[Federal Register Volume 82, Number 49 (Wednesday, March 15, 2017)]
[Notices]
[Pages 13809-13811]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05115]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[CDC-2017-0028, Docket Number NIOSH-290]


Draft Current Intelligence Bulletin: The Occupational Exposure 
Banding Process: Guidance for the Evaluation of Chemical Hazards; 
Notice of Public Meeting; Request for Comments

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: The National Institute for Occupational Safety and Health 
(NIOSH) of the Centers for Disease Control and Prevention (CDC) 
announces the availability of a draft Current Intelligence Bulletin 
entitled The Occupational Exposure Banding Process: Guidance for the 
Evaluation of Chemical Hazards for public comment. NIOSH is seeking 
comments on the draft document and plans to have a public meeting to 
discuss the document. The draft document can be found at 
www.regulations.gov by entering CDC-2017-0028 in the search field and 
clicking ``Search.''

Table of Contents

 Dates
 Addresses
 For Further Information Contact
 Supplementary Information
 Background


DATES: A public meeting will be held on Tuesday, May 23, 2016, from 
9:00 a.m. to 3:00 p.m. Eastern Time, or until the last public presenter 
has spoken, whichever occurs first. 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. Electronic or written 
comments must be received by June 13, 2017.

ADDRESSES: The public meeting will be held at the Robert A. Taft 
Laboratories, Auditorium, 1150 Tusculum Avenue, Cincinnati, Ohio 45226. 
The meeting will also be available through a conference call phone 
number and Webcast live on the Internet for a limited number of 
participants.
    Written Comments: You may submit written comments, identified by 
CDC-2017-0028 and Docket Number NIOSH-290, by either of the following 
two 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.
    All information received in response to this notice must include 
the agency name and docket number [CDC-2017-0028; NIOSH-290]. All 
relevant comments received, including any personal information 
provided, will be posted without change to www.regulations.gov. To 
access the docket, read background documents or read comments, go to 
www.regulations.gov and enter CDC-2017-0028 in the search field and 
clicking ``Search.'' All information received in response to this 
notice will be available for public examination and

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copying at the NIOSH Docket Office, 1150 Tusculum Avenue, Room 155, 
Cincinnati, Ohio 45226-1998.

FOR FURTHER INFORMATION CONTACT: Melissa Seaton, NIOSH, Education and 
Information Division, 1090 Tusculum Avenue, MS C-32, Cincinnati, OH 
45226, telephone (513) 533-8248, Fax (513) 533-8230 (not toll free 
numbers), email [email protected].

SUPPLEMENTARY INFORMATION:
    Registration: Notification of intent to attend the meeting, for 
both in-person and remote participation, or to provide oral comments 
must be made to the NIOSH Docket Office, at [email protected], (513) 
533-8611 (not a toll free number), no later than April 21, 2017 for 
U.S. citizens, and no later than April 7, 2017 for non-U.S. citizens, 
to allow sufficient time for mandatory facility security clearance 
procedures to be completed. 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. 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. Oral presentations 
will be limited to 15 minutes per presenter. If additional time becomes 
available, presenters will be notified.
    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. Oral comments 
given at the meeting will be recorded and included in the docket.
    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.
    Status: The meeting is open to the public, limited only by the 
space available. The meeting space accommodates approximately 100 
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 April 21, 2017 with the contact person in this notice.
    Security Considerations: Due to mandatory security clearance 
procedures at the Robert A Taft Laboratories, 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 April 7, 2017 to the contact person in this 
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.
    Non-U.S. Citizens must provide the following information in writing 
to the NIOSH Docket Office at the address above no later than April 7, 
2017: 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. If access approval is not granted to a non-U.S. Citizen, the 
individual may participate through a conference call phone number and 
Webcast live on the Internet.

