for the production of such data, the Ad-
ministrator may proceed in accordance
with clause (iv) of section 3(c)(2)(B) or
other provisions of this section, as appro-
priate, regarding the continued registration
of the affected products with the minor use
and shall inform the public of such action.
Notwithstanding the provisions of this sub-
paragraph, the Administrator may take ac-
tion to modify or revoke the extension
under this subparagraph if the Adminis-
trator determines that the extension for
the minor use may cause an unreasonable
adverse affect on the environment. In such
circumstance, the Administrator shall pro-
vide written notice to the registrant revok-
ing the extension of time for submission of
data. Such data shall instead be due in ac-
cordance with the date then established by
the Administrator for submission of the
data.’’.
(d) MINOR USE WAIVER.—Section 3(c)(2) (7 U.S.C.
136a(c)(2)) is amended—
(1) by inserting ‘‘IN GENERAL.—’’ after ‘‘(A)’’;
(2) by inserting ‘‘ADDITIONAL DATA.—’’ after
‘‘(B)’’;
(3) by inserting ‘‘SIMPLIFIED PROCEDURES.—’’
after ‘‘(C)’’; and
(4) by adding at the end the following:
‘‘(E) MINOR
USE
WAIVER.—In handling
the registration of a pesticide for a minor use,
the Administrator may waive otherwise applica-
ble data requirements if the Administrator de-
termines that the absence of such data will not
prevent the Administrator from determining—
‘‘(i) the incremental risk presented by
the minor use of the pesticide; and
‘‘(ii) that such risk, if any, would not
be an unreasonable adverse effect on the
environment.’’.
(e) EXPEDITING MINOR USE REGISTRATIONS.—Sec-
tion 3(c)(3) (7 U.S.C. 136a(c)(3)) is amended —
(1) by inserting after ‘‘(A)’’ the following: ‘‘IN
GENERAL.—’’;
(2) by inserting after ‘‘(B)’’ the following:
‘‘IDENTICAL OR SUBSTANTIALLY SIMILAR.—’’; and
(3) by adding at the end the following:
‘‘(C) MINOR USE REGISTRATION.—
‘‘(i) The Administrator shall, as expe-
ditiously as possible, review and act on any
complete application—
‘‘(I) that proposes the initial reg-
istration of a new pesticide active in-
gredient if the active ingredient is
proposed to be registered solely for
minor uses, or proposes a registration
amendment solely for minor uses to
an existing registration; or
‘‘(II) for a registration or a reg-
istration amendment that proposes
significant minor uses.
‘‘(ii) For the purposes of clause (i)—
‘‘(I) the term ‘as expeditiously as
possible’ means that the Adminis-
trator shall, to the greatest extent
practicable, complete a review and
evaluation of all data, submitted with
a complete application, within 12
months after the submission of the
complete application, and the failure
of the Administrator to complete such
a review and evaluation under clause
(i) shall not be subject to judicial re-
view; and
‘‘(II) the term ‘significant minor
uses’ means 3 or more minor uses
proposed for every nonminor use, a
minor use that would, in the judgment
of the Administrator, serve as a re-
placement for any use which has been
canceled in the 5 years preceding the
receipt of the application, or a minor
use that in the opinion of the Admin-
istrator would avoid the reissuance of
an emergency exemption under section
18 for that minor use.
‘‘(D) ADEQUATE TIME FOR SUBMISSION OF
MINOR USE DATA.—If a registrant makes a re-
quest for a minor use waiver, regarding data re-
quired by the Administrator, pursuant to para-
graph (2)(E), and if the Administrator denies
in whole or in part such data waiver request,
the registrant shall have a full-time period for
providing such data. For purposes of this sub-
paragraph, the term ‘full-time period’ means
the time period originally established by the Ad-
ministrator for submission of such data, begin-
ning with the date of receipt by the registrant
of the Administrator’s notice of denial.’’.
(f) TEMPORARY EXTENSION OF REGISTRATION FOR
UNSUPPORTED MINOR USES.—
(1) REREGISTRATION.—
(A) Sections 4(d)(6) and 4(f)(3) (7 U.S.C.
136a–1(d)(6) and (f)(3)) are each amended by
adding at the end the following: ‘‘If the reg-
istrant does not commit to support a specific
minor use of the pesticide, but is supporting
and providing data in a timely and adequate
fashion to support uses of the pesticide on a
food, or if all uses of the pesticide are nonfood
uses and the registrant does not commit to sup-
port a specific minor use of the pesticide but is
supporting and providing data in a timely and
adequate fashion to support other nonfood uses
of the pesticide, the Administrator, at the writ-
ten request of the registrant, shall not take any
action pursuant to this paragraph in regard to
such unsupported minor use until the final
deadline established as of the date of enactment
of the Food Quality Protection Act of 1996, for
the submission of data under this section for
the supported uses identified pursuant to this
paragraph unless the Administrator determines
that the absence of the data is significant
enough to cause human health or environmental
concerns. On such a determination the Admin-
istrator may refuse the request for extension by
the registrant. Upon receipt of the request from
the registrant, the Administrator shall publish
in the Federal Register a notice of the receipt
of the request and the effective date upon which
the uses not being supported will be voluntarily
deleted from the registration pursuant to sec-
tion 6(f)(1). If the Administrator grants an ex-
tension under this paragraph, the Adminis-
trator shall monitor the development of the
data for the uses being supported and shall en-
sure that the registrant is meeting the schedule
for the production of such data. If the Adminis-
trator determines that the registrant is not
meeting or has not met the schedule for the
production of such data, the Administrator may
proceed 
in 
accordance 
with 
section
3(c)(2)(B)(iv) regarding the continued registra-
tion of the affected products with the minor
and other uses and shall inform the public of
such action in accordance with section 6(f)(2).
production of such data, the Administrator may
proceed 
in 
accordance 
with 
section
3(c)(2)(B)(iv) regarding the continued registra-
tion of the affected products with the minor
and other uses and shall inform the public of
such action in accordance with section 6(f)(2).
Notwithstanding this subparagraph, the Admin-
istrator may deny, modify, or revoke the tem-
porary extension under this subparagraph if the
Administrator determines that the continuation
of the minor use may cause an unreasonable
adverse effect on the environment. In the event
of modification or revocation, the Administrator
shall provide, in writing, to the registrant a no-
tice revoking the temporary extension and es-
tablish a new effective date by which the minor
use shall be deleted from the registration.’’.
(2) 
DATA.—Section 
3(c)(2)(B) 
(7 
U.S.C.
136a(c)(2)(B)), as amended by subsection (c)(1), is
further amended by adding at the end the following:
‘‘(vii) If the registrant does not commit to
support a specific minor use of the pesticide,
but is supporting and providing data in a timely
and adequate fashion to support uses of the
pesticide on a food, or if all uses of the pes-
ticide are nonfood uses and the registrant does
not commit to support a specific minor use of
the pesticide but is supporting and providing
data in a timely and adequate fashion to sup-
port other nonfood uses of the pesticide, the
Administrator, at the written request of the
registrant, shall not take any action pursuant
to this clause in regard to such unsupported
minor use until the final deadline established as
of the date of enactment of the Food Quality
Protection Act of 1996, for the submission of
data under section 4 for the supported uses
identified pursuant to this clause unless the Ad-
ministrator determines that the absence of the
data is significant enough to cause human
health or environmental concerns. On the basis
of such determination, the Administrator may
refuse the request for extension by the reg-
istrant. Upon receipt of the request from the
registrant, the Administrator shall publish in
the Federal Register a notice of the receipt of
the request and the effective date upon which
the uses not being supported will be voluntarily
deleted from the registration pursuant to sec-
tion 6(f)(1). If the Administrator grants an ex-
tension under this clause, the Administrator
shall monitor the development of the data for
the uses being supported and shall ensure that
the registrant is meeting the schedule for the
production of such data. If the Administrator
determines that the registrant is not meeting or
has not met the schedule for the production of
such data, the Administrator may proceed in
accordance with clause (iv) of this subpara-
graph regarding the continued registration of
the affected products with the minor and other
uses and shall inform the public of such action
in accordance with section 6(f)(2). Notwith-
standing the provisions of this clause, the Ad-
ministrator may deny, modify, or revoke the
temporary extension under this subparagraph if
the Administrator determines that the continu-
ation of the minor use may cause an unreason-
able adverse effect on the environment. In the
event of modification or revocation, the Admin-
istrator shall provide, in writing, to the reg-
istrant a notice revoking the temporary exten-
sion and establish a new effective date by which
the minor use shall be deleted from the reg-
istration.’’.
(g) Section 6(f) (7 U.S.C. 136d(f)) is amended—
(1) in paragraph (1)(C)(ii) by striking ‘‘90-
day’’ each place it appears and inserting ‘‘180-day’’;
and
(2) in paragraph (3)(A) by striking ‘‘90-day’’
and inserting ‘‘180-day’’.
(h) UTILIZATION OF DATA FOR VOLUNTARILY CAN-
CELED CHEMICALS.—Section 6(f) (7 U.S.C. 136d(f)) is
amended by adding at the end the following:
‘‘(4) UTILIZATION OF DATA FOR VOLUNTARILY
CANCELED PESTICIDE.—When an application is filed
with the Administrator for the registration of a pes-
ticide for a minor use and another registrant subse-
quently voluntarily cancels its registration for an
identical or substantially similar pesticide for an
identical or substantially similar use, the Adminis-
trator shall process, review, and evaluate the pend-
ing application as if the voluntary cancellation had
not yet taken place except that the Administrator
shall not take such action if the Administrator deter-
mines that such minor use may cause an unreason-
able adverse effect on the environment. In order to
rely on this subsection, the applicant must certify
that it agrees to satisfy any outstanding data re-
quirements necessary to support the reregistration of
the pesticide in accordance with the data submission
schedule established by the Administrator.’’.
(i) ENVIRONMENTAL PROTECTION AGENCY MINOR
USE PROGRAM.—The Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. 136 et seq.), as amended by
section 121, is amended by adding after section 30 the
following:
‘‘SEC. 31. ENVIRONMENTAL PROTECTION AGENCY MINOR
USE PROGRAM.
