[Federal Register Volume 65, Number 96 (Wednesday, May 17, 2000)]
[Notices]
[Pages 31309-31310]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-12394]


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ENVIRONMENTAL PROTECTION AGENCY

[FRL-6700-5]


Integrated Risk Information System (IRIS): Announcement of 2000 
Program--Addendum; Request for Information

AGENCY: Environmental Protection Agency.

ACTION: Notice; addendum to announcement of IRIS 2000 program and 
request for scientific information on health effects that may result 
from chronic exposure to chemical substances.

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SUMMARY: The Integrated Risk Information System (IRIS) is an 
Environmental Protection Agency (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 
January 12, 2000, EPA announced the 2000 IRIS agenda and solicited 
scientific information from the public for consideration in assessing 
health effects from specific chemical substances. This notice adds the 
chemical substances hexachlorobenzene and hexahydro-1,3,5-trinitro-
triazine (``RDX'') to the IRIS agenda, and solicits scientific data and 
evaluations for consideration in EPA's assessments.

DATES: Please submit information in response to this notice by July 17, 
2000.

ADDRESSES: Please send relevant scientific information to the IRIS 
Submission Desk in accordance with the instructions provided under 
``Submission of Information'' in this notice.

FOR FURTHER INFORMATION CONTACT: For information on the IRIS program, 
contact Amy Mills, National Center for Environmental Assessment (mail 
code 8601D), 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 Risk Information Hotline at (513) 569-
7254.

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 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 
noncancer health effects resulting from oral exposure, the reference 
concentration for noncancer 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.

The IRIS Program

    EPA's process for developing IRIS consists of: (1) An annual 
Federal Register announcement of EPA's IRIS agenda and call for 
scientific information from the public on the selected chemical 
substances, (2) a search of the current literature, (3) development of 
health assessments and draft 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.

Purpose of This Notice

    EPA is adding the chemical substances hexachlorobenzene (CAS No. 
118-74-1) and hexahydro-1,3,5-trinitro-triazine or ``RDX,'' (CAS 
No.121-82-4) to its assessment agenda for fiscal year 2000. EPA is 
hereby requesting scientific information from the public for 
consideration in these two assessments.
    As described in the January 12, 2000, Federal Register document (63 
FR 1863) announcing the IRIS agenda for fiscal year 2000, EPA is 
testing ways to cooperate with external parties, including other 
government agencies, in the development of supporting documentation for 
IRIS. The Agency is initiating these two assessments to build upon a 
common interest with other federal agencies. EPA's Superfund program 
has identified a strong need to update the existing IRIS entry for 
hexachlorobenzene. This substance is frequently found at Superfund 
sites and is critical to a number of human health risk assessments. 
Concurrently, the Agency for Toxic Substances and Disease Registry 
(ATSDR) has identified hexachlorobenzene as a priority substance for 
developing a revised Toxicological Profile. EPA and ATSDR will 
therefore coordinate their efforts in developing the IRIS Toxicological 
Review and the revised ATSDR Toxicological Profile for 
Hexachlorobenzene. Similarly, the U.S. Army has identified a strong 
need to update the existing IRIS entry for RDX, which frequently occurs 
at federal facilities operated by the U.S. Army and is critical to a 
number of human health risk assessments. EPA and the U.S. Army will 
coordinate their efforts in developing a Toxicological Review for RDX. 
New scientific information is available to evaluate and reassess the 
potential health effects of both substances.
    These joint efforts with other federal agencies is a pilot effort 
to utilize federal resources more effectively and provide more 
consistent information to the public. Completion of the 
hexachlorobenzene and RDX assessments and addition to the IRIS data 
base is expected by fiscal year 2002.

Submission of Information

    As in previous Federal Register documents announcing the annual 
IRIS agenda, EPA is soliciting public information on hexachlorobenzene 
and RDX. While EPA conducts a thorough literature search for each 
chemical substance, there may be other articles or unpublished studies 
we are not aware of. We would greatly appreciate receiving scientific 
information from the public during the information gathering. 
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, there is no need to resubmit that information. Information 
from the public is being solicited for 60 days via this notice.

Procedures for Submission

    As described in the January 12, 2000, Federal Register document, 
submissions will be handled in a three-step process:
    1. Submission Inventory: First, you should simply provide a list 
within 60

[[Page 31310]]

days of this notice briefly identifying all the information (reports, 
papers, articles, etc.) you wish to submit. The list should specify by 
name and CASRN (Chemical Abstract Service Registry Number) the chemical 
substance(s) to which the information pertains, state the type of 
assessment that is being addressed (e.g., carcinogenicity), and 
describe briefly the information to be submitted for consideration. 
Where possible, documents should be listed in scientific citation 
format, that is, author(s), title, journal, and date. Your 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. Mail two copies of the submission 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 the submission inventory and cover 
letter electronically to [email protected]. Electronic information must 
be submitted in WordPerfect or as an ASCII file. Information will also 
be accepted on 3.5'' disks. All information in electronic form must be 
identified as an IRIS submission.
    2. EPA Replies to Submission Inventory: 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. You will receive notification 
requesting full submission of the selected material.
    3. Full Submission of Selected Material: In the third step, you 
should send in the information indicated by EPA within 30 days of EPA's 
reply. Prompt response to EPA will ensure that your material can be 
considered in the assessment in a timely fashion. Submittals should 
include a cover letter addressing all of the points in item 1 above. In 
addition, when you submit results of new health effects studies 
concerning existing substances on IRIS, you should include a specific 
explanation of how and why the study results could change the 
information in IRIS.
    Please send two copies, at least one of which should be unbound, to 
the IRIS Submission Desk, as described in Step 1. The IRIS Submission 
Desk will acknowledge receipt of your information.
    Confidential Business Information (CBI) should not be submitted to 
the IRIS Submission Desk. CBI must be submitted to the appropriate EPA 
office via established procedures for submission of CBI (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 the 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 Manager (see FOR FURTHER INFORMATION CONTACT).

    Dated: May 4, 2000.
William H. Farland,
Director, National Center for Environmental Assessment.
[FR Doc. 00-12394 Filed 5-16-00; 8:45 am]
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