1,2-Ethylene Dichloride Tier I Program Review Testing; Notice of Availability and Solicitation of Comment, 52329-52333 [E6-14639]

Download as PDF Federal Register / Vol. 71, No. 171 / Tuesday, September 5, 2006 / Notices sroberts on PROD1PC70 with NOTICES administrative rule amendments and Hawaii’s intent to seek EPA authorization of its lead-based paint program. Comments were accepted for 40 days after the published date of March 29, 2004. There were no oral comments given at the hearings, but two sets of written comments were received. The written comments were technical in nature and some changes were made to remain as protective as the Federal standards. These changes were reviewed by the State Attorney General who deemed that no additional public hearing was required. The Post Hearing Small Business Impact Statement was written and approved by the Small Business Regulatory Review Board pursuant to section 201M-3, Hawaii Revised Statutes and the Hawaii’s Governor’s Administrative Directive No. 99–02. On September 19, 2005, the Governor of the State of Hawaii signed the final rule. The final rule became effective on October 3, 2005. The Hawaii Department of Health began implementing its program on October 3, 2005. Additional information, copies of the documents referenced above, and application forms for licensing and certification may be obtained by contacting: Tom Lileikis, Environmental Health Specialist, Hawaii Health Department, Noise, Radiation, and Indoor Air Quality Branch, 591 Ala Moana Blvd., #133, Honolulu, Hawaii 96813; telephone number: (808) 586– 5800; e-mail address:tlileiki@ehsd mail.health.state.hi.us. EPA determined that Hawaii’s original application of November 17, 2005, was incomplete as the transmittal letter from the State Governor requesting program approval was missing. The State of Hawaii submitted the Governor’s request on February 8, 2006, in accordance with 40 CFR 745.324(d), ‘‘Program Certification,’’ certifying that the State program meets the requirements contained in 40 CFR 745.324(e)(2)(i) and (e)(2)(ii). Therefore, as of November 17, 2005, the State of Hawaii is authorized to administer and enforce the lead-based paint program under TSCA section 402, until such time as the Administrator disapproves the application or withdraws the State’s program authorization. III. Federal Overfiling Section 404(b) of TSCA (15 U.S.C. 2684(b)) makes it unlawful for any person to violate, or fail or refuse to comply with, any requirement of an approved State or Tribal program. Therefore, EPA reserves the right to exercise its enforcement authority under TSCA against a violation of, or a failure VerDate Aug<31>2005 17:24 Sep 01, 2006 Jkt 208001 or refusal to comply with, any requirement of an authorized State or Tribal program. IV. Submission to Congress and the Comptroller General The Congressional Review Act, 5 U.S.C. 801 et seq. as amended by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before certain actions may take effect, the agency promulgating the action must submit a report, which includes a copy of the action, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this document in the Federal Register. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). List of Subjects Environmental protection, Hazardous substances, Lead, Reporting and recordkeeping requirements. Dated: August 3, 2006. Laura Yoshii, Acting Regional Administrator, Region IX. [FR Doc. E6–14588 Filed 9–01–06; 8:45 am] BILLING CODE 6560–50–S ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OPPT–2003–0010; FRL–8088–3] 1,2-Ethylene Dichloride Tier I Program Review Testing; Notice of Availability and Solicitation of Comment Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: SUMMARY: Under section 4 of the Toxic Substances Control Act (TSCA), EPA issued a testing consent order that incorporated an enforceable consent agreement (ECA) for 1,2-ethylene dichloride (EDC). The companies subject to the ECA agreed to conduct toxicity testing, develop a computational dosimetry model for route-to-route extrapolations, and develop pharmacokinetics and mechanistic testing data that are intended to satisfy the toxicological data needs for EDC identified in a TSCA section 4 proposed test rule for a number of hazardous air pollutant chemicals. This notice announces that EPA is starting the program review component of the EDC ECA alternative PO 00000 Frm 00013 Fmt 4703 Sfmt 4703 52329 testing program, and solicits comment on data received under the Tier I Program Review Testing segment of the EDC ECA. Comments are expected to inform EPA’s decision on whether data and computational dosimetry model development completed by the test sponsors are sufficient to proceed with the Tier II Testing and computational dosimetry modeling for route-to-route extrapolations listed in the EDC ECA. DATES: Comments must be received on or before October 5, 2006. ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA–HQ–OPPT–2003–0010, by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the on-line instructions for submitting comments. • Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460– 0001. • Hand Delivery: OPPT Document Control Office (DCO), EPA East, Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID Number EPA–HQ–OPPT–2003–0010. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is (202) 564–8930. Such deliveries are only accepted during the DCO’s normal hours of operation, and special arrangements should be made for deliveries of boxed information. Instructions: Direct your comments to docket ID number EPA–HQ–OPPT– 2003–0010. EPA’s policy is that all comments received will be included in the public docket without change and may be made available on-line at https:// www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information for which disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or email. 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 public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your E:\FR\FM\05SEN1.SGM 05SEN1 52330 Federal Register / Vol. 71, No. 171 / Tuesday, September 5, 2006 / Notices 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 regulations.gov index. Although listed in the index, some information is not publicly available, e.g., CBI or other information for which disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically at https:// www.regulations.gov, or in hard copy at the OPPT Docket, EPA Docket Center (EPA/DC), EPA West, Rm. B102, 1301 Constitution Ave., NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number of the Public Reading Room is (202) 566–1744, and the telephone number for the OPPT Docket is (202) 566–0280. FOR FURTHER INFORMATION CONTACT: For general information contact: Colby Lintner, Regulatory Coordinator, Environmental Assistance Division (7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (202) 554–1404; e-mail address: TSCA-Hotline@epa.gov. For technical information contact: Richard Leukroth or John Schaeffer, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (202) 564–8157; e-mail address: ccd.citb@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information sroberts on PROD1PC70 with NOTICES A. Does this Action Apply to Me? This action is directed to the public in general, and may be of particular interest to those persons who are or may be required to conduct testing of chemical substances under TSCA. Since other entities may also 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 