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 Committee on Agriculture

A BILL

To amend the Federal Insecticide, Fungicide, and

Rodenticide Act, and for other purposes.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Antimicrobial Pesticide

5 Registration Reform Act of 1995’’.

6 SEC. 2. REFERENCE.

7 Whenever in this Act an amendment or repeal is ex8 pressed in terms of an amendment to, or repeal of, a sec9 tion or other provision, the reference shall be considered
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1 to be made to a section or other provision of the Federal

2 Insecticide, Fungicide, and Rodenticide Act.

3 SEC. 3. ANTIMICROBIAL PRODUCTS.

4 (a) DEFINITIONS.—AMENDMENTS TO THE ACT.—

5 Section 2 (7 U.S.C. 136) is amended by adding at the

6 end the following new subsection:

7 ‘‘(hh) ANTIMICROBIAL PESTICIDE.—The term

8 ‘antimicrobial pesticide’ means a pesticide, including but

9 not limited to an antimicrobial active ingredient or an

10 antimicrobial end-use product (including composition,

11 packaging, and labeling), that—

12 ‘‘(1) is intended to—

13 ‘‘(A) disinfect, sanitize, reduce, or mitigate

14 growth or development of microbiological orga15 nisms; or

16 ‘‘(B) protect inanimate objects, industrial

17 processes or systems, surfaces, water or other

18 chemical substances from contamination, deg19 radation, fouling, inefficiency, or deterioration

20 caused by microbiological organisms (including,

21 but not limited to bacteria, viruses, fungi, algae

22 or composite slime); and

23 ‘‘(2) in the intended use is exempt from, or oth24 erwise not subject to, a tolerance under section 408
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1 or section 409 of the Federal Food, Drug, and Cos2 metic Act (21 U.S.C. 346a or 348).’’.

3 (b) REQUIREMENTS FOR REGISTRATION.—Section 3

4 (7 U.S.C. 136a) is amended by adding at the end the fol5 lowing new subsection:

6 ‘‘(g) REGISTRATION REQUIREMENTS FOR

7 ANTIMICROBIAL PESTICIDES.—

8 ‘‘(1) EVALUATION OF PROCESS.—The Adminis9 trator shall identify and evaluate reforms to the

10 antimicrobial registration process that will reduce

11 current review periods for—

12 ‘‘(A) new antimicrobial active ingredients;

13 ‘‘(B) new antimicrobial end-use products;

14 ‘‘(C) substantially similar or identical

15 antimicrobial pesticides; and

16 ‘‘(D) amendments to existing antimicrobial

17 pesticide registrations; by the maximum extent

18 practicable consistent with the degree and type

19 of review appropriate to the risks presented by

20 the antimicrobial pesticide.

21 ‘‘(2) REVIEW TIME PERIOD REDUCTION

22 GOAL.—The reforms identified under paragraph (1)

23 shall be designed to achieve the goal of reducing the

24 review periods for each of the antimicrobial pesticide

25 registration actions described below to the shorter of
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1 either a 75 percent reduction from the current re2 view time period or the following specific review

3 periods:

4 ‘‘(A) 12 months for a new antimicrobial

5 active ingredient pesticide registration.

6 ‘‘(B) 6 months for a new antimicrobial use

7 of a registered active ingredient.

8 ‘‘(C) 3 months for a new antimicrobial use

9 of a registered end-use product.

10 ‘‘(D) 3 months for a new antimicrobial

11 end-use product registration.

12 ‘‘(E) 3 months for a substantially similar

13 or identical antimicrobial product.

14 ‘‘(F) 3 months for an amendment to a cur15 rent antimicrobial registration that requires sci16 entific review of data.

17 ‘‘(G) 1 month for an application for an

18 amendment to a current antimicrobial registra19 tion that does not require scientific review of

20 data.

