[Federal Register Volume 64, Number 78 (Friday, April 23, 1999)] [Proposed Rules] [Pages 19958-19961] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 99-10237] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 152, 174, and 180 [OPP-300369A; FRL-6077-6] RIN 2070-AC02 Plant-Pesticides, Supplemental Notice of Availability of Information AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule; supplemental notice. ----------------------------------------------------------------------- SUMMARY: EPA is soliciting comment on a request to substitute an alternative name for the term ``plant-pesticide.'' This document also solicits suggestions for appropriate alternative names. DATES: Comments and data must be received on or before May 24, 1999. ADDRESSES: Comments and data may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Units I.C. and D. of this document. To ensure proper receipt by EPA, your comments and data must identify the docket control number [[Page 19959]] OPP-300369A in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: By mail: Philip Hutton, Biopesticides and Pollution Prevention Division (7511C), Office of Pesticide Programs, Environmental Protection Agency, 1921 Jefferson Davis Hwy., Arlington, VA 22202; telephone: (703) 308-8260; e-mail address: [email protected]. SUPPLEMENTARY INFORMATION: I. General Information A. Does This Document Apply To Me? You may be potentially affected by this document, if you conduct large scale field tests during the process of developing plant- pesticides, or if you sell or distribute plant-pesticides. Potentially affected entities may include, but are not limited to: ------------------------------------------------------------------------ Examples of potentially affected Category entities ------------------------------------------------------------------------ Field testing Universities; domestic, foreign, or multinational biotechnology companies; chemical companies; or seed companies Selling and distributing Domestic, foreign, or multinational biotechnology companies; chemical companies; or seed companies ------------------------------------------------------------------------ This table is not intended to be exhaustive, but rather provides a guide for readers regarding the types of entities potentially affected by this document. If you have any questions regarding the applicability of this document to a particular entity, consult the technical person listed in the ``FOR FURTHER INFORMATION CONTACT'' at the beginning of this document. B. How Can I Get Additional Information or Copies of This Document or Other Documents? 1. Electronically. You may obtain electronic copies of this document and other documents from the EPA Internet Home Page at http:// www.epa.gov/. On the Home Page, select ``Laws and Regulations'' and then look up the entry for this document under the ``Federal Register-- Environmental Documents.'' You can also go directly to the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. 2. In person or by phone. If you have any questions or need additional information about this document, you may contact the technical person identified in the ``FOR FURTHER INFORMATION CONTACT'' section of this document. In addition, the official record for this document, including the public version, has been established under docket control number OPP-300369A, (including comments and data submitted electronically as described in Unit I.C. of this document). This record not only includes the documents that are physically located in the docket, but also includes all the documents that are referenced in those documents. A public version of this record, including printed, paper versions of any electronic comments and data, which does not include any information claimed as Confidential Business Information (CBI) is available for inspection in Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Public Information and Records Integrity Branch telephone number is (703) 305-5805. C. How and To Whom Do I Submit Comments? You may submit comments and data through the mail, in person, or electronically. To ensure proper receipt by EPA, your comments and data must identify the docket control number OPP-300369A in the subject line on the first page of your response. 1. By mail. Submit written comments and data to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW. Washington, DC 20460. 2. In person or by courier. Deliver written comments and data to: Public Information and Records Integrity Branch, Information Resources and Services Division, Office of Pesticide Programs, Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. 3. Electronically. Submit your comments and data electronically by e-mail to: [email protected]. Do not submit any information electronically that you consider to be CBI. Submit comments and data as an ASCII file, avoiding the use of special characters and any form of encryption. Comments and data will also be accepted on standard disks in WordPerfect 5.1/6.1 or ASCII file format. All copies of electronic comments and data must be identified by the docket control number OPP- 300369A. Electronic comments on this document may be filed online at many Federal Depository Libraries. D. How Should I Handle CBI Information That I Want To Submit To the Agency? You may claim information that you submit in response to the document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the comment and data that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential will be included in the public docket by EPA without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult with the technical person identified in the ``FOR FURTHER INFORMATION CONTACT'' section. II. History Section 2(u) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136(u)) defines pesticide as: ``(1) any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest, (2) any substance or mixture of substances intended for use as a plant regulator, defoliant, or desiccant, and (3) any nitrogen stabilizer . . . .'' The substances plants produce for protection against pests are pesticides under the FIFRA definition of pesticide, if humans intend to use these substances for ``preventing, destroying, repelling, or mitigating any pest.'' EPA recognizes the unique use pattern of these pesticides, which are produced and used in the living plant. Thus, in a November 23, 1994, Federal Register document (59 FR 60496), EPA suggested giving these types of pesticides a unique name, ``plant-pesticides,'' in order to distinguish them from chemical, microbial, or biochemical pesticides. Since 1994, EPA has been using the term, ``plant- [[Page 19960]] pesticide,'' to refer to these unique pesticides. EPA believes a unique name for this category of pesticides benefits the public by providing the means to readily identify regulations specific to this type of pesticide in the Code of Federal Regulations (CFR). A ``plant- pesticide'' was described in the November 23, 1994, Federal Register document (59 FR 60496) as ``a pesticidal substance that is produced in a living plant and the genetic material necessary for production of the substance, where the substance is intended for use in the living plant.'' EPA received several letters during the official comment period for the November 23, 1994, Federal Register document (59 FR 60496) that expressed