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 Committee on Agriculture

A BILL

To reform antimicrobial pesticide registration, 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. DEFINITIONS.

7 Section 2 of the Federal Insecticide, Fungicide, and

8 Rodenticide Act (7 U.S.C. 136) is amended—

9 (1) in subsection (k), by striking ‘‘yeast, and

10 bacteria’’ and inserting ‘‘and yeast’’;
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1 (2) in subsection (u), by adding at the end the

2 following: ‘‘The term ‘pesticide’ does not include liq3 uid chemical sterilant products for use on a critical

4 or semi-critical medical or dental device, as defined

5 in section 201 of the Federal Food, Drug, and Cos6 metic Act (21 U.S.C. 321).’’; and

7 (3) by adding at the end the following:

8 ‘‘(hh) ANTIMICROBIAL PESTICIDE.—

9 ‘‘(1) IN GENERAL.—The term ‘antimicrobial

10 pesticide’ means a pesticide that—

11 ‘‘(A) is intended to—

12 ‘‘(i) disinfect, sanitize, reduce, or miti13 gate growth or development of micro14 biological organisms; or

15 ‘‘(ii) protect inanimate objects, indus16 trial processes or systems, surfaces, water,

17 or other chemical substances from con18 tamination, fouling, or deterioration caused

19 by bacteria, viruses, fungi, protozoa, algae,

20 or slime; and

21 ‘‘(B) in the intended use is exempt from,

22 or otherwise not subject to, a tolerance under

23 section 408 or 409 of the Federal Food, Drug,

24 and Cosmetic Act (21 U.S.C. 346a and 348).
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1 ‘‘(2) EXCLUDED PRODUCTS.—The term

2 ‘antimicrobial pesticide’ does not include—

3 ‘‘(A) a wood preservative or antifouling

4 paint product for which a claim of pesticidal ac5 tivity other than or in addition to an activity

6 described in paragraph (1) is made;

7 ‘‘(B) an agricultural fungicide product; or

8 ‘‘(C) an aquatic herbicide product.

9 ‘‘(3) INCLUDED PRODUCTS.—The term

10 ‘antimicrobial pesticide’ does include any other

11 chemical sterilant product (other than liquid chemi12 cal sterilant products exempt under subsection (u)),

13 any other disinfectant product, any other industrial

14 microbiocide product, and any other preservative

15 product that is not excluded by paragraph (2).’’.

16 SEC. 3. FEDERAL AND STATE DATA COORDINATION.

17 Section 3(c)(2)(B) of the Federal Insecticide, Fun18 gicide, and Rodenticide Act (7 U.S.C. 136a(c)(2)(B)) is

19 amended by adding at the end the following:

20 ‘‘(vi) COORDINATION OF DATA RE21 QUIREMENTS.—

22 ‘‘(I) IN GENERAL.—If data re23 quired to support registration of a

24 pesticide under subparagraph (A) is

25 requested by a Federal or State regu-
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1 latory authority, the Administrator

2 shall, to the extent practicable, coordi3 nate data requirements, test protocols,

4 timetables, and standards of review

5 and reduce burdens and redundancy

6 caused to the registrant by multiple

7 requirements on the registrant.

8 ‘‘(II) COOPERATIVE AGREE9 MENT.—The Administrator may enter

10 into a cooperative agreement with a

11 State to carry out subclause (I).

12 ‘‘(III) DISPARITIES.—Not later

13 than 1 year after the date of enact14 ment of this clause, the Administrator

15 shall develop a process to identify and

16 assist in alleviating future disparities

17 between Federal and State data re18 quirements.’’.

19 SEC. 4. LABEL AND LABELING.

20 Section 3(c) of the Federal Insecticide, Fungicide,

21 and Rodenticide Act (7 U.S.C. 136a(c)) is amended by

22 adding at the end the following:

23 ‘‘(9) LABELING.—

24 ‘‘(A) ADDITIONAL STATEMENTS.—Subject

25 to subparagraphs (B) and (C), it shall not be
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1 a violation of this Act for a registrant to modify

2 the labeling of an antimicrobial pesticide prod3 uct to include relevant information on product

4 efficacy, product composition, container com5 position or design, or other characteristics that

6 do not relate to any pesticidal claim or pes7 ticidal activity.

