Document 8247GJwk98B59m9DkjxVYaeJy

Chemical Manufacturers Associat on ; :C May 2,1996 j MAY 3' Dear Vinyl Chloride Health Committee Members: ^-------------------------- The following items are enclosed for your review and discussion on the May 9,1996 conference call: 1) agenda for the May 9,1996 conference call; 2) Federal Register notice of Tuesday, April 4,1996 regarding the EPA's Integrated Risk Information System (IRIS). The IRIS process already has begun for Vinyl Chloride (a new entry) with a request for identification of all technical information related to cancer and non-cancer assessments. Over the next six to eight months, EPA will compare submitted inventories with existing files and ' collect only that information which it has not previously compiled. By initially requesting only data inventories, EPA plans to avoid an influx of duplicative information. After EPA is satisfied that a comprehensive search has been conducted, it will develop draft health assessments for review by internal (within EPA) and external (outside EPA) peer review committees. Internal consensus review and management approval will determine the final entry into the IRIS database; 3) CMA letter to Joan Dollarhyde of EPA's IRIS Submission Desk explaining the Committee's intent to submit information on Vinyl Chloride for entry into the IRIS database and work with the Agency on its IRIS pilot project; 4) Proposal to Impact the Reevaluation of Vinyl Chloride (VC1) carcinogenicity." Please review this proposal carefully so that we can decide during the conference call whether we wish to retain ChemRisk's services. The cost estimates provided by ChemRisk are significantly higher than what the Committee has budgeted. Please identify any areas in the proposal that may be done by Health Committee members to reduce costs, if the Committee decides to retain ChemRisk's services; and, 5) Predicting Cancer Riskfrom Vinyl Chloride Exposure with a Physiologically Based Pharmacokinetic Model, Reitz, et. al. I am waiting for the protocol for the Brain Cancer Case-Control study from Carlo Tamburro, and the molecular research protocol from Jim Swenberg. I will fax the protocols to you when they arrive. The information on agenda items 6,7, and 8, was sent to you earlier. I will provide an update on these items during the conference call. Please call me at 703/741-5637 if you have any questions. t ' Sincerely, Hasmukh C. Shah, Ph.D. Manager, Vinyl Chloride Panel Enclosure Responsible Care* 1300 Wilson Boulevard, Arlington, VA 22209 Telephone 703-741-5000 Fax 703-741-6000 if APinflcComrrttmert SL 110311 CHEMICAL MANUFACTURERS ASSOCIATION Vinyl Chloride Health Committee Conference Call Tentative Agenda DATE: TIME: May 9,1996 10:00 a.m. EDT 1.0 Update on Brain Cancer Case-Control Study / University of Louisville 1.1 Status of Agreement with Carlo Tamburo 1.2 Timeline for Reviewing Draft Study P] rotocol 0 o 1.3 Discussion of Peer Review Process for the Draft Protocol . -r JUu. 9 2.0 Update on Vinyl Chloride Cohort Study at Applied Epidemiology Inc. 2.1 Status of Data Transfer from ENSR to AEI-Has Shah 2.2 Progress Report on the Study-Ken Mundt and Jonathan Ramlow 3.0 Review of Financial Statement 4.0 Update on EPA IRIS Pilot Project 4.1 Discussion of Proposal from ChemRisk 4.2 Request for Extension of Deadline for Submitting Response to EPA 4.3 Development of Strategy to Work with EPA 5.0 Update on Reproductive and Developmental Toxicity and Molecular Research Studies 5.1 Status of Memorandum of Understanding with ATSDR 5.2 Status of Agreement with Huntingdon Life Sciences 5.2.1 Discussion of Supplier of Vinyl Chloride Pre-test Sample and Test Material for the Study 5.2.2 Discussion of Storage Tank for the Test Material 5.2.3 Report on Site Visit to Huntingdon Laboratory 5.3 Discussion of Revised Proposal for Molecular Research from James Swenberg / University of North Carolina 5.4 Discussion of Providing C13-Vinyl Chloride to James Swenberg 5.5 Discussion of Selection of Study Monitors Including Retention of Bill Breslin of The Dow Chemical Company 5.6 Discussion of Retaining a Third Party Quality Assurance Auditor 6.0 Update on the Committee's Comments to ATSDR on the Draft Toxicological Profile for Vinyl Chloride 7.0 Update on the Committee's Comments to ATSDR on the Medical Management Practices Guidelines for Vinyl Chloride 8.0 Update on CalEPA Risk Assessment for Vinyl Chloride at a Superfund Site 9.0 Schedule Next Conference Call or Meeting -)1^ Xkxi--. Hasmukh C. Shah, Ph.D. Manager, Vinyl Chloride Panel 14570 Federal Regferer / Vol. 61, No, 04 / Tuesday. April It 1996 / Notices requirements; train personnel to be able to respond to a collection of lefrinwntinn: search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. Respondent/Affected Entities: 40. Estimated Number of Respondents: 40. Frequency of Response: Variable. Estimated Total Annual Hour Burden: 11.420 hours. Estimated Total Annualized Cost Burden: S347.739. Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods Of tniniraiging respondent burden, including through the use at automated collection techniques to the following addresses. Please refer to EPA ICR No. 0664 and OMB Control No. 2060-0006 in any correspondence. Ms. Sandy Farmer, U.S. Environmental Protection Agency, OPPE Regulatory Information Division (2137), 401 M Street. SW, Washington, DC 20460 and Office of Information and Regulatory Affairs, Office of Management and Budget, Attention; Desk Officer for EPA. 725 17th Street, NW. Washington, DC 10503. Dated: March 29.1996. Joseph Katrer. Director. Regulatory Information Division. (FR Doe. 96-7874 Filed 4-1-96; 8:45 ami UJNQ 0O0E (FRL-6452-Z) Integrated Risk Information System ORIS); Announcement of Pilot Program; Raquest for Information agency: U.S. Environmental Protection Agency. ACTION: Notice: Announcement of IRIS Pilot Program and request for technical information on Pilot chemical substances. SUMMARY: The Integrated Risk Information System tIRlS) is a data base of the United States Environmental Protection Agency (EPA) that contains EPA scientific consensus positions on potential human health effects from environmental contaminants. On February 25.1993 (58 FR 11490) EPA requested public comment to improve IRIS and make it more useful. In that notice EPA aiso described efforts in the Agency to idenurv .ssues m the development and presentation of miormaaon .n the data base. Manv of the .ssues concern the wav consensus health information la developed prior to entry into the data base. As a consequence of analyzing the IRIS program and considering suggestions received about IRIS over the past several years, EPA has initiated a Pilot Program to improve the consensus health information process and strengthen peer review. The Pilot will produce new or updated health assessments and IRIS entries for eleven priority environmental chemical substances utilizing this new process. The purpose of this Nodes is to advise the public that the Pilot is underway, and to request frfmirel information from the public on the eleven Pilot substances. - dates: Please submit information in response to this Nodes by May 2,1996. ADDRESSES: Please mail information (three copies, at least one of which should be unbound) to the IRIS Submission Desk, NCSA (MS-190), U.S. Environmental Protection Agency, 26 Martin Luther King Drive. Cincinnati, OH 45268. Information may be submitted electronically by sending electronic mail (e-mail) to: nUS.commentsOepainaiLepa.gov. Electronic information must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. Information will also be accepted an disks in WordPerfect 5.1 format or ASCII file format All information in electronic form must be identified as IRIS Submission. FOR FURTHER REFORMATION: For information on the Pilot, contact Amy Mills, National Center for Environmental Assessment (mail code 8623), U.S. Environmental Protection Agency, 401M St, SW., Washington, DC 20460. The public information phone line for the Pilot is (202) 260- 8930, or email inquiries may be addressed to mills.amyOepamail.epa.gov. SUPPLEMENTARY REFORMATION: Background The Integrated Risk Information System (IRIS) is an EPA data base containing Agency consensus scientific positions on potential adverse human health effects that may result from chronic (or lifetime) exposure to environmental contaminants. IRIS currently provides health effects information on over 500 specific chemical substances. IRIS contains chemical-specific summaries of qualitative and quantitative health information in support of the first 'wo steps of the risk assessment process. ..e., Hazard identification and cose-response evaluation. IRIS information includes the reference dose for Don-cancer health effects resulting from oral exposure,ibe reference