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Federal Register / Vol. 68, No. 151 / Wednesday, August 6, 2003 / Notices 46623 EPA by comparing the dietary exposure F. International Tolerances I. General Information from benoxacor to the no observed No Codex maximum residue levels A. Does this Action Apply to Me? adverse effect level (NOAEL) identified have been established forresidues of This action is directed to the public for use with the cancer risk assessment. benoxacor. Based on the NOAEL selected by EPA in general. As such, the Agency has not for cancer risk characterization of 0.4 [FR Doc. 03–19915 Filed 8–5–03; 8:45 am] attempted to describe the specific entities that this action may apply to. mg/kg/day, the cancer risk was BILLING CODE 6560–50–S Although others may be affected, this estimated to result in a MOE of 1,950 action applies directly to the submitter contributed through all the published ENVIRONMENTAL PROTECTION of the premanufacture notices addressed uses for benoxacor. Based upon the AGENCY in the action. If you have any questions extreme conservatism of the dietary regarding the applicability of this action exposure estimates and the fact that [OPPT–2003–0037; FRL–7322–4] to a particular entity, consult the person tumors were observed only at dose listed under FOR FURTHER INFORMATION levels far in excess of the selected Certain New Chemicals; Receipt and CONTACT. NOAEL, this MOE is at a level which Status Information the Agency does notconsider raising a B. How Can I Get Copies of This AGENCY: Environmental Protection Document and Other Related concern for excess lifetime cancer. Agency (EPA). Information? 2. Infants and children. EPA has ACTION: Notice. 1. Docket. EPA has established an previously determined that the official public docket for this action SUMMARY: Section 5 of the Toxic toxicological data base for evaluating under docket identification (ID) number prenatal and postnatal toxicity for Substances Control Act (TSCA) requires OPPT–2003–0037. The official public benoxacor is complete with respect to any person who intends to manufacture docket consists of the documents current data requirements. Because both (defined by statute to include import) a specifically referenced in this action, developmental and reproductive effects new chemical (i.e., a chemical not on any public comments received, and occurred in the presence of parental the TSCA Inventory) to notify EPA and other information related to this action. (systemic) toxicity, these data do not comply with the statutory provisions Although a part of the official docket, suggest anincreased prenatal or pertaining to the manufacture of new the public docket does not include postnatal sensitivity of children and chemicals. Under sections 5(d)(2) and Confidential Business Information (CBI) infants tobenoxacor exposure. Based on 5(d)(3) of TSCA, EPA is required to or other information whose disclosure is the above, EPA has previously publish a notice of receipt of a restricted by statute. The official public premanufacture notice (PMN) or an concludedthat reliable data support use docket is the collection of materials that application for a test marketing of a 100-fold MOE/uncertainty factor is available for public viewing at the exemption (TME), and to publish (UF),rather than the standard 1,000-fold EPA Docket Center, Rm. B102-Reading periodic status reports on the chemicals Room, EPA West, 1301 Constitution margin/factor to protect infants under review and the receipt of notices andchildren. EPA concludes that there Ave., NW., Washington, DC. The EPA of commencement to manufacture those Docket Center is open from 8:30 a.m. to is a reasonable certainty that noharm chemicals. This status report, which will result to infants and children from 4:30 p.m., Monday through Friday, covers the period from June 3, 2003 to excluding legal holidays. The EPA aggregate exposure tobenoxacor July 11, 2003, consists of the PMNs residues. Docket Center Reading Room telephone pending or expired, and the notices of number is (202) 566–1744 and the 3. Acute risk. Since there are no acute commencement to manufacture a new telephone number for the OPPT Docket, toxicological concerns for benoxacor, chemical that the Agency has received which is located in EPA Docket Center, EPA has no cause for concern for acute under TSCA section 5 during this time is (202) 566–0280. aggregate exposure. period. 