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TITLE II--MINOR USE CROP PROTECTION, ANTIMICROBIAL PESTICIDE REGISTRATION REFORM, AND PUBLIC HEALTH PESTICIDES

SEC. 201. REFERENCE.

Whenever in this title an amendment or repeal is expressed in terms of an amendment to, or repeal of, a section or other provision, the reference shall be considered to be made to a section or other provision of the Federal Insecticide, Fungicide, and Rodenticide Act.

SEC. 210. MINOR CROP PROTECTION.

• (a) DEFINITION

Section 2 (7 U.S.C. 136), as amended by section 120, is further amended by adding at the end the following:

• (ll) MINOR USE

The term 'minor use' means the use of a pesticide on an animal, on a commercial agricultural crop or site, or for the protection of public health where--

• (1) the total United States acreage for the crop is less than 300,000 acres, as determined by the Secretary of Agriculture; or
• (2) the Administrator, in consultation with the Secretary of Agriculture, determines that, based on information provided by an applicant for registration or a registrant, the use does not provide sufficient economic incentive to support the initial registration or continuing registration of a pesticide for such use and--
  • (A) there are insufficient efficacious alternative registered pesticides available for the use;
  • (B) the alternatives to the pesticide use pose greater risks to the environment or human health;
  • (C) the minor use pesticide plays or will play a significant part in managing pest resistance; or
  • (D) the minor use pesticide plays or will play a significant part in an integrated pest management program.

The status as a minor use under this subsection shall continue as long as the Administrator has not determined that, based on existing data, such use may cause an unreasonable adverse effect on the environment and the use otherwise qualifies for such status.

• (b) EXCLUSIVE USE OF MINOR USE PESTICIDES

Section 3(c)(1)(F) (7 U.S.C. 136a(c)(1)(F)) is amended--

• (1) by redesignating clauses (ii) and (iii) as clauses (iii) and (iv), respectively; and
• (2) by inserting after clause (i) the following:
  • (ii) The period of exclusive data use provided under clause (i) shall be extended 1 additional year for each 3 minor uses registered after the date of enactment of this clause and within 7 years of the commencement of the exclusive use period, up to a total of 3 additional years for all minor uses registered by the Administrator if the Administrator, in consultation with the Secretary of Agriculture, determines that, based on information provided by an applicant for registration or a registrant, that--
    • (I) there are insufficient efficacious alternative registered pesticides available for the use;
    • (II) the alternatives to the minor use pesticide pose greater risks to the environment or human health;
    • (III) the minor use pesticide plays or will play a significant part in managing pest resistance; or
    • (IV) the minor use pesticide plays or will play a significant part in an integrated pest management program.

The registration of a pesticide for a minor use on a crop grouping established by the Administrator shall be considered for purposes of this clause 1 minor use for each representative crop for which data are provided in the crop grouping. Any additional exclusive use period under this clause shall be modified as appropriate or terminated if the registrant voluntarily cancels the product or deletes from the registration the minor uses which formed the basis for the extension of the additional exclusive use period or if the Administrator determines that the registrant is not actually marketing the product for such minor uses.

• (3) in clause (iv), as amended by paragraph (1), by striking 'and (ii)' and inserting ', (ii), and (iii)'; and
• (4) at the end of the section, as amended by paragraph (1), by adding the following:
  • (v) The period of exclusive use provided under clause (ii) shall not take effect until 1 year after enactment of this clause, except where an applicant or registrant is applying for the registration of a pesticide containing an active ingredient not previously registered.
  • (vi) With respect to data submitted after the date of enactment of this clause by an applicant or registrant to support an amendment adding a new use to an existing registration that does not retain any period of exclusive use, if such data relates solely to a minor use of a pesticide, such data shall not, without the written permission of the original data submitter, be considered by the Administrator to support an application for a minor use by another person during the period of 10 years following the date of submission of such data. The applicant or registrant at the time the new minor use is requested shall notify the Administrator that to the best of their knowledge the exclusive use period for the pesticide has expired and that the data pertaining solely to the minor use of a pesticide is eligible for the provisions of this paragraph. If the minor use registration which is supported by data submitted pursuant to this subsection is voluntarily canceled or if such data are subsequently used to support a nonminor use, the data shall no longer be subject to the exclusive use provisions of this clause but shall instead be considered by the Administrator in accordance with the provisions of clause (i), as appropriate.

