One Hundred Tenth Congress of the United States of America
1st Session
Begun and held at the City of Washington on Thursday, the fourth day of January, two thousand and seven
S. 1983
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.
Short title
This Act may be cited as the
Pesticide Registration Improvement
Renewal Act
.
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—
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
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
.
Registration review
Section 3(g)(1) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a(g)(1)) is amended—
in subparagraph (A)—
in the first sentence, by striking
The registrations
and inserting the following:
In general
The registrations
;
in the second sentence, by striking
The Administrator
and inserting the following:
Regulations
In accordance with this subparagraph, the Administrator
; and
by striking The goal
and all
that follows through No registration
and inserting the
following:
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—
October 1, 2022; or
the date that is 15 years after the date on which the first pesticide containing a new active ingredient is registered.
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.
Cancellation
No registration
;
by redesignating subparagraph (B) as subparagraph (C); and
by inserting after subparagraph (A) the following:
Docketing
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—
the date that is 45 days after the meeting; or
the date of issuance of the registration review decision.
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.
.
Maintenance fees
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
.
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—
in subparagraph (D)—
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
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
in subparagraph (E)(i)—
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
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.
.
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.
Other fees
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
.
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:
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).
.
Reregistration and expedited processing fund
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—
in the first sentence, by inserting
and to offset the costs of registration review under section
3(g)
after paragraph (3)
;
in clause (i), by inserting and to
offset the costs of registration review under section 3(g)
after
paragraph (3)
; and
in clause (ii), by inserting and to
offset the costs of registration review under section 3(g)
after
paragraph (3)
.
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
.
Pesticide registration service fees
Documentation
Section 33(b)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(b)(2)) is amended—
in subparagraph (C), by striking clause (ii) and inserting the following:
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
by adding at the end the following:
Payment
The registration service fee required under this subsection shall be due upon submission of the application.
Applications subject to additional fees
An application may be subject to additional fees if—
the applicant identified the incorrect registration service fee and decision review period;
after review of a waiver request, the Administrator denies the waiver request; or
after review of the application, the Administrator determines that a different registration service fee and decision review period apply to the application.
Effect of failure to pay fees
The Administrator shall reject any application submitted without the required registration service fee.
Non-refundable portion of fees
In general
The Administrator shall retain 25 percent of the applicable registration service fee.
Limitation
Any waiver, refund, credit or other reduction in the registration service fee shall not exceed 75 percent of the registration service fee.
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.
.
Amount of fees
Section 33(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(b)) is amended—
in paragraph (3)—
in subparagraph (A), by striking
Pesticide Registration Improvement Act of 2003
and inserting
Pesticide Registration Improvement
Renewal Act
; and
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
by striking paragraph (6) and inserting the following:
Fee adjustment
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).
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.
Publication
The Administrator shall publish in the Federal Register the revised registration service fee schedules.
.
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—
in clause (ii), by striking
all
and inserting 75 percent
; and
in clause (iv)(II), by striking
all
and inserting 75 percent of the
applicable.
.
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.
.
Pesticide registration fund
Section 33(c) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(c)) is amended—
in paragraph (1)(B), by striking
paragraph (4)
and inserting paragraph (5)
;
in paragraph (3)—
by striking subparagraph (B) and inserting the following:
Worker protection
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.
Partnership grants
Of the amounts in the Fund, the Administrator shall use for partnership grants—
for each of fiscal years 2008 and 2009, $750,000; and
for each of fiscal years 2010 through 2012, $500,000.
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
by striking subparagraph (C); and
in paragraph (5)—
by redesignating subparagraphs (A) through (C) as clauses (i) through (iii), respectively;
by striking Amounts
and
inserting the following:
In general
Amounts
; and
by adding at the end the following:
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.
.
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
.
Decision review times
Section 33(f) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(f)) is amended—
in paragraph (1), by striking
Pesticide Registration Improvement Act of 2003
and inserting
Pesticide Registration Improvement
Renewal Act
;
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
in paragraph (4), by striking subparagraph (B) and inserting the following:
Completeness of application
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).
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.
Requirements of screening
In conducting an initial screening of an application, the Administrator shall determine whether—
the applicable registration service fee has been paid; or
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
the application contains all the necessary forms, data, and draft labeling, formatted in accordance with guidance published by the Administrator.
.
Reports
Section 33(k) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(k)) is amended—
in paragraph (1), by striking March
1, 2009
and inserting March 1, 2014
; and
in paragraph (2)—
in subparagraph (A)—
by redesignating clauses (ii) through and (iv) as clauses (v) through (vii), respectively;
by inserting after clause (i) the following:
the number of label amendments that have been reviewed using electronic means;
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);
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
in clause (vi) (as redesignated by clause (i))—
in subclause (II), by striking
and
at the end;
in subclause (III), by striking
and
at the end; and
by adding at the end the following:
providing for electronic submission and review of labels, including process improvements to further enhance the procedures used in electronic label review; and
the allowance and use of summaries of acute toxicity studies; and
;
in subparagraph (B), by striking
and
at the end;
in subparagraph (C), by striking the period at the end and inserting a semicolon; and
by adding at the end the following:
a review of the progress in carrying out section 3(g), including—
the number of pesticides or pesticide cases reviewed;
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;
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—
process improvements in the handling of registration review under section 3(g);
providing for accreditation of outside reviewers and the use of outside reviewers in the registration review process; and
streamlining the registration review process, consistent with section 3(g);
a review of the progress in meeting the timeline requirements for the review of antimicrobial pesticide products under section 3(h); and
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.
.
Termination of effectiveness
Section 33(m) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(m)) is amended—
in paragraph (1), by striking
2008
and inserting 2012
; and
in paragraph (2)—
in subparagraph (A)—
in the subparagraph heading, by striking
2009
and inserting 2013
; and
by striking 2009
and
inserting 2013
; and
in subparagraphs (B) and (C)—
in the subparagraph headings, by striking
2010
each place it appears and inserting
2014
; and
by striking 2010
each place
it appears and inserting 2014
; and
in subparagraph (D), by striking
2008
each place it appears and inserting
2012
.
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