‘‘(a) The Administrator shall assure coordination of
minor use issues through the establishment of a minor use
program within the Office of Pesticide Programs. Such of-
fice shall be responsible for coordinating the development
of minor use programs and policies and consulting with
growers regarding minor use issues and registrations and
amendments which are submitted to the Environmental
Protection Agency.
‘‘(b) The Office of Pesticide Programs shall prepare
a public report concerning the progress made on the reg-
istration of minor uses, including implementation of the
exclusive use as an incentive for registering new minor
uses, within 3 years of the passage of the Food Quality
Protection Act of 1996.’’.
(j) DEPARTMENT
OF AGRICULTURE MINOR USE
PROGRAM.—The Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. 136 et seq.), as amended by
subsection (i), is amended by adding after section 31 the
following:
‘‘SEC. 32. DEPARTMENT OF AGRICULTURE MINOR USE PRO-
GRAM.
‘‘(a) IN GENERAL.—The Secretary of Agriculture
(hereinafter in this section referred to as the ‘Secretary’)
shall assure the coordination of the responsibilities of the
Department of Agriculture related to minor uses of pes-
ticides, including—
‘‘(1) carrying out the Inter-Regional Project
Number 4 (IR–4) as described in section 2 of Public
Law 89–106 (7 U.S.C. 450i(e)) and the national
pesticide resistance monitoring program established
under section 1651 of the Food, Agriculture, Con-
servation, and Trade Act of 1990 (7 U.S.C. 5882);
‘‘(2) supporting integrated pest management
research;
‘‘(3) consulting with growers to develop data for
minor uses; and
‘‘(4) providing assistance for minor use reg-
istrations, tolerances, and reregistrations with the
Environmental Protection Agency.
‘‘(b)(1) MINOR USE PESTICIDE DATA.—
‘‘(A) GRANT
AUTHORITY.—The Secretary, in
consultation with the Administrator, shall establish a
program to make grants for the development of data
to support minor use pesticide registrations and re-
registrations. The amount of any such grant shall
not exceed 1⁄2 of the cost of the project for which the
grant is made.
‘‘(B) APPLICANTS.—Any person who wants to
develop data to support minor use pesticide registra-
tions and reregistrations may apply for a grant
under subparagraph (A). Priority shall be given to
an applicant for such a grant who does not directly
receive funds from the sale of pesticides registered
for minor uses.
‘‘(C) DATA OWNERSHIP.—Any data that is de-
veloped under a grant under subparagraph (A) shall
be jointly owned by the Department of Agriculture
and the person who received the grant. Such a per-
son shall enter into an agreement with the Secretary
under which such person shall share any fee paid to
such person under section 3(c)(1)(F).
‘‘(2) MINOR
USE
PESTICIDE
DATA
REVOLVING
FUND.—
‘‘(A) ESTABLISHMENT.—There is established in
the Treasury of the United States a revolving fund
to be known as the Minor Use Pesticide Data Re-
volving Fund. The Fund shall be available without
fiscal year limitation to carry out the authorized
purposes of this subsection.
‘‘(B) CONTENTS OF THE FUND.—There shall
be deposited in the Fund—
‘‘(i) such amounts as may be appropriated
to support the purposes of this subsection; and
‘‘(ii) fees collected by the Secretary for any
data developed under a grant under paragraph
(1)(A).
‘‘(C) AUTHORIZATIONS OF APPROPRIATIONS.—
There are authorized to be appropriated for each fis-
cal year to carry out the purposes of this subsection
$10,000,000 to remain available until expended.’’.
Subtitle B—Antimicrobial Pesticide
Registration Reform
SEC. 221. DEFINITIONS.
Section 2 (7 U.S.C. 136), as amended by section
210(a) is further amended—
(1) in subsection (u), by adding at the end the
following: ‘‘The term ‘pesticide’ does not include liq-
uid chemical sterilant products (including any
sterilant or subordinate disinfectant claims on such
products) for use on a critical or semi-critical device,
as defined in section 201 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321). For purposes of
the preceding sentence, the term ‘critical device’ in-
cludes any device which is introduced directly into
the human body, either into or in contact with the
bloodstream or normally sterile areas of the body
and the term ‘semi-critical device’ includes any de-
vice which contacts intact mucous membranes but
which does not ordinarily penetrate the blood barrier
or otherwise enter normally sterile areas of the
body.’’; and
(2) by adding at the end the following:
‘‘(mm) ANTIMICROBIAL PESTICIDE.—
‘‘(1) IN
GENERAL.—The term ‘antimicrobial
pesticide’ means a pesticide that—
‘‘(A) is intended to—
‘‘(i) disinfect, sanitize, reduce, or miti-
gate growth or development of micro-
biological organisms; or
‘‘(ii) protect inanimate objects, indus-
trial processes or systems, surfaces, water,
or other chemical substances from con-
tamination, fouling, or deterioration caused
by bacteria, viruses, fungi, protozoa, algae,
or slime; and
‘‘(B) in the intended use is exempt from,
or otherwise not subject to, a tolerance under
section 408 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 346a and 348) or a
food additive regulation under section 409 of
such Act.
‘‘(2) 
EXCLUDED
PRODUCTS.—The 
term
‘antimicrobial pesticide’ does not include —
‘‘(A) a wood preservative or antifouling
paint product for which a claim of pesticidal ac-
tivity other than or in addition to an activity
described in paragraph (1) is made;
‘‘(B) an agricultural fungicide product; or
‘‘(C) an aquatic herbicide product.
‘‘(3) 
INCLUDED
PRODUCTS.—The 
term
‘antimicrobial pesticide’ does include any other
chemical sterilant product (other than liquid chemi-
cal sterilant products exempt under subsection (u)),
any other disinfectant product, any other industrial
microbiocide product, and any other preservative
product that is not excluded by paragraph (2).’’.
SEC. 222. FEDERAL AND STATE DATA COORDINATION.
Section 3(c)(2)(B) (7 U.S.C. 136a(c)(2)(B)), as
amended by section 210(f)(2), is amended by adding at
the end the following:
‘‘(viii)(I) If data required to support reg-
istration of a pesticide under subparagraph (A)
is requested by a Federal or State regulatory
authority, the Administrator shall, to the extent
practicable, coordinate data requirements, test
protocols, timetables, and standards of review
and reduce burdens and redundancy caused to
the registrant by multiple requirements on the
registrant.
‘‘(II) The Administrator may enter into a
cooperative agreement with a State to carry out
subclause (I).
‘‘(III) Not later than 1 year after the date
of enactment of this clause, the Administrator
shall develop a process to identify and assist in
alleviating future disparities between Federal
and State data requirements.’’.
SEC. 223. LABEL AND LABELING.
Section 3(c) (7 U.S.C. 136a(c)) is amended by adding
at the end the following:
‘‘(9) LABELING.—
‘‘(A) ADDITIONAL STATEMENTS.—Subject
to subparagraphs (B) and (C), it shall not be
a violation of this Act for a registrant to modify
the labeling of an antimicrobial pesticide prod-
uct to include relevant information on product
efficacy, product composition, container com-
position or design, or other characteristics that
do not relate to any pesticidal claim or pes-
ticidal activity.
‘‘(B) REQUIREMENTS.—Proposed labeling
information under subparagraph (A) shall not
be false or misleading, shall not conflict with or
detract from any statement required by law or
the Administrator as a condition of registration,
and shall be substantiated on the request of the
Administrator.
‘‘(C) NOTIFICATION AND DISAPPROVAL.—
‘‘(i) NOTIFICATION.—A registration
may be modified under subparagraph (A)
if —
‘‘(I) the registrant notifies the
Administrator in writing not later
than 60 days prior to distribution or
sale of a product bearing the modified
labeling; and
‘‘(II) the Administrator does not
disapprove of the modification under
clause (ii).
‘‘(ii) DISAPPROVAL.—Not later than
30 days after receipt of a notification
under clause (i), the Administrator may
disapprove the modification by sending the
registrant notification in writing stating
that the proposed language is not accept-
able and stating the reasons why the Ad-
ministrator finds the proposed modification
unacceptable.
‘‘(iii) RESTRICTION ON SALE.—A reg-
istrant may not sell or distribute a product
bearing a disapproved modification.
‘‘(iv) OBJECTION.—A registrant may
file an objection in writing to a disapproval
under clause (ii) not later than 30 days
after receipt of notification of the dis-
approval.
‘‘(v) FINAL
ACTION.—A decision by
the Administrator following receipt and
consideration of an objection filed under
clause (iv) shall be considered a final agen-
cy action.
‘‘(D) USE DILUTION.—The label or label-
ing required under this Act for an antimicrobial
pesticide that is or may be diluted for use may
have a different statement of caution or protec-
tive measures for use of the recommended di-
luted solution of the pesticide than for use of a
concentrate of the pesticide if the Administrator
determines that —
‘‘(i) adequate data have been submit-
ted to support the statement proposed for
the diluted solution uses; and
‘‘(ii) the label or labeling provides
adequate protection for exposure to the di-
luted solution of the pesticide.’’.
SEC. 
224. 
REGISTRATION 
REQUIREMENTS 
FOR
ANTIMICROBIAL PESTICIDES.
Section 3 (7 U.S.C. 136a), as amended by section
106(b), is further amended by adding at the end the fol-
lowing:
‘‘(h) 
REGISTRATION
REQUIREMENTS
FOR
ANTIMICROBIAL PESTICIDES.—
‘‘(1) EVALUATION OF PROCESS.—To the maxi-
mum extent practicable consistent with the degrees
of risk presented by a antimicrobial pesticide and
the type of review appropriate to evaluate the risks,
the Administrator shall identify and evaluate re-
forms to the antimicrobial registration process that
would reduce review periods existing as of the date
of enactment of this subsection for antimicrobial
pesticide product registration applications and appli-
cations for amended registration of antimicrobial
pesticide products, including—
‘‘(A) new antimicrobial active ingredients;
‘‘(B) new antimicrobial end-use products;
‘‘(C) substantially similar or identical
antimicrobial pesticides; and
‘‘(D) amendments to antimicrobial pes-
ticide registrations.
