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Creosote Revised Risk Assessments and Qualitative Economic Analysis of the Alternatives; Notice of Availability and Solicitation of Risk Reduction Options
PDF Version (3 pp, 100K, About PDF) [Federal Register: April 16, 2008 (Volume 73, Number 74)] [Notices] [Page 20629-20631] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr16ap08-48] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2008-0248; FRL-8361-5] Creosote Revised Risk Assessments and Qualitative Economic Analysis of the Alternatives; Notice of Availability and Solicitation of Risk Reduction Options AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This notice announces the availability of EPA's revised risk assessments for the pesticide creosote. In addition, this notice solicits public comment on risk reduction options for creosote as well as solicits comments on the qualitative economic impacts analysis, (Phase 5 of 6-Phase Process). EPA is developing a Reregistration Eligibility Decision (RED) for creosote through the full, 6-Phase public participation process that the Agency uses to involve the public in developing pesticide reregistration and tolerance reassessment decisions. Through these programs, EPA is ensuring that all pesticides meet current health and safety standards. DATES: Comments must be received on or before June 16, 2008. ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2008-0248, by one of the following methods: • Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments. • Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805. Instructions: Direct your comments to docket ID number EPA-HQ-OPP- 2008-0248. EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or e- mail. The regulations.gov website is an ``anonymous access'' system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e- mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. Docket: All documents in the docket are listed in the docket index available in regulations.gov. To access the electronic docket, go to http://www.regulations.gov, select ``Advanced Search,'' then ``Docket Search.'' Insert the docket ID number where indicated and select the ``Submit'' button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. Although, listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at http:// www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305-5805. FOR FURTHER INFORMATION CONTACT: Jacqueline Cambpell-McFarlane, Antimicrobials Division (7510P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460- [[Page 20630]] 0001; telephone number: (703) 308-6416; fax number: (703) 308-6467; e- mail address: campbell-mcfarlane.jacqueline@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? This action is directed to the public in general, and may be of interest to a wide range of stakeholders including environmental, human health, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, 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 under FOR FURTHER INFORMATION CONTACT. B. What Should I Consider as I Prepare My Comments for EPA? 1. Submitting CBI. Do not submit this information to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes 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 docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 2. Tips for preparing your comments. When submitting comments, remember to: i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number). ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number. iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes. iv. Describe any assumptions and provide any technical information and/or data that you used. v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced. vi. Provide specific examples to illustrate your concerns and suggest alternatives. vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats. viii. Make sure to submit your comments by the comment period deadline identified. II. Background A. What Action is the Agency Taking? EPA is making available the Agency's revised risk assessments, initially issued for comment through a Federal Register notice published on December 5, 2003 (68 FR 68042) (FRL-7318-6); a response to comments; and related documents for creosote. EPA is also soliciting public comment on risk reduction options for creosote and comments on the qualitative economic impacts analysis. EPA developed the risk assessments for creosote as part of its public process for making pesticide reregistration eligibility and tolerance reassessment decisions. Through these programs, EPA is ensuring that pesticides meet current standards under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). Creosote, a restricted use pesticide, is a ``heavy duty wood preservative'' that was first registered in the United States in 1948. Presently, 13 products are registered as industrial wood preservatives for above and ground wood protection treatments, as well as wood used in marine environments. Creosote wood preservatives are used primarily in the pressure treatment of railroad ties/crossties (about 70% creosote use), utility poles/cross-arms (about 16% of all creosote use), and marine piles (> 4% creosote use. Assorted creosote-treated lumber products (e.g., timbers, poles, posts, and ground-line support structures) account for the remaining uses of this wood preservative. EPA issued cancellation orders in August 2004 that accepted the voluntary use termination request/product cancellation requests to either amend current label language to delete non-pressure treatment uses of creosote or to cancel the affected products (September 15, 2007; 69 FR 55623; FRL-7682). This action canceled three pesticide registrations and terminated certain uses of seven pesticide registrations as of December 31, 2004. EPA is providing an opportunity, through this notice, for interested parties to provide risk management proposals or otherwise comment on risk management for creosote. Risks of concern associated with the use of creosote are: Short-term, intermediate-term, and long- term non-cancer risks; and cancer risks for occupational handlers. Approximately one third of the dermal non-cancer scenarios indicate potential risks of concern. The non-cancer inhalation MOEs for occupational exposure to naphthalene (detected in 100% of the inhalation exposure samples when applying creosote) range from 23-1,900 with the inhalation MOEs for 16 of the 19 job functions being below the target MOE of 300. All of the cancer risks exceed the Agency's level of concern of 1 x 10-6 but only 4 of the scenarios had risks exceeding 1 x 10-4 (i.e., risks range from 1.6E-3 to 9.5E- 6). In targeting these risks of concern, the Agency solicits information on effective and practical risk reduction measures. EPA is applying the principles of public participation to all pesticides undergoing reregistration and tolerance reassessment. The Agency's Pesticide Tolerance Reassessment and Reregistration; Public Participation Process, published in the Federal Register on May 14, 2004, (69 FR 26819) (FRL-7357-9) explains that in conducting these programs, EPA is tailoring its public participation process to be commensurate with the level of risk, extent of use, complexity of issues, and degree of public concern associated with each pesticide. Due to its uses, risks, and other factors, creosote is being reviewed through the full 6-Phase public participation process. All comments should be submitted using the methods in ADDRESSES, and must be received by EPA on or before the closing date. Comments and proposals will become part of the Agency Docket for creosote. Comments received after the close of the comment period will be marked ``late''. EPA is not required to consider these late comments. After considering comments received, EPA will develop and issue for comment the creosote RED. B. What is the Agency's Authority for Taking this Action? Section 4(g)(2) of FIFRA, as amended, directs that, after submission of all data concerning a pesticide active ingredient, ``the Administrator shall determine whether pesticides containing such active ingredient are eligible for reregistration,'' before calling in product specific data on individual end-use products and either reregistering [[Page 20631]] products or taking other ``appropriate regulatory action.'' List of Subjects Environmental protection, Pesticides and pests, antimicrobials, creosote. Dated: April 11, 2008. Betty Shackleford, Acting Director, Antimicrobials Division, Office of Pesticide Programs. [FR Doc. E8-8169 Filed 4-15-08; 8:45 .am.] BILLING CODE 6560-50-S