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February 2015

New Proposition 65 Bill Introduced

On February 23, 2015, California Assemblyman Bill Quirk introduced AB 543, which would amend Section 25249.6 of Proposition 65 to clarify that a person in the course of doing business does not “knowingly and intentionally” expose an individual to a listed chemical in violation of the law, if the person has an exposure assessment that meets certain criteria. This bill, if passed, will promote the use of such assessments to guide a company’s decision to warn or not, will help reduce so-called “overwarning,” and will provide companies with another statutory basis to resist enforcement actions. Under this bill, an exposure assessment must meet the following criteria to establish lack of knowledge and intent: 1.  It has been conducted by, or under the supervision of, a qualified scientist in accordance with relevant Proposition 65 regulations.  The term “qualified scientist” is also defined in proposed Section 25249.11(c); 2.  It evaluates the same chemical in …Read More

EPA Proposes SNUR for Long-Chain Perfluroalkyl Carboxylate and PFAS Substances

On January 21, 2015, EPA published proposed Significant New Use Rules (SNURs) under the Toxic Substances Control Act for long-chain perfluroalkyl carboxylate (LCPFAC) and perfluroalkyl sulfonate (PFAS) substances.  The SNURs would require manufacturers, importers and processors to submit a Significant New Use Notice (SNUN) before commencing the identified significant new uses.  Comments must be submitted no later than March 23, 2015. PFAS chemicals are used in specialty chemical formulations in a variety of applications, including firefighting foam.  Perfluorooctanoic acid (PFOA), a LCPFAC chemical, is used in the manufacture of fluoropolymers.  Fluoropolymers are used in the manufacture of nonstick surfaces (as for cookware), molded automotive parts and other applications. It is likely that EPA will receive comments regarding ongoing uses that should not be subject to the SNUR, at least as to the manufacture, importation and processing of PFOA and its salts. EPA regulation of these classes of chemicals have a long …Read More

EPA Proposes SNUR for Toluene Diisocyanate

The U.S. Environmental Protection Agency has published a proposed Significant New Use Rule (SNUR) for 2,4-toluene diisocyanate, 2,6-toluene diisocyanate, and toluene diisocyanate unspecified isomers (collectively referred to as “toluene diisocyanate” and “TDI”) under the federal Toxic Substances Control Act.  The proposed significant new use is any use in a consumer product, except for coatings, elastomers, adhesives, binders and sealants that result in 0.1%or less (by weight) of TDI in a consumer product.  This regulatory action follows EPA’s 2011 Chemical Action Plan for TDI, in which EPA explicitly considered a SNUR as a possible next step in TDI regulation. Under TSCA Section 5, EPA may deem the use of an existing chemical substance as a “significant new use.” Section 5(a)(2) requires EPA to consider “all relevant factors” in making that determination, including the projected volume of manufacturing and processing of the substance and the extent to which the use increases the magnitude and duration …Read More

FDA Seeks Comment on UN Recommendations for Restrictions on A Widely Used Industrial Chemical

On January 27, 2015, the federal Food and Drug Administration published a notice seeking public comments on the World Health Organization’s (WHO) recommendation to impose international manufacturing and distribution restrictions on certain chemicals, including gamma butyrolactone (GBL).  GBL is widely used as an industrial solvent but is regulated under the federal Controlled Substances Act (CSA) because it may be diverted for illicit purposes. The WHO’s recommended restrictions could impair companies’ ability to use GBL for legitimate commercial purposes and disrupt exemptions to federal CSA regulatory requirements that are critical to a wide variety of industries in the U.S. which use GBL in their operations. Comments must be submitted to the FDA no later than February 26, 2015.  The FDA has not scheduled a public meeting on this issue, but affected stakeholders likely will request one. This FDA regulatory action arises from a United Nations treaty, the 1971 Convention on Psychotropic …Read More