Document 3NMVqzkw4QnoL2bdLXzpV21oE

PATTON BOGGS, L.L.P. 2550 M STREET, N.W. WASHINGTON, D.C. 20037-1350 (202) 457-6000 Facsimile. (202) 457-6315 WRITER'S DIRECT DIAL April 4, 1996 (202) 457-5270 MEMORANDUM FOR VINYL CHLORIDE PANEL Re: IRIS Update Attached is an EPA notice announcing the initiation of a Pilot Program to develop new or updated health assessments and entries in the Integrated Risk Information System (IRIS) for 11 chemicals. As previously indicated, one of these substances is vinyl chloride. The notice provides a three-step process for the submission of information on these substances, including new health effects studies and other information that would change the information currently on IRIS. After the information is submitted, the Pilot Program calls for both internal and external peer review followed by the preparation of final health effects summaries for the IRIS data base. When it submits relevant information on vinyl chloride, the Vinyl Chloride Panel may wish to comment as to the appropriate level of external peer review needed for vinyl chloride. The deadline for submission of information in response to the notice is May 2, 1996. Attachment CMA115842 14570 Fufanl Ragfeter / Vol. 81. Ha 04 / Tuesday, April requirements; train pmaud to be able to respond to a ooUeotkia of Information; search data aourcar, 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. health information is developed prior to entry into the data base. As a consequence ofanatyzfng the IRIS program and considering suggestions received about IRIS over the past several years, EPA has initiated a Pilot Program to improve the concensus health information process and strengthen peer review. The Pilot will produce new or updated heelth assessments and IRIS Estimated Total Annual Hour Burden: entries for eleven priority 11,420 hours. Estimated Total Annualized Cost environmental chemical substances utilizing this new process. The purpose Burden: $347,739. of this Notice is to advise the public that Send comments on the Agency's need the Pilot is underway, and to request for this information, the accuracy of the technical information from the public provided burden estimates, and any Suggested methods of minltniring respondent burden, including through the use at automated collection techniquee to the following addressee. Please refer to EPA ICR No. 0664 and QMB Control No. 2060-0006 in any correspondence. Ms. Sandy Fanner, U.S. Environmental Protection Agency, OPPE Regulatory Information Division (2137), 401 M on the eleven Pilot substances. OATES: Pleese submit information in response to this Notice by May 2,1996. ADDRESSES: Please mail information (throe copies, at least one of which should be unbound) to the IRIS Submission Desk, NCEA (MS-190), U.S Environmental Protection Agency, 26 Martin Luther King Drive, Cincinnati, OH 45268. Information may instead be submitted electronically by sending Street SW, Washington, DC 20460 and Office of Information and Regulatory Affairs, Office of Management and Budget Attention; Desk Officer for EPAt725 17th Street, NW, Washington, DC 10503. electronic mail (e-mail) to: IRIS.commentsCepamaiLepa.gov. Electronic information must be submitted as an ASCII file avoiding the use of special character* and any farm of encryption. Information will also be accepted an disks in WordPerfect 5.1 Dated: March 29.1996. Joeaphlrtw. Director, Regulatory Information Division. (FR Doc. 96--7^74 Filed 4-1-96; 8:45 ami format or ASCII file format All information in electronic form must be identified as IRIS Submission. FOR FURTHER MFORMATX3N: For information on the Pilot, contact Amy Miffs, National Center for JFW.-64S2-2] <, v Environmental Assessment (mail code 8623), U.S, Environmental Protection Integrated Risk Infonnatton System ORIS); Announcement of PUot Program; Request for Information Agency, 401M St, SW., Washington, DC 20460. The public information phone line for the Pilot is (202) 260 -8930, or email inquiries may be AGENCY: U.S. Environmental Protection addressed to Agency. mills.amyffiepamaiLepa.gov. ACTION; Notice; Announcement of IRIS Pilot Program and request for technical information on Pilot chemical substances. SUMMARY: The Integrated Risk Information System (IRIS) is a data base of the United States Environmental Protecticm 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 SUPPLEMENTARY INFORMATION: 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 horn chronic (or lifetime) exposure to environmental contaminants. IRIS currently provides heelth effects information on over 500 specific chemical substances. IRIS contains chemical-specific IRIS and make it more useful. In that summaries of qualitative and notice. EPA also described efforts in the quantitative health information in Agency to identify .ssues in the development and presentation of support of the first two steps of the risk assessment process, i.e.. hazard information in the data base. Many of identification and dose-response the issues concern the way consensus evaluation. IRIS information includes the reference doee for aon-cancsr health effects resulting from oral exposure, ihe refseiiccoQCCDtnttcfcvnoncencer health effects rosuMngfrom Inhalation exposure, and the carcinogen . assessment for both oral and inhalation exposure. Combined with specific situational exposure assessment information, the summary health hazard information in DUS may be used as a source in evaluating potential public health risks from environmental contaminants. As the 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 brand spectrum of outside scientists mid the public. In 1993, an EPA tmw evaluated the status of DUS and proposed options for improvement This effort was announced in a Notice in the Federal Register of February 25, 1993 (58 FR 11490). The Notice addressed the use of DUS, and avenues for public involvement and external scientific peer review of DUS 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 to express support for maintaining IRIS and strengthening the process far developing consensus health information, public involvement, and peer review. This support has given rise