Environmental Protection Agency.
Notice; announcement of the IRIS 2003 program and request for scientific information on health effects that may result from exposure to chemical substances; announcement of the stakeholder workshop on priority-setting criteria for the assessment of chemical substances.
IRIS is an Environmental Protection Agency (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 January 9, 2002, EPA announced the 2002 IRIS agenda and solicited scientific information from the public for consideration in assessing health effects from specific chemical substances. Most of the health assessments listed in the notice are in progress or near completion. Today, EPA is adding some additional health assessments to the IRIS agenda. This notice describes the Agency's plans and solicits scientific data and evaluations for consideration in EPA's new assessments. Additional new assessments may be announced in the Federal Register later this year. This notice also announces a stakeholder workshop on the criteria that EPA's IRIS program uses to establish annual priorities for assessing chemical substances and provides information for observer registration.
Please submit scientific information in response to this notice in the form of an initial “submission inventory” in accordance with the instructions in this notice by April 7, 2003.
The stakeholder workshop on criteria for establishing priorities for assessing chemical substances for IRIS will be held March 4, 2003. This notice includes instructions for observer registration.
A “submission inventory” should be sent to the IRIS Submission Desk in accordance with the instructions provided under “Submission of Information” in this notice.Start Further Info
FOR FURTHER INFORMATION CONTACT:
For information on the IRIS program, contact Amy Mills, Program Director, 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 firstname.lastname@example.org. For general questions about access to IRIS or the content of IRIS, please call the IRIS Hotline at (301) 345-2870 or send electronic mail inquiries to email@example.com.End Further Info End Preamble Start Supplemental Information
IRIS is an EPA data base containing Agency consensus scientific positions on potential adverse human health effects that may result from exposure to chemical substances found in the environment. IRIS currently provides information on health effects associated with chronic exposure to 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 noncancer 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 Start Printed Page 5871and supporting documents into the IRIS data base.
This notice provides: (1) A list of the IRIS assessments completed in FY 2002 and early FY 2003, (2) a list of the IRIS assessments in progress that the Agency expects to complete in FY 2003-2005, (3) an update on EPA's IRIS “needs assessment” report, (4) an announcement of a stakeholder workshop on EPA's criteria for selecting chemical substances for the annual agenda, (5) a list of the new assessments beginning in FY 2003, and (6) instructions to the public for submitting scientific information to EPA pertinent to the development of IRIS assessments.
Assessments Completed in FY 2002 and Early FY 2003
The following assessments were completed and entered into IRIS in FY 2002 and early FY 2003. These assessments were listed in the Federal Register of January 9, 2002 (67 FR 1212). All health endpoints were assessed. Where information was available, both qualitative and quantitative assessments were developed.
|Substance name||CAS No.|
|Chloroform (oral route)||67-66-3|
Assessments in Progress
The following assessments are underway or generally complete and are planned for entry into IRIS in FY 2003 or FY 2004. Those that are likely to be delayed to FY 2005 are indicated by an asterisk (*). All of the assessments below were listed in the January 9, 2002, Federal Register. All health endpoints, cancer and noncancer, are being assessed unless otherwise noted. For all endpoints assessed, both qualitative and quantitative assessments are being developed where information is available. Pesticides denoted with a double asterisk (**) are having only oral reference dose and carcinogenicity endpoints assessed.
Substances denoted with a triple asterisk (***) are being evaluated for effects from acute and/or subchronic exposure, in addition to chronic exposure. These substances are part of a pilot test to evaluate the application of methods, procedures, and resource needs for adding less-than-lifetime exposure duration information to IRIS. For some substances listed, the less-than-lifetime evaluation is being initiated in FY 2003, and may therefore be completed and made available on IRIS sometime after the chronic exposure evaluation.
|Substance name||CAS No.|
|Ammonium perchlorate (and other perchlorate salts)||7790-98-9|
|Antimony and compounds||7440-36-0|
|Chloroform (inhalation route)||67-66-3|
|Methyl ethyl ketone||78-93-3|
|Methyl isobutyl ketone (MIBK)||108-10-1|
|Methyl tert-butyl ether (MTBE)||1634-04-4|
|Naphthalene (cancer effects; inh. route)||91-20-3|
|Nickel (soluble salts)||[N.A.—various]|
|Perfluorooctanoic acid—ammonium salt||3825-26-1|
|Perfluorooctane sulfonate—potassium salt||2795-39-3|
|Polychlorinated biphenyls (PCBs-noncancer endpoints)||1336-36-3|
|Refractory ceramic fibers||[N.A.]|
|Zinc and compounds||7440-66-6|
IRIS summaries and support documents for all substances listed above will be provided on the IRIS Web site at http://www.epa.gov/iris as they are completed. This publicly available web site is EPA's primary location for IRIS documents. In addition, external peer review drafts of IRIS documents can be found during their peer review periods via the “What's New” page of the IRIS web site. Interested parties should check the “What's New” page frequently for the availability of these drafts.
