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Notice of Filing Pesticide Petitions to Establish Tolerances for Certain Pesticide Chemicals in or on Food
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[Federal Register: December 6, 2000 (Volume 65, Number 235)] [Notices] [Page 76241-76244] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr06de00-65] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY [PF-978; FRL-6748-9] Notice of Filing Pesticide Petitions to Establish Tolerances for Certain Pesticide Chemicals in or on Food AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This notice announces the initial filing of pesticide petitions proposing the establishment of regulations for residues of certain pesticide chemicals in or on various food commodities. DATES: Comments, identified by docket control number PF-978, must be received on or before January 5, 2001. ADDRESSES: Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket control number PF-978 in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: By mail: Carol E. Frazer, Biopesticides and Pollution Prevention Division (7511C), [[Page 76242]] Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 308-8810; e-mail address: frazer.carol@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be affected by this action if you are an agricultural producer, food manufacturer or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to: ------------------------------------------------------------------------ Examples of Categories NAICS codes potentially affected entities ------------------------------------------------------------------------ Industry 111 Crop production 112 Animal production 311 Food manufacturing 32532 Pesticide manufacturing ------------------------------------------------------------------------ This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents? 1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Page select ``Laws and Regulations,'' ``Regulations and Proposed Rules,'' 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. The Agency has established an official record for this action under docket control number PF-978. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as confidential business information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805. C. How and to Whom Do I Submit Comments? You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number PF-978 in the subject line on the first page of your response. 1. By mail. Submit your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 2. In person or by courier. Deliver your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805. 3. Electronically. You may submit your comments electronically by e-mail to: opp-docket@epa.gov, or you can submit a computer disk as described above. Do not submit any information electronically that you consider to be CBI. Avoid the use of special characters and any form of encryption. Electronic submissions will be accepted in Wordperfect 6.1/ 8.0 or ASCII file format. All comments in electronic form must be identified by docket control number PF-978. Electronic comments may also be filed online at many Federal Depository Libraries. D. How Should I Handle CBI That I Want to Submit to the Agency? Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this 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. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person identified under FOR FURTHER INFORMATION CONTACT. E. What Should I Consider as I Prepare My Comments for EPA? You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Make sure to submit your comments by the deadline in this notice. 7. To ensure proper receipt by EPA, be sure to identify the docket control number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation. II. What Action is the Agency Taking? EPA has received pesticide petitions as follows proposing the establishment and/or amendment of regulations for residues of certain pesticide chemicals in or on various food commodities under section 408 of the Federal Food, Drug, and Comestic Act (FFDCA), 21 U.S.C. 346a. EPA has determined that these petitions contain data or information regarding the elements set forth in section 408(d)(2); however, EPA has not fully evaluated the sufficiency [[Page 76243]] of the submitted data at this time or whether the data support granting of these petitions. Additional data may be needed before EPA rules on the petitions. List of Subjects Environmental protection, Agricultural commodities, Feed additives, Food additives, Pesticides and pests, Reporting and recordkeeping requirements. Dated: November 17, 2000. Janet L. Andersen, Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs. Summaries of Petitions The petitioner summaries of the pesticide petitions are printed below as required by section 408(d)(3) of the FFDCA. The summaries of the petitions were prepared by the petitioner and represent the view of the petitioner. EPA is publishing the petitioner's summaries verbatim without editing it in any way. The petitioner's summaries announces the availability of a description of the analytical methods available to EPA for the detection and measurement of the pesticide chemicals residues or an explanation of why no such method is needed. 