Document X79komMQp60OdLYN1o1e7Jv44

LMr^i Chemical Manufacturers Association May 2,1996 Ms. Joan Dollarhyde Integrated Risk Information System (IRIS) Submission Desk NCEA (MS-190) U.S. Environmental Protection Agency (EPA) 26 Martin Luther King Drive Cincinnati, OH 45268 Dear Ms. Dollarhyde: In accordance with the Federal Register notice of Tuesday, April 4, 1996, this is to inform you of our intent to submit information about Vinyl Chloride (CAS. NO. 75-01-4) for the IRIS Pilot Project. The purpose of our submission is to identify cancer and non-cancer risk assessment materials which may not be readily accessible to EPA's internal and external peer review groups. Specifically, we intend to submit information on the following: Reitz, R.H.,et al, "Predicting Cancer Risk from Vinyl Chloride Exposure with a Physiologically Based harmacokinetic Model." Toxicology and Applied Pharmacology 137, 253-267 (1996) Clewell, H.J., et al, "Considering Pharmacokinetic and Mechanistic Information in Cancer Risk Assessments for Environmental Contaminants: Examples with Vinyl Chloride and Trichloroethylene." In Press. a In addition, through a Memorandum of Understanding with the Agency for Toxic Substances and Disease Registry , CMA is conducting a combined inhalation two-generation reproductive and developmental toxidty study of Vinyl Chloride in rats. The results of this study also will be made available to EPA for the IRIS Pilot Project. CMA's interest in the IRIS Pilot Project represents the concern of its Vinyl Chloride Health Committee which is composed of representatives from all U.S. manufacturers of Vinyl Chloride. The Committee also will be gathering information on Vinyl Chloride in the near future which may not be easily accessible to EPA. We believe that the organization of this material is of key importance to a comprehensive characterization of Vinyl Chloride risk assessment. We look forward to working with EPA on this issue. Any questions about this material should be referred to me at 703/741-5639. Sincerely, .' '/L-i, 'z <' - - Robert A. Venezia, Dr.P.H. Manager, CHEMSTAR CMA 115681 1300 Wilson Boulevard, Arlington, VA 22209 Telephone 703-741-5000 Fax 703-741-6000 14570 Federal Register / Vol. 61. No. B4 / Tuesday, April X. 1996 / Notices requirements; train personnel to be able to respond to a collection of information; 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: $347,739, Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods of minimising respondent burden, including through the use of 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 Retxer. Director, Regulatory Information Division. IFR Doc. 96--"874 Filed 4-1-96; 8:45 ami kum coot use-ao-M [FRL-5452-ZJ Integrated Risk Information System (IRIS); Announcement of Pilot Program; Request 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 fIRlS) 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 nonce SPA uso described efforts in the Ageacv ;o idenufv ssues ,n the development met aresentation of information .n the data base. Manv of the issues concern the wav consensus health information is 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 Notice is to advise the public that the Pilot is underway, and to request technical information hum the public on the eleven Pilot substances. DATES: Please submit information in response to this Notice by May 2, 1996. ADDRESSES: Please mail information (three 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 electronic mail (e-mail) to: QUS.comments@epamail.epa.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 on disks in WordPerfect 5.1 format or ASCQ file format. All information in electronic form must be identified as IRIS Submission. FOR FURTHER INFORMATION: For information on the Pilot, contact Amy Mills, National Center for Environmental Assessment (mail code 8623), U.S. Environmental Protection Agency, 401 M SL, SW., Washington, DC 20460. The public information phone line for the Pilot is (202) 2608930, or email inquiries may be addressed to mills.amy@epamaii.epa.gov. SUPPLEMENTARY INFORMATION: Background The Integrated Risk Information System iLRIS) 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 it fie first -wo steps of fie risk issessment process . a., nazard identification ma nose-response evaluation IRIS information includes the reference dose for non-cancer health effects resulting from oral exposure, the reference concentration for non-cancer health effects resulting from 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 IRIS 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 hroad spectrum of outside scientists and the public In 1993, an EPA learn evaluated the status of IRIS 