IRIS “Needs Assessment”
On July 20, 2001, EPA published a Federal Register notice (66 FR 37958) requesting public input to compile a “needs assessment” for planning the IRIS program. This notice requested that the public identify those chemical substances for which assessments either need to be added to IRIS or updated. The responses were considered along with EPA program priorities in the development of new starts for the FY 2003 agenda below. The notice also requested input on whether other types of evaluations are needed on IRIS such as toxicological evaluations for health effects associated with less-than-lifetime (i.e., acute or subchronic) exposure durations. The notice also requested input on what priority any new type of evaluation should have compared to Start Printed Page 5872evaluation of health effects associated with chronic exposures. Further, the notice asked whether or how EPA should work with external parties such as other government agencies, industries, or other organizations to develop health assessments that may be used as supporting documents for IRIS. The final “IRIS Needs Assessment” report will be made available on the IRIS web site when it is completed.
Stakeholder Workshop on Priority-Setting Criteria
EPA will be sponsoring a stakeholder workshop on the priority-setting criteria for selecting chemical substances for IRIS assessment. The purpose of the workshop is to get input from individuals and organizations outside of EPA on the criteria EPA uses to determine the annual IRIS agenda. Invited participants will include individuals or organizations that have previously expressed interest in the IRIS agenda through the IRIS Needs Assessment, the IRIS Submission Desk, other correspondence, or related activities. The workshop will be held March 4, 2003, from 1-5 pm at the Crystal City Marriott Hotel, 1999 Jefferson Davis Highway, Arlington, VA 22202. Versar, Inc., an EPA contractor, will convene and facilitate the workshop. To register to attend the workshop as an observer, contact Ms. Traci Bludis, Versar, Inc.; telephone: (703) 750-3000, extension 449; facsimile: (703) 642-6954; or e-mail: firstname.lastname@example.org. Space for observers may be limited, therefore, registration will be accepted on a first-come, first-served basis.
Information Requested on New Assessments for FY 2003
EPA will continue building and updating the IRIS data base. The Agency recognizes that a number of the assessments on IRIS need updating to incorporate new scientific information and methodologies. Further, many additional substances are candidates to be added to the IRIS data base. 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 2003. The substances listed below are priorities for IRIS due to one or more reasons: (1) Agency statutory, regulatory, or program implementation needs; (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, including interest expressed via responses to 66 FR 37958; and (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. Additional criteria for prioritizing chemical substances are currently under consideration for developing future IRIS agendas.
EPA may add resources to the IRIS program this year, and if so, may publish a supplement to this FY 2003 agenda with additional priority substances selected for assessment. EPA also plans to publish a solicitation later in the year for public nominations for substances to consider for assessment beginning in FY 2004.
The following IRIS health assessments have recently begun or will be started in FY 2003, with completion expected in FY 2004 or FY 2005. It is for these substances that the Agency is primarily requesting information from the public for consideration in the assessments. Unless otherwise noted, noncancer and cancer endpoints will be assessed for each substance. For all endpoints assessed, both qualitative and quantitative assessments are being developed where information is available. Substances denoted with a double asterisk (**) are being evaluated for effects from acute and/or subchronic exposure, in addition to chronic exposure. These substances, along with those similarly indicated on the previous list of assessments in progress, are part of a pilot test to evaluate the application of methods, procedures, and resource needs for adding less-than-lifetime exposure duration information to IRIS.
|Substance name||CAS No.|
|Hexachlorocyclopentadiene*** (acute exposure only)||77-47-4|
|Polybrominated diphenyl ethers (PBDEs):|
|Decabromodiphenyl ether (deBDE)||1163-19-5|
|Hexabromodiphenyl ether (hxBDE)||36483-60-0|
|Pentabromodiphenyl ether (PeBDE)||32534-81-9|
|Tetrabromodiphenyl ether (TeBDE)||40088-47-9|
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 2003. While EPA conducts a thorough literature search for each chemical substance, there may be unpublished studies or other primary technical sources that we may not otherwise obtain through open literature searches. 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 analyses, studies, and other pertinent scientific information. Also note that if you have submitted certain information previously to the IRIS Submission Desk, then there is no need to resubmit that information. While EPA is primarily soliciting information on new assessments announced in this notice, the public may submit information on any chemical substance at any time. Start Printed Page 5873
Procedures for Submission
Similar to the process described in the January 9, 2002, Federal Register, 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 (studies, reports, 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 a brief description of information to be 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 person(s) to contact for additional information. Mail two copies of the submission inventory to the IRIS Submission Desk, c/o ASRC, 6301 Ivy Lane, Suite 300, Greenbelt, MD 20770.
Alternatively, you may submit the submission inventory and cover letter electronically to IRIS.email@example.com. Electronic information must be submitted in WordPerfect format or as an ASCII file. Information also will 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 of whether full submission of the information is requested.
3. Full Submission of Selected Material: In the third step, you should submit 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. Submissions 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 Item 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 material must be submitted to the appropriate EPA office via established procedures (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 Director (see FOR FURTHER INFORMATION CONTACT).Start Signature
Dated: January 30, 2003.
George W. Alapas,
Acting Director, National Center for Environmental Assessment.
[FR Doc. 03-2768 Filed 2-4-03; 8:45 am]
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