The eRulemaking Program

10/28/2024 | Press release | Distributed by Public on 10/28/2024 06:07

Request for Public Comment on the Draft Skin Notation Profiles: Allyl Alcohol, Formamide, Formic Acid, Phenothiazine, and Picric Acid

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket Number CDC-2024-0085, NIOSH-153-F]

Request for Public Comment on the Draft Skin Notation Profiles: Allyl Alcohol, Formamide, Formic Acid, Phenothiazine, and Picric Acid

AGENCY:

Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

ACTION:

Request for comment.

SUMMARY:

The National Institute for Occupational Safety and Health (NIOSH) in the Centers for Disease Control and Prevention (CDC), an Operating Division of the Department of Health and Human Services (HHS), requests public comment on the draft Skin Notation Profiles: Allyl alcohol, Formamide, Formic Acid, Phenothiazine, and Picric Acid.

DATES:

Electronic or written comments must be received by December 27, 2024.

ADDRESSES:

You may submit comments, identified by docket number CDC-2024-0085 and docket number NIOSH-153-F, by either of the following methods:

Federal eRulemaking Portal: https://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 45226-1998.

Instructions: All information received in response to this notice must include the agency name and docket number (CDC-2024-0085; NIOSH-153-F). All relevant comments, including any personal information provided, will be posted without change to https://www.regulations.gov. Do not submit comments by email. CDC does not accept comments by email. For access to the docket to read background documents or comments received, go to https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:

Naomi Hudson, DrPH, National Institute for Occupational Safety and Health, MS C-15, 1090 Tusculum Avenue, Cincinnati, OH 45226-1998. Telephone: (513) 533-8388.

SUPPLEMENTARY INFORMATION:

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?

The draft Skin Notation Profiles were developed to provide the scientific rationale behind the development of skin notation designations for the following chemicals:

  • 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)

The Skin Notation Profiles provide a detailed summary of the health hazards of chemical exposure to the skin. The final publication, which will address public comments, will be available on the NIOSH website and in the NIOSH docket (153-F) and in Regulations.gov (CDC-2024-0085).

Background: In 2009, NIOSH published Current Intelligence Bulletin (CIB) 61: A Strategy for Assigning New NIOSH Skin Notations [NIOSH 2009]. The CIB presents a strategic framework that is a form of hazard identification designed to do the following:

  • Ensure that the assigned skin notations reflect the contemporary state of scientific knowledge
  • Provide transparency behind the assignment process
  • Communicate the hazards of chemical exposures of the skin
  • 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. The five draft Skin Notation Profiles available for review were developed following the framework in NIOSH CIB 61.

Reference

NIOSH [2009]. Current Intelligence Bulletin 61: A strategy for assigning new NIOSH skin notations. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication 2009-147, https://www.cdc.gov/niosh/docs/2009-147/.

Dated: October 23, 2024.
John J. Howard,
Director, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, Department of Health and Human Services.
[FR Doc. 2024-24983 Filed 10-25-24; 8:45 am]
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