Request for Public Comment on the Draft Skin notation profiles: Allyl alcohol, Formamide, Formic Acid, Phenothiazine, and Picric Acid

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 support technical documents, entitled Skin Notations Profiles, for 5 chemicals.

NIOSH seeks comments on the draft skin notation (SK) assignments and Skin Notation Profiles. 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. The draft Skin Notation Profiles were developed to provide the scientific rationale behind the hazard-specific SK assignments for the following chemicals:

Substance(s)

· Allyl alcohol (CAS: 107-18-6)

· Formamide (CAS: 75-12-7)

· Formic acid (CAS: 64-18-6)

· Picric acid (CAS: 88-89-1)

· Phenothiazine (CAS: 92-84-2)

To facilitate the review of these documents, NIOSH requests that the following questions be taken into consideration:

NIOSH is requesting public comment on draft Skin Notation Profile documents for the chemicals Allyl alcohol, Formamide, Formic Acid, Phenothiazine, and Picric Acid. To facilitate the review of these documents, NIOSH requests responses to the following specific questions for each draft Profile document:

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)? If not clear, what clarification is suggested?
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)? If not clear, what clarification is suggested?
5. Does this document clearly outline the immune-mediated responses (allergic response) 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 assigned (e.g., insufficient data, no identified health hazard)? If not clear, what clarification is suggested?
7. If the ID (SK) or SK were assigned, are the rationale and logic outlined clearly within the document? If not clear, what clarification is suggested?
8. Are the conclusions supported by the data? If not, what changes are suggested?
9. Are the tables clear and appropriate? If not, what changes are suggested?
10.  Are you aware of any scientific data reported in governmental publications, databases, peer-reviewed journals, or other sources that should be considered within this document? Please include the full reference citation for any additional scientific data to be considered.
11. There have been considerable improvements and advancements in dermal absorption studies and modeling since the publication of NIOSH Current Intelligence Bulletin 61: A Strategy for Assigning New NIOSH Skin Notations [NIOSH 2017]. In response to expert external peer reviewers’ comments regarding the limitation of the skin to inhalation dose (SI) ratio information, the SI ratio was removed from the individual skin notation profile documents. Do you have any information to support removing or including the SI ratio information in these NIOSH documents?

To view the notice and related materials, visit https://www.regulations.gov and enter CDC-2024-0085 in the search field and click “Search.”

Public Comment Period

Comments will be accepted until 11:59 p.m. ET on December 27, 2024.

Written comments, identified by CDC-2024-0085 and docket number NIOSH-153-F, may be submitted by any of the following methods:

• Federal rulemaking portal: Follow the instructions for submitting comments.

• Instructions: All submissions received must include the agency name and docket number. All relevant comments, including any personal information provided, will be posted without change to https://www.regulations.gov

• Mail: NIOSH Docket Office
  1090 Tusculum Avenue
  MS-C34
  Cincinnati, OH 45226