In a Federal Register notice published March 12, the U.S. Consumer Product Safety Commission (CPSC) announced new guidance to clarify the definition of “strong sensitizer” as the term applies to substances and products regulated by the CPSC. The CPSC also issued a proposal to update the supplemental definition of “strong sensitizer” under the Federal Hazardous Substances Act (FHSA).
The CPSC guidance document is titled “Strong Sensitizer Guidance.” The CPSC issued the document to assist manufacturers of chemical products in understanding how the CPSC assesses whether such products might be strong sensitizers and thus require cautionary labeling under the FHSA. The document describes the types of data that the CPSC considers in making such a determination and available methods for generating such data. It notes that a determination that a particular product is a strong sensitizer must occur on a case-by-case basis and does not solely depend upon the presence of a strong sensitizer in the product.
The guidance document is available on the CPSC website at http://www.cpsc.gov/Global/Regulations-Laws-and-Standards/Regulated-Prod...
The CPSC proposal to update the definition of “strong sensitizer” under the FHSA would update the definitions for “sensitizer,” “significant potential for causing hypersensitivity,” “normal living tissue,” and “severity of reaction.” The goals of the updated definitions are to “eliminate redundancy, remove certain subjective factors, incorporate new and anticipated technology, rank the criteria for classification of strong sensitizers in order of importance, define criteria for ‘severity of reaction,’ and indicate that a weight-of-evidence approach will be used to determine the strength of the sensitizer.”
CPSC is accepting comments on the proposal through May 28, 2013. Instructions for submitting comments are included in the Federal Register notice announcing the proposal, which is available on the FDSys website at http://www.gpo.gov/fdsys/pkg/FR-2013-03-12/pdf/2013-05577.pdf or http://www.gpo.gov/fdsys/pkg/FR-2013-03-12/html/2013-05577.htm.