Draft Current Intelligence Bulletin “Update of NIOSH Carcinogen Classification and Target Risk Level Policy for Chemical Hazards in the Workplace”, 68849-68850 [2013-27375]

Download as PDF Federal Register / Vol. 78, No. 221 / Friday, November 15, 2013 / Notices LeRoy Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2013–27402 Filed 11–14–13; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [CDC–2013–0023; Docket Number NIOSH 240–A] Draft Current Intelligence Bulletin ‘‘Update of NIOSH Carcinogen Classification and Target Risk Level Policy for Chemical Hazards in the Workplace’’ 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 draft document available for public comment and public meeting. AGENCY: The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability of the following draft document for public comment entitled ‘‘Current Intelligence Bulletin: Update of NIOSH Carcinogen Classification and Target Risk Level Policy for Chemical Hazards in the Workplace.’’ To view the notice, document and related materials, visit http://www.regulations.gov and enter CDC–2013–0023 in the search field and click ‘‘Search.’’ Additional information is also located at the following Web site: http://www.cdc.gov/niosh/topics/ cancer/policy.html. Comments may be provided to the NIOSH docket, as well as given orally at the following meeting. Public Comment Period: Comments must be received by February 13, 2014. Public Meeting Time and Date: December 16, 2013, 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: Surface Transportation Board Hearing Room, Patriots Plaza One, 395 E Street SW., 1st Floor, Room 120, Washington, DC 20201. emcdonald on DSK67QTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 16:58 Nov 14, 2013 Jkt 232001 Status: The meeting is open to the public, limited only by the space available. The meeting space accommodates approximately 150 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 register by December 3, 2013 with the NIOSH Docket Office at 513/533–8611 or email niocindocket@cdc.gov. Security Considerations: Due to mandatory security clearance procedures at the Patriots Plaza 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: Because of CDC Security Regulations, any non-U.S. citizen wishing to attend this meeting must provide the following information in writing to the NIOSH Docket Officer at the address below no later than November 22, 2013 to allow time for mandatory CDC facility security clearance procedures to be completed. 1. Name: 2. Gender: 3. Date of Birth: 4. Place of birth (city, province, state, country): 5. Citizenship: 6. Passport Number: 7. Date of Passport Issue: 8. Date of Passport Expiration: 9. Type of Visa: 10. U.S. Naturalization Number (if a naturalized citizen): 11. U.S. Naturalization Date (if a naturalized citizen): 12. Visitor’s Organization: 13. Organization Address: 14. Organization Telephone Number: 15. Visitor’s Position/Title within the Organization: This information will be transmitted to the CDC Security Office for approval. Visitors will be notified as soon as approval has been obtained. Non-U.S. citizens are encouraged to participate in the audio conferencing due to the extra clearance involved with in-person attendance. Attendee and Speaker Registration: Attendees are encouraged to sign up by December 3, 2013 with the NIOSH Docket Office. Individuals wishing to speak during the meeting may sign up when registering with the NIOSH Docket Office no later than December 3, at 513/533–8611 or by email at nioshdocket@cdc.gov. Those who have not signed up to present in advance may be allowed to present at the meeting if time allows. PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 68849 Persons wanting to provide oral comments will be permitted up to 20 minutes. If additional time becomes available, presenters will be notified. Oral comments given at the meeting must also be submitted to the docket in writing in order to be considered by the Agency. Priority for attendance will be given to those providing oral comments. Other requests to attend the meeting will then be accommodated on a first-come basis. Unreserved walk-in attendees will not be admitted due to security clearance requirements. Purpose of Meeting: To discuss and obtain comments on the draft document, ‘‘Current Intelligence Bulletin: Update of NIOSH Carcinogen Classification and Target Risk Level Policy for Chemical Hazards in the Workplace.’’ Special emphasis will be placed on discussion of the following: Overall Questions (1) Are the proposed carcinogen policies consistent with the current scientific knowledge of toxicology, risk assessment, industrial hygiene, and occupational cancer? If not, provide specific information and references that should be considered. (2) Is there additional scientific information related to the issues of the proposed NIOSH carcinogen policies that should be considered for inclusion? If so, provide information and specify references for consideration. Is there any discussion in the document that should be omitted? (3) Is the proposed carcinogen classification policy explained in a clear and transparent manner? Is the basis for the proposed policy adequately explained? If not, specify (section, page, and line number) where clarification is needed. (4) Are there issues relevant to the classification of occupational carcinogens that have not been adequately addressed in this proposed policy? If so, provide information and specify references for consideration. (5) NIOSH adapted the OSHA Hazard Communication Table Relating Approximate Equivalences among IARC, NTP RoC, and GHS Carcinogenicity Classifications (Appendix F, Part D, OSHA Globally Harmonized System for Hazard Communication) to provide a simple, systematic method of determining GHS cancer hazard categories. However, NIOSH has further considered the GHS carcinogen categories 1B and 2 because NTP classification reasonably anticipated to be a human carcinogen and IARC classification 2B have criteria that overlap the two GHS categories. E:\FR\FM\15NON1.SGM 15NON1 emcdonald on DSK67QTVN1PROD with NOTICES 68850 Federal Register / Vol. 78, No. 221 / Friday, November 15, 2013 / Notices NIOSH has reviewed the criteria for GHS classification and has determined that chemicals classified by NTP as reasonably anticipated and chemicals classified as IARC 2B ‘‘that have sufficient evidence from animal data’’ meet the criteria for GHS Carcinogen Category 1B. Chemicals classified by NTP as reasonably anticipated and chemicals classified by IARC as 2B ‘‘that have limited evidence from animal data’’ meet the criteria for GHS Carcinogen Category 2. NIOSH is requesting comments on the validity of the NIOSH Correspondence table (Table 2) and its usefulness as a guide to determine GHS hazard categories. (6) Is the proposed target risk level policy explained in a clear and transparent manner? Is the basis for the proposed policy adequately explained? If not, specify (section, page, and line number) where clarification is needed. (7) An analytical feasibility (AF) notation will be used to identify those RELs that are established to reflect the limitations of the sampling and analytical method (i.e., AF) and not the target risk level of 1 in 1,000. Is this notation adequately explained? (8) Is the proposed analytical feasibility and technical achievability policy explained in a clear and transparent manner? Is the basis for the proposed policy adequately explained? If not, specify (section, page, and line number) where clarification is needed. Written comments will be accepted at the meeting. Written comments may also be submitted by any of the following methods: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. • Mail: NIOSH Docket Office, Robert A. Taft Laboratories, 4676 Columbia Parkway, MS C–34, Cincinnati, Ohio 45226. All material submitted to the Agency should reference the agency name and docket number [CDC–2013–0023; NIOSH 240–A]. All electronic comments should be formatted as Microsoft Word. Please make reference to CDC–2013–0023 and Docket Number NIOSH 240–A. Transcript: A transcript will be prepared and posted to NIOSH Docket 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. All information received in response to this notice will be available for public examination and copying at the NIOSH VerDate