[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.comments@epamail.epa.gov. 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 mills.amy@epamail.epa.gov.
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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