either VerDate Aug<31>2005 17:24 Sep 01, 2006 Jkt 208001 technical person listed under FOR FURTHER INFORMATION CONTACT. B. What Should I Consider as I Prepare My Comments for EPA? 1. Technical and scientific considerations. EPA invites interested parties to provide views on the test sponsors’ Tier I Program Review Testing reports entitled: 1,2-Dichloroethane (EDC): Limited Pharmacokinetics and Metabolism Study in Fischer 344 Rats and Physiologically Based Pharmacokinetic Model Development and Simulations for Ethylene Dichloride (1,2-Dichloroethane) in Rats (Refs. 1 and 2). These reports describe a computational dosimetry model for route-to-route extrapolation and development of pharmacokinetics and mechanistic data (PK/MECH data) that will support the use of this model for quantitative route-to-route extrapolations specific to endpoints listed under Tier II of the EDC ECA. The computational dosimetry model and PK/MECH data described in these reports, if deemed acceptable to EPA, will be applied to support the EDC ECA Tier II Testing and computational dosimetry model extrapolation reporting called for under Tier II of the EDC ECA. EPA is interested in comments on the PK/MECH data, the EDC computational dosimetry model for route-to-route extrapolation, and the utility of resulting derived computational data from the EDC computational dosimetry model that will be developed under Tier II of the EDC ECA. 2. Submitting CBI. Do not submit CBI to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information contained 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 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. 3. 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. As discussed in Unit I.B.1., the Agency asks you to PO 00000 Frm 00014 Fmt 4703 Sfmt 4703 respond to specific questions regarding the EDC ECA program review. iii. Explain why you agree or disagree with the materials under consideration for the EDC ECA program review; provide a convincing argument for your views or offer alternative ways to improve the science. 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 suggested 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 Testing is EPA Requiring for EDC? EPA proposed health effects testing under TSCA section 4(a) for a number of hazardous air pollutants (HAPs or HAP chemicals), including EDC, in the Federal Register of June 26, 1996 (Ref. 3), as amended (Refs. 4 and 5). The testing needs for EDC identified in the HAPs proposed rule, as amended, are acute toxicity, subchronic toxicity, developmental toxicity, reproductive toxicity, and neurotoxicity (acute and subchronic), to be conducted by the inhalation route of exposure. In that proposed TSCA section 4(a) rule, EPA also invited the submission of proposals that could use the performance of PK studies and computional dosimetry modeling to permit extrapolation from oral data to predict risk from inhalation exposure. Such proposals could provide the scientific basis for alternative testing to the testing proposed under the rule and form the basis for developing needed HAPs data via ECAs (Refs. 3, 4, and 5). On November 22, 1996, Dow Chemical Company, Vulcan Materials Company, Occidental Chemical Corporation, Oxy Vinyls, LP, Georgia Gulf Corporation, Westlake Chemical Corporation, PPG Industries, Inc., and Formosa Plastics Corporation, U.S.A. (the Companies), under the auspices of the HAP Task Force (the principal testing sponsor), submitted a proposal for alternative testing of EDC that included physiologically based pharmacokinetics (PBPK) studies and computational dosimetry model development to support route-to-route E:\FR\FM\05SEN1.SGM 05SEN1 Federal Register / Vol. 71, No. 171 / Tuesday, September 5, 2006 / Notices sroberts on PROD1PC70 with NOTICES extrapolation of testing to be conducted under the ECA by the oral route (Ref. 6). EPA considered this proposal sufficient (Ref. 7) to enter into ECA negotiations with the Companies and other interested parties (Ref. 8). The ECA for EDC was announced in the Federal Register of June 3, 2003 (Ref. 9). Under the EDC ECA (Ref. 10), the HAPs data needs for EDC are being addressed via an alternative testing program that utilizes testing by inhalation and the oral route, computational dosimetry model development, and development of PK/MECH data to support route-toroute extrapolation modeling for health effects endpoints identified in the ECA. EPA anticipates fulfilling all of the health effects testing requirements identified in the HAPs proposed rule, as amended, by implementation of the testing to be performed under the EDC ECA and Order. B. How is EPA Implementing Testing for EDC Under the ECA? The EDC ECA alternative testing program has four segments, as follows: Tier I HAPs Testing, Tier I Program Review Testing, EPA Program Review, and Tier II Testing and/or Extrapolation Reporting. 1. Tier I HAPs Testing. The ECA testing and reporting requirements for Tier I HAPs Testing have been completed. Under this segment of the EDC ECA, the Companies performed endpoint testing for acute toxicity, with bronchoalveolar lavage (BAL) and histopathology, and acute neurotoxicity (Ref. 11). These studies were conducted under a combined protocol by inhalation exposure. The ECA acknowledged that macrophage function testing (a component of EPA’s acute toxicity test guideline 40 CFR 799.9135) is adequately fulfilled by existing data published by Sherwood et al. (1987; Ref. 12) and also acknowledged that the developmental studies reported by Rao et al. (1980; Ref. 13), in rabbits, and Payan et al. (1995; Ref. 14) in rats, adequately fulfill the HAPs rulemaking testing requirements for developmental toxicity testing for EDC. 2. Tier I Program Review Testing. The ECA testing and reporting requirements for Tier I Program Review Testing have been completed. Under this segment of the EDC ECA the Companies conducted studies to extend the computational dosimetry model of D’Souza et al. (1987, 1988; Refs. 15 and 16) in order to apply the model to the specific health effects endpoints for EDC listed in the ECA, validate the model, and verify the model’s ability to perform quantitative route-to-route extrapolations of dose response. The ECA provided for the VerDate Aug<31>2005 17:24 Sep 01, 2006 Jkt 208001 development of PK/MECH data to support the application of the computational dosimetry model for the endpoints listed under Tier II of the EDC ECA. The Companies also provided model simulations with point and uncertainty estimates of internal dose metrics (parent chemical peak and area under the curve (AUC) concentrations in blood and brain, and 24–hour total glutathione (GSH)-dependent metabolism in lung and liver) in rats and humans to inform quantitative route-to-route extrapolations of the EDC dose response. Furthermore, based on an additional analysis of the D’Souza et al. model, the ECA was modified to include the kidney in the examination of GSH-dependent metabolism (Refs. 17, 18, and 19). Information derived from the GSH-metabolism, PK/MECH data, and model simulations will be used to evaluate the acceptability of performing: i. Oral-to-inhalation extrapolation of subchronic toxicity data reported by Daniel, et al. (1994; Ref. 20) relevant to corn oil gavage. ii. Oral-to-inhalation extrapolation of subchronic neurotoxicity data relevant to drinking water exposure of a study to be conducted under Tier II Testing. iii. Oral-to-inhalation extrapolation of reproductive effects testing conducted under Tier II Testing and each dosing paradigm of studies reported by Alumot et al. (1976; Ref. 21), Rao et al. (1980, Ref. 13), and Lane et al. (1982; Ref. 22). 