                operator, or agent in charge of the establishment shall 
                submit a registration to the Secretary; and
                    ``(B) for a foreign establishment, the owner, 
                operator, or agent in charge of the establishment shall 
                submit a registration to the Secretary and shall 
                include with the registration the name of the United 
                States agent for the establishment.
            ``(2) Registration.--An entity (referred to in this section 
        as the `registrant') shall submit a registration under 
        paragraph (1) to the Secretary containing information necessary 
        to notify the Secretary of the name and address of each 
        establishment at which, and all trade names under which, the 
        registrant manufactures or packages cosmetics. The registrant 
        shall notify the Secretary in a timely manner of changes to 
        such information. The registrant shall notify the Secretary of 
        any change in the products, function, or legal status of each 
        such establishment (including cessation of business activities) 
        not later than 30 days after the date of such change.
            ``(3) Procedure.--Upon receipt of a completed registration 
        described in paragraph (1), the Secretary shall notify the 
        registrant of the receipt of such registration and assign a 
        registration number to each registered establishment.
            ``(4) List.--The Secretary shall compile and maintain an 
        up-to-date list of establishments that are registered under 
        this section. The Secretary shall remove from such list the 
        name of any establishment that fails to reregister in 
        accordance with this section and shall treat such removal as a 
        suspension of the establishment's registration. Such list and 
        any registration documents submitted pursuant to this 
        subsection shall not be subject to disclosure under section 552 
        of title 5, United States Code. Information derived from such 
        list or registration documents shall not be subject to 
        disclosure under section 552 of title 5, United States Code, to 
        the extent that such information discloses the identity or 
        location of a specific registered person.
    ``(b) Establishment.--For purposes of this section:
            ``(1) The term `domestic establishment' means an 
        establishment located in any State (as defined in section 201).
            ``(2)(A) The term `foreign establishment' means an 
        establishment that manufactures or packages cosmetics that are 
        exported to the United States without further processing or 
        packaging outside the United States.
            ``(B) A cosmetic may not be considered to have undergone 
        further processing or packaging for purposes of subparagraph 
        (A) solely on the basis that labeling was added or that any 
        similar activity of a de minimis nature was carried out with 
        respect to the cosmetic.''.

SEC. 302. COSMETIC AND INGREDIENT STATEMENTS.

    (a) Misbranding.--Section 602, as amended by section 301 of this 
Act, is amended by adding at the end the following:
    ``(h) If its manufacturer is in violation of section 605 for 
failure to submit a cosmetic and ingredient statement with respect to 
the cosmetic.''.
    (b) Statements.--Chapter VI, as amended by section 301 of this Act, 
is amended by adding at the end the following:

``SEC. 605. COSMETIC AND INGREDIENT STATEMENTS.

    ``(a) In General.--The Secretary shall require by regulation that 
every establishment engaged in the manufacture of a cosmetic intended 
to be marketed in the United States submit to the Secretary for each 
cosmetic manufactured in the establishment, within 60 days after 
beginning manufacture of the product, a cosmetic and ingredient 
statement containing--
            ``(1) the registration number of the manufacturing 
        establishment where the cosmetic is manufactured or, if the 
        same cosmetic is manufactured in more than one establishment, 
        the registration number of each establishment where it is 
        manufactured;
            ``(2) the brand name or names for the cosmetic;
            ``(3) the applicable cosmetic category or categories for 
        the cosmetic;
            ``(4) the ingredients in the cosmetic in descending order 
        of predominance by weight, except that--
                    ``(A) flavors and fragrances may be designated as 
                such; and
                    ``(B) all variations in color, flavor, or fragrance 
                may be included in one statement; and
            ``(5) the title and full contact information for the 
        individual or individuals responsible for submitting and 
        maintaining the statement.
The registrant shall notify the Secretary in a timely manner of any 
change to the information required to be in such statement.
    ``(b) Procedure.--Upon receipt of a completed cosmetic and 
ingredient statement described in paragraph (a), the Secretary shall 
notify the registrant of the receipt of such statement and assign a 
cosmetic and ingredient statement number.
    ``(c) List.--The Secretary shall compile and maintain an up-to-date 
list of cosmetics and ingredients for which statements are submitted 
under this section.''.