‘‘(2) 
REVIEW
TIME
PERIOD
REDUCTION
GOAL.—Each reform identified under paragraph (1)
shall be designed to achieve the goal of reducing the
review period following submission of a complete ap-
plication, consistent with the degree of risk, to a pe-
riod of not more than —
‘‘(A) 540 days for a new antimicrobial ac-
tive ingredient pesticide registration;
‘‘(B) 270 days for a new antimicrobial use
of a registered active ingredient;
‘‘(C) 
120 
days 
for 
any 
other 
new
antimicrobial product;
‘‘(D) 90 days for a substantially similar or
identical antimicrobial product;
‘‘(E) 90 days for an amendment to an
antimicrobial registration that does not require
scientific review of data; and
‘‘(F) 90 to 180 days for an amendment to
an antimicrobial registration that requires sci-
entific review of data and that is not otherwise
described in this paragraph.
‘‘(3) IMPLEMENTATION.—
‘‘(A) PROPOSED RULEMAKING.—
‘‘(i) ISSUANCE.—Not later than 270
days after the date of enactment of this
subsection, the Administrator shall publish
in the Federal Register proposed regula-
tions to accelerate and improve the review
of antimicrobial pesticide products de-
signed to implement, to the extent prac-
ticable, the goals set forth in paragraph
(2).
‘‘(ii) REQUIREMENTS.—Proposed reg-
ulations issued under clause (i) shall —
‘‘(I) define the various classes of
antimicrobial use patterns, including
household, industrial, and institutional
disinfectants and sanitizing pesticides,
preservatives, water treatment, and
pulp and paper mill additives, and
other such products intended to dis-
infect, sanitize, reduce, or mitigate
growth or development of micro-
biological organisms, or protect inani-
mate objects, industrial processes or
systems, surfaces, water, or other
chemical substances from contamina-
tion, fouling, or deterioration caused
by bacteria, viruses, fungi, protozoa,
algae, or slime;
‘‘(II) differentiate the types of re-
view undertaken for antimicrobial pes-
ticides;
‘‘(III) conform the degree and
type of review to the risks and bene-
fits presented by antimicrobial pes-
ticides and the function of review
under this Act, considering the use
patterns of the product, toxicity, ex-
pected exposure, and product type;
‘‘(IV) ensure that the registration
process is sufficient to maintain
antimicrobial pesticide efficacy and
that antimicrobial pesticide products
continue to meet product performance
standards and effectiveness levels for
each type of label claim made; and
‘‘(V) implement effective and reli-
able deadlines for process manage-
ment.
‘‘(iii) COMMENTS.—In developing the
proposed regulations, the Administrator
shall solicit the views from registrants and
other affected parties to maximize the ef-
fectiveness of the rule development process.
‘‘(B) FINAL REGULATIONS.—
‘‘(i) ISSUANCE.—The Administrator
shall issue final regulations not later than
240 days after the close of the comment
period for the proposed regulations.
‘‘(ii) FAILURE TO MEET GOAL.—If a
goal described in paragraph (2) is not met
by the final regulations, the Administrator
shall identify the goal, explain why the goal
was not attained, describe the element of
the regulations included instead, and iden-
tify future steps to attain the goal.
‘‘(iii) 
REQUIREMENTS.—In 
issuing
final regulations, the Administrator shall—
‘‘(I) consider the establishment of
a certification process for regulatory
actions involving risks that can be re-
sponsibly managed, consistent with
the degree of risk, in the most cost-ef-
ficient manner;
‘‘(II) consider the establishment
of a certification process by approved
laboratories as an adjunct to the re-
view process;
‘‘(III) use all appropriate and
cost-effective review mechanisms, in-
cluding—
‘‘(aa) expanded use of notifi-
cation and non-notification proce-
dures;
‘‘(bb) revised procedures for
application review; and
‘‘(cc) allocation of appro-
priate 
resources 
to 
ensure
streamlined 
management 
of
antimicrobial pesticide registra-
tions; and
‘‘(IV) clarify criteria for deter-
mination of the completeness of an
application.
‘‘(C) 
EXPEDITED
REVIEW.—This 
sub-
section does not affect the requirements or ex-
tend the deadlines or review periods contained
in subsection (c)(3).
‘‘(D) ALTERNATIVE REVIEW PERIODS.—If
the final regulations to carry out this paragraph
are not effective 630 days after the date of en-
actment of this subsection, until the final regu-
lations become effective, the review period, be-
ginning on the date of receipt by the Agency of
a complete application, shall be —
‘‘(i) 2 years for a new antimicrobial
active ingredient pesticide registration;
‘‘(ii) 1 year for a new antimicrobial
use of a registered active ingredient;
‘‘(iii) 180 days for any other new
antimicrobial product;
‘‘(iv) 90 days for a substantially simi-
lar or identical antimicrobial product;
‘‘(v) 90 days for an amendment to an
antimicrobial registration that does not re-
quire scientific review of data; and
‘‘(vi) 240 days for an amendment to
an antimicrobial registration that requires
scientific review of data and that is not
otherwise described in this subparagraph.
‘‘(E) WOOD PRESERVATIVES.—An applica-
tion for the registration, or for an amendment
to the registration, of a wood preservative prod-
uct for which a claim of pesticidal activity listed
in section 2(mm) is made (regardless of any
other pesticidal claim that is made with respect
to the product) shall be reviewed by the Admin-
istrator within the same period as that estab-
lished 
under 
this 
paragraph 
for 
an
antimicrobial pesticide product application, con-
sistent with the degree of risk posed by the use
of the wood preservative product, if the applica-
tion requires the applicant to satisfy the same
data requirements as are required to support an
application for a wood preservative product that
is an antimicrobial pesticide.
‘‘(F) NOTIFICATION.—
‘‘(i) IN GENERAL.—Subject to clause
(iii), the Administrator shall notify an ap-
plicant whether an application has been
granted or denied not later than the final
day of the appropriate review period under
this paragraph, unless the applicant and
the Administrator agree to a later date.
‘‘(ii) FINAL DECISION.—If the Admin-
istrator fails to notify an applicant within
the period of time required under clause
(i), the failure shall be considered an agen-
cy action unlawfully withheld or unreason-
ably delayed for purposes of judicial review
under chapter 7 of title 5, United States
Code.
‘‘(iii) 
EXEMPTION.—This 
subpara-
graph does not apply to an application for
an antimicrobial pesticide that is filed
under subsection (c)(3)(B) prior to 90
days after the date of enactment of this
subsection.
‘‘(4) ANNUAL REPORT.—
‘‘(A) SUBMISSION.—Beginning on the date
of enactment of this subsection and ending on
the date that the goals under paragraph (2) are
achieved, the Administrator shall, not later than
March 1 of each year, prepare and submit an
annual report to the Committee on Agriculture
of the House of Representatives and the Com-
mittee on Agriculture, Nutrition, and Forestry
of the Senate.
‘‘(B) REQUIREMENTS.—A report submit-
ted under subparagraph (A) shall include a de-
scription of—
‘‘(i) measures taken to reduce the
backlog of pending registration applica-
tions;
‘‘(ii) progress toward achieving re-
forms under this subsection; and
‘‘(iii) recommendations to improve the
activities of the Agency pertaining to
antimicrobial registrations.’’.
SEC. 225. DISPOSAL OF HOUSEHOLD, INDUSTRIAL, OR IN-
STITUTIONAL ANTIMICROBIAL PRODUCTS.
Section 19(h) (7 U.S.C. 136q(h)) is amended—
(1) by striking ‘‘Nothing in’’ and inserting the
following:
‘‘(1) IN GENERAL.—Nothing in’’; and
(2) by adding at the end the following:
‘‘(2) ANTIMICROBIAL PRODUCTS.—A household,
industrial, or institutional antimicrobial product that
is not subject to regulation under the Solid Waste
Disposal Act (42 U.S.C. 6901 et seq.) shall not be
subject to the provisions of subsections (a), (e), and
(f), unless the Administrator determines that such
product must be subject to such provisions to pre-
vent an unreasonable adverse effect on the environ-
ment.’’.
Subtitle C—Public Health
Pesticides
SEC. 230. DEFINITIONS.
(a) ADVERSE EFFECTS.—Section 2(bb) (7 U.S.C.
136(bb)) is amended by adding at the end the following:
‘‘The Administrator shall consider the risks and benefits
of public health pesticides separate from the risks and
benefits of other pesticides. In weighing any regulatory ac-
tion concerning a public health pesticide under this Act,
the Administrator shall weigh any risks of the pesticide
against the health risks such as the diseases transmitted
by the vector to be controlled by the pesticide.’’.
(b) NEW DEFINITIONS.—Section 2 (7 U.S.C. 136),
as amended by section 221, is amended by adding at the
end the following:
‘‘(nn) PUBLIC HEALTH PESTICIDE.—The term ‘pub-
lic health pesticide’ means any minor use pesticide product
registered for use and used predominantly in public health
programs for vector control or for other recognized health
protection uses, including the prevention or mitigation of
viruses, bacteria, or other microorganisms (other than vi-
ruses, bacteria, or other microorganisms on or in living
man or other living animal) that pose a threat to public
health.
‘‘(oo) VECTOR.—The term ‘vector’ means any orga-
nism capable of transmitting the causative agent of human
disease or capable of producing human discomfort or in-
jury, including mosquitoes, flies, fleas, cockroaches, or
other insects and ticks, mites, or rats.’’.
SEC. 231. REGISTRATION.
Section 3(c)(2)(A) (7 U.S.C. 136a(c)(2)(A)) is
amended—
(1) by inserting after ‘‘pattern of use,’’ the fol-
lowing: ‘‘the public health and agricultural need for
such minor use,’’; and
(2) by striking ‘‘potential exposure of man and
the environment to the pesticide’’ and inserting ‘‘po-
tential beneficial or adverse effects on man and the
environment’’.
SEC. 232. REREGISTRATION.