3. EPA Program Review. As indicated in Unit VI.C. of the EDC ECA and Unit II.B.3. of this notice, computational dosimetry model development and data from Tier I Program Review Testing are subject to an EPA Program Review. The EPA Program Review will determine whether the computational dosimetry model and the PK/MECH data used to support the route-to-route extrapolations of dose response are scientifically sound and provide the highest quality data. Specifically, as described in Unit VII. of the EDC ECA, the EPA Program Review will determine: i. Whether it is feasible and appropriate to apply Tier I Program Review Testing data and data from other studies acceptable to EPA to support computational route-to-route extrapolations of dose response for any or all of the endpoints listed in the Tier II Testing segment of the ECA, including endpoint data from extant studies cited in the EDC ECA; ii. Whether the data from the Tier I Program Review Testing segment provide a sufficient basis for conducting the endpoint testing and/or the computational route-to-route extrapolations for the dose responses PO 00000 Frm 00015 Fmt 4703 Sfmt 4703 52331 specified in the Tier II Testing segment; and/or iii. The nature and scope of any additional work (e.g., development of additional PK/MECH data, modification to the EDC computational dosimetry model) that may be required to support Tier II Testing and application of the EDC computational dosimetry model for route-to-route extrapolation of doseresponse reporting for the testing endpoints listed under Tier II of the EDC ECA. 4. Tier II Testing and/or Extrapolation Reporting. This segment of the EDC ECA alternative testing program will consist of endpoint testing by drinking water exposure for subchronic neurotoxicity and reproductive toxicity. The reproductive effects toxicity testing is intended to confirm studies reported by Alumot et al. (1976; Ref. 21), Rao et al. (1980; Ref. 13), and Lane et al. (1982; Ref. 22), and provide data needed on fertility index, gestation index, gross necropsy, organ weight, histopathology, estrous cycle, sperm evaluation, vaginal opening, and preputial separation as described in the ECA. This segment will also include application of the EDC computational dosimetry model for quantitative route-to-route extrapolation reporting (oral to inhalation) for Tier II endpoint testing (subchronic neurotoxicity and reproductive toxicity) and similar computational extrapolation reporting for extant subchronic toxicity reported by Daniel et al. (1994; Ref. 20). III. What Action is the Agency Taking? A. What Opportunity is There for Public Involvement in EPA’s Program Review? Tier I HAPs Testing for EDC is completed and reports for Tier I Program Review Testing have been submitted by the Companies. Copies of these submissions are available in the public docket (EPA–HQ–OPPT–2003– 0010). As described in Unit II.B.3. and stated in Part VI. of the EDC ECA, the next step is for EPA to conduct a Program Review on the data collected from the Tier I Program Review Testing segment of the EDC ECA alternative testing program. As noted in Unit I.B., this notice of availability and request for written comments provides an opportunity for public comment on reports subject to this EPA Program Review. B. What Happens at the Conclusion of EPA’s Program Review? A description of the possible outcomes of the EPA Program Review is provided in Part VII. of the EDC ECA. Following the EPA Program Review, EPA will place in the public docket for E:\FR\FM\05SEN1.SGM 05SEN1 52332 Federal Register / Vol. 71, No. 171 / Tuesday, September 5, 2006 / Notices sroberts on PROD1PC70 with NOTICES this action (under docket ID number EPA–HQ–OPPT–2003–0010) a copy of each comment received, and a copy of the letter informing the HAP Task Force of the outcome from EPA’s Program Review. EPA will publish a Federal Register notice which announces the availability of a report describing the findings and conclusions of the Program Review, responds to comments on the Tier I Program Review Testing, identifies any modifications to Tier II ECA activities, and establishes revised deadlines as needed for completion of Tier II Testing and route-to-route computational dosimetry modeling for extrapolations listed under Tier II of the ECA for EDC. IV. Materials in the Docket The docket for this document has been established under docket ID number EPA–HQ–OPPT–2003–0010. The public docket is available for review as specified in ADDRESSES. The following is a listing of the documents referenced in this preamble that have been placed in the public docket for this document: 1. HAP Task Force. Letter from Peter E. Voytek to the Document Control Office with attachment entitled: 1,2Dichloroethane (EDC): Limited Pharmacokinetics and Metabolism Study in Fischer 344 Rats. March 2, 2006. (See Document ID No. EPA–HQ– OPPT–2003–0010–0081 (for letter) and Document ID No. EPA–HQ–OPPT– 2003–0010–0082 (for attachment)). 2. HAP Task Force. Letter from Peter E. Voytek to the Document Control Office with attachment entitled: Physiologically Based Pharmacokinetic Model Development and Simulations for Ethylene Dichloride (1,2Dichloroethane) in Rats. July 7, 2006. (See Document ID No. EPA–HQ–OPPT– 2003–0010–0086). 3. EPA. Proposed Test Rule for Hazardous Air Pollutants. Proposed Rule. Federal Register (61 FR 33178, June 26, 1996) (FRL–4869–1). Available on-line at https://www.epa.gov/fedrgstr/. 4. EPA. Amended Proposed Test Rule for Hazardous Air Pollutants; Extension of Comment Period. Proposed Rule. Federal Register (62 FR 67466, December 24, 1997) (FRL–5742–2). Available on-line at https:// www.epa.gov/fedrgstr/. 5. EPA. Amended Proposed Test Rule for Hazardous Air Pollutants; Extension of Comment Period. Proposed Rule. Federal Register (63 FR 19694, April 21, 1998) (FRL–5780–6). Available on-line at https://www.epa.gov/fedrgstr/. 6. HAP Task Force. Letter from Peter E. Voytek to the Document Control Office with attachment entitled: VerDate Aug<31>2005 17:24 Sep 01, 2006 Jkt 208001 Proposal for Pharmacokinetics Study of Ethylene Dichloride, November 22, 1996. November 22, 1996. (See Document ID No. EPA–HQ–OPPT– 2003–0010–0034). 7. EPA. Letter from Charles M. Auer to Peter E. Voytek with attachment entitled: Preliminary EPA Technical Analysis of Proposed Industry Pharmacokinetics (PK) Strategy for Ethylene Dichloride, June, 1997. June 26, 1997. (See Document ID No. EPA– HQ–OPPT–2003–0010–0035). 8. EPA. Enforceable Consent Agreement Development for Ethylene Dichloride; Solicitation of Interested Parties and Notice of Public Meeting. Notice. Federal Register (62 FR 6626, December 19, 1997) (FRL–5763–1). Available on-line at https:// www.epa.gov/fedrgstr/. 9. EPA. 1,2-Ethylene Dichloride; Final Enforceable Consent Agreement and Testing Consent Order. Notice. Federal Register (68 FR 33125, June 3, 2003) (FRL–7300–6). Available on-line at https://www.epa.gov/fedrgstr/. 10. EPA. Enforceable Consent Agreement for 1,2-Ethylene Dichloride. May 15, 2003. (CAS No. 107–06–2) (See Document ID No. EPA–HQ–OPPT– 2003–0010–0002). 11. HAP Task Force. Letter from Peter E. Voytek to the Document Control Office with attachment entitled: 1,2Dichloroethane (EDC): Acute Inhalation Toxicity with Bronchoalveolar Lavage and Histopathology/Acute Inhalation Neurotoxicity Study in F344/DUCRL Rats. June 21, 2006. (See Document ID Nos. EPA–HQ–OPPT–2003–0010–0087 through EPA–HQ–OPPT–2003–0010– 0087.6). 