2. Electronic access. You may access 4. Chronic risk. Using the DATES: Comments identified by the this Federal Register document conservative exposure assumptions docket ID number OPPT–2003–0037 electronically through the EPA Internet described above, EPA has previously and the specific PMN number or TME under the ‘‘Federal Register’’ listings at number, must be received on or before concluded that aggregate exposure to http://www.epa.gov/fedrgstr/. September 5, 2003. benoxacor from food will range from An electronic version of the public docket is available through EPA’s 3.69% of the RfD for females13+ years, ADDRESSES: Comments may be electronic public docket and comment to 20.7% of the RfD for non-nursing submitted electronically, by mail, or system, EPA Dockets. You may use EPA infants less than 1–yearold. EPA through hand delivery/courier. Follow the detailed instructions as provided in Dockets at http://www.epa.gov/edocket/ generally has no concern for exposures Unit I. of the SUPPLEMENTARY to submit or view public comments, below 100% of theRfD because the RfD INFORMATION. access the index listing of the contents represents the level at or below which of the official public docket, and to FOR FURTHER INFORMATION CONTACT: dailyaggregate dietary exposure over a access those documents in the public Barbara Cunningham, Acting Director, lifetime will not pose appreciablerisks docket that are available electronically. Environmental Assistance Division, to human health. EPA does not expect Although not all docket materials may Office of Pollution Prevention and the aggregate exposure toexceed 100% be available electronically, you may still Toxics (7408M), Environmental of the RfD. EPA has previously access any of the publicly available Protection Agency, 1200 Pennsylvania concluded that there isa reasonable docket materials through the docket Ave., NW., Washington, DC 20460– certainty that no harm will result to facility identified in Unit I.B.1. Once in 0001; telephone number: (202) 554– infants and childrenfrom aggregate the system, select ‘‘search,’’ then key in 1404; e-mail address: TSCA- exposure to benoxacor residues. the appropriate docket ID number. [email protected]. Certain types of information will not SUPPLEMENTARY INFORMATION: be placed in the EPA Dockets. VerDate jul<14>2003 19:35 Aug 05, 2003 Jkt 200001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\06AUN1.SGM 06AUN1 46624 Federal Register / Vol. 68, No. 151 / Wednesday, August 6, 2003 / Notices Information claimed as CBI and other Please ensure that your comments are public docket, and made available in information whose disclosure is submitted within the specified comment EPA’s electronic public docket. restricted by statute, which is not period. Comments received after the iii. Disk or CD ROM. You may submit included in the official public docket, close of the comment period will be comments on a disk or CD ROM that will not be available for public viewing marked ‘‘late.’’ EPA is not required to you mail to the mailing address in EPA’s electronic public docket. EPA’s consider these late comments. If you identified in Unit I.C.2. These electronic policy is that copyrighted material will wish to submit CBI or information that not be placed in EPA’s electronic public is otherwise protected by statute, please submissions will be accepted in docket but will be available only in follow the instructions in Unit I.D. Do WordPerfect or ASCII file format. Avoid printed, paper form in the official public not use EPA Dockets or e-mail to submit the use of special characters and any docket. To the extent feasible, publicly CBI or information protected by statute. form of encryption. available docket materials will be made 1. Electronically. If you submit an 2. By mail. Send your comments to: available in EPA’s electronic public electronic comment as prescribed in this Document Control Office (7407M), docket. When a document is selected unit, EPA recommends that you include Office of Pollution Prevention and from the index list in EPA Dockets, the your name, mailing address, and an e- Toxics (OPPT), Environmental system will identify whether the mail address or other contact Protection Agency, 1200 Pennsylvania document is available for viewing in information in the body of your Ave., NW., Washington, DC 20460– EPA’s electronic public docket. comment. Also include this contact 0001. Although not all docket materials may information on the outside of any disk be available electronically, you may still or CD ROM you submit, and in any 3. By hand delivery or courier. Deliver access any of the publicly available cover letter accompanying the disk or your comments to: OPPT Document docket materials through the docket CD ROM. This ensures that you can be Control Office (DCO) in EPA East facility identified in Unit I.B.1. EPA identified as the submitter of the Building Rm. 6428, 1201 Constitution intends to work towards providing comment and allows EPA to contact you Ave., NW., Washington, DC. Attention: electronic access to all of the publicly in case EPA cannot read your comment Docket ID Number OPPT–2003–0037 available docket materials through due to technical difficulties or needs and PMN Number or TME Number. The EPA’s electronic public docket. further information on the substance of DCO is open from 8 a.m. to 4 p.m., For public commenters, it is your comment. EPA’s policy is that EPA Monday through Friday, excluding legal important to note that EPA’s policy is will not edit your comment, and any holidays.
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