concern about the name, ``plant-pesticide.'' These comments expressed the opinion that the term ``pesticide'' has a negative connotation, and requested that EPA consider another name. III. Request for Comment EPA is requesting comment on the advisability of substituting another name for the term, ``plant-pesticide.'' EPA also requests suggestions for appropriate alternative names, as no alternative names were suggested during the official comment period. Alternative names may be names in common scientific use, e.g., ``plant defense compounds,'' or names created specifically to describe this type of pesticide, e.g., ``caedeflors'' or ``floragens.'' EPA, specifically, requests comment on whether the alternative name, ``plant-expressed protectants,'' would be an acceptable name for this category of pesticides. EPA is only seeking comments on the advisability of substituting another name for the term ``plant-pesticides'' and on appropriate alternative names. The Agency is not reopening the comment period on previously published Federal Register documents dealing with plant-pesticides as described in Unit IV. of this document. If EPA changes the name describing the pesticides currently termed, ``plant-pesticides,'' the change will only affect the name. It will not affect the status of the pesticidal substance or the genetic material necessary to produce it. These will still be pesticides under FIFRA section 2(u). Similarly, a change of name will not affect any regulatory requirements. IV. Sources of Additional Information Commenters, who wish to obtain further information on plant- pesticides and on EPA's approach to them, should consult the documents listed in this unit, as well as the dockets for these documents. In the November 23, 1994, Federal Register, EPA published a package of five separate documents (59 FR 60496, 60519, 60535, 60542, and 60545) (FRL- 4755-2, FRL-4755-3, FRL-4758-8, FRL-4755-5, and FRL-4755-4) which described EPA's policy and proposals for plant-pesticides. On July 22, 1996, EPA published a supplemental document in the Federal Register (61 FR 37891) (FRL-5387-4) on one aspect of its November 23, 1994, Federal Register documents; i.e., how the concept of inert ingredient related to plant-pesticides. On May 16, 1997, EPA published in the Federal Register three supplemental documents (62 FR 27132, 27142, and 27149) (FRL-5717-2, FRL-5716-7, and FRL-5715-6) to provide the public an opportunity to comment on EPA's analysis of how certain amendments to the Federal Food, Drug, and Cosmetic Act (FFDCA) and FIFRA by the Food Quality Protection Act (FQPA) apply to EPA's proposed exemptions under FFDCA section 408 for certain categories of residues of plant- pesticides and proposed exemptions under FIFRA for certain categories of plant-pesticides. Included in the dockets cited in this unit are: 1. Relevant Federal Register documents, such as the June 26, 1986, policy statement issued by the Office of Science and Technology Policy, the ``Coordinated Framework for Regulation of Biotechnology'' (51 FR 23302). 2. All public comments received in response to all of the documents cited in this unit, including comments received after the close of the official public comment periods for the documents, such as the report from 11 professional scientific societies entitled ``Appropriate Oversight for Plants with Inherited Traits for Resistance to Pests.'' 3. Reports of the scientific advisory committees on plant- pesticides, such as the January 21, 1994, joint meeting of a Subpanel of the FIFRA Scientific Advisory Panel and a Subcommittee of the EPA Biotechnology Science Advisory Committee. 4. All support documents and reports. 5. Published literature cited in the documents. V. Regulatory Assessment Requirements A. Certains and Executive Orders This supplemental document only seeks comment on an alternative name for the term ``plant-pesticide.'' As such, this document does not require review by the Office of Management and Budget (OMB) under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993), the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). For the same reason, it does not require any action under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub.L. 104-4), or Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994). In addition, no action is needed under the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.). B. Executive Order 12875 Under Executive Order 12875, entitled Enhancing the Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may not issue a regulation that is not required by statute and that creates a mandate upon a State, local, or tribal government, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by those governments. If the mandate is unfunded, EPA must provide to OMB a description of the extent of EPA's prior consultation with representatives of affected State, local, and tribal governments, the nature of their concerns, copies of any written communications from the governments, and a statement supporting the need to issue the regulations. In addition, Executive Order 12875 requires EPA to develop an effective process permitting elected officials and other representatives of State, local, and tribal governements ``to provide meaningful and timely input in the development of regulatory proposals containing significant unfunded mandates.'' Today's supplemental document does not create an unfunded Federal mandate on State, local, or tribal governments. This action does not impose any enforceable duties on these entities. Accordingly, the requirements of section 1(a) of Executive Order 12875 do not apply to this supplemental document. C. Executive Order 13084 Under Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not issue a regulation that is not required by statute, that significantly or uniquely affects the communities of Indian tribal governments, and that imposes substantial direct compliance costs on those communities, unless the Federal [[Page 19961]] government provides the funds necessary to pay the direct compliance costs incurred by the tribal governments. If the mandate is unfunded, EPA must provide OMB, in a separately identified section of the preamble to the rule, a description of the extent of EPA's prior consultation with representatives of affected tribal governments, a summary of the nature of their concerns, and a statement supporting the need to issue the regulation. In addition, Executive Order 13084 requires EPA to develop an effective process permitting elected and other representatives of Indian tribal governments ``to provide meaningful and timely input in the development of regulatory policies on matters that significantly or uniquely affect their communities.'' Today's supplemental document does not significantly or uniquely affect the communities of Indian tribal governments. This action does not involve or impose any requirements that affect Indian tribes. Accordingly, the requirements of section 3(b) of Executive Order 13084 do not apply to this supplemental document. List of Subjects in Parts 152, 174, and 180 Environmental protection, Agricultural commodities, Pesticides and pests, Plants. Dated: April 16, 1999. Susan Wayland, Acting Assistant Administrator for Prevention, Pesticides and Toxic Substances. [FR Doc. 99-10237 Filed 4-22-99; 8:45 am] BILLING CODE 6560-50-F