concentration for non-cancer health effects resulting from inhalation exposure, end the carcinogen assessment for both oral and inhalation exposure. Combined with specific situational exposure assessment information, foe summary health hazard information in IRIS may be used as a source in evaluating potential public health risks from environmental contaminants. As foe data base has expanded and its use has increased over the last decade, issues have surfaced with regard to entering new information in a timely manner, while soliciting information from a broad spectrum of outside scientists and foe public. In 1993. an EPA team evaluated foe status of IRIS and proposed options for improvement This effort was announced in a Notice in foe Federal Register of February 25, 1993 (56 FR 11490). The Notice addressed the use of IRIS, and avenues for public involvement and external scientific peer review of IRIS summaries and supporting documents. Public involvement means opportunities for affected or interested parties to have some level of input into DUS health hazard information, such as providing relevant health data. Public involvement can involve a broader spectrum of participants than external peer review, which refers to a critical scientific appraisal by experts outside of EPA. The Agency and the public have continued *o express support for maintaining DUS and strengthening foe process for developing consensus health information, public involvement, and peer review. This support has given rise to foe new Pilot Program. The Pilot Program As a consequence of analyzing foe DUS program and considering suggestions received about DUS over foe past several years, foe Agency has decided to test some improvements through a Pilot Program. The Pilot will primarily address foe identific consensus and review process that precedes DUS data base entries. EPA wiii develop `or update, for existing emries) all non-cancer and canco information for the eleven Pilot substances. The ilot process will consist of, (1) A call for technical information on foe eleven substances from foe public via this FR Notice. (2) a search of foe current literature. (3) development of health assessments and draft iRIS summar.es. i'3! .menial peer redrew ii.ts.. within EPA:. 4i external peer review outside EPAi, i5) consensus review and management SL 110313 approval within EPA. (6) VHparatiooof flVui iris summaiiet and TMppw**f document*, and (7) entry oftummariee Into the IRIS data base. The appropriate level of external pew review will be determined for each chemical substance. Depending upon the complexity of the scientific information and other betas, the form of the peer review will either be vie mail, forums of experts, or formal federal advisory committee*. The Pilot will also test some Brovements in IRIS entries to more j characterize health information associated with each chemical. Fa example, the IRIS summaries will provide greater elaboration of. uncertainties in the data, and our confidence in the assessment Pilot Substances The eleven Pilot chemical substances were chosen on the bests of the Agency's need for new or updated hazard or dose-response information, and in an effort to represent a range of technical complexity so the new process is realistically tested. Qualitative and quantitative information will be developed for non-cancer and cancer effects of all Pilot substances, far tome cases, the assessment will be developed for the first time; in others, the assessment will be reviewed in light of new information and updated in IRIS if appropriate. The following substances will be reviewed under the Pilot Program: NameACAS.No. Arsenic--7440-38-2 Bentazon--25057-89-0 Beryllium--7440-41-7 Chlordane--57-74-9 Chromium (HR--16065-83-1 Chromium (VI)--18540-29-9 Total chromium--7440-47-3 Cumene--98-82-8 Methyl methacrylate--80-62-6 Methvlene diphenyl isocyanate-- 101-68-8 Naphthalene--91-20-3 Tributyltin oxide--56-35-9 Vinyl chloride--75-01-4 Note that EPA may initiate other chemical substance reviews during the Pilot period; the Pilot does not preclude additional work on IRIS. Submittal of Information . The Pilot Program is designed to provide eerly opportunity for public involvement. While the Agency conducts a thorough literature search for each chemical substance, there mav be other articles or unpublished studies we are not aware of. The Agency would greatlv