[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3610 Introduced in House (IH)]







110th CONGRESS
  1st Session
                                H. R. 3610

 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
safety of food and drugs imported into the United States, and for other 
                               purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           September 20, 2007

 Mr. Dingell (for himself, Mr. Pallone, and Mr. Stupak) 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 with respect to the 
safety of food and drugs imported into the United States, 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; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Food and Drug 
Import Safety Act of 2007''.
    (b) Table of Contents.--The table of contents of this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Research on testing techniques for use in inspections of 
                            imported food safety; priority regarding 
                            detection of intentional adulteration.
Sec. 3. User fees regarding inspections of imported food safety.
Sec. 4. User fees regarding inspections of imported drug safety.
Sec. 5. Authority to restrict food importation to specific ports of 
                            entry.
Sec. 6. Country of origin labeling.
Sec. 7. Safe and secure food importation program.
Sec. 8. Civil penalties.
Sec. 9. Continued operation of field laboratories.
Sec. 10. Recall authority.
Sec. 11. Inspection and other standards; applicability, enforcement; 
                            certifications.
Sec. 12. Regulations on adequate testing of processed food.
Sec. 13. Records of interstate shipment.
Sec. 14. Labeling requirement for meat, poultry products, and seafood 
                            that contain carbon monoxide.

SEC. 2. RESEARCH ON TESTING TECHNIQUES FOR USE IN INSPECTIONS OF 
              IMPORTED FOOD SAFETY; PRIORITY REGARDING DETECTION OF 
              INTENTIONAL ADULTERATION.

    Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
381) is amended by adding at the end the following:
    ``(p) Research on Testing Techniques for Use in Inspections of 
Imported Food Safety.--
            ``(1) In general.--The Secretary shall (directly or through 
        grants or contracts) provide for research on the development of 
        tests and sampling methodologies, for use in inspections of 
        food under this section--
                    ``(A) whose purpose is to determine whether food is 
                adulterated by reason of being contaminated with 
                microorganisms, chemical toxins, or pesticide chemicals 
                or related residues; and
                    ``(B) whose results are available not later than 
                approximately 60 minutes after the administration of 
                the tests.
            ``(2) Priority.--In providing for research under paragraph 
        (1), the Secretary shall give priority to conducting research 
        on the development of tests that are suitable for inspections 
        of food at ports of entry into the United States, with the 
        greatest priority given to the development of such tests that 
        the Secretary determines would be useful in detecting the 
        intentional adulteration of food. In providing for research 
        under paragraph (1), the Secretary shall under the preceding 
        sentence give priority to conducting research on the 
        development of tests for detecting the presence in food of the 
        pathogens E. coli, salmonella, cyclospora, cryptosporidium, 
        hepatitis A, or listeria, the presence in or on food of 
        pesticide chemicals and related residues, the presence in or on 
        food of chemical toxins, and the presence in or on food of such 
        other pathogens or substances as the Secretary determines to be 
        appropriate, including any pathogen or substance that the 
        Secretary determines is a candidate for use to intentionally 
        adulterate food. The Secretary shall establish the goal of 
        developing, by the expiration of the 3-year period beginning on 
        the date of the enactment of the this subsection, tests under 
        paragraph (1) for each of the pathogens and substances 
        receiving priority under the preceding sentence.
            ``(3) Periodic reports.--The Secretary shall submit to the 
        Congress periodic reports describing the progress that has been 
        made toward the goal referred to in paragraph (1) and 
        describing plans for future research toward the goal. Each of 
        the reports shall provide an estimate by the Secretary of the 
        amount of funds needed to meet such goal, and shall provide a 
        determination by the Secretary of whether there is a need for 
        further research under this subsection. The first such report 
        shall be submitted not later than March 1, 2008, and subsequent 
        reports shall be submitted semiannually after the submission of 
        the first report until the goal is met.
            ``(4) Consultation.--The Secretary shall carry out the 
        program of research under paragraph (1) in consultation with 
        the Director of the Centers for Disease Control and Prevention, 
        the Director of the National Institutes of Health, and the 
        Administrator of the Environmental Protection Agency. The 
        Secretary shall with respect to such research coordinate the 
        activities of the Department of Health and Human Services. The 
        Secretary shall in addition consult with the Secretary of 
        Agriculture (acting through the Food Safety and Inspection 
        Service of the Department of Agriculture) in carrying out the 
        program.''.

