[110th Congress Public Law 94]
[From the U.S. Government Printing Office]
[DOCID: f:publ094.110]
[[Page 999]]
PESTICIDE REGISTRATION IMPROVEMENT RENEWAL ACT
[[Page 121 STAT. 1000]]
Public Law 110-94
110th Congress
An Act
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. <<NOTE: Oct. 9, 2007 - [S. 1983]>>
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, <<NOTE: Pesticide
Registration Improvement Renewal Act.>>
SECTION 1. <<NOTE: 7 USC 136 note.>> 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.
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 <<NOTE: Deadline.>> 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.
[[Page 121 STAT. 1001]]
``(iv) Subsequent <<NOTE: Deadline.>> 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 <<NOTE: Deadline.>> 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.''.
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.''
[[Page 121 STAT. 1002]]
(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 <<NOTE: Effective
date. Termination date.>> 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''.
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.--
[[Page 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 <<NOTE: Deadline.>> 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 <<NOTE: Effective
date. Termination date.>> 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 <<NOTE: Effective date.>> 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 <<NOTE: Federal
Register, publication.>> 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.--
[[Page 121 STAT. 1004]]
``(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 <<NOTE: Deadlines.>> 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.
[[Page 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
[[Page 121 STAT. 1006]]
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''.
[[Page 121 STAT. 1007]]
SEC. 6. <<NOTE: 7 USC 136a note.>> EFFECTIVE DATE.
This Act and the amendments made by this Act take effect on October
1, 2007.
Approved October 9, 2007.
LEGISLATIVE HISTORY--S. 1983:
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CONGRESSIONAL RECORD, Vol. 153 (2007):
Aug. 2, considered and passed Senate.
Sept. 24, considered and passed House.
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