0597.11_Attachment I

Attachment I.pdf

Tolerance Petitions for Pesticides on Food/Feed Crops and New Inert Ingredients

0597.11_Attachment I

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PUBLIC LAW 110–94—OCT. 9, 2007

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PESTICIDE REGISTRATION IMPROVEMENT
RENEWAL ACT

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121 STAT. 1000

PUBLIC LAW 110–94—OCT. 9, 2007

Public Law 110–94
110th Congress
An Act
Oct. 9, 2007
[S. 1983]

Pesticide
Registration
Improvement
Renewal Act.
7 USC 136 note.

To amend the Federal Insecticide, Fungicide, and Rodenticide Act to renew and
amend the provisions for the enhanced review of covered pesticide products,
to authorize fees for certain pesticide products, to extend and improve the collection
of maintenance fees, and for other purposes.

Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.

This Act may be cited as the ‘‘Pesticide Registration Improvement Renewal Act’’.
SEC. 2. REVIEW OF APPLICATIONS.

Section 3(c)(3)(B)(ii) of the Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. 136a(c)(3)(B)(ii)) is amended—
(1) in subparagraph (I), by striking ‘‘within 45 days’’ and
all that follows through ‘‘and,’’ and inserting ‘‘review the
application in accordance with section 33(f)(4)(B) and,’’; and
(2) in subparagraph (II), by striking ‘‘within’’ and inserting
‘‘not later than the applicable decision review time established
pursuant to section 33(f)(4)(B), or, if no review time is established, not later than’’.
SEC. 3. REGISTRATION REVIEW.

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Deadline.

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Section 3(g)(1) of the Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. 136a(g)(1)) is amended—
(1) in subparagraph (A)—
(A) in the first sentence, by striking ‘‘The registrations’’
and inserting the following:
‘‘(i) IN GENERAL.—The registrations’’;
(B) in the second sentence, by striking ‘‘The Administrator’’ and inserting the following:
‘‘(ii) REGULATIONS.—In accordance with this subparagraph, the Administrator’’; and
(C) by striking ‘‘The goal’’ and all that follows through
‘‘No registration’’ and inserting the following:
‘‘(iii) INITIAL REGISTRATION REVIEW.—The Administrator shall complete the registration review of each pesticide or pesticide case, which may be composed of 1 or
more active ingredients and the products associated with
the active ingredients, not later than the later of—
‘‘(I) October 1, 2022; or
‘‘(II) the date that is 15 years after the date on
which the first pesticide containing a new active ingredient is registered.

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PUBLIC LAW 110–94—OCT. 9, 2007

121 STAT. 1001

‘‘(iv) SUBSEQUENT REGISTRATION REVIEW.—Not later
than 15 years after the date on which the initial registration review is completed under clause (iii) and each 15
years thereafter, the Administrator shall complete a subsequent registration review for each pesticide or pesticide
case.
‘‘(v) CANCELLATION.—No registration’’;
(2) by redesignating subparagraph (B) as subparagraph
(C); and
(3) by inserting after subparagraph (A) the following:
‘‘(B) DOCKETING.—
‘‘(i) IN GENERAL.—Subject to clause (ii), after meeting
with 1 or more individuals that are not government
employees to discuss matters relating to a registration
review, the Administrator shall place in the docket minutes
of the meeting, a list of attendees, and any documents
exchanged at the meeting, not later than the earlier of—
‘‘(I) the date that is 45 days after the meeting;
or
‘‘(II) the date of issuance of the registration review
decision.
‘‘(ii) PROTECTED INFORMATION.—The Administrator
shall identify, but not include in the docket, any confidential business information the disclosure of which is prohibited by section 10.’’.

Deadline.

Deadline.

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SEC. 4. MAINTENANCE FEES.

(a) TOTAL AMOUNT OF FEES.—Section 4(i)(5)(C) of the Federal
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a–
1(i)(5)(C)) is amended by striking ‘‘amount of’’ and all that follows
through the end of clause (v) and inserting ‘‘amount of $22,000,000
for each of fiscal years 2008 through 2012’’.
(b) AMOUNTS FOR REGISTRANTS.—Section 4(i)(5) of the Federal
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a–1(i)(5)
is amended—
(1) in subparagraph (D)—
(A) in clause (i), by striking by striking ‘‘shall be’’
and all that follows through the end of subclause (IV)
and inserting ‘‘shall be $71,000 for each of fiscal years
2008 through 2012; and’’; and
(B) in clause (ii), by striking ‘‘shall be’’ and all that
follows through the end of subclause (IV) and inserting
‘‘shall be $123,000 for each of fiscal years 2008 through
2012.’’; and
(2) in subparagraph (E)(i)—
(A) in subclause (I), by striking ‘‘shall be’’ and all
that follows through the end of item (dd) and inserting
‘‘shall be $50,000 for each of fiscal years 2008 through
2012; and’’; and
(B) in subclause (II), by striking ‘‘shall be’’ and all
that follows through the end of item (dd) and inserting
‘‘shall be $86,000 for each of fiscal years 2008 through
2012.’’.
(c) EXTENSION OF AUTHORITY FOR COLLECTING MAINTENANCE
FEES.—Section 4(i)(5)(H) of the Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. 136a–1(i)(5)(H) is amended by striking
‘‘2008’’ and inserting ‘‘2012.’’

