HR 3610 IHCommentsClose CommentsPermalink

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.CommentsClose CommentsPermalink

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 CommerceCommentsClose CommentsPermalink

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.CommentsClose CommentsPermalink

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

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'.CommentsClose CommentsPermalink





(b) Table of Contents- The table of contents of this Act is as follows:CommentsClose CommentsPermalink





Sec. 1. Short title; table of contents.CommentsClose CommentsPermalink





Sec. 2. Research on testing techniques for use in inspections of imported food safety; priority regarding detection of intentional adulteration.CommentsClose CommentsPermalink





Sec. 3. User fees regarding inspections of imported food safety.CommentsClose CommentsPermalink





Sec. 4. User fees regarding inspections of imported drug safety.CommentsClose CommentsPermalink





Sec. 5. Authority to restrict food importation to specific ports of entry.CommentsClose CommentsPermalink





Sec. 6. Country of origin labeling.CommentsClose CommentsPermalink





Sec. 7. Safe and secure food importation program.CommentsClose CommentsPermalink





Sec. 8. Civil penalties.CommentsClose CommentsPermalink





Sec. 9. Continued operation of field laboratories.CommentsClose CommentsPermalink





Sec. 10. Recall authority.CommentsClose CommentsPermalink





Sec. 11. Inspection and other standards; applicability, enforcement; certifications.CommentsClose CommentsPermalink





Sec. 12. Regulations on adequate testing of processed food.CommentsClose CommentsPermalink





Sec. 13. Records of interstate shipment.CommentsClose CommentsPermalink





Sec. 14. Labeling requirement for meat, poultry products, and seafood that contain carbon monoxide.CommentsClose CommentsPermalink

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:CommentsClose CommentsPermalink





`(p) Research on Testing Techniques for Use in Inspections of Imported Food Safety-CommentsClose CommentsPermalink





`(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--CommentsClose CommentsPermalink





`(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; andCommentsClose CommentsPermalink





`(B) whose results are available not later than approximately 60 minutes after the administration of the tests.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.'.CommentsClose CommentsPermalink

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:CommentsClose CommentsPermalink

`USER FEES REGARDING FOOD SAFETY

`Sec. 801A. (a) In General-CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(2) PURPOSE OF FEES-CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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:CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(ii) The Secretary shall reserve not more than 10 percent for carrying out research under section 801(p).CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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).CommentsClose CommentsPermalink





`(c) Adjustments-CommentsClose CommentsPermalink





`(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--CommentsClose CommentsPermalink





`(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); orCommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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).CommentsClose CommentsPermalink





`(e) Assessment of Fees-CommentsClose CommentsPermalink





`(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--CommentsClose CommentsPermalink





`(A) the amounts appropriated under subsection (f)(3) for the fiscal years involved;CommentsClose CommentsPermalink





`(B) the amounts appropriated under section 801B(f)(3) for such fiscal years; andCommentsClose CommentsPermalink





`(C) the amounts appropriated under section 736(g) for such fiscal years.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(f) Crediting and Availability of Fees-CommentsClose CommentsPermalink





`(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).CommentsClose CommentsPermalink





`(2) COLLECTIONS AND APPROPRIATION ACTS- The fees authorized in subsection (a)--CommentsClose CommentsPermalink





`(A) shall be collected in each fiscal year in accordance with subsections (a)(3) and (b); andCommentsClose CommentsPermalink





`(B) shall only be collected and available for the purpose specified in subsection (a)(2).CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.'.CommentsClose CommentsPermalink

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:CommentsClose CommentsPermalink

`USER FEES REGARDING DRUG SAFETY

`Sec. 801B. (a) In General-CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(2) PURPOSE OF FEES-CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(B) PRIORITY- In expending the fee revenue amounts collected under paragraph (1), the Secretary shall give priority to--CommentsClose CommentsPermalink





`(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; andCommentsClose CommentsPermalink





`(ii) inspections of good manufacturing practices conducted abroad.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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).CommentsClose CommentsPermalink





`(c) Adjustments-CommentsClose CommentsPermalink





`(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--CommentsClose CommentsPermalink





`(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); orCommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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).CommentsClose CommentsPermalink





`(e) Assessment of Fees-CommentsClose CommentsPermalink





`(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--CommentsClose CommentsPermalink





`(A) the amounts appropriated under subsection (f)(3) for the fiscal years involved;CommentsClose CommentsPermalink





`(B) the amounts appropriated under section 801A(f)(3) for such fiscal years; andCommentsClose CommentsPermalink





`(C) the amounts appropriated under section 736(g) for such fiscal years.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(f) Crediting and Availability of Fees-CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(2) COLLECTIONS AND APPROPRIATION ACTS- The fees authorized in subsection (a)--CommentsClose CommentsPermalink





`(A) shall be collected in each fiscal year in accordance with subsections (a)(3) and (b); andCommentsClose CommentsPermalink





