[Federal Register Volume 63, Number 237 (Thursday, December 10, 1998)] [Notices] [Pages 68285-68287] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 98-32892] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY [FRL-6200-3] Integrated Risk Information System (IRIS); Announcement of 1999 Program; Request for Information AGENCY: Environmental Protection Agency. ACTION: Notice; Announcement of IRIS 1999 Program and request for scientific information on chronic health effects of chemical substances. ----------------------------------------------------------------------- SUMMARY: The Integrated Risk Information System (IRIS) is an EPA data base that contains EPA scientific consensus positions on potential human health effects from environmental contaminants. On January 2, 1998 EPA announced the 1998 IRIS agenda and solicited scientific information from the public for consideration in assessing the chronic health effects of a list of chemical substances (63 FR 75). Most of the assessments listed are complete or near completion, and EPA is preparing a new set of chemical health assessments for IRIS. This Notice describes the Agency's plans, and solicits scientific data and evaluations for consideration in EPA's new assessments. DATES: Please submit information in response to this Notice by February 12, 1999. [[Page 68286]] ADDRESSES: Please send relevant scientific information to the IRIS Submission Desk in accordance with the instructions provided under ``Submission of Information'' in this Notice. FOR FURTHER INFORMATION: For information on the IRIS program, contact Amy Mills, National Center for Environmental Assessment (mail code 8601D), U.S. Environmental Protection Agency, 401 M St. SW, Washington, DC 20460, or call (202) 564-3204, or send electronic mail inquiries to [email protected]. For general questions about access to IRIS, the content of IRIS, or how to submit information in response to this Notice, please call the Risk Information Hotline at (513) 569-7254. SUPPLEMENTARY INFORMATION: Background 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 two steps of the risk assessment process, i.e., hazard identification and dose- 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. The IRIS Program EPA completed the IRIS Pilot Program, which focused on improving the scientific consensus and review process that precedes IRIS data base entries. A set of chemical assessments were developed (or updated, for existing entries) for IRIS utilizing the pilot process. This process has been adopted for the post-Pilot program and consists of, (1) an annual Federal Register announcement of EPA's IRIS agenda and call for scientific information from the public on the selected chemical substances, (2) a search of the current literature, (3) development of health assessments and draft IRIS summaries, (4) peer review within EPA, (5) peer review outside EPA, (6) EPA consensus review and management approval, (7) preparation of final IRIS summaries and supporting documents, and (8) entry of summaries and supporting documents into the IRIS data base. Assessments Completed in FY 1998 The following assessments were completed and entered into IRIS in FY 1998 and early FY 1999. These assessments were announced in the Federal Register notice of January 2, 1998. All health endpoints, cancer and non-cancer, were assessed unless otherwise noted. Where information was available, oral reference doses, inhalation reference concentrations, and cancer unit risks and slope factors were developed. ------------------------------------------------------------------------ Name CAS No. ------------------------------------------------------------------------ Arsenic [text added in carcinogenicity 7440-38-2 section]. Barium................................... 7440-39-3 Bentazon................................. 25057-89-0 Benzene [inhalation cancer assessment]... 71-43-2 Beryllium................................ 7440-41-7 Chlordane................................ 12789-03-6 Chromium (III ).......................... 16065-83-1 Chromium (VI)............................ 18540-29-9 Methyl methacrylate...................... 80-62-6 Methylene diphenyl diisocyanate.......... 101-68-8 Naphthalene.............................. 91-20-3 ------------------------------------------------------------------------ Assessments in Progress--Completion Planned for FY 1999 or FY 2000 The following assessments are underway or generally complete, and are planned for entry into IRIS in FY 1999 or FY 2000. These assessments were announced in the January 2, 1998 Federal Register notice. All health endpoints, cancer and non-cancer, are being assessed unless otherwise noted. Where information is available, oral reference doses, inhalation reference concentrations, cancer unit risks and slope factors are being developed. ------------------------------------------------------------------------ Name CAS No. ------------------------------------------------------------------------ Acetonitrile............................. 75-05-8 Benzene [non-cancer; oral cancer 71-43-2 endpoints]. Boron.................................... 7440-42-8 Bromate.................................. 7758-01-2 1,3-Butadiene............................ 106-99-0 Cadmium.................................. 7440-43-9 Chloral hydrate.......................... 75-87-6 Chloroethane............................. 75-00-3 Chloroform............................... 67-66-3 Dichloroacetic acid...................... 79-43-6 1,3-Dichloropropene...................... 542-75-6 Diesel emissions......................... [N.A.] Ethylene glycol butyl ether.............. 111-76-2 Formaldehyde............................. 50-00-0 Nitrobenzene............................. 98-95-3 Pentachlorophenol........................ 87-86-5 Polychlorinated biphenyls (PCBs)-- 1336-36-3 [noncancer endpoints]. Styrene.................................. 100-42-5 Tetrachloroethylene [``perc'']........... 127-18-4 Tetrahydrofuran.......................... 109-99-9 Toxaphene................................ 8001-35-2 Trichloroethylene........................ 79-01-6 Vinyl acetate............................ 108-05-4 Vinyl chloride........................... 