12. Sherwood, R.L.; O’Shea, W.; Thomas, P.T.; Ratajczak, H.V.; and Aranyi, C. Effects of inhalation of ethylene dichloride on pulmonary defenses of mice and rats. Toxicology and Applied Pharmacology 91: 491–496 (1987). 13. Rao, K.S.; Murray, J.S.; Deacon, M.M.; John, J.A.; Calhoun, L.L.; and Young, J.T. Teratogenicity and reproduction studies in animals inhaling ethylene dichloride. Banbury Report 5: 149–166 (1980). 14. Payan, J.P.; Saillenfait, A.M.; Bonnet, P.; Fabry, J.P.; Langonne, I.; and Sabate J.P. Assessment of the developmental toxicity and placental transfer of the 1,2-dichloroethane in rats. Fundamental and Applied Toxicology 28: 187–198 (1995). 15. D’Souza, R.W.; Francis, W.R.; Bruce R.D.; and Andersen, M.E. Physiologically based pharmacokinetic model for ethylene dichloride and its application in risk assessment, pp 286– 301. Pharmacokinetics in Risk PO 00000 Frm 00016 Fmt 4703 Sfmt 4703 Assessment. National Academy Press. Washington, DC (1987). 16. D’Souza, R.W.; Francis, W.R.; and Andersen, M.E. Physiological model for tissue glutathione depletion and increased resynthesis after ethylene dichloride exposure. Journal of Pharmacology and Experimental Therapeutics 245(2): 563–568 (1988). 17. EPA. Letter dated March 24, 2004 from Wardner G. Penberthy to Peter E. Voytek with two attachments entitled: i. Addendum Modification to Enforceable Consent Agreement for 1,2,Ethylene Dichloride (EDC). ii. Application of a PBPK model for cancer and non-cancer risk assessment of 1,2-dicholoroethane. Phase I: Evaluation of issues related to the use of a PBPK model for DCE. Requisition Reference No. 2WE59, QT–DC–030387. (See Document ID Nos. EPA–HQ– OPPT–2003–0010–0059 (for letter) and EPA–HQ–OPPT–2003–0010–0060 (for attachments)). 18. HAP Task Force. Letter from Peter E. Voytek to the Document Control Office Re: Testing Consent Order for Ethylene Dichloride; Request for Modification of Enforceable Consent Agreement. June 21, 2004. (See Document ID No. EPA–HQ–OPPT– 2003–0010–0063). 19. EPA. Letter dated July 14, 2004 from Wardner G. Penberthy to Peter E. Voytek RE: 1,2-Ethylene Dichloride (EDC), Request for Modification of PBPK Testing in Tier I Testing of the EDC ECA. (See Document ID No. EPA–HQ– OPPT–2003–0010–0065). 20. Daniel, F.B.; Robinson, M.; Olson, G.R.; York, R.G.; and Condie, L.W. Ten and ninety-day toxicity studies of 1,2dichloroethane in Sprague-Dawley rats. Drug and Chemical Toxicology 17: 463– 477 (1994). 21. Alumot, E.; Nachtomi, E.; Mandel, E.; Holstein, P.; Bondi, A.; and Herzberg, M. Tolerance and acceptable daily intake of chlorinated fumigants in the rat diet. Food, Cosmetics and Toxicology 14: 105–110 (1976). 22. Lane, R.W.; Riddle, B.L.; and Borzelleca, J.F. Effects of 1,2dichloroethane and 1,1,1trichloroethane in drinking water on reproduction and development in mice. Toxicology and Applied Pharmacology 63: 409–421 (1982). List of Subjects Environmental protection, 1,2Ethylene Dichloride, Hazardous chemicals. E:\FR\FM\05SEN1.SGM 05SEN1 Federal Register / Vol. 71, No. 171 / Tuesday, September 5, 2006 / Notices 52333 Dated: August 24, 2006. Wardner G. Penberthy, Acting Director, Chemical Control Division, Office of Pollution Prevention and Toxics. [FR Doc. E6–14639 Filed 9–1–06; 8:45 am] Board of Governors of the Federal Reserve System, August 30, 2006. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E6–14615 Filed 9–1–06; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 6560–50–S BILLING CODE 6210–01–S [60Day–06–05CL] FEDERAL RESERVE SYSTEM DEPARTMENT OF HEALTH AND HUMAN SERVICES sroberts on PROD1PC70 with NOTICES Formations of, Acquisitions by, and Mergers of Bank Holding Companies The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR Part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below. The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The application also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Additional information on all bank holding companies may be obtained from the National Information Center Web site at www.ffiec.gov/nic/. Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than September 29, 2006. A. Federal Reserve Bank of Atlanta (Andre Anderson, Vice President) 1000 Peachtree Street, N.E., Atlanta, Georgia 30303: 1. Traders & Farmers Bancshares, Inc. Haleyville, Alabama; to become a bank holding company by acquiring 100 percent of the outstanding shares of Traders & Farmers Bank, Haleyville, Alabama. VerDate Aug<31>2005 17:24 Sep 01, 2006 Jkt 208001 National Committee on Vital and Health Statistics: Meeting Pursuant to the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) announces the following advisory committee meeting. Name: National Committee on Vital and Health Statistics (NCVHS), Subcommittee on Populations. Time and Date: September 18, 2006, 8:30 a.m.–5 p.m. September 19, 2006, 8:30 a.m.– 5 p.m. Place: Renaissance Washington, DC Hotel, 999 Ninth Street, NW., Washington, DC 20001. (202) 898–9000. Status: Open. Purpose: The purpose of the meeting is to identify data linkages for statistical purposes within and among Federal government agencies with a view to promoting best practices. For Further Information Contact: Substantive program information as well as summaries of meetings and a roster of Committee members may be obtained from Joan Turek, Ph.D., Staff to the Subcommittee on Populations, Office of the Assistant Secretary for Planning and Evaluation, Room 434E, 200 Independence Avenue, SW., Washington, DC 20201, telephone (202) 690– 5945, e-mail joan.turek@hhs.gov; or Marjorie S. Greenberg, Executive Secretary, NCVHS, National Center for Health Statistics, Centers for Disease Control and Prevention, 3311 Toledo Road, Room 2402, Hyattsville, Maryland 20782, telephone (301) 458–4245. Information also is available on the NCVHS home page of the HHS Web site: https:// www.ncvhs.hhs.gov/, where further information including an agenda will be posted when available. Should you require reasonable accommodation, please contact the CDC Office of Equal Employment Opportunity on (301) 458–4EEO (4336) as soon as possible. Dated: August 28, 2006. James Scanlon, Deputy Assistant Secretary for Science and Data Policy, Office of the Assistant Secretary for Planning and Evaluation. [FR Doc. 06–7403 Filed 9–1–06; 8:45 am] BILLING CODE 4151–05–M PO 00000 Frm 00017 Fmt 4703 Sfmt 4703 Centers for Disease Control and Prevention Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404–639–5960 and send comments to Seleda Perryman, CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MS–D74, Atlanta, GA 30333 or send an e-mail to omb@cdc.gov. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice. Proposed Project Formative Evaluation of Adults’ and Children’s Views Related to Promotion of Healthy Food Choices—New— National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description In FY 2004, Congress directed the Centers for Disease Control and Prevention (CDC) to conduct formative research on the attitudes of children and parents regarding nutrition behavior. Specifically, the conferees’ FY 2004 Appropriation Language instructs CDC to research parents’ and children’s viewpoints on ‘‘the characteristics of effective marketing of foods to children to promote healthy food choices.’’ Upon completion, a report detailing CDC’s E:\FR\FM\05SEN1.SGM 05SEN1