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 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 IRIS 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 ind fie public lave ^ contmued 'o express support for maintaining IRIS and strengthening fie process for developing consensus health information, public involvement, and peer review. This support has given rise to the new Pilot Program. The Pilot Program As a consequence of analyzing the IRIS program and considering suggestions received about IRIS over the past several years, the Agency has decided to test some improvements through a Pilot Program. The Pilot will primarily address the scientific consensus and review process fiat precedes IRIS lata base entries. EPA wiii develop or update, for existing entries) all non-cancer and cancer information for fie eleven Pilot substances. The 3ilot process will consist of. (1) A call for technical information on fie eleven substances from the public via this FR Notice. (2) a search of the current literature. (3) development of health assessments and draft JUS summaries. ;3) menial Deer -ev'ew witfiin EPA . 4, external Deer review outside EPA,, :5| consensus review and management CMA115682 1 Federal Rag/ Vol. 61, No. 64 / Tuesday, April 2. 1996 / Notices approval within EPA, (6) preparation of final IRIS summaries and supporting documents, and (7) entry of summaries into the IRIS 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, the form of the peer review will either be via mail, forums of experts, or formal federal advisory committees. The Pilot will also test some improvements in IRIS entries to more fully characterize health information associated with each chemical. For example, the IRIS summaries will provide greater elaboration ofuncertainties 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-cancer and cancer effects of all Pilot substances. In 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: NanMvCAS.No. Arsenic--7440-38-2 Bentazon--25057-89-0 Beryllium--7440--41-7 Chlordane--57-74-9 Chromium (ID)--16065-83-1 Chromium (VI)--18540-29-9 Total chromium--7440--47-3 Cumene--98-82-8 Methyl methacrylate--BO-62-6 Methvlene diphenyl isocyanate-- 101-68-8' Naphthalene--.91-20-3 Tnbutvltin oxide--56-35-9 Vinyl chlor.de--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 early opportunity for public involvement. While the Agency conducts a thorough literature search for each 'hemicai substance, there mav be other articles or unpubhsned studies we are not aware of. The Agency wouid greatly appreciate receiving scientific information from the public during the information gathering stage of the Pilot. Interested persons should provide scientific comments, analyses, studies, and other pertinent scientific information. The most 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 from the public is being solicited for 30 days via this Notice. As described in the 1993 FR Notice, submissions will be handled in a 'hreestep process: 1. Frst. interested parties should simply provide a list (submission 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 Registry) number the Pilot chemical substanC^ t> which the information pertains, state the assessment that is being addressed (e.g., carcinogenicity), and describe briefly the information being submitted for consideration. Where 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 uiatenal. 3. In the third step, the submitter should promptly send in the information requested by EPA. Submittals should include a cover letter addressing ail 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 ADDRESSES), 'he \gencv nso welcomes electronic momittai it .nlormation n response to his Nonce EPA will Tnnster ail corresoonuence received electronically into printed, paper form aa it it rebribed and will place the paper copies wSl. with all information submitted directly in writing to the IRIS Submission QMl Receipt of Information will be acknowiedged 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 IRIS Submission Desk. CBI must be submitted to the appropriate office via approved Agency procedures for submission of CBI as codified in the Code of Federal Regulations (40 CFR, Part 2. Subpart B). If a submitter believes that a CBI submission contains information with implications for IRIS, it should be noted in the cover Utter accompanying the submission to the appropriate office. Dated: March Z7, 1996. Robert J. Huggett, Assistant Administratorfor Research and Development. [FR Doc. 96-8007 Filed 4-1-96; 8:45 am) mujno coot taao-so-e [FRL-S451-6 Agency information Collection Activities Under OMB Review AGENCY: Environmental _tection Agency EPA). ACTION: Notice. Summary: In compliance with the