[Federal Register: August 13, 2003 (Volume 68, Number 156)]
[Notices]
[Page 48359-48362]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13au03-77]
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ENVIRONMENTAL PROTECTION AGENCY
[FRL-7543-3]
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.
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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
[[Page 48360]]
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
[[Page 48361]]
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.
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Reason(s) for
Chemical CAS No. assessment/
reassessment
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Acrylonitrile...................... 107-13-1 Need for CAA hazardous
air pollutant and
residual risk
programs.
New scientific
information is
available.
Public interest.
Beryllium (cancer update).......... 7440-41-7 New scientific
information is
available.
n-Hexane........................... 110-54-3 CERCLA need--Regional
EPA interest.
New scientific
information is
available.
Relevant assessment
document is
available.
Methylene chloride (Dichloro-...... 75-09-2 RCRA hazard
methane)........................... identification and
corrective action.
New scientific
information is
available.
Public interest.
Relevant assessment
document is
available.
Trichloroacetic acid............... 76-03-9 SDWA need--Stage 2
disinfection
byproduct regulation.
Relevant assessment
document is
available.
1,2,3-Trichloropropane............. 96-18-4 CERCLA need--Regional
EPA interest.
New scientific
information is
available.
Relevant assessment
document is
available.
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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:
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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)?
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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.
Dated: August 8, 2003.
Peter W. Preuss,
Director, National Center for Environmental Assessment.
[FR Doc. 03-20528 Filed 8-12-03; 8:45 am]
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