Agencies

[Federal Register Volume 71, Number 171 (Tuesday, September 5, 2006)]
[Notices]
[Pages 52329-52333]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-14639]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2003-0010; FRL-8088-3]


1,2-Ethylene Dichloride Tier I Program Review Testing; Notice of 
Availability and Solicitation of Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: Under section 4 of the Toxic Substances Control Act (TSCA), 
EPA issued a testing consent order that incorporated an enforceable 
consent agreement (ECA) for 1,2-ethylene dichloride (EDC). The 
companies subject to the ECA agreed to conduct toxicity testing, 
develop a computational dosimetry model for route-to-route 
extrapolations, and develop pharmacokinetics and mechanistic testing 
data that are intended to satisfy the toxicological data needs for EDC 
identified in a TSCA section 4 proposed test rule for a number of 
hazardous air pollutant chemicals. This notice announces that EPA is 
starting the program review component of the EDC ECA alternative 
testing program, and solicits comment on data received under the Tier I 
Program Review Testing segment of the EDC ECA. Comments are expected to 
inform EPA's decision on whether data and computational dosimetry model 
development completed by the test sponsors are sufficient to proceed 
with the Tier II Testing and computational dosimetry modeling for 
route-to-route extrapolations listed in the EDC ECA.

DATES: Comments must be received on or before October 5, 2006.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2003-0010, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001.
     Hand Delivery: OPPT Document Control Office (DCO), EPA 
East, Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention: 
Docket ID Number EPA-HQ-OPPT-2003-0010. The DCO is open from 8 a.m. to 
4 p.m., Monday through Friday, excluding legal holidays. The telephone 
number for the DCO is (202) 564-8930. Such deliveries are only accepted 
during the DCO's normal hours of operation, and special arrangements 
should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2003-0010. EPA's policy is that all comments received will be included 
in the public docket without change and may be made available on-line 
at https://www.regulations.gov, including any personal information 
provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information for which 
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 public docket and made available 
on the Internet. If you submit an electronic comment, EPA recommends 
that you include your

[[Page 52330]]

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 
regulations.gov index. Although listed in the index, some information 
is not publicly available, e.g., CBI or other information for which 
disclosure is restricted by statute. Certain other material, such as 
copyrighted material, will be publicly available only in hard copy. 
Publicly available docket materials are available either electronically 
at https://www.regulations.gov, or in hard copy at the OPPT Docket, EPA 
Docket Center (EPA/DC), EPA West, Rm. B102, 1301 Constitution Ave., 
NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 
4:30 p.m., Monday through Friday, excluding legal holidays. The 
telephone number of the Public Reading Room is (202) 566-1744, and the 
telephone number for the OPPT Docket is (202) 566-0280.