Section 4 (7 U.S.C. 136a–1) is amended—
(1) in subsection (i)(4), by redesignating sub-
paragraphs (B) and (C) as subparagraphs (C) and
(D), respectively, and by adding after subparagraph
(A) the following:
‘‘(B) The Administrator shall exempt any
public health pesticide from the payment of the
fee prescribed under paragraph (3) if, in con-
sultation with the Secretary of Health and
Human Services, the Administrator determines,
based on information supplied by the registrant,
that the economic return to the registrant from
sales of the pesticide does not support the reg-
istration or reregistration of the pesticide.’’;
(2) in subsection (i)(5), by redesignating sub-
paragraphs (F) and (G) as subparagraphs (G) and
(H), respectively, and by adding after subparagraph
(E) the following:
‘‘(F) The Administrator shall exempt any
public health pesticide from the payment of the
fee prescribed under paragraph (3) if, in con-
sultation with the Secretary of Health and Hu-
mans Services, the Administrator determines,
based on information supplied by the registrant,
that the economic return to the registrant from
sales of the pesticide does not support the reg-
istration or reregistration of the pesticide.’’;
(3) in subsection (i)(7)(B), by striking ‘‘or to
determine’’ and inserting ‘‘, to determine’’ and by
inserting before the period the following: ‘‘, or to de-
termine the volume usage for public health pes-
ticides’’; and
(4) in subsection (k)(3)(A), by striking ‘‘or’’ at
the end of clause (i), by striking the period at the
end of clause (ii) and inserting thereof ‘‘; or’’, and
by adding after clause (ii) the following:
‘‘(iii) proposes the initial or amended
registration of an end use pesticide that, if
registered as proposed, would be used for
a public health pesticide.’’.
SEC. 233. CANCELLATION.
Section 6(b) (7 U.S.C. 136d(b)) is amended by add-
ing after the eighth sentence the following: ‘‘When a public
health use is affected, the Secretary of Health and Human
Services should provide available benefits and use informa-
tion, or an analysis thereof, in accordance with the proce-
dures followed and subject to the same conditions as the
Secretary of Agriculture in the case of agricultural pes-
ticides.’’.
SEC. 234. VIEWS OF THE SECRETARY OF HEALTH AND
HUMAN SERVICES.
Section 21 (7 U.S.C. 136s) is amended by redesignat-
ing subsections (b) and (c) as subsections (c) and (d), re-
spectively, and by adding after subsection (a) the follow-
ing:
‘‘(b) SECRETARY OF HEALTH AND HUMAN SERV-
ICES.—The Administrator, before publishing regulations
under this Act for any public health pesticide, shall solicit
the views of the Secretary of Health and Human Services
in the same manner as the views of the Secretary of Agri-
culture are solicited under section 25(a)(2).’’.
SEC. 235. AUTHORITY OF ADMINISTRATOR.
Section 25(a)(1) (7 U.S.C. 136w(a)(1)) is amend-
ed—
(1) by inserting after ‘‘various classes of pes-
ticides’’ the following: ‘‘, including public health pes-
ticides,’’; and
(2) by striking ‘‘and nonagricultural pesticides’’
and inserting ‘‘, nonagricultural, and public health
pesticides’’.
SEC. 236. IDENTIFICATION OF PESTS.
Section 28 (7 U.S.C. 136w–3) is amended by adding
at the end the following:
‘‘(d) PUBLIC HEALTH PESTS.—The Administrator,
in coordination with the Secretary of Agriculture and the
Secretary of Health and Human Services, shall identify
pests of significant public health importance and, in co-
ordination with the Public Health Service, develop and im-
plement programs to improve and facilitate the safe and
necessary use of chemical, biological, and other methods
to combat and control such pests of public health impor-
tance.’’.
SEC. 237. PUBLIC HEALTH DATA.
Section 4 (7 U.S.C. 136a–1) is amended by adding
at the end the following:
‘‘(m) AUTHORIZATION OF FUNDS TO DEVELOP PUB-
LIC HEALTH DATA.—
‘‘(1) DEFINITION.—For the purposes of this
section, ‘Secretary’ means the Secretary of Health
and Human Services, acting through the Public
Health Service.
‘‘(2) CONSULTATION.—In the case of a pes-
ticide registered for use in public health programs
for vector control or for other uses the Adminis-
trator determines to be human health protection
uses, the Administrator shall, upon timely request by
the registrant or any other interested person, or on
the Administrator’s own initiative may, consult with
the Secretary prior to taking final action to suspend
registration under section 3(c)(2)(B)(iv), or cancel a
registration under section 4, 6(e), or 6(f). In con-
sultation with the Secretary, the Administrator shall
prescribe the form and content of requests under
this section.
‘‘(3) BENEFITS TO SUPPORT FAMILY.—The Ad-
ministrator, after consulting with the Secretary,
shall make a determination whether the potential
benefits of continued use of the pesticide for public
health or health protection purposes are of such sig-
nificance as to warrant a commitment by the Sec-
retary to conduct or to arrange for the conduct of
the studies required by the Administrator to support
continued registration under section 3 or reregistra-
tion under section 4.
‘‘(4) ADDITIONAL TIME.—If the Administrator
determines that such a commitment is warranted
and in the public interest, the Administrator shall
notify the Secretary and shall, to the extent nec-
essary, amend a notice issued under section
3(c)(2)(B) to specify additional reasonable time peri-
ods for submission of the data.
‘‘(5) ARRANGEMENTS.—The Secretary shall
make such arrangements for the conduct of required
studies as the Secretary finds necessary and appro-
priate to permit submission of data in accordance
with the time periods prescribed by the Adminis-
trator. Such arrangements may include Public
Health Service intramural research activities, grants,
contracts, or cooperative agreements with academic,
public health, or other organizations qualified by ex-
perience and training to conduct such studies.
‘‘(6) SUPPORT.—The Secretary may provide for
support of the required studies using funds author-
ized to be appropriated under this section, the Pub-
lic Health Service Act, or other appropriate authori-
ties. After a determination is made under subsection
(d), the Secretary shall notify the Committees on
Appropriations of the House Representatives and
the Senate of the sums required to conduct the nec-
essary studies.
‘‘(7) AUTHORIZATION
OF
APPROPRIATIONS.—
There is authorized to be appropriated to carry out
the purposes of this section $12,000,000 for fiscal
year 1997, and such sums as may be necessary for
succeeding fiscal years.’’.
Subtitle D—Expedited Registration
of Reduced Risk Pesticides
SEC. 250. EXPEDITED REGISTRATION OF PESTICIDES .
Section 3(c) (7 U.S.C. 136a(c)), as amended by sec-
tion 223, is amended—
(1) by adding at the end of paragraph (1) the
following:
‘‘(G) If the applicant is requesting that the
registration or amendment to the registration of
a pesticide be expedited, an explanation of the
basis for the request must be submitted, in ac-
cordance with paragraph (10) of this sub-
section.’’; and
(2) by adding at the end the following:
‘‘(10) EXPEDITED
REGISTRATION
OF
PES-
TICIDES.—
‘‘(A) Not later than 1 year after the date
of enactment of this paragraph, the Adminis-
trator shall, utilizing public comment, develop
procedures and guidelines, and expedite the re-
view of an application for registration of a pes-
ticide or an amendment to a registration that
satisfies such guidelines.
‘‘(B) Any application for registration or an
amendment, including biological and conven-
tional pesticides, will be considered for expe-
dited review under this paragraph. An applica-
tion for registration or an amendment shall
qualify for expedited review if use of the pes-
ticide proposed by the application may reason-
ably be expected to accomplish 1 or more of the
following:
‘‘(i) Reduce the risks of pesticides to
human health.
‘‘(ii) Reduce the risks of pesticides to
nontarget organisms.
‘‘(iii) Reduce the potential for con-
tamination of groundwater, surface water,
or other valued environmental resources.
‘‘(iv) Broaden the adoption of inte-
grated pest management strategies, or
make such strategies more available or
more effective.
‘‘(C) The Administrator, not later than 30
days after receipt of an application for expe-
dited review, shall notify the applicant whether
the application is complete. If it is found to be
incomplete, the Administrator may either reject
the request for expedited review or ask the ap-
plicant for additional information to satisfy the
guidelines developed under subparagraph (A).’’.
TITLE 
III—DATA 
COLLECTION
ACTIVITIES TO ASSURE THE
HEALTH 
OF 
INFANTS 
AND
CHILDREN AND OTHER MEAS-
URES
SEC. 301. DATA COLLECTION ACTIVITIES TO ASSURE THE
HEALTH OF INFANTS AND CHILDREN.
(a) IN GENERAL.—The Secretary of Agriculture, in
consultation with the Administrator of the Environmental
Protection Agency and the Secretary of Health and
Human Services, shall coordinate the development and im-
plementation of survey procedures to ensure that adequate
data on food consumption patterns of infants and children
are collected.
(b) PROCEDURES.—To the extent practicable, the
procedures referred to in subsection (a) shall include the
collection of data on food consumption patterns of a statis-
tically valid sample of infants and children.
(c) RESIDUE DATA COLLECTION.—The Secretary of
Agriculture shall ensure that the residue data collection
activities conducted by the Department of Agriculture in
cooperation with the Environmental Protection Agency
and the Department of Health and Human Services, pro-
vide for the improved data collection of pesticide residues,
including guidelines for the use of comparable analytical
and standardized reporting methods, and the increased
sampling of foods most likely consumed by infants and
children.
SEC. 302. COLLECTION OF PESTICIDE USE INFORMATION.
(a) IN GENERAL.—The Secretary of Agriculture shall
collect data of statewide or regional significance on the
use of pesticides to control pests and diseases of major
crops and crops of dietary significance, including fruits
and vegetables.
(b) COLLECTION.—The data shall be collected by sur-
veys of farmers or from other sources offering statistically
reliable data.
(c) COORDINATION.—The Secretary of Agriculture
shall, as appropriate, coordinate with the Administrator
of the Environmental Protection Agency in the design of
the surveys and make available to the Administrator the
aggregate results of the surveys to assist the Adminis-
trator.
SEC. 303. INTEGRATED PEST MANAGEMENT.
