CPSC Revises Definition of “Strong Sensitizers” That May Need Hazard Labels
The Consumer Product Safety Commission has issued a final rule that, effective March 17, will revise the supplemental definition of “strong sensitizer” under the Federal Hazardous Substances Act. Strong sensitizers or products containing them are subject to the FHSA’s cautionary labeling requirement if they meet the Act’s definition of “hazardous substance;” i.e., the concentrations and availability of the substance could cause substantial injury or illness as a result of reasonably foreseeable handling or use.
Under this rule, those substances that sensitize through atypical mechanisms rather than by inducing an obvious “immunologically-mediated response” will be considered sensitizers. The rule also eliminates the last sentence of the current definition based on concerns that it may be misinterpreted such that substances that cause an irritant response only (the response that is noted after the first exposure to a substance is more frequently an irritant response and not an allergic response) could be included in the category of “strong sensitizers.”
In addition, this final rule (i) reiterates the statutory requirement that before designating any substance a strong sensitizer the CPSC must find that the substance has significant potential for causing hypersensitivity; (ii) adds qualifiers for susceptibility profiles - genetics, age, gender and atopic status - to the list of information or data that may be considered in determining whether a substance has a significant potential for causing hypersensitivity; (iii) replaces the term “normal” with “non-sensitized;” (iv) incorporates into the subsection explaining significant potential for causing hypersensitivity the factors to be considered in determining whether a substance is a strong sensitizer; (v) makes clear that a weight-of-the-evidence approach is to be used in determining the strength of a sensitizer; and (vi) lists additional factors the CPSC can consider in determining a substance’s sensitizing potential for which validated methods currently do not exist but are in development.
The CPSC has made available a guidance document intended to clarify each component of the revised “strong sensitizer” definition and assist manufacturers in understanding how CPSC staff will assess whether a substance and/or product containing that substance should be considered a strong sensitizer.