Antimicrobial Pesticide Registration Reform Act of 1995 - Amends the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to exclude: (1) bacteria from the definition of "fungus"; and (2) liquid chemical sterilant products for use on a critical or semi-critical medical or dental device from the definition of "pesticide."
Directs the Administrator of the Environmental Protection Agency to: (1) coordinate data requirements, test protocols, timetables, and standards of review and reduce burdens and redundancy caused to the registrant, whenever data in support of a pesticide registration is requested by one or more State or Federal agencies; and (2) develop a process to identify and assist in alleviating future disparities between Federal and State data requirements.
Provides, with respect to the labeling of an antimicrobial pesticide product, that: (1) a registrant may modify the labeling to include relevant information on the product's efficacy, composition, or container or other characteristics unrelated to a pesticidal claim or activity; (2) such labeling shall not be false or misleading or in conflict with statements required as a condition of registration and be substantiated upon request; (3) modifications shall be subject to a notification and approval process; and (4) different cautionary statements for use dilutions may be included in the labeling upon approval of the Administrator.
Directs the Administrator, to the maximum extent practicable, to identify and evaluate changes to the process for registration of antimicrobial pesticides that will reduce current time periods for review. Details rulemaking requirements regarding the review of such pesticides. Requires an annual report to the Congress on measures taken to effect such changes.
Exempts from applicability of certain FIFRA storage, disposal, transportation, and container requirements household, industrial, or institutional antimicrobial products that are not subject to regulation under the Solid Waste Disposal Act, unless the Administrator determines that their application is necessary to prevent an unreasonable adverse effect on the environment.
[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[S. 1491 Introduced in Senate (IS)]
104th CONGRESS
1st Session
S. 1491
To reform antimicrobial pesticide registration, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
December 20, 1995
Mr. Grams (for himself, Mr. Heflin, Mr. Pryor, Mr. McConnell, Mr.
Conrad, Mr. Coverdell, and Mr. Santorum) introduced the following bill;
which was read twice and referred to the Committee on Agriculture,
Nutrition, and Forestry
_______________________________________________________________________
A BILL
To reform antimicrobial pesticide registration, 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 ``Antimicrobial Pesticide Registration
Reform Act of 1995''.
SEC. 2. DEFINITIONS.
Section 2 of the Federal Insecticide, Fungicide, and Rodenticide
Act (7 U.S.C. 136) is amended--
(1) in subsection (k), by striking ``yeast, and bacteria''
and inserting ``and yeast'';
(2) in subsection (u), by adding at the end the following:
``The term `pesticide' does not include liquid chemical
sterilant products for use on a critical or semi-critical
medical or dental device, as defined in section 201 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).''; and
(3) by adding at the end the following:
``(hh) Antimicrobial Pesticide.--
``(1) In general.--The term `antimicrobial pesticide' means
a pesticide that--
``(A) is intended to--
``(i) disinfect, sanitize, reduce, or
mitigate growth or development of
microbiological organisms; or
``(ii) protect inanimate objects,
industrial processes or systems, surfaces,
water, or other chemical substances from
contamination, fouling, or deterioration caused
by bacteria, viruses, fungi, protozoa, algae,
or slime; and
``(B) 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 (21
U.S.C. 346a and 348).
``(2) Excluded products.--The term `antimicrobial
pesticide' does not include--
``(A) a wood preservative or antifouling paint
product for which a claim of pesticidal activity other
than or in addition to an activity described in
paragraph (1) is made;
``(B) an agricultural fungicide product; or
``(C) an aquatic herbicide product.
``(3) Included products.--The term `antimicrobial
pesticide' does include any other chemical sterilant product
(other than liquid chemical sterilant products exempt under
subsection (u)), any other disinfectant product, any other
industrial microbiocide product, and any other preservative
product that is not excluded by paragraph (2).''.
SEC. 3. FEDERAL AND STATE DATA COORDINATION.
Section 3(c)(2)(B) of the Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. 136a(c)(2)(B)) is amended by adding at the
end the following:
``(vi) Coordination of data requirements.--
``(I) In general.--If data required
to support registration of a pesticide
under subparagraph (A) is requested by
a Federal or State regulatory
authority, the Administrator shall, to
the extent practicable, coordinate data
requirements, test protocols,
timetables, and standards of review and
reduce burdens and redundancy caused to
the registrant by multiple requirements
on the registrant.
``(II) Cooperative agreement.--The
Administrator may enter into a
cooperative agreement with a State to
carry out subclause (I).
``(III) Disparities.--Not later
than 1 year after the date of enactment
of this clause, the Administrator shall
develop a process to identify and
assist in alleviating future
disparities between Federal and State
data requirements.''.
SEC. 4. LABEL AND LABELING.
Section 3(c) of the Federal Insecticide, Fungicide, and Rodenticide
Act (7 U.S.C. 136a(c)) is amended by adding at the end the following:
``(9) Labeling.--
``(A) Additional statements.--Subject to
subparagraphs (B) and (C), it shall not be a violation
of this Act for a registrant to modify the labeling of
an antimicrobial pesticide product to include relevant
information on product efficacy, product composition,
container composition or design, or other
characteristics that do not relate to any pesticidal
claim or pesticidal activity.