The Secretary of Agriculture, in cooperation with the
Administrator, shall implement research, demonstration,
and education programs to support adoption of Integrated
Pest Management. Integrated Pest Management is a sus-
tainable approach to managing pests by combining biologi-
cal, cultural, physical, and chemical tools in a way that
minimizes economic, health, and environmental risks. The
Secretary of Agriculture and the Administrator shall make
information on Integrated Pest Management widely avail-
able to pesticide users, including Federal agencies. Federal
agencies shall use Integrated Pest Management techniques
in carrying out pest management activities and shall pro-
mote Integrated Pest Management through procurement
and regulatory policies, and other activities.
SEC. 304. COORDINATION OF CANCELLATION.
Section 2(bb) (7 U.S.C. 136(bb)) is amended—
(1) by inserting ‘‘(1)’’ after ‘‘means’’; and
(2) by striking the period at the end of the first
sentence and inserting ‘‘, or (2) a human dietary
risk from residues that result from a use of a pes-
ticide in or on any food inconsistent with the stand-
ard under section 408 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 346a).’’.
SEC. 305. PESTICIDE USE INFORMATION STUDY.
(a) The Secretary of Agriculture shall, in consultation
with the Administrator of the Environmental Protection
Agency, prepare a report to Congress evaluating the cur-
rent status and potential improvements in Federal pes-
ticide use information gathering activities. This report
shall at least include—
(1) an analysis of the quality and reliability of
the information collected by the Department of Agri-
culture, the Environmental Protection Agency, and
other Federal agencies regarding the agricultural
use of pesticides; and
(2) an analysis of options to increase the effec-
tiveness of national pesticide use information collec-
tion, including an analysis of costs, burdens placed
on agricultural producers and other pesticide users,
and effectiveness in tracking risk reduction by those
options.
(b) The Secretary shall submit this report to Con-
gress not later than 1 year following the date of enactment
of this section.
TITLE IV—AMENDMENTS TO THE
FEDERAL FOOD, DRUG, AND
COSMETIC ACT
SEC 401. SHORT TITLE AND REFERENCE.
(a) SHORT TITLE.—This title may be cited as the
‘‘Food Quality Protection Act of 1996 ’’.
(b) REFERENCE.—Whenever in this title an amend-
ment or repeal is expressed in terms of an amendment
to, or repeal of, a section or other provision, the reference
shall be considered to be made to a section or other provi-
sion of the Federal Food, Drug, and Cosmetic Act.
SEC. 402. DEFINITIONS.
(a) SECTION 201(q).—Section 201(q) (21 U.S.C.
321(q)) is amended to read as follows:
‘‘(q)(1) The term ‘pesticide chemical’ means any sub-
stance that is a pesticide within the meaning of the Fed-
eral Insecticide, Fungicide, and Rodenticide Act, including
all active and inert ingredients of such pesticide.
‘‘(2) The term ‘pesticide chemical residue’ means a
residue in or on raw agricultural commodity or processed
food of—
‘‘(A) a pesticide chemical; or
‘‘(B) any other added substance that is present
on or in the commodity or food primarily as a result
of the metabolism or other degradation of a pesticide
chemical.
‘‘(3) Notwithstanding paragraphs (1) and (2), the
Administrator may by regulation except a substance from
the definition of ‘pesticide chemical’ or ‘pesticide chemical
residue’ if—
‘‘(A) its occurrence as a residue on or in a raw
agricultural commodity or processed food is attrib-
utable primarily to natural causes or to human ac-
tivities not involving the use of any substances for
a pesticidal purpose in the production, storage, proc-
essing, or transportation of any raw agricultural
commodity or processed food; and
‘‘(B) the Administrator, after consultation with
the Secretary, determines that the substance more
appropriately should be regulated under one or more
provisions 
of 
this 
Act 
other 
than 
sections
402(a)(2)(B) and 408.’’.
(b) SECTION 201(s).—Paragraphs (1) and (2) of sec-
tion 201(s) (21 U.S.C. 321(s)) are amended to read as
follows:
‘‘(1) a pesticide chemical residue in or on a raw
agricultural commodity or processed food; or
‘‘(2) a pesticide chemical; or’’.
(c) SECTION 201.—Section 201 (21 U.S.C. 321) is
amended by adding at the end the following:
‘‘(gg) The term ‘processed food’ means any food
other than a raw agricultural commodity and includes any
raw agricultural commodity that has been subject to proc-
essing, such as canning, cooking, freezing, dehydration, or
milling.
‘‘(hh) The term ‘Administrator’ means the Adminis-
trator of the United States Environmental Protection
Agency.’’.
SEC. 403. PROHIBITED ACTS.
Section 301(j) (21 U.S.C. 331(j)) is amended in the
first sentence by inserting before the period the following:
‘‘; or the violating of section 408(i)(2) or any regulation
issued under that section.’’.
SEC. 404. ADULTERATED FOOD.
Section 402(a) (21 U.S.C. 342(a)) is amended by
striking ‘‘(2)(A) if it bears’’ and all that follows through
‘‘(3) if it consists’’ and inserting the following: ‘‘(2)(A)
if it bears or contains any added poisonous or added dele-
terious substance (other than a substance that is a pes-
ticide chemical residue in or on a raw agricultural com-
modity or processed food, a food additive, a color additive,
or a new animal drug) that is unsafe within the meaning
of section 406; or (B) if it bears or contains a pesticide
chemical residue that is unsafe within the meaning of sec-
tion 408(a); or (C) if it is or if it bears or contains (i)
any food additive that is unsafe within the meaning of sec-
tion 409; or (ii) a new animal drug (or conversion product
thereof) that is unsafe within the meaning of section 512;
or (3) if it consists’’.
SEC. 405. TOLERANCES AND EXEMPTIONS FOR PESTICIDE
CHEMICAL RESIDUES.
Section 408 (21 U.S.C. 346a) is amended to read as
follows:
‘‘TOLERANCES AND EXEMPTIONS FOR PESTICIDE
CHEMICAL RESIDUES
‘‘SEC. 408. (a) REQUIREMENT FOR TOLERANCE OR
EXEMPTION.—
‘‘(1) GENERAL RULE.—Except as provided in
paragraph (2) or (3), any pesticide chemical residue
in or on a food shall be deemed unsafe for the pur-
pose of section 402(a)(2)(B) unless—
‘‘(A) a tolerance for such pesticide chemi-
cal residue in or on such food is in effect under
this section and the quantity of the residue is
within the limits of the tolerance; or
‘‘(B) an exemption from the requirement
of a tolerance is in effect under this section for
the pesticide chemical residue.
For the purposes of this section, the term ‘food’,
when used as a noun without modification, shall
mean a raw agricultural commodity or processed
food.
‘‘(2) 
PROCESSED
FOOD.—Notwithstanding
paragraph (1)—
‘‘(A) if a tolerance is in effect under this
section for a pesticide chemical residue in or on
a raw agricultural commodity, a pesticide chem-
ical residue that is present in or on a processed
food because the food is made from that raw
agricultural commodity shall not be considered
unsafe 
within 
the 
meaning 
of 
section
402(a)(2)(B) despite the lack of a tolerance for
the pesticide chemical residue in or on the proc-
essed food if the pesticide chemical has been
used in or on the raw agricultural commodity in
conformity with a tolerance under this section,
such residue in or on the raw agricultural com-
modity has been removed to the extent possible
in good manufacturing practice, and the con-
centration of the pesticide chemical residue in
the processed food is not greater than the toler-
ance prescribed for the pesticide chemical resi-
due in the raw agricultural commodity; or
‘‘(B) if an exemption for the requirement
for a tolerance is in effect under this section for
a pesticide chemical residue in or on a raw agri-
cultural commodity, a pesticide chemical residue
that is present in or on a processed food be-
cause the food is made from that raw agricul-
tural commodity shall not be considered unsafe
within the meaning of section 402(a)(2)(B).
‘‘(3) RESIDUES OF DEGRADATION PRODUCTS.—
If a pesticide chemical residue is present in or on a
food because it is a metabolite or other degradation
product of a precursor substance that itself is a pes-
ticide chemical or pesticide chemical residue, such a
residue shall not be considered to be unsafe within
the meaning of section 402(a)(2)(B) despite the lack
of a tolerance or exemption from the need for a tol-
erance for such residue in or on such food if—
‘‘(A) the Administrator has not determined
that the degradation product is likely to pose
any potential health risk from dietary exposure
that is of a different type than, or of a greater
significance than, any risk posed by dietary ex-
posure to the precursor substance;
‘‘(B) either—
‘‘(i) a tolerance is in effect under this
section for residues of the precursor sub-
stance in or on the food, and the combined
level of residues of the degradation product
and the precursor substance in or on the
food is at or below the stoichiometrically
equivalent level that would be permitted by
the tolerance if the residue consisted only
of the precursor substance rather than the
degradation product; or
‘‘(ii) an exemption from the need for
a tolerance is in effect under this section
for residues of the precursor substance in
or on the food; and
‘‘(C) the tolerance or exemption for resi-
dues of the precursor substance does not state
that it applies only to particular named sub-
stances and does not state that it does not
apply to residues of the degradation product.
‘‘(4) EFFECT
OF
TOLERANCE
OR
EXEMP-
TION.—While a tolerance or exemption from the re-
quirement for a tolerance is in effect under this sec-
tion for a pesticide chemical residue with respect to
any food, the food shall not by reason of bearing or
containing any amount of such a residue be consid-
ered to be adulterated within the meaning of section
402(a)(1).
‘‘(b) AUTHORITY
AND
STANDARD
FOR
TOLER-
ANCE.—
‘‘(1) AUTHORITY.—The Administrator may
issue regulations establishing, modifying, or revoking
a tolerance for a pesticide chemical residue in or on
a food—
‘‘(A) in response to a petition filed under
subsection (d); or
‘‘(B) on the Administrator’s own initiative
under subsection (e).
As used in this section, the term ‘modify’ shall not
mean expanding the tolerance to cover additional
foods.
‘‘(2) STANDARD.—
‘‘(A) GENERAL RULE.—
‘‘(i) STANDARD.—The Administrator
may establish or leave in effect a tolerance
for a pesticide chemical residue in or on a
food only if the Administrator determines
that the tolerance is safe. The Adminis-
trator shall modify or revoke a tolerance if
the Administrator determines it is not safe.