21 ‘‘(3) ADVANCE NOTICE OF PROPOSED RULE22 MAKING.—Not later than 90 days after the date of

23 enactment of this subsection, the Administrator shall

24 publish in the Federal Register an advance notice of
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1 proposed rulemaking to solicit input for rulemaking

2 to—

3 ‘‘(A) define the different classes of

4 antimicrobial use patterns, including but not

5 limited to household and similarly-formulated

6 industrial and institutional disinfectants and

7 sanitizing pesticides, preservatives, water treat8 ment, and pulp and paper mill additives;

9 ‘‘(B) differentiate the types of review (such

10 as those described in paragraphs (1) and (2))

11 undertaken for antimicrobial pesticides;

12 ‘‘(C) conform and degree and type of re13 view to the risks and benefits presented by

14 antimicrobial pesticides and the function of re15 view under this Act considering the use pat16 terns of the product, toxicity, and product type;

17 ‘‘(D) ensure that the review process is suf18 ficient to maintain antimicrobial pesticide effi19 cacy and that household and similarly-formu20 lated industrial and institutional disinfectant

21 and sanitizing pesticides continue to meet prod22 uct performance standards and specific effec23 tiveness levels reflected in subdivision G of the

24 Agency’s Pesticide Assessment Guidelines for

25 each type of label claim made; and
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1 ‘‘(E) implement effective deadlines for

2 process management, that can be relied upon by

3 both the registrant and the Agency.

4 ‘‘(4) IMPLEMENTATION.—

5 ‘‘(A) REGULATIONS.—Within 1 year of the

6 date of enactment of this subsection, the Ad7 ministrator shall propose regulations, to be ef8 fective within 180 days of their publication in

9 the Federal Register, to carry out and meet the

10 goals set forth in paragraph (2). The Adminis11 trator shall consider the establishment of a cer12 tification process for regulatory actions involv13 ing risks that can be responsibly managed con14 sistent with their degree in the most cost effi15 cient manner. The Administrator shall also con16 sider, as an adjunct to the review process, the

17 establishment of a certification process by ap18 proved laboratories. In addition to considering

19 certification processes, the Administrator shall

20 also utilize all appropriate and cost effective re21 view mechanisms, including—

22 ‘‘(i) expanded use of notification and

23 non-notification procedures;

24 ‘‘(ii) revised procedures for application

25 review; and
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1 ‘‘(iii) allocation of appropriate and

2 sufficient resources to ensure streamlined

3 management of antimicrobial pesticide reg4 istrations.

5 ‘‘(B) TRANSITION PERIOD.—In the case of

6 an antimicrobial pesticide application filed after

7 90 days after the date of enactment of this sub8 section, the following shall apply:

9 ‘‘(i) The review period for the reg10 istration of an antimicrobial end-use pes11 ticide that, if registered as proposed, would

12 be substantially similar or identical in com13 position and labeling to a currently-reg14 istered antimicrobial pesticide identified in

15 the application, or that would differ in

16 composition and labeling from such cur17 rently-registered antimicrobial pesticide

18 only in ways that would not significantly

19 increase the risk of unreasonable adverse

20 effects on the environment, shall be not

21 more than 135 days.

22 ‘‘(ii) The review period for an amend23 ment to a current registration that does

24 not require scientific review of data shall

25 be no more than 135 days.
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1 ‘‘(iii) No rule promulgated under sub2 paragraph (A) may extend, absent consent

3 of the registrant, the time periods estab4 lished under this subparagraph.

5 ‘‘(C) ALTERNATIVE REVIEW PERIODS.—In

6 the case of antimicrobial pesticide applications

7 other than those described in subparagraph

8 (B), if the final rules to carry out this para9 graph are not effective 545 days after the date

10 of enactment of this subsection, the following

11 review periods, beginning on the date of receipt

12 by the Agency of a complete application, shall

13 apply:

14 ‘‘(i) 18 months for a new active ingre15 dient pesticide registration.

16 ‘‘(ii) 12 months for a new use of a

17 registered active ingredient.

18 ‘‘(iii) 6 months for a new use of a reg19 istered end-use product.

20 ‘‘(iv) 6 months for a new end-use

21 product registration.

22 ‘‘(v) 135 days for a substantially simi23 lar or identical product.
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1 ‘‘(vi) 6 months for an amendment to

2 a current registration that requires sci3 entific review of data.

4 ‘‘(vii) 135 days for an application for

5 an amendment to a current registration

6 that does not require scientific review of

7 data.

8 ‘‘(D) NOTIFICATION.—

9 ‘‘(i) IN GENERAL.—The Administrator

10 shall notify the registrant prior to the end

11 of the appropriate review period specified

12 in subparagraph (B) or (C) whether an ap13 plication has been granted or denied.

