[Federal Register Volume 61, Number 64 (Tuesday, April 2, 1996)]
[Notices]
[Pages 14570-14571]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8007]



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ENVIRONMENTAL PROTECTION AGENCY
[FRL-5452-2]


Integrated Risk Information System (IRIS); Announcement of Pilot 
Program; Request for Information

AGENCY: U.S. Environmental Protection Agency.

ACTION: Notice; Announcement of IRIS Pilot Program and request for 
technical information on Pilot chemical substances.

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SUMMARY: The Integrated Risk Information System (IRIS) is a data base 
of the United States Environmental Protection Agency (EPA) that 
contains EPA scientific consensus positions on potential human health 
effects from environmental contaminants. On February 25, 1993 (58 FR 
11490) EPA requested public comment to improve IRIS and make it more 
useful. In that notice, EPA also described efforts in the Agency to 
identify issues in the development and presentation of information in 
the data base. Many of the issues concern the way consensus health 
information is developed prior to entry into the data base. As a 
consequence of analyzing the IRIS program and considering suggestions 
received about IRIS over the past several years, EPA has initiated a 
Pilot Program to improve the consensus health information process and 
strengthen peer review. The Pilot will produce new or updated health 
assessments and IRIS entries for eleven priority environmental chemical 
substances utilizing this new process. The purpose of this Notice is to 
advise the public that the Pilot is underway, and to request technical 
information from the public on the eleven Pilot substances.

DATES: Please submit information in response to this Notice by May 2, 
1996.

ADDRESSES: Please mail information (three copies, at least one of which 
should be unbound) to the IRIS Submission Desk, NCEA (MS-190), U.S. 
Environmental Protection Agency, 26 Martin Luther King Drive, 
Cincinnati, OH 45268. Information may instead be submitted 
electronically by sending electronic mail (e-mail) to: 
IRIS.[email protected]. Electronic information must be submitted 
as an ASCII file avoiding the use of special characters and any form of 
encryption. Information will also be accepted on disks in WordPerfect 
5.1 format or ASCII file format. All information in electronic form 
must be identified as IRIS Submission.

FOR FURTHER INFORMATION: For information on the Pilot, contact Amy 
Mills, National Center for Environmental Assessment (mail code 8623), 
U.S. Environmental Protection Agency, 401 M St., SW., Washington, DC 
20460. The public information phone line for the Pilot is (202) 260-
8930, or email inquiries may be addressed to [email protected].

SUPPLEMENTARY INFORMATION:

Background

    The Integrated Risk Information System (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 environmental contaminants. 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.
    As the data base has expanded and its use has increased over the 
last decade, issues have surfaced with regard to entering new 
information in a timely manner, while soliciting information from a 
broad spectrum of outside scientists and the public. In 1993, an EPA 
team evaluated the status of IRIS and proposed options for improvement. 
This effort was announced in a Notice in the Federal Register of 
February 25, 1993 (58 FR 11490). The Notice addressed the use of IRIS, 
and avenues for public involvement and external scientific peer review 
of IRIS summaries and supporting documents. Public involvement means 
opportunities for affected or interested parties to have some level of 
input into IRIS health hazard information, such as providing relevant 
health data. Public involvement can involve a broader spectrum of 
participants than external peer review, which refers to a critical 
scientific appraisal by experts outside of EPA.
    The Agency and the public have continued to express support for 
maintaining IRIS and strengthening the process for developing consensus 
health information, public involvement, and peer review. This support 
has given rise to the new Pilot Program.

The Pilot Program

    As a consequence of analyzing the IRIS program and considering 
suggestions received about IRIS over the past several years, the Agency 
has decided to test some improvements through a Pilot Program. The 
Pilot will primarily address the scientific consensus and review 
process that precedes IRIS data base entries. EPA will develop (or 
update, for existing entries) all non-cancer and cancer information for 
the eleven Pilot substances. The Pilot process will consist of, (1) A 
call for technical information on the eleven substances from the public 
via this FR Notice, (2) a search of the current literature, (3) 
development of health assessments and draft IRIS summaries, (3) 
internal peer review (i.e., within EPA), (4) external peer review 
(outside EPA), (5) consensus review and management

[[Page 14571]]
approval within EPA, (6) preparation of final IRIS summaries and 
supporting documents, and (7) entry of summaries into the IRIS data 
base.
    The appropriate level of external peer review will be determined 
for each chemical substance. Depending upon the complexity of the 
scientific information and other factors, the form of the peer review 
will either be via mail, forums of experts, or formal federal advisory 
committees.
    The Pilot will also test some improvements in IRIS entries to more 
fully characterize health information associated with each chemical. 
For example, the IRIS summaries will provide greater elaboration of 
uncertainties in the data, and our confidence in the assessment.

