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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.
Output:
FQPA Implementation Act of 1999 - Amends the Federal Food, Drug, and Cosmetic Act to prohibit the Administrator of the Environmental Protection Agency, upon determining that there may be grounds for modifying, suspending, or revoking a tolerance or exemption for a pesticide chemical residue in or on food, from taking any such action until considering any additional data submitted to support the continuation of a tolerance or exemption.
Makes certain requirements for the Administrator's review of tolerances and exemptions for pesticide chemical residues in effect before the enactment of the Food Quality Protection Act of 1996 (FQPA) that relate to periods of time applicable only to the extent determined by the Administrator to be in the public interest. (Current law requires specified percentages of such tolerances and exemptions to be reviewed by certain dates.)
Authorizes the Administrator to issue 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 and 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.
Directs the Administrator to report to Congress on financial resources needed for FY 2001 through 2005 to carry out the amendments made by the FQPA to the Federal Food, Drug, and Cosmetic Act and the Federal Insecticide, Fungicide, and Rodenticide Act. Requires the Secretary of Agriculture to report to Congress the financial resources needed for such fiscal years in order to carry out responsibilities under the FQPA.
Directs the Secretary to: (1) establish a program to monitor continuously the competitive strength of major U.S. agricultural commodity sectors in the international marketplace; (2) 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 FQPA; and (3) submit periodic reports on such requirements and factors to Congress.