‘‘(ii) DETERMINATION OF SAFETY.—
As used in this section, the term ‘safe’,
with respect to a tolerance for a pesticide
chemical residue’, means that the Adminis-
trator has determined that there is a rea-
sonable certainty that no harm will result
from aggregate exposure to the pesticide
chemical residue, including all anticipated
dietary exposures and all other exposures
for which there is reliable information.
‘‘(iii) RULE
OF
CONSTRUCTION.—
With respect to a tolerance, a pesticide
chemical residue meeting the standard
under clause (i) is not an eligible pesticide
chemical residue for purposes of subpara-
graph (B).
‘‘(B) TOLERANCES
FOR
ELIGIBLE
PES-
TICIDE CHEMICAL RESIDUES.—
‘‘(i) DEFINITION.—As used in this
subparagraph, the term ‘eligible pesticide
chemical residue’ means a pesticide chemi-
cal residue as to which—
‘‘(I) the Administrator is not able
to identify a level of exposure to the
residue at which the residue will not
cause or contribute to a known or an-
ticipated harm to human health (re-
ferred to in this section as a ‘non-
threshold effect’);
‘‘(II) the lifetime risk of experi-
encing the nonthreshold effect is ap-
propriately assessed by quantitative
risk assessment; and
‘‘(III) with regard to any known
or anticipated harm to human health
for which the Administrator is able to
identify a level at which the residue
will not cause such harm (referred to
in this section as a ‘threshold effect’),
the Administrator determines that the
level of aggregate exposure is safe.
‘‘(ii) DETERMINATION
OF
TOLER-
ANCE.—Notwithstanding 
subparagraph
(A)(i), a tolerance for an eligible pesticide
chemical residue may be left in effect or
modified under this subparagraph if—
‘‘(I) at least one of the conditions
described in clause (iii) is met; and
‘‘(II) both of the conditions de-
scribed in clause (iv) are met.
‘‘(iii) CONDITIONS REGARDING USE.—
For purposes of clause (ii), the conditions
described in this clause with respect to a
tolerance for an eligible pesticide chemical
residue are the following:
‘‘(I) Use of the pesticide chemical
that produces the residue protects
consumers from adverse effects on
health that would pose a greater risk
than the dietary risk from the residue.
‘‘(II) Use of the pesticide chemi-
cal that produces the residue is nec-
essary to avoid a significant disrup-
tion in domestic production of an ade-
quate, wholesome, and economical
food supply.
‘‘(iv) 
CONDITIONS
REGARDING
RISK.—For purposes of clause (ii), the
conditions described in this clause with re-
spect to a tolerance for an eligible pesticide
chemical residue are the following:
‘‘(I) The yearly risk associated
with the nonthreshold effect from ag-
gregate exposure to the residue does
not exceed 10 times the yearly risk
that would be allowed under subpara-
graph (A) for such effect.
‘‘(II) The tolerance is limited so
as to ensure that the risk over a life-
time associated with the nonthreshold
effect from aggregate exposure to the
residue is not greater than twice the
lifetime risk that would be allowed
under subparagraph (A) for such ef-
fect.
‘‘(v) REVIEW.—Five years after the
date on which the Administrator makes a
determination to leave in effect or modify
a tolerance under this subparagraph, and
thereafter as the Administrator deems ap-
propriate, the Administrator shall deter-
mine, after notice and opportunity for com-
ment, whether it has been demonstrated to
the Administrator that a condition de-
scribed in clause (iii)(I) or clause (iii)(II)
continues to exist with respect to the toler-
ance and that the yearly and lifetime risks
from aggregate exposure to such residue
continue to comply with the limits specified
in clause (iv). If the Administrator deter-
mines by such date that such demonstra-
tion has not been made, the Administrator
shall, not later than 180 days after the
date of such determination, issue a regula-
tion under subsection (e)(1) to modify or
revoke the tolerance.
‘‘(vi) INFANTS AND CHILDREN.—Any
tolerance under this subparagraph shall
meet the requirements of subparagraph
(C).
‘‘(C) EXPOSURE OF INFANTS AND CHIL-
DREN.—In establishing, modifying, leaving in
effect, or revoking a tolerance or exemption for
a pesticide chemical residue, the Adminis-
trator—
‘‘(i) shall assess the risk of the pes-
ticide chemical residue based on—
‘‘(I) available information about
consumption patterns among infants
and children that are likely to result
in disproportionately high consump-
tion of foods containing or bearing
such residue among infants and chil-
dren in comparison to the general
population;
‘‘(II) available information con-
cerning the special susceptibility of in-
fants and children to the pesticide
chemical residues, including neuro-
logical differences between infants and
children and adults, and effects of in
utero exposure to pesticide chemicals;
and
‘‘(III) available information con-
cerning the cumulative effects on in-
fants and children of such residues
and other substances that have a com-
mon mechanism of toxicity; and
‘‘(ii) shall—
‘‘(I) ensure that there is a rea-
sonable certainty that no harm will re-
sult to infants and children from ag-
gregate exposure to the pesticide
chemical residue; and
‘‘(II) publish a specific deter-
mination regarding the safety of the
pesticide chemical residue for infants
and children.
The Secretary of Health and Human Services
and the Secretary of Agriculture, in consulta-
tion with the Administrator, shall conduct sur-
veys to document dietary exposure to pesticides
among infants and children. In the case of
threshold effects, for purposes of clause (ii)(I)
an additional tenfold margin of safety for the
pesticide chemical residue and other sources of
exposure shall be applied for infants and chil-
dren to take into account potential pre- and
post-natal toxicity and completeness of the data
with respect to exposure and toxicity to infants
and children. Notwithstanding such require-
ment for an additional margin of safety, the
Administrator may use a different margin of
safety for the pesticide chemical residue only if,
on the basis of reliable data, such margin will
be safe for infants and children.
‘‘(D) FACTORS.—In establishing, modify-
ing, leaving in effect, or revoking a tolerance or
exemption for a pesticide chemical residue, the
Administrator shall consider, among other rel-
evant factors—
‘‘(i) the validity, completeness, and re-
liability of the available data from studies
of the pesticide chemical and pesticide
chemical residue;
‘‘(ii) the nature of any toxic effect
shown to be caused by the pesticide chemi-
cal or pesticide chemical residue in such
studies;
‘‘(iii) available information concerning
the relationship of the results of such stud-
ies to human risk;
‘‘(iv) available information concerning
the dietary consumption patterns of con-
sumers (and major identifiable subgroups
of consumers);
‘‘(v) available information concerning
the cumulative effects of such residues and
other substances that have a common
mechanism of toxicity;
‘‘(vi) available information concerning
the aggregate exposure levels of consumers
(and major identifiable subgroups of con-
sumers) to the pesticide chemical residue
and to other related substances, including
dietary exposure under the tolerance and
all other tolerances in effect for the pes-
ticide chemical residue, and exposure from
other non-occupational sources;
‘‘(vii) available information concerning
the variability of the sensitivities of major
identifiable subgroups of consumers;
‘‘(viii) such information as the Admin-
istrator may require on whether the pes-
ticide chemical may have an effect in hu-
mans that is similar to an effect produced
by a naturally occurring estrogen or other
endocrine effects; and
‘‘(ix) safety factors which in the opin-
ion of experts qualified by scientific train-
ing and experience to evaluate the safety of
food additives are generally recognized as
appropriate for the use of animal experi-
mentation data.
‘‘(E) DATA AND INFORMATION REGARDING
ANTICIPATED AND ACTUAL RESIDUE LEVELS.—
‘‘(i) AUTHORITY.—In establishing, modify-
ing, leaving in effect, or revoking a tolerance for
a pesticide chemical residue, the Administrator
may consider available data and information on
the anticipated residue levels of the pesticide
chemical in or on food and the actual residue
levels of the pesticide chemical that have been
measured in food, including residue data col-
lected by the Food and Drug Administration.
‘‘(ii) REQUIREMENT.—If the Administrator
relies on anticipated or actual residue levels in
establishing, modifying, or leaving in effect a
tolerance, the Administrator shall pursuant to
subsection (f)(1) require that data be provided
five years after the date on which the tolerance
is established, modified, or left in effect, and
thereafter as the Administrator deems appro-
priate, demonstrating that such residue levels
are not above the levels so relied on. If such
data are not so provided, or if the data do not
demonstrate that the residue levels are not
above the levels so relied on, the Administrator
shall, not later than 180 days after the date on
which the data were required to be provided,
issue a regulation under subsection (e)(1), or
an order under subsection (f)(2), as appro-
priate, to modify or revoke the tolerance.
‘‘(F) 
PERCENT
OF
FOOD
ACTUALLY
TREATED.—In establishing, modifying, leaving
in effect, or revoking a tolerance for a pesticide
chemical residue, the Administrator may, when
assessing chronic dietary risk, consider available
data and information on the percent of food ac-
tually treated with the pesticide chemical (in-
cluding aggregate pesticide use data collected
by the Department of Agriculture) only if the
Administrator—
‘‘(i) finds that the data are reliable
and provide a valid basis to show what per-
centage of the food derived from such crop
is likely to contain such pesticide chemical
residue;
‘‘(ii) finds that the exposure estimate
does not understate exposure for any sig-
nificant subpopulation group;
‘‘(iii) finds that, if data are available
on pesticide use and consumption of food
in a particular area, the population in such
area is not dietarily exposed to residues
above those estimated by the Adminis-
trator; and
‘‘(iv) provides for the periodic reevalu-
ation of the estimate of anticipated dietary
exposure.
‘‘(3) DETECTION METHODS.—
‘‘(A) GENERAL RULE.—A tolerance for a
pesticide chemical residue in or on a food shall
not be established or modified by the Adminis-
trator unless the Administrator determines,
after consultation with the Secretary, that there
is a practical method for detecting and measur-
ing the levels of the pesticide chemical residue
in or on the food.
‘‘(B) DETECTION LIMIT.—A tolerance for
a pesticide chemical residue in or on a food
shall not be established at or modified to a level
lower than the limit of detection of the method
for detecting and measuring the pesticide chem-
ical residue specified by the Administrator
under subparagraph (A).