SEC. 3. USER FEES REGARDING INSPECTIONS OF IMPORTED FOOD SAFETY.

    Chapter VIII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
381 et seq.) is amended by inserting after section 801 the following:

                   ``user fees regarding food safety

    ``Sec. 801A.  (a) In General.--
            ``(1) Assessment.--Beginning in fiscal year 2008, the 
        Secretary shall in accordance with this section assess and 
        collect fees on food imported into the United States.
            ``(2) Purpose of fees.--
                    ``(A) In general.--The purpose of fees under 
                paragraph (1) is to defray the costs of carrying out 
                section 801 with respect to food over the costs of 
                carrying out such section with respect to food in 
                fiscal year 2007 multiplied by the adjustment factor. 
                Fees under paragraph (1) may be used to pay for 
                overseas inspection with respect to food by the 
                Department of Health and Human Services.
                    ``(B) Allocations by secretary.--Of the total fee 
                revenues collected under paragraph (1) for a fiscal 
                year, the Secretary shall reserve and expend amounts in 
                accordance with the following:
                            ``(i) The Secretary shall reserve not less 
                        than 90 percent for carrying out section 801 
                        with respect to food, other than research under 
                        section 801(p). In expending the amount so 
                        reserved, the Secretary shall give priority to 
                        inspections conducted at ports of entry into 
                        the United States, with the greatest priority 
                        given to inspections to detect the intentional 
                        adulteration of food.
                            ``(ii) The Secretary shall reserve not more 
                        than 10 percent for carrying out research under 
                        section 801(p).
                    ``(C) Laboratory testing.--In this paragraph, the 
                term `costs of carrying out section 801' with respect 
                to food being imported or offered for import includes 
                the costs of laboratory testing of such food, including 
                laboratory personnel costs.
            ``(3) Amount of fee; collection.--A fee under paragraph (1) 
        shall be assessed on each line item of food, as defined by the 
        Secretary by regulation. The amount of the fee shall be based 
        on the number of line items, and may not exceed $50 per line 
        item, notwithstanding subsection (b). The liability for the fee 
        constitutes a personal debt due to the United States, and such 
        liability accrues on the date on which the Secretary approves 
        the food under section 801(c)(1). The Secretary may coordinate 
        with and seek the cooperation of other agencies of the Federal 
        Government regarding the collection of such fees.
    ``(b) Total Fee Revenues.--The total fee revenues collected under 
subsection (a) for a fiscal year shall be the amount appropriated under 
subsection (f)(3).
    ``(c) Adjustments.--
            ``(1) Inflation adjustment.--With respect to the amount of 
        total fee revenues referred to in subsection (b), the amount 
        authorized in subsection (f)(3) for a fiscal year shall be 
        adjusted by the Secretary (and as adjusted shall be published 
        in the Federal Register) to reflect the greater of--
                    ``(A) the total percentage change that occurred 
                during the preceding fiscal year in the Consumer Price 
                Index for all urban consumers (all items; U.S. city 
                average); or
                    ``(B) the total percentage change for such 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.
            ``(2) Annual fee adjustment.--Not later than 60 days after 
        the end of each fiscal year beginning after fiscal year 2008, 
        the Secretary, subject to not exceeding the maximum fee amount 
