[Federal Register Volume 64, Number 240 (Wednesday, December 15, 1999)] [Notices] [Pages 70023-70025] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 99-32385] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY [OPP-00633; FRL-6395-8] Proposed Test Guidelines; Notice of Availability and Request for Comments AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of availability and request for comments. ----------------------------------------------------------------------- SUMMARY: EPA has established a unified library for test guidelines issued by the Office of Prevention, Pesticides and Toxic Substances (OPPTS) for use in testing chemical substances to develop data for submission to EPA under the Toxic Substances Control Act (TSCA), the Federal Food, Drug, and Cosmetic Act (FFDCA), or the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). These test guidelines represent an Agency effort that began in 1991 to harmonize the test guidelines within OPPTS, as well as to harmonize the OPPTS test guidelines with those of the Organization for Economic Cooperation and Development (OECD). The process for developing and amending these test guidelines includes public participation and the extensive involvement of the scientific community, including peer review by the Scientific Advisory Panel (SAP) and the Scientific Advisory Board (SAB) and other expert scientific organizations. With this notice, EPA is announcing the availability of the proposed tests for the Series 810- Product Performance Testing Guidelines titled ``OPPTS 810.3700 Insect Repellents For Human Skin and Outdoor Premises'' and a Pesticide Registration (PR) Notice titled ``Insect Repellants: Labeling, Data Citations, and Testing Criteria'' explaining specific areas of the guideline and recommended label language. DATES: Comments, identified by docket control number OPP-00633, must be received by EPA on or before January 14, 2000. ADDRESSES: Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit III. of the ``SUPPLEMENTARY INFORMATION.'' To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP-00633 in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: For general information contact: Toxic Substances Control Act (TSCA) information contact: TSCA Hotline at TAIS/7408, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460; telephone number: (202) 554-1404; fax number: (202) 554-5603; e-mail address: TSCA-H[email protected]. Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) information contact: Communications Services Branch (7506C), Field and External Affairs Division, Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460; telephone number: (703) 305-5017; fax number: (703) 305-5558. For technical information contact: Robyn Rose, Office of Pesticide Programs, Biopesticides and Pollution Prevention Division (7511C), Environmental Protection Agency, 401 M St., SW., Washington, DC 20460; telephone number: (703) 308-9581; e-mail address: [email protected]. SUPPLEMENTARY INFORMATION: I. Does this Action Apply to Me? This action is directed to the public in general. Although this action may be [[Page 70024]] of particular interest to those persons who are or may be required to conduct testing of chemical substances under the Toxic Substances Control Act (TSCA), the Federal Food, Drug, and Cosmetic Act (FFDCA), or the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under ``FOR FURTHER INFORMATION CONTACT.'' II. How Can I Get Additional Information, Including Copies of this Document or Other Related Documents? A. 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'' 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/. You may also obtain copies of test guidelines from the EPA Internet Home Page by selecting ``Researchers and Scientists/Test Methods and Guidelines/OPPTS Harmonized Test Guidelines'' at http:// www.epa.gov/epahome/research.htm. B. Fax on demand. You may request a faxed copy of the PR Notice titled ``Insect Repellants: Labeling, Data Citations, and Testing Criteria'' by using a faxphone to call (202) 401-0527 and selecting item 6122. You may also follow the automated menu. C. In person. The Agency has established an official record for this proposed guideline under docket control number OPP-00633. 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. III. How Can I Respond to this Action? A. 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 OPP-00633 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, 401 M St., SW., 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. Submit your comments electronically by e-mail to: ``[email protected],'' or mail your computer disk to the address identified above. Do not submit any information electronically that you consider to be CBI. Electronic comments must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. Comments and data will also be accepted on standard computer disks in Wordperfect 6.1/8.0 or ASCII file format. All comments in electronic form must be identified by the docket control number OPP-00633. Electronic comments may also be filed online at many Federal Depository Libraries. B. 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 technical person identified under ``FOR FURTHER INFORMATION CONTACT.'' C. 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. Offer alternative ways to improve the notice or collection activity. 7. Make sure to submit your comments by the deadline in this document. 