I
104TH CONGRESS
1ST SESSION
H. R. 1680
To amend the Federal Insecticide, Fungicide, and Rodenticide Act, and for
other purposes.
IN THE HOUSE OF REPRESENTATIVES
MAY 18, 1995
Mr. ROBERTS (for himself, Mr. DE
LA GARZA, Mr. EMERSON, and Mr.
CONDIT) introduced the following bill; which was referred to the Commit-
tee on Agriculture
A BILL
To amend the Federal Insecticide, Fungicide, and
Rodenticide Act, 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. REFERENCE.
Whenever in this Act an amendment or repeal is ex-
pressed in terms of an amendment to, or repeal of, a sec-
tion or other provision, the reference shall be considered
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to be made to a section or other provision of the Federal
Insecticide, Fungicide, and Rodenticide Act.
SEC. 3. ANTIMICROBIAL PRODUCTS.
(a) DEFINITIONS.—AMENDMENTS TO THE ACT.—
Section 2 (7 U.S.C. 136) is amended by adding at the
end the following new subsection:
‘‘(hh) 
ANTIMICROBIAL
PESTICIDE.—The 
term
‘antimicrobial pesticide’ means a pesticide, including but
not limited to an antimicrobial active ingredient or an
antimicrobial end-use product (including composition,
packaging, and labeling), that—
‘‘(1) is intended to—
‘‘(A) disinfect, sanitize, reduce, or mitigate
growth or development of microbiological orga-
nisms; or
‘‘(B) protect inanimate objects, industrial
processes or systems, surfaces, water or other
chemical substances from contamination, deg-
radation, fouling, inefficiency, or deterioration
caused by microbiological organisms (including,
but not limited to bacteria, viruses, fungi, algae
or composite slime); and
‘‘(2) in the intended use is exempt from, or oth-
erwise not subject to, a tolerance under section 408
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or section 409 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 346a or 348).’’.
(b) REQUIREMENTS FOR REGISTRATION.—Section 3
(7 U.S.C. 136a) is amended by adding at the end the fol-
lowing new subsection:
‘‘(g) 
REGISTRATION
REQUIREMENTS
FOR
ANTIMICROBIAL PESTICIDES.—
‘‘(1) EVALUATION OF PROCESS.—The Adminis-
trator shall identify and evaluate reforms to the
antimicrobial registration process that will reduce
current review periods for—
‘‘(A) new antimicrobial active ingredients;
‘‘(B) new antimicrobial end-use products;
‘‘(C) substantially similar or identical
antimicrobial pesticides; and
‘‘(D) amendments to existing antimicrobial
pesticide registrations; by the maximum extent
practicable consistent with the degree and type
of review appropriate to the risks presented by
the antimicrobial pesticide.
‘‘(2) 
REVIEW
TIME
PERIOD
REDUCTION
GOAL.—The reforms identified under paragraph (1)
shall be designed to achieve the goal of reducing the
review periods for each of the antimicrobial pesticide
registration actions described below to the shorter of
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either a 75 percent reduction from the current re-
view time period or the following specific review
periods:
‘‘(A) 12 months for a new antimicrobial
active ingredient pesticide registration.
‘‘(B) 6 months for a new antimicrobial use
of a registered active ingredient.
‘‘(C) 3 months for a new antimicrobial use
of a registered end-use product.
‘‘(D) 3 months for a new antimicrobial
end-use product registration.
‘‘(E) 3 months for a substantially similar
or identical antimicrobial product.
‘‘(F) 3 months for an amendment to a cur-
rent antimicrobial registration that requires sci-
entific review of data.
‘‘(G) 1 month for an application for an
amendment to a current antimicrobial registra-
tion that does not require scientific review of
data.
‘‘(3) ADVANCE
NOTICE
OF
PROPOSED
RULE-
MAKING.—Not later than 90 days after the date of
enactment of this subsection, the Administrator shall
publish in the Federal Register an advance notice of
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proposed rulemaking to solicit input for rulemaking
to—
‘‘(A) 
define 
the 
different 
classes 
of
antimicrobial use patterns, including but not
limited to household and similarly-formulated
industrial and institutional disinfectants and
sanitizing pesticides, preservatives, water treat-
ment, and pulp and paper mill additives;
‘‘(B) differentiate the types of review (such
as those described in paragraphs (1) and (2))
undertaken for antimicrobial pesticides;
‘‘(C) conform and degree and type of re-
view to the risks and benefits presented by
antimicrobial pesticides and the function of re-
view under this Act considering the use pat-
terns of the product, toxicity, and product type;
‘‘(D) ensure that the review process is suf-
ficient to maintain antimicrobial pesticide effi-
cacy and that household and similarly-formu-
lated industrial and institutional disinfectant
and sanitizing pesticides continue to meet prod-
uct performance standards and specific effec-
tiveness levels reflected in subdivision G of the
Agency’s Pesticide Assessment Guidelines for
each type of label claim made; and
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‘‘(iii) No rule promulgated under sub-
paragraph (A) may extend, absent consent
of the registrant, the time periods estab-
lished under this subparagraph.
