[Federal Register Volume 78, Number 226 (Friday, November 22, 2013)]
[Notices]
[Pages 70047-70049]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-28019]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[CDC-2013-0022; Docket Number NIOSH 153-B]


Request for the Technical Review of 25 Draft Skin Notation 
Assignments and Skin Notation 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 comments.

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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 skin notations and supporting 
technical documents entitled, Skin Notations Profiles, for 25 
chemicals. NIOSH is requesting technical reviews of the draft Skin 
Notation Profiles. This review is consistent with the process used for 
the publication of the first 20 Skin Notation Profiles, Docket Number 
NIOSH 153-A [http://www.cdc.gov/niosh/docket/archive/docket153A.html]. 
To facilitate

[[Page 70048]]

the review of these documents, NIOSH requests that the following 
questions be taken into consideration for each Skin Notation Profile:
    1. Does this document clearly outline the systemic health hazards 
associated with exposures of the skin to the chemical? If not, what 
specific information is missing from the document?
    2. If the SYS or SYS (FATAL) notations are assigned, are the 
rationale and logic behind the assignment clear? If not assigned, is 
the logic clear why it was not (e.g., insufficient data, no identified 
health hazard)?
    3. Does this document clearly outline the direct (localized) health 
hazards associated with exposures of the skin to the chemical? If not, 
what specific information is missing from the document?
    4. If the DIR, DIR (IRR), or DIR (COR) notations are assigned, are 
the rationale and logic behind the assignment clear? If not assigned, 
is the logic clear why it was not (e.g., insufficient data, no 
identified health hazard)?
    5. Does this document clearly outline the immune-mediated responses 
(allergic response) health hazards associated with exposures of the 
skin to the chemical? If not, what specific information is missing from 
the document?
    6. If the SEN notation is assigned, are the rationale and logic 
behind the assignment clear? If not assigned, is the logic clear why it 
was not (e.g., insufficient data, no identified health hazard)?
    7. If the ID (SK) or SK were assigned, are the rationale and logic 
outlined within the document?
    8. Are the conclusions supported by the data?
    9. Are the tables clear and appropriate?
    10. Is the document organized appropriately? If not, what 
improvements are needed?
    11. 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?

DATES: Electronic or written comments on the 25 documents contained 
within Group B must be received on or before January 21, 2014.

ADDRESSES: You may submit comments, identified by CDC-2013-0022 and 
docket number NIOSH 153-B, by any of the two following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: NIOSH Docket Office, Robert A. Taft Laboratories, 
MS-C34, 4676 Columbia Parkway, Cincinnati, OH 45226.
    All information received in response to this notice must include 
the agency name and docket number [CDC-2013-0022; NIOSH 153-B]. 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. To view this 
notice and related materials, visit www.regulations.gov and enter CDC-
2013-0022 in the search field and click ``search.''
    All information received in response to this notice will be 
available for public examination and copying at the NIOSH Docket 
Office, 4676 Columbia Parkway, Cincinnati, Ohio 45226.

FOR FURTHER INFORMATION CONTACT: Naomi Hudson, NIOSH, Robert A. Taft 
Laboratories, MS-C32, 4676 Columbia Parkway, Cincinnati, OH 45226, 
telephone (513) 533-8388 or G. Scott Dotson, NIOSH, Robert A. Taft 
Laboratories, MS-C32, 4676 Columbia Parkway, Cincinnati, OH 45226, 
telephone (513) 533-8540.