• (c) TIME EXTENSIONS FOR DEVELOPMENT OF MINOR USE DATA
  • (1) DATA CALL-IN- Section 3(c)(2)(B) (7 U.S.C. 136a(c)(2)(B)) is amended by adding at the end the following:
    • (vi) Upon the request of a registrant the Administrator shall, in the case of a minor use, extend the deadline for the production of residue chemistry data under this subparagraph for data required solely to support that minor use until the final deadline for submission of data under section 4 for the other uses of the pesticide established as of the date of enactment of the Food Quality Protection Act of 1996, if--
      • (I) the data to support other uses of the pesticide on a food are being provided;
      • (II) the registrant, in submitting a request for such an extension, provides a schedule, including interim dates to measure progress, to assure that the data production will be completed before the expiration of the extension period;
      • (III) the Administrator has determined that such extension will not significantly delay the Administrator's schedule for issuing a reregistration eligibility determination required under section 4; and
      • (IV) the Administrator has determined that based on existing data, such extension would not significantly increase the risk of any unreasonable adverse effect on the environment. If the Administrator grants an extension under this clause, the Administrator shall monitor the development of the data and shall ensure that the registrant is meeting the schedule for the production of the data. If the Administrator determines that the registrant is not meeting or has not met the schedule for the production of such data, the Administrator may proceed in accordance with clause (iv) regarding the continued registration of the affected products with the minor use and shall inform the public of such action. Notwithstanding the provisions of this clause, the Administrator may take action to modify or revoke the extension under this clause if the Administrator determines that the extension for the minor use may cause an unreasonable adverse effect on the environment. In such circumstance, the Administrator shall provide, in writing to the registrant, a notice revoking the extension of time for submission of data. Such data shall instead be due in accordance with the date established by the Administrator for the submission of the data.
  • (2) REREGISTRATION- Sections 4(d)(4)(B), 4(e)(2)(B), and 4(f)(2)(B) (7 U.S.C. 136a-1(d)(4)(B), (e)(2)(B), and (f)(2)(B)) are each amended by adding at the end the following: 'Upon application of a registrant, the Administrator shall, in the case of a minor use, extend the deadline for the production of residue chemistry data under this subparagraph for data required solely to support that minor use until the final deadline for submission of data under this section for the other uses of the pesticide established as of the date of enactment of the Food Quality Protection Act of 1996 if--
    • (i) the data to support other uses of the pesticide on a food are being provided;
    • (ii) the registrant, in submitting a request for such an extension provides a schedule, including interim dates to measure progress, to assure that the data production will be completed before the expiration of the extension period;
    • (iii) the Administrator has determined that such extension will not significantly delay the Administrator's schedule for issuing a reregistration eligibility determination required under this section; and
    • (iv) the Administrator has determined that based on existing data, such extension would not significantly increase the risk of any unreasonable adverse effect on the environment. If the Administrator grants an extension under this subparagraph, the Administrator shall monitor the development of the data and shall ensure that the registrant is meeting the schedule for the production of the data. If the Administrator determines that the registrant is not meeting or has not met the schedule for the production of such data, the Administrator may proceed in accordance with clause (iv) of section 3(c)(2)(B) or other provisions of this section, as appropriate, regarding the continued registration of the affected products with the minor use and shall inform the public of such action. Notwithstanding the provisions of this subparagraph, the Administrator may take action to modify or revoke the extension under this subparagraph if the Administrator determines that the extension for the minor use may cause an unreasonable adverse effect on the environment. In such circumstance, the Administrator shall provide written notice to the registrant revoking the extension of time for submission of data. Such data shall instead be due in accordance with the date then established by the Administrator for submission of the data.

