[Federal Register Volume 65, Number 8 (Wednesday, January 12, 2000)] [Notices] [Pages 1863-1865] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 00-732] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY [FRL-6422-4] Integrated Risk Information System (IRIS); Announcement of 2000 Program; Request for Information AGENCY: Environmental Protection Agency. ACTION: Notice; Announcement of IRIS 2000 Program and request for scientific information on health effects that may result from chronic exposure to chemical substances. ----------------------------------------------------------------------- SUMMARY: The Integrated Risk Information System (IRIS) is an EPA data base that contains EPA scientific consensus positions on human health effects that may result from chronic exposure to chemical substances in the environment. On December 10, 1998, EPA announced the 1999 IRIS agenda and solicited scientific information from the public for consideration in assessing health effects from specific chemical substances (63 FR 68285). Most of the assessments listed are 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. This Notice also discusses public availability of draft assessments, and cooperation between EPA and external parties on assessment development. DATES: Please submit information in response to this Notice by March 13, 2000. ADDRESSES: Please send relevant scientific information to the IRIS Submission Desk in accordance with the instructions provided under ``Submission of Information'' in this Notice. Note the new address for the IRIS Submission Desk. 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, Washington, DC 20460, or call (202) 564-3204, or send electronic mail inquiries to [email protected]. For general questions about access to IRIS, or the content of IRIS, 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 chemical substances found in the environment. 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's process for developing IRIS 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 1999 and Early FY 2000 The following assessments were completed and entered into IRIS in FY 1999 and early FY 2000. These assessments were announced in the Federal Register notice of December 10, 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. ------------------------------------------------------------------------ Acetonitrile.............................................. 75-05-8 Benzene (inhalation carcinogenicity)...................... 71-43-2 Ethylene glycol monobutyl ether........................... 111-76-2 ------------------------------------------------------------------------ Assessments in Progress--Completion Planned for FY 2000 or FY 2001 The following assessments are underway or generally complete, and are planned for entry into IRIS in FY 2000 or FY 2001. These assessments were announced in the December 10, 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. ------------------------------------------------------------------------ Acetaldehyde.............................................. 75-07-0 Acetone................................................... 67-64-1 Ammonium perchlorate (and associated salts)............... 7790-98-9 Benzene (oral carcinogenicity and non-cancer endpoints)... 71-43-2 Benzo[a]pyrene............................................ 50-32-8 Boron..................................................... 7440-42-8 Bromate................................................... 7758-01-2 1,3-Butadiene............................................. 106-99-0 Cadmium................................................... 7440-43-9 Chloral hydrate........................................... 75-87-6 Chlorine dioxide.......................................... 10049-04-4 Chlorite (sodium salts)................................... 7758-19-2 Chloroethane.............................................. 75-00-3 Chloroform................................................ 67-66-3 Chloroprene............................................... 126-99-8 Copper.................................................... 7440-50-8 Cyclohexane............................................... 110-82-7 Dichloroacetic acid....................................... 79-43-6 1,3-Dichloropropene....................................... 542-75-6 Di(2-ethylhexyl)phthalate................................. 117-81-7 Diflubenzuron............................................. 35367-38-5 Diesel emissions.......................................... [N.A.] Ethylbenzene.............................................. 100-41-4 Ethylene oxide............................................ 75-21-8 Formaldehyde.............................................. 50-00-0 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 [[Page 1864]] Nickel (soluble salts).................................... [N.A.] Nitrobenzene.............................................. 98-95-3 Pendimethalin............................................. 40487-42-1 Phenol.................................................... 108-95-2 Quinoline................................................. 91-22-5 Pentachlorophenol......................................... 87-86-5 Polychlorinated biphenyls (PCBs) (noncancer endpoints).... 1336-36-3 Silica (crystalline)...................................... 14808-60-7 Styrene................................................... 100-42-5 Tetrachloroethylene (``perc'')............................ 127-18-4 Tetrahydrofuran........................................... 109-99-9 Toxaphene................................................. 8001-35-2 Trichlopyr................................................ 55335-06-3 Trichloroethylene......................................... 79-01-6 Uranium (natural)*........................................ 7440-61-1 Vinyl acetate............................................. 108-05-4 Vinyl chloride............................................ 75-01-4 Xylenes................................................... 1330-20-7 Zinc and compounds........................................ 7440-66-6 ------------------------------------------------------------------------ * FY 2001--2002 completion. 