2015-10289. 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.

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. [phone] (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 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)
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)
1-Bromopropane	(CAS #106-94-5)

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.