• (d) MINOR USE WAIVER

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

• (1) by inserting IN GENERAL after '(A)';
• (2) by inserting ADDITIONAL DATA after '(B)';
• (3) by inserting SIMPLIFIED PROCEDURES after '(C)'; and
• (4) by adding at the end the following:
  • (E) MINOR USE WAIVER- In handling the registration of a pesticide for a minor use, the Administrator may waive otherwise applicable data requirements if the Administrator determines that the absence of such data will not prevent the Administrator from determining--
    • (i) the incremental risk presented by the minor use of the pesticide; and
    • (ii) that such risk, if any, would not be an unreasonable adverse effect on the environment.

• (e) EXPEDITING MINOR USE REGISTRATIONS

Section 3(c)(3) (7 U.S.C. 136a(c)(3)) is amended--

• (1) by inserting after '(A)' the following: 'IN GENERAL- ';
• (2) by inserting after '(B)' the following: 'IDENTICAL OR SUBSTANTIALLY SIMILAR- '; and
• (3) by adding at the end the following:
  • (C) MINOR USE REGISTRATION-
    • (i) The Administrator shall, as expeditiously as possible, review and act on any complete application--
      • (I) that proposes the initial registration of a new pesticide active ingredient if the active ingredient is proposed to be registered solely for minor uses, or proposes a registration amendment solely for minor uses to an existing registration; or
      • (II) for a registration or a registration amendment that proposes significant minor uses.
    • (ii) For the purposes of clause (i)--
      • (I) the term 'as expeditiously as possible' means that the Administrator shall, to the greatest extent practicable, complete a review and evaluation of all data, submitted with a complete application, within 12 months after the submission of the complete application, and the failure of the Administrator to complete such a review and evaluation under clause (i) shall not be subject to judicial review; and
      • (II) the term 'significant minor uses' means 3 or more minor uses proposed for every nonminor use, a minor use that would, in the judgment of the Administrator, serve as a replacement for any use which has been canceled in the 5 years preceding the receipt of the application, or a minor use that in the opinion of the Administrator would avoid the reissuance of an emergency exemption under section 18 for that minor use.
  • (D) ADEQUATE TIME FOR SUBMISSION OF MINOR USE DATA- If a registrant makes a request for a minor use waiver, regarding data required by the Administrator, pursuant to paragraph (2)(E), and if the Administrator denies in whole or in part such data waiver request, the registrant shall have a full-time period for providing such data. For purposes of this subparagraph, the term 'full-time period' means the time period originally established by the Administrator for submission of such data, beginning with the date of receipt by the registrant of the Administrator's notice of denial.

