[Federal Register Volume 78, Number 48 (Tuesday, March 12, 2013)]
[Pages 15710-15711]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-05578]



Strong Sensitizer Guidance

AGENCY: Consumer Product Safety Commission.

ACTION: Notice of availability.


SUMMARY: The U.S. Consumer Product Safety Commission (CPSC or 
Commission) is announcing the availability of a document prepared by 
CPSC staff titled, ``Strong Sensitizer

[[Page 15711]]

Guidance.'' 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.

ADDRESSES: The guidance document is available from the Commission's Web 
site at http://www.cpsc.gov/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.

Manager, Office of Hazard Identification and Reduction, U.S. Consumer 
Product Safety Commission, 5 Research Place, Rockville, MD 20850; 
telephone (301) 987-2564; jmatheson@cpsc.gov.

SUPPLEMENTARY 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.

    Dated: March 7, 2013.
Todd A. Stevenson,
Secretary, U.S. Consumer Product Safety Commission.
[FR Doc. 2013-05578 Filed 3-11-13; 8:45 am]