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. In addition to the assessment of the individual polynuclear aromatic hydrocarbon (PAH) benzo[a]pyrene, EPA also initiated in FY 1999 a literature review on the health effects of a larger set of PAHs. Additional health assessments on this class of chemicals will be considered for initiation in FY 2001. The reassessment of Lindane [CAS No. 58-89-9] discussed in the previous Federal Register notice has been deleted from the IRIS agenda for this year due to delays in a cancer study anticipated for use in the reassessment. Public Availability of Draft IRIS Assessments In response to public interest, and in an effort to provide greater transparency of the IRIS program, EPA has decided to make draft assessments widely available for public viewing. Concurrent with each external peer review period, EPA will post draft IRIS assessments on the Internet for public information. Although EPA is not required to invite comments on draft IRIS assessments or respond to individual comments received, EPA will consider any scientific views pertaining to the assessment submitted by the general public during each external peer review period. EPA will then summarize and address any major scientific issues received from the public and external peer reviewers in an appendix to the final IRIS Toxicological Review or other EPA support document for the final assessment. External peer review draft documents will be available from the ``What's New'' page of the IRIS web site at www.epa.gov/iris, along with EPA's charge to the external peer reviewers, and information on where the public may submit any scientific views for EPA's consideration. Interested parties should check the ``What's New'' page frequently for the availability of these drafts. Information Requested on New Assessments for FY 2000 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 2000. 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 2000, with completion expected between FY 2001 and FY 2002. 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. ------------------------------------------------------------------------ Name CAS No. ------------------------------------------------------------------------ Acrolein.................................................. 107-02-8 Antimony and compounds.................................... 7440-36-0 Arsenic, inorganic........................................ 7440-38-2 Bisphenol-A............................................... 80-05-7 Carbon tetrachloride...................................... 56-23-5 Chlorothalonil............................................ 1897-45-6 1,2-Dichlorobenzene....................................... 95-50-1 1,3-Dichlorobenzene....................................... 541-73-1 1,4-Dichlorobenzene....................................... 106-46-7 1,1-Dichloroethylene...................................... 75-35-4 Ethylene dibromide........................................ 106-93-4 Ethylene dichloride....................................... 107-06-2 Glyphosate................................................ 1071-83-6 Hydrogen sulfide.......................................... 7783-06-4 Methyl mercury (noncancer endpts.)........................ 22967-92-6 Methylene chloride........................................ 75-09-2 Mirex..................................................... 2385-85-5 Pebulate.................................................. 1114-71-2 Phosgene.................................................. 75-44-5 Refractory ceramic fibers................................. [N.A.] 2,3,7,8-TCDD (dioxin)..................................... 1746-01-6 ------------------------------------------------------------------------ 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 As in previous Federal Register notices announcing the annual IRIS agenda, EPA is soliciting public involvement in new assessments starting in FY 2000. 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. Procedures for Submission Similar to the process described in the December 10, 1998, Federal Register notice, submissions will be handled in a three-step process: 1. Submission Inventory: First, you should simply provide a list within 60 days of this Notice briefly identifying all the information (reports, papers, articles, etc.) you wish to submit. The list should specify by name and CASRN (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 to be submitted for consideration. Where possible, documents should be listed in [[Page 1865]] 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. Mail two copies of the submission to the IRIS Submission Desk, c/o Courtney R. Johnson, National Center for Environmental Assessment (8601D), U.S. Environmental Protection Agency, Washington, DC 20460. Note that the address for the IRIS Submission Desk has changed. 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. EPA Replies to Submission Inventory: 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. Full Submission of Selected Material: In the third step, you should send in the information indicated by EPA within 30 days of EPA's reply. Prompt response to EPA will ensure that your material can be considered in the assessment in a timely fashion. 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 two copies, at least one of which should be unbound, to the IRIS Submission Desk, as described in Step 1. 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 (see FOR FURTHER INFORMATION). Assessment Development Input from External Parties In addition to the opportunity for public input via the IRIS Submission Desk described above, EPA is testing ways to involve the public in the development of health assessment documents which are submitted to EPA by external parties as supporting documents for IRIS. Considerable expertise in assessing health risks exists outside of EPA, such as in other government agencies, industries, universities, professional organizations, and other non-governmental organizations. Cooperation between EPA and external parties in the assessment development process can improve the quality of IRIS supporting documents. EPA can provide scientific dialogue and feedback during the development of external parties' assessments. For several assessments in progress now, specifically for the chemical substances Ethylene oxide, Styrene, and Toxaphene, external parties are developing assessment documents with dialogue and feedback from EPA. EPA will then consider these documents, in whole or in part, as possible sources or supporting documents for IRIS assessments. Over the coming year, EPA will evaluate its experience with these three externally-generated assessments in terms of process efficiency and quality of the documents produced. If the experience is positive, EPA will invite similar involvement on future health assessments in the IRIS program. Dated: January 5, 2000. William H. Farland, Director, National Center for Environmental Assessment. [FR Doc. 00-732 Filed 1-11-00; 8:45 am] BILLING CODE 6560-50-P