SEC. 303. SERIOUS AND UNEXPECTED ADVERSE EVENT REPORTS FOR COSMETICS.

    (a) Prohibited Acts.--Section 301 is amended--
            (1) in paragraph (e), by striking ``or 761'' each place it 
        appears and inserting ``761, or 762''; and
            (2) in paragraph (ii)--
                    (A) by striking ``or the'' and inserting ``, the''; 
                and
                    (B) by striking the period at the end and inserting 
                ``, or the falsification of a report submitted under 
                section 762 to the Secretary.''.
    (b) Adverse Event Reporting.--Subchapter H of chapter VII is 
amended by adding at the end the following:

``SEC. 762. SERIOUS AND UNEXPECTED ADVERSE EVENT REPORTS FOR COSMETICS.

    ``(a) In General.--The Secretary shall require by regulation that 
the manufacturer, packager, or distributor whose name appears on the 
label of a cosmetic marketed in the United States pursuant to section 
602(b)(1) submit to the Secretary under subsection (b) a report 
containing information received concerning any serious and unexpected 
adverse event in the United States associated with the use of the 
cosmetic.
    ``(b) Submission of Reports.--
            ``(1) In general.--A report under subsection (a) shall be 
        submitted to the Secretary no later than 15 business days after 
        information concerning the adverse event is received at the 
        place of business labeled on the cosmetic under section 
        602(b)(1).
            ``(2) Contents.--A report under subsection (a) shall 
        include the following information, to the extent to which the 
        person submitting the report has been able to verify the 
        information--
                    ``(A) an identifiable patient;
                    ``(B) an identifiable reporter;
                    ``(C) a suspect cosmetic; and
                    ``(D) a serious and unexpected adverse event.
            ``(3) Additional information.--The person submitting a 
        report under subsection (a) may include in the submission any 
        additional pertinent information and may supplement the report 
        with additional information at a later time.
    ``(c) Relation to Other Provisions.--A report under subsection (a) 
(including all information submitted in the initial report or added 
later) shall be considered to be--
            ``(1) a safety report under section 756;
            ``(2) a record about an individual under section 552a of 
        title 5, United States Code; and
            ``(3) a medical or similar file the disclosure of which 
        would constitute a violation of section 552(b)(6) of such title 
        5, United States Codes, and shall not be disclosed under 
        section 552 of such title.
    ``(d) Definitions.--In this section:
            ``(1) The term `serious', with respect to an adverse event, 
        means--
                    ``(A) resulting in--
                            ``(i) death;
                            ``(ii) a life-threatening experience;
                            ``(iii) inpatient hospitalization;
                            ``(iv) a persistent and significant 
                        disability or incapacity; or
                            ``(v) a congenital anomaly or birth defect; 
                        or
                    ``(B) requiring, based on reasonable medical 
                judgment, a medical or surgical intervention to prevent 
                an outcome described in subparagraph (A).
            ``(2) The term `unexpected', with respect to an adverse 
        event, means not identified in the current labeling for the 
        cosmetic.''.

SEC. 304. GOOD MANUFACTURING PRACTICES FOR COSMETICS.

    Section 601 is amended by adding at the end the following:
    ``(f) If the methods used in, or the facilities or controls used 
for, its manufacture, processing, packaging, storage, or holding do not 
conform to current good manufacturing practice, as prescribed by the 
Secretary in regulations, to ensure that the cosmetic is safe and 
otherwise in compliance with this Act.''.

SEC. 305. AUTHORIZATION OF APPROPRIATIONS.

    Chapter VI, as amended by sections 301 and 302, is amended by 
adding at the end the following:

``SEC. 606. AUTHORIZATION OF APPROPRIATIONS.

    ``To carry out this chapter and section 762, there is authorized to 
be appropriated $10,000,000 for each of fiscal years 2010 through 
2014.''.

SEC. 306. EFFECTIVE DATE.

    The amendments made by sections 301, 302, 303, and 304 shall take 
effect 18 months after the date of the enactment of this Act.

                        TITLE IV--MISCELLANEOUS

SEC. 401. REGISTRATION FOR COMMERCIAL IMPORTERS OF FOOD, DRUGS, 
              DEVICES, AND COSMETICS; FEE.

