[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[H.R. 967 Reported in House (RH)]
Union Calendar No. 431
103d CONGRESS
2d Session
H. R. 967
[Report No. 103-784]
_______________________________________________________________________
A BILL
To amend the Federal Insecticide, Fungicide, and Rodenticide Act with
respect to minor use pesticides.
_______________________________________________________________________
October 3, 1994
Reported with an amendment, committed to the Committee of the Whole
House on the State of the Union, and ordered to be printed
Union Calendar No. 431
103d CONGRESS
2d Session
H. R. 967
[Report No. 103-784]
To amend the Federal Insecticide, Fungicide, and Rodenticide Act with
respect to minor use pesticides.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
February 18, 1993
Mr. de la Garza (for himself, Mr. Roberts, Mr. Stenholm, Mr. Smith of
Oregon, Mr. Thomas of California, Mr. Rowland, Mr. Inslee, Mr.
Kopetski, Mr. Lehman, Mr. Fazio, Mr. Dooley, and Mr. Condit) introduced
the following bill; which was referred to the Committee on Agriculture
July 9, 1993
Additional sponsors: Mr. LaRocco, Mr. Henry, Mr. Ravenel, Mr. Stump,
Mr. Paxon, Mr. Swift, Mr. Barrett of Nebraska, Mr. Camp, Mr. Allard,
Mr. Upton, Mr. Gekas, Mr. McHugh, Mr. Lewis of Flordia, Mr. Lewis of
California, Mr. Gallegly, Mr. Boehner, Mr. Emerson, Mr. Doolittle, Mr.
Kingston, Mr. Gillmor, Mr. Kanjorski, Mr. McDade, Mr. Holden, Mr.
Quillen, Mr. Hughes, Mr. Kyl, Mr. Johnson of South Dakota, Mr. Roth,
Mr. Smith of Michigan, Mr. Orton, Mr. Packard, Mr. Ewing, Mr. Pastor,
Mr. Spratt, Mr. Pomeroy, Mr. Barcia of Michigan, Ms. Slaughter, Mr.
Nussle, Mr. Baccus of Florida, Mr. Bonilla, Mr. Hoekstra, Mr. Bliley,
Mr. Shaw, Mr. Crapo, Mr. Kolbe, Mr. Houghton, Mr. English of Oklahoma,
Mr. Canady, Mr. McCandless, Mr. Dornan, Mr. Bereuter, Mr. Sarpalius,
Mr. Moorhead, Mr. Sisisky, Mr. Pombo, Mr. Walsh, Mr. Dickey, Mr.
Peterson of Minnesota, Mr. Ridge, Mr. Hansen, Mr. Walker, Mr. Olver,
Mr. Dreier, Mr. Matsui, Mr. Santorum, Mr. Herger, Mr. Baker of
Louisiana, Mr. Bishop, Mr. Clyburn, Mr. Gunderson, Mr. Darden, Mrs.
Thurman, Mr. Traficant, Mrs. Fowler, Mr. Bateman, Mr. Calvert, Mr.
Gilman, Mr. McCollum, Ms. Snowe, Mr. Bevill, Mr. Fields of Texas, Mr.
Andrews of New Jersey, Mr. Zeliff, Mr. Johnston of Florida, Mr. Baker
of California, Mr. Johnson of Georgia, Mr. Castle, Mr. Goodling, and
Mr. Stearns
October 3, 1994
Additional sponsors: Mr. Ballenger, Mr. Carr of Michigan, Mr.
Cunningham, Mr. Hobson, Mr. Murtha, Mr. Machtley, Mr. Hancock, Mr.
Peterson of Florida, Mr. Young of Alaska, Mr. Inglis of South Carolina,
Ms. Dunn, Mr. Stupak, Mr. Solomon, Mr. Jacobs, Mr. Blute, Mr. Talent,
Mr. Hastert, Mr. Lightfoot, Ms. Kaptur, Mr. Cox, Mr. Clement, Mr.
Cramer, Mr. Levy, Ms. Furse, Mr. Mica, Mr. Goodlatte, Mr. Smith of New
Jersey, Mr. Grandy, Mr. Farr of California, Mr. Smith of Texas, Mrs.