FOR FURTHER INFORMATION CONTACT: For general information contact: Colby 
Lintner, Regulatory Coordinator, Environmental Assistance Division 
(7408M), Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 554-1404; e-mail address: TSCA-
Hotline@epa.gov.
    For technical information contact: Richard Leukroth or John 
Schaeffer, Chemical Control Division (7405M), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: 
(202) 564-8157; e-mail address: ccd.citb@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 
particular interest to those persons who are or may be required to 
conduct testing of chemical substances under TSCA. Since other entities 
may also 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 either technical person listed under FOR 
FURTHER INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Technical and scientific considerations. EPA invites interested 
parties to provide views on the test sponsors' Tier I Program Review 
Testing reports entitled: 1,2-Dichloroethane (EDC): Limited 
Pharmacokinetics and Metabolism Study in Fischer 344 Rats and 
Physiologically Based Pharmacokinetic Model Development and Simulations 
for Ethylene Dichloride (1,2-Dichloroethane) in Rats (Refs. 1 and 2). 
These reports describe a computational dosimetry model for route-to-
route extrapolation and development of pharmacokinetics and mechanistic 
data (PK/MECH data) that will support the use of this model for 
quantitative route-to-route extrapolations specific to endpoints listed 
under Tier II of the EDC ECA. The computational dosimetry model and PK/
MECH data described in these reports, if deemed acceptable to EPA, will 
be applied to support the EDC ECA Tier II Testing and computational 
dosimetry model extrapolation reporting called for under Tier II of the 
EDC ECA. EPA is interested in comments on the PK/MECH data, the EDC 
computational dosimetry model for route-to-route extrapolation, and the 
utility of resulting derived computational data from the EDC 
computational dosimetry model that will be developed under Tier II of 
the EDC ECA.
    2. Submitting CBI. Do not submit CBI 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 contained 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 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.
    3. 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. As discussed in Unit I.B.1., the Agency asks 
you to respond to specific questions regarding the EDC ECA program 
review.
    iii. Explain why you agree or disagree with the materials under 
consideration for the EDC ECA program review; provide a convincing 
argument for your views or offer alternative ways to improve the 
science.
    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 
suggested 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 Testing is EPA Requiring for EDC?

    EPA proposed health effects testing under TSCA section 4(a) for a 
number of hazardous air pollutants (HAPs or HAP chemicals), including 
EDC, in the Federal Register of June 26, 1996 (Ref. 3), as amended 
(Refs. 4 and 5). The testing needs for EDC identified in the HAPs 
proposed rule, as amended, are acute toxicity, subchronic toxicity, 
developmental toxicity, reproductive toxicity, and neurotoxicity (acute 
and subchronic), to be conducted by the inhalation route of exposure.
    In that proposed TSCA section 4(a) rule, EPA also invited the 
submission of proposals that could use the performance of PK studies 
and computional dosimetry modeling to permit extrapolation from oral 
data to predict risk from inhalation exposure. Such proposals could 
provide the scientific basis for alternative testing to the testing 
proposed under the rule and form the basis for developing needed HAPs 
data via ECAs (Refs. 3, 4, and 5).
    On November 22, 1996, Dow Chemical Company, Vulcan Materials 
Company, Occidental Chemical Corporation, Oxy Vinyls, LP, Georgia Gulf 
Corporation, Westlake Chemical Corporation, PPG Industries, Inc., and 
Formosa Plastics Corporation, U.S.A. (the Companies), under the 
auspices of the HAP Task Force (the principal testing sponsor), 
submitted a proposal for alternative testing of EDC that included 
physiologically based pharmacokinetics (PBPK) studies and computational 
dosimetry model development to support route-to-route

[[Page 52331]]

extrapolation of testing to be conducted under the ECA by the oral 
route (Ref. 6). EPA considered this proposal sufficient (Ref. 7) to 
enter into ECA negotiations with the Companies and other interested 
parties (Ref. 8). The ECA for EDC was announced in the Federal Register 
of June 3, 2003 (Ref. 9). Under the EDC ECA (Ref. 10), the HAPs data 
needs for EDC are being addressed via an alternative testing program 
that utilizes testing by inhalation and the oral route, computational 
dosimetry model development, and development of PK/MECH data to support 
route-to-route extrapolation modeling for health effects endpoints 
identified in the ECA. EPA anticipates fulfilling all of the health 
effects testing requirements identified in the HAPs proposed rule, as 
amended, by implementation of the testing to be performed under the EDC 
ECA and Order.