        specified in subsection (a)(3), shall adjust the amounts that 
        otherwise would under subsection (a) be assessed as fees during 
        the fiscal year in which the adjustment occurs so that the 
        total revenues collected in such fees for such fiscal year 
        equal the amount applicable pursuant to subsection (b) for the 
        fiscal year.
    ``(d) Fee Waiver or Reduction.--The Secretary shall grant a waiver 
from or a reduction of a fee assessed under subsection (a) where the 
Secretary finds that the fee to be paid will exceed the anticipated 
present and future costs incurred by the Secretary in carrying out 
section 801 with respect to food (which finding may be made by the 
Secretary using standard costs).
    ``(e) Assessment of Fees.--
            ``(1) Limitation.--Fees may not be assessed under 
        subsection (a) for a fiscal year beginning after fiscal year 
        2008 unless the amount appropriated for salaries and expenses 
        of the Food and Drug Administration for such fiscal year is 
        equal to or greater than the amount appropriated for salaries 
        and expenses of the Food and Drug Administration for fiscal 
        year 2008 multiplied by the adjustment factor applicable to the 
        fiscal year involved, except that in making determinations 
        under this paragraph for the fiscal years involved there shall 
        be excluded--
                    ``(A) the amounts appropriated under subsection 
                (f)(3) for the fiscal years involved;
                    ``(B) the amounts appropriated under section 
                801B(f)(3) for such fiscal years; and
                    ``(C) the amounts appropriated under section 736(g) 
                for such fiscal years.
            ``(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 of the fees, at any time in such fiscal year 
        notwithstanding the provisions of subsection (a)(3) relating to 
        the time at which fees are to be paid.
    ``(f) Crediting and Availability of Fees.--
            ``(1) In general.--Fees collected for a fiscal year 
        pursuant to subsection (a) shall be credited to the 
        appropriation account for salaries and expenses of the Food and 
        Drug Administration and shall be available in accordance with 
        appropriation Acts until expended without fiscal year 
        limitation. 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. The sums transferred shall be available 
        solely for carrying out section 801 with respect to food, and 
        the sums are subject to allocations under subsection (a)(2)(B).
            ``(2) Collections and appropriation acts.--The fees 
        authorized in subsection (a)--
                    ``(A) shall be collected in each fiscal year in 
                accordance with subsections (a)(3) and (b); and
                    ``(B) shall only be collected and available for the 
                purpose specified in subsection (a)(2).
            ``(3) Authorization of appropriations; allocations by 
        secretary.--Subject to paragraph (4) and subsection (c)(1), 
        there is authorized to be appropriated for fees under this 
        section $500,000,000 for each of the fiscal years 2008 through 
        2012.
            ``(4) Offset.--Any amount of fees collected for a fiscal 
        year under subsection (a) that exceeds the amount of fees 
        specified in appropriation Acts for such fiscal year 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 pursuant to 
        appropriation Acts for a subsequent fiscal year.
    ``(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 as requiring 
that the number of full-time equivalent positions in the Department of 
Health and Human Services, for officers, employees, and advisory 
committees not engaged in carrying out section 801 with respect to food 
be reduced to offset the number of officers, employees, and advisory 
committees so engaged.
    ``(i) Definition of Adjustment Factor.--For purposes of 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 April of the preceding fiscal year divided by 
such Index for April 2007.''.