Vucanovich, Mr. Royce, Mr. Wolf, Mr. Deutsch, Mr. Barca of Wisconsin,
and Mr. Ehlers
October 3, 1994
Reported with an amendment, committed to the Committee of the Whole
House on the State of the Union, and ordered to be printed
[Strike out all after the enacting clause and insert the part printed
in italic]
[For text of introduced bill, see copy of bill as introduced on
February 18, 1993]
_______________________________________________________________________
A BILL
To amend the Federal Insecticide, Fungicide, and Rodenticide Act with
respect to minor use pesticides.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; REFERENCE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Minor Crop
Protection Act of 1994''.
(b) Reference.--Whenever in this Act an amendment 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 provision of the Federal Insecticide, Fungicide, and Rodenticide
Act.
(c) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; reference; table of contents.
TITLE I--MINOR CROP PROTECTION
Sec. 101. Minor crop protection.
TITLE II--PUBLIC HEALTH PESTICIDES
Sec. 201. Definitions.
Sec. 202. Registration.
Sec. 203. Reregistration.
Sec. 204. Cancellation.
Sec. 205. Views of the Secretary of Health and Human Services.
Sec. 206. Authority of Administrator.
Sec. 207. Identification of pests.
Sec. 208. Authorization of appropriations.
TITLE III--ANTIMICROBIAL PESTICIDES
Sec. 301. Antimicrobial pesticides.
Sec. 302. Pesticide labeling.
TITLE IV--EXPEDITED REVIEW OF CERTAIN PESTICIDE REGISTRATIONS
Sec. 401. Office of accelerated review.
Sec. 402. Expedited review of certain pesticide registrations.
Sec. 403. Conditional registration for certain pesticides.
Sec. 404. Integrated pest management.
Sec. 405. Resistance management.
TITLE I--MINOR CROP PROTECTION
SEC. 101. MINOR CROP PROTECTION.
(a) Definition.--Section 2 (7 U.S.C. 136) is amended by adding at
the end the following:
``(hh) Minor Use.--The term `minor use' means the use of a
pesticide on an animal, on a commercial agricultural crop or site, or
for the protection of public health where--
``(1) the Administrator, in consultation with the Secretary
of Agriculture, determines that, based on information provided
by an applicant, the use does not provide sufficient economic
incentive to support the initial registration or continuing
registration of a pesticide for such use; and
``(2) the Administrator has not determined that, based on
existing data, such use presents a risk of an unreasonable
adverse effect on the environment.''.
(b) Exclusive Use of Minor Use Pesticides.--Section 3(c)(1)(F) (7
U.S.C. 136a(c)(1)(F)) is amended by redesignating clauses (ii) and
(iii) as clauses (iii) and (iv), respectively, and by inserting after
clause (i) the following:
``(ii) The period of exclusive data use for
data submitted to support the application for
the original registration of a pesticide under
clause (i) shall be granted an additional 3
years if, after the date of enactment of this
clause, the Administrator approves at least 3
minor uses of the pesticide before the
expiration of the period of exclusive use under
this clause. Any additional exclusive use
period under this clause shall terminate if the
original data submitter voluntarily cancels all
registrations of the pesticide containing such
minor uses.''.
(c) Time Extensions for Development of Minor Use Data.--
(1) Data call-in.--Subparagraph (B) of section 3(c)(2) (7
U.S.C. 136a(c)(2)(B)) is amended by adding at the end the
following:
``(vi) Upon the request of a registrant,
the Administrator shall, in the case of a minor
use, extend the deadline for the production of
residue chemistry data under this subsection
for data required solely to support that minor
use until the final deadline for submission of
data under section 4 for the other uses of the
pesticide if--
``(I) the data to support other
uses of the pesticide are being
provided;
``(II) the registrant, in
submitting a request for such an
extension, provides a schedule,
including dates to measure progress, to
assure that the data production will be
completed before the expiration of the
extension period;
``(III) the Administrator has
determined that such extension will not
significantly delay the Administrator's
schedule for issuing a reregistration
eligibility determination required
under section 4; and
``(IV) the Administrator has
determined in writing that based on
existing data, such extension would not
significantly increase the risk of any
unreasonable adverse effect on the
environment.
If the Administrator grants an extension under
this clause, the Administrator shall monitor
the development of the data and shall ensure
that the registrant is meeting the schedule for
the production of the data. If the
Administrator determines that the registrant is
not meeting the schedule for the production of
such data, the Administrator may proceed in
accordance with clause (iv) regarding the
continued registration of the minor use and
shall inform the public of such action. If,
during the extension period, the Administrator
is furnished data which are sufficient to
determine that an unreasonable adverse effect
exists involving the minor use of the
pesticide, the Administrator shall provide, in
writing, to the registrant, a notice revoking
the extension of time for submission of data.
