[Federal Register Volume 80, Number 84 (Friday, May 1, 2015)]
[Notices]
[Pages 24930-24931]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-10295]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket Number CDC-2015-0020; NIOSH 156-A]


Request for the Technical Review of 14 Draft Immediately 
Dangerous to Life or Health (IDLH) Value Profiles

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: Request for information and comment.

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SUMMARY: The National Institute for Occupational Safety and Health 
(NIOSH) of the Centers for Disease Control and Prevention (CDC) is 
conducting a public review of the draft immediately dangerous to life 
or health (IDLH) values and support technical documents, entitled IDLH 
Values Profiles, for 14 chemicals. NIOSH is requesting technical 
reviews of the draft IDLH Value Profiles.

DATES: Electronic or written comments on the 14 documents contained 
within Group A must be received on or before June 30, 2015.

ADDRESSES: You may submit comments, identified by CDC-2015-0020 and 
docket number NIOSH 156-A, by either of the two following methods:
     Federal eRulemaking Portal: http://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, 
OH 45226.
    Instructions: All information received in response to this notice 
must include the agency name and docket number [CDC-2015-0020; NIOSH 
156-A]. All relevant comments received will be posted without change to 
www.regulations.gov, including any personal information provided. All 
electronic comments should be formatted as Microsoft Word. For access 
to the docket to read background documents or comments received, go to 
www.regulations.gov. All information received in response to this 
notice will also be available for public examination and copying at the 
NIOSH Docket Office, 1150 Tusculum Avenue, Room 155, Cincinnati, OH 
45226.

FOR FURTHER INFORMATION CONTACT: G. Scott Dotson, NIOSH, Robert A. Taft 
Laboratories, MS C-32, 1090 Tusculum Avenue, Cincinnati, OH 45226. 
(513) 533-8540 (not a toll free number).

SUPPLEMENTARY INFORMATION: The draft documents are based on the process 
outlined in the NIOSH Current Intelligence Bulletin 66--Derivation of 
Immediately Dangerous to Life or Health (IDLH) Values http://www.cdc.gov/niosh/docs/2014-100/pdfs/2014-100.pdf. To facilitate the 
review of these documents, NIOSH requests that the following questions 
be taken into consideration:
    1. Does this document clearly outline the health hazards associated 
with acute (or short-term) exposures to the chemical? If not, what 
specific information is missing from the document?
    2. Are the rationale and logic behind the derivation of an IDLH 
value for a specific chemical clearly explained? If not, what specific 
information is needed to clarify the basis of the IDLH value?
    3. Are the conclusions supported by the data?
    4. Are the tables clear and appropriate?
    5. Is the document organized appropriately? If not, what 
improvements are needed?
    6. Are you aware of any scientific data reported in governmental 
publications, databases, peer-reviewed journals, or other sources that 
should be included within this document?
    NIOSH seeks comments on 14 draft IDLH values and IDLH Value 
Profiles. The draft IDLH Value Profiles were developed to provide the 
scientific rationale behind derivation of IDLH values for the following 
chemicals:

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             Document No.                          Chemical(s)
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A-01..................................  Acrylonitrile...................  (CAS# 107-13-1)
A-02..................................  Benzonitrile....................  (CAS# 100-47-0)
A-03..................................  Methyl isocyanate...............  (CAS# 624-83-9)
A-04..................................  HCFC-141B.......................  (CAS# 1717-00-6)
A-05..................................  Chloroacetyl chloride...........  (CAS# 79-04-9)
A-06..................................  Chlorine pentafluoride..........  (CAS# 13637-63-3)
                                        Bromine pentafluoride...........  (CAS# 7789-30-2)
A-07..................................  Iron pentacarbonyl..............  (CAS# 13463-40-6)
A-08..................................  1,3-Butadiene...................  (CAS# 106-99-0)
A-09..................................  Diketene........................  (CAS# 674-82-8)
A-10..................................  Furan...........................  (CAS# 110-00-9)
A-11..................................  Hexafluoroacetone...............  (CAS# 684-16-2)
A-12..................................  n-Butyl acrylate................  (CAS# 141-32-2)
A-13..................................  Peracetic acid..................  (CAS# 79-21-0)
A-14..................................  Butane..........................  (CAS# 106-97-8).
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    Each IDLH Value Profile provides a detailed summary of the health 
hazards of acute exposures to high airborne concentrations and the 
rationale for the proposed IDLH value with the chemical(s) of interest.
    In 2013, NIOSH published Current Intelligence Bulletin (CIB) 66--
Derivation of Immediately Dangerous to Life or Health (IDLH) Values 
[NIOSH 2014-100; http://www.cdc.gov/niosh/docs/2014-100/pdfs/2014-100.pdf]. The draft documents available for public review use the 
methodology in this document. Since the establishment of the IDLH 
values in the 1970s, NIOSH has continued to review available scientific 
data to improve the protocol used to derive acute exposure guidelines, 
in addition to the chemical-specific IDLH values. The information 
presented in this CIB represents the most recent update of the 
scientific rationale and the methodology (hereby referred to as the 
IDLH methodology) used to derive IDLH values. The primary objectives of 
this document are to:
    1. Provide a brief history of the development of IDLH values
    2. Update the scientific basis and risk assessment methodology used 
to derive IDLH values from quality data
    3. Provide transparency behind the rationale and derivation process 
for IDLH values

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    4. Demonstrate how scientifically credible IDLH values can be 
derived from available data resources
    The IDLH methodology outlined in this CIB reflects the modern 
principles and understanding in the fields of risk assessment, 
toxicology, and occupational health and provides the scientific 
rationale for the derivation of IDLH values based on contemporary risk 
assessment practices. According to this protocol, IDLH values are based 
on health effects considerations determined through a critical 
assessment of the toxicology and human health effects data. This 
approach ensures that the IDLH values reflect an airborne concentration 
of a substance that represents a high-risk situation that may endanger 
workers' lives or health. Relevant airborne concentrations are 
typically addressed through the characterization of inhalation 
exposures; however, airborne chemicals can also contribute to toxicity 
through other exposure routes, such as the skin and eyes. In this 
document, airborne concentrations are referred to as acute inhalation 
limits or guidelines to adhere to commonly used nomenclature.
    The emphasis on health effects is consistent with both the 
traditional use of IDLH values as a component of the respirator 
selection logic and the growing applications of IDLH values in Risk 
Management Plan (RMPs) for non-routine work practices governing 
operations in high-risk environments (e.g., confined spaces) and the 
development of Emergency Preparedness Plans (EPPs). Incorporated in the 
IDLH methodology are the standing guidelines and procedures used for 
the development of community-based acute exposure limits called Acute 
Exposure Guideline Levels (AEGLs). The inclusion of the AEGL 
methodology has helped ensure that the health-based IDLH values derived 
with use of the guidance provided in this document are based on 
validated scientific rationale.
    The IDLH methodology is based on a weight-of-evidence approach that 
applies scientific judgment for critical evaluation of the quality and 
consistency of scientific data and in extrapolation from the available 
data to the IDLH value. The weight-of-evidence approach refers to 
critical examination of all available data from diverse lines of 
evidence and the derivation of a scientific interpretation on the basis 
of the collective body of data, including its relevance, quality, and 
reported results. This is in contrast to a purely hierarchical or 
strength-of-evidence approach, which relies on rigid decision criteria 
for selecting a critical adverse effect, a point of departure (POD), or 
the point on the dose-response curve from which dose extrapolation is 
initiated and for applying default uncertainty factors (UFs) to derive 
the IDLH value. Conceptually, the derivation process for IDLH values is 
similar to that used in other risk assessment applications, including 
these steps:
    1. Hazard characterization.
    2. Identification of critical adverse effects.
    3. Identification of a POD.
    4. Application of appropriate UFs, based on the study and POD.

    Dated: April 24, 2015.
John Howard,
Director, National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention.
[FR Doc. 2015-10295 Filed 4-30-15; 8:45 am]
 BILLING CODE 4163-19-P