[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1334 Introduced in House (IH)]







106th CONGRESS
  1st Session
                                H. R. 1334

 To provide for the enhanced implementation of the amendments made to 
the Federal Food, Drug, and Cosmetic Act by the Food Quality Protection 
                  Act of 1996, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 25, 1999

  Mr. LaHood (for himself, Mr. Blunt, and Mr. Hastings of Washington) 
 introduced the following bill; which was referred to the Committee on 
Commerce, and in addition to the Committee on Agriculture, for a period 
    to be subsequently determined by the Speaker, in each case for 
consideration of such provisions as fall within the jurisdiction of the 
                          committee concerned

_______________________________________________________________________

                                 A BILL


 
 To provide for the enhanced implementation of the amendments made to 
the Federal Food, Drug, and Cosmetic Act by the Food Quality Protection 
                  Act of 1996, 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.

    This Act may be cited as the ``FQPA Implementation Act of 1999''.

SEC. 2. FINDINGS.

    The Congress finds as follows:
            (1) The Food Quality Protection Act of 1996, enacted on 
        August 3, 1996, made a number of significant modifications to 
        section 408 of the Federal Food, Drug, and Cosmetic Act (``the 
        Act''). Section 408 as amended sets forth new criteria and 
        procedures for use by the Administrator of the Environmental 
        Protection Agency in assessing and reassessing the 
        acceptability of tolerances that govern the level of pesticide 
        chemical residues that may be present in or on any food that 
        enters or is present in interstate commerce or is imported into 
        the United States.
            (2) Under section 408 of the Act as amended, the 
        Administrator must use these new criteria and procedures in 
        deciding whether new tolerances may be issued, and thus whether 
        new pesticides or new pesticide uses may be approved for use 
        under the Federal Insecticide, Fungicide, and Rodenticide Act. 
        Such section also requires that all tolerances in effect on the 
        date of the enactment of the 1996 amendment be reassessed under 
        the new criteria and procedures.
            (3) The Food Quality Protection Act of 1996 requires the 
        use of a number of important new risk assessment criteria and 
        concepts that had never previously been used by the 
        Administrator and that require the development of major 
        modifications to existing Agency practices. New regulatory 
        concepts introduced by such Act include, but are not limited 
        to, those associated with new statutory terms such as 
        ``exposures for which there is reliable information'', 
        ``aggregate exposure'', ``reasonable certainty that no harm 
        will result'', ``common mechanism of toxicity'', ``cumulative 
        effects'', ``potential pre- and post-natal toxicity'', 
        ``completeness of the data with respect to exposure and 
        toxicity'', ``significant subpopulation group'', ``additional 
        data or information [that] are reasonably required to support 
        the continuation of a tolerance'', and ``pose the greatest risk 
        to human health''. How these terms are defined and used by the 
        Administrator, singly and in combination, will greatly affect 
        the outcome of the assessments and reassessments required to be 
        conducted under the Act as amended.
            (4) The Act as amended requires the Environmental 
        Protection Agency to revoke tolerances now in effect if the 
        Administrator finds that the sum of the exposure from all the 
        tolerances exceeds safe levels. However, the Act as amended 
        does not provide any criteria for determining which of the 
        tolerances should be revoked in such situations in order to 
        reduce the exposure sufficiently. Nor does the Act as amended 
        establish procedures for providing pesticide producers, 
        agricultural producers, food processors and distributors, and 
        non-food pesticide users the opportunity to participate in such 
        decision making before proposed rules are issued by the 
        Administrator.
            (5) Under the revised criteria of the Act as amended, 
        entirely new categories of data regarding toxicity, metabolism, 
        cumulative effects, and dietary, drinking water, and other 
        nonoccupational exposure levels are required to allow the 
        Administrator to reach sound, accurate, valid, and 
        understandable decisions on tolerance assessments and 
        reassessments. In some areas, massive data collection efforts 
        are underway but will not yield results for another year or 
        more. In other areas, the need for new data depends on 
        decisions not yet made by the Administrator about what kinds of 
        tests should be conducted and which compounds should be the 
        subjects of these new test requirements.
            (6) The Administrator has instituted public proceedings to 
        discuss how the new criteria of the Act as amended should be 
        interpreted and amended, what new kinds of data are needed and 
        how the new data would be used once available, how criteria can 
        be made more transparent, equitable, and understandable, how 
        the Administrator should use available authority to be 
        flexible, how to decide which tolerances should be revoked when 
        some action is decided to be necessary, and how to provide 
        needed transition periods in case some existing products or 
        product uses should be removed from the market. These 
        proceedings are not yet finished and in some cases planned 
        public proceedings have been scheduled but have not yet begun.
            (7) Unless the Administrator implements section 408 of the 
        Act as amended carefully and wisely, decisions made under it 
        could cause great harm to American agriculture, to food 
        production, food storage and transportation, and related 
        industries, and to other business. Such decisions could reduce 
        availability of fruits and vegetables, and other foods known to 
aid human health, and could also have highly disruptive and problematic 
effects on a variety of other important public and private areas such 
as public health protection against insects and other disease vectors 
and residential and business pest control. A major concern is that some 
products will be removed from the market that are essential in 
integrated pest management programs or pesticide resistance management 
programs, and that pest species will more easily develop resistance to 
the fewer remaining products that remain available.
            (8) The regulatory requirements under the Food Quality 
        Protection Act of 1996 could have both short and long term 
        deleterious effects on U.S. agricultural products as these 
        producers move to a free market system as envisioned by the 
        Freedom to Farm Act.
            (9) These disruptive and harmful effects could occur 
        without necessarily bringing about any significant health 
        benefits or risk reductions. The Administrator is now engaged 
        in making decisions on tolerance assessments and reassessments 
        at the same time that the Administrator is conducting a massive 
        program of policy development and reevaluation, and while the 
        Administrator is determining what data would be needed under 
        the new criteria and policies to answer some of the new 
        questions. If these decisions on individual pesticides are 
        issued and put into effect before the new policies are in place 
        or before the needed data are available, they may be based on 
        outdated and overly stringent policies, worst-case assumptions, 
        or both. These actions may be accompanied by adverse publicity 
        that could lead to unwarranted concern and could effectively 
        destroy the marketability of products that in fact are safe.
            (10) The Act as amended has caused a major slowing of the 
        process for approval of new pesticide chemicals, new uses of 
        pesticides already registered for other uses, and applications 
        for emergency exemptions from the need for registration. This 
        is traceable to--
                    (A) the Agency's need to develop new criteria and 
                procedures;
                    (B) the diversion of resources to developing such 
                criteria and procedures and to the reassessment of 
                existing tolerances and registrations;
                    (C) the requirement that no new tolerance can be 
                issued until the Administrator determines that all 
                existing tolerances for the pesticide have been 
                reassessed and found safe; and
                    (D) the priority choices and resource allocation 
                decisions that are either dictated by the Act as 
                amended or chosen by the Administrator as a matter of 
                discretion.
            (11) Congressional guidance for the Administrator is needed 
        to ensure that decisions are reasonable, well supported, and 
        balanced; to avoid disruptions in agriculture, other sectors of 
        the economy, and international trade caused by prematurely 
        implemented decisions or by public misunderstanding or 
        unwarranted speculation about tentative decisions. Much of the 
        potential problem can be avoided if the Administrator uses 
        available authority to resolve policy issues, announce data 
        needs, avoid unneeded use of assumptions in lieu of data, make 
        clear the tentative and preliminary nature of findings made in 
        the short term, and provide extended implementation periods for 
        adverse decisions when appropriate.