appreciate receiving scientific ---------------- - -----------------rr Information from the public during the into printed, paper form as it is i information gathering stage of the PiloC end will piece the papa copies i Interested persons should provide with all information submitted dir scientific comments, analyses, studies, in writing to the DUS Submission) and other pertinent scientific Receipt of information will be information. The most useful acknowledged in the manna in whidi documents fa EPA are unpublished it is received, that is. in writing a studies a other primary technical electronically. sources that we may not otherwise Other aspects of the information obtain through open literature Marches. submittal process are unchanged arid Also note that if you have submitted are detailed In the 1993 FR Notice. Most certain information previously, such as importantly. Confidential Business in response to the 1993 FR Notice, then information (CBI) should not be there is no need to resubmit that submitted to the IRIS Submission Desk. information. Information from the CBI must be submitted to the ^ public is being solicited for 30 days via appropriate office via approved Agency this Notice. procedures for submission of CBI as- As described in the 1993 FR Notice, codified in the Code of Federal submissions will be handled in a three- Regulations (40 CFR, Part 2, Subpart B). Step process: If a submitter believes that a CBI 1. First, interested parties should submission *<" information with simply provide a list (submission implications fa DUS, it should be noted inventory), briefly identifying all the in the cover letter accompanying tbs information they wish to submit to the submission to the appropriate office;' DUS Information Submission Desk. The list should specify by name and CAS (Chemical Abstract Rsgfotnr) number the Pilot chemical substanGS*fo which the information pertains, state the assessment that is being addreeeed (e.g., Dated: March 27.1996. ' "' Rabat! I. Assistant Administratorfor Research and Development. (FR Doc 96-8007 Filed 4-1-96; 0:45 ami carcinogenicity), and describe briefly the information being submitted for consideration. Where possible, (FRL-64S1-6 documents should be listed in scientific citation format, that is, suthorfe), title, ' Agency Information CoBection journal, and date. A cover letter should Activttiee Under OMB Review state that the correspondence is an DUS Submission, describe in general terms the purpose of the submission, and include names, addresses, and AGENCY: Environmental Protection Agency (EPA). action: Notice. telephone numbers of persons to contact for additional information on the submission. 2. In the second step, EPA will compare the submission inventory to existing files and identify the information that should be submitted. This step will help prevent an influx of duplicative information. The submitter will receive notification requesting foil submission of the selected uiaterial. 3. In the third step, the submitter should promptly send in the information requested by EPA. Submittals should include a cover letter addressing all of the points in item 1 above. In addition, persons submitting SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq), this notice announces the Office of Management and Budget's (OMB) responses to Agency PRA clearance requests. An agency may not conduct a sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EP.Vs regulations are listed in 40 CFR Part 9 and 48 CFR Qiapter 15. FOR FURTHER MFORMATKM CONTACT: Sandy Farmer !202) 260-2740. Please refer `o the EPA ICR No. results of new health effects studies SUPPLEMENTARY INFORMATION: should include a specific explanation of how and why the study results could change the information in DUS. Submitters sending paper copies are OMB Responses to Agency PRA Clearance Requests OMB Approvals requested to send three copies, at least one of which should be unbound. As mentioned previously {see ADDRESSES), rhe \gency also welcomes electronic ?UDmntai n .nformation in response to bis Nonce. EPA will 'ransfer all EPA ICR No. 1560.04; National Water Quality Inventory Reports--Clean Water Act Sections 305(b), 303ld), 3141 ai and 106ie*: was approved 02/21,96 "MB No 2040--)07`. expires 02/28/99. EPA ICR No '.598.02: Report-.:^ md corrosDonuence received electronically Recordkeeping Requirements .r.i^r I SL 110314