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)
Centers for Disease Control and Prevention
Federal Register Volume 81, Issue 27 (February 10, 2016)
| Page Range | 7122-7123 | |
| FR Document | 2016-02650 |
[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] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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
![7122 Federal Register / Vol. 81, No. 27 / Wednesday, February 10, 2016 / Notices
Model EBA 75 CCER for Mining. handling of 1–BP-containing materials. communication, development of
Pursuant to 42 CFR 84.301, NIOSH is seeking comments on the draft exposure measurement and control
manufacturers may continue to document and plans to have a public strategies).
manufacture, label, and sell large- meeting to discuss the document. The As part of the review of this draft
capacity CCERs approved under the draft document and instructions for criteria document, reviewers are asked
former regulatory standard in subpart H submitting comments can be found at to address the following critical
(those CCERs with a rated service time www.regulations.gov. questions:
of greater than 50 minutes) for mining, (1) Does the draft criteria document
DATES: The public meeting will be held
until 1 year after this approval date, or accurately identify and characterize the
on March 30, 2016, 9:00 a.m.–3:00 p.m. health hazards of occupational
until January 4, 2017. Eastern Time, or after the last public
All types of CCERs approved under exposures to 1–BP based on the current
commenter has spoken, whichever understanding of the scientific
subpart H that were manufactured and
occurs first. Comments must be received literature? Please identify any additional
labeled as NIOSH-approved and sold by
by April 29, 2016. relevant literature that NIOSH should
April 9, 2015, as well as those units
ADDRESSES: The public meeting will be consider when developing its
manufactured and labeled as NIOSH-
approved and sold during the extended held at the NIOSH/CDC Robert A. Taft recommendations. Is the risk estimation
time periods pursuant to § 84.301, may Laboratories, Auditorium, 1150 for 1–BP presented in the draft criteria
continue to be used as NIOSH-approved Tusculum Avenue, Cincinnati, Ohio document a reasonable reflection of the
respirators until the end of their service 45226. current understanding of the scientific
life. FOR FURTHER INFORMATION CONTACT: G. literature? Please describe any changes
Dated: February 1, 2016. Scott Dotson, NIOSH, Education and in the risk estimation that NIOSH
John Howard,
Information Division, Robert A. Taft should consider and provide supporting
Laboratories, 1090 Tusculum Avenue, scientific literature.
Director, National Institute for Occupational
Cincinnati, OH 45226, (513) 533–8540 (2) Are there other risk assessment
Safety and Health, Centers for Disease Control
and Prevention. (not a toll free number). methods or health endpoints that
SUPPLEMENTARY INFORMATION: NIOSH should consider for estimating
[FR Doc. 2016–02649 Filed 2–9–16; 8:45 am]
risks of 1–BP? Please provide
BILLING CODE 4163–19–P I. Background supporting scientific literature or other
On September 16, 2009, the National evidence to support your
DEPARTMENT OF HEALTH AND Institute for Occupational Safety and recommendations.
Health (NIOSH), Centers for Disease (3) In this draft criteria document,
HUMAN SERVICES
Control and Prevention (CDC) NIOSH proposes a recommended
Centers for Disease Control and announced in the Federal Register exposure limit (REL) to prevent a risk of
Prevention plans to evaluate the scientific data on one excess cancer in 1000 workers
1-bromopropane (1–BP) and to issue its exposed to 1–BP for a 45-year working
[Docket Number CDC–2016–0003; NIOSH lifetime. During development of the
findings on the potential health risks.
057–A]
The results of this evaluation are draft criteria document, NIOSH also
Draft Criteria for a Recommended presented in the draft document, considered setting the REL at a level to
Standard: Occupational Exposure to 1- Criteria for a Recommended Standard: prevent 1 excess cancer in 10,000
Bromopropane (1–BP); Notice of Occupational Exposure to workers for a 45-year working lifetime.
Public Meeting; Availability of Draft 1-Bromopropane (1–BP). The purpose of Please comment on the excess cancer
Document for Comment the public meeting and public comment risk level and resulting REL for 1–BP.
period is to obtain comments on the (4) Is the relationship between
AGENCY: National Institute for draft document. Special emphasis will exposure to 1–BP and biological activity
Occupational Safety and Health be placed on the following: (toxicity) accurately presented in the
(NIOSH) of the Centers for Disease • Whether the health hazard draft criteria document?