‘‘(C) ALTERNATIVE REVIEW PERIODS.—In
the case of antimicrobial pesticide applications
other than those described in subparagraph
(B), if the final rules to carry out this para-
graph are not effective 545 days after the date
of enactment of this subsection, the following
review periods, beginning on the date of receipt
by the Agency of a complete application, shall
apply:
‘‘(i) 18 months for a new active ingre-
dient pesticide registration.
‘‘(ii) 12 months for a new use of a
registered active ingredient.
‘‘(iii) 6 months for a new use of a reg-
istered end-use product.
‘‘(iv) 6 months for a new end-use
product registration.
‘‘(v) 135 days for a substantially simi-
lar or identical product.
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‘‘(vi) 6 months for an amendment to
a current registration that requires sci-
entific review of data.
‘‘(vii) 135 days for an application for
an amendment to a current registration
that does not require scientific review of
data.
‘‘(D) NOTIFICATION.—
‘‘(i) IN GENERAL.—The Administrator
shall notify the registrant prior to the end
of the appropriate review period specified
in subparagraph (B) or (C) whether an ap-
plication has been granted or denied.
‘‘(ii) FINAL DECISION.—If the Admin-
istrator fails to timely notify the registrant
under clause (i) whether an application has
been granted or denied, the application
shall be deemed to be denied and such de-
nial shall be considered a final agency ac-
tion subject to judicial review under section
551 of title 5, United States Code, et seq.
‘‘(E) OVERSIGHT.—The Committee on Ag-
riculture of the House of Representatives and
the Committee on Agriculture, Nutrition, and
Forestry of the Senate shall thereafter conduct
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such oversight as is necessary to ensure that
the reform goal for the antimicrobial registra-
tion process are met.
‘‘(5) ANNUAL REPORT.—Not later than March
1 of each year after date of enactment of this sub-
section until the reform goals specified in this sub-
section have been achieved, the Administrator shall
prepare and submit an annual report to the Commit-
tee on Agriculture of the House of Representatives
and the Committee on Agriculture, Nutrition, and
Forestry of the Senate. This report shall include
those measures taken to reduce the backlog of pend-
ing registration applications, progress toward achiev-
ing the reforms, and recommendations to improve
the 
activities 
of 
the 
Agency 
pertaining 
to
antimicrobial registrations.’’.
‘‘(c) LABEL AND LABELING STATEMENTS.—Section
3(c) (7 U.S.C. 136a(c)) is amended by adding at the end
the following new paragraph:
‘‘(9) LABEL AND LABELING STATEMENTS.—
‘‘(A) ADDITIONAL
STATEMENTS.—A reg-
istrant of an antimicrobial pesticide may not
change the label or labeling statements required
under this Act or by regulation including the
pesticidal claims, ingredient statement, direc-
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tions for use, warning and caution statements
and Agency registration numbers, without the
approval of the Administrator. A registrant of
an antimicrobial pesticide may make or alter
other label or labeling statements or amend-
ments that are truthful and not misleading and
that do not relate to or affect such required
label or labeling statements.
‘‘(B) USE
DILUTION.—For antimicrobial
pesticides that are or may be diluted for use,
the label or labeling required under this Act
may have a different statement of caution or
protective measures for use of recommended di-
luted solutions of the pesticide than for the use
of concentrates of the pesticide. Such a pre-
cautionary statement shall provide adequate
protection for exposure to the diluted solution
of the pesticide.’’.
(d) DISPOSAL
AND HOUSEHOLD
AND SIMILARLY
FORMULATED INDUSTRIAL
AND INSTITUTIONAL DIS-
INFECTANT AND SANITIZER PRODUCTS.—Section 19(h)
(7 U.S.C. 136q(h)) is amended by adding at the end the
following new sentence: ‘‘Household and similarly-formu-
lated industrial and institutional disinfectant and sanitizer
products which are not otherwise subject to regulation
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under the Solid Waste Disposal Act (42 U.S.C. 6901 et.
seq.) shall not be subject to regulation under this sec-
tion.’’.
(e) DATA COORDINATION AND SYNCHRONIZATION.—
Section 3(c)(2)(B) (7 U.S.C. 136a(c)(2)(B)) is amended
by adding at the end the following new clause:
‘‘(vi) Whenever data of a type specified in the
guidelines published under subparagraph (A) is re-
quested by one or more State or Federal agencies,
the Administrator shall, to the extent practicable,
share data and information and shall coordinate and
synchronize such data requests including, but not
limited to, test protocols, timetables, and standards
of review among the agencies so as to reduce bur-
dens and to avoid unnecessary repetition and redun-
dancy. In addition, within one year after the date of
enactment of this clause, the Administrator shall, by
rule, develop and implement procedures for such co-
ordination and synchronization by the Administrator
so as to result in identical and concurrent data re-
quirements by all the agencies. Nothing in this
clause shall be interpreted as affecting the authority
of States to regulate pesticides as provided in section
24(a).’’.
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