The Review of 19 Draft Skin Notation Assignments and Skin Notation Profiles

The purpose of the Skin Notation Profiles is to summarize the available data on the hazards of dermal exposure to the chemical(s)-of-interest and provide the scientific rationale for the assignment of hazard-specific skin notations (SK) for systemic, direct, and sensitizing effects. These technical documents have been designed to provide exposure recommendations to occupational health practitioners, researchers, policy- and decision-makers, employers, and workers concerned about dermal exposures so that improved risk-management practices may be developed to better protect workers from the risks of dermal contact with the chemical(s)-of-interest. Historically, skin notations have been published in the NIOSH Pocket Guide to Chemical Hazards [NIOSH 2005-149], and this practice will continue for each evaluated chemical. The Skin Notation Profiles do not have the force and effect of law.

Document Review Process: In 2015, NIOSH posted in the Federal Register [80 FR 24932] an announcement of the availability of the draft Skin Notation Profiles for public review and comment. The external review, which included reviews by peers, stakeholders, and the public, was conducted in accordance with the Office of Management and Budget (OMB) guidelines under the Federal Data Quality Act 2000 (Public Law 106-554, Section 1(a)(3)[515]) based on the classification of the draft technical reports by NIOSH as a Highly Influential Scientific Assessments (HISA). The draft technical reports were submitted for review to peers that were selected because they are recognized as subject matter experts (SMEs) in the fields of toxicology, industrial hygiene, occupational medicine, dermatology, and human health risk assessment. In addition, stakeholders and the public were provided the opportunity to review the draft technical reports and submit comments via the Federal rulemaking portal: https://www.regulations.gov and the NIOSH docket office. All comments that were received during the external review were evaluated for their scientific and technical merit. The final Skin Notation Profiles include changes that are based on the comments submitted from peer reviewers, in addition to stakeholders and the public.

To view the notice and related materials, visit https://www.regulations.gov and enter CDC-2015-0021 in the search field and click “Search.”

Final Skin Notation Profiles

The following 19 NIOSH Skin Notation Profile documents include changes that are based on the comments submitted from peer reviewers, in addition to the stakeholders and public.

To view the final Skin Notation Profiles visit the Skin Notation Profiles website.

Peer Review

Subject: NIOSH Skin Notation Profiles

Purpose: Provide information about the health risks associated with dermal contact and uptake of specific high priority workplace chemicals.

Timing of Review: Public comment period for 14 profiles: May 2015 – June 2015. Public comment period for 10 profiles: November 2013 – January 2014, Peer review during public comment period.

Primary Disciplines or Expertise Needed for Review: Toxicology, risk assessment, industrial hygiene, occupational medicine

Type of Review: Individual

Number of Reviewers: 2-3 reviewers per Skin Notation Profile

Reviewers Selected by: NIOSH

Public Nominations Requested for Reviewers: No

Opportunities for the Public to Comment: Yes

Peer Reviewers Provided with Public Comments Before Their Review: No

Peer Reviewers

Charge to Peer Reviewers

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, is 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, is 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, is 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, is 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?