81 FR 7122 - Draft Criteria for a Recommended Standard: Occupational Exposure to 1-Bromopropane (1-BP); Notice of Public Meeting; Availability of Draft Document for Comment

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 81, Issue 27 (February 10, 2016)

On September 16, 2009, the National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC) announced in the Federal Register https://www.gpo.gov/fdsys/pkg/ FR-2009-09-16/pdf/E9-22297.pdf plans to evaluate the scientific data on 1-bromopropane (1-BP) and to issue its findings on the potential health risks. A draft document entitled, Criteria for a Recommended Standard: Occupational Exposure to 1-Bromopropane (1-BP), has been developed which contains an assessment of toxicological data and provides recommendations for the safe handling of 1-BP-containing materials. NIOSH is seeking comments on the draft document and plans to have a public meeting to discuss the document. The draft document and instructions for submitting comments can be found at www.regulations.gov.

[Federal Register Volume 81, Number 27 (Wednesday, February 10, 2016)]
[Notices]
[Pages 7122-7123]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-02650]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket Number CDC-2016-0003; NIOSH 057-A]


Draft Criteria for a Recommended Standard: Occupational Exposure 
to 1-Bromopropane (1-BP); Notice of Public Meeting; Availability of 
Draft Document for Comment

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 meeting and availability of draft document for 
public comment.

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SUMMARY: On September 16, 2009, the National Institute for Occupational 
Safety and Health (NIOSH), Centers for Disease Control and Prevention 
(CDC) announced in the Federal Register https://www.thefederalregister.org/fdsys/pkg/FR-2009-09-16/pdf/E9-22297.pdf plans to evaluate the scientific data on 
1-bromopropane (1-BP) and to issue its findings on the potential health 
risks. A draft document entitled, Criteria for a Recommended Standard: 
Occupational Exposure to 1-Bromopropane (1-BP), has been developed 
which contains an assessment of toxicological data and provides 
recommendations for the safe handling of 1-BP-containing materials. 
NIOSH is seeking comments on the draft document and plans to have a 
public meeting to discuss the document. The draft document and 
instructions for submitting comments can be found at 
www.regulations.gov.

DATES: The public meeting will be held on March 30, 2016, 9:00 a.m.-
3:00 p.m. Eastern Time, or after the last public commenter has spoken, 
whichever occurs first. Comments must be received by April 29, 2016.

ADDRESSES: The public meeting will be held at the NIOSH/CDC Robert A. 
Taft Laboratories, Auditorium, 1150 Tusculum Avenue, Cincinnati, Ohio 
45226.

FOR FURTHER INFORMATION CONTACT: G. Scott Dotson, NIOSH, Education and 
Information Division, Robert A. Taft Laboratories, 1090 Tusculum 
Avenue, Cincinnati, OH 45226, (513) 533-8540 (not a toll free number).

SUPPLEMENTARY INFORMATION: 

I. Background

    On September 16, 2009, the National Institute for Occupational 
Safety and Health (NIOSH), Centers for Disease Control and Prevention 
(CDC) announced in the Federal Register plans to evaluate the 
scientific data on 1-bromopropane (1-BP) and to issue its findings on 
the potential health risks. The results of this evaluation are 
presented in the draft document, Criteria for a Recommended Standard: 
Occupational Exposure to 1-Bromopropane (1-BP). The purpose of the 
public meeting and public comment period is to obtain comments on the 
draft document. Special emphasis will be placed on the following:
     Whether the health hazard identification, risk estimation, 
and discussion of health effects of 1-BP are a reasonable reflection of 
the current understanding of the scientific literature;
     Identifying workplaces and occupations where exposure to 
1-BP may occur;
     Identifying studies on health effects associated with 
occupational exposure to 1-BP that were not identified in the draft;
     Identifying current strategies for controlling or 
preventing exposure to 1-BP (e.g., engineering controls, work 
practices, personal protective equipment);
     Identifying current exposure measurement methods and 
challenges in measuring workplace exposures to 1-BP; and
     Identifying areas for future collaborative efforts (e.g., 
research, communication, development of exposure measurement and 
control strategies).
    As part of the review of this draft criteria document, reviewers 
are asked to address the following critical questions:
    (1) Does the draft criteria document accurately identify and 
characterize the health hazards of occupational exposures to 1-BP based 
on the current understanding of the scientific literature? Please 
identify any additional relevant literature that NIOSH should consider 
when developing its recommendations. Is the risk estimation for 1-BP 
presented in the draft criteria document a reasonable reflection of the 
current understanding of the scientific literature? Please describe any 
changes in the risk estimation that NIOSH should consider and provide 
supporting scientific literature.
    (2) Are there other risk assessment methods or health endpoints 
that NIOSH should consider for estimating risks of 1-BP? Please provide 
supporting scientific literature or other evidence to support your 
recommendations.
    (3) In this draft criteria document, NIOSH proposes a recommended 
exposure limit (REL) to prevent a risk of one excess cancer in 1000 
workers exposed to 1-BP for a 45-year working lifetime. During 
development of the draft criteria document, NIOSH also considered 
setting the REL at a level to prevent 1 excess cancer in 10,000 workers 
for a 45-year working lifetime. Please comment on the excess cancer 
risk level and resulting REL for 1-BP.
    (4) Is the relationship between exposure to 1-BP and biological 
activity (toxicity) accurately presented in the draft criteria 
document?
    (5) Are the recommended strategies for controlling or preventing 
exposure to 1-BP (e.g., engineering controls, work practices, personal 
protective equipment) reasonable and technically feasible?
    (6) Are there other techniques or technologies capable of 
controlling workplace exposures to 1-BP that should be discussed in the 
draft criteria document?
    (7) Are the exposure measurement methods and the associated 
challenges in measuring workplace exposures to 1-BP adequately 
addressed in the draft criteria document?
    (8) Are there medical screening and surveillance measures, such as 
specific diagnostic tests, guidelines, and metrics, that should be 
implemented for workers expected of being exposed to 1-BP that are not 
discussed in the draft criteria document?

