[Federal Register Volume 76, Number 163 (Tuesday, August 23, 2011)]
[Pages 52664-52665]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-21405]



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.


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, 

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.


    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, 
    (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 
    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]