Such data shall instead be due within 30 days
of receipt of such notice by the registrant.
Nothing in this clause shall preclude the
Administrator from proceeding in accordance
with the provisions of section 6.''.
(2) Reregistration.--Sections 4(d)(4)(B), 4(e)(2)(B), and
4(f)(2)(B) (7 U.S.C. 136a-1(d)(4)(B), (e)(2)(B), and (f)(2)(B))
are each amended by adding at the end the following: ``Upon the
request of a registrant, the Administrator shall, in the case
of a minor use, extend the deadline for the production of
residue chemistry data under this subsection for data required
solely to support that minor use until the final deadline for
submission of data under section 4 for the other uses of the
pesticide if--
``(i) the data to support other uses of the
pesticide are being provided;
``(ii) the registrant, in submitting a
request for such an extension provides a
schedule, including interim dates to measure
progress, to assure that the data production
will be completed before the expiration of the
extension period;
``(iii) the Administrator has determined
that such extension will not significantly
delay the Administrator's schedule for issuing
a reregistration eligibility determination
required under this section; and
``(iv) the Administrator has determined in
writing that based on existing data, such
extension would not significantly increase the
risk of any unreasonable adverse effect on the
environment.
If the Administrator determines that the registrant is
not meeting the schedule for the production of such
data, the Administrator may proceed in accordance with
section 3(c)(2)(B)(iv) regarding the continued
registration of the minor use and shall inform the
public of such action. If, during the extension period,
the Administrator is furnished data which are
sufficient to determine that an unreasonable adverse
effect exists involving the minor use of the pesticide,
the Administrator shall provide in writing, to the
registrant, a notice revoking the extension of time for
submission of data. Such data shall instead be due
within 30 days of receipt of such notice by the
registrant. Nothing in this subparagraph shall preclude
the Administrator from proceeding in accordance with
the provisions of section 6.''.
(d) Minor Use Waiver.--Section 3(c)(2) (7 U.S.C. 136a(c)(2)) is
amended--
(1) by inserting ``In general'' after ``(A)'', by inserting
``Additional data'' after ``(B)'', and by inserting
``Simplified procedures'' after ``(C)'', and
(2) 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 applicable data
requirements if the Administrator determines 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.--Section 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
expeditiously as possible, review and act on
any application (I) that proposes the initial
registration of a new pesticide active
ingredient if the active ingredient is proposed
to be registered solely for minor uses or for
non-minor uses and significant minor uses, or
(II) for a registration or a registration
amendment that proposes a new minor use.
``(ii) For the purposes of clause (i)--
``(I) the term `as expeditiously as
possible' means that the Administrator
shall complete a review and evaluation
of all data submitted with the
application, to the greatest extent
practicable, no later than 6 months
after the submission of the
application, and
``(II) the term `significant minor
uses' means 3 or more minor uses
proposed for every non-minor use, a
minor use that would, in the judgment
of the Administrator, serve as a
replacement 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
Administrator 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 good faith request for a
minor use waiver regarding data required by the
Administrator pursuant to paragraph (2)(B), 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. Such full time period
extension shall not be available if the Administrator
determines that the data waiver request was not made in
good faith. Any determination by the Administrator that
a data waiver request was not submitted in good faith
shall be made in writing to the registrant and shall be
subject to judicial review under the procedures
prescribed by section 16(b).''.
(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 registrant is not
supporting a specific minor use of the pesticide, but
is supporting and providing data in a timely fashion to
support other food uses the Administrator, at the
written request of the registrant, shall not take any
action pursuant to this paragraph in regard to such
unsupported minor use until the final deadline for the
submission of data under section 4 for the supported
uses under this paragraph. 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. Notwithstanding the provisions of this
paragraph, the Administrator may take action to cancel
or suspend such minor use, pursuant to section 6, if
the Administrator determines that the continuation of
the minor use may cause an unreasonable adverse effect
on the environment.''.
(B) Section 4(e)(3)(A) (7 U.S.C. 136a-1(e)(3)(A))
is amended by adding at the end the following: ``If the
registrant is not supporting a specific minor use of
the pesticide, but is supporting and providing data in
a timely fashion to support other food uses, the
Administrator, at the written request of the
registrant, shall not take any action pursuant to this
subparagraph in regard to such unsupported minor use
until the final deadline for the submission of data for
the supported uses under this subparagraph. 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.