• (f) TEMPORARY EXTENSION OF REGISTRATION FOR UNSUPPORTED MINOR USES
  • (1) REREGISTRATION-
    • (A) Sections 4(d)(6) and 4(f)(3) (7 U.S.C. 136a-1(d)(6) and (f)(3)) are each amended by adding at the end the following: 'If the registrant does not commit to support a specific minor use of the pesticide, but is supporting and providing data in a timely and adequate fashion to support uses of the pesticide on a food, or if all uses of the pesticide are nonfood uses and the registrant does not commit to support a specific minor use of the pesticide but is supporting and providing data in a timely and adequate fashion to support other nonfood uses of the pesticide, the Administrator, at the written request of the registrant, shall not take any action pursuant to this paragraph in regard to such unsupported minor use until the final deadline established as of the date of enactment of the Food Quality Protection Act of 1996, for the submission of data under this section for the supported uses identified pursuant to this paragraph unless the Administrator determines that the absence of the data is significant enough to cause human health or environmental concerns. On such a determination the Administrator may refuse the request for extension by the registrant. Upon receipt of the request from the registrant, the Administrator shall publish in the Federal Register a notice of the receipt of the request and the effective date upon which the uses not being supported will be voluntarily deleted from the registration pursuant to section 6(f)(1). If the Administrator grants an extension under this paragraph, the Administrator shall monitor the development of the data for the uses being supported and shall ensure that the registrant is meeting the schedule for the production of such data. If the Administrator determines that the registrant is not meeting or has not met the schedule for the production of such data, the Administrator may proceed in accordance with section 3(c)(2)(B)(iv) regarding the continued registration of the affected products with the minor and other uses and shall inform the public of such action in accordance with section 6(f)(2). Notwithstanding this subparagraph, the Administrator may deny, modify, or revoke the temporary extension under this paragraph if the Administrator determines that the continuation of the minor use may cause an unreasonable adverse effect on the environment. In the event of modification or revocation, the Administrator shall provide, in writing, to the registrant a notice revoking the temporary extension and establish a new effective date by which the minor use shall be deleted from the registration.
    • (B) Section 4(e)(3)(A) (7 U.S.C. 136a-1(e)(3)(A)) is amended by adding at the end the following: 'If the registrant does not commit to support a specific minor use of the pesticide, but is supporting and providing data in a timely and adequate fashion to support uses of the pesticide on a food, or if all uses of the pesticide are nonfood uses and the registrant does not commit to support a specific minor use of the pesticide but is supporting and providing data in a timely and adequate fashion to support other nonfood uses of the pesticide, the Administrator, at the written request of the registrant, shall not take any action pursuant to this subparagraph in regard to such unsupported minor use until the final deadline established as of the date of enactment of the Food Quality Protection Act of 1996, for the submission of data under this section for the supported uses identified pursuant to this subparagraph unless the Administrator determines that the absence of the data is significant enough to cause human health or environmental concerns. On the basis of such determination, the Administrator may refuse the request for extension by the registrant. Upon receipt of the request from the registrant, the Administrator shall publish in the Federal Register a notice of the receipt of the request and the effective date upon which the uses not being supported will be voluntarily deleted from the registration pursuant to section 6(f)(1). If the Administrator grants an extension under this subparagraph, the Administrator shall monitor the development of the data for the uses being supported and shall ensure that the registrant is meeting the schedule for the production of such data. If the Administrator determines that the registrant is not meeting or has not met the schedule for the production of such data, the Administrator may proceed in accordance with section 3(c)(2)(B)(iv) regarding the continued registration of the affected products with the minor and other uses and shall inform the public of such action in accordance with section 6(f)(2). Notwithstanding this subparagraph, the Administrator may deny, modify, or revoke the temporary extension under this subparagraph if the Administrator determines that the continuation of the minor use may cause an unreasonable adverse effect on the environment. In the event of modification or revocation, the Administrator shall provide, in writing, to the registrant a notice revoking the temporary extension and establish a new effective date by which the minor use shall be deleted from the registration.
  • (2) DATA- Section 3(c)(2)(B) (7 U.S.C. 136a(c)(2)(B)), as amended by subsection (c)(1), is further amended by adding at the end the following:
    • (vii) If the registrant does not commit to support a specific minor use of the pesticide, but is supporting and providing data in a timely and adequate fashion to support uses of the pesticide on a food, or if all uses of the pesticide are nonfood uses and the registrant does not commit to support a specific minor use of the pesticide but is supporting and providing data in a timely and adequate fashion to support other nonfood uses of the pesticide, the Administrator, at the written request of the registrant, shall not take any action pursuant to this clause in regard to such unsupported minor use until the final deadline established as of the date of enactment of the Food Quality Protection Act of 1996, for the submission of data under section 4 for the supported uses identified pursuant to this clause unless the Administrator determines that the absence of the data is significant enough to cause human health or environmental concerns. On the basis of such determination, the Administrator may refuse the request for extension by the registrant. Upon receipt of the request from the registrant, the Administrator shall publish in the Federal Register a notice of the receipt of the request and the effective date upon which the uses not being supported will be voluntarily deleted from the registration pursuant to section 6(f)(1). If the Administrator grants an extension under this clause, the Administrator shall monitor the development of the data for the uses being supported and shall ensure that the registrant is meeting the schedule for the production of such data. If the Administrator determines that the registrant is not meeting or has not met the schedule for the production of such data, the Administrator may proceed in accordance with clause (iv) of this subparagraph regarding the continued registration of the affected products with the minor and other uses and shall inform the public of such action in accordance with section 6(f)(2). Notwithstanding the provisions of this clause, the Administrator may deny, modify, or revoke the temporary extension under this subparagraph if the Administrator determines that the continuation of the minor use may cause an unreasonable adverse effect on the environment. In the event of modification or revocation, the Administrator shall provide, in writing, to the registrant a notice revoking the temporary extension and establish a new effective date by which the minor use shall be deleted from the registration.

