[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 1776 Introduced in Senate (IS)]







110th CONGRESS
  1st Session
                                S. 1776

 To amend the Federal Food, Drug, and Cosmetic Act to establish a user 
       fee program to ensure food safety, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             July 12, 2007

 Mr. Durbin (for himself and Mr. Brown) introduced the following bill; 
  which was read twice and referred to the Committee on Agriculture, 
                        Nutrition, and Forestry

_______________________________________________________________________

                                 A BILL


 
 To amend the Federal Food, Drug, and Cosmetic Act to establish a user 
       fee program to ensure food safety, 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; FINDINGS.

    (a) Short Title.--This Act may be cited as the ``Imported Food 
Security Act of 2007''.
    (b) Findings.--Congress finds that--
            (1) the safety and integrity of the United States food 
        supply is vital to the public health, to public confidence in 
        the food supply, and to the success of the food sector of the 
        Nation's economy;
            (2) illnesses and deaths of individuals and companion pets 
        caused by contaminated food--
                    (A) have contributed to a loss of public confidence 
                in food safety; and
                    (B) have caused significant economic losses to 
                manufacturers and producers not responsible for 
                contaminated food items;
            (3) the task of preserving the safety of the food supply of 
        the United States faces tremendous pressures with regard to--
                    (A) emerging pathogens and other contaminants and 
                the ability to detect all forms of contamination; and
                    (B) an increasing volume of imported food, without 
                adequate monitoring and inspection;
            (4) the United States is increasing the amount of food that 
        it imports such that--
                    (A) from 2003 to the present, the value of food 
                imports has increased from $45,600,000,000 to 
                $64,000,000,000; and
                    (B) imported food accounts for 13 percent of the 
                average Americans diet including 31 percent of fruits, 
                juices, and nuts, 9.5 percent of red meat and 78.6 
                percent of fish and shellfish; and
            (5) the number of full time equivalent Food and Drug 
        Administration employees conducting inspections has decreased 
        from 2003 to 2007.

SEC. 2. 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. Costs referred to in 
                the preceding sentence include 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 carrying out such section.
                    ``(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 50 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 first 
                        priority to inspections conducted at ports of 
                        entry into the United States and second 
                        priority to the implementation of the import 
                        certification program under section 805.
                            ``(ii) The Secretary shall reserve not more 
                        than 50 percent for carrying out research under 
                        section 801(p).
            ``(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 $20 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) 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; and
                    ``(B) 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), there is authorized to be 
        appropriated for fees under this section such sums as may be 
        necessary to carry out the purposes of this section for each of 
        the fiscal years 2008 through 2012. Such appropriated funds may 
        be in addition to any other funds appropriated for such 
        purposes.
            ``(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. 3. RESEARCH ON TESTING TECHNIQUES FOR FOOD SAFETY INSPECTIONS OF 
              IMPORTED FOOD; 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 Food Safety Inspections of 
Imported Food.--
            ``(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 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. 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, and the presence in 
        or on food of such other pathogens or substances as the 
        Secretary determines to be appropriate. 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 
        Imported Food Security Act of 2007, 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 
        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.
            ``(5) Awards to private entities.--Of the amounts reserved 
        under section 801A(a)(2)(B)(ii) for a fiscal year for carrying 
        out the program of research under paragraph (1), the Secretary 
        shall make available not less than 50 percent for making awards 
        of grants or contracts to private entities to conduct such 
        research.''.

SEC. 4. CERTIFICATION OF FOOD IMPORTS.

    (a) In General.--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. CERTIFICATION OF FOOD IMPORTS.