8 ‘‘(B) REQUIREMENTS.—Proposed labeling

9 information under subparagraph (A) shall not

10 be false or misleading, shall not conflict with or

11 detract from any statement required by law or

12 the Administrator as a condition of registration,

13 and shall be substantiated on the request of the

14 Administrator.

15 ‘‘(C) NOTIFICATION AND DISAPPROVAL.—

16 ‘‘(i) NOTIFICATION.—A registration

17 may be modified under subparagraph (A)

18 if—

19 ‘‘(I) the registrant notifies the

20 Administrator in writing not later

21 than 60 days prior to distribution or

22 sale of a product bearing the modified

23 labeling; and
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1 ‘‘(II) the Administrator does not

2 disapprove of the modification under

3 clause (ii).

4 ‘‘(ii) DISAPPROVAL.—Not later than

5 30 days after receipt of a notification

6 under clause (i), the Administrator may

7 disapprove the modification by sending the

8 registrant notification in writing stating

9 that the proposed language is not accept10 able and stating the reasons why the Ad11 ministrator finds the proposed modification

12 unacceptable.

13 ‘‘(iii) RESTRICTION ON SALE.—A reg14 istrant may not sell or distribute a product

15 bearing a disapproved modification.

16 ‘‘(iv) OBJECTION.—A registrant may

17 file an objection in writing to a disapproval

18 under clause (ii) not later than 30 days

19 after receipt of notification of the dis20 approval.

21 ‘‘(v) FINAL ACTION.—A decision by

22 the Administrator following receipt and

23 consideration of an objection filed under

24 clause (iv) shall be considered a final agen25 cy action.
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1 ‘‘(D) USE DILUTION.—The label or label2 ing required under this Act for an antimicrobial

3 pesticide that is or may be diluted for use may

4 have a different statement of caution or protec5 tive measures for use of the recommended di6 luted solution of the pesticide than for use of a

7 concentrate of the pesticide if the Administrator

8 determines that—

9 ‘‘(i) adequate data have been submit10 ted to support the statement proposed for

11 the diluted solution uses; and

12 ‘‘(ii) the label or labeling provides

13 adequate protection for exposure to the di14 luted solution of the pesticide.’’.

15 SEC. 5. REGISTRATION REQUIREMENTS FOR ANTI16 MICROBIAL PESTICIDES.

17 Section 3 of the Federal Insecticide, Fungicide, and

18 Rodenticide Act (7 U.S.C. 136a) is amended by adding

19 at the end the following:

20 ‘‘(g) REGISTRATION REQUIREMENTS FOR

21 ANTIMICROBIAL PESTICIDES.—

22 ‘‘(1) EVALUATION OF PROCESS.—To the maxi23 mum extent practicable consistent with the degrees

24 of risk presented by a antimicrobial pesticide and

25 the type of review appropriate to evaluate the risks,
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1 the Administrator shall identify and evaluate re2 forms to the antimicrobial registration process that

3 would reduce review periods existing as of the date

4 of enactment of this subsection for antimicrobial

5 pesticide product registration applications and appli6 cations for amended registration of antimicrobial

7 pesticide products, including—

8 ‘‘(A) new antimicrobial active ingredients;

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

10 ‘‘(C) substantially similar or identical

11 antimicrobial pesticides; and

12 ‘‘(D) amendments to antimicrobial pes13 ticide registrations.

14 ‘‘(2) REVIEW TIME PERIOD REDUCTION

15 GOAL.—Each reform identified under paragraph (1)

16 shall be designed to achieve the goal of reducing the

17 review period following submission of a complete ap18 plication, consistent with the degree of risk, to a pe19 riod of not more than—

20 ‘‘(A) 540 days for a new antimicrobial ac21 tive ingredient pesticide registration;

22 ‘‘(B) 270 days for a new antimicrobial use

23 of a registered active ingredient;

24 ‘‘(C) 120 days for any other new

25 antimicrobial product;
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1 ‘‘(D) 90 days for a substantially similar or

2 identical antimicrobial product;

3 ‘‘(E) 90 days for an amendment to an

4 antimicrobial registration that does not require

5 scientific review of data; and

6 ‘‘(F) 90 to 180 days for an amendment to

7 an antimicrobial registration that requires sci8 entific review of data and that is not otherwise

9 described in this paragraph.

