[Federal Register Volume 63, Number 1 (Friday, January 2, 1998)] [Notices] [Pages 75-77] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 97-34198] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY [FRL-5945-3] Integrated Risk Information System (IRIS); Announcement of 1998 Program; Request for Information AGENCY: U.S. Environmental Protection Agency. ACTION: Notice; Announcement of IRIS 1998 Program and request for scientific information on chronic health effects of chemical substances. ----------------------------------------------------------------------- SUMMARY: The Integrated Risk Information System (IRIS) 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 April 2, 1996 EPA announced the IRIS Pilot Program and solicited scientific information from the public for consideration in assessing the chronic health effects of eleven chemical substances. (See FR Vol. 61 No. 64 p. 14570.) The Pilot program is near completion, and the Agency is preparing a new set of chemical health assessments for IRIS. The purpose of this notice is to communicate to the public the Agency's plans, and solicit scientific data and evaluations for consideration in EPA's new assessments. DATES: Please submit information in response to this notice by March 3, 1998. 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 CONTACT: For information on the IRIS program, contact Amy Mills, National Center for Environmental Assessment (mail code 8623), U.S. Environmental Protection Agency, 401 M St. SW, Washington, DC 20460, or call (202) 260-0569, 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. For scientific issues contact Terry Harvey, National Center for Environmental Assessment, 26 Martin Luther King Drive, Cincinnati, OH 45268, or call (513) 569-7531, or send electronic mail inquiries to [email protected]. 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 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 Pilot Program As a consequence of analyzing the IRIS program and considering suggestions received about IRIS through 1995, the Agency tested some improvements through a Pilot Program. The Pilot focused on improving the scientific consensus and review process that precedes IRIS data base entries. EPA developed (or updated, for existing entries) non- cancer and cancer information for eleven Pilot substances. The Pilot process consisted of, (1) a call for technical information on the eleven substances from the public via a FR Notice, April 2, 1996, (2) a search of the current literature, (3) development of health assessments and draft IRIS summaries, (3) internal peer review (i.e., within EPA), (4) external peer review (i.e., outside EPA), (5) Agency consensus review and management approval within EPA, (6) preparation of final IRIS summaries and supporting documents, and (7) entry of summaries into the IRIS data base. The last stage is currently underway for most of the Pilot substances. EPA's evaluation of the Pilot provided the basis for designing the operation of the future IRIS program. For example, the Agency standardized (1) the solicitation of scientific information from the public via a FR notice, (2) the use of the ``Toxicological Review'' as a preferred support document for IRIS entries which combines cancer and noncancer assessments, and (3) the use of rigorous external peer review procedures for IRIS summaries and Toxicological Reviews. The final Agency consensus review process, while still being tested, is replacing the former ``CRAVE'' and ``RfD/RfC Work Groups''. The following substances were reviewed under the Pilot Program: ------------------------------------------------------------------------ Name CAS. No. ------------------------------------------------------------------------ Arsenic.................................................... 7440-38-2 Bentazon................................................... 25057-89-0 Beryllium.................................................. 7440-41-7 Chlordane.................................................. 12789-03-6 Chromium: Cr (III)................................................. 16065-83-1 Cr (VI).................................................. 18540-29-9 Total Cr................................................. 7440-47-3 Cumene..................................................... 98-82-8 Methyl methacrylate........................................ 80-62-6 Diphenylmethane diisocyanate............................... 101-68-8 Naphthalene................................................ 91-20-3 Tributyltin oxide.......................................... 56-35-9 [[Page 76]] Vinyl chloride............................................. 75-01-4 ------------------------------------------------------------------------ A cancer assessment for polychlorinated biphenyls (PCBs) and an oral noncancer assessment for trinitrobenzene were also added to IRIS during the Pilot period. The IRIS summaries and support documents for the substances listed above are now provided on the IRIS web site at www.epa.gov/iris, or will be provided shortly. This publicly-available web site will be the primary location for all new IRIS summaries and Toxicological Reviews. New Starts and Completions for FY 1998 EPA will continue building and updating the IRIS data base utilizing the experiences gained from the IRIS Pilot. 