[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4080 Introduced in House (IH)]







105th CONGRESS
  2d Session
                                H. R. 4080

 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
                 safety of food from foreign countries.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             June 18, 1998

 Mr. Dingell (for himself, Mr. Brown of Ohio, Mr. Stupak, Mr. Pallone, 
Mr. Waxman, Mr. Markey, Mr. Boucher, Mr. Manton, Mr. Gordon, Ms. Furse, 
Mr. Rush, Mr. Klink, Mr. Wynn, Mr. Green, Ms. McCarthy of Missouri, and 
 Ms. DeGette) introduced the following bill; which was referred to the 
                         Committee on Commerce

_______________________________________________________________________

                                 A BILL


 
 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
                 safety of food from foreign countries.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Imported Food Safety Act of 1998''.

SEC. 2. ADDITIONAL AUTHORITIES OF FOOD AND DRUG ADMINISTRATION 
              REGARDING FOOD SAFETY.

    (a) Requirement for Prior Approval of Secretary for Commercial 
Distribution and Related Activities.--Section 801 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 381) is amended--
            (1) by striking ``(b) Pending decision'' and inserting 
        ``(b)(1) Pending decision'', and by redesignating subsection 
        (c) as paragraph (2) of subsection (b); and
            (2) by inserting after subsection (b) the following 
        subsection:
    ``(c)(1) Food entering the United States shall not, without the 
prior approval of the Secretary, be--
            ``(A) transferred from the control of the person who held 
        control when the food entered the United States;
            ``(B) commercially distributed within the United States; or
            ``(C) removed from its intact state, with respect to the 
        manner in which the food was packed for transport.
    ``(2) In determining whether to grant approval under paragraph (1), 
the Secretary shall consider the following:
            ``(A) Whether the person or persons preparing, packing, 
        holding, manufacturing, or processing the food involved 
        cooperate with the Secretary in inspections regarding the food 
        that are conducted by the Secretary (including inspections 
        conducted in foreign countries).
            ``(B) Whether the person or persons have a history of 
        failing to comply with applicable provisions of this Act 
        regarding food.
            ``(C) Whether the food (as a particular type of product) 
        has such a history.
            ``(D) Whether there is such a history with respect to a 
        particular foreign country.
            ``(E) Whether the system of regulating food maintained in 
        the foreign country provides at least the same level of 
        protection as domestic laws that affect the safety of the food 
        supply.
            ``(F) Whether the foreign country permits the Secretary to 
        conduct within the country inspections regarding food.
            ``(G) Such other factors as the Secretary determines to be 
        appropriate.
    ``(3)(A) If the system of regulating food maintained in a foreign 
country does not provide at least the same level of protection as 
domestic laws that affect the safety of the food supply, or if the 
foreign country does not permit the Secretary to conduct within the 
country inspections regarding food, the Secretary shall deny approval 
under paragraph (1) for all food prepared, packed, held, manufactured, 
or processed in the foreign country, except as provided in subparagraph 
(B).
    ``(B) In the case of a foreign country with respect to which 
approval under paragraph (1) has been denied under subparagraph (A), a 
shipment of food prepared, packed, held, manufactured, or processed in 
the foreign country may be granted approval under such paragraph if the 
Secretary receives proof satisfactory to the Secretary that food in the 
shipment is not adulterated. The Secretary shall require for purposes 
of the preceding sentence that proof be presented that the shipment has 
been tested for the presence of microbial pathogens and pesticide 
chemicals or related residues, and for such other substances as the 
Secretary determines to be appropriate.
    ``(4) The Secretary shall by regulation provide for the marking of 
any shipment of food that has been denied approval under paragraph (1) 
in a manner making it readily apparent that the food has been refused 
admission into the United States.
    ``(5) The Secretary shall give high priority to increasing 
significantly, relative to fiscal year 1998, the number of inspections 
under this section, including the testing of imported food for 
pesticide and microbial contamination, that are conducted with respect 
to food at ports of entry into the United States.
    ``(6)(A) The Secretary shall submit to the Congress periodic 
reports describing the activities of the Secretary under this section 
with respect to the safety of food.
    ``(B) Each report under subparagraph (A) shall, for each port of 
entry into the United States, specify the number of inspections and 
tests that were conducted under this section with respect to food 
during the preceding fiscal year, and the extent to which such number 
is an increase over the number of such inspections specified for such 
port in the preceding report under subparagraph (A).
    ``(C) Each report under subparagraph (A) shall state the 
statistical methodologies used by the Secretary in sampling food for 
purposes of inspections under this section, including the testing of 
imported food for pesticide and microbial contamination, and the levels 
of confidence associated with the methodologies.
    ``(D) The first report under subparagraph (A) shall be submitted 
not later than December 1, 1999, and subsequent reports shall be 
submitted annually thereafter.''.
    (b) Criminal Penalties.--
            (1) Acting without approval of secretary.--Section 301 of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is 
        amended by adding at the end the following:
    ``(aa)(1) In the case of food, the carrying out of any act in 
violation of section 801(c)(1).''.
            (2) Failure to dispose of foods denied entry.--Section 
        301(aa) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        331(aa)), as added by paragraph (1), is amended by adding at 
        the end the following:
    ``(2) The failure to comply with an order under section 801 
regarding the disposition of food that for purposes of such section has 
been refused admission or denied the approval of the Secretary.''.
            (3) Failure to provide country-of-origin labeling for 
        certain foods.--Section 403 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 343) is amended by adding at the end 
        the following:
    ``(t) If it is a food intended for human consumption, it is grown, 
prepared, packed, manufactured, or processed in a foreign country, and 
it fails, at the time the food is offered for retail sale, to bear or 
be accompanied by labeling that identifies the country or countries in 
which the food was grown, prepared, packed, manufactured, or processed, 
except that this paragraph does not apply to food offered for retail 
sale by restaurants or other eating establishments.''.
    (c) Conforming Amendment.--Section 801 of the Federal Food, Drug, 
and Cosmetic Act, as amended by subsection (a), is amended in 
subsection (b)(2) by striking ``subsection (b)'' and inserting 
``paragraph (1)''.