    ``(a) In General.--Not later than 2 years after the date of 
enactment of this section, the Secretary shall establish a system under 
which a foreign government or foreign food establishment seeking to 
import food to the United States shall submit a request for 
certification to the Secretary.
    ``(b) Certification Standard.--A foreign government or foreign food 
establishment requesting a certification to import food to the United 
States shall demonstrate, in a manner determined appropriate by the 
Secretary, that food produced under the supervision of a foreign 
government or by the foreign food establishment has met standards for 
food safety, inspection, labeling, and consumer protection that are at 
least equivalent to standards applicable to food produced in the United 
States.
    ``(c) Certification Approval.--
            ``(1) Request by foreign government.--Prior to granting the 
        certification request of a foreign government, the Secretary 
        shall review, audit, and certify the food safety program of a 
        requesting foreign government (including all statutes, 
        regulations, and inspection authority) as at least equivalent 
        to the food safety program in the United States, as 
        demonstrated by the foreign government.
            ``(2) Request by foreign food establishment.--Prior to 
        granting the certification request of a foreign food 
        establishment, the Secretary shall certify, based on an onsite 
        inspection, the food safety programs and procedures of a 
        requesting foreign firm as at least equivalent to the food 
        safety programs and procedures of the United States.
    ``(d) Limitation.--A foreign government or foreign firm approved by 
the Secretary to import food to the United States under this section 
shall be certified to export only the approved food products to the 
United States for a period not to exceed 5 years.
    ``(e) Withdrawal of Certification.--The Secretary may withdraw 
certification of any food from a foreign government or foreign firm--
            ``(1) if such food is linked to an outbreak of human 
        illness;
            ``(2) following an investigation by the Secretary that 
        finds that the foreign government programs and procedures or 
        foreign food establishment is no longer equivalent to the food 
        safety programs and procedures in the United States; or
            ``(3) following a refusal to allow United States officials 
        to conduct such audits and investigations as may be necessary 
        to fulfill the requirements under this section.
    ``(f) Renewal of Certification.--The Secretary shall audit foreign 
governments and foreign food establishments at least every 5 years to 
ensure the continued compliance with the standards set forth in this 
section.
    ``(g) Required Routine Inspection.--The Secretary shall routinely 
inspect food and food animals (via a physical examination) before it 
enters the United States to ensure that it is--
            ``(1) safe;
            ``(2) labeled as required for food produced in the United 
        States; and
            ``(3) otherwise meets requirements under this Act.
    ``(h) Enforcement.--The Secretary is authorized to--
            ``(1) deny importation of food from any foreign government 
        that does not permit United States officials to enter the 
        foreign country to conduct such audits and inspections as may 
        be necessary to fulfill the requirements under this section;
            ``(2) deny importation of food from any foreign government 
        or foreign firm that does not consent to an investigation by 
        the Secretary when food from that foreign country or foreign 
        firm is linked to a food-borne illness outbreak or is otherwise 
        found to be adulterated or mislabeled; and
            ``(3) promulgate rules and regulations to carry out the 
        purposes of this section, including setting terms and 
        conditions for the destruction of products that fail to meet 
        the standards of this Act.
    ``(i) Detention and Seizure.--Any food imported for consumption in 
the United States may be detained, seized, or condemned pursuant to 
section 304.
    ``(j) Definition.--For purposes of this section, the term `food 
establishment'--
            ``(1) means a slaughterhouse, factory, warehouse, or 
        facility owned or operated by a person located in any State 
        that processes food or a facility that holds, stores, or 
        transports food or food ingredients; and
            ``(2) does not include a farm, restaurant, other retail 
        food establishment, nonprofit food establishment in which food 
        is prepared for or served directly to the consumer, or fishing 
        vessel (other than a fishing vessel engaged in processing, as 
        that term is defined in section 123.3 of title 21, Code of 
        Federal Regulations).''.
    (b) Transitional Program.--Not later than 180 days after the date 
of enactment of this Act, the Secretary of Health and Human Services 
shall promulgate regulations to establish a transitional food safety 
import review program, with minimal disruption to commerce, that shall 
be in effect until the date of implementation of the food import 
certification program under section 805 of the Federal Food, Drug, and 
Cosmetic Act (as added by subsection (a)).
                                 <all>