01-18198. Integrated Risk Information System (IRIS); Notice; Request for Information

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice; request for information on needs for health assessments on EPA's Integrated Risk Information System.

SUMMARY:

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 February 22, 2001, EPA announced the 2001 IRIS agenda and solicited scientific information from the public for consideration in assessing health effects from specific chemical substances. Today, EPA is requesting information from the public to define needs for new and revised health assessments on IRIS in 2002-2005.

DATES:

Information should be submitted by September 18, 2001.

ADDRESSES:

Please send information in response to this notice to the IRIS Submission Desk, c/o Courtney R. Johnson, National Center for Environmental Assessment (8601D), U.S. Environmental Protection Agency, Washington, DC 20460. Alternatively, you may submit your response electronically to [e-mail]. 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.

FOR FURTHER INFORMATION CONTACT:

For general information on the IRIS program, contact Amy Mills, National Center for Environmental Assessment (Mail Code 8601D), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460, or call [phone], or send electronic mail inquiries to [e-mail].

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 substance-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 summary health hazard information in IRIS may be used as a source in evaluating potential public health risks from environmental contaminants.

History of the IRIS Program

EPA began the IRIS program in 1985 to build consensus opinions across the Agency on the potential health effects of chemical substances of concern to Program Offices and Regional Offices. The IRIS program has continually provided toxicity values and carcinogenicity assessments for the hazard and dose-response components of risk assessment. IRIS information has been used by Agency regulatory offices and in site-specific risk assessments. States and other organizations have also chosen to adopt IRIS information in their risk-based decision-making.

In response to public interest in access to IRIS, EPA released IRIS to the public in 1988(53 FR 20162). In 1993, EPA requested public comment on peer review procedures for IRIS health assessments and on public involvement in IRIS assessment development and review (58 FR 11490). In 1995, EPA initiated the IRIS Pilot, whereby various improvements were tested including procedures for peer review, public involvement, and consensus review. Many of these procedures were then adopted for the permanent IRIS program (61 FR 14570). In 1996, EPA provided access to IRIS on EPA's Internet site, enabling easier access for the Agency and the public. In 1997, EPA made the Internet site the official repository for IRIS.

Between 1998 and 2001, EPA has implemented numerous improvements identified in the IRIS Pilot, including publishing an annual Federal Register document announcing the IRIS agenda for the year, and requesting scientific information from the public to consider in new assessments. During this period, EPA also initiated evaluations or re-evaluations of over 100 chemicals for the IRIS program. As the use and demand for the IRIS data base continues to grow, EPA plans to continue updating older assessments and adding new ones.

Process for Building and Updating IRIS

EPA will continue building and updating the IRIS data base in 2002. The Agency recognizes that many of the assessments on IRIS may need updating to incorporate new scientific information and methodologies. Further, many additional substances may be candidates for adding to IRIS. However, due to limited resources in the Agency to address the spectrum of needs, EPA develops an annual list of priority substances for assessment development. Substances are chosen for 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; 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. The annual agenda is then refined based on available staff and other resources to carry out the assessments.

Purpose of the Needs Assessment

EPA is responding to the U.S. Senate request that EPA solicit public input in defining needs for new and updated specific chemical substances on the IRIS data base. Senate Report 106-410 specifically states,

The committee requests that EPA conduct needs assessments with public input to determine the need for increasing [this] annual rate of updates to existing IRIS files during 2002-2005, as well as the need to add new IRIS files for chemicals not now included.

Information submitted in response to this Federal Register document will be used to help plan the IRIS agenda for 2002-2005. Specifically, the Agency is seeking information addressing the following questions:

1. How do you/your organization use IRIS? What actions or decisions are based on information in IRIS?

2. What additional chemical substance assessments do you need on IRIS? For each, why is this assessment needed?

3. For existing chemical substance assessments on IRIS, which do you think are in greatest need of scientific update? What is the basis for identifying these assessments for update (e.g., newer study available, newer methodology to apply)?

4. What additional types of substance-specific Agency consensus information would you like to have on IRIS? For example, EPA is considering adding consensus health assessments for exposures of less than chronic duration, such as acute and possibly other subchronic exposures. Would these new types of information be of value to you? If so, how important would this information be to you in comparison to having updated information on chronic health effects?

5. EPA is currently testing collaborative efforts with external parties on the development of assessments for IRIS (66 FR 11165). The purpose is to involve the scientific knowledge and capability of organizations outside of EPA to improve the quality of IRIS supporting documents. External parties may include other government agencies, industries, universities, professional organizations, and other non-governmental organizations. EPA will evaluate the efficiency of the process and quality of documents produced to determine if the collaborative program should be expanded. Do you favor EPA's collaboration with external parties as a means of developing assessments for IRIS? If so, how could this collaboration be conducted?

EPA will compile the information received from the public in response to this notice along with internal EPA assessments of need, and develop a summary document that will be available for viewing on the IRIS web site. EPA expects to complete the summary document in December 2001.

Dated: July 10, 2001.

George W. Alapas,

Acting Director, National Center for Environmental Assessment.