10 ‘‘(3) IMPLEMENTATION.—

11 ‘‘(A) PROPOSED RULEMAKING.—

12 ‘‘(i) ISSUANCE.—Not later than 270

13 days after the date of enactment of this

14 subsection, the Administrator shall publish

15 in the Federal Register proposed regula16 tions to accelerate and improve the review

17 of antimicrobial pesticide products de18 signed to implement, to the extent prac19 ticable, the goals set forth in paragraph

20 (2).

21 ‘‘(ii) REQUIREMENTS.—Proposed reg22 ulations issued under clause (i) shall—

23 ‘‘(I) define the various classes of

24 antimicrobial use patterns, including

25 household, industrial, and institutional
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1 disinfectants and sanitizing pesticides,

2 preservatives, water treatment, and

3 pulp and paper mill additives, and

4 other such products intended to dis5 infect, sanitize, reduce, or mitigate

6 growth or development of micro7 biological organisms, or protect inani8 mate objects, industrial processes or

9 systems, surfaces, water, or other

10 chemical substances from contamina11 tion, fouling, or deterioration caused

12 by bacteria, viruses, fungi, protozoa,

13 algae, or slime;

14 ‘‘(II) differentiate the types of re15 view undertaken for antimicrobial pes16 ticides;

17 ‘‘(III) conform the degree and

18 type of review to the risks and bene19 fits presented by antimicrobial pes20 ticides and the function of review

21 under this Act, considering the use

22 patterns of the product, toxicity, ex23 pected exposure, and product type;

24 ‘‘(IV) ensure that the registration

25 process is sufficient to maintain
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1 antimicrobial pesticide efficacy and

2 that antimicrobial pesticide products

3 continue to meet product performance

4 standards and effectiveness levels for

5 each type of label claim made; and

6 ‘‘(V) implement effective and reli7 able deadlines for process manage8 ment.

9 ‘‘(iii) COMMENTS.—In developing the

10 proposed regulations, the Administrator

11 shall solicit the views from registrants and

12 other affected parties to maximize the ef13 fectiveness of the rule development process.

14 ‘‘(B) FINAL REGULATIONS.—

15 ‘‘(i) ISSUANCE.—The Administrator

16 shall issue final regulations not later than

17 240 days after the close of the comment

18 period for the proposed regulations.

19 ‘‘(ii) FAILURE TO MEET GOAL.—If a

20 goal described in paragraph (2) is not met

21 by the final regulations, the Administrator

22 shall identify the goal, explain why the goal

23 was not attained, describe the element of

24 the regulations included instead, and iden25 tify future steps to attain the goal.
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1 ‘‘(iii) REQUIREMENTS.—In issuing

2 final regulations, the Administrator shall—

3 ‘‘(I) consider the establishment of

4 a certification process for regulatory

5 actions involving risks that can be re6 sponsibly managed, consistent with

7 the degree of risk, in the most cost-ef8 ficient manner;

9 ‘‘(II) consider the establishment

10 of a certification process by approved

11 laboratories as an adjunct to the re12 view process;

13 ‘‘(III) use all appropriate and

14 cost-effective review mechanisms, in15 cluding—

16 ‘‘(aa) expanded use of notifi17 cation and non-notification proce18 dures;

19 ‘‘(bb) revised procedures for

20 application review; and

21 ‘‘(cc) allocation of appro22 priate resources to ensure

23 streamlined management of

24 antimicrobial pesticide registra25 tions; and
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1 ‘‘(IV) clarify criteria for deter2 mination of the completeness of an

3 application.

4 ‘‘(C) EXPEDITED REVIEW.—This sub5 section does not affect the requirements or ex6 tend the deadlines or review periods contained

7 in subsection (c)(3).

