MINOR CROP PROTECTION.

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.”. 110 STAT. 1494 (b) Exclusive Use of Minor Use Pesticides.— Section 3(c)(1)(F) (7 U.S.C. 136a(c)(l)(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 110 STAT. 1495the 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 subclause, 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 subclause (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 subclause, the Administrator may take action to modify or revoke the extension under this subclause 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 reg-110 STAT. 1496istrant, 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–l(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 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) 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 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 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 110 STAT. 1497 (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 ‘fulltime period’ means the time period originally established by the Administrator for submission of such data, beginning 110 STAT. 1498with 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–l(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 ofthe 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(cX2)(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—l(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 110 STAT. 1499specific 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 Federal Register, the request from the registrant, the Administrator shall publication, 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 110 STAT. 1500absence 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 (l)(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: 110 STAT. 1501 “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 re registrations 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 ½ 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 110 STAT. 1502Minor 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.”.