[Federal Register Volume 68, Number 156 (Wednesday, August 13, 2003)]
[Notices]
[Pages 48359-48362]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-20528]


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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 [email protected]. 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 [email protected].

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 [email protected].

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.

------------------------------------------------------------------------
                                                       Reason(s) for
              Chemical                 CAS No.          assessment/
                                                       reassessment
------------------------------------------------------------------------
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.
------------------------------------------------------------------------

    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 [email protected]. 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:
 Name------------------------------------------------------------------
 Title-----------------------------------------------------------------
 Affiliation-----------------------------------------------------------
 Phone-----------------------------------------------------------------
 Address---------------------------------------------------------------
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 E-mail address--------------------------------------------------------

    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)?

[[Page 48362]]

    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 [email protected]. 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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