8. To ensure proper receipt by EPA, be sure to identify the docket control number OPP-00633 in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation. IV. What Action is EPA Taking? EPA is announcing the availability of a proposed test guideline for the Series 810 guidelines titled ``OPPTS 810.3700 Insect Repellents For Human Skin and Outdoor Premises Product Performance Testing Guidelines'' and a PR notice titled ``Insect Repellants: Labeling, Data Citations, and Testing Criteria'' explaining specific areas of the guideline and recommended label language. V. How Were these Test Guidelines Developed? A. Product Performance Testing Guidelines for Insect Repellents These product performance testing guidelines are intended to update EPA, Pesticide Assessment Guidelines, Subdivision G: OPP guidelines 95-9 Treatments to control pests of humans and pets and 95- 10 Mosquito, black fly, [[Page 70025]] non-biting midge, and biting midge. These guidelines are concerned with product performance testing for evaluation of pesticides used to repel biting flies, fleas, chiggers and ticks from human skin and outdoor premises. Commercial pesticide formulations used to repel mosquitoes, fleas, chiggers and ticks from human skin include, but are not limited to, liquid or pressurized spray products, impregnated material or articles with the repellent, lotions, coils, candles, or vaporizing mats. The recommendations contained within these guidelines address the conduct of product performance testing of insect repellents. Because they are guidelines, mandatory requirements are not imposed. However, they do reflect the considered judgment of the Agency and recognized experts as to what minimum steps are necessary to produce reliable data on product performance. Accordingly, EPA advises that any deviations from final guidelines be fully explained and justified. B. Pesticide Regulation Notice Inconsistencies have developed in product performance testing and labeling of insect repellents. In order to minimize this variance, EPA is developing product performance testing guidelines and recommended label language. The label language proposed by the Agency is intended to standardize and improve the information provided to the consumer. EPA intends to use the data from the guideline studies to help determine the adequacy of the labeling of insect repellent products. EPA will review label statements as products are initially registered as well as for previously registered products. VI. Specific Areas For Comment Please comment on all aspects of the guidelines and PR Notice. The Agency is particularly looking for comments to the following questions: 1. Do you agree with the Agency's proposed decision to recommend that data be evaluated based upon the mean time to the first bite or a 95% reduction in bites rather than relying on the first confirmed bite test? 2. Is the Agency's recommended biting pressure adequate to verify the insect is being repelled by the pesticide? 3. Are 5 treated test subjects for a label claim of 4 hours of repellency and 10 treated test subjects for a label claim of 5 or more hours of repellency enough test subjects for statistically credible results? (For more information reference: Rutledge, L.C., and R.K. Gupta. 1999. Variation in the protection periods of repellents on individual human subjects: an analytical review. J. Am. Mosq. Cont. Ass. 15(3) 348-355.) 4. Although it is preferred, the Agency did not think it was feasible to expect an equal number of male and female test subjects. Do you agree? 5. Do the proposed application rates correlate to typical consumer use? 6. The Agency did not believe it was feasible to recommend all treated test subjects leave an untreated limb exposed to bites. Is it acceptable to allow one untreated test subject? Why or why not? 7. Is a 50% reduction in bites an acceptable level of efficacy for candles, coils, and vaporizing mats? Can this be justified statistically? 8. The Agency acquired several different methods to test repellency of fleas and ticks. Due to the high incidence of Lyme disease in the U.S., EPA did not recommend field tests for deer ticks. Due to the difficulty to find an area with adequate biting pressure, the Agency did not recommend field tests for fleas. Will the proposed laboratory tests provide adequate data to determine deer tick and flea repellency? 9. Are positive and negative controls under replicate test conditions adequate to provide a foundation against which efficacy can be assessed? VII. Are there Any Applicable Voluntary Consensus Standards that EPA Should Consider? This notice of availability does not involve a proposed regulatory action that would require the Agency to consider voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Section 12(d) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA requires EPA to provide an explanation to Congress, through OMB, when the Agency decides not to use available and applicable voluntary consensus standards when the NTTAA directs the Agency to do so. These test guidelines represent an Agency effort to harmonize the test guidelines within OPPTS, as well as to harmonize the OPPTS test guidelines with those of the OECD. The process for developing and amending these test guidelines, which began in 1991, includes public participation and the extensive involvement of the scientific community, including peer review by the SAP and the SAB and other expert scientific organizations. In the future, these test guidelines could be incorporated into regulatory actions taken by EPA under TSCA, i.e., with regard to the section 4 testing program. Although the NTTAA requirements do not specifically apply to the issuance of these particular test guidelines today, EPA invites your comment on whether or not there are any voluntary consensus standards that should be considered during the development of the final test guidelines or any future regulatory action that may be taken under TSCA. Future regulatory actions under TSCA section 4 may involve notice and comment rulemaking or negotiated voluntary testing enforcement consent agreements/orders/decrees. Nevertheless, the Agency is interested in whether or not there are any voluntary consensus standards that EPA should consider either as part of the development of the test guidelines themselves or in lieu of these test guidelines when the Agency develops any future regulatory action that incorporates these test guidelines. Any comments provided will assist the Agency in complying with the NTTAA by facilitating the Agency's identification of voluntary consensus standards that should be addressed in the test guideline or considered during the development of a proposed regulatory action that incorporates any standards included in the final test guidelines. Please submit your comments as directed in Unit III. of the ``SUPPLEMENTARY INFORMATION.'' List of Subjects Environmental protection, Administrative practice and procedure, Agricultural commodities, Chemical testing, Pesticides and pests, Test guideline. Dated: December 7, 1999. Marcia E. Mulkey, Director, Office of Pesticide Programs. [FR Doc. 99-32385 Filed 12-14-99; 8:45 am] BILLING CODE 6560-50-F