Notwithstanding the provisions of this subparagraph,
the Administrator may take action to cancel or suspend
such minor use, pursuant to section 6, if the
Administrator determines that the continuation of the
minor use may cause an unreasonable adverse effect on
the environment .''.
(2) Data.--Section 3(c)(2)(B) (7 U.S.C. 136a(c)(2)(B)), as
amended by subsection (c), is further amended by adding at the
end the following:
``(vii) If the registrant is not supporting a
specific minor use of the pesticide, but is supporting
and providing data in a timely fashion to support other
food uses, the Administrator, at the written request of
the registrant, shall not take any action pursuant to
this subparagraph in regard to such unsupported minor
use until the final deadline for the submission of data
under section 4 for the supported uses under this
paragraph. 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. Notwithstanding the provisions of this
subparagraph, the Administrator may take action to
cancel or suspend such minor use, pursuant to section
6, if the Administrator determines that the
continuation of the minor use would violate the
criteria contained in section 6.''.
(g) Utilization of Data for Voluntarily Canceled Chemicals.--
Section 6(f) (7 U.S.C. 136d) is amended by adding at the end the
following:
``(4) Utilization of data for voluntarily canceled
chemicals.--When an application is filed with the Administrator
for the registration of a pesticide for a minor use not later
than 2 years after another registrant voluntarily cancels its
registration for an identical or substantially similar
pesticide for an identical or substantially similar use, the
Administrator shall process, review, and evaluate the pending
application as if the voluntary cancellation had not yet taken
place for purposes of the use of data from such registration,
except that the Administrator may not take such action if the
Administrator has evidence that such minor use presents a risk
of an unreasonable adverse effect on the environment.''.
(h) Environmental Protection Agency Minor Use Program.--The Federal
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 121 et seq.) is
amended by redesignating sections 30 and 31 as sections 32 and 33,
respectively and adding after section 29 the following:
``SEC. 30. ENVIRONMENTAL PROTECTION AGENCY MINOR USE PROGRAM.
``The Environmental Protection Agency shall assure coordination of
minor use issues through the establishment of a minor use program
within the Office of Pesticide Programs. Such office shall be
responsible for coordinating the development of minor use programs and
policies, consulting with growers regarding minor use issues and
registrations, and tracking and expediting minor use registrations and
amendments which are submitted to the Environmental Protection
Agency.''.
(i) Department of Agriculture Minor Use Program.--The Federal
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 121 et seq.), as
amended by subsection (h), is amended by adding at the end the
following:
``SEC. 31. DEPARTMENT OF AGRICULTURE MINOR USE PROGRAM.
``(a) In General.--The Secretary of Agriculture (hereinafter in
this section referred to as the `Secretary') shall ensure the
coordination of the responsibilities of the Department of Agriculture
related to minor uses of pesticides, including--
``(1) carrying out the Inter-Regional Research Project
Number 4 (IR-4) as described in section 2(e) of the Act
entitled `An Act to facilitate the work of the Department of
Agriculture, and for other purposes' (7 U.S.C. 4501(e)) and the
national pesticide resistance monitoring program established
under section 1651 of the Food, Agriculture, Conservation, 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 registrations,
tolerances, and reregistrations with the Environmental
Protection Agency.
``(b) Matching Fund Program.--
``(1) Establishment.--The Secretary of Agriculture shall
establish a minor use matching fund program. The matching fund
program shall be utilized to ensure the continued availability
of minor use crop protection chemicals, including the
development of data to support minor use pesticide
registrations and reregistrations. Access to the matching fund
program shall be available to any entity which desires to
develop data to support minor use registrations. Access to the
fund shall be given only those entities that do not directly
receive funds from the sale of products registered on minor
uses. Any entity that seeks such funding under this paragraph
shall be required to match such funds with an equal amount of
its own funds. Any data developed through the matching fund
program shall be jointly owned by the Department of Agriculture
and by the entity that receives such funding. All fees received
by the Department of Agriculture in return for the use of such
data under the matching fund program shall be returned to a
revolving fund which will support the matching fund program.
``(2) Authorization.-- There is authorized to be
appropriated for the revolving fund for the matching fund
program an annual sum not to exceed $10,000,000.''.
TITLE II--PUBLIC HEALTH PESTICIDES
SEC. 201. 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
action 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 101, is amended by adding at the end the following:
``(ii) Public Health Pesticide.--The term `public 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
viruses, bacteria, or other microorganisms on or in living man or other
living animal) that pose a threat to public health.
``(jj) Vector.--The term `vector' means any organism capable of
transmitting the causative agent of human disease or capable of
producing human discomfort or injury, including mosquitoes, flies,
fleas, cockroaches, or other insects and ticks, mites, or rats.''.
SEC. 202. REGISTRATION.
Section 3(c)(2)(A) (7 U.S.C 136a(c)(2)(A)) is amended--
(1) by inserting after ``pattern of use,'' the following:
``the public health and agricultural need for such minor
use,'', and
(2) by striking out ``potential exposure of man and the
environment to the pesticide'' and inserting in lieu thereof
``potential beneficial or adverse effects on man and the
environment''.
SEC. 203. REREGISTRATION.
Section 4 (7 U.S.C. 136a-1) is amended--
(1) in subsection (i)(4), by redesignating subparagraphs
(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 consultation 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 registration or reregistration of the pesticide.'';
(2) in subsection (i)(5), by redesignating subparagraphs
(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 consultation 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 registration or reregistration of the pesticide.'';
(3) in subsection (i)(7)(B), by striking out ``or to
determine'' and inserting in lieu thereof ``, to determine''
and by inserting before the period the following: ``, or to
determine the volume usage for public health pesticides''; and
(4) in subsection (k)(3)(A), by striking out ``or'' at the
end of clause (i), by striking the period at the end of clause
(ii) and inserting in lieu thereof ``; or'', and by inserting
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. 204. CANCELLATION.
Section 6(b) is amended by striking out ``or'' at the end of
paragraph (1), by striking out the period at the end of paragraph (2)
and inserting in lieu thereof ``; or'', and by adding after paragraph
(2) the following:
``(3) if a pesticide is registered or proposed for
registration for public health uses, to send the notice
specified in this subsection to the Secretary of Health and
Human Services for review.
The Secretary of Health and Human Services shall comment under this
subsection in accordance with the procedures followed and subject to
the same conditions as comments by the Secretary of Agriculture in the
case of agricultural pesticides.''.
SEC. 205. VIEWS OF THE SECRETARY OF HEALTH AND HUMAN SERVICES.
Section 21 (7 U.S.C. 136s) is amended by redesignating subsections
(b) and (c) as subsections (c) and (d), respectively, and by adding
after subsection (a) the following:
``(b) Secretary of Health and Human Services.--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
Agriculture are solicited under section 25(a).''.
SEC. 206. AUTHORITY OF ADMINISTRATOR.
Section 25(a)(1) (7 U.S.C 136w(a)(1)) is amended--
(1) by inserting after ``various classes of pesticides''
the following: ``, including public health pesticides,'', and
(2) by striking out ``and nonagricultural pesticides'' and
inserting in lieu thereof ``, nonagricultural, and public
health pesticides''.
SEC. 207. 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 Health and Human Services, shall identify pests of
significant public health importance and, in coordination with the
Public Health Service, develop and implement 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
importance.''.
SEC. 208. AUTHORIZATION OF APPROPRIATIONS.
There is authorized to be appropriated to carry out the purposes of
this title $12,000,000 for fiscal year 1995 and such sums as may be
necessary for succeeding fiscal years.
TITLE III--ANTIMICROBIAL PESTICIDES
SEC. 301. ANTIMICROBIAL PESTICIDES.
(a) Definitions.--Section 2 (7 U.S.C. 136), as amended by sections
101 and 201, is amended by adding at the end the following:
``(kk) Antimicrobial Pesticide.--The term `antimicrobial pesticide'
means a pesticide which--
``(1) is intended to sterilize, disinfect, sanitize,
mitigate growth and development, or protect inanimate objects,
industrial processes or systems, surfaces, or chemical
substances from contamination, degradation, fouling,
inefficiency, or deterioration caused by microbiological
organisms (including bacteria, viruses, fungi, algae, or
composite slime); and
``(2) in the intended use is exempt from, or otherwise not
subject to, a tolerance under section 408 or 409 of the Federal
Food, Drug, and Cosmetic Act.''.
