(1) ADMINISTRATOR.—The term ‘‘Adminis-
trator’’ means the Administrator of the Environ-
mental 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 con-
sider new kinds of information and use additional
criteria in regulating pesticide residues and in re-
viewing 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 regu-
late 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 de-
mands new scientific tools in addition to those that
were available when the FQPA was enacted.
(3) To reach sound, suitably protective deci-
sions 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 die-
tary exposure and toxicity, so that it can be deter-
mined 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 interpreta-
tions 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 pro-
ceedings have been scheduled but have not yet
begun.
(5) The FQPA added to the FFDCA several
provisions that provide flexibility to the Adminis-
trator in making the transition to the new approach.
The FFDCA anticipates a continuing process of re-
finement and improvement in tolerance decision-
making, as additional information is collected and as
new policies and methods are developed and adopted
for the practical implementation of the new require-
ments. The FFDCA provides that the data require-
ments for tolerances must be set out clearly in regu-
lations and guidelines, so that the regulated commu-
nity 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 Con-
gress 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 need-
ed and a reasonable opportunity to collect the data.
Thus, when an existing tolerance is under review
and the Administrator determines that additional in-
formation is needed to support the continuation of
the tolerance, the FFDCA now authorizes the Ad-
ministrator to postpone the effective date of any tol-
erance rule resulting from a review, and this author-
ity can be utilized as appropriate where additional
information is pertinent to a tolerance review. Fi-
nally, the current FFDCA permits the Agency to
conduct a review in stages, as allowed by the avail-
able, reliable information.
(6) Although these authorities already are pro-
vided 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 transi-
tion to revised standards, procedures, and require-
ments, 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 pub-
lic trust in the food supply.
(7) Unless the Administrator implements sec-
tion 408 of the FFDCA carefully and wisely, deci-
sions made under it could cause great harm to the
presently safe and affordable food supply, to Amer-
ican agriculture (including food, fiber, nursery, and
forestry production, and food storage and transpor-
tation), to related industries, and to other private
and public sector activities such as public health pro-
tection against bacteria and other microorganisms,
control of insects and other disease vectors, and resi-
dential and business pest control.
SEC. 4. REQUIREMENTS FOR TRANSITION ANALYSIS AND
DESCRIPTION OF BASIS FOR DECISIONS.
(a) IN GENERAL.—This section applies to any pro-
posed or final rule, order, notice, report, guidance docu-
ment, 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 Ad-
ministrator 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 RE-
PORT.—Before issuing any document to which this section
applies, the Administrator shall conduct a transition anal-
ysis 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 ex-
tent to which the conclusions in the document are ten-
tative, preliminary, or subject to possible modification be-
cause of policy reevaluation, correction of data defi-
ciencies, or use of new data to replace assumptions. A
transition analysis statement under this section shall de-
scribe 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 as-
sumption 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 rea-
sonably representative of risks to consumers or
to major identifiable subgroups of consumers,
on a national or regional basis;
(3) any assumption about exposure from drink-
ing water or other non-occupational, non-dietary ex-
posure routes, if data that would make use of the
assumption unnecessary, and would likely dem-
onstrate a lower level of exposure than that used in
the assumption or model—
(A) are being developed and will be sub-
mitted within a reasonable period, in accord-
ance 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 in-
terested 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 Admin-
istrator to interested persons and sufficient time has
been provided to allow the data to be developed, sub-
mitted, and subsequently evaluated by the Agency;
(5) any calculation developed by use of the ad-
ditional 
safety 
factor 
described 
by 
section
408(b)(2)(C) of the Federal Food, Drug, and Cos-
metic 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 sub-
sequently 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 transi-
tion analysis report under this section shall:
(1) Summarize and respond briefly to com-
ments 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 suit-
ability 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 produc-
tion within the United States;
(B) an increase in imports of cor-
responding commodities;
(C) an increase in pest control costs;
(D) pest crop damage and yield loss, in-
cluding 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 identi-
fied 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 Adminis-
trator 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 Adminis-
trator by an action taken in accordance
with section 408(f) of such Act;
(B) any use of data on the presence or ab-
sence 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 sched-
uled to be conducted.
