Regulatory Fairness and Openness Act of 1999
HR 1592 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.
(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.
(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--
(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.
(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.
END