Skip to Content


Strong Sensitizer Guidance

Document Details

Information about this document as published in the Federal Register.

Document Statistics
Document page views are updated periodically throughout the day and are cumulative counts for this document including its time on Public Inspection. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day.
Enhanced Content

Relevant information about this document from provides additional context. This information is not part of the official Federal Register document.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble


Consumer Product Safety Commission.


Notice of availability.


The U.S. Consumer Product Safety Commission (CPSC or Commission) is announcing the availability of a document prepared by CPSC staff titled, “Strong Sensitizer Start Printed Page 15711Guidance.” This guidance document is intended to clarify the “strong sensitizer” definition, assist manufacturers in understanding how CPSC staff would assess whether a substance and/or product containing that substance should be considered a “strong sensitizer,” and how the Commission would make such a determination. The staff guidance document is available on the Commission's Web site and from the Commission's Office of the Secretary.


The guidance document is available from the Commission's Web site at​Global/​Regulations-Laws-and-Standards/​Regulated-Products-Rules/​strongsensitizerguidance.pdf. Copies may also be obtained from the Consumer Product Safety Commission, Office of the Secretary, Room 820, 4330 East West Highway, Bethesda, MD 20814; telephone 301-504-7923.

Start Further Info


Joanna Matheson, Ph.D., Project Manager, Office of Hazard Identification and Reduction, U.S. Consumer Product Safety Commission, 5 Research Place, Rockville, MD 20850; telephone (301) 987-2564;

End Further Info End Preamble Start Supplemental Information


Elsewhere in this issue of the Federal Register, the Commission is publishing a notice of proposed rulemaking for the purpose of revising the supplemental definition of “strong sensitizer” found at 16 CFR 1500.3(c)(5). The Commission is proposing to revise the supplemental definition of “strong sensitizer” due to advancements in the science of sensitization that have occurred since the current supplemental definition of “strong sensitizer” was promulgated in 1986. Toward this end, the Commission convened a panel of scientific experts from academia, industry, and the Federal Government who evaluated the current definition in light of scientific advances in the field of sensitization and made recommendations for proposed changes to the current definition, which eliminate redundancy, remove certain subjective factors, incorporate new and future technology for determining the sensitization characteristics of substances, rank the criteria for classification of strong sensitizers in order of importance (e.g., human over animal data), define criteria for “severity of reaction”, and adopt a weight-of-the-evidence approach to determine the strength of the sensitizer.

Commission staff has prepared a document titled, “Strong Sensitizer Guidelines,” which explains and clarifies each section of the proposed “strong sensitizer” supplemental definition by explaining the current scientific rationale underlying the methodologies and analysis that staff will consider when assessing whether a substance is a strong sensitizer. The CPSC expects that the guidance document will assist manufacturers and other stakeholders in understanding how CPSC staff and the Commission would assess whether a substance or product containing a substance should be considered a “strong sensitizer.” The staff guidance document is available on the Commission's Web site and from the Commission's Office of the Secretary, both listed in the ADDRESSES section of this notice.

Start Signature

Dated: March 7, 2013.


Todd A. Stevenson,

Secretary, U.S. Consumer Product Safety Commission.

End Signature End Supplemental Information

[FR Doc. 2013-05578 Filed 3-11-13; 8:45 am]