[Federal Register Volume 64, Number 144 (Wednesday, July 28, 1999)] [Notices] [Pages 40871-40873] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 99-19271] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY [OPP-00597; FRL-6078-6] 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 and the Scientific Advisory Board (SAB) and other expert scientific organizations. With this notice, EPA is announcing the availability of a combined chronic toxicity and carcinogenicity test guideline for the Series 870-Health Effects Test Guidelines for use in the testing of fibrous particles in the development of test data (OPPTS 870.8355). Natural and synthetic fibers are one group of substances that have been identified to be of potential health concern to humans. An EPA SAB meeting to review the proposed test guideline will be scheduled after incorporation of public comments. Complete details of this meeting will be announced in a subsequent Federal Register notice. DATES: Comments, identified by docket control number OPP-00597, must be received by EPA on or before September 27, 1999. 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'' section. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP-00597 in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: For general information contact: Christine M. Augustyniak, Associate Director, Environmental Assistance Division (7408), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 401 M Street, SW., Washington, DC 20460; telephone numbers: (202) 554-1404 and TDD: (202) 554-0551; e- mail address: TSCA-H[email protected]. For technical information contact: David Lai, Risk Assessment Division, Office of Pollution Prevention and Toxics (7403), Environmental Protection Agency, 401 M Street, SW., Washington, DC 20460; telephone number: (202) 260-6222; 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 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 person listed in the ``FOR FURTHER INFORMATION CONTACT'' section. II. How Can I Get Additional Information, Including Copies of This Document or Other Related Documents? A. Electronically You may obtain copies of this document and certain other available documents from the EPA 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 ``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. In Person The Agency has established an official record for this proposed guideline under docket control number OPP-00597. 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, 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 Public Information and Records Integrity Branch telephone number is (703) 305- 5805. [[Page 40872]] 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-00597 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 Confidential Business Information (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 5.1/6.1 or ASCII file format. All comments in electronic form must be identified by the docket control number OPP-00597. 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 in the ``FOR FURTHER INFORMATION CONTACT'' section. IV. What Action is EPA Taking? EPA is announcing the availability of and seeking comment on proposed test guidelines for developing a combined chronic toxicity and carcinogenicity test guideline for use in the testing of respirable fibrous substances (OPPTS 870.8355). Natural and synthetic fibers are one group of substances that have been identified to be of potential health concern to humans. For many of these fibers there are limited, inconclusive, or virtually no information about their health effects. As a result, EPA has added a ``respirable fibers'' category as priority substance for health effects and exposure testing to obtain the necessary data to evaluate the extent and magnitude of health risks to exposed individuals and populations. However, the Agency's current test guidelines for chronic inhalation toxicity and/or carcinogenicity studies of chemical substances are not sufficiently specific for the testing of fibrous particles, and there is no general agreement upon test protocols for chronic inhalation toxicity and carcinogenicity testing of fibers for regulatory purposes. On May 8-10, 1995, EPA, in collaboration with National Institute of Environmental Health Sciences (NIEHS), the National Institute for Occupational Safety and Health (NIOSH), and the Occupational Safety and Health Administration (OSHA), conducted a workshop to obtain input from the scientific community on a number of issues related to fiber testing. The proposed test guideline has been developed based largely on the recommendations from the workshop expert panel and participants. All interested parties are encouraged to submit comments on this proposed guideline. Specific comments should reference the specific number and paragraph or subparagraph of the related provision in the proposed test guidelines. Recommended technical or scientific changes/ modifications should be supported by current scientific/technical knowledge and include supporting references. References may be to the published literature, studies submitted to OPPTS, or to unpublished data. Citations must be sufficiently detailed to allow OPPTS to access and evaluate the published information, original documents submitted, or unpublished data. V. 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), Pub. L. 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, business practices, etc.) 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. 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 NTTA 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 considered either as part of the development of the test guidelines themselves or in leu 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 [[Page 40873]] comments as directed in Unit III. of this document. List of subject Environmental protection, Chemical testing, Test guideline. Dated: July 13, 1999. Susan H. Wayland, Acting Assistant Administrator for Prevention, Pesticides and Toxic Substances. [FR Doc. 99-19271 Filed 7-27-99; 8:45 am] BILLING CODE 6560-50-F