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Today the U.S. Environmental Protection Agency (EPA) promulgated a final rule amending the polymer exemption rule, which provides an exemption from the premanufacture notification (PMN) requirements of the Toxic Substances Control Act (TSCA). The amendment excludes from eligibility polymers containing as an integral part of their composition, except as impurities, certain perfluoroalkyl moieties consisting of a CF3- or longer chain length. This exclusion includes polymers that contain any one or more of the following: perfluoroalkyl sulfonates (PFAS); perfluoroalkyl carboxylates (PFAC); fluorotelomers; or perfluoroalkyl moieties that are covalently bound to either a carbon or sulfur atom where the carbon or sulfur atom is an integral part of the polymer molecule (affected polymers). EPA states that, in general, any person who intends to manufacture (which is defined by TSCA to include import) any of these polymers not already on the TSCA Inventory must complete the TSCA PMN review process prior to commencing the manufacture or import of such polymers. Alternatively, manufacturers or importers may submit a request for a different exemption, such as the Low Volume Exemption (LVE) or Low Release and Exposure Exemption (LoREX), for affected polymers that they reasonably believe may qualify for such exemptions. Under the final rule, those persons who are currently manufacturing or importing affected polymers, or who have previously manufactured or imported them but are not doing so now, in full compliance with the 1995 polymer exemption rule, may continue manufacturing or importing them until January 27, 2012. After that date, manufacture of these polymers will no longer be authorized under the polymer exemption rule, and continued manufacture or import must be authorized under a different TSCA Section 5(h)(4) exemption or under a different TSCA Section 5 authority, such as TSCA Section 5(a)(1) or Section 5(e). EPA states that the amendment to the exemption is necessary “because, based on current information, EPA can no longer conclude that these polymers ‘will not present an unreasonable risk to human health or the environment’ under the terms of the polymer exemption rule, which is the determination necessary to support an exemption under TSCA section 5(h)(4).” The final rule is effective February 26, 2010.
In today’s Federal Register notice, EPA states that it made two changes to its March 7, 2006, proposed rule. The first applies to the effective date of the final rule, which will be 30 days after date of publication in the Federal Register instead of 12 months, as was proposed. The second will allow persons who are currently manufacturing or importing affected polymers, or who have previously manufactured or imported them but are not doing so now, in full compliance with the 1995 polymer exemption rule, 24 months to complete the TSCA Section 5 review process instead of 12 months, as was proposed. EPA is also clarifying that manufacturers and importers of affected polymers may submit a request for a different TSCA Section 5(h)(4) exemption, such as a LVE or LoREX request, in lieu of a PMN, if they reasonably believe that the subject polymers may qualify for those exemptions.