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GLIN==> Comments sought, EPA Guidance on Carcinogenic Risk Assessment




[Federal Register: November 29, 2001 (Volume 66, Number 230)]
[Notices]
[Page 59593-59594]
 >From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29no01-53]

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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 <A 
HREF="http://www.epa.gov/ncea/raf/cancer.htm";>www.epa.gov/ncea/raf/cancer.htm</A>. 

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 ``<A HREF="mailto:a-and-r-Docket@epa.gov";>a-and-r-Docket@epa.gov</A>.'' 
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 <A HREF="mailto:risk.forum@epa.gov";>risk.forum@epa.gov</A>.

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 <A 
HREF="http://www.epa.gov/ncea/raf/cancer.htm";>www.epa.gov/ncea/
raf/cancer.htm</A> 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]
BILLING CODE 6560-50-P


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Environmental Enforcement, Technical Review, Public Policy and
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PO Box 39,  East Lansing, MI  48826-0039
(517) 332-6971; (517) 332-8987 (fax); ajs@sagady.com
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