Background

    Occupational exposure banding is a process of quickly assigning 
chemicals into specific categories or bands. These bands are assigned 
based on a chemical's potency and the negative health outcomes 
associated with exposure to the chemical. The output of this process is 
an occupational exposure band (OEB), which corresponds to a range of 
exposure concentrations that is expected to be protective to worker 
health. Recently NIOSH has developed a process to apply the 
occupational exposure banding process to a broad spectrum of 
occupational settings. The NIOSH occupational exposure banding process 
uses available, but often limited, toxicological data to determine a 
potential range of chemical exposure levels that can be used as targets 
for exposure controls to reduce risk among workers.
    The purpose of the public meeting and public comment period is to 
obtain comments on the draft document. Comments are being sought from 
individuals including scientists and representatives from various 
government agencies, industry, labor, and other stakeholders, and also 
the public. If there are errors of fact, unsubstantiated claims, 
evidence of careless experimental work, inclusion of too much 
information already in the literature, or statements that are 
inaccurate, please note such in your review comments.
    I. Technical Review and Charge Questions. The authors ask that 
special emphasis be placed on technical review of the following issues:
    1. If a chemical can cause an immediate effect (necrosis, 
sensitization, pulmonary edema, central nervous system (CNS) effects), 
should there be special guidelines for assigning a short term OEB or 
emphasizing the importance of keeping even short duration exposures 
below the OEB for those types of toxicants?
    2. If a skin toxicant is a corrosive, irritant, or sensitizer, 
should there be any special designation assigned along with the 
occupational exposure band (OEB)? Additionally, please comment on the 
utility of using skin and eye effects to create inhalation based bands.
    3. The comparison of Tier 1 and Tier 2 results for a set of 
chemicals showed that Tier 1 and Tier 2 produce the same band for 65% 
of the chemicals tested. Tier 1 is more protective for 17.5% of the 
chemicals, while Tier 2 is more protective for 17.5% of the chemicals. 
NIOSH currently recommends that both the tier 1 and tier 2 process be 
completed for a particular chemical. Do you agree with this 
recommendation? If not, what approach should NIOSH take?
    4. NIOSH has proposed a number of sources of information for the 
different human health and toxicological endpoints under consideration. 
Are there other sources of information that should be recommended? Are 
there some sources that should be omitted?
    5. In tier 1, the NIOSH method does not currently assign chemicals 
to an OEB based on H335 or H336 (drowsiness and dizziness). Should 
NIOSH include H335/H336 in the tier 1 methodology? If so, what criteria 
should be used for banding and why?
    6. In Section 3.2 the process for assessing whether enough 
information is available to conduct occupational exposure banding is 
presented. Please comment on the use of a numerical scale (determinant 
scores) to document endpoint-specific data availability. Further, is 
the minimum value of 30 out

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of a possible total of 125 (for the total determinant score) a suitable 
choice for the data sufficiency threshold? Is the relative weight for 
each score appropriate?
    7. How should NIOSH consider data collected on structural analogs 
or related chemicals in the banding scheme?
    8. Qualitative and quantitative technical criteria have been 
adopted for some endpoints. Is this approach adequately justified and 
suitably explained in the document? If not, how should the explanations 
be refined?
    9. If a chemical has two forms (vapor or particulate) in the 
workplace, we have recommended that the most protective OEB take 
precedence. Please comment on the utility and adequacy of that 
recommendation.
    10. Acute toxicity information may be presented in an array of 
different units. We have attempted to address those possibilities in 
the banding criteria for the acute toxicity endpoint, especially for 
inhalation exposures. Is this information sufficiently clear? Are 
suitable rubrics for unit conversions provided?
    11. Does this draft document adequately describe the occupational 
exposure banding process in a way that supports its use in assigning 
ranges of exposure concentrations to protect worker health in the 
occupational setting?

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: March 10, 2017.
Frank Hearl,
Chief of Staff, National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention.
[FR Doc. 2017-05115 Filed 3-14-17; 8:45 am]
 BILLING CODE 4163-19-P