NIOSH Proposes Revised Definitions for Levels of Evidence for Skin Notation Profiles

Published March 15, 2017

​Last week, NIOSH issued a proposal to clarify the definitions for the different “levels of evidence” for the designation of NIOSH skin notations, which offer warnings about the direct, systemic, and sensitizing effects of chemical exposures to the skin. The levels of evidence are defined in Current Intelligence Bulletin (CIB) 61: A Strategy for Assigning New NIOSH Skin Notations, which explains the rationale for assigning new NIOSH skin notations. According to CIB 61, NIOSH uses a weight-of-evidence approach to evaluate scientific data when conflicting findings are reported during the process used to assign skin notations. NIOSH is proposing to clarify the definitions for “sufficient,” “limited,” and “insufficient” levels of evidence for the designation of NIOSH skin notations. These terms were originally defined in Appendix E of CIB 61.

In a Federal Register notice, the agency proposes the following definitions for sufficient, limited, and insufficient levels of evidence:

“Data sets classified as sufficient are those that include human and/or animal studies conducted using standardized protocols and that provide complete descriptions of the exposure conditions and study findings. Data sets classified as limited are those that include human and/or animal studies conducted using non-standardized protocols or that provide incomplete descriptions of the exposure conditions or study findings. Data sets classified as insufficient are those that include human and/or animal studies conducted using non-standardized protocols and that provide incomplete descriptions of the exposure conditions and study findings.”

According to NIOSH, its strategy for assigning skin notation profiles is a form of hazard identification that is intended to ensure that the assigned skin notations reflect the contemporary state of scientific knowledge, provide transparency behind the assignment process, and communicate the hazards of chemical exposures of the skin. The agency also seeks to meet the needs of health professionals, employers, and others in protecting workers from chemical contact with the skin.

NIOSH skin notation profiles are agency-authored technical documents that summarize the data used to determine skin notations. Forty-five skin notation profiles are currently available as PDFs on the NIOSH website. To learn more about the NIOSH strategy for assigning skin notations, see CIB 61.