Pilot Substances

    The eleven Pilot chemical substances were chosen on the basis of 
the Agency's need for new or updated hazard or dose-response 
information, and in an effort to represent a range of technical 
complexity so the new process is realistically tested. Qualitative and 
quantitative information will be developed for non-cancer and cancer 
effects of all Pilot substances. In some cases, the assessment will be 
developed for the first time; in others, the assessment will be 
reviewed in light of new information and updated in IRIS if 
appropriate.
    The following substances will be reviewed under the Pilot Program:

Name/CAS.No.

     Arsenic--7440-38-2
     Bentazon--25057-89-0
     Beryllium--7440-41-7
     Chlordane--57-74-9
     Chromium (III)--16065-83-1
      Chromium (VI)--18540-29-9
      Total chromium--7440-47-3
     Cumene--98-82-8
     Methyl methacrylate--80-62-6
     Methylene diphenyl isocyanate--101-68-8
     Naphthalene--91-20-3
     Tributyltin oxide--56-35-9
     Vinyl chloride--75-01-4
    Note that EPA may initiate other chemical substance reviews during 
the Pilot period; the Pilot does not preclude additional work on IRIS.

Submittal of Information

    The Pilot Program is designed to provide early opportunity for 
public involvement. While the Agency conducts a thorough literature 
search for each chemical substance, there may be other articles or 
unpublished studies we are not aware of. The Agency would greatly 
appreciate receiving scientific information from the public during the 
information gathering stage of the Pilot. 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, such as in response 
to the 1993 FR Notice, then there is no need to resubmit that 
information. Information from the public is being solicited for 30 days 
via this Notice.
    As described in the 1993 FR Notice, submissions will be handled in 
a three-step process:
    1. First, interested parties should simply provide a list 
(submission inventory), briefly identifying all the information they 
wish to submit to the IRIS Information Submission Desk. The list should 
specify by name and CAS (Chemical Abstract Registry) number the Pilot 
chemical substance(s) to which the information pertains, state the 
assessment that is being addressed (e.g., carcinogenicity), and 
describe briefly the information being submitted for consideration. 
Where possible, documents should be listed in scientific citation 
format, that is, author(s), title, journal, and date. A 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 on the submission.
    2. 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. The 
submitter will receive notification requesting full submission of the 
selected material.
    3. In the third step, the submitter should promptly send in the 
information requested by EPA. Submittals should include a cover letter 
addressing all of the points in item 1 above. In addition, persons 
submitting results of new health effects studies should include a 
specific explanation of how and why the study results could change the 
information in IRIS.
    Submitters sending paper copies are requested to send three copies, 
at least one of which should be unbound. As mentioned previously (see 
Addresses), the Agency also welcomes electronic submittal of 
information in response to this Notice. EPA will transfer all 
correspondence received electronically into printed, paper form as it 
is received and will place the paper copies along with all information 
submitted directly in writing to the IRIS Submission Desk. Receipt of 
information will be acknowledged in the manner in which it is received, 
that is, in writing or electronically.
    Other aspects of the information submittal process are unchanged 
and are detailed in the 1993 FR Notice. Most importantly, Confidential 
Business Information (CBI) should not be submitted to the IRIS 
Submission Desk. CBI must be submitted to the appropriate office via 
approved Agency procedures for submission of CBI as codified in the 
Code of Federal Regulations (40 CFR, Part 2, Subpart B). If a submitter 
believes that a CBI submission contains information with implications 
for IRIS, it should be noted in the cover letter accompanying the 
submission to the appropriate office.

    Dated: March 27, 1996.
Robert J. Huggett,
Assistant Administrator for Research and Development.
[FR Doc. 96-8007 Filed 4-1-96; 8:45 am]
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