SEC. 4. USER FEES REGARDING INSPECTIONS OF IMPORTED DRUG SAFETY.

    Chapter VIII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
381 et seq.), as amended by section 3, is further amended by inserting 
after section 801A the following:

                   ``user fees regarding drug safety

    ``Sec. 801B.  (a) In General.--
            ``(1) Assessment.--Beginning in fiscal year 2008, the 
        Secretary shall in accordance with this section assess and 
        collect fees on drugs imported into the United States.
            ``(2) Purpose of fees.--
                    ``(A) In general.--The purpose of fees under 
                paragraph (1) is to defray the costs of carrying out 
                section 801 with respect to drugs over the costs of 
                carrying out such section with respect to drugs in 
                fiscal year 2007 multiplied by the adjustment factor. 
                Fees under paragraph (1) may be used to pay for 
                overseas inspection with respect to drugs by the 
                Department of Health and Human Services.
                    ``(B) Priority.--In expending the fee revenue 
                amounts collected under paragraph (1), the Secretary 
                shall give priority to--
                            ``(i) inspections conducted at ports of 
                        entry into the United States, with the greatest 
                        priority given to inspections to detect the 
                        intentional adulteration or misbranding of 
                        drugs; and
                            ``(ii) inspections of good manufacturing 
                        practices conducted abroad.
                    ``(C) Laboratory testing.--In this paragraph, the 
                term `costs of carrying out section 801' with respect 
                to drugs being imported or offered for import includes 
                the costs of laboratory testing of such drugs, 
                including laboratory personnel costs.
            ``(3) Amount of fee; collection.--A fee under paragraph (1) 
        shall be assessed on each line item of drugs, as defined by the 
        Secretary by regulation. The amount of the fee shall be based 
        on the number of line items, and may not exceed $1000 per line 
        item, notwithstanding subsection (b). The liability for the fee 
        constitutes a personal debt due to the United States, and such 
        liability accrues on the date on which the Secretary approves 
        the drugs under section 801(c)(1). The Secretary may coordinate 
        with and seek the cooperation of other agencies of the Federal 
        Government regarding the collection of such fees.
    ``(b) Total Fee Revenues.--The total fee revenues collected under 
subsection (a) for a fiscal year shall be the amount appropriated under 
subsection (f)(3).
    ``(c) Adjustments.--
            ``(1) Inflation adjustment.--With respect to the amount of 
        total fee revenues referred to in subsection (b), the amount 
        authorized in subsection (f)(3) for a fiscal year shall be 
        adjusted by the Secretary (and as adjusted shall be published 
        in the Federal Register) to reflect the greater of--
                    ``(A) the total percentage change that occurred 
                during the preceding fiscal year in the Consumer Price 
                Index for all urban consumers (all items; U.S. city 
                average); or
                    ``(B) the total percentage change for such 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.
            ``(2) Annual fee adjustment.--Not later than 60 days after 
        the end of each fiscal year beginning after fiscal year 2008, 
        the Secretary, subject to not exceeding the maximum fee amount 
        specified in subsection (a)(3), shall adjust the amounts that 
        otherwise would under subsection (a) be assessed as fees during 
        the fiscal year in which the adjustment occurs so that the 
        total revenues collected in such fees for such fiscal year 
        equal the amount applicable pursuant to subsection (b) for the 
        fiscal year.
    ``(d) Fee Waiver or Reduction.--The Secretary shall grant a waiver 
from or a reduction of a fee assessed under subsection (a) where the 
Secretary finds that the fee to be paid will exceed the anticipated 
present and future costs incurred by the Secretary in carrying out 
section 801 with respect to drugs (which finding may be made by the 
Secretary using standard costs).
    ``(e) Assessment of Fees.--
            ``(1) Limitation.--Fees may not be assessed under 
        subsection (a) for a fiscal year beginning after fiscal year 
        2008 unless the amount appropriated for salaries and expenses 
        of the Food and Drug Administration for such fiscal year is 
        equal to or greater than the amount appropriated for salaries 
        and expenses of the Food and Drug Administration for fiscal 
        year 2008 multiplied by the adjustment factor applicable to the 
        fiscal year involved, except that in making determinations 
        under this paragraph for the fiscal years involved there shall 
        be excluded--
                    ``(A) the amounts appropriated under subsection 
                (f)(3) for the fiscal years involved;
                    ``(B) the amounts appropriated under section 
                801A(f)(3) for such fiscal years; and
                    ``(C) the amounts appropriated under section 736(g) 
                for such fiscal years.
            ``(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 of the fees, at any time in such fiscal year 
        notwithstanding the provisions of subsection (a)(3) relating to 
        the time at which fees are to be paid.
    ``(f) Crediting and Availability of Fees.--
            ``(1) In general.--Fees collected for a fiscal year 
        pursuant to subsection (a) shall be credited to the 
        appropriation account for salaries and expenses of the Food and 
        Drug Administration and shall be available in accordance with 
        appropriation Acts until expended without fiscal year 
        limitation. 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. The sums transferred shall be available 
        solely for carrying out section 801 with respect to drugs.
            ``(2) Collections and appropriation acts.--The fees 
        authorized in subsection (a)--
                    ``(A) shall be collected in each fiscal year in 
                accordance with subsections (a)(3) and (b); and
                    ``(B) shall only be collected and available for the 
                purpose specified in subsection (a)(2).
            ``(3) Authorization of appropriations; allocations by 
        secretary.--Subject to paragraph (4) and subsection (c)(1), 
        there is authorized to be appropriated for fees under this 
        section $300,000,000 for each of the fiscal years 2008 through 
        2012.
            ``(4) Offset.--Any amount of fees collected for a fiscal 
        year under subsection (a) that exceeds the amount of fees 
        specified in appropriation Acts for such fiscal year 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 pursuant to 
        appropriation Acts for a subsequent fiscal year.
    ``(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 as requiring 
that the number of full-time equivalent positions in the Department of 
Health and Human Services, for officers, employees, and advisory 
committees not engaged in carrying out section 801 with respect to 
drugs be reduced to offset the number of officers, employees, and 
advisory committees so engaged.
    ``(i) Definition of Adjustment Factor.--For purposes of 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 April of the preceding fiscal year divided by 
such Index for April 2007.''.