    (a) Prohibitions.--Section 301 (21 U.S.C. 331), as amended by 
sections 102, 104, 112, and 207, is amended by adding at the end the 
following:
    ``(ss) The importation of food, drugs, devices, or cosmetics other 
than only for personal use by an importer that is not registered with 
respect to such food, drugs, devices, or cosmetics under section 415, 
510, or 604, respectively, unless the importer is registered under 
section 801(t).''.
    (b) Registration.--Section 801, as amended by sections 123, 203, 
and 208, is amended by adding at the end the following:
    ``(t) The Secretary shall by regulation require that an importer of 
food, drugs, devices, or cosmetics, other than only for personal use, 
that is not required to be registered with respect to such food, drugs, 
devices, or cosmetics under section 415, 510, or 604, respectively, 
shall be registered with the Secretary in a form and manner specified 
by the Secretary. The Secretary shall assign a unique identification 
number to each importer so registered.''.
    (c) Fee.--Subchapter C of chapter VII (21 U.S.C. 379f et seq.) is 
amended by adding at the end the following:

            ``PART 6--IMPORTERS OF FOOD, DRUGS, AND DEVICES

``SEC. 742. IMPORTERS OF FOOD, DRUGS, AND DEVICES.

    ``(a) In General.--The Secretary shall assess and collect an annual 
fee for the registration of an importer of food, drugs, or devices 
under section 801(t).
    ``(b) Amount of Fee.--The amount of the fee under this section 
shall be $10,000.
    ``(c) Rule of Construction.--This section shall not be construed to 
authorize the assessment or collection of any fee from an importer of 
food, drugs, or devices if, with respect to such food, drugs, or 
devices, the importer is registered under section 415 or 510 and 
required to pay a fee under section 736C or 741.''.
    (d) Effective Date.--
            (1) Registration.--Not later than 1 year after the date of 
        the enactment of this Act, the Secretary of Health and Human 
        Services shall establish procedures for the registration of 
        importers under section 801(t) of the Federal Food, Drug, and 
        Cosmetic Act, as added by subsection (a).
            (2) Registration.--The amendments made by this section 
        shall first apply not later than 1 year after the date of the 
        enactment of this Act.

SEC. 402. UNIQUE IDENTIFICATION NUMBER FOR FOOD, DRUG, AND DEVICE 
              FACILITIES AND ESTABLISHMENTS.

    (a) Food and Cosmetics.--Section 415(a)(3) (21 U.S.C. 350d(a)(3)) 
is amended by inserting ``unique'' before ``registration number''.
    (b) Drugs and Devices.--Section 510(e) (21 U.S.C. 360(e)) is 
amended by adding after the first sentence the following: ``The 
registration number shall be the unique identification number for each 
such establishment.''.
    (c) Effective Date.--The Secretary of Health and Human Services 
shall implement the amendments made by this section not later than 1 
year after the date of the enactment of this Act.

SEC. 403. PROHIBITION AGAINST DELAYING OR LIMITING INSPECTION.

    Section 301(f) (21 U.S.C. 331(e)) is amended to read as follows:
    ``(f) The delay or limitation of an inspection, or the refusal to 
permit entry or inspection, as authorized by section 510(h) or 704, 
including any such delay, limitation, or refusal by an agent of a 
governmental authority in a foreign country.''.

SEC. 404. DEDICATED FOREIGN INSPECTORATE.

    Section 704 (21 U.S.C. 374) is amended by adding at the end the 
following:
    ``(i) The Secretary shall establish and maintain a corps of 
inspectors dedicated to inspections of foreign food, drug, device, and 
cosmetics facilities and establishments. This corps shall be staffed 
and funded by the Secretary at a level sufficient to allow it to 
conduct inspections of foreign food, drug, device, and cosmetic 
facilities and establishments at a frequency at least equivalent to the 
inspection rate of domestic food, drug, device, and cosmetic facilities 
and establishments.''.

SEC. 405. CONTINUED OPERATION OF FIELD LABORATORIES.