(b) Requirements for Registration.--Section 3 (7 U.S.C. 136a) is
amended by adding at the end the following:
``(g) Registration Requirements for Antimicrobial Pesticides.--
Within 1 year of the date of the enactment of the Minor Crop Protection
Act of 1994, the Administrator shall propose regulations establishing
requirements for the registration of antimicrobial pesticides,
including guidelines specifying the information and data required for
registration. Such guidelines shall provide applicants for registration
with information sufficient to determine each scientific study that
must be submitted as part of a registration application, specify
required methods for data developed or submitted in support of a
registration, and describe registration application format requirements
and any objective criteria for evaluating the completeness of the
application.
``(h) Study of Antimicrobial Registration Procedures.--Not later
than 2 years after the date of the enactment of this subsection, the
Administrator shall prepare a report for Congress that evaluates the
process for registering antimicrobial pesticides. The Administrator
shall submit the report to the Committee on Agriculture of the House of
Representatives and the Committee on Agriculture, Nutrition, and
Forestry of the Senate. The report shall include the following:
``(1) An evaluation of different ways to accelerate the
review of pesticides which meet the criteria of paragraph
(3)(B)(i) and an estimate of the resources the Administrator
would need to implement such changes.
``(2) An estimate of the resources needed to make a
decision--
``(A) within 90 days of receipt of an application
to register a pesticide that meets the criteria of
paragraph (3)(B)(i), whether to approve the
application;
``(B) within 300 days of receipt of an application
to register an antimicrobial pesticide that contains a
new active ingredient, whether to approve the
application;
``(C) within 200 days of receipt of an application
to add a new use to the registration of an
antimicrobial pesticide, whether to approve the
application.
``(3) A calculation of the amount of fees paid under
section 4(i)(5) that are paid for antimicrobial pesticides.
``(4) A calculation of the amount of appropriated funds
involving the registration and reregistration of antimicrobial
pesticides.''.
SEC. 302. PESTICIDE LABELING.
For pesticides that are or may be diluted for use, the label or
labeling required under the Federal Insecticide, Fungicide, and
Rodenticide Act may have a different statement of caution or protective
measures for use of recommended diluted solutions of the pesticide than
for use of concentrates of the pesticide. Such a precautionary
statement shall provide adequate protection for exposure to the dilute
solution of the pesticide.
TITLE IV--EXPEDITED REVIEW OF CERTAIN PESTICIDE REGISTRATIONS
SEC. 401. OFFICE OF ACCELERATED REVIEW.
The Administrator shall establish within the Office of Pesticide
Programs an office to oversee and expedite the evaluation of
applications for the registration of pesticides that meet the criteria
of paragraph (9) of section 3(c) of the Federal Insecticide, Fungicide,
and Rodenticide Act.
SEC. 402. EXPEDITED REVIEW OF CERTAIN PESTICIDE REGISTRATIONS.
Section 3(c) (7 U.S.C. 136a(c)) is amended--
(1) in paragraph (1) by adding at the end the following:
``(G) If the applicant is requesting the expedited
registration, or amendment to the registration, of a
pesticide, an explanation of the basis for the request,
in accordance with paragraph (9) of this subsection.'';
and
(2) by adding at the end the following:
``(9) Expedited registration of certain pesticides.--
``(A)(i) Not later than 1 year after the date of
the enactment of this paragraph and after opportunity
for public comment, the Administrator shall develop
regulations and guidelines for the expedited review of
applications for the registration of pesticides that
meet the criteria of this subparagraph.
``(ii) The Administrator shall expedite the review
of an application for registration of a pesticide or an
amendment to a registration that satisfies the
guidelines developed under this subparagraph.
Biological pesticides will be presumed to qualify for
expedited review under this paragraph. In developing
guidelines for the expedited review of a pesticide
under this paragraph, the Administrator shall consider
the extent to which a pesticide may reasonably be
expected to--
``(I) reduce the risks of pesticides to
human health;
``(II) exhibit a high degree of specificity
for the target pest and pose a low risk for
nontarget organisms;
``(III) facilitate the management of pests
while conserving existing natural controls; or
``(IV) minimize the potential for ground
water or surface water contamination, or other
valued environmental resources.
``(B)(i) The Administrator, not later than 30 days
after receipt of an application for expedited review,
shall notify the applicant whether the application is
complete. If it is found to be incomplete, the
Administrator shall reject the request for an expedited
review.
``(ii) If the application is complete, the
Administrator shall notify the applicant whether the
application qualifies for expedited review within 60
days.