Paperwork Reduction Act (44 II 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 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 EP Cs regulations are listed in 40 CFR Fan 9 and 48 CFR Chapter 15. FOR FURTHER INFORMATION CONTACT: Sandy Farmer '202) 260-2740. Please refer -o the EP \ ICR No. SUPPLEMENTARY INFORMATION: CMB Responses to Agency PRA Clearance Requests OMB Approvals EPA ICR No. 1560.04: National Water Quality Inventory Reports--Clean Water Ac: Sections 305(b), 303ldl. i'4U, and !06ie!. was lporoved 02.21 96 .ViB No 2040--* >07* expires 02; 28. EPA '.CR No '.698 J2. Repi n. ind Recordkeeping Requirements ''r J CMA 115683 Fwtoll Ragkir I Vol- 61. No. 64 / Tuesday, April 2, 1996 / Notices approval within O'A, (6) preparation of final IRIS summaries and supporting documents, and (7) entry of summaries Into the IRIS data base. The appropriate level of external pear review will be determined to each chemical substance. Depending upon the complexity of the scientific information and other factors, the form of the peer review will either be via mail, forums of experts, or formal federal advisory committees. The Pilot will also test some improvements in IRIS entries to more fully characterize health information associated with each chemical. For example, the IRIS summaries will provide greater elaboration ofuncertainties 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-cancer and cancer effects of all Pilot substances. In 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; NameA2AS.No. Arsenic--7440-38-2 Bentazon--25057-89-0 Beryllium--7440-41-7 Chiordane--57-74-9 Chromium (III)--16065-83-1 Chromium (VI)--18540-29-9 Total chromium--7440-47-3 Cumene--98-82-8 Methyl methacrylate--80-62-8 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 IRIS. 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 may be other articles or unpublished studies we are ooi aware or. The Agency would greatly appreciate receiving scientific information from the public during the information gathering stage of the Pilot. Interested persons should provide scientific comments, analyses, studies, and other pertinent scientific information. The most 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 from the public is being solicited for 30 days via this Notice. As described in the 1993 FR Notice, submissions will be handled in a threeStep process: 1. First, interested parties should simply provide a list (submission inventory), briefly identifying all the information they wish to submit to the IRIS Information Submission Desk. The list should specify by nttu and CAS (Chemical Abstract Registry) number the Pilot chemical substancj*te which the information pertains, state the assessment that is being addressed (e.g., carcinogenicity), and describe briefly the information being submitted for consideration. Where possible, documents should be listed in Kientific citation format that is, authorfs). 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 foil 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 sdaressing ail 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 ADDRESSES), the Agency also welcomes electronic tuomittai of niormation m response to his Notice. EPA will transfer ail corresoonuence received electronically Into printed, paper form an it is i and will place the paper copies i with all information submitted i in writing to the DUS Submission] Receipt of information 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 IRIS Submission Desk. CBI must be submitted to the - appropriate office vis approved Agency procedures for submission of CBI as- codified in the Code of Federal Regulations (40 CFR, Part 2, Subpart B). If a submitter believes that a CBI submission TM*im information with implications for DUS. it should be noted in the cover letter accompanying the'' submission to the appropriate office:" Dated: March 27,1996. Robert J. Huggett, Assistant Administratorfor Research and Development. (FR Doc 96--8007 Filed 4-1-96; 8:45 am) SJJNQ COOS I [FRL-6451-6 Agency information Collection Activities Under OMB Review AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. summary: In compliance with the Paperwork Reduction Act (44 U S.C. 3501 et seqX this notice announces the Office of Management and Budget's (OMB) responses to Agency PRA clearance requests. An agency may not 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 EP As regulations are listed in 40 CFR Pirt 9 and 48 CFR Chapter 15. FOR FURTHER INFORMATION CONTACT: Sandy Farmer 1202) 260-2740, Please refer *o 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). 