1. Auxein Corporation PP 7F4842 and PP 7F4843 EPA has received pesticide petitions PP 7F4842 and PP 7F4843 from Auxein Corporation, 3125 Sovereign Drive, Suite B, Lansing, MI 48911- 4240, proposing pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 180 to establish amendments of existing tolerance exemptions for the biochemical pesticides L-glutamic acid and gamma aminobutyric acid (GABA) pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended. Auxein Corporation has submitted the following summaries of information, data, and arguments in support of their pesticide petitions. These summaries were prepared by Auxein Corporation and EPA has not fully evaluated the merits of the pesticide petitions. The summaries may have been edited by EPA if the terminology used was unclear, the summaries contained extraneous material, or the summaries unintentionally made the reader conclude that the findings reflected EPA's position and not the position of the petitioner. PP 7F4842 In the Federal Register of October 29, 1997 (62 FR 56268, FRL-5751- 3), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 346a(e) announcing the filing of a pesticide tolerance petition (PF- 772) by Auxein Corporation. This notice included a summary of the petition prepared by the petitioner and this summary contained conclusions and arguments to support its conclusion that the petition complied with the Food Quality Protection Act (FQPA) of 1996. This petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of the biological pest control agent glutamic acid in or on all raw agricultural commodities. The final rule exempted the biochemical glutamic acid from the requirement of a tolerance on all raw agricultural commodities when used as a plant growth enhancer in accordance with good agricultural practices. EPA published a final rule establishing a tolerance exemption in the Federal Register on January 7, 1998 (63 FR 679-682) (FRL-5764-4) amending 40 CFR 1180.1187. An amendment to this petition and thus the final rule establishing a tolerance exemption, was requested by Auxein Corporation to change the name of the active ingredient from the above to L-glutamic acid. In the Federal Register of September 25, 1998 (63 FR 51302) Auxein Corporation requested a correction to the name. Throughout the preamble to the final rule and in the codified text (40 CFR 180.1187), reference was made to ``glutamic acid.'' Auxein Corporation brought to the Agency's attention that the requested tolerance was for residues of ``L-glutamic acid'' rather than ``glutamic acid.'' This technical amendment corrected the preamble and the codified text in the January 7, 1998 final rule. Therefore, in the preamble to FR Doc. 98-359, published at 63 FR 679, FRL-6029-1, January 7, 1998, reference to ``glutamic acid'' was changed to refer to ``L-glutamic acid.'' Recent research performed on this active ingredient indicates the method of protection is not restricted to growth enhancement, and Auxein wishes to delete the wording ``when used as a plant growth enhancer'' from the present exemption as well as correct the term ``raw agricultural commodities'' to ``food commodities.'' A. Product Name and Proposed Use Practices AuxiGro WP Plant Metabolic Primer. When used as directed, AuxiGro has been shown to increase yields and/or quality of treated commodities, early ripening in certain vegetables, increased root growth, early flowering and fruit set, faster seed germination and rooting. B. Product Identity/Chemistry 1. Identity of the pesticide and corresponding residues. Supporting data for this section were submitted with PP 7F4842. Supporting product chemistry data for the end-use product, AuxiGro WP (EPA Reg. No. 70810- 1 was submitted on June 12, 1997 (MRID 44296801) and February 16, 1998 (MRID 44538701). 2. Magnitude of residue at the time of harvest and method used to determine the residue. Supporting data for this section was submitted with PP 7F4842. 3. A statement of why an analytical method for detecting and measuring the levels of the pesticide residue are not needed. Supporting data for this section was submitted with PP 7F4842. C. Mammalian Toxicological Profile Supporting data for this section was submitted with PP 7F4842. D. Aggregate Exposure 1. Dietary exposure-- i. Food. No differences in exposure are expected compared to those described in PP 7F4842. ii. Drinking water. No differences in exposure are expected compared to those described in PP 7F4842. 