CPSC finalizes new definition for "strong sensitizer."

Last week, the U.S. Consumer Product Safety Commission (CPSC or the Commission) released a Final Rule changing the supplemental definition for “strong sensitizer” under the Federal Hazardous Substances Act (FHSA), which requires appropriate cautionary labeling on certain hazardous household products. The revised definition becomes effective March 17, 2014.

The FHSA defines “strong sensitizer” as “a substance which will cause [a hypersensitivity] on normal living tissue through an allergic or photodynamic process.” The CPSC promulgated a supplemental definition in a 1986 rule. In 2005, the Commission initiated an extensive process to update the definition, first convening a panel of scientific experts to make recommendations to CPSC staff, and then developing a draft technical report that underwent federal agency and external scientific peer review. A Notice of Proposed Rulemaking and accompanying guidance document (Strong Sensitizer Guidance) were published together on March 12, 2013.

The new supplemental definition of “strong sensitizer” aims to bring the definition in better alignment with current science on sensitization. According to the CPSC, the revised definition:

  • eliminates redundancy;
  • removes certain subjective factors;
  • incorporates new and anticipated technology;
  • ranks the criteria for classification in order of importance;
  • defines criteria for “severity of reaction”; and
  • provides for a “weight-of-evidence” approach to determining whether a substance qualifies as a strong sensitizer.

In promulgating the new definition, the CPSC addressed several comments, summarized as follows:

Implementing GHS would be too far-reaching. Two commenters urged the Commission to implement the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). The Commission clarified that GHS is not a standard-setting regulatory scheme but a set of criteria for classifying and communicating hazards. Moreover, CPSC stated that implementing GHS “would be broad-reaching, with potential impact beyond the FHSA,” and is far beyond the scope of the rulemaking.

No far-reaching effects. The CPSC rejected one commenter’s assertion that the revised definition would have “far-reaching effects,” since substances would still be subject to case-by-case hazard assessments which incorporate an approach based on science and risk.

No differentiation needed for different allergy types. The CPSC acknowledged a commenter’s recommendation to address Type I and Type IV allergies separately, but argued that this would make the definition “significantly and unnecessarily more complex.” Instead, the Commission posited that the criteria in the definition is sufficiently flexible to assess all types of allergic reactions without specifically differentiating them, and that the Strong Sensitizer Guidance released last year would provide further assistance in evaluating substances.

QSAR data accepted but not prioritized. The Commission emphasized that data from Quantitative Structure-Activity Relationship (QSAR) models was specified in the rule as a factor to be considered in a weight-of-evidence analysis of whether a substance has significant potential for causing hypersensitivity. However, QSAR data would not be given precedence over “high-quality human and animal data.”

Consumer incident reports may be considered. One comment urged including the CPSC’s and manufacturers’ records of incidents of hypersensitivity as factors to be considered in determining a substance’s ability to cause hypersensitivity. In response, the Commission emphasized that the revised definition includes “case histories” as a factor, which encompasses consumer-submitted incident reports received by the manufacturer or CPSC. The CPSC will also consider revising the Strong Sensitizer Guidance to elaborate on “the types and sources of incident reports” to use in determining whether a substance is a “strong sensitizer.”

The CPSC also defended and maintained the proposed order of ranked data criteria; changed the potential “clinically important reaction” of “substantial physical discomfort or distress” to “substantial physiological effects, such as discomfort and distress,” for purposes of clarity; and made other minor drafting changes.

Analysis: The “strong sensitizer” definition in the Final Rule does not significantly deviate from the revision proposed last year, so there is not much unexpected here. Moreover, a substance will, as before, have to undergo an individualized evaluation by the CPSC as to whether it can cause hypersensitivity and be determined to be a “strong sensitizer.” The CPSC’s possible revision of the Strong Sensitizer Guidance to address consumer incident reports will be an issue to keep an eye on.

EPA Grants TSCA Section 21 Petition on Cadmium


On August 30, 2010, EPA granted a citizen’s petition filed under section 21 of the Toxic Substances Control Act (TSCA) requesting Agency action on cadmium and cadmium compounds.  Empire State Consumer Project, the Sierra Club, the Center for Environmental Health, and Rochesterians Against the Misuse of Pesticides filed the petition on May 28, 2010.  The petitioners wanted the Consumer Product Safety Commission (CPSC) to act to protect children against cadmium present in toy jewelry, but if the CPSC did not act, they wanted EPA to take action under TSCA.  The petitioners argued that analysis of Chinese imports strongly suggested that cadmium was being used in toy jewelry as a cheap substitute for lead, which is now strictly regulated by the CPSC.  The petition followed several recalls ordered by the CPSC and numerous warnings to Chinese exporters and others.

The Petition

The petition demanded that CPSC take several actions, including: (1) classifying as a banned hazardous substance under sections 2 and 3 of the Federal Hazardous Substance Act (FHSA) toy metal jewelry containing cadmium above trace amounts, thereby requiring manufacturers, importers, and processors to test and certify their products under the Consumer Product Safety Safety Improvement Act of 2008 (CPSIA); (2) revising the test method, if the cadmium limit is to be based on the amount that can be extracted, to better reflect usage scenarios; and (3) using its participation on the Interagency Testing Committee (ITC) established under TSCA to request EPA’s immediate adoption of testing and reporting methods, if CPSC believes that it lacks sufficient information on the extent of cadmium in children’s products or needs additional information to determine the appropriate limit for cadmium in those products.

The petition also sought specific EPA actions, including: (1) requiring health and safety data reporting for cadmium and cadmium compounds under section 8(d) of TSCA; and (2) issuing under section 6 a rule setting limits on cadmium and cadmium compounds in toy jewelry.   The section 8(d) rule was to apply to producers, importers, and processors of cadmium and cadmium compounds reasonably likely to be incorporated into consumer products.  Petitioners demanded that EPA seek lists and/or copies of the following types of ongoing and completed health and safety studies:

a.   epidemiological or clinical studies;
b.   studies of occupational exposure;
c.   health effects studies;
d.   ecological effects studies; and
e.   environmental fate studies (including relevant physicochemical properties).

The Agencies Respond

On August 19, 2010, the CPSC published a Federal Register notice, requesting public comments on the petition.  The public comment period closes October 18, 2010.  Many observers anticipate CPSC’s eventual adoption of restrictions on cadmium in certain consumer products, including metal toy jewelry.

EPA is further along in responding to the petition.  In a letter, dated August 30, 2010, EPA Assistant Administrator Steve Owens agreed to have EPA issue a TSCA Section 8(d) rule regarding cadmium and cadmium compounds used in consumer products, especially metal toy jewelry.  The rule will require reporting by producers, importers, and processors of cadmium and cadmium compounds that are reasonably likely to be incorporated into consumer products.   He also indicated that the Agency is willing to consider banning or restricting the metal if the CPSC does not address consumer uses of cadmium; however, the Agency has not used its section 6 authority in many years and it is unlikely to need to do so in light of anticipated CPSC action.

* * * *

Check back occasionally for additional posts concerning the evolving debate over the appropriate regulation of cadmium and cadmium compounds.