Source: https://www.regulations.gov/?_escaped_fragment_=documentDetail;D=CPSC-2013-0010-0001
Timestamp: 2016-07-25 11:59:56
Document Index: 109320886

Matched Legal Cases: ['art 1500', 'art 1500', 'art 1500', 'art 1500', '§ 1500', 'art 1500']

Skip Navigation HomeHelpResourcesContact Us Advanced Search Start of Main Content Hazardous Substances and Articles; Supplemental Definition of Strong Sensitizer This Proposed Rule document was issued by the Consumer Product Safety Commission (CPSC) For related information, Open Docket Folder Show agency attachment(s) CONSUMER PRODUCT SAFETY COMMISSION
[CPSC Docket No. CPSC-2013-0010]
SummaryThe U.S. Consumer Product Safety Commission (CPSC or Commission) proposes to update the supplemental definition of “strong sensitizer” under the Federal Hazardous Substances Act (FHSA). The proposed amendment clarifies or adds language 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.
DatesWritten comments must be received by May 28, 2013.
AddressesYou may submit comments identified by Docket No. CPSC-2013-0010, by any of the following methods: Electronic SubmissionsSubmit electronic comments in the following way:
To ensure timely processing of comments, the Commission is no longer accepting comments submitted by electronic mail (email) except through www.regulations.gov. Written SubmissionsSubmit written submissions in the following way:
Instructions: All submissions received must include the agency name and docket number for this proposed rulemaking. All comments received may be posted without change, including any personal identifiers, contact information, or other personal information provided, to http://www.regulations.gov. Do not submit confidential business information, trade secret information, or other sensitive or protected information electronically.Such information should be submitted in writing.
Docket: For access to the docket to read background documents or comments received, go to http://www.regulations.gov. For Further Information ContactJoanna Matheson, Ph.D., Project 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 InformationA. BackgroundThe FHSA, 15 U.S.C. 1261-1278, requires appropriate cautionary labeling on certain hazardous household products to alert consumers to the potential hazards that a product may present. Among the hazards addressed by the FHSA are products that are toxic, corrosive, irritants, flammable, combustible, or strong sensitizers.
Recognizing that the science on sensitization has changed since promulgation of the supplemental definition in 1986, the CPSC convened a panel of scientific experts from academia, industry, and the federal government to examine the available scientific and medical information concerning sensitizers, and if appropriate, propose revisions to the supplemental definition of strong sensitizer.B. Effect of Strong Sensitizer DeterminationThe Commission is proposing to revise its supplemental definition of strong sensitizer. Additional Commission action would be needed for any substance to be designated a strong sensitizer. In order for the Commission to issue a rule declaring any particular substance (or product containing that substance) to be a strong sensitizer, it must engage in notice and comment rulemaking, separate from this rulemaking, and make the findings specified in 15 U.S.C. 1261(k), i.e., that based upon consideration of the frequency of occurrence and the severity of the reaction, the substance has a significant potential for causing hypersensitivity. However, a determination that a substance is a strong sensitizer does not automatically trigger a labeling requirement for products containing that substance. Under the FHSA a substance (or product containing that substance) that is a hazardous substance requires appropriate labeling. 15 U.S.C. 1261(p). If manufacturers of products containing a designated strong sensitizer determine that the strong sensitizer in their products may cause substantial injury or illness as a result of reasonably foreseeable handling or use, that product would be a “hazardous substance” as defined under the FHSA, and therefore would warrantappropriate labeling. Alternatively, where there is uncertainty, the Commission has the option under section 3(a)(1) of the FHSA to determine through notice and comment rulemaking that a product containing a strong sensitizer is a “hazardous substance.” Hazardous substances intended or packaged in a form suitable for use in the household that do not bear the appropriate cautionary labeling would be considered “misbranded” in violation of the FHSA. 15 U.S.C. 1261(p).
Such cautionary labeling would be insufficient, however, if a toy or other article intended for the use of children is, bears, or contains a hazardous substance (as that term is defined in section 2(f) of the FHSA), and the hazardous substance is accessible to a child to whom the article is entrusted. Under that scenario, the toy or children's article would be considered a “banned hazardous substance” under section 2(q)(1)(A) of the FHSA unless a particular exemption applies. 15 U.S.C. 1261(q)(1)(A).C. Proposed AmendmentThe proposed amendment to 16 CFR part 1500 clarifies or adds language to the supplemental definition of “strong sensitizer” 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.