    (a) In General.--Subject to subsections (b) and (d), the Secretary 
of Health and Human Services (in this section referred to as the 
``Secretary'') shall not--
            (1) terminate any of the 13 field laboratories that were 
        operated by the Office of Regulatory Affairs of the Food and 
        Drug Administration as of January 1, 2007;
            (2) consolidate any such laboratory with any other 
        laboratory;
            (3) terminate any of the 20 district offices or any of the 
        inspection or compliance functions of any of the 20 district 
        offices of the Food and Drug Administration functioning as of 
        January 1, 2007; or
            (4) consolidate--
                    (A) any such district office with an office in any 
                other district; or
                    (B) transfer any of the compliance or inspection 
                functions of any such district office to any other 
                district.
    (b) Report by Secretary.--
            (1) Submission.--The Secretary shall submit a 
        reorganization plan involving the termination or consolidation 
        of the laboratories, the district offices, or the functions of 
        such district offices specified in subsection (a) 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.
            (2) Consultation.--In preparing the reorganization plan 
        described in paragraph (1), the Secretary shall consult with 
        personnel and unions to be affected by the plan.
    (c) Report by GAO.--The Comptroller General shall study the cost 
effectiveness of the reorganization plan described in subsection (b) 
and its impact on the safety of food, drug, and other products 
regulated under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 
et seq.) and the Public Health Service Act (42 U.S.C. 201 et seq.) and 
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.
    (d) Reorganization.--
            (1) Congressional review.--The reorganization plan 
        described in subsection (b) 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.
            (2) Effective date.--Notwithstanding section 801(a)(3) of 
        title 5, United States Code, the reorganization plan described 
        in subsection (b) shall take effect (unless disapproved under 
        section 802 of such title) on the date that is specified in 
        such plan, but not earlier than 180 days after the date on 
        which the Comptroller General submits the report required by 
        subsection (c).

SEC. 406. 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: ``food, drug, or 
biological product''.
    (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. 407. SUBPOENA AUTHORITY.

    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 the Act, or
            ``(2) any hearing, investigation, or other proceeding to 
        determine if a person is in violation of a specific provision 
        of the Act,
the Commissioner may issue subpoenas requiring the attendance and 
testimony of witnesses and the production of documentary evidence. Such 
attendance of witnesses and production of evidence at the designated 
place of such hearing, investigation, or other proceeding may be 
required from any place in the United States or in any territory or 
possession of the United States. 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. 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. Witnesses so 
subpoenaed shall be paid the same fees and mileage as are paid 
witnesses in the district courts of the United States.
    ``(b) 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 requiring such person to appear and give testimony or to 
appear and produce evidence, or both. The failure to obey such order of 
the court may be punished by the court as contempt thereof. 
Furthermore, the failure or refusal to obey such a subpoena shall be 
treated as a prohibited act under section 301(a).
    ``(c) 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.''.

SEC. 408. WHISTLEBLOWER PROTECTIONS.

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

``SEC. 911. 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 that submits or is required to submit 
to the Secretary, a registration under section 415, 510, or 604, a new 
drug application under section 505(b), an abbreviated new drug 
application under section 505(j), a biologics license application under 
section 351 of the Public Health Service Act, an application for an 
investigational new drug exemption under section 505(i), a new animal 
drug application under section 512(b), an abbreviated new animal drug 
application under section 512(b), an application under section 571, a 
request under section 572, an application or report for premarket 
approval under section 515, an application for an investigational 
device exemption under section 520(g), a report under section 510(k), 
an application for a humanitarian device exemption under section 
520(m), an amendment, supplement, or other submission with respect to 
any such registration, application, or report, or a record or report 
related to an adverse event, a postapproval study, a postapproval 
clinical trial, a report, or postmarket surveillance under section 
505(k), 505(o), 519, 522, or 760, or any officer, employee, contractor, 
subcontractor, or agent of such a 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 section 351 of the Public Health 
        Service Act, any other provision of Federal law relating to the 
        safety or effectiveness of a drug, biological product, or 
        device or to the safety of a food or cosmetic, or any provision 
        of Federal law prohibiting fraud against the Food and Drug 
        Administration, 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) 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, or within 90 days after receiving a final 
                decision or order from the Secretary, and there is no 
                showing that such delay is due to the bad faith of the 
                claimant, 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 paragraph (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 reinstate the complainant to his or her 
                former position together with compensation (including 
                back pay) and restore the terms, conditions, and 
                privileges associated with his or her employment; and
                    ``(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.''.
                                 <all>