• (g) Section 6(f)

(7 U.S.C. 136d(f)) is amended--

• (1) in paragraph (1)(C)(ii) by striking '90-day' each place it appears and inserting '180-day'; and
• (2) in paragraph (3)(A) by striking '90-day' and inserting '180-day'.

• (h) UTILIZATION OF DATA FOR VOLUNTARILY CANCELED CHEMICALS

Section 6(f) (7 U.S.C. 136d(f)) is amended by adding at the end the following:

• (4) UTILIZATION OF DATA FOR VOLUNTARILY CANCELED PESTICIDE- When an application is filed with the Administrator for the registration of a pesticide for a minor use and another registrant subsequently voluntarily cancels its registration for an identical or substantially similar pesticide for an identical or substantially similar use, the Administrator shall process, review, and evaluate the pending application as if the voluntary cancellation had not yet taken place except that the Administrator shall not take such action if the Administrator determines that such minor use may cause an unreasonable adverse effect on the environment. In order to rely on this subsection, the applicant must certify that it agrees to satisfy any outstanding data requirements necessary to support the reregistration of the pesticide in accordance with the data submission schedule established by the Administrator.

• (i) ENVIRONMENTAL PROTECTION AGENCY MINOR USE PROGRAM

The Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.), as amended by section 121, is amended by adding after section 30 the following:

• SEC. 31. ENVIRONMENTAL PROTECTION AGENCY MINOR USE PROGRAM.
  • (a) The Administrator shall assure coordination of minor use issues through the establishment of a minor use program within the Office of Pesticide Programs. Such office shall be responsible for coordinating the development of minor use programs and policies and consulting with growers regarding minor use issues and registrations and amendments which are submitted to the Environmental Protection Agency.
  • (b) The Office of Pesticide Programs shall prepare a public report concerning the progress made on the registration of minor uses, including implementation of the exclusive use as an incentive for registering new minor uses, within 3 years of the passage of the Food Quality Protection Act of 1996.

• (j) DEPARTMENT OF AGRICULTURE MINOR USE PROGRAM

The Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.), as amended by subsection (i), is amended by adding after section 31 the following:

• SEC. 32. DEPARTMENT OF AGRICULTURE MINOR USE PROGRAM.
  • (a) IN GENERAL

  The Secretary of Agriculture (hereinafter in this section referred to as the 'Secretary') shall assure the coordination of the responsibilities of the Department of Agriculture related to minor uses of pesticides, including--