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, a list of priority substances was developed internally by EPA for attention in FY 1998. The following lists 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. Unless otherwise noted, noncancer and cancer endpoints will be assessed for each substance. Assessments in Progress--Completion Planned for FY 1998 In addition to completing the remaining Pilot assessments, the following assessments are underway or generally complete, and are planned for update on IRIS in FY 1998: ------------------------------------------------------------------------ Name CAS No. ------------------------------------------------------------------------ Acetonitrile............................................... 75-05-8 Barium..................................................... 7440-39-3 Benzene.................................................... 71-43-2 1,3-Butadiene.............................................. 106-99-0 Cadmium.................................................... 7440-43-9 Chloroethane............................................... 75-00-3 Diesel emissions........................................... [N.A.] Ethylene glycol butyl ether................................ 111-76-2 ------------------------------------------------------------------------ Information requested on new assessments The following IRIS health assessments have recently begun or will be started in FY 1998, with completion expected between late FY 1998 and early FY 2000. It is for these substances that the Agency is primarily requesting information from the public for consideration in the assessment. ------------------------------------------------------------------------ Name CAS No. ------------------------------------------------------------------------ Boron...................................................... 7440-42-8 Bromate.................................................... 7758-01-2 Chloral hydrate............................................ 75-87-6 Chloroform................................................. 67-66-3 Dichloroacetic acid........................................ 79-43-6 1,3-Dichloropropene........................................ 542-75-6 Formaldehyde............................................... 50-00-0 Lindane.................................................... 58-89-9 Nitrobenzene............................................... 98-95-3 Pentachlorophenol.......................................... 87-86-5 Polychlorinated biphenyls (PCBs)--[noncancer endpoints].... 1336-36-3 Styrene.................................................... 100-42-5 Tetrachloroethylene........................................ 127-18-4 Tetrahydrofuran............................................ 109-99-9 Toxaphene.................................................. 8001-35-2 Trichloroethylene.......................................... 79-01-6 Vinyl acetate.............................................. 108-05-4 ------------------------------------------------------------------------ Check the IRIS web site at www.epa.gov/iris for any additions to the above list during the course of FY 1998. Follow-up 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 (See FR Vol. 61 no. 64 p. 32799, June 25, 1996). Submission of Information The IRIS program is providing an opportunity for public involvement on new assessments starting in FY 1998. While the Agency conducts a thorough literature search for each chemical substance, there may be other articles or unpublished studies we are not aware of. The Agency 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 FR Notice for the IRIS Pilot, submissions will be handled in a three-step process: 1. First, interested parties should simply provide a list (submission inventory), briefly identifying all the information they wish to submit to the IRIS Submission Desk. The list should specify by name and CAS (Chemical Abstract 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. 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. Three copies of the submittal should be mailed to the IRIS Submission Desk, NCEA (MS-105), U.S. Environmental Protection Agency, 26 Martin Luther King Drive, Cincinnati, OH 45268. The submission inventory and cover letter may instead be submitted 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. The submitter will receive notification requesting full submission of the selected material. 3. In the third step, the submitter must send in the information requested by EPA within 30 days to ensure its consideration in the assessment. 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 concerning existing substances on IRIS should include a specific explanation of how and why the study results could change the information in IRIS. [[Page 77]] Submitters are requested to send three copies, at least one of which should be unbound. The submittal should be mailed to the IRIS Submission Desk, NCEA (MS-105), U.S. Environmental Protection Agency, 26 Martin Luther King Drive, Cincinnati, OH 45268. Receipt of information will be acknowledged by the IRIS Submission Desk. Confidential Business Information (CBI) should not be submitted to the IRIS Submission Desk. CBI must be submitted to the appropriate EPA 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 letter accompanying the submission to the appropriate office. Submitters may also request to augment their submission with a scientific briefing to EPA staff. Such requests should be made directly to Amy Mills, acting IRIS Assessment Manager (see Addressees). Dated: December 24, 1997. William H. Farland, Director, National Center for Environmental Assessment. [FR Doc. 97-34198 Filed 12-31-97; 8:45 am] BILLING CODE 6560-50-P