[Federal Register Volume 66, Number 230 (Thursday, November 29, 2001)]
[Notices]
[Pages 59593-59594]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-29647]


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ENVIRONMENTAL PROTECTION AGENCY

[FRL-7110-6]


Notice of Opportunity To Provide Additional Information and 
Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of opportunity to provide additional information and 
comment on draft revised Guidelines for Carcinogen Risk Assessment 
(July 1999), availability of draft revised Guidelines, and adoption of 
draft revised Guidelines as interim guidance.

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SUMMARY: EPA is today announcing its intent to proceed to issue final 
revised Guidelines for Carcinogen Risk Assessment in 2002. The Agency 
is soliciting additional scientific information and comments that could 
assist us in completing the final Guidelines. In 1996, EPA published 
for public comment proposed revisions to EPA's 1986 Guidelines for 
Carcinogen Risk Assessment. Since the 1996 proposal, we have benefitted 
from extensive public comment and scientific peer review, including 
three reviews by EPA's Science Advisory Board (SAB). EPA scientists are 
currently addressing these comments under the auspices of the Agency's 
Science Policy Council. The draft revised Guidelines from which the 
Agency will proceed to make its final revisions is that provided to the 
SAB in July 1999 (with minor formatting changes). Even though EPA has 
received considerable input from the public during the 1996 public 
comment period and thereafter, we are providing an additional 
opportunity for the public to provide (1) information or comment on 
experience gained in applying the 1996 proposed Guidelines or the 1999 
draft revised Guidelines and (2) other new information or comment that 
addresses issues raised during the public comment period and the SAB 
reviews. The major issues currently being considered by EPA as it 
proceeds to issue final Guidelines are identified in the Supplementary 
Information section of this notice. Information and comments already 
submitted to EPA need not be resubmitted. Until final Guidelines are 
issued, the July 1999 draft revised Guidelines will serve as EPA's 
interim guidance to EPA risk assessors preparing cancer risk 
assessments.

DATES: Information and comments should be received by January 28, 2002.

ADDRESSES: The draft revised Guidelines for Carcinogen Risk Assessment 
are available via the Internet from www.epa.gov/ncea/raf/cancer.htm. 
Also available here are supplementary materials described within the 
Supplementary Information section of this notice. A limited number of 
paper copies of the draft revised Guidelines are available from the 
Technical Information Staff (8623D), NCEA-W, U.S. Environmental 
Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; 
telephone: 202-564-3261; facsimile: 202-565-0050.
    You may submit information and comments in paper form or by e-mail. 
Your comments will be most useful if you include appropriate and 
detailed supporting rationale, data, and analysis. Send paper copies of 
information and

[[Page 59594]]

comments (in duplicate if possible) to the Air Docket at the address 
listed below. You may also submit information and comments via e-mail 
to ``[email protected].'' In your correspondence, refer to Docket 
ORD-CAN-2001-01. EPA's Air Docket makes materials related to this 
notice available for review in Public Docket No. ORD-CAN-2001-01 at the 
following address: U.S. Environmental Protection Agency (EPA), Air 
Docket (6102), Room M-1500 (on the ground floor in Waterside Mall), 401 
M Street, SW., Washington, DC 20460 between 8 a.m. and 5:30 p.m., 
Monday through Friday, except on government holidays. You can reach the 
Air Docket by telephone at (202) 260-7548, and by facsimile (202) 260-
4400. We may charge a reasonable fee for copying docket materials, as 
provided in 40 CFR part 2.
    Persons providing information or comments should not submit 
personal information (such as medical data). If you submit proprietary 
information for our consideration, you should clearly separate it from 
non-proprietary information and comments by labeling it Confidential 
Business Information and send it directly to the contact person listed 
below under For Further Information instead of the public docket. This 
will help ensure that no one inadvertently places proprietary 
information in the public docket. Acknowledgments will not be sent.

FOR FURTHER INFORMATION CONTACT: Dr. William P. Wood, Risk Assessment 
Forum (mail code 8601D), U.S. Environmental Protection Agency, 
Washington, DC 20460, telephone (202) 564-3361, or send electronic mail 
inquiries to [email protected].

