Revision of the supplemental definition of “strong sensitizer”.
The original “strong sensitizer” definition was established under the US Food and Drug Administration (FDA) in 1961. The 1961 definition listed five substances that the FDA had determined met the statutory definition for “strong sensitizer”, published at that time as 16 CFR 1500.13:
(a) Paraphenylenediamine and products containing it.
(b) Powdered orris root and products containing it.
(c) Epoxy resins systems containing in any concentration ethylenediamine, diethylenetriamine, and diglycidyl ethers of molecular weight less than 200.
(d) Formaldehyde and products containing 1 percent or more of formaldehyde.
(e) Oil of bergamot and products containing 2 percent or more of oil of bergamot.
There have been no additions to the original 1961 list.
In 1986, under the CPSC, a supplemental definition was added to clarify the interpretation of the original definition and the factors that would be considered in determining whether a substance is a “strong sensitizer”. These have basically remained unchanged since that time.
Due to changes in technology and the science related to sensitization since the original definitions had been established, a panel of experts convened by the CPSC in 2005, was tasked with examining the available scientific and medical information concerning sensitizers and proposing revisions to the supplemental definition. Based on input from that panel a technical report was drafted by CPSC staff outlining proposed revisions to the supplemental definition. Between 2007 and 2008 the technical report underwent considerable scientific peer and federal agency review, eventually culminating in the updated supplemental definition in a proposed final rule (https://www.federalregister.gov/
The final rule as published in the Federal Register became effective 17 March, 2014 and the complete revised supplemental definition can be read in 16 CFR 1500.3(c)(5)
Changes in the Supplemental Definition
The revised definition of “strong sensitizer” achieves the following:
- eliminates redundancy,
- removes certain subjective factors,
- incorporates new and anticipated technology,
- places the criteria for classification of strong sensitizers in the order of importance,
- defines criteria for “severity of reaction”, and
- provides for the use of a weight-of-evidence approach to determine whether a substance is a “strong sensitizer”.
The Commission has issued a guidance document (http://www.cpsc.gov/
References:
(1) Final Rule: Revisions to Supplemental Definition of “Strong Sensitizer” http://www.cpsc.gov/
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