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121 STAT. 1002

PUBLIC LAW 110–94—OCT. 9, 2007
(d) OTHER FEES.—
(1) IN GENERAL.—Section 4(i)(6) of the Federal Insecticide,
Fungicide, and Rodenticide Act (7 U.S.C. 136a–1(i)(6)) is
amended by striking ‘‘2010’’ and inserting ‘‘2014’’.
(2) PROHIBITION ON TOLERANCE FEES.—Section 408(m) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a(m))
is amended by adding at the end the following:
‘‘(3) PROHIBITION.—During the period beginning on the
effective date of the Pesticide Registration Improvement
Renewal Act and ending on September 30, 2012, the Administrator shall not collect any tolerance fees under paragraph
(1).’’.
(e) REREGISTRATION AND EXPEDITED PROCESSING FUND.—
(1) SOURCE AND USE.—Section 4(k)(2)(A) of the Federal
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a–
1(k)(2)(A)) is amended—
(A) in the first sentence, by inserting ‘‘and to offset
the costs of registration review under section 3(g)’’ after
‘‘paragraph (3)’’;
(B) in clause (i), by inserting ‘‘and to offset the costs
of registration review under section 3(g)’’ after ‘‘paragraph
(3)’’; and
(C) in clause (ii), by inserting ‘‘and to offset the costs
of registration review under section 3(g)’’ after ‘‘paragraph
(3)’’.
(2) EXPEDITED PROCESSING OF SIMILAR APPLICATIONS.—Section 4(k)(3)(A) of the Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. 136a–1(k)(3)(A)) is amended by
striking ‘‘2007 and 2008’’ and inserting ‘‘2008 through 2012’’.

Effective date.
Termination
date.

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SEC. 5. PESTICIDE REGISTRATION SERVICE FEES.

(a) DOCUMENTATION.—Section 33(b)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(b)(2)) is
amended—
(1) in subparagraph (C), by striking clause (ii) and inserting
the following:
‘‘(ii) payment of at least 25 percent of the registration service fee and a request for a waiver from or
reduction of the remaining amount of the registration
service fee.’’; and
(2) by adding at the end the following:
‘‘(D) PAYMENT.—The registration service fee required
under this subsection shall be due upon submission of
the application.
‘‘(E) APPLICATIONS SUBJECT TO ADDITIONAL FEES.—An
application may be subject to additional fees if—
‘‘(i) the applicant identified the incorrect registration service fee and decision review period;
‘‘(ii) after review of a waiver request, the Administrator denies the waiver request; or
‘‘(iii) after review of the application, the Administrator determines that a different registration service
fee and decision review period apply to the application.
‘‘(F) EFFECT OF FAILURE TO PAY FEES.—The Administrator shall reject any application submitted without the
required registration service fee.
‘‘(G) NON-REFUNDABLE PORTION OF FEES.—

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PUBLIC LAW 110–94—OCT. 9, 2007