SEC. 3. SPECIAL DATA REQUIREMENTS; REQUIREMENT FOR CALLING IN 
              ADDITIONAL DATA.

    (a) In General.--Section 408(f) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 346a(f)) is amended--
            (1) by redesignating paragraph (2) as paragraph (3); and
            (2) by striking ``(1) Requiring submission'' and all that 
        follows through ``(A) issue a notice requiring the person'' and 
        inserting the following:
            ``(1) Requiring submission of additional data.--
                    ``(A) Continuation of tolerance or exemption.--If 
                the Administrator determines that additional data or 
                information are reasonably required to support the 
                continuation of a tolerance or exemption that is in 
                effect under this section for a pesticide chemical 
                residue on a food, the Administrator shall obtain 
                additional data or information through any of the 
                methods described in paragraph (2).
                    ``(B) Modifying, suspending, or revoking tolerance 
                or exemption.--If the Administrator makes a 
                determination that there may be grounds for modifying, 
                suspending, or revoking a tolerance or exemption in 
                effect under this section for a pesticide chemical 
                residue in or on food, the Administrator may not 
                modify, suspend, or revoke the tolerance or exemption 
                until the Administrator has considered additional data 
                or information obtained by the Administrator (after 
                making such determination). The Administrator shall 
                obtain the required additional data or information 
                through any of the methods described in paragraph (2).
            ``(2) Methods of obtaining additional data.--For purposes 
        of obtaining additional data or information under subparagraph 
        (A) or (B) of paragraph (1), the Administrator shall--
                    ``(A) issue a notice requiring the person''.
    (b) Conforming Amendments.--Section 408 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 346a) is amended--
            (1) in subsection (b)(2)(E)(ii), by striking ``(f)(2)'' and 
        inserting ``(f)(3)''; and
            (2) in subsection (g), in each of paragraphs (1) and 
        (2)(A), by striking ``(f)(2)'' and inserting ``(f)(3)''.

SEC. 4. REVIEW.

    (a) Agency Authority for Certain Public-Interest Determinations.--
Section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
346a) is amended in subparagraph (C) of subsection (q)(1) by striking 
the period at the end and inserting a comma, and in the matter 
immediately after and below such subparagraph by inserting before the 
sentence the following: ``except that such requirements relating to 
periods of time apply only to the extent determined by the 
Administrator to be in the public interest. Any such determination 
shall be published in the Federal Register, together with a statement 
of the reasons underlying the determination.''.
    (b) Public Input.--Section 408(q)(1) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 346a(q)(1)) is amended in the matter after and 
below subparagraph (C) by inserting before the period at the end the 
following: ``, except that before issuing a final rule under subsection 
(d)(4) the Administrator shall issue a proposed rule with a period of 
60 days for public comment, and before issuing a proposed rule under 
subsection (e) the Administrator shall issue an advance notice of 
proposed rulemaking in order to provide for a preliminary exchange of 
information and comments between the Administrator and the public''.

SEC. 5. TOLERANCES FOR EMERGENCY USES.

    Section 408(l)(6) of the Federal Food, Drug, and Cosmetic Act is 
amended in the last sentence by inserting before the period the 
following: ``, except that the Administrator may issue such a tolerance 
or exemption associated with an emergency exemption without regard to 
other tolerances or exemptions for the pesticide chemical residue and 
before reassessing such tolerances or exemptions, if the Administrator 
determines that any incremental exposure that may result from the 
tolerance or exemption associated with the emergency exemption alone 
will not pose any significant dietary risk''.

SEC. 6. REPORTS ON RESOURCES AND PRIORITIES.

    (a) Environmental Protection Agency.--
            (1) In general.--Not later than January 15, 2000, the 
        Administrator of the Environmental Protection Agency (in this 
        subsection referred to as the ``Administrator'') shall submit 
        to the Congress a report specifying the financial resources 
        needed by the Administrator for the fiscal years 2001 through 
        2005 in order to carry out the amendments made by the Food 
        Quality Protection Act of 1996 to the Federal Food, Drug, and 
        Cosmetic Act and the Federal Insecticide, Fungicide, and 
        Rodenticide Act, including providing for the prompt processing 
        of all registration applications and petitions for tolerances, 
        requests for experimental use permits, and requests for 
        emergency exemptions and for decisions on the merits of such 
        applications, petitions, and requests, in addition to 
        performing tolerance reassessments and other duties required by 
        such amendments.
            (2) Determination of effects of not receiving increased 
        amount of appropriations; reallocation of resources.--The 
        report under paragraph (1) shall, in addition to provisions 
        required in such paragraph, contain a determination of the 
        effects with respect to carrying out the amendments referred to 
        in such paragraph that would occur if relative to fiscal year 
        2000 an increased amount of appropriations is not made 
        available to the Administrator for carrying out the amendments, 
        including a description of the reallocations of existing 
        resources of the Environmental Protection Agency that would be 
        required in order to carry out the amendments.
    (b) Department of Agriculture.--
            (1) In general.--Not later than January 15, 2000, the 
        Secretary of Agriculture (in this section referred to as the 
        ``Secretary'') shall submit to the Congress a report specifying 
        the financial resources needed by the Secretary for the fiscal 
        years 2001 through 2005 in order to carry out the 
        responsibilities of the Secretary under the Food Quality 
        Protection Act of 1996.
            (2) Determination of effects of not receiving increased 
        amount of appropriations; reallocation of resources.--The 
        report under paragraph (1) shall, in addition to provisions 
        required in such paragraph, contain a determination of the 
        effects with respect to carrying out the responsibilities 
        referred to in such paragraph that would occur if relative to 
        fiscal year 2000 an increased amount of appropriations is not 
        made available to the Secretary for carrying out the 
        responsibilities, including a description of the reallocations 
        of existing resources of the Department of Agriculture that 
        would be required in order to carry out the responsibilities.

SEC. 7. INTERNATIONAL TRADE EFFECTS.

    (a) Study.--
            (1) In general.--The Secretary of Agriculture (in this 
        section referred to as the ``Secretary''), after consultation 
        with the Administrator of the Environmental Protection Agency 
        and the United States Trade Representative, shall establish and 
        administer a program to continuously monitor the competitive 
        strength of major United States agricultural commodity sectors 
        in the international marketplace. Such commodity sectors 
        include but are not limited to fruits and vegetables, corn, 
        wheat, cotton, rice, soybeans, and nursery crops.
            (2) Certain factors.--In carrying out the requirements of 
        paragraph (1), the Secretary shall examine factors pertinent to 
        assessing, by sector, the sustainability and competitive 
        strength in the international marketplace and the relationship 
        of such factors to regulatory decisions issued under the 
        amendments made by the Food Quality Protection Act of 1996. 
        Such factors include but are not limited to sector changes, 
        regional changes, price, quality, and ratio of imports to 
        exports.
    (b) Reports.--The Secretary shall prepare periodic reports 
addressing the requirements and factors of paragraphs (1) and (2) of 
subsection (a). Each such report shall be submitted to the Congress, 
with referrals to the committees of jurisdiction in the House of 
Representatives and the Senate. The first report shall be submitted not 
later than October 1, 2000, and subsequent reports shall be submitted 
biennially thereafter.
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