[Federal Register Volume 66, Number 140 (Friday, July 20, 2001)]
[Notices]
[Pages 37958-37959]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-18198]


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ENVIRONMENTAL PROTECTION AGENCY

[FRL-7015-6]


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.

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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 [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.

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 (202) 564-
3204, or send electronic mail inquiries to [email protected].

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

[[Page 37959]]

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.
[FR Doc. 01-18198 Filed 7-19-01; 8:45 am]
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