121 STAT. 1003

‘‘(i) IN GENERAL.—The Administrator shall retain
25 percent of the applicable registration service fee.
‘‘(ii) LIMITATION.—Any waiver, refund, credit or
other reduction in the registration service fee shall
not exceed 75 percent of the registration service fee.
‘‘(H) COLLECTION OF UNPAID FEES.—In any case in
which the Administrator does not receive payment of a
registration service fee (or applicable portion of the registration service fee) by the date that is 30 days after
the fee is due, the fee shall be treated as a claim of
the United States Government subject to subchapter II
of chapter 37 of title 31, United States Code.’’.
(b) AMOUNT OF FEES.—Section 33(b) of the Federal Insecticide,
Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(b)) is amended—
(1) in paragraph (3)—
(A) in subparagraph (A), by striking ‘‘Pesticide Registration Improvement Act of 2003’’ and inserting ‘‘Pesticide
Registration Improvement Renewal Act’’; and
(B) in subparagraph (B), by striking ‘‘S11631’’ and
all that follows through the end of the subparagraph and
inserting ‘‘S10409 through S10411, dated July 31, 2007.’’;
and
(2) by striking paragraph (6) and inserting the following:
‘‘(6) FEE ADJUSTMENT.—
‘‘(A) IN GENERAL.—Effective for a covered pesticide registration application received during the period beginning
on October 1, 2008, and ending on September 30, 2010,
the Administrator shall increase by 5 percent the registration service fee payable for the application under paragraph
(3).
‘‘(B) ADDITIONAL ADJUSTMENT.—Effective for a covered
pesticide registration application received on or after
October 1, 2010, the Administrator shall increase by an
additional 5 percent the registration service fee in effect
as of September 30, 2010.
‘‘(C) PUBLICATION.—The Administrator shall publish
in the Federal Register the revised registration service
fee schedules.’’.
(c) WAIVERS AND REDUCTIONS.—Section 33(b)(7)(F) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–
8(b)(7)(F)) is amended—
(1) in clause (ii), by striking ‘‘all’’ and inserting ‘‘75 percent’’;
and
(2) in clause (iv)(II), by striking ‘‘all’’ and inserting ‘‘75
percent of the applicable.’’.
(d) REFUNDS.—Section 33(b)(8)(A) of the Federal Insecticide,
Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(b)(8)(A)) is
amended by striking ‘‘10 percent’’ and inserting ‘‘25 percent.’’.
(e) PESTICIDE REGISTRATION FUND.—Section 33(c) of the Federal
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(c))
is amended—
(1) in paragraph (1)(B), by striking ‘‘paragraph (4)’’ and
inserting ‘‘paragraph (5)’’;
(2) in paragraph (3)—
(A) by striking subparagraph (B) and inserting the
following:
‘‘(B) WORKER PROTECTION.—

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Deadline.

Effective date.
Termination
date.

Effective date.

Federal Register,
publication.

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121 STAT. 1004

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Deadlines.

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PUBLIC LAW 110–94—OCT. 9, 2007

‘‘(i) IN GENERAL.—For each of fiscal years 2008
through 2012, the Administrator shall use approximately 1⁄17 of the amount in the Fund (but not less
than $1,000,000) to enhance scientific and regulatory
activities relating to worker protection.
‘‘(ii) PARTNERSHIP GRANTS.—Of the amounts in the
Fund, the Administrator shall use for partnership
grants—
‘‘(I) for each of fiscal years 2008 and 2009,
$750,000; and
‘‘(II) for each of fiscal years 2010 through 2012,
$500,000.
‘‘(iii) PESTICIDE SAFETY EDUCATION PROGRAM.—Of
the amounts in the Fund, the Administrator shall use
$500,000 for each of fiscal years 2008 through 2012
to carry out the pesticide safety education program.’’;
and
(B) by striking subparagraph (C); and
(3) in paragraph (5)—
(A) by redesignating subparagraphs (A) through (C)
as clauses (i) through (iii), respectively;
(B) by striking ‘‘Amounts’’ and inserting the following:
‘‘(A) IN GENERAL.—Amounts’’; and
(C) by adding at the end the following:
‘‘(B) USE OF INVESTMENT INCOME.—After consultation
with the Secretary of the Treasury, the Administrator may
use income from investments described in clauses (ii) and
(iii) of subparagraph (A) to carry out this section.’’.
(f) ASSESSMENT OF FEES.—Section 33(d)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(d)(2)) is
amended by striking ‘‘For fiscal years 2004, 2005 and 2006 only,
registration’’ and inserting ‘‘Registration’’.
(g) DECISION REVIEW TIMES.—Section 33(f) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(f)) is
amended—
(1) in paragraph (1), by striking ‘‘Pesticide Registration
Improvement Act of 2003’’ and inserting ‘‘Pesticide Registration
Improvement Renewal Act’’;
(2) in paragraph (2), by striking ‘‘S11631’’ and all that
follows through the end of the paragraph and inserting ‘‘S10409
through S10411, dated July 31, 2007.’’; and
(3) in paragraph (4), by striking subparagraph (B) and
inserting the following:
‘‘(B) COMPLETENESS OF APPLICATION.—
‘‘(i) IN GENERAL.—Not later than 21 days after
receiving an application and the required registration
service fee, the Administrator shall conduct an initial
screening of the contents of the application in accordance with clause (iii).
‘‘(ii) REJECTION.—If the Administrator determines
under clause (i) that the application does not pass
the initial screening and cannot be corrected within
the 21-day period, the Administrator shall reject the
application not later than 10 days after making the
determination.

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PUBLIC LAW 110–94—OCT. 9, 2007

121 STAT. 1005

‘‘(iii) REQUIREMENTS OF SCREENING.—In conducting
an initial screening of an application, the Administrator shall determine whether—
‘‘(I)(aa) the applicable registration service fee
has been paid; or
‘‘(bb) at least 25 percent of the applicable registration service fee has been paid and the application contains a waiver or refund request for the
outstanding amount and documentation establishing the basis for the waiver request; and
‘‘(II) the application contains all the necessary
forms, data, and draft labeling, formatted in
accordance with guidance published by the
Administrator.’’.
(h) REPORTS.—Section 33(k) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(k)) is amended—
(1) in paragraph (1), by striking ‘‘March 1, 2009’’ and
inserting ‘‘March 1, 2014’’; and
(2) in paragraph (2)—
(A) in subparagraph (A)—
(i) by redesignating clauses (ii) through and (iv)
as clauses (v) through (vii), respectively;
(ii) by inserting after clause (i) the following:
‘‘(ii) the number of label amendments that have
been reviewed using electronic means;
‘‘(iii) the amount of money from the Reregistration
and Expedited Processing Fund used to carry out inert
ingredient review and review of similar applications
under section 4(k)(3);
‘‘(iv) the number of applications completed for identical or substantially similar applications under section
3(c)(3)(B), including the number of such applications
completed within 90 days pursuant to that section;’’;
and
(iii) in clause (vi) (as redesignated by clause (i))—
(I) in subclause (II), by striking ‘‘and’’ at the
end;
(II) in subclause (III), by striking ‘‘and’’ at
the end; and
(III) by adding at the end the following:
‘‘(IV) providing for electronic submission and
review of labels, including process improvements
to further enhance the procedures used in electronic label review; and
‘‘(V) the allowance and use of summaries of
acute toxicity studies; and’’;
(B) in subparagraph (B), by striking ‘‘and’’ at the end;
(C) in subparagraph (C), by striking the period at
the end and inserting a semicolon; and
(D) by adding at the end the following:
‘‘(D) a review of the progress in carrying out section
3(g), including—
‘‘(i) the number of pesticides or pesticide cases
reviewed;
‘‘(ii) a description of the staffing and resources
relating to the costs associated with the review and

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121 STAT. 1006

PUBLIC LAW 110–94—OCT. 9, 2007

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decision making relating to reregistration and registration review for compliance with the deadlines specified
in this Act;
‘‘(iii) to the extent determined appropriate by the
Administrator and consistent with the authorities of
the Administrator and limitations on delegation of
functions by the Administrator, recommendations for—
‘‘(I) process improvements in the handling of
registration review under section 3(g);
‘‘(II) providing for accreditation of outside
reviewers and the use of outside reviewers in the
registration review process; and
‘‘(III) streamlining the registration review
process, consistent with section 3(g);
‘‘(E) a review of the progress in meeting the timeline
requirements for the review of antimicrobial pesticide products under section 3(h); and
‘‘(F) a review of the progress in carrying out the review
of inert ingredients, including the number of applications
pending, the number of new applications, the number of
applications reviewed, staffing, and resources devoted to
the review of inert ingredients and recommendations to
improve the timeliness of review of inert ingredients.’’.
(i) TERMINATION OF EFFECTIVENESS.—Section 33(m) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–
8(m)) is amended—
(1) in paragraph (1), by striking ‘‘2008’’ and inserting
‘‘2012’’; and
(2) in paragraph (2)—
(A) in subparagraph (A)—
(i) in the subparagraph heading, by striking ‘‘2009’’
and inserting ‘‘2013’’; and
(ii) by striking ‘‘2009’’ and inserting ‘‘2013’’; and
(B) in subparagraphs (B) and (C)—
(i) in the subparagraph headings, by striking ‘‘2010’’
each place it appears and inserting ‘‘2014’’; and
(ii) by striking ‘‘2010’’ each place it appears and
inserting ‘‘2014’’; and
(C) in subparagraph (D), by striking ‘‘2008’’ each place
it appears and inserting ‘‘2012’’.

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PUBLIC LAW 110–94—OCT. 9, 2007

121 STAT. 1007

SEC. 6. EFFECTIVE DATE.

7 USC 136a note.

This Act and the amendments made by this Act take effect
on October 1, 2007.
Approved October 9, 2007.

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LEGISLATIVE HISTORY—S. 1983:
CONGRESSIONAL RECORD, Vol. 153 (2007):
Aug. 2, considered and passed Senate.
Sept. 24, considered and passed House.

Æ

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