  • (1) carrying out the Inter-Regional Project Number 4 (IR-4) as described in section 2 of Public Law 89-106 (7 U.S.C. 450i(e)) and the national pesticide resistance monitoring program established under section 1651 of the Food, Agriculture, Conservation, and Trade Act of 1990 (7 U.S.C. 5882);
  • (2) supporting integrated pest management research;
  • (3) consulting with growers to develop data for minor uses; and
  • (4) providing assistance for minor use registrations, tolerances, and reregistrations with the Environmental Protection Agency.
• (b)(1) MINOR USE PESTICIDE DATA
  • (A) GRANT AUTHORITY- The Secretary, in consultation with the Administrator, shall establish a program to make grants for the development of data to support minor use pesticide registrations and reregistrations. The amount of any such grant shall not exceed 1/2 of the cost of the project for which the grant is made.
  • (B) APPLICANTS- Any person who wants to develop data to support minor use pesticide registrations and reregistrations may apply for a grant under subparagraph (A). Priority shall be given to an applicant for such a grant who does not directly receive funds from the sale of pesticides registered for minor uses.
  • (C) DATA OWNERSHIP- Any data that is developed under a grant under subparagraph (A) shall be jointly owned by the Department of Agriculture and the person who received the grant. Such a person shall enter into an agreement with the Secretary under which such person shall share any fee paid to such person under section 3(c)(1)(F).
• (2) MINOR USE PESTICIDE DATA REVOLVING FUND
  • (A) ESTABLISHMENT- There is established in the Treasury of the United States a revolving fund to be known as the Minor Use Pesticide Data Revolving Fund. The Fund shall be available without fiscal year limitation to carry out the authorized purposes of this subsection.
  • (B) CONTENTS OF THE FUND- There shall be deposited in the Fund--
    • (i) such amounts as may be appropriated to support the purposes of this subsection; and
    • (ii) fees collected by the Secretary for any data developed under a grant under paragraph (1)(A).
  • (C) AUTHORIZATIONS OF APPROPRIATIONS- There are authorized to be appropriated for each fiscal year to carry out the purposes of this subsection $10,000,000 to remain available until expended.

SEC. 221. DEFINITIONS.

Section 2 (7 U.S.C. 136), as amended by section 210(a) is further amended--

• (1) in subsection (u), by adding at the end the following:
  • The term 'pesticide' does not include liquid chemical sterilant products (including any sterilant or subordinate disinfectant claims on such products) for use on a critical or semi-critical device, as defined in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321). For purposes of the preceding sentence, the term 'critical device' includes any device which is introduced directly into the human body, either into or in contact with the bloodstream or normally sterile areas of the body and the term 'semi-critical device' includes any device which contacts intact mucous membranes but which does not ordinarily penetrate the blood barrier or otherwise enter normally sterile areas of the body.; and
  • (2) by adding at the end the following:
    • (mm) 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 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a and 348) or a food additive regulation under section 409 of such Act.
    • (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. 222. FEDERAL AND STATE DATA COORDINATION.

Section 3(c)(2)(B) (7 U.S.C. 136a(c)(2)(B)), as amended by section 210(f)(2), is amended by adding at the end the following:

• (viii)
  • (I) 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) The Administrator may enter into a cooperative agreement with a State to carry out subclause (I).
  • (III) 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. 223. LABEL AND LABELING.

Section 3(c) (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. 224. REGISTRATION REQUIREMENTS FOR ANTIMICROBIAL PESTICIDES.

Section 3 (7 U.S.C. 136a), as amended by section 106(b), is further amended by adding at the end the following:

• (h) REGISTRATION REQUIREMENTS FOR ANTIMICROBIAL PESTICIDES-
  • (1) EVALUATION OF PROCESS- To the maximum extent practicable consistent with the degrees of risk presented by an 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(mm) 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 chapter 7 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. 225. DISPOSAL OF HOUSEHOLD, INDUSTRIAL, OR INSTITUTIONAL ANTIMICROBIAL PRODUCTS.

Section 19(h) (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.

SEC. 230. DEFINITIONS.

• (a) ADVERSE EFFECTS-

Section 2(bb) (7 U.S.C. 136(bb)) is amended by adding at the end the following: 'The Administrator shall consider the risks and benefits of public health pesticides separate from the risks and benefits of other pesticides. In weighing any regulatory action concerning a public health pesticide under this Act, the Administrator shall weigh any risks of the pesticide against the health risks such as the diseases transmitted by the vector to be controlled by the pesticide.

• (b) NEW DEFINITIONS-

Section 2 (7 U.S.C. 136), as amended by section 221, is amended by adding at the end the following:

• (nn) PUBLIC HEALTH PESTICIDE- The term 'public health pesticide' means any minor use pesticide product registered for use and used predominantly in public health programs for vector control or for other recognized health protection uses, including the prevention or mitigation of viruses, bacteria, or other microorganisms (other than viruses, bacteria, or other microorganisms on or in living man or other living animal) that pose a threat to public health.
• (oo) VECTOR- The term 'vector' means any organism capable of transmitting the causative agent of human disease or capable of producing human discomfort or injury, including mosquitoes, flies, fleas, cockroaches, or other insects and ticks, mites, or rats.