‘‘(4) INTERNATIONAL
STANDARDS.—In estab-
lishing a tolerance for a pesticide chemical residue in
or on a food, the Administrator shall determine
whether a maximum residue level for the pesticide
chemical has been established by the Codex
Alimentarius Commission. If a Codex maximum resi-
due level has been established for the pesticide
chemical and the Administrator does not propose to
adopt the Codex level, the Administrator shall pub-
lish for public comment a notice explaining the rea-
sons for departing from the Codex level.
‘‘(c) AUTHORITY
AND
STANDARD
FOR
EXEMP-
TIONS.—
‘‘(1) AUTHORITY.—The Administrator may
issue a regulation establishing, modifying, or revok-
ing an exemption from the requirement for a toler-
ance for a pesticide chemical residue in or on food—
‘‘(A) in response to a petition filed under
subsection (d); or
‘‘(B) on the Administrator’s initiative
under subsection (e).
‘‘(2) STANDARD.—
‘‘(A) GENERAL RULE.—
‘‘(i) STANDARD.—The Administrator
may establish or leave in effect an exemp-
tion from the requirement for a tolerance
for a pesticide chemical residue in or on
food only if the Administrator determines
that the exemption is safe. The Adminis-
trator shall modify or revoke an exemption
if the Administrator determines it is not
safe.
‘‘(ii) DETERMINATION OF SAFETY.—
The term ‘safe’, with respect to an exemp-
tion for a pesticide chemical residue,
means that the Administrator has deter-
mined that there is a reasonable certainty
that no harm will result from aggregate ex-
posure to the pesticide chemical residue,
including all anticipated dietary exposures
and all other exposures for which there is
reliable information.
‘‘(B) FACTORS.—In making a determina-
tion under this paragraph, the Administrator
shall take into account, among other relevant
considerations, the considerations set forth in
subparagraphs (C) and (D) of subsection
(b)(2).
‘‘(3) LIMITATION.—An exemption from the re-
quirement for a tolerance for a pesticide chemical
residue in or on food shall not be established or
modified by the Administrator unless the Adminis-
trator determines, after consultation with the Sec-
retary—
‘‘(A) that there is a practical method for
detecting and measuring the levels of such pes-
ticide chemical residue in or on food; or
‘‘(B) that there is no need for such a
method, and states the reasons for such deter-
mination in issuing the regulation establishing
or modifying the exemption.
‘‘(d) PETITION FOR TOLERANCE OR EXEMPTION.—
‘‘(1) PETITIONS AND PETITIONERS.—Any per-
son may file with the Administrator a petition pro-
posing the issuance of a regulation—
‘‘(A) establishing, modifying, or revoking a
tolerance for a pesticide chemical residue in or
on a food; or
‘‘(B) establishing, modifying, or revoking
an exemption from the requirement of a toler-
ance for such a residue.
‘‘(2) PETITION CONTENTS.—
‘‘(A) ESTABLISHMENT.—A petition under
paragraph (1) to establish a tolerance or ex-
emption for a pesticide chemical residue shall
be supported by such data and information as
are specified in regulations issued by the Ad-
ministrator, including—
‘‘(i)(I) an informative summary of the
petition and of the data, information, and
arguments submitted or cited in support of
the petition; and
‘‘(II) a statement that the petitioner
agrees that such summary or any informa-
tion it contains may be published as a part
of the notice of filing of the petition to be
published under this subsection and as
part of a proposed or final regulation is-
sued under this section;
‘‘(ii) the name, chemical identity, and
composition of the pesticide chemical resi-
due and of the pesticide chemical that pro-
duces the residue;
‘‘(iii) data showing the recommended
amount, frequency, method, and time of
application of that pesticide chemical;
‘‘(iv) full reports of tests and inves-
tigations made with respect to the safety of
the pesticide chemical, including full infor-
mation as to the methods and controls
used in conducting those tests and inves-
tigations;
‘‘(v) full reports of tests and inves-
tigations made with respect to the nature
and amount of the pesticide chemical resi-
due that is likely to remain in or on the
food, including a description of the analyt-
ical methods used;
‘‘(vi) a practical method for detecting
and measuring the levels of the pesticide
chemical residue in or on the food, or for
exemptions, a statement why such a meth-
od is not needed;
‘‘(vii) a proposed tolerance for the
pesticide chemical residue, if a tolerance is
proposed;
‘‘(viii) if the petition relates to a toler-
ance for a processed food, reports of inves-
tigations conducted using the processing
method(s) used to produce that food;
‘‘(ix) such information as the Admin-
istrator may require to make the deter-
mination under subsection (b)(2)(C);
‘‘(x) such information as the Adminis-
trator may require on whether the pes-
ticide chemical may have an effect in hu-
mans that is similar to an effect produced
by a naturally occurring estrogen or other
endocrine effects;
‘‘(xi) information regarding exposure
to the pesticide chemical residue due to
any tolerance or exemption already granted
for such residue;
‘‘(xii) practical methods for removing
any amount of the residue that would ex-
ceed any proposed tolerance; and
‘‘(xiii) such other data and informa-
tion as the Administrator requires by regu-
lation to support the petition.
If information or data required by this subpara-
graph is available to the Administrator, the per-
son submitting the petition may cite the avail-
ability of the information or data in lieu of sub-
mitting it. The Administrator may require a pe-
tition to be accompanied by samples of the pes-
ticide chemical with respect to which the peti-
tion is filed.
‘‘(B) MODIFICATION
OR
REVOCATION.—
The Administrator may by regulation establish
the requirements for information and data to
support a petition to modify or revoke a toler-
ance or to modify or revoke an exemption from
the requirement for a tolerance.
‘‘(3) NOTICE.—A notice of the filing of a peti-
tion that the Administrator determines has met the
requirements of paragraph (2) shall be published by
the Administrator within 30 days after such deter-
mination. The notice shall announce the availability
of a description of the analytical methods available
to the Administrator for the detection and measure-
ment of the pesticide chemical residue with respect
to which the petition is filed or shall set forth the
petitioner’s statement of why such a method is not
needed. The notice shall include the summary re-
quired by paragraph (2)(A)(i)(I).
‘‘(4) ACTIONS BY THE ADMINISTRATOR.—
‘‘(A) IN
GENERAL.—The Administrator
shall, after giving due consideration to a peti-
tion filed under paragraph (1) and any other
information available to the Administrator—
‘‘(i) issue a final regulation (which
may vary from that sought by the petition)
establishing, modifying, or revoking a tol-
erance for the pesticide chemical residue or
an exemption of the pesticide chemical res-
idue from the requirement of a tolerance
(which final regulation shall be issued
without further notice and without further
period for public comment);
‘‘(ii) issue a proposed regulation
under subsection (e), and thereafter issue
a final regulation under such subsection; or
‘‘(iii) issue an order denying the peti-
tion.
‘‘(B) 
PRIORITIES.—The 
Administrator
shall give priority to petitions for the establish-
ment or modification of a tolerance or exemp-
tion for a pesticide chemical residue that ap-
pears to pose a significantly lower risk to
human health from dietary exposure than pes-
ticide chemical residues that have tolerances in
effect for the same or similar uses.
‘‘(C) EXPEDITED REVIEW OF CERTAIN PE-
TITIONS.—
‘‘(i) DATE CERTAIN FOR REVIEW.—If
a person files a complete petition with the
Administrator proposing the issuance of a
regulation establishing a tolerance or ex-
emption for a pesticide chemical residue
that presents a lower risk to human health
than a pesticide chemical residue for which
a tolerance has been left in effect or modi-
fied under subsection (b)(2)(B), the Ad-
ministrator shall complete action on such
petition under this paragraph within 1
year.
‘‘(ii) REQUIRED DETERMINATIONS.—
If the Administrator issues a final regula-
tion establishing a tolerance or exemption
for a safer pesticide chemical residue under
clause (i), the Administrator shall, not
later than 180 days after the date on
which the regulation is issued, determine
whether a condition described in subclause
(I) or (II) of subsection (b)(2)(B)(iii) con-
tinues to exist with respect to a tolerance
that has been left in effect or modified
under subsection (b)(2)(B). If such condi-
tion does not continue to exist, the Admin-
istrator shall, not later than 180 days after
the date on which the determination under
the preceding sentence is made, issue a
regulation under subsection (e)(1) to mod-
ify or revoke the tolerance.
‘‘(e) ACTION
ON ADMINISTRATOR’S OWN INITIA-
TIVE.—
‘‘(1) GENERAL RULE.—The Administrator may
issue a regulation—
‘‘(A) establishing, modifying, suspending
under subsection (l)(3), or revoking a tolerance
for a pesticide chemical or a pesticide chemical
residue;
‘‘(B) establishing, modifying, suspending
under subsection (l)(3), or revoking an exemp-
tion of a pesticide chemical residue from the re-
quirement of a tolerance; or
‘‘(C) establishing general procedures and
requirements to implement this section.
‘‘(2) NOTICE.—Before issuing a final regulation
under paragraph (1), the Administrator shall issue
a notice of proposed rulemaking and provide a pe-
riod of not less than 60 days for public comment on
the proposed regulation, except that a shorter period
for comment may be provided if the Administrator
for good cause finds that it would be in the public
interest to do so and states the reasons for the find-
ing in the notice of proposed rulemaking.
‘‘(f) SPECIAL DATA REQUIREMENTS.—
‘‘(1) REQUIRING SUBMISSION OF ADDITIONAL
DATA.—If the Administrator determines that addi-
tional 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—
‘‘(A) issue a notice requiring the person
holding the pesticide registrations associated
with such tolerance or exemption to submit the
data or information under section 3(c)(2)(B) of
the 
Federal 
Insecticide, 
Fungicide, 
and
Rodenticide Act;
‘‘(B) issue a rule requiring that testing be
conducted on a substance or mixture under sec-
tion 4 of the Toxic Substances Control Act; or
‘‘(C) publish in the Federal Register, after
first providing notice and an opportunity for
comment of not less than 60 days’ duration, an
order—
‘‘(i) requiring the submission to the
Administrator by one or more interested
persons of a notice identifying the person
or persons who will submit the required
data and information;
‘‘(ii) describing the type of data and
information required to be submitted to
the Administrator and stating why the
data and information could not be obtained
under the authority of section 3(c)(2)(B)
of the Federal Insecticide, Fungicide, and
Rodenticide Act or section 4 of the Toxic
Substances Control Act;
‘‘(iii) describing the reports of the Ad-
ministrator required to be prepared during
and after the collection of the data and in-
formation;
‘‘(iv) requiring the submission to the
Administrator of the data, information,
and reports referred to in clauses (ii) and
(iii); and
‘‘(v) establishing dates by which the
submissions described in clauses (i) and
(iv) must be made.