Mar<15>2010 16:58 Nov 14, 2013 Jkt 232001 Docket Office, Room 111, 4676 Columbia Parkway, Cincinnati, Ohio 45226. Background: This draft NIOSH document provides an update of the NIOSH Carcinogen Classification and relevant Recommended Exposure Limit (REL) policies. The proposed update of policies is prompted by comments from the public and stakeholders and recent developments in how the carcinogenic risk to substances is assessed. NIOSH stakeholders have recently expressed concerns about limitations in the NIOSH approach to classifying and controlling carcinogens. A major limitation identified is use of the term ‘‘Potential Occupational Carcinogen’’ which dates to the OSHA hazard classification for carcinogens outlined in 29 CFR 1990.103 (see below). The adjective ‘‘potential’’ conveys uncertainty that is not warranted with many carcinogens such as asbestos, benzene, and others. Further, the existing NIOSH carcinogen 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 National Toxicology Program (NTP), the International Agency for Research on Cancer (IARC) and the Environmental Protection Agency (EPA) have differential classification systems with categories that reflect the weight of scientific evidence. Coincident with NIOSH recognition of this language limitation was international recognition of the need for more efficient and faster classification of substances and the consideration of alternative substances that are less toxic and more environmentally sustainable. In August 2011, NIOSH published in the Federal Register its intent to review and request for information regarding its approach to classifying carcinogens and establishing recommended exposure limits for occupational exposures to hazards associated with cancer. The initial comment period of September 22, 2011 was subsequently extended until December 30, 2011. On December 12, 2011, a public meeting was held at the Hubert H. Humphrey Building in Washington, DC to engage stakeholders and members of the public in discussions of the relevant issues pertaining to the NIOSH assessment. Input received from the public and stakeholders during this process was considered and is reflected in the draft document now available for public review. To view this docket’s previous information go to: http://www.cdc.gov/ niosh/docket/archive/docket240.html. PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 The purpose of the public review of the draft document is to obtain comments on whether NIOSH has adequately explained the basis for its revised policies on classifying chemicals as carcinogens and deriving RELs that are transparent, consistent, and that contribute to the effective risk management of chemical carcinogens in the workplace. Contact Persons for Technical Information: 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: November 8, 2013. John Howard, Director, National Institute for Occupational Safety and Health. [FR Doc. 2013–27375 Filed 11–14–13; 8:45 am] BILLING CODE 4163–19–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60-Day–14–0210] Proposed Data Collections Submitted for Public Comment and Recommendations; List of Ingredients Added to Tobacco in the Manufacture of Cigarette Products; Withdrawn Centers for Disease Control and Prevention (CDC), Office on Smoking and Health, National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Department of Health and Human Services (HHS). ACTION: Notice Withdrawal. In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 FR Doc. 2013– 26469 Filed 11–4–13; 8:45am. AGENCY: The Centers for Disease Control and Prevention requests withdrawal from publication the 60-Day Federal Register Notice (FRN) 14 0210 concerning the List of Ingredients Added to Tobacco in the Manufacture of Cigarette Products (FR Doc. 2013– 26469), which was submitted on October 30, 2013 for public inspection in the Federal Register. The purpose behind this notice withdrawal request is that an original 60-day FRN was previously published on October 31, 2013 (Document Number—2013–25799). A duplicate 60day FRN was inadvertently published on November 5, 2013. Please disregard the duplicate FRN. SUMMARY: E:\FR\FM\15NON1.SGM 15NON1