SEC. 3. RESEARCH ON TESTING TECHNIQUES FOR USE IN INSPECTIONS OF FOOD 
              SAFETY.

    Section 801 of the Federal Food, Drug, and Cosmetic Act, as amended 
by section 2(a), is amended in subsection (c) by adding at the end the 
following paragraph:
    ``(7)(A) 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--
            ``(i) whose purpose is to determine whether food is 
        adulterated by reason of being contaminated with microorganisms 
        or pesticide chemicals or related residues; and
            ``(ii) whose results are available not later than 
        approximately 60 minutes after the administration of the tests.
    ``(B) In providing for research under subparagraph (A), 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.
    ``(C)(i) In providing for research under subparagraph (A), the 
Secretary shall under subparagraph (B) 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 three-year period beginning on the date of the 
enactment of the Imported Food Safety Act of 1998, tests under 
subparagraph (A) for each of the pathogens and substances receiving 
priority under the preceding sentence.
    ``(ii) The Secretary shall submit to the Congress periodic reports 
describing the progress that has been made toward the goal referred to 
in clause (i) 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 paragraph. The first such report shall be submitted 
not later than March 1, 1999, and subsequent reports shall be submitted 
semiannually after the submission of the first report until the goal is 
met.
    ``(D) The Secretary shall carry out the program of research under 
subparagraph (A) 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 Inspection Service of the Department of 
Agriculture) in carrying out the program.
    ``(E) Of the amounts reserved under section 801A(a)(2)(B)(ii) for a 
fiscal year for carrying out the program of research under subparagraph 
(A), 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. USER FEES REGARDING INSPECTIONS OF 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 
section:

                   ``user fees regarding food safety

    ``Sec. 801A. (a) In General.--
            ``(1) Assessment.--Beginning in fiscal year 1999, 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 increases in the costs of 
                the resources allocated for carrying out section 801 
                with respect to food over the costs of carrying out 
                such section with respect to food in fiscal year 1998 
                multiplied by the adjustment factor. Increases 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 
                        subsection (c)(7) of such section. In expending 
                        the amount so reserved, the Secretary shall 
                        give priority to inspections conducted at ports 
                        of entry into the United States.
                            ``(ii) The Secretary shall reserve not more 
                        than 50 percent for carrying out research under 
                        section 801(c)(7).
            ``(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) 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 1999, 
        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 
        1999 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 1999 multiplied by the adjustment factor applicable to the 
        fiscal year involved, except that in making determinations 
        under this subparagraph 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) and subsection (c)(1), 
        there is authorized to be appropriated for fees under this 
        section $56,000,000 for each of the fiscal years 1999 through 
        2003.
            ``(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, employers, 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 lower of--
            ``(1) 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 1998; or
            ``(2) the total of discretionary budget authority provided 
        for programs in categories other than the defense category for 
        the immediately preceding fiscal year (as reported in the 
        Office of Management and Budget sequestration preview report, 
        if available, required under section 254(c) of the Balanced 
        Budget and Emergency Deficit Control Act of 1985) divided by 
        such budget authority for fiscal year 1998 (as reported in the 
        Office of Management and Budget final sequestration report 
        submitted after the end of the 105th Congress, 2d Session).
The terms `budget authority' and `category' in subparagraph (B) are as 
defined in the Balanced Budget and Emergency Deficit Control Act of 
1985.''.
                                 <all>