8 ‘‘(D) ALTERNATIVE REVIEW PERIODS.—If

9 the final regulations to carry out this paragraph

10 are not effective 630 days after the date of en11 actment of this subsection, until the final regu12 lations become effective, the review period, be13 ginning on the date of receipt by the Agency of

14 a complete application, shall be—

15 ‘‘(i) 2 years for a new antimicrobial

16 active ingredient pesticide registration;

17 ‘‘(ii) 1 year for a new antimicrobial

18 use of a registered active ingredient;

19 ‘‘(iii) 180 days for any other new

20 antimicrobial product;

21 ‘‘(iv) 90 days for a substantially simi22 lar or identical antimicrobial product;

23 ‘‘(v) 90 days for an amendment to an

24 antimicrobial registration that does not re25 quire scientific review of data; and
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1 ‘‘(vi) 240 days for an amendment to

2 an antimicrobial registration that requires

3 scientific review of data and that is not

4 otherwise described in this subparagraph.

5 ‘‘(E) WOOD PRESERVATIVES.—An applica6 tion for the registration, or for an amendment

7 to the registration, of a wood preservative prod8 uct for which a claim of pesticidal activity listed

9 in section 2(hh)(1) is made (regardless of any

10 other pesticidal claim that is made with respect

11 to the product) shall be reviewed by the Admin12 istrator within the same period as that estab13 lished under this paragraph for an

14 antimicrobial pesticide product application, con15 sistent with the degree of risk posed by the use

16 of the wood preservative product, if the applica17 tion requires the applicant to satisfy the same

18 data requirements as are required to support an

19 application for a wood preservative product that

20 is an antimicrobial pesticide.

21 ‘‘(F) NOTIFICATION.—

22 ‘‘(i) IN GENERAL.—Subject to clause

23 (iii), the Administrator shall notify an ap24 plicant whether an application has been

25 granted or denied not later than the final
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1 day of the appropriate review period under

2 this paragraph, unless the applicant and

3 the Administrator agree to a later date.

4 ‘‘(ii) FINAL DECISION.—If the Admin5 istrator fails to notify an applicant within

6 the period of time required under clause

7 (i), the failure shall be considered an agen8 cy action unlawfully withheld or unreason9 ably delayed for purposes of judicial review

10 under section 706(1) of title 5, United

11 States Code.

12 ‘‘(iii) EXEMPTION.—This subpara13 graph does not apply to an application for

14 an antimicrobial pesticide that is filed

15 under subsection (c)(3)(B) prior to 90

16 days after the date of enactment of this

17 subsection.

18 ‘‘(4) ANNUAL REPORT.—

19 ‘‘(A) SUBMISSION.—Beginning on the date

20 of enactment of this subsection and ending on

21 the date that the goals under paragraph (2) are

22 achieved, the Administrator shall, not later than

23 March 1 of each year, prepare and submit an

24 annual report to the Committee on Agriculture

25 of the House of Representatives and the Com-
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1 mittee on Agriculture, Nutrition, and Forestry

2 of the Senate.

3 ‘‘(B) REQUIREMENTS.—A report submit4 ted under subparagraph (A) shall include a de5 scription of—

6 ‘‘(i) measures taken to reduce the

7 backlog of pending registration applica8 tions;

9 ‘‘(ii) progress toward achieving re10 forms under this subsection; and

11 ‘‘(iii) recommendations to improve the

12 activities of the Agency pertaining to

13 antimicrobial registrations.’’.

14 SEC. 6. DISPOSAL OF HOUSEHOLD, INDUSTRIAL, OR INSTI15 TUTIONAL ANTIMICROBIAL PRODUCTS.

16 Section 19(h) of the Federal Insecticide, Fungicide,

17 and Rodenticide Act (7 U.S.C. 136q(h)) is amended—

18 (1) by striking ‘‘Nothing in’’ and inserting the

19 following:

20 ‘‘(1) IN GENERAL.—Nothing in’’; and

21 (2) by adding at the end the following:

22 ‘‘(2) ANTIMICROBIAL PRODUCTS.—A household,

23 industrial, or institutional antimicrobial product that

24 is not subject to regulation under the Solid Waste

25 Disposal Act (42 U.S.C. 6901 et seq.) shall not be
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1 subject to the provisions of subsections (a), (e), and

2 (f), unless the Administrator determines that such

3 product must be subject to such provisions to pre4 vent an unreasonable adverse effect on the environ5 ment.’’.

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