SEC. 231. REGISTRATION.

Section 3(c)(2)(A) (7 U.S.C. 136a(c)(2)(A)) is amended--

• (1) by inserting after 'pattern of use,' the following: 'the public health and agricultural need for such minor use,'; and
• (2) by striking 'potential exposure of man and the environment to the pesticide' and inserting 'potential beneficial or adverse effects on man and the environment'.

SEC. 232. REREGISTRATION.

Section 4 (7 U.S.C. 136a-1) is amended--

• (1) in subsection (i)(4), by redesignating subparagraphs (B) and (C) as subparagraphs (C) and (D), respectively, and by adding after subparagraph (A) the following:
  • (B) The Administrator shall exempt any public health pesticide from the payment of the fee prescribed under paragraph (3) if, in consultation with the Secretary of Health and Human Services, the Administrator determines, based on information supplied by the registrant, that the economic return to the registrant from sales of the pesticide does not support the registration or reregistration of the pesticide
• (2) in subsection (i)(5), by redesignating subparagraphs (F) and (G) as subparagraphs (G) and (H), respectively, and by adding after subparagraph (E) the following:
  • (F) The Administrator shall exempt any public health pesticide from the payment of the fee prescribed under paragraph (3) if, in consultation with the Secretary of Health and Humans Services, the Administrator determines, based on information supplied by the registrant, that the economic return to the registrant from sales of the pesticide does not support the registration or reregistration of the pesticide.
• (3) in subsection (i)(7)(B), by striking 'or to determine' and inserting ', to determine' and by inserting before the period the following: ', or to determine the volume usage for public health pesticides'; and
• (4) in subsection (k)(3)(A), by striking 'or' at the end of clause (i), by striking the period at the end of clause (ii) and inserting thereof '; or', and by adding after clause (ii) the following: '(iii) proposes the initial or amended registration of an end use pesticide that, if registered as proposed, would be used for a public health pesticide.

SEC. 233. CANCELLATION.

Section 6(b) (7 U.S.C. 136d(b)) is amended by adding after the eighth sentence the following: 'When a public health use is affected, the Secretary of Health and Human Services should provide available benefits and use information, or an analysis thereof, in accordance with the procedures followed and subject to the same conditions as the Secretary of Agriculture in the case of agricultural pesticides.

SEC. 234. VIEWS OF THE SECRETARY OF HEALTH AND HUMAN SERVICES.

Section 21 (7 U.S.C. 136s) is amended by redesignating subsections (b) and (c) as subsections (c) and (d), respectively, and by adding after subsection (a) the following:

• (b) SECRETARY OF HEALTH AND HUMAN SERVICES- The Administrator, before publishing regulations under this Act for any public health pesticide, shall solicit the views of the Secretary of Health and Human Services in the same manner as the views of the Secretary of Agriculture are solicited under section 25(a)(2).

SEC. 235. AUTHORITY OF ADMINISTRATOR.

Section 25(a)(1) (7 U.S.C. 136w(a)(1)) is amended--

• (1) by inserting after 'various classes of pesticides' the following: ', including public health pesticides,'; and
• (2) by striking 'and nonagricultural pesticides' and inserting ', nonagricultural, and public health pesticides'.

SEC. 236. IDENTIFICATION OF PESTS.

Section 28 (7 U.S.C. 136w-3) is amended by adding at the end the following:

• (d) PUBLIC HEALTH PESTS- The Administrator, in coordination with the Secretary of Agriculture and the Secretary of Health and Human Services, shall identify pests of significant public health importance and, in coordination with the Public Health Service, develop and implement programs to improve and facilitate the safe and necessary use of chemical, biological, and other methods to combat and control such pests of public health importance.