Control and Prevention (CDC), identification, risk estimation, and (5) Are the recommended strategies
Department of Health and Human discussion of health effects of 1–BP are for controlling or preventing exposure to
Services (HHS). a reasonable reflection of the current 1–BP (e.g., engineering controls, work
ACTION: Notice of public meeting and understanding of the scientific practices, personal protective
availability of draft document for public literature; equipment) reasonable and technically
comment. • Identifying workplaces and feasible?
occupations where exposure to 1–BP (6) Are there other techniques or
SUMMARY: On September 16, 2009, the may occur; technologies capable of controlling
National Institute for Occupational • Identifying studies on health effects workplace exposures to 1–BP that
Safety and Health (NIOSH), Centers for associated with occupational exposure should be discussed in the draft criteria
Disease Control and Prevention (CDC) to 1–BP that were not identified in the document?
announced in the Federal Register draft; (7) Are the exposure measurement
https://www.gpo.gov/fdsys/pkg/FR- • Identifying current strategies for methods and the associated challenges
2009-09-16/pdf/E9-22297.pdf plans to controlling or preventing exposure to 1– in measuring workplace exposures to 1–
asabaliauskas on DSK9F6TC42PROD with NOTICES2
evaluate the scientific data on BP (e.g., engineering controls, work BP adequately addressed in the draft
1-bromopropane (1–BP) and to issue its practices, personal protective criteria document?
findings on the potential health risks. A equipment); (8) Are there medical screening and
draft document entitled, Criteria for a • Identifying current exposure surveillance measures, such as specific
Recommended Standard: Occupational measurement methods and challenges diagnostic tests, guidelines, and metrics,
Exposure to 1-Bromopropane (1–BP), in measuring workplace exposures to 1– that should be implemented for workers
has been developed which contains an BP; and expected of being exposed to 1–BP that
assessment of toxicological data and • Identifying areas for future are not discussed in the draft criteria
provides recommendations for the safe collaborative efforts (e.g., research, document?
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![Federal Register / Vol. 81, No. 27 / Wednesday, February 10, 2016 / Notices 7123
(9) Are there biological indices or Oral comments will be permitted for Date of Passport Issue:
metrics that should be used to aid in the 15 minutes. If additional time becomes Date of Passport Expiration:
interpretation of biomonitoring data for available, presenters will be notified. Type of Visa:
U.S. Naturalization Number (if a naturalized
1–BP? What is the most appropriate All requests to present should contain citizen):
biomarker that can confirm and quantify the name, address, telephone number, U.S. Naturalization Date (if a naturalized
occupational exposures to 1–BP? and relevant business affiliations of the citizen):
(10) Should acute exposure presenter, topic of the presentation, Visitor’s Organization:
recommendations, such as a short term whether you will be presenting in Organization Address:
exposure limit (STEL), be derived for 1– person or by phone, and the Organization Telephone Number:
BP? If so, what data support the approximate time requested for the Visitor’s Position/Title within the
development of the STEL? Organization:
presentation. An email confirming
(11) NIOSH provided Globally registration will be sent from the NIOSH This information will be transmitted
Harmonized System (GHS) of Docket Office and will include details to the CDC Security Office for approval.
Classification and Labelling of needed to participate. Oral comments Visitors will be notified as soon as
Chemicals designations for health given at the meeting will be recorded approval has been obtained.
endpoints evaluated in the criteria and included in the docket. Public Review
document. Please comment on the After reviewing the requests for
utility of these classifications for hazard The external review of the draft
presentations, NIOSH will notify the
communication. Are these document has been (1) developed in
presenter when his/her presentation is
classifications helpful for employers? accordance with Office of Management
scheduled. If a participant is not in
and Budget (OMB) guidelines, (2) is
II. Public Meeting attendance when his/her presentation is
consistent with NIOSH peer review
scheduled to begin, the remaining
NIOSH will hold a public meeting on practice, and (3) is meant to ensure that
participants will be heard in order. After
the draft document Criteria for a credible and appropriate science is
the last scheduled speaker is heard,
Recommended Standard: Occupational reflected within the draft document.