The proposed amendment reflects the traditional definition for sensitization; sensitization is a multi-stage immune mediated process which occurs over a period of time. Under the proposed amendment, those substances that sensitize through atypical mechanisms, rather than by inducing an obvious “immunologically-mediated response” will be captured by the assessment process. The proposed amendment 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 (1)
(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 erroneously included in the category of “strong sensitizers.” Typically, allergic responses are the result of a two-step process: (1) Induction (sensitization) which requires sufficient or cumulative exposure to induce an immune response with few or no symptoms and (2) elicitation when an individual who has been sensitized demonstrates symptoms upon subsequent exposures. The phrase “variable period of exposure” is included in the proposed amendment to reflect the latency period which is a characteristic in the development of sensitization.
The proposed amendment eliminates the “quantitative or qualitative risk assessment factor” because the Commission believes this terminology is a source of confusion in that it places a risk assessment step within the hazard identification step of the overall process of determining whether a product containing a strong sensitizer requires labeling. The proposed amendment makes clear that a weight-of-the-evidence approach is to be used in determining the strength of a sensitizer because of the imprecise nature of some of the current factors and the potential lack of information or data available to permit useful consideration of certain factors. Rather than allowing an “any or all” approach to what factors would be considered by the Commission in determining whether a sensitizer is strong, the amendment ranks data sources in order of importance, following the FHSA preference for human data over animal data; and the amendment takes into consideration the value and relevance that certain data would provide in evaluating the potential of a substance to cause hypersensitivity. For example, the proposed amendment expresses a preference for general population epidemiological studies over occupational studies because the degree of sensitization in the workplace is likely to be greater than that of the general population, due to greaterexposure (both in time and concentration) to the sensitizing agent.
The proposed revision to this section adds several factors the Commission can consider in determining a substance's sensitizing potential, for which validated methods currently do not exist but are in development, such as: Quantitative Structure-Activity Relationships (QSARs), and in silico (2)
data, along with the caveat that using these techniques would be in addition to consideration of human and animal data. We expect that in vitro and in silico validated methods will be available as part of an integrated testing strategy within the next 5 years, and including these components in the amendment ensures that the definition is compatible with current science. The proposed revision also includes a definition of “bioavailability” (i.e., the dose of the substance available to interact with a tissue and that tissue's ability to absorb the substance and the actual penetrating ability of the substance).
The proposed amendment eliminates this subsection and incorporates the factors to be considered in determining whether a substance is a “strong” sensitizer into the proposed revised section Significant potential for causing hypersensitivity. D. Staff Guidance and Notice of AvailabilityCommission staff has developed a guidance document that is intended to clarify the “strong sensitizer” definition and assist manufacturers in understanding how CPSC staff would assess whether a substance and/or product containing that substance should be considered a “strong sensitizer.” A Notice of Availability is published elsewhere in this issue of theFederal Register, which provides a link to the location on the Commission's Web site where the staff guidance document can be found.E. Impact on Small BusinessesUnder the Regulatory Flexibility Act (RFA), when an agency issues a proposed rule, it generally must prepare an initial regulatory flexibility analysis describing the impact the proposed rule is expected to have on small entities. 5 U.S.C. 603. The RFA does not require a regulatory flexibility analysis if the head of the agency certifies that the rule will not have a significant effect on a substantial number of small entities. Id. 605(b).