``(B) Requirements.--Proposed labeling information
under subparagraph (A) shall not be false or
misleading, shall not conflict with or detract from any
statement required by law or the Administrator as a
condition of registration, and shall be substantiated
on the request of the Administrator.
``(C) Notification and disapproval.--
``(i) Notification.--A registration may be
modified under subparagraph (A) if--
``(I) the registrant notifies the
Administrator in writing not later than
60 days prior to distribution or sale
of a product bearing the modified
labeling; and
``(II) the Administrator does not
disapprove of the modification under
clause (ii).
``(ii) Disapproval.--Not later than 30 days
after receipt of a notification under clause
(i), the Administrator may disapprove the
modification by sending the registrant
notification in writing stating that the
proposed language is not acceptable and stating
the reasons why the Administrator finds the
proposed modification unacceptable.
``(iii) Restriction on sale.--A registrant
may not sell or distribute a product bearing a
disapproved modification.
``(iv) Objection.--A registrant may file an
objection in writing to a disapproval under
clause (ii) not later than 30 days after
receipt of notification of the disapproval.
``(v) Final action.--A decision by the
Administrator following receipt and
consideration of an objection filed under
clause (iv) shall be considered a final agency
action.
``(D) Use dilution.--The label or labeling required
under this Act for an antimicrobial pesticide that is
or may be diluted for use may have a different
statement of caution or protective measures for use of
the recommended diluted solution of the pesticide than
for use of a concentrate of the pesticide if the
Administrator determines that--
``(i) adequate data have been submitted to
support the statement proposed for the diluted
solution uses; and
``(ii) the label or labeling provides
adequate protection for exposure to the diluted
solution of the pesticide.''.
SEC. 5. REGISTRATION REQUIREMENTS FOR ANTIMICROBIAL PESTICIDES.
Section 3 of the Federal Insecticide, Fungicide, and Rodenticide
Act (7 U.S.C. 136a) is amended by adding at the end the following:
``(g) Registration Requirements for Antimicrobial Pesticides.--
``(1) Evaluation of process.--To the maximum extent
practicable consistent with the degrees of risk presented by a
antimicrobial pesticide and the type of review appropriate to
evaluate the risks, the Administrator shall identify and
evaluate reforms to the antimicrobial registration process that
would reduce review periods existing as of the date of
enactment of this subsection for antimicrobial pesticide
product registration applications and applications for amended
registration of antimicrobial pesticide products, including--
``(A) new antimicrobial active ingredients;
``(B) new antimicrobial end-use products;
``(C) substantially similar or identical
antimicrobial pesticides; and
``(D) amendments to antimicrobial pesticide
registrations.
``(2) Review time period reduction goal.--Each reform
identified under paragraph (1) shall be designed to achieve the
goal of reducing the review period following submission of a
complete application, consistent with the degree of risk, to a
period of not more than--
``(A) 540 days for a new antimicrobial active
ingredient pesticide registration;
``(B) 270 days for a new antimicrobial use of a
registered active ingredient;
``(C) 120 days for any other new antimicrobial
product;
``(D) 90 days for a substantially similar or
identical antimicrobial product;
``(E) 90 days for an amendment to an antimicrobial
registration that does not require scientific review of
data; and
``(F) 90 to 180 days for an amendment to an
antimicrobial registration that requires scientific
review of data and that is not otherwise described in
this paragraph.
``(3) Implementation.--
``(A) Proposed rulemaking.--
``(i) Issuance.--Not later than 270 days
after the date of enactment of this subsection,
the Administrator shall publish in the Federal
Register proposed regulations to accelerate and
improve the review of antimicrobial pesticide
products designed to implement, to the extent
practicable, the goals set forth in paragraph
(2).
``(ii) Requirements.--Proposed regulations
issued under clause (i) shall--
``(I) define the various classes of
antimicrobial use patterns, including
household, industrial, and
institutional disinfectants and
sanitizing pesticides, preservatives,
water treatment, and pulp and paper
mill additives, and other such products
intended to disinfect, sanitize,
reduce, or mitigate growth or
development of microbiological
organisms, or protect inanimate
objects, industrial processes or
systems, surfaces, water, or other
chemical substances from contamination,
fouling, or deterioration caused by
bacteria, viruses, fungi, protozoa,
algae, or slime;
``(II) differentiate the types of
review undertaken for antimicrobial
pesticides;
``(III) conform the degree and type
of review to the risks and benefits
presented by antimicrobial pesticides
and the function of review under this
Act, considering the use patterns of
the product, toxicity, expected
exposure, and product type;
``(IV) ensure that the registration
process is sufficient to maintain
antimicrobial pesticide efficacy and
that antimicrobial pesticide products
continue to meet product performance
standards and effectiveness levels for
each type of label claim made; and
``(V) implement effective and
reliable deadlines for process
management.