participants who missed their assigned
Exposure to 1-Bromopropane (1–BP) to Dated: February 4, 2016.
times may be allowed to speak, limited
allow commenters to provide oral John Howard,
by time available.
comments on the draft document, to Attendees who wish to speak but did Director, National Institute for Occupational
inform NIOSH about additional relevant not submit a request for the opportunity Safety and Health, Centers for Disease Control
data or information, and to ask to make a presentation may be given and Prevention.
questions on the draft document and this opportunity after the scheduled [FR Doc. 2016–02650 Filed 2–9–16; 8:45 am]
NIOSH recommendations. speakers are heard, at the discretion of BILLING CODE 4163–19–P
This meeting is open to the public.
the presiding officer and limited by time
Attendance is limited only by the space
available.
available. The meeting room DEPARTMENT OF HEALTH AND
You may submit comments, identified
accommodates 100 people. The meeting HUMAN SERVICES
by CDC 2016–0003 and NIOSH 057–A,
will be open to a limited number of
by either of the following methods:
participants through a conference call • Federal eRulemaking Portal: Centers for Disease Control and
phone number and Webcast live on the www.regulations.gov. Follow the Prevention
Internet. instructions for submitting comments.
Notification of intent to attend the Disease, Disability, and Injury
• Mail: National Institute for
meeting, for in-person and remote Prevention and Control Special
Occupational Safety and Health, NIOSH Emphasis Panel (SEP): Initial Review
participation, must be made to the Docket Office, 1090 Tusculum Avenue,
NIOSH Docket Office, at nioshdocket@ MS C–34, Cincinnati, Ohio 45226–1998. In accordance with Section 10(a)(2) of
cdc.gov, (513) 533–8611, no later than Instructions: All information received the Federal Advisory Committee Act
March 16, 2016. Priority for attendance in response to this notice must include (Pub. L. 92–463), the Centers for Disease
will be given to those providing oral the agency name and docket number Control and Prevention (CDC)
comments. Other requests to attend the [CDC–2016–0003; NIOSH 057–A]. All announces a meeting for the initial
meeting will then be accommodated on relevant comments received will be review of applications in response to
a first-come, first-served basis. posted without change to Funding Opportunity Announcement
Registration is required for in-person www.regulations.gov including any (FOA) DP16–004, Childhood Obesity
attendance and remote participation. personal information provided. All Research Demonstration 2.0.
Because this meeting is being held at a information will be available for public Time and Date: 10:00 a.m.–6:00 p.m.,
federal site, pre-registration is required examination and copying at the NIOSH EST, March 15–16, 2016 (Closed).
on or before March 16, 2016 and a Docket Office, 1150 Tusculum Avenue, Place: Teleconference.
government-issued photo ID (driver’s Room 155, Cincinnati, Ohio 45226. Status: The meeting will be closed to
license, military ID or passport) will be Non-U.S. Citizens: Because of CDC the public in accordance with
required to obtain entrance to the Security Regulations, any non-U.S. provisions set forth in Section
facility. There will be an airport-type citizen wishing to attend this meeting 552b(c)(4) and (6), Title 5 U.S.C., and
security check. Non-US citizens need to must provide the following information the determination of the Director,
asabaliauskas on DSK9F6TC42PROD with NOTICES2
register by February 24, 2016 to allow in writing to the NIOSH Docket Officer Management Analysis and Services
sufficient time for mandatory facility at the address below no later than Office, CDC, pursuant to Public Law 92–
security clearance procedures to be February 24, 2016. 463.
completed. This information will be Matters for Discussion: The meeting
Name:
transmitted to the CDC Security Office Gender:
will include the initial review,
for approval. An email confirming Date of Birth: discussion, and evaluation of
registration will be sent from NIOSH for Place of Birth (city, province, state, country): applications received in response to
both in-person participation and audio Citizenship: FOA DP16–004, Childhood Obesity
conferencing participation. Passport Number: Research Demonstration 2.0.
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Document Created: 2016-02-10 00:19:27
Document Modified: 2016-02-10 00:19:27
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of public meeting and availability of draft document for public comment. | |
| 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. | |
| 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). | |
| FR Citation | 81 FR 7122 |
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