to the new Pilot Program. '# % '1 | < Q , The Pilot Prograaa As a consequence of analyzing the DUS program and considering suggestions received about DUS over the past several yean, the Agency has decided to test some improvements through a Pilot Program. The Pilot will primarily address the scientific consensus and review process that precedes DUS data base entries. EPA will develop (or update, for existing entries) all non-cancer and cancer information for the eleven Pilot substances. The PUot process will Consist ot (1) A call for technical information on the eleven substances from the public via this FR Notice. (2) a search of the current literature, (3) development of health assessments and draft DUS summaries, (3) internal peer review (La., within EPA).'41 external 'Ji*4. peer review (outside EPAi, i5j consensus review and management CMA115843 / Vol. 61. $to. 04 / Tuewlay, April 2, 2996 / Notices 1 approval within SPA, (6) preparation of final HUS summaries and supporting documents, and (7) entry of summaries into the HUS data base- The appropriate level of external peer review will be determined for each chemical substance. Depending upon the complexity of the scientific information and other factors, die form of the peer review will either be vie mail, forums of experts, or formal federal advisory committees. The Pilot will also teat some improvements in IRIS entries to more fully characterize health information associated with each chemical. For example, the IRIS summaries will provide greeter elaboration of. uncertainties in the data, and our confidence in the assessment Pilot Substances The eleven Pilot chemical substances were chosen on the basis 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-cencer and cancer effects of all Pilot substances, hi some 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: NimCAS.No, Arsenic--7440-38-2 Bentazon--25057-89-0 Beryllium--7440 41-7 Chlordane--57-74-9 Chromium (IQ)--16065-85-1 Chromium (VI)--18540-29-9 Total chromium--7440-47-3 Cumene--98-82-8 Methyl methacrylate--80-62-6 Methylene 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 DUS. Submittal of Information The Pilot Program is designed to provide early 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 greatly appreciate receiving scientific Information bom tha public during the informationgathering stage of the Pilot Interested persons should provide scientific comments, analyses, studies, and other pertinent scientific information. The moat useful documents for EPA are unpublished studies or other primary technical sources that we may not otherwise obtain through open literature searches. Also note that if you have submitted certain information previously, such as in response to the 1993 FR Notice, then there is no need to resubmit that information. Information bom the public is being solicited for 30 days via this Notice. As described in the 1993 FR Notice, submissions will be handled in a three- step process; 1. First, interested parties should simply provide a list (submisscm inventory], briefly identifying all the information they wish to submit to the IRIS Information Submission Desk. The list should specify by name and CAS (Chemical Abstract Reghtey) number the Pilot chemical substatG^Se which the information pertains, the assessment that is being addressed (e.g., carcinogenicity), and describe briefly the information being submitted for consideration. When possible, documents should be listed in scientific citation format, that is, authors), title, journal, and date. A cover letter should state that the correspondence is an IRIS Submission, describe in general terms the purpose of the submission, and include names, addresses, and 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 full submission of the selected material. 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 results of new health effects studies should include a specific explanation of how and why the study results could change the information in IRIS. Submitters sending paper copies are requested to send three copies, at least one of which should be unbound. As mentioned previously (see ADOAESSES), the Agency also welcomes electronic submittal of information in response to Jus Notice. EPA will transfer all correspondence received electronically intoprinted, paperfonn as it is j and wlUpfoce^Tpqw cop* with all Information submitted in writingto the IRIS Submission j Receipt ofinformation will be acknowledged in the manner in which it is received, that is. in writing or electronically. Other aspects of the information submittal process are unchanged and are detailed in the 1993 FR Notice. Most importantly. Confidential Business Information (CBI) should not be submitted to the IRK Submission Desk. CBI must be submitted to the appropriate office via approved Agamy procedures for submission of CBI sscodified in the Code of Federal Regulations (40 CFR, Part 2, Subpart B). If a submitter believes that a CBI submission rrmtaine information with implications far IRIS, it should be noted in the cover letter accompanying the submission to the appropriate office;' Dated; March 27,1996. Kebert J. HnggMt, Assistant Administratorfar Research and Development. |FR Doc- 96-8007 Filed 4-1-96; 8:45 am) (FRL-6451-6 Agency Information Collection Activities Under OMB Review AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: in compliance with die Paperwork Reduction Act (44 U.S.C. 3501 et seqX this notice announces tfae Office of Management and Budget's . (OMB) responses to Agency PRA clearance requests. An agency may udt conduct or 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 EPA s regulations are Usted in 40 CFR Fin 9 and 48 CFR Chapter 15. FOR FURTHER MFORMATON CONTACT: Sandy Farmer (202) 260-2740. Please refer to the EPA ICR No. SUPPLEMENTARY INFORMATION: OMB Responses to Agency PRA Clearance Requests OMB Approvals EPA ICR No. 1560.04; National Water Quality Inventory Reports--Clean Water Act Sections 305(b), 303(d). 3l4tal and 106(e); was approved 02/21.96. 'MB No. 2040-0071. expires 02/2B/99. EPA ICR No. 1698.02; Reporting ind Recordkeeping Requirements Vnder CMA 115844