`(B) shall only be collected and available for the purpose specified in subsection (a)(2).CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.'.CommentsClose CommentsPermalink

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:CommentsClose CommentsPermalink





`(q) Authority To Restrict Food Importation to Specific Ports of Entry-CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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--CommentsClose CommentsPermalink





`(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; orCommentsClose CommentsPermalink





`(B) there is a reasonable probability that the type food involved will not cause serious, adverse health consequences or death.CommentsClose CommentsPermalink





`(3) IMPLEMENTATION- The Secretary shall implement this subsection beginning not later than 5 years after the date of the enactment of this subsection.'.CommentsClose CommentsPermalink

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:CommentsClose CommentsPermalink





`(z) If the labeling of the food fails to identify the country of origin of the food.'.CommentsClose CommentsPermalink





(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:CommentsClose CommentsPermalink





`(y) If it is a drug or device and its labeling fails to identify the country of origin of the drug or device.'.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink

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:CommentsClose CommentsPermalink

`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--CommentsClose CommentsPermalink





`(1) persons importing food into the United States voluntarily agree to abide by the food safety and security guidelines developed under subsection (b); andCommentsClose CommentsPermalink





`(2) the Secretary agrees to expedite the movement of such food through the inspection process.CommentsClose CommentsPermalink





`(b) Guidelines-CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(2) FACTORS- The guidelines developed under paragraph (1) shall take into account the following factors:CommentsClose CommentsPermalink





`(A) The personnel of the person importing the food.CommentsClose CommentsPermalink





`(B) The physical and procedural safety and security of such person's food supply chain.CommentsClose CommentsPermalink





`(C) The sufficiency of access controls for food and ingredients purchased by such person.CommentsClose CommentsPermalink





`(D) The need for tracking and maintaining records on food and ingredients purchased by such person or moved through the supply chain.CommentsClose CommentsPermalink





`(E) Documentation processing through such person's supply chain.CommentsClose CommentsPermalink





`(F) Access by the Secretary to such person's business records for review.CommentsClose CommentsPermalink





`(G) Vendor and supplier information.CommentsClose CommentsPermalink





`(H) Such other factors as the Secretary determines necessary.'.CommentsClose CommentsPermalink

SEC. 8. CIVIL PENALTIES.

Section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amended--CommentsClose CommentsPermalink





(1) by redesignating subsection (g) (relating to civil penalties) as subsection (f): andCommentsClose CommentsPermalink





(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--CommentsClose CommentsPermalink





`(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; orCommentsClose CommentsPermalink





`(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.'.CommentsClose CommentsPermalink

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--CommentsClose CommentsPermalink





(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;CommentsClose CommentsPermalink





(2) consolidate any such laboratory with any other laboratory;CommentsClose CommentsPermalink





(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; orCommentsClose CommentsPermalink





(4) consolidate--CommentsClose CommentsPermalink





(A) any such district office with an office in any other district; orCommentsClose CommentsPermalink





(B) transfer any of the compliance or inspection functions of any such district office to any other district.CommentsClose CommentsPermalink





(b) Report by Secretary-CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(d) Reorganization-CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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).CommentsClose CommentsPermalink

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:CommentsClose CommentsPermalink

`SEC. 418. RECALL AUTHORITY.

`(a) Order To Cease Distribution-CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(b) Order To Recall-CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(2) CERTAIN ACTIONS- An amended order under paragraph (1) shall not include recall of a food from individuals.'.CommentsClose CommentsPermalink

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:CommentsClose CommentsPermalink

`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.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(c) Random Inspections- The Secretary shall enforce this section through appropriate random inspections, sampling, and testing.CommentsClose CommentsPermalink





`(d) Certifications Regarding Foreign Facilities-CommentsClose CommentsPermalink





`(1) REQUIREMENT- No food shall be permitted entry into the United States from a foreign facility in a foreign country unless there is--CommentsClose CommentsPermalink





`(A) a certification for such facility in effect under paragraph (2)(A); orCommentsClose CommentsPermalink





`(B) a certification for such country under paragraph (2)(B).CommentsClose CommentsPermalink





`(2) CERTIFICATION-CommentsClose CommentsPermalink





`(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).CommentsClose CommentsPermalink





`(B) FOREIGN COUNTRY- A foreign country may obtain a certification by the Secretary stating that--CommentsClose CommentsPermalink





`(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; andCommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.'.CommentsClose CommentsPermalink

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:CommentsClose CommentsPermalink

`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.CommentsClose CommentsPermalink





`(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.'.CommentsClose CommentsPermalink

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--CommentsClose CommentsPermalink





(1) by striking `upon the request' and inserting `upon the written or oral request'; andCommentsClose CommentsPermalink





(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)'.CommentsClose CommentsPermalink

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

(a) Labeling Requirement-CommentsClose CommentsPermalink





(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:CommentsClose CommentsPermalink





`(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.'.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink