[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1592 Introduced in House (IH)]







106th CONGRESS
  1st Session
                                H. R. 1592

To establish certain requirements regarding the Food Quality Protection 
                  Act of 1996, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             April 28, 1999

Mr. Pombo (for himself, Mr. Towns, Mr. Condit, Mr. Boyd, Mr. Kolbe, Mr. 
 John, Mr. Istook, Mr. Strickland, Mr. Shows, Mrs. Bono, Mr. Boucher, 
 Mr. Etheridge, Mr. Doolittle, Mr. Sandlin, Mr. Goode, Mr. Hunter, Mr. 
Salmon, Mr. Hill of Montana, Mr. Radanovich, Mr. Canady of Florida, Mr. 
 Nethercutt, and Mr. Bishop) 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 establish certain requirements regarding 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 ``Regulatory Fairness and Openness Act 
of 1999''.

SEC. 2. DEFINITIONS.

    As used in this Act:
            (1) Administrator.--The term ``Administrator'' means the 
        Administrator of the Environmental Protection Agency.
            (2) Agency.--The term ``Agency'' means the Environmental 
        Protection Agency.
            (3) Secretary.--The term ``Secretary'' means the Secretary 
        of Agriculture.
            (4) Tolerance.--The term ``tolerance'' means a regulation 
        establishing a tolerance, including an exemption from the 
        requirement for a tolerance, under section 408 of the Federal 
        Food, Drug, and Cosmetic Act.

SEC. 3. FINDINGS.

    The Congress finds as follows:
            (1) The Food Quality Protection Act of 1996 (Public Law 
        104-170), enacted on August 3, 1996, made many major 
        modifications to section 408 of the Federal Food, Drug, and 
        Cosmetic Act (``FFDCA''), requiring the Administrator to 
        consider new kinds of information and use additional criteria 
        in regulating pesticide residues and in reviewing existing 
        tolerances that had previously been found to be adequate to 
        protect the public health.
            (2) The Food Quality Protection Act of 1996 (``FQPA'') 
        prescribes the use of a number of new risk assessment criteria 
        that require the development of major modifications to existing 
        regulatory policies and procedures used by the Administrator to 
        regulate pesticide tolerances. Since the enactment of the FQPA 
        it has become clear that several of the new concepts embodied 
        in it involve a high degree of complexity. Practical 
        implementation of them demands new scientific tools in addition 
        to those that were available when the FQPA was enacted.
            (3) To reach sound, suitably protective decisions on 
        tolerance reviews under the new criteria, the Administrator 
        also will need a great deal of new data, not only on the newly 
        considered non-food routes of exposure, but also, in some 
        cases, on dietary exposure and toxicity, so that it can be 
        determined whether pesticides that were found safe under the 
        former criteria satisfy the new criteria as well. Some data 
        collection efforts are underway, but will not yield results for 
        one or more years. In some 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 
        tested.
            (4) The Administrator has instituted public proceedings on 
        such topics as what new interpretations and policies are 
        needed, what new kinds of data are needed, how the new data 
        would be used, and how the needed regulatory transition can be 
        achieved. These proceedings are not yet finished, and on some 
        issues public notice-and-comment proceedings have been 
        scheduled but have not yet begun.
            (5) The FQPA added to the FFDCA several provisions that 
        provide flexibility to the Administrator in making the 
        transition to the new approach. The FFDCA anticipates a 
        continuing process of refinement and improvement in tolerance 
        decisionmaking, as additional information is collected and as 
        new policies and methods are developed and adopted for the 
        practical implementation of the new requirements. The FFDCA 
        provides that the data requirements for tolerances must be set 
        out clearly in regulations and guidelines, so that the 
        regulated community will know what types of information the 
        Agency requires and what testing procedures should be used to 
        develop the information. The FQPA only allows the use of 
        ``reliable'' information on the non-dietary exposure routes 
        that were not previously considered in risk assessments 
affecting tolerances. The Congress did not anticipate that a tolerance 
would be revoked because of Agency reliance on estimates or assumptions 
stemming from absence of such data, without first providing notice of 
what data are needed and a reasonable opportunity to collect the data. 
Thus, when an existing tolerance is under review and the Administrator 
determines that additional information is needed to support the 
continuation of the tolerance, the FFDCA now authorizes the 
Administrator to postpone the effective date of any tolerance rule 
resulting from a review, and this authority can be utilized as 
appropriate where additional information is pertinent to a tolerance 
review. Finally, the current FFDCA permits the Agency to conduct a 
review in stages, as allowed by the available, reliable information.
            (6) Although these authorities already are provided by law, 
        it appears that further congressional guidance is needed to 
        ensure that Agency decisions are reasonable, well supported, 
        and balanced, and to avoid disruptions in agriculture, other 
        sectors of the economy, and international trade. During the 
        transition to revised standards, procedures, and requirements, 
        the Administrator must ensure that decisions are balanced, 
        reasonable, understandable, and based on and supported by sound 
        information, in order to avoid unnecessary disruptions in 
        agriculture, the economy, and world trade, and to maintain the 
        public trust in the food supply.
            (7) Unless the Administrator implements section 408 of the 
        FFDCA carefully and wisely, decisions made under it could cause 
        great harm to the presently safe and affordable food supply, to 
        American agriculture (including food, fiber, nursery, and 
        forestry production, and food storage and transportation), to 
        related industries, and to other private and public sector 
        activities such as public health protection against bacteria 
        and other microorganisms, control of insects and other disease 
        vectors, and residential and business pest control.

SEC. 4. REQUIREMENTS FOR TRANSITION ANALYSIS AND DESCRIPTION OF BASIS 
              FOR DECISIONS.

    (a) In General.--This section applies to any proposed or final 
rule, order, notice, report, guidance document, or risk assessment 
issued by the Administrator that is based on or results from a review 
or reassessment of an existing tolerance or of the uses of a pesticide 
having an existing tolerance. However, this section does not apply to 
any document that concludes or recommends that no revocation or denial 
of a tolerance, or other adverse action against a tolerance, is 
required.
    (b) Period of Applicability.--This section applies to any document 
described by subsection (a) that the Administrator issues or otherwise 
discloses to any member of the public during the period beginning on 
January 1, 1999, and ending on the date of completion of the process of 
tolerance review under section 408(q) of the Federal Food, Drug, and 
Cosmetic Act.
    (c) Requirement for Transition Analysis Report.--Before issuing any 
document to which this section applies, the Administrator shall conduct 
a transition analysis of the findings and regulatory steps recommended 
by or set forth in the document. The document shall include a report 
describing the results of the analysis and the extent to which the 
conclusions in the document are tentative, preliminary, or subject to 
possible modification because of policy reevaluation, correction of 
data deficiencies, or use of new data to replace assumptions. A 
transition analysis statement under this section shall describe the 
extent to which any finding or regulatory step recommended by or set 
forth in the analyzed document is based in whole or in part on--
            (1) any assumption, if the Administrator is in possession 
        of data that would make use of the assumption unnecessary;
            (2) any information about possible exposure from drinking 
        water or other non-occupational, non-dietary exposure routes 
        that is derived from use of--
                    (A) worst-case assumptions;
                    (B) computations or modeling results that are based 
                on high-end or upper-bound inputs or are designed to be 
                worst-case, high-end, or bounding estimates; or
                    (C) information that otherwise is not reasonably 
                representative of risks to consumers or to major 
                identifiable subgroups of consumers, on a national or 
                regional basis;
            (3) any assumption about exposure from drinking water or 
        other non-occupational, non-dietary exposure routes, if data 
        that would make use of the assumption unnecessary, and would 
        likely demonstrate a lower level of exposure than that used in 
        the assumption or model--
                    (A) are being developed and will be submitted 
                within a reasonable period, in accordance with a 
                request by the Administrator under section 408(f) of 
                the Federal Food, Drug, and Cosmetic Act or any of the 
                authorities referred to in such section or at the 
                initiative of an interested person; or
                    (B) could be obtained by the Administrator by an 
                action taken in accordance with section 408(f) of such 
                Act;
            (4) any assumption regarding the method for determining the 
        aggregate exposure to a pesticide chemical or the cumulative 
        effect of exposure to two or more pesticides having a common 
        mechanism of toxicity, if the use of such assumption is based 
        in whole or in part on the absence of data that could be 
obtained by the Administrator by an action taken in accordance with 
section 408(f) of the Federal Food, Drug, and Cosmetic Act, unless the 
data that would eliminate the need for use of the assumption have been 
identified and made known by the Administrator to interested persons 
and sufficient time has been provided to allow the data to be 
developed, submitted, and subsequently evaluated by the Agency;
            (5) any calculation developed by use of the additional 
        safety factor described by section 408(b)(2)(C) of the Federal 
        Food, Drug, and Cosmetic Act, if the use of such additional 
        safety factor is based in whole or in part on the absence of 
        data that could be obtained by the Administrator by an action 
        taken in accordance with section 408(f) of such Act, unless the 
        data that would eliminate the need for use of the assumption 
        have been identified and made known by the Administrator to 
        interested persons and sufficient time has been provided to 
        allow the data to be developed, submitted, and subsequently 
        evaluated by the Agency; or
            (6) any information about an alleged adverse effect if the 
        information is anecdotal, unverified, or scientifically 
        implausible, or comes from any study whose design and conduct 
        has not been found by the Administrator to be scientifically 
        sound with regard to design, conduct, reporting, and data 
        availability.
    (d) Additional Contents of Report.--A transition analysis report 
under this section shall:
            (1) Summarize and respond briefly to comments received by 
        the Administrator from any other persons regarding the 
        applicability of any provision of subsection (c) to the 
        document analyzed under this section.
            (2) Discuss briefly the availability and suitability of 
        pesticidal and nonpesticidal alternatives to the pesticide uses 
        being reviewed or reassessed. At a minimum, the Administrator, 
        in consultation with the Secretary of Agriculture, shall 
        include in the analysis a determination on the extent to which 
        an effective and economical alternative to the pesticidal 
        tolerance under review has been approved and whether revocation 
        or modification of the tolerance will result in--
                    (A) a significant regional shift of production 
                within the United States;
                    (B) an increase in imports of corresponding 
                commodities;
                    (C) an increase in pest control costs;
                    (D) pest crop damage and yield loss, including 
                quality degradation, due to the lack of an effective 
                alternative; or
                    (E) a disruption of domestic production of an 
                adequate, wholesome and economical food supply.
            (3) Identify the data that, if available, would make 
        unnecessary any reliance on any information, calculation, or 
        assumption described in paragraph (2), (3), (4), or (5) of 
        subsection (c) that is identified in the report.
            (4) Describe the extent to which any finding or regulatory 
        step recommended by or set forth in the analyzed document is 
        based in whole or in part on--
                    (A) any assumption about toxicity, dietary 
                exposure, or risk from dietary exposure, if data that 
                would make use of the assumption unnecessary--
                            (i) are being developed and will be 
                        submitted within a reasonable period, in 
                        accordance with a request by the Administrator 
                        under section 408(f) of the Federal Food, Drug, 
                        and Cosmetic Act or any of the authorities 
                        referred to in that section or at the 
                        initiative of an interested person; or
                            (ii) could be obtained by the Administrator 
                        by an action taken in accordance with section 
                        408(f) of such Act;
                    (B) any use of data on the presence or absence of 
                non-adverse effects, rather than data on the presence 
                or absence of adverse effects, as the basis for 
                calculation of allowable exposure levels; or
                    (C) any policy that the Administrator may revise 
                after completion of any reevaluation of such policy 
                that is being conducted or is scheduled to be 
                conducted.

SEC. 5. INTERIM PROCEDURES FOR REVIEWS OR REASSESSMENTS.

    (a) Documents and Actions to Which this Section Applies.--To the 
extent provided by subsection (b), this section applies to--
            (1) any review or reassessment by the Administrator of any 
        existing tolerance for a pesticide chemical, whether initiated 
        by the Administrator or by petition by another person; and
            (2) any review or reassessment by the Administrator of any 
        pesticide registration under the Federal Insecticide, 
        Fungicide, and Rodenticide Act that is associated with or 
        results from such a tolerance review or reassessment.
    (b) Period of Applicability.--This section applies to any review or 
reassessment described by subsection (a) that the Administrator issues 
during the period beginning on January 1, 1999, and ending on the date 
of completion of the process of tolerance review under section 408(q) 
of the Federal Food, Drug, and Cosmetic Act.
    (c) Limitation.--Notwithstanding any provision of section 408 of 
the Federal Food, Drug, and Cosmetic Act:
            (1) In any tolerance review or reassessment to which this 
        section applies, the Administrator may not base the revocation 
        of or other adverse action against an existing tolerance on any 
        information, calculation, or assumption described in section 
        4(c).
            (2) In any review or reassessment of the registration of a 
        pesticide product to which this section applies, the 
        Administrator may not base any adverse action against the 
        registration under the Federal Insecticide, Fungicide, and 
        Rodenticide Act on any information, calculation, or assumption 
        described in section 4(c).