SEC. 5. AUTHORITY TO RESTRICT FOOD IMPORTATION TO SPECIFIC PORTS OF 
              ENTRY.

    Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
381), as amended by section 2, is further amended by adding at the end 
the following:
    ``(q) Authority To Restrict Food Importation to Specific Ports of 
Entry.--
            ``(1) In general.--The Secretary shall restrict the 
        importation of all food to ports of entry that are located in a 
        metropolitan area with a laboratory of the Food and Drug 
        Administration for testing such food.
            ``(2) Waiver.--The Secretary may waive the requirement of 
        paragraph (1) and authorize the importation of food to a port 
        of entry not described in such paragraph if the Secretary 
        certifies that--
                    ``(A) the importation of such food through such 
                port will not increase the probability that such food 
                will cause serious, adverse health consequences or 
                death; or
                    ``(B) there is a reasonable probability that the 
                type food involved will not cause serious, adverse 
                health consequences or death.
            ``(3) Implementation.--The Secretary shall implement this 
        subsection beginning not later than 5 years after the date of 
        the enactment of this subsection.''.

SEC. 6. COUNTRY OF ORIGIN LABELING.

    (a) Food.--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 the labeling of the food fails to identify the country of 
origin of the food.''.
    (b) Drugs and Devices.--Section 502 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the 
following:
    ``(y) If it is a drug or device and its labeling fails to identify 
the country of origin of the drug or device.''.
    (c) Regulations.--Not later than 180 days after the date of the 
enactment of this Act, the Secretary shall promulgate final regulations 
to carry out sections 403(z) and 502(y) of the Federal Food, Drug, and 
Cosmetic Act, as added by subsections (a) and (b), respectively.
    (d) Effective Date.--The requirements of sections 403(z) and 502(y) 
of the Federal Food, Drug, and Cosmetic Act, as added by subsections 
(a) and (b), respectively, take effect on the date that is 180 days 
after the date of the enactment of this Act.

SEC. 7. SAFE AND SECURE FOOD IMPORTATION PROGRAM.

    Chapter VIII of the Federal Food, Drug, and Cosmetic Act (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--
            ``(1) persons importing food into the United States 
        voluntarily agree to abide by the food safety and security 
        guidelines developed under subsection (b); and
            ``(2) the Secretary agrees to expedite the movement of such 
        food through the inspection process.
    ``(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.--The guidelines developed under paragraph 
        (1) 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) The need for tracking and maintaining records 
                on food and ingredients purchased by such person or 
                moved through the supply chain.
                    ``(E) Documentation processing through such 
                person's supply chain.
                    ``(F) Access by the Secretary to such person's 
                business records for review.
                    ``(G) Vendor and supplier information.
                    ``(H) Such other factors as the Secretary 
                determines necessary.''.