SUPPLEMENTARY INFORMATION:

Background

    In 1983, the National Academy of Sciences (NAS)/National Research 
Council (NRC) published its report entitled Risk Assessment in the 
Federal Government: Managing the Process. In that report, the NRC 
recommended that Federal regulatory agencies establish ``inference 
guidelines'' to promote consistency and technical quality in risk 
assessments and to ensure that the risk assessment process was 
maintained as a scientific effort separate from risk management. EPA 
responded to this recommendation by publishing a set of risk assessment 
guidelines in 1986, including Guidelines for Carcinogen Risk Assessment 
(51 FR 33992, Sept. 24, 1986). These Guidelines set forth principles 
and procedures to guide EPA scientists in assessing the cancer risks 
from chemicals or other agents in the environment and inform the public 
about these procedures. EPA continues to revise its risk assessment 
guidelines and to develop new guidelines as experience and scientific 
understanding evolve. Revisions to the Guidelines for Carcinogen Risk 
Assessment are intended to make greater use of the increasing 
scientific understanding of the mechanisms that underlie the 
carcinogenic process. As part of that process, the Agency published 
Proposed Guidelines for Carcinogen Risk Assessment in 1996 (61 FR 
17960, Apr. 23, 1996).
    The draft revisions to the Guidelines have been subject to 
extensive public comment and scientific peer review, including three 
reviews by EPA's Science Advisory Board (SAB). The SAB provided its 
initial comments to the Agency in September 1997. In July 1999, the SAB 
provided additional comments on major sections of the 1996 proposed 
Guidelines that had been revised to address prior SAB and public 
comments. In September 2000, the SAB provided further comments on new 
discussions focusing on assessing risks to children that are contained 
in the draft revised Guidelines (July 1999). This review, while 
supportive of EPA's efforts, did not reach a consensus on several 
important issues. Such lack of consensus is not uncommon in peer 
reviews. Since 1996, EPA has also hosted scientific workshops on 
children's cancer risks and received input from EPA's Children's Health 
Protection Advisory Committee.

Issues in Completing the Revised Guidelines

    EPA has commenced the process to issue final Cancer Guidelines in 
light of these reviews and activities, as well as public comments 
received. The July 1999 draft revised Guidelines will be the basis from 
which the Agency moves forward to issue final Guidelines and are being 
made available today. EPA is in the process of evaluating peer review 
and public comments received in order to determine what revisions to 
the draft revised Guidelines may be appropriate. Additionally, EPA is 
providing an opportunity for the public to provide (1) information or 
comment on experience gained in applying the 1996 proposed Guidelines 
or the July 1999 draft revised Guidelines and (2) other new information 
or comment that addresses issues raised during the public comment 
period and in the SAB reviews, particularly the 1999 and 2000 SAB 
reports. The issues currently being considered by EPA as it proceeds to 
issue final Guidelines are described in the January 2001 response to 
the SAB (see Supplementary Materials). Issues include, but are not 
limited to, the nature and use of default assumptions; definition and 
application of hazard descriptors; identification of carcinogenic 
mode(s) of action and, in particular, consideration of relevancy for 
children (e.g., the potential for differential life stage 
susceptibility); and guidance on the use of the margin of exposure 
analysis.

Supplementary Materials

    In addition to the July 1999 draft revised Guidelines, 
supplementary materials are available at the website www.epa.gov/ncea/raf/cancer.htm relevant to the development of the current draft revised 
Guidelines. These materials include the SAB's review letter (September 
1997) and EPA's (March 1998) response covering the 1996 proposed 
Guidelines; the SAB's review letter (July 1999) summarizing the January 
1999 review of selected revised sections of the 1996 Guidelines; the 
SAB's review letter (September 2000) covering EPA's July 1999 revisions 
to address the protection of children; EPA's January 2001 response to 
the latter two SAB reviews; a letter (May 1999) from EPA's Children's 
Health Protection Advisory Committee which presented issues for 
consideration by the Agency; and a summary of a workshop co-sponsored 
by EPA on information needs to address children's cancer risk.

Interim Use of 1999 Draft Revised Guidelines

    Effective immediately, the July 1999 draft revised Guidelines will 
serve as EPA's interim guidance to EPA risk assessors preparing cancer 
risk assessments. As with all previous versions of the cancer risk 
assessment Guidelines, the predominant guidance provided in the July 
1999 draft revised Guidelines is for risk assessors to use the best 
science and risk assessment techniques available to them at the time a 
risk assessment is conducted. Thus, while the July 1999 draft revised 
Guidelines will be available to EPA risk assessors as guidance, any 
final cancer risk assessment may take a different approach depending on 
evolving science, the facts of a particular case, or comments from peer 
reviewers, the public or others.

    Dated: November 20, 2001.
Henry L. Longest II,
Acting Assistant Administrator for Research and Development.
[FR Doc. 01-29647 Filed 11-28-01; 8:45 am]
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