[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 1983 Enrolled Bill (ENR)]
S.1983
One Hundred Tenth Congress
of the
United States of America
AT THE FIRST SESSION
Begun and held at the City of Washington on Thursday,
the fourth day of January, two thousand and seven
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.
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.
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.
``(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.''.
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.''
(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''.
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.--
``(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.--
``(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.
``(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
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''.
SEC. 6. EFFECTIVE DATE.
This Act and the amendments made by this Act take effect on October
1, 2007.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.