The Administrator may under subparagraph
(C) revise any such order to correct an error.
The Administrator may under this paragraph
require data or information pertaining to
whether the pesticide chemical may have an ef-
fect in humans that is similar to an effect pro-
duced by a naturally occurring estrogen or
other endocrine effects.
‘‘(2) NONCOMPLIANCE.—If a submission re-
quired by a notice issued in accordance with para-
graph (1)(A), a rule issued under paragraph (1)(B),
or an order issued under paragraph (1)(C) is not
made by the time specified in such notice, rule, or
order, the Administrator may by order published in
the Federal Register modify or revoke the tolerance
or exemption in question. In any review of such an
order under subsection (g)(2), the only material
issue shall be whether a submission required under
paragraph (1) was not made by the time specified.
‘‘(g) EFFECTIVE DATE, OBJECTIONS, HEARINGS,
AND ADMINISTRATIVE REVIEW.—
‘‘(1) EFFECTIVE DATE.—A regulation or order
issued under subsection (d)(4), (e)(1), or (f)(2) shall
take effect upon publication unless the regulation or
order specifies otherwise. The Administrator may
stay the effectiveness of the regulation or order if,
after issuance of such regulation or order, objections
are filed with respect to such regulation or order
pursuant to paragraph (2).
‘‘(2) FURTHER PROCEEDINGS.—
‘‘(A) OBJECTIONS.—Within 60 days after
a regulation or order is issued under subsection
(d)(4), (e)(1)(A), (e)(1)(B), (f)(2), (n)(3), or
(n)(5)(C), any person may file objections there-
to with the Administrator, specifying with par-
ticularity the provisions of the regulation or
order deemed objectionable and stating reason-
able grounds therefor. If the regulation or order
was issued in response to a petition under sub-
section (d)(1), a copy of each objection filed by
a person other than the petitioner shall be
served by the Administrator on the petitioner.
‘‘(B) HEARING.—An objection may include
a request for a public evidentiary hearing upon
the objection. The Administrator shall, upon
the initiative of the Administrator or upon the
request of an interested person and after due
notice, hold a public evidentiary hearing if and
to the extent the Administrator determines that
such a public hearing is necessary to receive
factual evidence relevant to material issues of
fact raised by the objections. The presiding offi-
cer in such a hearing may authorize a party to
obtain discovery from other persons and may
upon a showing of good cause made by a party
issue a subpoena to compel testimony or pro-
duction of documents from any person. The
presiding officer shall be governed by the Fed-
eral Rules of Civil Procedure in making any
order for the protection of the witness or the
content of documents produced and shall order
the payment of a reasonable fees and expenses
as a condition to requiring testimony of the wit-
ness. On contest, such a subpoena may be en-
forced by a Federal district court.
‘‘(C) FINAL DECISION.—As soon as prac-
ticable after receiving the arguments of the par-
ties, the Administrator shall issue an order
stating the action taken upon each such objec-
tion and setting forth any revision to the regu-
lation or prior order that the Administrator has
found to be warranted. If a hearing was held
under subparagraph (B), such order and any
revision to the regulation or prior order shall,
with respect to questions of fact at issue in the
hearing, be based only on substantial evidence
of record at such hearing, and shall set forth in
detail the findings of facts and the conclusions
of law or policy upon which the order or regula-
tion is based.
100
‘‘(h) JUDICIAL REVIEW.—
‘‘(1) PETITION.—In a case of actual con-
troversy as to the validity of any regulation issued
under subsection (e)(1)(C), or any order issued
under subsection (f)(1)(C) or (g)(2)(C), or any regu-
lation that is the subject of such an order, any per-
son who will be adversely affected by such order or
regulation may obtain judicial review by filing in the
United States Court of Appeals for the circuit
wherein that person resides or has its principal place
of business, or in the United States Court of Ap-
peals for the District of Columbia Circuit, within 60
days after publication of such order or regulation, a
petition praying that the order or regulation be set
aside in whole or in part.
‘‘(2) RECORD AND JURISDICTION.—A copy of
the petition under paragraph (1) shall be forthwith
transmitted by the clerk of the court to the Adminis-
trator, or any officer designated by the Adminis-
trator for that purpose, and thereupon the Adminis-
trator shall file in the court the record of the pro-
ceedings on which the Administrator based the order
or regulation, as provided in section 2112 of title 28,
United States Code. Upon the filing of such a peti-
tion, the court shall have exclusive jurisdiction to af-
101
firm or set aside the order or regulation complained
of in whole or in part. As to orders issued following
a public evidentiary hearing, the findings of the Ad-
ministrator with respect to questions of fact shall be
sustained only if supported by substantial evidence
when considered on the record as a whole.
‘‘(3) ADDITIONAL EVIDENCE.—If a party ap-
plies to the court for leave to adduce additional evi-
dence and shows to the satisfaction of the court that
the additional evidence is material and that there
were reasonable grounds for the failure to adduce
the evidence in the proceeding before the Adminis-
trator, the court may order that the additional evi-
dence (and evidence in rebuttal thereof) shall be
taken before the Administrator in the manner and
upon the terms and conditions the court deems
proper. The Administrator may modify prior find-
ings as to the facts by reason of the additional evi-
dence so taken and may modify the order or regula-
tion accordingly. The Administrator shall file with
the court any such modified finding, order, or regu-
lation.
‘‘(4) FINAL JUDGMENT; SUPREME COURT RE-
VIEW.—The judgment of the court affirming or set-
ting aside, in whole or in part, any regulation or any
102
order and any regulation which is the subject of
such an order shall be final, subject to review by the
Supreme Court of the United States as provided in
section 1254 of title 28 of the United States Code.
The commencement of proceedings under this sub-
section shall not, unless specifically ordered by the
court to the contrary, operate as a stay of a regula-
tion or order.
‘‘(5) APPLICATION.—Any issue as to which re-
view is or was obtainable under this subsection shall
not be the subject of judicial review under any other
provision of law.
‘‘(i) CONFIDENTIALITY AND USE OF DATA.—
‘‘(1) GENERAL RULE.—Data and information
that are or have been submitted to the Adminis-
trator under this section or section 409 in support
of a tolerance or an exemption from a tolerance shall
be entitled to confidential treatment for reasons of
business confidentiality and to exclusive use and
data compensation to the same extent provided by
sections 3 and 10 of the Federal Insecticide, Fun-
gicide, and Rodenticide Act.
‘‘(2) EXCEPTIONS.—
‘‘(A) IN GENERAL.—Data and information
that are entitled to confidential treatment
103
under paragraph (1) may be disclosed, under
such security requirements as the Adminis-
trator may provide by regulation, to—
‘‘(i) employees of the United States
authorized by the Administrator to exam-
ine such data and information in the carry-
ing out of their official duties under this
Act or other Federal statutes intended to
protect the public health; or
‘‘(ii) contractors with the United
States authorized by the Administrator to
examine such data and information in the
carrying out of contracts under this Act or
such statutes.
‘‘(B) CONGRESS.—This subsection does
not authorize the withholding of data or infor-
mation from either House of Congress or from,
to the extent of matter within its jurisdiction,
any committee or subcommittee of such com-
mittee or any joint committee of Congress or
any subcommittee of such joint committee.
‘‘(3) SUMMARIES.—Notwithstanding any provi-
sion of this subsection or other law, the Adminis-
trator may publish the informative summary re-
quired by subsection (d)(2)(A)(i) and may, in issu-
104
ing a proposed or final regulation or order under
this section, publish an informative summary of the
data relating to the regulation or order.
‘‘(j) STATUS
OF
PREVIOUSLY
ISSUED
REGULA-
TIONS.—
‘‘(1) REGULATIONS UNDER SECTION 406.—Reg-
ulations affecting pesticide chemical residues in or
on raw agricultural commodities promulgated, in ac-
cordance with section 701(e), under the authority of
section 406(a) upon the basis of public hearings in-
stituted before January 1, 1953, shall be deemed to
be regulations issued under this section and shall be
subject to modification or revocation under sub-
sections (d) and (e), and shall be subject to review
under subsection (q).
‘‘(2) REGULATIONS UNDER SECTION 409.—Reg-
ulations that established tolerances for substances
that are pesticide chemical residues in or on proc-
essed food, or that otherwise stated the conditions
under which such pesticide chemicals could be safely
used, and that were issued under section 409 on or
before the date of the enactment of this paragraph,
shall be deemed to be regulations issued under this
section and shall be subject to modification or rev-
105
ocation under subsection (d) or (e), and shall be
subject to review under subsection (q).
‘‘(3) REGULATIONS UNDER SECTION 408.—Reg-
ulations that established tolerances or exemptions
under this section that were issued on or before the
date of the enactment of this paragraph shall remain
in effect unless modified or revoked under subsection
(d) or (e), and shall be subject to review under sub-
section (q).
‘‘(k) TRANSITIONAL PROVISION.—If, on the day be-
fore the date of the enactment of this subsection, a sub-
stance that is a pesticide chemical was, with respect to
a particular pesticidal use of the substance and any result-
ing pesticide chemical residue in or on a particular food—
‘‘(1) regarded by the Administrator or the Sec-
retary as generally recognized as safe for use within
the meaning of the provisions of subsection (a) or
section 201(s) as then in effect; or
‘‘(2) regarded by the Secretary as a substance
described by section 201(s)(4);
such a pesticide chemical residue shall be regarded as ex-
empt from the requirement for a tolerance, as of the date
of enactment of this subsection. The Administrator shall
by regulation indicate which substances are described by
this subsection. Any exemption under this subsection may