Request for Information: Announcement of Carcinogen and Recommended Exposure Limit (REL) Policy Assessment, 52664-52665 [2011-21405]

Download as PDF 52664 Federal Register / Vol. 76, No. 163 / Tuesday, August 23, 2011 / Notices Approximate Number of Awards: 15– 17. Approximate Average Award: $625,000. Fiscal Year Funds: 2011. Anticipated Award Date: September 30, 2011. Budget Period: 12 months. Project Period: 1 year. Application Selection Process Only applicants who have applied for and have been selected as Prevention Research Centers under CDC Program Announcement DP–09–001 were eligible to apply for the annual continuation funding. mstockstill on DSK4VPTVN1PROD with NOTICES Funding Authority CDC will add the following Authority to that which is reflected in the published Funding Opportunity: —Section 4002 of the Patient Protection and Affordable Care Act (Pub. L. 111– 148.). DATES: The effective date for this action is August 23, 2011 and remains in effect until the expiration of the project period of the ACA funded applications. FOR FURTHER INFORMATION CONTACT: Elmira Benson, Deputy Director, Procurement and Grants Office, Centers for Disease Control and Prevention, 2920 Brandywine Road, Atlanta, GA 30341, telephone (770) 488–2802, e-mail Elmira.Benson@cdc.gov. SUPPLEMENTARY INFORMATION: On March 23, 2010, the President signed into law the Patient Protection and Affordable Care Act (ACA). ACA is designed to improve and expand the scope of health care coverage for Americans. Cost savings through disease prevention is an important element of this legislation and ACA has established a Prevention and Public Health Fund (PPHF) for this purpose. Specifically, the legislation states in Section 4002 that the PPHF is to ‘‘provide for expanded and sustained national investment in prevention and public health programs to improve health and help restrain the rate of growth in private and public sector health care costs. ACA and the Prevention and Public Health Fund make improving public health a priority with investments to improve public health. The PPHF states that the Secretary shall transfer amounts in the Fund to accounts within the Department of Health and Human Services to increase funding, over the fiscal year 2008 level, for programs authorized by the Public Health Services Act, for prevention, wellness and public health activities including prevention research and health screenings, such as the VerDate Mar<15>2010 16:33 Aug 22, 2011 Jkt 223001 Community Transformation Grant Program, the Education and Outreach Campaign for Preventative Benefits, and Immunization Programs. ACA legislation affords an important opportunity to advance public health across the lifespan and to reduce health disparities by supporting an intensive community approach to chronic disease prevention and control. Therefore, the FOA program activities CDC proposes to fund with ACA appropriations are authorized by the amendment to the Public Health Services Act which authorized the Prevention and Wellness Program. Dated: August 9, 2011. Tanja Popovic, Deputy Associate Director for Science, Centers for Disease Control and Prevention. [FR Doc. 2011–21343 Filed 8–22–11; 8:45 am] BILLING CODE 4163–18–P 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 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. AGENCY: 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 https:// www.cdc.gov/niosh/topics/cancer/ SUMMARY: PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 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: nioshdocket@cdc.gov. 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 https://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 E:\FR\FM\23AUN1.SGM 23AUN1 Federal Register / Vol. 76, No. 163 / Tuesday, August 23, 2011 / Notices 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? 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. mstockstill on DSK4VPTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: VerDate Mar<15>2010 16:33 Aug 22, 2011 Jkt 223001 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 https://www.cdc.gov/niosh/enews/ enewsV8N12.html and on the NIOSH Cancer and REL Policy Web Topic Page [see https://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] BILLING CODE 4163–19–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0129] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Comparing Nutrition Knowledge, Attitude, and Behavior Among English-Dominant Hispanics, Spanish-Dominant Hispanics, and Other Consumers AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by September 22, 2011. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or e-mailed to SUMMARY: PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 52665 oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–New and title ‘‘Comparing Nutrition Knowledge, Attitude, and Behavior Among EnglishDominant Hispanics, Spanish-Dominant Hispanics, and Other Consumers.’’ Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 3793. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Comparing Nutrition Knowledge, Attitude, and Behavior Among EnglishDominant Hispanics, SpanishDominant Hispanics, and Other Consumers—(OMB Control Number 0910–NEW) I. Background Recent estimates suggest that Hispanics (defined as those who identify themselves as of Hispanic or Latino origin) are the largest and fastest growing minority group in the nation; the proportion of the U.S. population that was Hispanic was 14 percent in 2005 and is projected to increase to 29 percent in 2050 (Ref. 1). Data from the Centers for Disease Control and Prevention (CDC) indicate that, in 2005 and 2006, 34.3 percent and 32.7 percent of the U.S. adult population are obese and overweight, respectively (Ref. 2). According to CDC, Hispanics had 21 percent higher obesity prevalence than Whites in 2008 (Ref. 3). CDC data also indicate variations in prevalence of obesity among adults of different race-gender groups; for example, during 2006 through 2008, non-Hispanic Blacks had the greatest prevalence of obesity (35.7 percent), followed by Hispanics (28.7 percent), and non-Hispanic Whites (23.7 percent); non-Hispanic Black women had the greatest prevalence (39.2 percent), followed by non-Hispanic Black men (31.6 percent), Hispanic women (29.4 percent), Hispanic men (27.8 percent), non-Hispanic White men (25.4 percent), and non-Hispanic White women (21.8 percent) (Ref. 3). While some Hispanics living in the United States use the English language exclusively or more often than Spanish (English-dominant Hispanics), other U.S. Hispanics predominantly use the Spanish language in their daily lives E:\FR\FM\23AUN1.SGM 23AUN1

Agencies

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


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 
https://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: nioshdocket@cdc.gov.
    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 https://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 https://www.cdc.gov/niosh/enews/enewsV8N12.html and on the NIOSH Cancer and REL Policy Web Topic Page 
[see https://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]
BILLING CODE 4163-19-P
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