``(iii) If an application for registration or an
amendment qualifies for expedited review under this
paragraph, the Administrator shall, not later than 6
months after accepting such application, notify the
registrant if the application has been granted or
denied. If the application is denied, the Administrator
shall comply with the procedure under section 3(c)(6).
``(C) If at any time after the expedited
registration of a pesticide, the registrant has
additional information bearing on the pesticide's
ability to meet the guidelines established under
subparagraph (A), the registrant shall immediately
submit a report containing such information to the
Administrator.''.
SEC. 403. CONDITIONAL REGISTRATION FOR CERTAIN PESTICIDES.
Section 3(c)(7) (7 U.S.C. 136a(c)(7)) is amended by adding at the
end the following:
``(D)(i) The Administrator may conditionally
register or amend the registration of a pesticide that
meets the criteria of paragraph (9) if--
``(I) the applicant agrees to generate any
additional data that the Administrator deems
appropriate to evaluate the pesticide; and
``(II) the applicant agrees to submit
periodic reports as the Administrator may
require.
A conditional registration under this subparagraph
shall be granted only if the Administrator determines,
based on available information, that use of the
pesticide during such period will not cause any
unreasonable adverse effect on the environment and that
use of the pesticide is in the public interest.
``(ii) If at any time after a conditional
registration is approved under this subparagraph, and
before a complete set of data has been submitted in
support of the registration, the Administrator
determines that a pesticide does not meet the criteria
specified in clause (i), the Administrator may by order
suspend the registration until such time as the
registrant demonstrates that the criteria for
conditional registration are met. Such order shall be
sent to the registrant and published in the Federal
Register. The order shall include the bases for
suspension together with a description of the types of
information the Administrator believes must be
submitted to determine whether the pesticide meets the
criteria for conditional registration.
``(iii) A registrant, or any other interested
person with the concurrence of the registrant, may,
within 30 days of publication of the suspension order
in the Federal Register, petition the Administrator to
reconsider the issuance of the suspension order. A
petitioner must include in the petition specific bases
supporting the petition. The Administrator shall,
within 90 days of receipt of the last of such
petitions, issue an order granting or denying petitions
timely received. Such order shall be sent to the
petitioner and published in the Federal Register, and
shall include the factual and legal bases for the
Administrator's determination of the petition.
``(iv) If the Administrator receives information or
a petition with respect to any adverse effects of a
pesticide for which a conditional registration has been
granted under this subparagraph, the Administrator may
refer the matter to a Scientific Advisory Panel for
review.''.
SEC. 404. INTEGRATED PEST MANAGEMENT.
(a) Integrated Pest Management Projects.--The Secretary of
Agriculture, in consultation with the Administrator of the
Environmental Protection Agency, shall encourage integrated pest
management projects to be organized around specific pests and specific
environmental problems faced by growers and others in partnership with
scientists from local research organizations, including land-grant or
other universities and the Department, or growers, and funded by a
competitive, peer review grants program.
(b) Goals and Objectives.--The goals and objectives of integrated
pest management projects shall be area-specific and commodity or crop-
specific in manner that allows the projects to be qualitatively and
quantitatively evaluated. The Environmental Protection Agency and the
Department of Agriculture shall evaluate the implementation and
effectiveness of integrated pest management projects based on the
following criteria:
(1) Risks to growers from crop losses and drastic yield
variations.
(2) Effectiveness of the utilization of alternative
pesticides, including resistant hosts, biological control
agents, and cultural controls.
(3) Use of practices that avoid or minimize the development
of genetic resistance in pests to chemicals or other tactics
used to control them.
SEC. 405. RESISTANCE MANAGEMENT.
Section 3(c) (7 U.S.C. 136a(c)), as amended by section 402, is
amended by adding at the end the following:
``(10) Evidence of pest resistance.--If the Secretary of
Agriculture, in consultation with the Administrator, determines
that pest resistance to a pesticide is detected and is likely
to diminish the efficacy of the product or threatens to
accelerate the evolution of resistance to other registrations
of the same or similar products, the Administrator shall
require the applicant or registrant to--
``(A) develop a plan to minimize the potential for
development of resistance that includes amended
labeling directions for resistance strategies; and
``(B) conduct monitoring and submit reports as the
Administrator may deem necessary to evaluate the
effectiveness of the resistance plan.
The plan developed under subparagraph (A) should also address
the potential for resistance development in other geographical
areas of the United States.''.
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