Integrated Risk Information System (IRIS); 2003/2004 Program; Notice and Request for Scientific Information on Supplemental 2003 Program; Request for Chemical Substance Nominations for 2004 Program

AGENCY:

Environmental Protection Agency.

ACTION:

Notice; Announcement of supplement to the IRIS 2003 program and request for scientific information on health effects that may result from exposure to chemical substances; and request for chemical substance nominations for the IRIS 2004 program.

SUMMARY:

The Integrated Risk Information System (IRIS) is an Environmental Protection Agency (EPA) data base that contains the Agency's scientific consensus positions on human health effects that may result from exposure to chemical substances in the environment. On February 5, 2003, in a Federal Register (68 FR 5870), EPA announced the 2003 IRIS agenda and solicited scientific information from the public for consideration in assessing health effects from specific chemical substances. The notice also stated that later in 2003: (1) Additional assessments may be announced in the Federal Register; and (2) EPA would solicit public nominations for chemical substances for its 2004 agenda. Today, EPA is following up on these two actions.

DATES:

EPA invites the public to submit scientific information pertaining to the specific chemical substances listed in this notice, and/or nominations for substances to be considered for an assessment in 2004 in accordance with the instructions provided at the end of this notice by October 14, 2003.

ADDRESSES:

Please submit relevant scientific information to the IRIS Submission Desk in accordance with the address and instructions provided at the end of this notice. Similarly, chemical substance nominations should be submitted to the IRIS Submission Desk, or on-line, in accordance with the address and instructions provided at the end of this notice.

FOR FURTHER INFORMATION:

For information on the IRIS program, contact Amy Mills, Program Director, National Center for Environmental Assessment (mail code 8601D), Office of Research and Development, U.S. Environmental Protection Agency, Washington, DC 20460, or call (202) 564-3204, or send electronic mail inquiries to mills.amy@epa.gov. 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 hotline.iris@epa.gov.

SUPPLEMENTARY INFORMATION:

Background

IRIS is an EPA data base containing Agency consensus scientific positions on potential adverse human health effects that might result from exposure to chemical substances found in the environment. IRIS currently provides information on health effects associated with more than 500 chemical substances.

The data base includes 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. Combined with specific situational exposure assessment information, the information in IRIS may be used as a source in evaluating potential public health risks from environmental contaminants.

EPA's overall process for developing IRIS assessments consists of: (1) An annual Federal Register announcement of EPA's IRIS agenda and call for scientific information from the public on selected chemical substances; (2) a search of the current literature; (3) development of draft health assessments and 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.

The IRIS Annual Agenda

Each year, EPA develops a list of priority chemical substances and an annual agenda for the IRIS program. EPA uses four general criteria to set these priorities: (1) EPA statutory, regulatory, or program-specific implementation needs; (2) availability of new scientific information or methodology that might significantly change the current IRIS information; (3) interest to other levels of government or the public; and (4) availability of other scientific assessment documents such that only a modest additional effort would be needed to complete the review and documentation for IRIS. The decision to assess any given chemical substance hinges on available Agency resources. Timing of EPA's risk assessment guidance, guidelines, and science policy decisions may also play a role in deciding when the Agency has the appropriate methods to assess a chemical substance.

On February 5, 2003, EPA stated (68 FR 5870) that it might publish a supplement to its fiscal year 2003 agenda by identifying additional priority chemical substances selected for assessment. Accordingly, today's notice supplements the priority list published in the Federal Register on February 5, 2003, (68 FR 5870) by providing a list of additional health assessments beginning in fiscal year 2003 and instructions for submitting scientific information to EPA pertinent to the development of health assessments for these chemical substances. The February 5, 2003, notice also stated that EPA planned to publish a solicitation later in the year for public nomination of chemical substances to consider for assessment beginning in fiscal year 2004. Consequently, today's notice provides instructions for nominating additional chemical substances for EPA's consideration.

EPA continues to build and update the IRIS data base by addressing the foremost user needs, as expressed by EPA and the public. EPA will also work toward updating all assessments in the data base where new scientific information is available to do so.

Stakeholder Workshop on Priority-Setting Criteria

As announced in the February 5, 2003, Federal Register notice (68 FR 5870), EPA sponsored a stakeholder workshop on March 4, 2003, concerning priority-setting criteria that are used or should be used to select chemical substances for an IRIS assessment. Versar, Inc., an EPA contractor, convened and facilitated this workshop to obtain input and suggestions from a spectrum of IRIS users on the appropriateness of EPA's current priority-setting criteria, and whether other criteria such as public health impact or economic impact should be added. In general, the panel members agreed that IRIS is an important international scientific resource with a valuable core purpose of providing high-quality health assessments of chemical substances with potentially significant impacts on public health. While workshop panelists generally supported the current priority-setting criteria, they suggested that EPA evaluate whether public health concerns are sufficiently addressed by the current criterion for statutory, regulatory, and programmatic need. Panel members also discussed possible alternatives to the current priority-setting system. Some cautioned that the development of a more elaborate priority-setting system might make the process overly complex and burdensome to the Agency, leading to unnecessary delays.

In response to the panelists' suggestion, EPA reviewed previous chemical substance nominations to determine if public health concerns were implicitly covered by the statutory, regulatory, or programmatic needs driving the nominations. Public health impact is defined, for this purpose, as being associated with adverse human health effects and widespread exposure. EPA determined that most of the chemicals nominated in the annual priority-setting process have known or suspected toxicity and known or suspected widespread exposure. EPA concludes that public health concerns appear to be adequately subsumed in the current IRIS nomination process and that no specific additional public health criterion is needed at this time.

Many panel members also recommended that EPA focus its improvement efforts on making the IRIS priority setting process more transparent by including information concerning why each chemical substance was selected for an assessment. To that end, this notice adds transparency by listing supplemental fiscal year 2003 chemical substances with the corresponding rationale for each selection. With additional resources available to the IRIS program, EPA is also able to provide an open public chemical substance nomination process for 2004 to better respond to the broader IRIS user community. Additional information on the stakeholder workshop and EPA's position of how public health concerns are addressed in its current priority-setting criteria can be obtained by calling the IRIS Hotline (301) 345-2870, or by sending electronic mail inquiries to hotline.iris@epa.gov.

Submission of Scientific Information on Supplementary Assessments for Fiscal Year 2003

With the publication of this notice, EPA announces the start of assessments for the following chemical substances in 2003. At this time, the completion of these new assessments is expected between fiscal years 2004-2006. The listed substances are annotated with the basis for their selection.

Unless otherwise noted, EPA will assess noncancer and cancer endpoints for each substance. For all endpoints assessed, both qualitative and quantitative assessments will be developed if data is available.

Consistent with previous Federal Register notices announcing the annual IRIS agenda, EPA is soliciting public involvement in supplementary assessments announced in this notice. While EPA conducts a thorough literature search for each chemical substance, there may be unpublished studies or other primary technical sources that EPA might not otherwise obtain through open literature searches. We are requesting the submission of scientific information from the public during the information gathering stage for the supplementary “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, there is no need to resubmit that information. While EPA is primarily soliciting information on supplementary fiscal year 2003 assessments announced in this notice, the public may submit information on any chemical substance at any time.

Procedures for Submission of Scientific Information

Within 60 days of this notice, provide all information (studies, reports, articles, etc.) you wish to submit. Note that this process is streamlined from previous years in which you were asked to provide an initial submission inventory. Your submission should specify the chemical substance to which your information pertains, CASRN (Chemical Abstract Service Registry Number), and the topic or aspect of the assessment that is being addressed (e.g., carcinogenicity, mode of action). In addition, when you submit results of new health effects studies concerning existing substances on IRIS, you should include a specific explanation of how the study results could change the information in IRIS. All citations should be listed in scientific citation format, that is, author(s), title, journal, and date. Include names, addresses, and telephone numbers of person(s) to contact for additional information. Mail two copies, one of which should be unbound, to the IRIS Submission Desk, c/o ASRC, 6301 Ivy Lane, Suite 300, Greenbelt, MD 20770. Alternatively, you may submit the materials electronically to IRIS.desk@epa.gov. Electronic information must be submitted in WordPerfect format or as an ASCII file. Information also will be accepted on 3.5″ floppy disks or CD. 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 your 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).

Submission of Nominations for New Assessments for the Fiscal Year 2004 IRIS Program

Today's notice invites voluntary public nominations for chemical substances not already listed today or in the February 5, 2003, Federal Register notice (68 FR 5870). All nominations should identify the nominator and address the following questions for each chemical substance:

Identification of nominator:

Name

Title

Affiliation

Phone

Address

E-mail address

1. What is the chemical substance name, most common synonym (if applicable), and CAS number?

2. Is this assessment needed to fulfill a chemical-specific EPA mandate or program need (e.g., statutory, regulatory, or court-ordered deadline)? If so, what is the time frame?

3. Is this assessment a priority for stakeholders outside of EPA (e.g., states, tribes, local governments, environmental organizations, industries, other IRIS users)?

4. Are you aware if another assessment of this substance is available to EPA (e.g, an EPA program has assessed this substance but it has not received Agency-wide IRIS review, or another government organization has assessed this substance)?

5. For substances being nominated for IRIS reassessment, what, if any, significant new scientific data or new EPA risk assessment methodology is available that you believe would be likely to appreciably change the existing IRIS assessment?

6. Are there other factors that would make this substance a priority for IRIS assessment (e.g., widespread exposure, expected toxicity, potentially susceptible populations)?

Nominations are requested within 60 days of this notice, and may be submitted online at www.epa.gov/iris/whatsnew/2004nominations or by mail or electronic mail. Submissions by mail may be made to the IRIS Submission Desk, c/o ASRC, 6301 Ivy Lane, Suite 300, Greenbelt, MD 20770. Please send two copies, with one copy unbound. Alternatively, nominations may be sent electronically to IRIS.desk@epa.gov. Electronic information must be submitted in WordPerfect format or as an ASCII file. Information also will be accepted on 3.5″ floppy disks or CD. The IRIS Submission Desk will acknowledge receipt of your information.