80 FR 24932 - Request for the Technical Review of 19 Draft Skin Notation Assignments and Skin Notation Profiles

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

Federal Register Volume 80, Issue 84 (May 1, 2015)

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 19 chemicals. NIOSH is requesting technical reviews of the draft Skin Notation Profiles.

[Federal Register Volume 80, Number 84 (Friday, May 1, 2015)]
[Notices]
[Pages 24932-24934]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-10289]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket Number CDC-2015-0021, NIOSH 153-C]


Request for the Technical Review of 19 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 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 skin notations and supporting 
technical documents entitled, Skin Notations Profiles, for 19 
chemicals. NIOSH is requesting technical reviews of the draft Skin 
Notation Profiles.

DATES: Electronic or written comments must be received by June 30, 
2015.

ADDRESSES: You may submit comments, identified by CDC-2015-0021 and 
docket number NIOSH 153-C, by any 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-2015-0021; NIOSH 
153-C]. 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 
45226-1998.

FOR FURTHER INFORMATION CONTACT: Naomi Hudson, NIOSH Robert A. Taft 
Laboratories, MS-C32, 1190 Tusculum Ave., Cincinnati, OH 45226. 
(513)533-8388 (not a toll free number).

SUPPLEMENTARY INFORMATION: This review follows the publication of 22 
Skin Notation Profiles, Docket Number NIOSH 153-A http://www.cdc.gov/niosh/docket/archive/docket153A.html and the external review of an 
additional 25 Skin Notation Profiles, Docket Number NIOSH 153-B http://www.cdc.gov/niosh/docket/archive/docket153B.html. To facilitate 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

[[Page 24933]]

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?
    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, http://www.cdc.gov/niosh/npg/]. 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 19 chemicals. The draft Skin Notation 
Profiles were developed to provide the scientific rationale behind the 
hazard-specific skin notation (SK) assignments for the following 
chemicals:

------------------------------------------------------------------------
             Substance(s)
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Trichloroethylene....................  (CAS #79-01-06)
Acrylic acid.........................  (CAS #79-10-7)
Tetraethyl lead......................  (CAS #78-00-2)
Tetramethyl lead.....................  (CAS #75-74-1)
2-Hydropropyl acrylate...............  (CAS #999-61-1)
Dimethyl sulfate.....................  (CAS #77-78-1)
Arsenic..............................  (CAS #7440-38-2)
Pentachlorophenol....................  (CAS #87-86-5)
Dichlorvos...........................  (CAS #62-73-7)
Heptachlor...........................  (CAS #76-44-8)
Disulfoton...........................  (CAS #298-04-4)
Atrazine.............................  (CAS #1912-24-9)
Morpholine...........................  (CAS #110-91-8)
EPN..................................  (CAS #2104-64-5)
Sodium fluoroacetate.................  (CAS #62-74-8)
Chlorinated camphene.................  (CAS #8001-35-2)
Dioxathion...........................  (CAS#78-34-2)
Catechol.............................  (CAS #120-80-9)

[[Page 24934]]

 
1-Bromopropane.......................  (CAS #106-94-5)
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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: April 22, 2015.
John Howard,
Director, National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention.
[FR Doc. 2015-10289 Filed 4-30-15; 8:45 am]
 BILLING CODE 4163-19-P