The Commission's Directorate for Economic Analysis prepared a preliminary assessment of the impact of revising the supplemental definition of “strong sensitizer.” That assessment found that there would be little or no effect on small businesses and other entities because the proposed amendment, which simply modifies the existing supplemental definition of “strong sensitizer,” will not result in product modifications to comply; nor will the revised supplemental definition impose any additional testing or recordkeeping burdens. The obligation to label a product as a “strong sensitizer” and any costs associated with that obligation will not arise until the Commission has designated a substance contained in the product as a “strong sensitizer,” which would occur only in connection with a separate notice and comment rulemaking proceeding. Thereafter, we would assess the potential small business impact of designating the particular substance as a strong sensitizer. Moreover, the proposed amendment is not expected to impose any indirect burden on small businesses or other entities because it is not expected to lead to any additional substances being designated as strong sensitizers that would not be so designated in the absence of the amendment. Based upon the foregoing assessment, the Commission finds preliminarily that the proposed rule would not have a significant impact on a substantial number of small entities.F. Environmental ConsiderationsGenerally, CPSC rules are considered to “have little or no potential for affecting the human environment,” and environmental assessments and environmental impact statements are not usually prepared for these rules (see 16 CFR 1021.5(c)(1)). The Commission does not expect the proposed rule to have any adverse impact on the environment under this categorical exclusion.G. Executive OrdersAccording to Executive Order 12988 (February 5, 1996), agencies must state in clear language the preemptive effect, if any, of new regulations. Section 18 of the FHSA addresses the preemptive effect of certain rules issued under the FHSA. 15 U.S.C. 1261n. Because this rulemaking would revise a regulatory definition rather than issue a labeling or banning requirement, section 18 of the FHSA does not provide for the proposed rule to have preemptive effect.H. Paperwork Reduction ActThis rule would not impose any information collection requirements. Accordingly, this rule is not subject to the Paperwork Reduction Act, 44 U.S.C. 3501-3520.I. Effective DateThe Administrative Procedure Act generally requires that a substantive rule be published not less than 30 days before its effective date, unless the agency finds, for good cause shown, that a lesser time period is required. 5 U.S.C. 553(d)(3). We propose that the rule would take effect 30 days afterpublication of a final rule in theFederal Register.
List of Subjects in 16 CFR Part 1500Consumer protection, Hazardous substances, Imports, Infants and children, Labeling, Law enforcement, Reporting and recordkeeping requirements, and Toys.
Accordingly, 16 CFR part 1500 is proposed to be amended as follows:Part 1500 Amended
Authority15 U.S.C. 1261-1278.
2. In § 1500.3, revise paragraph (c)(5) to read as follows:
[FR Doc. 2013-05577 Filed 3-11-13; 8:45 am]BILLING CODE 6355-01-PFootnotes
An “irritant response” is a nonimmune mediated response and one that results from direct injury to the tissue. An irritant is any agent that is capable of producing cell damage in any individual if applied for sufficient time and concentration.
QSARs are mathematical models that relate a quantitative measure of chemical structure to biological activity. In silico data is a computational approach using sophisticated computer models for the determination of a sensitizing potential. Both of these approaches are evolving methodologies that have not yet been validated, but are being pursued as testing options that would reduce the numbers of expensive laboratory and animal experiments being carried out.
Attachments View All (0) View document: No documents available. Attachments View All (0) Comment Now! Comment Period Closed May 28 2013, at 11:59 PM ET ID: CPSC-2013-0010-0001 Tracking Number: View original printed format: Document Information Date Posted: Mar 12, 2013RIN: Not AssignedCFR: 16 CFR Part 1500Federal Register Number: 2013-05577 Show More Details Submitter Information Comments5 Comments Received* Final Comment from the organization that submitted comment CPSC-2013-0010-0007
See Attached View Comment See attached file(s) View Comment Dear Dr. Matheson, Please find attached the American Chemistry Council Diisocyanates Panel comments on the Notice of Proposed Rulemaking on Hazardous... View Comment Docket Information This document is contained in CPSC-2013-0010 Related Dockets: NoneRelated RINs: NoneRelated Documents: Hazardous Substances and Articles; Administration and...Strong Sensitizer Guidance; Availability Related Comments: View all * This count refers to the total comment/submissions received on this document, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document. Document text and images courtesy of the Federal Register Home Search Advanced Search Browse By Category Learn About Us eRulemaking Program Media Toolkit Agencies Awards & Recognition Enhancements & Fixes Resources Site Data Regulatory Agenda Agency Reports Required by Statute API Overview Developers Help How to use Regulations.gov FAQs Glossary Connect With Contact Us Privacy and Security Notice User Notice Accessibility Statement Partner Sites We the People Federal Register Reginfo Congress.gov USA.gov E-Gov Opengov Participate Today!