B. How is EPA Implementing Testing for EDC Under the ECA?

    The EDC ECA alternative testing program has four segments, as 
follows: Tier I HAPs Testing, Tier I Program Review Testing, EPA 
Program Review, and Tier II Testing and/or Extrapolation Reporting.
    1. Tier I HAPs Testing. The ECA testing and reporting requirements 
for Tier I HAPs Testing have been completed. Under this segment of the 
EDC ECA, the Companies performed endpoint testing for acute toxicity, 
with bronchoalveolar lavage (BAL) and histopathology, and acute 
neurotoxicity (Ref. 11). These studies were conducted under a combined 
protocol by inhalation exposure. The ECA acknowledged that macrophage 
function testing (a component of EPA's acute toxicity test guideline 40 
CFR 799.9135) is adequately fulfilled by existing data published by 
Sherwood et al. (1987; Ref. 12) and also acknowledged that the 
developmental studies reported by Rao et al. (1980; Ref. 13), in 
rabbits, and Payan et al. (1995; Ref. 14) in rats, adequately fulfill 
the HAPs rulemaking testing requirements for developmental toxicity 
testing for EDC.
    2. Tier I Program Review Testing. The ECA testing and reporting 
requirements for Tier I Program Review Testing have been completed. 
Under this segment of the EDC ECA the Companies conducted studies to 
extend the computational dosimetry model of D'Souza et al. (1987, 1988; 
Refs. 15 and 16) in order to apply the model to the specific health 
effects endpoints for EDC listed in the ECA, validate the model, and 
verify the model's ability to perform quantitative route-to-route 
extrapolations of dose response. The ECA provided for the development 
of PK/MECH data to support the application of the computational 
dosimetry model for the endpoints listed under Tier II of the EDC ECA. 
The Companies also provided model simulations with point and 
uncertainty estimates of internal dose metrics (parent chemical peak 
and area under the curve (AUC) concentrations in blood and brain, and 
24-hour total glutathione (GSH)-dependent metabolism in lung and liver) 
in rats and humans to inform quantitative route-to-route extrapolations 
of the EDC dose response. Furthermore, based on an additional analysis 
of the D'Souza et al. model, the ECA was modified to include the kidney 
in the examination of GSH-dependent metabolism (Refs. 17, 18, and 19). 
Information derived from the GSH-metabolism, PK/MECH data, and model 
simulations will be used to evaluate the acceptability of performing:
    i. Oral-to-inhalation extrapolation of subchronic toxicity data 
reported by Daniel, et al. (1994; Ref. 20) relevant to corn oil gavage.
    ii. Oral-to-inhalation extrapolation of subchronic neurotoxicity 
data relevant to drinking water exposure of a study to be conducted 
under Tier II Testing.
    iii. Oral-to-inhalation extrapolation of reproductive effects 
testing conducted under Tier II Testing and each dosing paradigm of 
studies reported by Alumot et al. (1976; Ref. 21), Rao et al. (1980, 
Ref. 13), and Lane et al. (1982; Ref. 22).
    3. EPA Program Review. As indicated in Unit VI.C. of the EDC ECA 
and Unit II.B.3. of this notice, computational dosimetry model 
development and data from Tier I Program Review Testing are subject to 
an EPA Program Review. The EPA Program Review will determine whether 
the computational dosimetry model and the PK/MECH data used to support 
the route-to-route extrapolations of dose response are scientifically 
sound and provide the highest quality data. Specifically, as described 
in Unit VII. of the EDC ECA, the EPA Program Review will determine:
    i. Whether it is feasible and appropriate to apply Tier I Program 
Review Testing data and data from other studies acceptable to EPA to 
support computational route-to-route extrapolations of dose response 
for any or all of the endpoints listed in the Tier II Testing segment 
of the ECA, including endpoint data from extant studies cited in the 
EDC ECA;
    ii. Whether the data from the Tier I Program Review Testing segment 
provide a sufficient basis for conducting the endpoint testing and/or 
the computational route-to-route extrapolations for the dose responses 
specified in the Tier II Testing segment; and/or
    iii. The nature and scope of any additional work (e.g., development 
of additional PK/MECH data, modification to the EDC computational 
dosimetry model) that may be required to support Tier II Testing and 
application of the EDC computational dosimetry model for route-to-route 
extrapolation of dose-response reporting for the testing endpoints 
listed under Tier II of the EDC ECA.
    4. Tier II Testing and/or Extrapolation Reporting. This segment of 
the EDC ECA alternative testing program will consist of endpoint 
testing by drinking water exposure for subchronic neurotoxicity and 
reproductive toxicity. The reproductive effects toxicity testing is 
intended to confirm studies reported by Alumot et al. (1976; Ref. 21), 
Rao et al. (1980; Ref. 13), and Lane et al. (1982; Ref. 22), and 
provide data needed on fertility index, gestation index, gross 
necropsy, organ weight, histopathology, estrous cycle, sperm 
evaluation, vaginal opening, and preputial separation as described in 
the ECA. This segment will also include application of the EDC 
computational dosimetry model for quantitative route-to-route 
extrapolation reporting (oral to inhalation) for Tier II endpoint 
testing (subchronic neurotoxicity and reproductive toxicity) and 
similar computational extrapolation reporting for extant subchronic 
toxicity reported by Daniel et al. (1994; Ref. 20).

III. What Action is the Agency Taking?

A. What Opportunity is There for Public Involvement in EPA's Program 
Review?

    Tier I HAPs Testing for EDC is completed and reports for Tier I 
Program Review Testing have been submitted by the Companies. Copies of 
these submissions are available in the public docket (EPA-HQ-OPPT-2003-
0010). As described in Unit II.B.3. and stated in Part VI. of the EDC 
ECA, the next step is for EPA to conduct a Program Review on the data 
collected from the Tier I Program Review Testing segment of the EDC ECA 
alternative testing program. As noted in Unit I.B., this notice of 
availability and request for written comments provides an opportunity 
for public comment on reports subject to this EPA Program Review.

B. What Happens at the Conclusion of EPA's Program Review?

    A description of the possible outcomes of the EPA Program Review is 
provided in Part VII. of the EDC ECA. Following the EPA Program Review, 
EPA will place in the public docket for

[[Page 52332]]

this action (under docket ID number EPA-HQ-OPPT-2003-0010) a copy of 
each comment received, and a copy of the letter informing the HAP Task 
Force of the outcome from EPA's Program Review. EPA will publish a 
Federal Register notice which announces the availability of a report 
describing the findings and conclusions of the Program Review, responds 
to comments on the Tier I Program Review Testing, identifies any 
modifications to Tier II ECA activities, and establishes revised 
deadlines as needed for completion of Tier II Testing and route-to-
route computational dosimetry modeling for extrapolations listed under 
Tier II of the ECA for EDC.