SEC. 8. CIVIL PENALTIES.

    Section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
333) is amended--
            (1) by redesignating subsection (g) (relating to civil 
        penalties) as subsection (f): and
            (2) in subparagraph (A) of paragraph (2) of subsection (f), 
        as so redesignated, by striking ``Any person who introduces'' 
        and all that follows through the end of the subparagraph and 
        inserting the following: ``Any person who introduces into 
        interstate commerce or delivers for introduction into 
        interstate commerce an article of food that is adulterated 
        within the meaning of section 402(a)(2)(B) shall be subject to 
        a civil money penalty of--
                    ``(i) not more than $50,000 in the case of any 
                individual and $250,000 in the case of any other person 
                for such introduction or delivery, not to exceed 
                $500,000 for all such violations adjudicated in a 
                single proceeding; or
                    ``(ii) notwithstanding clause (i), if such person 
                is the manufacturer or the importer of the food, not 
                more than $100,000 in the case of any individual and 
                $500,000 in the case of any other person for such 
                introduction or delivery, not to exceed $1,000,000 for 
                all such violations adjudicated in a single 
                proceeding.''.

SEC. 9. 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, 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 180 days after 
        the date on which the Comptroller General submits the report 
        required by subsection (c).

SEC. 10. RECALL AUTHORITY.

    Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
351 et seq.), as amended by section 6 of this Act, is amended by adding 
at the end the following:

``SEC. 418. RECALL AUTHORITY.

    ``(a) Order To Cease Distribution.--
            ``(1) In general.--If the Secretary finds that a food may 
        cause serious, adverse health consequences or death, the 
        Secretary shall issue an order requiring the appropriate person 
        (including the manufacturers, importers, distributors, or 
        retailers of the food) to immediately cease distribution of the 
        food.
            ``(2) Informal hearing.--An order under paragraph (1) shall 
        provide the person subject to the order 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 the actions required 
        by the order and on whether the order should be amended to 
        require a recall of the food involved. If, after providing an 
        opportunity for such a hearing, the Secretary determines that 
        inadequate grounds exist to support the actions required by the 
        order, the Secretary shall vacate the order.
    ``(b) Order To Recall.--
            ``(1) In general.--If, after providing an opportunity for 
        an informal hearing under subsection (a)(2), the Secretary 
        determines that the order should be amended to include a recall 
        of the food with respect to which the order was issued, the 
        Secretary shall, except as provided in paragraphs (2) and (3), 
        amend the order to require a recall. The Secretary shall 
        specify a timetable in which the food recall will occur and 
        shall require periodic reports to the Secretary describing the 
        progress of the recall.
            ``(2) Certain actions.--An amended order under paragraph 
        (1) shall not include recall of a food from individuals.''.

SEC. 11. INSPECTION AND OTHER STANDARDS; APPLICABILITY, ENFORCEMENT; 
              CERTIFICATIONS.

    Chapter IV of the Federal Food, Drug, and Cosmetic Act, as amended 
by section 10 of this Act, is amended by adding at the end the 
following:

``SEC. 419. INSPECTION AND OTHER STANDARDS; APPLICABILITY, ENFORCEMENT; 
              CERTIFICATIONS.