SEC. 6. IMPLEMENTATION RULES.

    (a) In General.--The Administrator shall issue rules in accordance 
with section 408(e) of the Federal Food, Drug, and Cosmetic Act 
establishing general procedures and requirements to implement section 
408 of such Act, including guidance regarding the provisions of such 
Act regarding aggregate exposure to residues of a single pesticide and 
cumulative effects of exposure to pesticides having a common mechanism 
of toxicity. The Administrator shall include in such rules general 
procedures and requirements to implement this Act.
    (b) Rules.--The rules described by subsection (a) shall be issued 
in proposed form not later than 6 months after the date of enactment of 
this Act and in final form not later than one year after the date of 
enactment of this Act, and shall be revised thereafter as necessary and 
appropriate.

SEC. 7. DATA IN SUPPORT OF TOLERANCES AND REGISTRATIONS.

    (a) Guidelines.--Section 408(f) of the Federal Food, Drug, and 
Cosmetic Act is amended by adding at the end the following:
            ``(3) Issuance of guidelines.--The Administrator shall 
        issue guidelines specifying the kinds of information that will 
        be required to support the issuance or continuation of a 
        tolerance or exemption from the requirement for a tolerance and 
        shall revise such guidelines from time to time. Such guidelines 
        shall specify the conditions under which data requirements will 
        apply to particular types of pesticide chemicals. Notice and 
        comment procedures shall be used in the issuance of such 
        guidelines, except for those guidelines that already have been 
        issued after notice and comment under section 3(c)(2)(A) of the 
        Federal Insecticide, Fungicide, and Rodenticide Act.''.
    (b) FIFRA.--Section 3(c)(2)(A) of the Federal Insecticide, 
Fungicide, and Rodenticide Act is amended by striking the period at the 
end and inserting ``, after first providing notice and opportunity for 
comment by interested parties.''.

SEC. 8. EXPEDITING CERTAIN MATTERS.

    (a) In General.--
            (1) FIFRA.--Section 3(c)(3) of the Federal Insecticide, 
        Fungicide, and Rodenticide Act is amended by adding at the end 
        the following:
                    ``(E) Expedited action to provide effective, 
                economic alternatives.--The Administrator shall 
                expedite the review of any complete application for 
                registration or amended registration of a product under 
                section 3, for an experimental use permit under section 
                5, or for an emergency exemption under section 18, if 
                such application seeks approval for the registration or 
                use of a product that, in the opinion of the 
                Administrator, is likely to provide an effective, 
                economic alternative to the use of a pesticide that has 
                been or is likely to be removed from the market as a 
                result of a review conducted under section 408 of the 
                Federal Food, Drug, and Cosmetic Act and for which 
                there is no currently registered effective and 
                economical alternative or for which the number of such 
                alternatives is insufficient to avoid problems such as 
                pest resistance.''.
            (2) Coordination with priorities under ffdca.--Section 
        408(d)(4)(B) of the Federal Food, Drug, and Cosmetic Act is 
        amended--
                    (A) by striking ``for a pesticide chemical residue 
                that appears to pose'' and inserting the following: 
                ``for a pesticide chemical residue that--
                            ``(i) appears to pose'';
                    (B) by striking ``same or similar uses.'' and 
                inserting ``same or similar uses; or''; and
                    (C) by adding at the end the following:
                            ``(ii) is needed in connection with a 
                        request under section 3(c)(3)(E) of the Federal 
                        Insecticide, Fungicide, and Rodenticide Act for 
                        approval of an effective, economic 
                        alternative.''.
    (b) Amendment.--Section 408(l)(6) of the Federal Food, Drug, and 
Cosmetic Act is amended by striking the period at the end and inserting 
``, except that the Administrator may issue a tolerance associated with 
an emergency exemption without regard to other tolerances for the 
pesticide and before reassessing those other tolerances, if the 
Administrator determines that any incremental exposure that may result 
from the tolerance associated with the emergency exemption will not 
pose any significant risk to food consumers.''.

SEC. 9. PRIORITIES AND RESOURCES.