``(iii) Comments.--In developing the
proposed regulations, the Administrator shall
solicit the views from registrants and other
affected parties to maximize the effectiveness
of the rule development process.
``(B) Final regulations.--
``(i) Issuance.--The Administrator shall
issue final regulations not later than 240 days
after the close of the comment period for the
proposed regulations.
``(ii) Failure to meet goal.--If a goal
described in paragraph (2) is not met by the
final regulations, the Administrator shall
identify the goal, explain why the goal was not
attained, describe the element of the
regulations included instead, and identify
future steps to attain the goal.
``(iii) Requirements.--In issuing final
regulations, the Administrator shall--
``(I) consider the establishment of
a certification process for regulatory
actions involving risks that can be
responsibly managed, consistent with
the degree of risk, in the most cost-
efficient manner;
``(II) consider the establishment
of a certification process by approved
laboratories as an adjunct to the
review process;
``(III) use all appropriate and
cost-effective review mechanisms,
including--
``(aa) expanded use of
notification and non-
notification procedures;
``(bb) revised procedures
for application review; and
``(cc) allocation of
appropriate resources to ensure
streamlined management of
antimicrobial pesticide
registrations; and
``(IV) clarify criteria for
determination of the completeness of an
application.
``(C) Expedited review.--This subsection does not
affect the requirements or extend the deadlines or
review periods contained in subsection (c)(3).
``(D) Alternative review periods.--If the final
regulations to carry out this paragraph are not
effective 630 days after the date of enactment of this
subsection, until the final regulations become
effective, the review period, beginning on the date of
receipt by the Agency of a complete application, shall
be--
``(i) 2 years for a new antimicrobial
active ingredient pesticide registration;
``(ii) 1 year for a new antimicrobial use
of a registered active ingredient;
``(iii) 180 days for any other new
antimicrobial product;
``(iv) 90 days for a substantially similar
or identical antimicrobial product;
``(v) 90 days for an amendment to an
antimicrobial registration that does not
require scientific review of data; and
``(vi) 240 days for an amendment to an
antimicrobial registration that requires
scientific review of data and that is not
otherwise described in this subparagraph.
``(E) Wood preservatives.--An application for the
registration, or for an amendment to the registration,
of a wood preservative product for which a claim of
pesticidal activity listed in section 2(hh)(1) is made
(regardless of any other pesticidal claim that is made
with respect to the product) shall be reviewed by the
Administrator within the same period as that
established under this paragraph for an antimicrobial
pesticide product application, consistent with the
degree of risk posed by the use of the wood
preservative product, if the application requires the
applicant to satisfy the same data requirements as are
required to support an application for a wood
preservative product that is an antimicrobial
pesticide.
``(F) Notification.--
``(i) In general.--Subject to clause (iii),
the Administrator shall notify an applicant
whether an application has been granted or
denied not later than the final day of the
appropriate review period under this paragraph,
unless the applicant and the Administrator
agree to a later date.
``(ii) Final decision.--If the
Administrator fails to notify an applicant
within the period of time required under clause
(i), the failure shall be considered an agency
action unlawfully withheld or unreasonably
delayed for purposes of judicial review under
section 706(1) of title 5, United States Code.
``(iii) Exemption.--This subparagraph does
not apply to an application for an
antimicrobial pesticide that is filed under
subsection (c)(3)(B) prior to 90 days after the
date of enactment of this subsection.
``(4) Annual report.--
``(A) Submission.--Beginning on the date of
enactment of this subsection and ending on the date
that the goals under paragraph (2) are achieved, the
Administrator shall, not later than March 1 of each
year, prepare and submit an annual report to the
Committee on Agriculture of the House of
Representatives and the Committee on Agriculture,
Nutrition, and Forestry of the Senate.
``(B) Requirements.--A report submitted under
subparagraph (A) shall include a description of--
``(i) measures taken to reduce the backlog
of pending registration applications;
``(ii) progress toward achieving reforms
under this subsection; and
``(iii) recommendations to improve the
activities of the Agency pertaining to
antimicrobial registrations.''.
SEC. 6. DISPOSAL OF HOUSEHOLD, INDUSTRIAL, OR INSTITUTIONAL
ANTIMICROBIAL PRODUCTS.
Section 19(h) of the Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. 136q(h)) is amended--
(1) by striking ``Nothing in'' and inserting the following:
``(1) In general.--Nothing in''; and
(2) by adding at the end the following:
``(2) Antimicrobial products.--A household, industrial, or
institutional antimicrobial product that is not subject to
regulation under the Solid Waste Disposal Act (42 U.S.C. 6901
et seq.) shall not be subject to the provisions of subsections
(a), (e), and (f), unless the Administrator determines that
such product must be subject to such provisions to prevent an
unreasonable adverse effect on the environment.''.
<all>
S 1491 IS----2
Introduced in Senate
Sponsor introductory remarks on measure. (CR S19009-19010)
Read twice and referred to the Committee on Agriculture.
Committee on Agriculture. Hearings held.
Committee on Agriculture. Measure incorporated into measure S. 1166 ordered to be reported.
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