14 ‘‘(ii) FINAL DECISION.—If the Admin15 istrator fails to timely notify the registrant

16 under clause (i) whether an application has

17 been granted or denied, the application

18 shall be deemed to be denied and such de19 nial shall be considered a final agency ac20 tion subject to judicial review under section

21 551 of title 5, United States Code, et seq.

22 ‘‘(E) OVERSIGHT.—The Committee on Ag23 riculture of the House of Representatives and

24 the Committee on Agriculture, Nutrition, and

25 Forestry of the Senate shall thereafter conduct
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1 such oversight as is necessary to ensure that

2 the reform goal for the antimicrobial registra3 tion process are met.

4 ‘‘(5) ANNUAL REPORT.—Not later than March

5 1 of each year after date of enactment of this sub6 section until the reform goals specified in this sub7 section have been achieved, the Administrator shall

8 prepare and submit an annual report to the Commit9 tee on Agriculture of the House of Representatives

10 and the Committee on Agriculture, Nutrition, and

11 Forestry of the Senate. This report shall include

12 those measures taken to reduce the backlog of pend13 ing registration applications, progress toward achiev14 ing the reforms, and recommendations to improve

15 the activities of the Agency pertaining to

16 antimicrobial registrations.’’.

17 ‘‘(c) LABEL AND LABELING STATEMENTS.—Section

18 3(c) (7 U.S.C. 136a(c)) is amended by adding at the end

19 the following new paragraph:

20 ‘‘(9) LABEL AND LABELING STATEMENTS.—

21 ‘‘(A) ADDITIONAL STATEMENTS.—A reg22 istrant of an antimicrobial pesticide may not

23 change the label or labeling statements required

24 under this Act or by regulation including the

25 pesticidal claims, ingredient statement, direc-
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1 tions for use, warning and caution statements

2 and Agency registration numbers, without the

3 approval of the Administrator. A registrant of

4 an antimicrobial pesticide may make or alter

5 other label or labeling statements or amend6 ments that are truthful and not misleading and

7 that do not relate to or affect such required

8 label or labeling statements.

9 ‘‘(B) USE DILUTION.—For antimicrobial

10 pesticides that are or may be diluted for use,

11 the label or labeling required under this Act

12 may have a different statement of caution or

13 protective measures for use of recommended di14 luted solutions of the pesticide than for the use

15 of concentrates of the pesticide. Such a pre16 cautionary statement shall provide adequate

17 protection for exposure to the diluted solution

18 of the pesticide.’’.

19 (d) DISPOSAL AND HOUSEHOLD AND SIMILARLY

20 FORMULATED INDUSTRIAL AND INSTITUTIONAL DIS21 INFECTANT AND SANITIZER PRODUCTS.—Section 19(h)

22 (7 U.S.C. 136q(h)) is amended by adding at the end the

23 following new sentence: ‘‘Household and similarly-formu24 lated industrial and institutional disinfectant and sanitizer

25 products which are not otherwise subject to regulation
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1 under the Solid Waste Disposal Act (42 U.S.C. 6901 et.

2 seq.) shall not be subject to regulation under this sec3 tion.’’.

4 (e) DATA COORDINATION AND SYNCHRONIZATION.—

5 Section 3(c)(2)(B) (7 U.S.C. 136a(c)(2)(B)) is amended

6 by adding at the end the following new clause:

7 ‘‘(vi) Whenever data of a type specified in the

8 guidelines published under subparagraph (A) is re9 quested by one or more State or Federal agencies,

10 the Administrator shall, to the extent practicable,

11 share data and information and shall coordinate and

12 synchronize such data requests including, but not

13 limited to, test protocols, timetables, and standards

14 of review among the agencies so as to reduce bur15 dens and to avoid unnecessary repetition and redun16 dancy. In addition, within one year after the date of

17 enactment of this clause, the Administrator shall, by

18 rule, develop and implement procedures for such co19 ordination and synchronization by the Administrator

20 so as to result in identical and concurrent data re21 quirements by all the agencies. Nothing in this

22 clause shall be interpreted as affecting the authority

23 of States to regulate pesticides as provided in section

24 24(a).’’.

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