    The Administrator and the Secretary shall prepare a report that 
shall be delivered to the Congress not later than 6 months after the 
date of enactment of this Act. The report shall include a proposal for 
revising the priorities of and resources available to the Administrator 
that will allow the Administrator to process promptly all registration 
applications and petitions for tolerances or exemptions, requests for 
experimental use permits, requests for approval of new inert 
ingredients, and requests for emergency exemptions and for decisions on 
the merits of such applications, petitions, and requests, in addition 
to performing tolerance reviews and reassessments and other duties 
required by the Federal Food, Drug, and Cosmetic Act and the Federal 
Insecticide, Fungicide, and Rodenticide Act. The report shall also 
include a proposal for revising the priorities of and resources 
available to the Secretary that will allow the Secretary to obtain and 
provide to the Administrator adequate and timely information on food 
consumption, pesticide residues in or on food and drinking water, and 
pesticide use and usage, to review actions proposed by the 
Administrator under the Federal Food, Drug, and Cosmetic Act and the 
Federal Insecticide, Fungicide, and Rodenticide Act, and to perform 
other duties related to the regulation of pesticides and pesticide 
chemical residues.

SEC. 10. INTERNATIONAL TRADE EFFECTS.

    (a) Study.--
            (1) Program.--The Secretary 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 
        fruits and vegetables, corn, wheat, cotton, rice, soybeans, and 
        nursery and forest products.
            (2) Examination.--In carrying out the requirements of 
        paragraph (1) of this section, 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 Federal Food, Drug, and Cosmetic Act and the Federal 
        Insecticide, Fungicide, and Rodenticide Act. Such factors 
        include sector changes, regional changes, prices, quality, 
        input costs and availability, and ratio of imports to exports.
    (b) Report.--The Secretary shall prepare periodic reports 
describing the findings from the program conducted under subsection 
(a). The first such report shall be submitted to the House Committee on 
Agriculture and the Senate Committee on Agriculture, Nutrition, and 
Forestry not later than October 1, 2000, with subsequent reports 
submitted by October 1 of every second year thereafter until 2010.

SEC. 11. ADVISORY COMMITTEE.

    (a) Establishment and Purpose.--There is established a Federal 
advisory committee to be known as the Pesticide Advisory Committee (in 
this section referred to as the ``Advisory Commitee''). The purpose of 
the Advisory Committee shall be to provide advice to the Administrator 
and the Secretary on matters related to implementation of section 408 
of the Federal Food, Drug, and Cosmetic Act and this Act, including 
proposed and final rules, policies, procedures, and testing guidelines 
used to regulate pesticide tolerances and registrations, and to foster 
communication between the Administrator, the Secretary, and the various 
stakeholder organizations who represent persons having particular 
interest in the regulation of pesticides under Federal Food, Drug, and 
Cosmetic Act. The Advisory Committee shall be permanent, and shall 
among other things assume the functions formerly performed by the 
Tolerance Reassessment Advisory Committee. The Secretary shall provide 
staff to serve as a secretariat for the Advisory Committee.
    (b) Membership.--The Advisory Committee shall be composed of 
representatives of organizations interested in the regulation of 
pesticides, and shall consist of 20 members appointed by the 
Administrator and Secretary utilizing a system of staggered terms of 
appointment. The membership of the Advisory Committee shall be chosen 
to represent a wide variety of interests and viewpoints, and shall 
include representatives of organizations that represent the following 
groups: Food consumers, persons with a special interest in 
environmental protection, farm workers, agricultural producers 
(including crop production, livestock and poultry production, and 
nursery and forestry), non-agricultural pesticide users, food 
manufacturers and processors, food distributors and marketers, 
manufacturers of agricultural and nonagricultural pesticides, and 
Federal and State agencies. The Administrator may extend the term of a 
member of the Advisory Committee until the new member is appointed to 
fill the vacancy. The Administrator shall publish in the Federal 
Register the name, address, and professional affiliations of each 
nominee. Each member of the Advisory Committee shall be entitled to be 
reimbursed by the Administrator for reasonable costs of lodging, meals, 
and travel associated with attendance at meetings of the advisory 
committee, as determined by the Administrator.
    (c) Meetings.--The Advisory Committee shall conduct its principal 
business in meetings that are open to the public in facilities that can 
accommodate the reasonably foreseeable number of attendees, or by 
teleconferences with open access. Written communications between the 
Secretary or Administrator and the Committee shall be docketed and 
available to any person upon request. The Secretary shall be 
responsible for providing or making arrangements for the meeting 
facilities. Meetings of the full committee shall be held at least two 
times per year at times determined jointly by the Administrator and the 
Secretary. All meetings of the Advisory Committee shall be the subject 
of notices published in the Federal Register by the Administrator not 
less than two weeks before the date of the meeting.
                                 <all>