75-01-4 ------------------------------------------------------------------------ The reassessment of Lindane [CAS No. 58-89-9 ] announced in the January 2, 1998 Federal Register notice has been postponed to begin in FY 2000 pending results from an ongoing cancer study. The IRIS summaries and support documents for the substances listed above will be provided on the IRIS web site at www.epa.gov/iris. This publicly-available web site is EPA's primary location for IRIS documents. Information Requested on New Assessments for FY 1999 EPA will continue building and updating the IRIS data base. The Agency recognizes that many of the assessments on IRIS need updating to incorporate new scientific information and methodologies. Further, many additional substances are candidates for adding to IRIS. However, due to limited resources in the Agency to address the spectrum of needs, EPA developed a list of priority substances for attention beginning in FY 1999. The following list of substances are priorities for IRIS due to one or more of the following reasons: (1) Agency statutory, regulatory, or program implementation need; (2) new scientific information or methodology is available that might significantly change current IRIS information, (3) interest to other levels of government or the public, (4) most of the scientific assessment work has been completed while meeting other Agency requirements, and only a modest additional effort will be needed to complete the review and documentation for IRIS. The following IRIS health assessments have recently begun or will be started in FY 1999, with completion expected between FY 2000 and FY 2001. It is for these substances that the Agency is primarily requesting information from the public for consideration in the assessment. Unless otherwise noted, noncancer and cancer endpoints will be assessed for each substance. Where information is available, oral reference doses, inhalation reference concentrations, and cancer unit risks and slope factors will be developed. [[Page 68287]] ------------------------------------------------------------------------ Name CAS No. ------------------------------------------------------------------------ Acetaldehyde............................. 75-07-0 Acetone.................................. 67-64-1 Ammonium perchlorate [and associated 7790-98-9 salts]. Benzo[a]pyrene........................... 50-32-8 Chlorine dioxide......................... 10049-04-4 Chlorite (sodium salts).................. 7758-19-2 Chloroprene.............................. 126-99-8 Copper................................... 7440-50-8 Cyclohexane.............................. 110-82-7 Di(2-ethylhexyl)phthalate................ 117-81-7 Diflubenzuron............................ 35367-38-5 Ethylbenzene............................. 100-41-4 Ethylene oxide........................... 75-21-8 Hexachlorocyclopentadiene................ 77-47-4 Isopropanol.............................. 67-63-0 Methyl chloride.......................... 74-87-3 Methyl isobutyl ketone (MIBK)............ 108-10-1 Methyl tert-butyl ether (MTBE)........... 1634-04-4 Nickel (various)......................... 7440-02-0 Pendimethalin............................ 40487-42-1 Phenol................................... 108-95-2 Quinoline................................ 91-22-5 Silica (quartz).......................... 14808-60-7 Trichlopyr............................... 55335-06-3 Uranium (natural)........................ 7440-61-1 Xylenes.................................. 1330-20-7 Zinc and compounds....................... 7440-66-6 ------------------------------------------------------------------------ In addition to Benzo[a]pyrene, EPA will also be initiating in FY 1999 a literature review on health effects of other polynuclear aromatic hydrocarbons (PAHs). EPA welcomes scientific information from the public on health effects of PAHs. Additional health assessments on this class of chemicals will commence in FY 2000. Follow-up annual Federal Register notices will address new starts for subsequent fiscal years. In the future, these notices will include chemical substances selected for assessment or reassessment under EPA's new guidelines for carcinogen risk assessment that are also planned for inclusion in IRIS (64 FR 32799, June 25, 1996). Submission of Information The IRIS program is providing an opportunity for public involvement on new assessments starting in FY 1999. While EPA conducts a thorough literature search for each chemical substance, there may be other articles or unpublished studies we are not aware of. We would greatly appreciate receiving scientific information from the public during the information gathering stage for the list of ``new assessments'' listed above. 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 then there is no need to resubmit that information. Information from the public is being solicited for 60 days via this notice. Similar to the process described in the January 2, 1998 Federal Register notice, submissions will be handled in a three-step process: 1. First, you should simply provide a list (submission inventory), briefly identifying all the information you wish to submit to the IRIS Submission Desk. The list should specify by name and CAS (Chemical Abstract Service) registry number the chemical substance(s) to which the information pertains, state the type of 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, author(s), title, journal, and date. Your 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. Mail three copies of the submittal to the IRIS Submission Desk, NCEA (MS-105), U.S. Environmental Protection Agency, 26 Martin Luther King Drive, Cincinnati, OH 45268. Alternatively, you may submit the submission inventory and cover letter electronically to IRIS.[email protected]. Electronic information must be submitted in WordPerfect or as an ASCII file. Information will also be accepted on 3.5'' floppy disks. All information in electronic form must be identified as an IRIS 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. You will receive notification requesting full submission of the selected material. 3. In the third step, you should send in the information requested by EPA within 30 days to ensure that EPA can consider it in the assessment. Submittals should include a cover letter addressing all of the points in item 1 above. In addition, when you submit results of new health effects studies concerning existing substances on IRIS, you should include a specific explanation of how and why the study results could change the information in IRIS. Please send three copies, at least one of which should be unbound, to the IRIS Submission Desk, NCEA (MS-105), U.S. Environmental Protection Agency, 26 Martin Luther King Drive, Cincinnati, OH 45268. The IRIS Submission Desk will acknowledge receipt of your information. Confidential Business Information (CBI) should not be submitted to the IRIS Submission Desk. CBI must be submitted to the appropriate EPA Office via established procedures for submission of CBI (see 40 CFR, Part 2, Subpart B). If you believe that a CBI submission contains information with implications for IRIS, please note that in the cover letter accompanying the submission to the appropriate office. You may also request to augment your submission with a scientific briefing to EPA staff. Such requests should be made directly to Amy Mills, IRIS Program Manager (Addressees). Dated: December 3, 1998. William H. Farland, Director, National Center for Environmental Assessment. [FR Doc. 98-32892 Filed 12-9-98; 8:45 am] BILLING CODE 6560-50-P