[[Page 7123]]

    (9) Are there biological indices or metrics that should be used to 
aid in the interpretation of biomonitoring data for 1-BP? What is the 
most appropriate biomarker that can confirm and quantify occupational 
exposures to 1-BP?
    (10) Should acute exposure recommendations, such as a short term 
exposure limit (STEL), be derived for 1-BP? If so, what data support 
the development of the STEL?
    (11) NIOSH provided Globally Harmonized System (GHS) of 
Classification and Labelling of Chemicals designations for health 
endpoints evaluated in the criteria document. Please comment on the 
utility of these classifications for hazard communication. Are these 
classifications helpful for employers?

II. Public Meeting

    NIOSH will hold a public meeting on the draft document Criteria for 
a Recommended Standard: Occupational Exposure to 1-Bromopropane (1-BP) 
to allow commenters to provide oral comments on the draft document, to 
inform NIOSH about additional relevant data or information, and to ask 
questions on the draft document and NIOSH recommendations.
    This meeting is open to the public. Attendance is limited only by 
the space available. The meeting room accommodates 100 people. The 
meeting will be open to a limited number of participants through a 
conference call phone number and Webcast live on the Internet.
    Notification of intent to attend the meeting, for in-person and 
remote participation, must be made to the NIOSH Docket Office, at 
[email protected], (513) 533-8611, no later than March 16, 2016. 
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, first-served basis.
    Registration is required for in-person attendance and remote 
participation. Because this meeting is being held at a federal site, 
pre-registration is required on or before March 16, 2016 and a 
government-issued photo ID (driver's license, military ID or passport) 
will be required to obtain entrance to the facility. There will be an 
airport-type security check. Non[hyphen]US citizens need to register by 
February 24, 2016 to allow sufficient time for mandatory facility 
security clearance procedures to be completed. This information will be 
transmitted to the CDC Security Office for approval. An email 
confirming registration will be sent from NIOSH for both in-person 
participation and audio conferencing participation.
    Oral comments will be permitted for 15 minutes. If additional time 
becomes available, presenters will be notified. All requests to present 
should contain the name, address, telephone number, and relevant 
business affiliations of the presenter, topic of the presentation, 
whether you will be presenting in person or by phone, and the 
approximate time requested for the presentation. An email confirming 
registration will be sent from the NIOSH Docket Office and will include 
details needed to participate. Oral comments given at the meeting will 
be recorded and included in the docket.
    After reviewing the requests for presentations, NIOSH will notify 
the presenter when his/her presentation is scheduled. If a participant 
is not in attendance when his/her presentation is scheduled to begin, 
the remaining participants will be heard in order. After the last 
scheduled speaker is heard, participants who missed their assigned 
times may be allowed to speak, limited by time available.
    Attendees who wish to speak but did not submit a request for the 
opportunity to make a presentation may be given this opportunity after 
the scheduled speakers are heard, at the discretion of the presiding 
officer and limited by time available.
    You may submit comments, identified by CDC 2016-0003 and NIOSH 057-
A, by either of the following methods:
     Federal eRulemaking Portal: www.regulations.gov. Follow 
the instructions for submitting comments.
     Mail: National Institute for Occupational Safety and 
Health, NIOSH Docket Office, 1090 Tusculum Avenue, MS C-34, Cincinnati, 
Ohio 45226-1998.
    Instructions: All information received in response to this notice 
must include the agency name and docket number [CDC-2016-0003; NIOSH 
057-A]. All relevant comments received will be posted without change to 
www.regulations.gov including any personal information provided. All 
information will be available for public examination and copying at the 
NIOSH Docket Office, 1150 Tusculum Avenue, Room 155, Cincinnati, Ohio 
45226.
    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 February 24, 2016.

Name:
Gender:
Date of Birth:
Place of Birth (city, province, state, country):
Citizenship:
Passport Number:
Date of Passport Issue:
Date of Passport Expiration:
Type of Visa:
U.S. Naturalization Number (if a naturalized citizen):
U.S. Naturalization Date (if a naturalized citizen):
Visitor's Organization:
Organization Address:
Organization Telephone Number:
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.

Public Review

    The external review of the draft document has been (1) developed in 
accordance with Office of Management and Budget (OMB) guidelines, (2) 
is consistent with NIOSH peer review practice, and (3) is meant to 
ensure that credible and appropriate science is reflected within the 
draft document.

    Dated: February 4, 2016.
John Howard,
Director, National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention.
[FR Doc. 2016-02650 Filed 2-9-16; 8:45 am]
 BILLING CODE 4163-19-P