SUPPLEMENTARY INFORMATION: In 2009, NIOSH published Current 
Intelligence Bulletin (CIB) 61--A Strategy for Assigning New NIOSH Skin 
Notations [NIOSH 2009-147; http://www.cdc.gov/niosh/docs/2009-147/pdfs/2009-147.pdf]. The CIB presents a strategic framework that is a form of 
hazard identification that has been designed to do the following:
    1. Ensure that the assigned skin notations reflect the contemporary 
state of scientific knowledge
    2. Provide transparency behind the assignment process
    3. Communicate the hazards of chemical exposures of the skin
    4. Meet the needs of health professionals, employers, and other 
interested parties in protecting workers from chemical contact with the 
skin.
    This strategy involves the assignment of multiple skin notations 
for distinguishing systemic (SYS), direct (DIR), and sensitizing (SEN) 
effects caused by exposure of skin (SK) to chemicals. Chemicals that 
are highly or extremely toxic and may be potentially lethal or life-
threatening following exposures of the skin are designated with the 
systemic subnotation (FATAL). Potential irritants and corrosive 
chemicals are indicated by the direct effects subnotations (IRR) and 
(COR), respectively. Thus with the new strategy, chemicals labeled as 
SK: SYS are recognized to contribute to systemic toxicity through 
dermal absorption. Chemicals assigned the notation SK: SYS (FATAL) have 
been identified as highly or extremely toxic and have the potential to 
be lethal or life-threatening following acute contact with the skin. 
Substances identified to cause direct effects (i.e., damage or 
destruction) to the skin limited to or near the point of contact are 
labeled SK: DIR, and those resulting in skin irritation and corrosion 
at the point of contact are labeled as SK: DIR (IRR) and SK: DIR (COR), 
respectively. The SK: SEN notation is used for substances identified as 
causing or contributing to allergic contact dermatitis (ACD) or other 
immune-mediated responses, such as airway hyper reactivity (asthma). 
Candidate chemicals may be assigned more than one skin notation when 
they are identified to cause multiple effects resulting from skin 
exposure. For example, if a chemical is identified as corrosive and 
also contributes to systemic toxicity, it will be labeled as SK: SYS-
DIR (COR). When scientific data for a chemical indicate that skin 
exposure does not produce systemic, direct, or sensitizing effects, the 
compound will be assigned the notation (SK). The ID\(SK)\ notation is 
assigned to indicate that insufficient data on the health hazards 
associated with skin exposure to a substance exist at the time of the 
review to determine whether the chemical has the potential to act as a 
systemic, direct, or sensitizing agent. The ND notation indicates that 
a chemical has not been evaluated by the strategy outlined in this CIB 
and that the health hazards associated with skin exposure are unknown.
    Historically, skin notations have been published in the NIOSH 
Pocket Guide to Chemical Hazards [NIOSH 2005-149]. This practice will 
continue with the NIOSH skin notation assignments for each evaluated 
chemical being integrated as they become available. A support document 
called a Skin Notation Profile has been developed for each evaluated 
chemical. NIOSH submitted the first group of Skin Notation Profiles for 
external review in 2010 [75 FR 22148] and published the finalized 
reports in 2011 [http://www.cdc.gov/niosh/topics/skin/skin-notation_profiles.html]. The Skin Notation Profile for a chemical is intended to 
provide information supplemental to the skin notation, including a 
summary of all relevant data used to aid in determining the hazards 
associated with skin exposures.
    NIOSH seeks comments on the draft skin notation assignments and 
Skin Notation Profiles for 25 chemicals. The draft Skin Notation 
Profiles were developed to provide the scientific rationale behind the 
hazard-specific

[[Page 70049]]

skin notation (SK) assignments for the following chemicals:

------------------------------------------------------------------------
             Document                           Substance(s)
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B-01..............................  Allyl glycidyl ether (CAS
                                     108-92-3).
B-02..............................  2-Diethylaminoethanol (CAS
                                     100-37-8).
B-03..............................  Methyl isocyanate (CAS 624-
                                     83-9).
B-04..............................  2-Ethoxyethyl acetate (CAS
                                     111-15-9).
B-05..............................  Propargyl alcohol (CAS 107-
                                     19-7).
B-06..............................  Ethyl acrylate (CAS 140-88-
                                     5).
B-07..............................  Isophorone diisocyanate (CAS 4098-71-9).
B-08..............................  Nitrobenzene (CAS 98-95-3).
B-09..............................  Phenylhydrazine (CAS 100-63-
                                     0).
B-10..............................  2-Mercaptobenzothiazole (CAS 149-30-4).
B-11..............................  Aniline (CAS 62-53-3).
B-12..............................  Captafol (CAS 2425-06-1).
B-13..............................  Dinitro-o-cresol (CAS 534-
                                     52-1).
B-14..............................  Aldrin (CAS 309-00-2).
B-15..............................  Dieldrin (CAS 60-57-1).
B-16..............................  Parathion (CAS 56-38-2).
B-17..............................  Nicotine (CAS 54-11-5).
B-18..............................  Azinphos-methyl (CAS 86-50-
                                     0).
B-19..............................  Endrin (CAS 72-20-8).
B-20..............................  Methyl parathion (CAS 298-
                                     00-0).
B-21..............................  Phorate (CAS 298-02-2).
B-22..............................  Phosdrin (CAS 7786-34-7).
B-23..............................  TEDP (CAS 3689-24-5).
B-24..............................  TEPP (CAS 107-49-3).
B-25..............................  Chlordane (CAS 57-74-9).
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    Each Skin Notation Profile provides a detailed summary of the 
health hazards of skin contact and rationale for the proposed SK 
assignment with the chemical(s)-of-interest.

    Dated: November 14, 2013.
John Howard,
Director, National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention.
[FR Doc. 2013-28019 Filed 11-21-13; 8:45 am]
BILLING CODE 4163-19-P