SEC. 237. PUBLIC HEALTH DATA.

Section 4 (7 U.S.C. 136a-1) is amended by adding at the end the following:

• (m) AUTHORIZATION OF FUNDS TO DEVELOP PUBLIC HEALTH DATA-
  • (1) DEFINITION- For the purposes of this section, 'Secretary' means the Secretary of Health and Human Services, acting through the Public Health Service.
  • (2) CONSULTATION- In the case of a pesticide registered for use in public health programs for vector control or for other uses the Administrator determines to be human health protection uses, the Administrator shall, upon timely request by the registrant or any other interested person, or on the Administrator's own initiative may, consult with the Secretary prior to taking final action to suspend registration under section 3(c)(2)(B)(iv), or cancel a registration under section 4, 6(e), or 6(f). In consultation with the Secretary, the Administrator shall prescribe the form and content of requests under this section.
  • (3) BENEFITS TO SUPPORT FAMILY- The Administrator, after consulting with the Secretary, shall make a determination whether the potential benefits of continued use of the pesticide for public health or health protection purposes are of such significance as to warrant a commitment by the Secretary to conduct or to arrange for the conduct of the studies required by the Administrator to support continued registration under section 3 or reregistration under section 4.
  • (4) ADDITIONAL TIME- If the Administrator determines that such a commitment is warranted and in the public interest, the Administrator shall notify the Secretary and shall, to the extent necessary, amend a notice issued under section 3(c)(2)(B) to specify additional reasonable time periods for submission of the data.
  • (5) ARRANGEMENTS- The Secretary shall make such arrangements for the conduct of required studies as the Secretary finds necessary and appropriate to permit submission of data in accordance with the time periods prescribed by the Administrator. Such arrangements may include Public Health Service intramural research activities, grants, contracts, or cooperative agreements with academic, public health, or other organizations qualified by experience and training to conduct such studies.
  • (6) SUPPORT- The Secretary may provide for support of the required studies using funds authorized to be appropriated under this section, the Public Health Service Act, or other appropriate authorities. After a determination is made under subsection (d), the Secretary shall notify the Committees on Appropriations of the House of Representatives and the Senate of the sums required to conduct the necessary studies.
  • (7) AUTHORIZATION OF APPROPRIATIONS- There is authorized to be appropriated to carry out the purposes of this section $12,000,000 for fiscal year 1997, and such sums as may be necessary for succeeding fiscal years.

SEC. 250. EXPEDITED REGISTRATION OF PESTICIDES.

Section 3(c) (7 U.S.C. 136a(c)), as amended by section 223, is amended--

• (1) by adding at the end of paragraph (1) the following:
  • (G) If the applicant is requesting that the registration or amendment to the registration of a pesticide be expedited, an explanation of the basis for the request must be submitted, in accordance with paragraph (10) of this subsection.'; and (2) by adding at the end the following:
    • (10) EXPEDITED REGISTRATION OF PESTICIDES-
      • (A) Not later than 1 year after the date of enactment of this paragraph, the Administrator shall, utilizing public comment, develop procedures and guidelines, and expedite the review of an application for registration of a pesticide or an amendment to a registration that satisfies such guidelines.
      • (B) Any application for registration or an amendment, including biological and conventional pesticides, will be considered for expedited review under this paragraph. An application for registration or an amendment shall qualify for expedited review if use of the pesticide proposed by the application may reasonably be expected to accomplish 1 or more of the following:
        • (i) Reduce the risks of pesticides to human health.
        • (ii) Reduce the risks of pesticides to nontarget organisms.
        • (iii) Reduce the potential for contamination of groundwater, surface water, or other valued environmental resources.
        • (iv) Broaden the adoption of integrated pest management strategies, or make such strategies more available or more effective.
      • (C) The Administrator, not later than 30 days after receipt of an application for expedited review, shall notify the applicant whether the application is complete. If it is found to be incomplete, the Administrator may either reject the request for expedited review or ask the applicant for additional information to satisfy the guidelines developed under subparagraph (A).

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