    ``(a) In General.--Notwithstanding any other provision of law, all 
food that is offered for importation into the United States shall be 
subject to the food safety standards applied to such food produced in 
the United States.
    ``(b) Enforcement.--Any food that appears to not meet all the 
standards referred to in subsection (a) shall be considered adulterated 
and shall not be permitted entry into the United States.
    ``(c) Random Inspections.--The Secretary shall enforce this section 
through appropriate random inspections, sampling, and testing.
    ``(d) Certifications Regarding Foreign Facilities.--
            ``(1) Requirement.--No food shall be permitted entry into 
        the United States from a foreign facility in a foreign country 
        unless there is--
                    ``(A) a certification for such facility in effect 
                under paragraph (2)(A); or
                    ``(B) a certification for such country under 
                paragraph (2)(B).
            ``(2) Certification.--
                    ``(A) Foreign facility.--Each foreign facility 
                seeking to import food into the United States may 
                obtain a certification by the Secretary stating that 
                the facility maintains a program using reliable 
                analytical methods to ensure compliance with all the 
                standards referred to in subsection (a).
                    ``(B) Foreign country.--A foreign country may 
                obtain a certification by the Secretary stating that--
                            ``(i) the country has in effect and is 
                        enforcing food safety standards at least as 
                        protective of food safety as the standards 
                        applicable to food in the United States; and
                            ``(ii) the country has a program in effect 
                        to monitor and enforce its food safety 
                        standards with respect to food being exported 
                        from such country to the United States.
            ``(3) Periodic review.--The Secretary shall periodically 
        review certifications under paragraph (2) and shall revoke any 
        certification if the Secretary determines that the foreign 
        facility or foreign country involved is no longer meeting the 
        requirements described in such paragraph.
            ``(4) Inspection.--The consideration of any application for 
        a certification under paragraph (2) and the review of any such 
        certification, by the Secretary, may include the inspection of 
        foreign facilities to ensure that the inspection program of the 
        foreign facility involved is meeting such standards.
            ``(5) Foreign facility.--In this subsection, the term 
        `foreign facility' means a foreign facility (as defined in 
        section 415(b)(3)) that is required to be registered under 
        section 415.
            ``(6) Effective date.--This subsection takes effect 
        beginning on the date that is 5 years after the date of the 
        enactment of the Food and Drug Import Safety Act of 2007.''.

SEC. 12. REGULATIONS ON ADEQUATE TESTING OF PROCESSED FOOD.

    Chapter IV of the Federal Food, Drug, and Cosmetic Act, as amended 
by section 11 of this Act, is amended by adding at the end the 
following:

``SEC. 420. REGULATIONS ON ADEQUATE TESTING OF PROCESSED FOOD.

    ``(a) In General.--Not later than 2 years after the date of the 
enactment of the Food and Drug Import Safety Act of 2007, the Secretary 
shall by regulation require that, as good manufacturing practices, 
processed food undergo testing to detect substances in the food that 
may render the food adulterated, including microbial pathogens, toxic 
chemicals, and such other substances as the Secretary determines to be 
appropriate.
    ``(b) Review of Test Results.--Regulations under subsection (a) 
shall require that the results of tests under such subsection be 
provided to the Secretary upon demand.''.

SEC. 13. RECORDS OF INTERSTATE SHIPMENT.

    Subsection (a) of section 703 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 373) is amended--
            (1) by striking ``upon the request'' and inserting ``upon 
        the written or oral request''; and
            (2) by striking ``, except that evidence obtained under 
        this section, or any evidence which is directly or indirectly 
        derived from such evidence, shall not be used in a criminal 
        prosecution of the person from whom obtained, and except that 
        carriers shall not be subject to the other provisions of this 
        Act by reason of their receipt, carriage, holding, or delivery 
        of food, drugs, devices, or cosmetics in the usual course of 
        business as carriers, except as provided in subsection (b)''.

SEC. 14. LABELING REQUIREMENT FOR MEAT, POULTRY PRODUCTS, AND SEAFOOD 
              THAT CONTAIN CARBON MONOXIDE.

    (a) Labeling Requirement.--
            (1) In general.--Paragraph (t) of section 201 of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(t)) is 
        amended by adding at the end the following new paragraph:
            ``(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 finfish, molluscan shellfish, 
        crustaceans, and other forms of aquatic animal life) intended 
        for human consumption as food within the meaning of section 
        201(f) of this Act (referred to collectively in this subsection 
        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: `SAFETY 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 or 
        safety of the product. Discard any product with an unpleasant 
        odor, slime, or a bulging package.'''.
            (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)(1), 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.
                                 <all>