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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460
MAR 1 1 2002
OFFICE OF PREVENTION, PESTICIDES AND
TOXIC SUBSTANCES
Dear Interested Party:
Attached please find copies of two related documents that published in today's Federal Register: a Final Rule (67 FR 11008) on 13 known discontinued perfluoroalkyl sulfonate (PFAS) chemicals making any new manufacture or importation a significant new use; and a Supplemental Proposed Rule (67 FR 11014) on 75 additional chemicals, proposing to exclude from the definition of "significant new use" specifically defined, low volume, controlled exposure uses in semiconductor manufacture, aviation hydraulics, and photography, but to otherwise require submission of a significant new use notice (SNUN) for any manufacture or import of these chemicals after December 31, 2002. These two actions build upon the original proposed significant new use rule (SNUR) (65 FR 62319, October 18, 2000).
In the original proposed SNUR, the subject chemicals were referred to collectively as perfluorooctyl sulfonates, or PFOS. Commenters noted that this generic usage of PFOS was inconsistent with 3M's use of PFOS to refer only to chemicals with an eight-carbon, or C8, chain length. Many of the chemicals in the original proposed SNUR included a range of carbon chain lengths, although they all did include C8 within the range. EPA has adopted the commenters' suggested nomenclature for these two follow-up actions, and thus is using the generic term PFAS
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to refer to any chain length, including higher and lower homologues as well as C8, and the term
PFOS to represent only those chemicals which are predominantly C8.
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Twenty-six comments were received during the comment period, which was extended from
November 17, 2000 to January 1, 2001. A public meeting was held on March 27, 2001.
Participants expressed interest in providing additional information on specific chemical uses,
sources, and releases. Multiple substantive data submissions were received through October 2001.
All comments, meeting presentation materials, and post-meeting submissions are included in
Docket 50639.
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In these two actions, the Agency finalizes the SNUR essentially as originally proposed for the 13 chemicals from the original list which were discontinued by 3M prior to December 31, 2000, were associated only with uses on which no comments were received, and were not alleged to be produced by any company other than 3M. In this final rule, EPA also removes from the original proposed SNUR two chemicals which were not included in the 3M phase-out plan. These two chemicals were listed in the original SNUR due to an error by EPA in correlating information from 3M with chemical identity data furnished by the Chemical Abstract Service.
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The supplemental proposed SNUR covers the remaining 75 chemicals from the original proposed SNUR, proposing that any manufacture or import for any use after December 31, 2002 would constitute a significant new use requiring prior notice to EPA, except that the following specific uses would not be considered significant new uses:
1. Use as an anti-erosion additive in fire-resistant phosphate ester aviation hydraulic fluids.
2. Use as a component o f a photoresist substance, including a photo acid generator or surfactant, or as a component o f an anti-reflective coating, used in a photomicrolithography process to produce semiconductors or similar components of electronic or other miniaturized devices.
3. Use as an intermediate only to produce other chemical substances to be used solely for the excluded aviation hydraulic fluid and photomicrolithography uses.
4. Use in a surface tension and static discharge control coating on films, papers, and printing plates, or as a surfactant or defoamer in solutions used to process films and papers, in traditional and laser medical imaging and in industrial and consumer film products.
These proposed exclusions from the significant new use definition respond to comments received on the original proposal. The semiconductor and aviation industries supplied substantial data to support a conclusion that their specific low volume, low exposure, and low release uses may not present risk concerns that would outweigh their economic and safety benefits. Particularly in the semiconductor area, they also indicated that 3M has not been the only source for certain specific chemicals on the list used in these applications. The use o f those specific non-3M chemicals in these applications would be considered ongoing and not subject to the SNUR, but the identities o f the specific chemicals were claimed as confidential business information (CBI) and thus could not be separated from the rest o f the SNUR chemicals to craft a chemical-specific exclusion. The proposed exclusion for specific photographic uses, including medical imaging, recognizes the data submitted by the photography industry, but includes the caveat that additional information on userelated exposures and releases may be needed to support the exclusion. This Final Rule and Supplemental Proposed Rule, taken together, will eliminate the bulk o f exposure to and release of these PFAS chemicals while not prohibiting their limited use in technologically demanding applications which are themselves characterized by low volume, low exposure, and low releases.
Comments on the Supplemental Proposed Rule must be submitted on or before April 10, 2002. The Final Rule will take effect on April 10, 2002. If you have questions on these documents, please contact Mary Dominiak by phone at 202-564-8104, by fax at 202-564-4775, or by email at dominiak.mary@epa.gov.
Sincerely,
Charles M. Auer, Director Chemical Control Division
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