I
104TH CONGRESS
2D SESSION
H. R. 3338
To reform antimicrobial pesticide registration, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
APRIL 25, 1996
Mr. ROBERTS (for himself, Mr. EMERSON, Mr. DE
LA GARZA, and Mr.
CONDIT) introduced the following bill; which was referred to the Commit-
tee on Agriculture
A BILL
To reform antimicrobial pesticide registration, and for other
purposes.
Be it enacted by the Senate and House of Representa-
tives 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 liq-
uid 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 Cos-
metic 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 miti-
gate growth or development of micro-
biological organisms; or
‘‘(ii) protect inanimate objects, indus-
trial processes or systems, surfaces, water,
or other chemical substances from con-
tamination, 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 ac-
tivity 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 chemi-
cal 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, Fun-
gicide, and Rodenticide Act (7 U.S.C. 136a(c)(2)(B)) is
amended by adding at the end the following:
‘‘(vi) COORDINATION
OF
DATA
RE-
QUIREMENTS.—
‘‘(I) IN
GENERAL.—If data re-
quired to support registration of a
pesticide under subparagraph (A) is
requested by a Federal or State regu-
latory authority, the Administrator
shall, to the extent practicable, coordi-
nate 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
AGREE-
MENT.—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 enact-
ment of this clause, the Administrator
shall develop a process to identify and
assist in alleviating future disparities
between Federal and State data re-
quirements.’’.
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 prod-
uct to include relevant information on product
efficacy, product composition, container com-
position or design, or other characteristics that
do not relate to any pesticidal claim or pes-
ticidal 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 accept-
able and stating the reasons why the Ad-
ministrator finds the proposed modification
unacceptable.
‘‘(iii) RESTRICTION ON SALE.—A reg-
istrant 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 dis-
approval.
‘‘(v) FINAL
ACTION.—A decision by
the Administrator following receipt and
consideration of an objection filed under
clause (iv) shall be considered a final agen-
cy action.
‘‘(D) USE DILUTION.—The label or label-
ing required under this Act for an antimicrobial
pesticide that is or may be diluted for use may
have a different statement of caution or protec-
tive measures for use of the recommended di-
luted solution of the pesticide than for use of a
concentrate of the pesticide if the Administrator
determines that—
‘‘(i) adequate data have been submit-
ted to support the statement proposed for
the diluted solution uses; and
‘‘(ii) the label or labeling provides
adequate protection for exposure to the di-
luted solution of the pesticide.’’.
SEC. 
5. 
REGISTRATION 
REQUIREMENTS 
FOR 
ANTI-
MICROBIAL 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 maxi-
mum 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 re-
forms 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 appli-
cations 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 pes-
ticide 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 ap-
plication, consistent with the degree of risk, to a pe-
riod of not more than—
‘‘(A) 540 days for a new antimicrobial ac-
tive 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 sci-
entific 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 regula-
tions to accelerate and improve the review
of antimicrobial pesticide products de-
signed to implement, to the extent prac-
ticable, the goals set forth in paragraph
(2).
‘‘(ii) REQUIREMENTS.—Proposed reg-
ulations 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 dis-
infect, sanitize, reduce, or mitigate
growth or development of micro-
biological organisms, or protect inani-
mate objects, industrial processes or
systems, surfaces, water, or other
chemical substances from contamina-
tion, fouling, or deterioration caused
by bacteria, viruses, fungi, protozoa,
algae, or slime;
‘‘(II) differentiate the types of re-
view undertaken for antimicrobial pes-
ticides;
‘‘(III) conform the degree and
type of review to the risks and bene-
fits presented by antimicrobial pes-
ticides and the function of review
under this Act, considering the use
patterns of the product, toxicity, ex-
pected 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 reli-
able deadlines for process manage-
ment.
‘‘(iii) COMMENTS.—In developing the
proposed regulations, the Administrator
shall solicit the views from registrants and
other affected parties to maximize the ef-
fectiveness 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 iden-
tify 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 re-
sponsibly managed, consistent with
the degree of risk, in the most cost-ef-
ficient manner;
‘‘(II) consider the establishment
of a certification process by approved
laboratories as an adjunct to the re-
view process;
‘‘(III) use all appropriate and
cost-effective review mechanisms, in-
cluding—
‘‘(aa) expanded use of notifi-
cation and non-notification proce-
dures;
‘‘(bb) revised procedures for
application review; and
‘‘(cc) allocation of appro-
priate 
resources 
to 
ensure
streamlined 
management 
of
antimicrobial pesticide registra-
tions; and
‘‘(IV) clarify criteria for deter-
mination of the completeness of an
application.
‘‘(C) 
EXPEDITED
REVIEW.—This 
sub-
section does not affect the requirements or ex-
tend 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 en-
actment of this subsection, until the final regu-
lations become effective, the review period, be-
ginning 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 simi-
lar or identical antimicrobial product;
‘‘(v) 90 days for an amendment to an
antimicrobial registration that does not re-
quire 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 applica-
tion for the registration, or for an amendment
to the registration, of a wood preservative prod-
uct 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 Admin-
istrator within the same period as that estab-
lished 
under 
this 
paragraph 
for 
an
antimicrobial pesticide product application, con-
sistent with the degree of risk posed by the use
of the wood preservative product, if the applica-
tion 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 ap-
plicant 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 Admin-
istrator fails to notify an applicant within
the period of time required under clause
(i), the failure shall be considered an agen-
cy action unlawfully withheld or unreason-
ably delayed for purposes of judicial review
under section 706(1) of title 5, United
States Code.
‘‘(iii) 
EXEMPTION.—This 
subpara-
graph 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 Com-
mittee on Agriculture, Nutrition, and Forestry
of the Senate.
‘‘(B) REQUIREMENTS.—A report submit-
ted under subparagraph (A) shall include a de-
scription of—
‘‘(i) measures taken to reduce the
backlog of pending registration applica-
tions;
‘‘(ii) progress toward achieving re-
forms under this subsection; and
‘‘(iii) recommendations to improve the
activities of the Agency pertaining to
antimicrobial registrations.’’.
SEC. 6. DISPOSAL OF HOUSEHOLD, INDUSTRIAL, OR INSTI-
TUTIONAL 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 pre-
vent an unreasonable adverse effect on the environ-
ment.’’.
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