Agencies

[Federal Register Volume 78, Number 221 (Friday, November 15, 2013)]
[Notices]
[Pages 68849-68850]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-27375]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[CDC-2013-0023; Docket Number NIOSH 240-A]


Draft Current Intelligence Bulletin ``Update of NIOSH Carcinogen 
Classification and Target Risk Level Policy for Chemical Hazards in the 
Workplace''

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 draft document available for public comment and 
public meeting.

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

SUMMARY: The National Institute for Occupational Safety and Health 
(NIOSH) of the Centers for Disease Control and Prevention (CDC) 
announces the availability of the following draft document for public 
comment entitled ``Current Intelligence Bulletin: Update of NIOSH 
Carcinogen Classification and Target Risk Level Policy for Chemical 
Hazards in the Workplace.'' To view the notice, document and related 
materials, visit http://www.regulations.gov and enter CDC-2013-0023 in 
the search field and click ``Search.'' Additional information is also 
located at the following Web site: http://www.cdc.gov/niosh/topics/cancer/policy.html. Comments may be provided to the NIOSH docket, as 
well as given orally at the following meeting.
    Public Comment Period: Comments must be received by February 13, 
2014.
    Public Meeting Time and Date: December 16, 2013, 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: Surface Transportation Board Hearing Room, Patriots Plaza 
One, 395 E Street SW., 1st Floor, Room 120, Washington, DC 20201.
    Status: The meeting is open to the public, limited only by the 
space available. The meeting space accommodates approximately 150 
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 
register by December 3, 2013 with the NIOSH Docket Office at 513/533-
8611 or email niocindocket@cdc.gov.
    Security Considerations: Due to mandatory security clearance 
procedures at the Patriots Plaza 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: Because of CDC Security Regulations, any non-
U.S. citizen wishing to attend this meeting must provide the following 
information in writing to the NIOSH Docket Officer at the address below 
no later than November 22, 2013 to allow time for mandatory CDC 
facility security clearance procedures to be completed.
    1. Name:
    2. Gender:
    3. Date of Birth:
    4. Place of birth (city, province, state, country):
    5. Citizenship:
    6. Passport Number:
    7. Date of Passport Issue:
    8. Date of Passport Expiration:
    9. Type of Visa:
    10. U.S. Naturalization Number (if a naturalized citizen):
    11. U.S. Naturalization Date (if a naturalized citizen):
    12. Visitor's Organization:
    13. Organization Address:
    14. Organization Telephone Number:
    15. Visitor's Position/Title within the Organization:
    This information will be transmitted to the CDC Security Office for 
approval. Visitors will be notified as soon as approval has been 
obtained. Non-U.S. citizens are encouraged to participate in the audio 
conferencing due to the extra clearance involved with in-person 
attendance.
    Attendee and Speaker Registration: Attendees are encouraged to sign 
up by December 3, 2013 with the NIOSH Docket Office. Individuals 
wishing to speak during the meeting may sign up when registering with 
the NIOSH Docket Office no later than December 3, at 513/533-8611 or by 
email at nioshdocket@cdc.gov. Those who have not signed up to present 
in advance may be allowed to present at the meeting if time allows.
    Persons wanting to provide oral comments will be permitted up to 20 
minutes. If additional time becomes available, presenters will be 
notified. Oral comments given at the meeting must also be submitted to 
the docket in writing in order to be considered by the Agency.
    Priority for attendance will be given to those providing oral 
comments. Other requests to attend the meeting will then be 
accommodated on a first-come basis. Unreserved walk-in attendees will 
not be admitted due to security clearance requirements.
    Purpose of Meeting: To discuss and obtain comments on the draft 
document, ``Current Intelligence Bulletin: Update of NIOSH Carcinogen 
Classification and Target Risk Level Policy for Chemical Hazards in the 
Workplace.'' Special emphasis will be placed on discussion of the 
following:

Overall Questions

    (1) Are the proposed carcinogen policies consistent with the 
current scientific knowledge of toxicology, risk assessment, industrial 
hygiene, and occupational cancer? If not, provide specific information 
and references that should be considered.
    (2) Is there additional scientific information related to the 
issues of the proposed NIOSH carcinogen policies that should be 
considered for inclusion? If so, provide information and specify 
references for consideration. Is there any discussion in the document 
that should be omitted?
    (3) Is the proposed carcinogen classification policy explained in a 
clear and transparent manner? Is the basis for the proposed policy 
adequately explained? If not, specify (section, page, and line number) 
where clarification is needed.
    (4) Are there issues relevant to the classification of occupational 
carcinogens that have not been adequately addressed in this proposed 
policy? If so, provide information and specify references for 
consideration.
    (5) NIOSH adapted the OSHA Hazard Communication Table Relating 
Approximate Equivalences among IARC, NTP RoC, and GHS Carcinogenicity 
Classifications (Appendix F, Part D, OSHA Globally Harmonized System 
for Hazard Communication) to provide a simple, systematic method of 
determining GHS cancer hazard categories. However, NIOSH has further 
considered the GHS carcinogen categories 1B and 2 because NTP 
classification reasonably anticipated to be a human carcinogen and IARC 
classification 2B have criteria that overlap the two GHS categories.

