[Federal Register Volume 76, Number 222 (Thursday, November 17, 2011)]
[Pages 71346-71348]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-29700]



Centers for Disease Control and Prevention

[Docket Number NIOSH-240]

Public Meeting and Request for Information: Carcinogen and 
Recommended Exposure Limit (REL) Policy Assessment

AGENCY: The 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 meeting and request for public comments.


SUMMARY: The National Institute for Occupational Safety and Health 
(NIOSH) of the Centers for Disease Control and Prevention (CDC), 
Department of Health and Human Services (HHS) announces a public 
meeting to review its approach to classifying carcinogens and 
establishing recommended exposure limits (RELs) for occupational 
exposures to hazards associated with cancer. NIOSH requested initial 
input on these issues (including answers to five questions listed below 
under SUPPLEMENTARY INFORMATION), to be submitted to NIOSH Docket 
number 240. Written comments to this Docket will be accepted until 
December 30, 2011. Written comments submitted to the docket will be 
used to inform NIOSH with the review and revision of the carcinogen 
policy and the REL policy. 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.

Table of Contents

Date and Time
Security Considerations
Attendee and Speaker Registration
For Registration Information Contact
Supplementary Information
I. Background
II. Matters to Be Discussed
III. Transcript
For Further Information Contact

DATES: Date and Time: December 12, 2011, 9 a.m.-4 p.m., Eastern Time. 
Please note that public comments may end before the time indicated, 
following the last call for comments. Members of the public who wish to 
provide public comments should plan to attend the meeting at the start 
time listed.
    Place: Hubert H. Humphrey Building, Room 800, U.S. Department of 
Health and Human Services (HHS), 200 Independence Avenue SW., 
Washington, DC 20201.
    Status: The meeting is open to the public, limited only by the 
space available. The meeting space accommodates approximately 135 
people. In addition, there will be an audio conference for those who 
cannot attend in person. There is no registration fee to attend this 
public meeting. However, those wishing to attend are encouraged to sign 
up by November 28, 2011 with the contact person in this notice.
    Security Considerations: Due to mandatory security clearance 
procedures at the Hubert H. Humphrey Federal Building, in-person 
attendees must present valid government-issued picture identification 
to security personnel upon entering the building and go through an 
airport-type security check.
    Non-U.S. citizens are encouraged to participate in the audio 
conferencing due to the extra clearance involved with in-person 
attendance. To attend in person, a non-U.S. citizen will have to call 
or send an email before November 28, 2011, to the contact person in 

[[Page 71347]]

notice, and provide passport information. If clearance is received, you 
will be notified; otherwise, you will not be able to attend the meeting 
in person.
    Attendee and Speaker Registration: Attendees are encouraged to sign 
up by November 28, 2011 with the contact person in this notice. 
Individuals wishing to speak during the meeting may sign up when 
registering with the contact person. Those who have not signed up to 
present in advance may be allowed to present at the meeting if time 
    Agenda: The meeting will begin with a brief introduction by Federal 
officials, followed by discussions focused on each of five questions 
related to the NIOSH Cancer and RELs policies (See SUPPLEMENTARY 
INFORMATION, II. Matters to Be Discussed). The intent of the meeting is 
to engage stakeholders and members of the public in discussions of the 
relevant issues pertaining to review and assessment of NIOSH Cancer 
(Carcinogens) and RELs policies. Following these discussions, time has 
been set aside for presentations from attendees who register to speak. 
Each speaker will be limited to five minutes in order to maximize the 
number of presentations during the meeting. If all registered 
presentations are made before the end time, there will be an open 
session to receive comments from anyone who has not signed up on the 
speaker registration list who may wish to speak. Open session comments 
will also be limited to five minutes per person. After the last speaker 
or at 3:50 p.m., whichever occurs first, there will be brief closing 
comments by Federal officials and the meeting will be adjourned.
    For Registration Information Contact: Karen Dragon or Sherri Diana 
(513) 533-8611, NIOSH Docket Office, Robert A. Taft Laboratories, MS-
C34, 4676 Columbia Parkway, Cincinnati, Ohio 45226, facsimile (513) 
533-8285, E-mail [email protected].


I. Background

    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 
    It is anticipated that NIOSH will develop a report on the revised 
NIOSH Carcinogen and REL Policies to be made available in 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].

II. Matters To Be Discussed

    Input from the public is sought on each of the five questions 
listed below pertaining to the NIOSH Cancer (Carcinogens) and RELs 
    (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 
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?

III. Transcript

    A transcript will be prepared and posted to NIOSH Docket number 240 
within 30 days after the meeting. Each person making a comment will be 
asked to give his or her name and affiliation, and all comments 
(including their name and affiliation) are considered to be in the 
public domain, and the transcript will be archived in the NIOSH Docket 
and posted on a public Web site.
    You may submit comments, identified by docket number NIOSH-240 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.
     Email: [email protected].
    All information received in response to this notice will be 
available for public examination and copying at the NIOSH Docket 
Office, Room 111, 4676 Columbia Parkway, Cincinnati, Ohio 45226. A 
complete electronic docket containing all comments submitted will be 
available within 30 days of the closing date 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.

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.

[[Page 71348]]

     Dated: November 9, 2011.
 John Howard,
Director, National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention.
[FR Doc. 2011-29700 Filed 11-16-11; 8:45 am]