IV. Materials in the Docket

    The docket for this document has been established under docket ID 
number EPA-HQ-OPPT-2003-0010. The public docket is available for review 
as specified in ADDRESSES. The following is a listing of the documents 
referenced in this preamble that have been placed in the public docket 
for this document:
    1. HAP Task Force. Letter from Peter E. Voytek to the Document 
Control Office with attachment entitled: 1,2-Dichloroethane (EDC): 
Limited Pharmacokinetics and Metabolism Study in Fischer 344 Rats. 
March 2, 2006. (See Document ID No. EPA-HQ-OPPT-2003-0010-0081 (for 
letter) and Document ID No. EPA-HQ-OPPT-2003-0010-0082 (for 
attachment)).
    2. HAP Task Force. Letter from Peter E. Voytek to the Document 
Control Office with attachment entitled: Physiologically Based 
Pharmacokinetic Model Development and Simulations for Ethylene 
Dichloride (1,2-Dichloroethane) in Rats. July 7, 2006. (See Document ID 
No. EPA-HQ-OPPT-2003-0010-0086).
    3. EPA. Proposed Test Rule for Hazardous Air Pollutants. Proposed 
Rule. Federal Register (61 FR 33178, June 26, 1996) (FRL-4869-1). 
Available on-line at https://www.epa.gov/fedrgstr/.
    4. EPA. Amended Proposed Test Rule for Hazardous Air Pollutants; 
Extension of Comment Period. Proposed Rule. Federal Register (62 FR 
67466, December 24, 1997) (FRL-5742-2). Available on-line at https://
www.epa.gov/fedrgstr/.
    5. EPA. Amended Proposed Test Rule for Hazardous Air Pollutants; 
Extension of Comment Period. Proposed Rule. Federal Register (63 FR 
19694, April 21, 1998) (FRL-5780-6). Available on-line at https://
www.epa.gov/fedrgstr/.
    6. HAP Task Force. Letter from Peter E. Voytek to the Document 
Control Office with attachment entitled: Proposal for Pharmacokinetics 
Study of Ethylene Dichloride, November 22, 1996. November 22, 1996. 
(See Document ID No. EPA-HQ-OPPT-2003-0010-0034).
    7. EPA. Letter from Charles M. Auer to Peter E. Voytek with 
attachment entitled: Preliminary EPA Technical Analysis of Proposed 
Industry Pharmacokinetics (PK) Strategy for Ethylene Dichloride, June, 
1997. June 26, 1997. (See Document ID No. EPA-HQ-OPPT-2003-0010-0035).
    8. EPA. Enforceable Consent Agreement Development for Ethylene 
Dichloride; Solicitation of Interested Parties and Notice of Public 
Meeting. Notice. Federal Register (62 FR 6626, December 19, 1997) (FRL-
5763-1). Available on-line at https://www.epa.gov/fedrgstr/.
    9. EPA. 1,2-Ethylene Dichloride; Final Enforceable Consent 
Agreement and Testing Consent Order. Notice. Federal Register (68 FR 
33125, June 3, 2003) (FRL-7300-6). Available on-line at https://
www.epa.gov/fedrgstr/.
    10. EPA. Enforceable Consent Agreement for 1,2-Ethylene Dichloride. 
May 15, 2003. (CAS No. 107-06-2) (See Document ID No. EPA-HQ-OPPT-2003-
0010-0002).
    11. HAP Task Force. Letter from Peter E. Voytek to the Document 
Control Office with attachment entitled: 1,2-Dichloroethane (EDC): 
Acute Inhalation Toxicity with Bronchoalveolar Lavage and 
Histopathology/Acute Inhalation Neurotoxicity Study in F344/DUCRL Rats. 
June 21, 2006. (See Document ID Nos. EPA-HQ-OPPT-2003-0010-0087 through 
EPA-HQ-OPPT-2003-0010-0087.6).
    12. Sherwood, R.L.; O'Shea, W.; Thomas, P.T.; Ratajczak, H.V.; and 
Aranyi, C. Effects of inhalation of ethylene dichloride on pulmonary 
defenses of mice and rats. Toxicology and Applied Pharmacology 91: 491-
496 (1987).
    13. Rao, K.S.; Murray, J.S.; Deacon, M.M.; John, J.A.; Calhoun, 
L.L.; and Young, J.T. Teratogenicity and reproduction studies in 
animals inhaling ethylene dichloride. Banbury Report 5: 149-166 (1980).
    14. Payan, J.P.; Saillenfait, A.M.; Bonnet, P.; Fabry, J.P.; 
Langonne, I.; and Sabate J.P. Assessment of the developmental toxicity 
and placental transfer of the 1,2-dichloroethane in rats. Fundamental 
and Applied Toxicology 28: 187-198 (1995).
    15. D'Souza, R.W.; Francis, W.R.; Bruce R.D.; and Andersen, M.E. 
Physiologically based pharmacokinetic model for ethylene dichloride and 
its application in risk assessment, pp 286-301. Pharmacokinetics in 
Risk Assessment. National Academy Press. Washington, DC (1987).
    16. D'Souza, R.W.; Francis, W.R.; and Andersen, M.E. Physiological 
model for tissue glutathione depletion and increased resynthesis after 
ethylene dichloride exposure. Journal of Pharmacology and Experimental 
Therapeutics 245(2): 563-568 (1988).
    17. EPA. Letter dated March 24, 2004 from Wardner G. Penberthy to 
Peter E. Voytek with two attachments entitled:
    i. Addendum Modification to Enforceable Consent Agreement for 
1,2,Ethylene Dichloride (EDC).
    ii. Application of a PBPK model for cancer and non-cancer risk 
assessment of 1,2-dicholoroethane. Phase I: Evaluation of issues 
related to the use of a PBPK model for DCE. Requisition Reference No. 
2WE59, QT-DC-030387.
(See Document ID Nos. EPA-HQ-OPPT-2003-0010-0059 (for letter) and EPA-
HQ-OPPT-2003-0010-0060 (for attachments)).
    18. HAP Task Force. Letter from Peter E. Voytek to the Document 
Control Office Re: Testing Consent Order for Ethylene Dichloride; 
Request for Modification of Enforceable Consent Agreement. June 21, 
2004. (See Document ID No. EPA-HQ-OPPT-2003-0010-0063).
    19. EPA. Letter dated July 14, 2004 from Wardner G. Penberthy to 
Peter E. Voytek RE: 1,2-Ethylene Dichloride (EDC), Request for 
Modification of PBPK Testing in Tier I Testing of the EDC ECA. (See 
Document ID No. EPA-HQ-OPPT-2003-0010-0065).
    20. Daniel, F.B.; Robinson, M.; Olson, G.R.; York, R.G.; and 
Condie, L.W. Ten and ninety-day toxicity studies of 1,2-dichloroethane 
in Sprague-Dawley rats. Drug and Chemical Toxicology 17: 463-477 
(1994).
    21. Alumot, E.; Nachtomi, E.; Mandel, E.; Holstein, P.; Bondi, A.; 
and Herzberg, M. Tolerance and acceptable daily intake of chlorinated 
fumigants in the rat diet. Food, Cosmetics and Toxicology 14: 105-110 
(1976).
    22. Lane, R.W.; Riddle, B.L.; and Borzelleca, J.F. Effects of 1,2-
dichloroethane and 1,1,1-trichloroethane in drinking water on 
reproduction and development in mice. Toxicology and Applied 
Pharmacology 63: 409-421 (1982).

List of Subjects

    Environmental protection, 1,2-Ethylene Dichloride, Hazardous 
chemicals.



[[Page 52333]]


    Dated: August 24, 2006.
Wardner G. Penberthy,
Acting Director, Chemical Control Division, Office of Pollution 
Prevention and Toxics.
[FR Doc. E6-14639 Filed 9-1-06; 8:45 am]
BILLING CODE 6560-50-S
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