[[Page 68850]]

NIOSH has reviewed the criteria for GHS classification and has 
determined that chemicals classified by NTP as reasonably anticipated 
and chemicals classified as IARC 2B ``that have sufficient evidence 
from animal data'' meet the criteria for GHS Carcinogen Category 1B. 
Chemicals classified by NTP as reasonably anticipated and chemicals 
classified by IARC as 2B ``that have limited evidence from animal 
data'' meet the criteria for GHS Carcinogen Category 2. NIOSH is 
requesting comments on the validity of the NIOSH Correspondence table 
(Table 2) and its usefulness as a guide to determine GHS hazard 
categories.
    (6) Is the proposed target risk level policy explained in a clear 
and transparent manner? Is the basis for the proposed policy adequately 
explained? If not, specify (section, page, and line number) where 
clarification is needed.
    (7) An analytical feasibility (AF) notation will be used to 
identify those RELs that are established to reflect the limitations of 
the sampling and analytical method (i.e., AF) and not the target risk 
level of 1 in 1,000. Is this notation adequately explained?
    (8) Is the proposed analytical feasibility and technical 
achievability policy explained in a clear and transparent manner? Is 
the basis for the proposed policy adequately explained? If not, specify 
(section, page, and line number) where clarification is needed.
    Written comments will be accepted at the meeting. Written comments 
may also be submitted by any of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: NIOSH Docket Office, Robert A. Taft Laboratories, 
4676 Columbia Parkway, MS C-34, Cincinnati, Ohio 45226.
    All material submitted to the Agency should reference the agency 
name and docket number [CDC-2013-0023; NIOSH 240-A]. All electronic 
comments should be formatted as Microsoft Word. Please make reference 
to CDC-2013-0023 and Docket Number NIOSH 240-A.
    Transcript: A transcript will be prepared and posted to NIOSH 
Docket 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.
    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.
    Background: This draft NIOSH document provides an update of the 
NIOSH Carcinogen Classification and relevant Recommended Exposure Limit 
(REL) policies. The proposed update of policies is prompted by comments 
from the public and stakeholders and recent developments in how the 
carcinogenic risk to substances is assessed. NIOSH stakeholders have 
recently expressed concerns about limitations in the NIOSH approach to 
classifying and controlling carcinogens. A major limitation identified 
is use of the term ``Potential Occupational Carcinogen'' which dates to 
the OSHA hazard classification for carcinogens outlined in 29 CFR 
1990.103 (see below). The adjective ``potential'' conveys uncertainty 
that is not warranted with many carcinogens such as asbestos, benzene, 
and others.
    Further, the existing NIOSH carcinogen 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 
National Toxicology Program (NTP), the International Agency for 
Research on Cancer (IARC) and the Environmental Protection Agency (EPA) 
have differential classification systems with categories that reflect 
the weight of scientific evidence.
    Coincident with NIOSH recognition of this language limitation was 
international recognition of the need for more efficient and faster 
classification of substances and the consideration of alternative 
substances that are less toxic and more environmentally sustainable.
    In August 2011, NIOSH published in the Federal Register its intent 
to review and request for information regarding its approach to 
classifying carcinogens and establishing recommended exposure limits 
for occupational exposures to hazards associated with cancer. The 
initial comment period of September 22, 2011 was subsequently extended 
until December 30, 2011. On December 12, 2011, a public meeting was 
held at the Hubert H. Humphrey Building in Washington, DC to engage 
stakeholders and members of the public in discussions of the relevant 
issues pertaining to the NIOSH assessment. Input received from the 
public and stakeholders during this process was considered and is 
reflected in the draft document now available for public review. To 
view this docket's previous information go to: http://www.cdc.gov/niosh/docket/archive/docket240.html.
    The purpose of the public review of the draft document is to obtain 
comments on whether NIOSH has adequately explained the basis for its 
revised policies on classifying chemicals as carcinogens and deriving 
RELs that are transparent, consistent, and that contribute to the 
effective risk management of chemical carcinogens in the workplace.
    Contact Persons for Technical Information: 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: November 8, 2013.
John Howard,
Director, National Institute for Occupational Safety and Health.
[FR Doc. 2013-27375 Filed 11-14-13; 8:45 am]
BILLING CODE 4163-19-P