[Federal Register Volume 76, Number 163 (Tuesday, August 23, 2011)]
[Notices]
[Pages 52664-52665]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-21405]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket Number NIOSH-240]
Request for Information: Announcement of Carcinogen and
Recommended Exposure Limit (REL) Policy Assessment
AGENCY: National Institute for Occupational Safety and Health (NIOSH)
of the Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice of public comment period.
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SUMMARY: The National Institute for Occupational Safety and Health
(NIOSH) of the Centers for Disease Control and Prevention (CDC) intends
to review its approach to classifying carcinogens and establishing
recommended exposure limits (RELs) for occupational exposures to
hazards associated with cancer. As part of this effort, NIOSH is
requesting initial input on these issues (including answers to the 5
questions in the following section), to be submitted to the NIOSH
Docket number 240, for a comment period lasting through September 22,
2011. This information will be taken under consideration and used to
inform NIOSH efforts to assess and document its carcinogen policy and
REL policy regarding occupational hazards associated with cancer. NIOSH
has also created a new NIOSH Cancer and REL Policy Web Topic Page [see
http://www.cdc.gov/niosh/topics/cancer/policy.html] to provide
additional details about this effort and progress updates.
Public Comment Period: Comments must be received by September 22,
2011.
ADDRESSES: Written comments, identified by docket number NIOSH-240, may
be submitted by any of the following methods:
Mail: NIOSH Docket Office, Robert A. Taft Laboratories,
MS-C34, 4676 Columbia Parkway, Cincinnati, Ohio 45226.
Facsimile: (513) 533-8285.
E-mail: [email protected].
All information received in response to this notice will be
available for public examination and copying at the NIOSH Docket
Office, 4676 Columbia Parkway, Room 111, Cincinnati, Ohio 45226. A
complete electronic docket containing all comments submitted will be
available on the NIOSH Web page at http://www.cdc.gov/niosh/docket, and
comments will be available in writing by request. NIOSH includes all
comments received without change in the docket, including any personal
information provided. All electronic comments should be formatted as
Microsoft Word. Please make reference to docket number NIOSH-240.
Background
NIOSH is announcing a Request for Information on key issues
identified and associated with the NIOSH Carcinogen and REL policies.
Special emphasis will be placed on consideration of technical and
scientific issues with the current NIOSH Cancer and REL Policies that
require further examination including the following:
(1) Should there explicitly be a carcinogen policy as opposed to a
broader policy on toxicant identification and classification (e.g.
carcinogens, reproductive hazards, neurotoxic agents)?
(2) What evidence should form the basis for determining that
substances are carcinogens? How should these criteria correspond to
nomenclature and categorizations (e.g., known, reasonably anticipated,
etc.)?
(3) Should 1 in 1,000 working lifetime risk (for persons
occupationally exposed) be the target level for a recommended exposure
limit (REL) for carcinogens or should lower targets be considered?
(4) In establishing NIOSH RELs, how should the phrase ``to the
extent feasible'' (defined in the 1995 NIOSH Recommended Exposure Limit
Policy) be interpreted and applied?
(5) In the absence of data, what uncertainties or assumptions are
[[Page 52665]]
appropriate for use in the development of RELs? What is the utility of
a standard ''action level'' (i.e., an exposure limit set below the REL
typically used to trigger risk management actions) and how should it be
set? How should NIOSH address worker exposure to complex mixtures?
SUPPLEMENTARY INFORMATION: NIOSH and stakeholders have expressed
concerns recently about limitations in the NIOSH Carcinogen Policy,
prompting NIOSH to initiate a review of the carcinogen policy in 2010.
A major limitation in the policy is the use of the term ``Potential
Occupational Carcinogen'' which dates to the 1980 OSHA hazard
classification for carcinogens outlined in 29 CFR 1990.103 and is
defined as ``* * * any substance, or combination or mixture of
substances, which causes an increased incidence of benign and/or
malignant neoplasms, or a substantial decrease in the latency period
between exposure and onset of neoplasms in humans or in one or more
experimental mammalian species as the result of any oral, respiratory
or dermal exposure, or any other exposure which results in the
induction of tumors at a site other than the site of administration.
This definition also includes any substance which is metabolized into
one or more potential occupational carcinogens by mammals.'' A major
limitation of this definition is that the policy allows for only one
cancer category, which is ``potential occupational carcinogen.'' The
adjective ``potential'' conveys uncertainty that is not warranted with
many carcinogens such as asbestos, benzene, and others. This policy
does not allow for classification on the basis of the magnitude and
sufficiency of the scientific evidence. In contrast, other
organizations, such as the International Agency for Research on Cancer
(IARC) and the National Toxicology Program (NTP) allow for a more
differential classification.
The revision of the NIOSH Carcinogen Policy also coincides with the
international realization that there is a need for more efficient and
quicker means of classifying chemicals. Qualitative and semi-
quantitative approaches such as hazard banding are increasingly being
investigated as a means of addressing the vast numbers of unregulated
chemicals. NIOSH has been in collaboration with various organizations
to consider utilizing hazard banding approaches to control chemicals.
This will also be reflected in the review of the carcinogen and RELs
policies.
This Federal Register notice serves to provide stakeholders and the
public an opportunity for input on the revision of the NIOSH Carcinogen
and REL Policies. It is anticipated that NIOSH will develop a report on
the revised NIOSH Carcinogen and REL Policies to be made available in
the Spring of 2012. Additional information regarding NIOSH plans to
assess and revise the Carcinogen and REL Policy can be found in the
April 2011 NIOSH e-news at http://www.cdc.gov/niosh/enews/enewsV8N12.html and on the NIOSH Cancer and REL Policy Web Topic Page
[see http://www.cdc.gov/niosh/topics/cancer/policy.html].
FOR FURTHER INFORMATION CONTACT: T.J. Lentz, telephone (513) 533-8260,
or Faye Rice, telephone (513) 533-8335, NIOSH, MS-C32, Robert A. Taft
Laboratories, 4676 Columbia Parkway, Cincinnati, Ohio 45226.
Dated: August 12, 2011.
John Howard,
Director, National Institute for Occupational Safety and Health,
Centers for Disease Control and Prevention.
[FR Doc. 2011-21405 Filed 8-22-11; 8:45 am]
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