2. Non-dietary exposure. No differences in exposure are expected compared to those described in PP 7F4842. E. Cumulative Exposure No differences in exposure are expected compared to those described in PP 7F4842. F. Safety Determination 1. U.S. population. Based on its abundance in nature and long history of use by humans without deleterious effects, there is reasonable certainty that no harm will result from aggregate exposure to the U.S. population, including infants and children, to residues of L-glutamic acid. This includes all dietary exposure and all other exposure for which there is reliable information. This is a reasonable conclusion because of the preponderance of data from open literature supporting the safe use of L-glutamic acid in foods, the supporting acute toxicity data on AuxiGro, and inconsequential exposure resulting from its application to crops. 2. Infants and children. No differences in exposure are expected [[Page 76244]] compared to those described in PP 7F4842. G. Existing Tolerances Existing tolerances have been established for L-glutamic acid, 40 CFR part 180.1187. H. International Tolerances No Codex maximum residue levels have been established for L- glutamic acid. PP 7F4843 In the Federal Register of October 29, 1997 (62 FR 57170, FRL-5751- 3) EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 346a(e) announcing the filing of a pesticide tolerance petition (PF- 772) by Auxein Corporation. This notice included a summary of the petition prepared by the petitioner and this summary contained conclusions and arguments to support its conclusion that the petition complied with the FQPA of 1996. This petition requested that 40 CFR 180 be amended by establishing an exemption from the requirement of a tolerance for residues of the biological pest control agent gamma aminobutyric acid in or on all food commodities. The final rule exempted the biochemical gamma aminobutyric acid from the requirement of a tolerance on all food commodities when used as a plant growth enhancer in accordance with good agricultural practices. EPA published a final rule establishing a tolerance exemption in the Federal Register on January 7, 1998 (63 FR 676-679) (FRL-5764-5) amending 40 CFR 1180.1188. Recent research performed on this active ingredient indicates the method of protection is not restricted to growth enhancement, and Auxein Corporation wishes to delete the wording ``when used as a plant growth enhancer'' from the present exemption. A. Product Name and Proposed Use Practices AuxiGro WP Plant Metabolic Primer. When used as directed, AuxiGro has been shown to increase yields and/or quality of treated commodities, early ripening in certain vegetables, increased root growth, early flowering and fruit set, faster seed germination and rooting. B. Product Identity/Chemistry 1. Identity of the pesticide and corresponding residues. Supporting data for this section were submitted with PP 7F4843. Supporting product chemistry data for the end-use product, AuxiGro WP (EPA Reg. No. 70810- 1) were submitted on June 12, 1997 (MRID 44296801) and February 16, 1998 (MRID 44538701). 2. Magnitude of residue at the time of harvest and method used to determine the residue. Supporting data for this section were submitted with PP 7F4843. 3. A statement of why an analytical method for detecting and measuring the levels of the pesticide residue are not needed. Supporting data for this section were submitted with PP 7F4843. C. Mammalian Toxicological Profile Supporting data for this section were submitted with PP 7F4843. D. Aggregate Exposure 1. Dietary exposure--i. Food. No differences in exposure are expected compared to those described in PP 7F4843. ii. Drinking water. No differences in exposure are expected compared to those described in PP 7F4843. 2. Non-dietary exposure. No differences in exposure are expected compared to those described in PP 7F4843. E. Cumulative Exposure No differences in exposure are expected compared to those described in PP 7F4843. F. Safety Determination 1. U.S. population. Based on its abundance in nature and long history of use by humans without deleterious effects, there is reasonable certainty that no harm will result from aggregate exposure to the U.S. population, including infants and children, to residues of GABA. This includes all anticipated dietary exposure and all other exposures for which there is reliable information. This is a reasonable conclusion because exposure to GABA resulting from label directed use is inconsequential, does not cross the blood-brain barrier, and is consumed daily by the human population from naturally occurring sources. 2. Infants and children. No differences in exposure are expected compared to those described in PP 7F4843. G. Existing Tolerances Existing tolerances have been extablished for gamma aminobutyric acid (GABA), 40 CFR part 180.1188. H. International Tolerances No Codex maximum residue levels have been established for gamma aminobutyric acid (GABA) [FR Doc. 00-30918 Filed 12-5-00; 8:45a.m.] BILLING CODE 6560-50-S