SEC. 5. INTERIM PROCEDURES FOR REVIEWS OR REAS-
SESSMENTS.
(a) DOCUMENTS AND ACTIONS TO WHICH THIS SEC-
TION APPLIES.—To the extent provided by subsection (b),
this section applies to—
(1) any review or reassessment by the Adminis-
trator of any existing tolerance for a pesticide chem-
ical, whether initiated by the Administrator or by
petition by another person; and
(2) any review or reassessment by the Adminis-
trator of any pesticide registration under the Fed-
eral 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 reg-
istration of a pesticide product to which this section
applies, the Administrator may not base any adverse
action against the registration under the Federal In-
secticide, Fungicide, and Rodenticide Act on any in-
formation, 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 proce-
dures 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 Adminis-
trator 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 ap-
propriate.
SEC. 7. DATA IN SUPPORT OF TOLERANCES AND REGISTRA-
TIONS.
(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 Adminis-
trator 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 re-
quirements 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 In-
secticide, Fungicide, and Rodenticide Act is amended by
striking the period at the end and inserting ‘‘, after first
providing notice and opportunity for comment by inter-
ested parties.’’.
SEC. 8. EXPEDITING CERTAIN MATTERS.
(a) IN GENERAL.—
(1) FIFRA.—Section 3(c)(3) of the Federal In-
secticide, Fungicide, and Rodenticide Act is amend-
ed by adding at the end the following:
‘‘(E) EXPEDITED ACTION TO PROVIDE EF-
FECTIVE, ECONOMIC ALTERNATIVES.—The Ad-
ministrator shall expedite the review of any
complete application for registration or amend-
ed 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 reg-
istration or use of a product that, in the opin-
ion 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 re-
moved 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 ec-
onomical alternative or for which the number of
such alternatives is insufficient to avoid prob-
lems 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 effec-
tive, 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 Adminis-
trator may issue a tolerance associated with an emergency
exemption without regard to other tolerances for the pes-
ticide 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 prior-
ities of and resources available to the Administrator that
will allow the Administrator to process promptly all reg-
istration applications and petitions for tolerances or ex-
emptions, 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 pro-
vide 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 ac-
tions proposed by the Administrator under the Federal
Food, Drug, and Cosmetic Act and the Federal Insecti-
cide, Fungicide, and Rodenticide Act, and to perform
other duties related to the regulation of pesticides and pes-
ticide 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 ag-
ricultural 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 re-
quirements of paragraph (1) of this section, the Sec-
retary 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 con-
ducted under subsection (a). The first such report shall
be submitted to the House Committee on Agriculture and
the Senate Committee on Agriculture, Nutrition, and For-
estry not later than October 1, 2000, with subsequent re-
ports submitted by October 1 of every second year there-
after until 2010.
SEC. 11. ADVISORY COMMITTEE.
(a) ESTABLISHMENT AND PURPOSE.—There is es-
tablished 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 Advi-
sory Committee shall be to provide advice to the Adminis-
trator and the Secretary on matters related to implemen-
tation of section 408 of the Federal Food, Drug, and Cos-
metic Act and this Act, including proposed and final rules,
policies, procedures, and testing guidelines used to regu-
late 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 pes-
ticides 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 mem-
bers appointed by the Administrator and Secretary uti-
lizing 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 rep-
resent the following groups: Food consumers, persons with
a special interest in environmental protection, farm work-
ers, agricultural producers (including crop production,
livestock and poultry production, and nursery and for-
estry), non-agricultural pesticide users, food manufactur-
ers and processors, food distributors and marketers, man-
ufacturers 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 nomi-
nee. Each member of the Advisory Committee shall be en-
titled to be reimbursed by the Administrator for reason-
able costs of lodging, meals, and travel associated with at-
tendance at meetings of the advisory committee, as deter-
mined by the Administrator.
(c) MEETINGS.—The Advisory Committee shall con-
duct its principal business in meetings that are open to
the public in facilities that can accommodate the reason-
ably foreseeable number of attendees, or by telecon-
ferences with open access. Written communications be-
tween the Secretary or Administrator and the Committee
shall be docketed and available to any person upon re-
quest. 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 be-
fore the date of the meeting.
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