3".4iaj and I06ie); was approved 02/21,96 OMB No 2040--007'. -expires 02/28/99 EPA ;CR No. '.698.02; Repomr.g tnd Recordkeeping Requirements . r.uer [j < 1 I 1 F 1 1 , ; CMA115684 14570 Federal Rggfotar / Vol. 61. No. 64 / Tuesday, April t, 1996 / Notices requirement!; train personnel to bo ablo to respond to a collection of Information; 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 minimising respondent burden, including through the use of automated collection techniques to the following addresses. 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 Street. SW. Washington, DC 20460 and Office of Information and Regulatory Affairs, Office of Management and Budget, Attention; Desk Officer for EPA. 72S 17th Street, NW, Washington. DC 10503. Dated: March 29. 1996. Joeeph Ketxer, Director, Regulatory information Division. [FR Doc. 96--'87S Filed 4-1-96; 8:45 *m| LUNQ [FRL-64S2-Z] Integrated Risk Information System (IRIS); Announcement of Pilot Program; Request for Information AGENCY: U.S. Environmental Protaction Agency. ACTION: Notice: Announcement of IRIS Pilot Program and request for technical information on Pilot chemical substances. SUMMARY: The Integrated Risk Information System fIRlS) 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 US and make it more useful. In that nonce EPA aiso described efforts in the Agencv to !denurv .ssues n the deveiooment ind presentation of information m '.be data base. Many of the issues concern me wav consensus health information ia developed prior to entry into the date base. As a consequence of analyzing the DUS 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 Notice is to advise the public that the Pilot is underway, and to request technical information from the public on the eleven Pilot substances. OATES: Please submit information in response to this Notice by May 2.1996. AOORE33ES: Please mail information (three copies, at least one of which should be unbound) to the DUS Submission Desk. NCSA (MS-190). U.S. Environmental Protection Agency, 26 Martin Luther King Drive, Cincinnati, OH 45268. Information may inat--H be submitted electronically by sending electronic mail (e-mail) to: IRIS.cominentsOepamaU.epa.gov. Electronic information must be submitted as an ASGD file avoiding the use of special characters and any form of encryption. Information will also be accepted on disks in WordPerfect 5.1 format or ASCII file format All information in electronic form must be identified as DUS Submission. FOR FURTHER INFORMATION: For information on the Pilot, contact Amy Mills, National Canter for. - . Environmental Assessment'("mil, code 8623), U.S. Environmental Protection ' Agency, 401 M SL, SW.. Washington, DC 20460. The public information phone line for the Pilot is (202) 2608930, or email inquiries may be addressed to mills.amydspamail.epa.gov. SUPPLEMENTARY MFORMATION: 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. US contains chemical-specific summaries of qualitative and quantitative health information in support of *be first wo steps of the risk assessment orocess. ,.e.. lazard identification tna cose-response evaluation. IRIS mformation includes the reference doee for non-cancer health effects resulting from oral exposure, the reference concentration for non-cancer health effects resulting from itTMiartTM exposure, and the carcinogen assessment for both oral and inhalation exposure. Combined with specific situational exposure assessment information, the summary health hazard information in IRIS may be used aa a source in evaluating potential public health risks from environmental 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 broad spectrum of outside scientists and the public. In 1993, an EPA team 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 IRIS, and avenues for public involvement and external scientific peer review of IRIS summaries and supporting documents. Public involvement means opportunities tor affected or interested parties to have some level of input into IRIS 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 IRIS and strengthening the process for developing consensus health information, public involvement, and peer review. This support has given rise to the new Pilot Program. The Pilot Program As a consequence of enalyzing the IRIS program and considering suggestions received about IRIS over the past several years, 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 IRIS aata base entries. EPA will develop 'or update, for existing entries) all non-cancer and cancer information for the eleven Pilot substances. The ailot process will consist of. (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 LRIS summar.es. (3) .atemal peer rev-ew ;i.e.. within EPAi. 4: eternal Deer review outside EPAi. 13i consensus review and management CMA 115685