Date: Jun 07, 2004
For polymers that are eligible, the current polymer exemption, 40 C.F.R. § 723.250, significantly relaxes the premanufacture notification requirements, 40 C.F.R. Part 720, under the Toxic Substances Control Act (TSCA) (15 U.S.C. § 2601 et seq.). In its Semiannual Regulatory Agenda, 68 Fed. Reg. 73643 (Dec. 22, 2003), the EPA announced it will propose to amend the polymer exemption. The new amendments will eliminate eligibility for polymers that contain perfluoroalkyl groups. The proposal was expected to be published in March of this year, but it has been delayed for undisclosed reasons.
Initially, under the original 1984 polymer exemption, polymers that contained perfluoroalkyl groups were not eligible. When the polymer exemption was amended in 1995, the atomic element fluorine was permitted if the fluorine was covalently bound to carbon. As one consequence, many polymers that incorporate perfluoroalkyl groups have been placed on the market under the current polymer exemption.
The Agency's stated rationale for amending the polymer exemption is data on perfluorooctyl sulfonic acid, perfluorooctanoic acid, and their derivatives. The EPA says these data indicate that, as a class, such substances might persist in the environment, bioaccumulate, and be toxic. On the basis of these concerns, the EPA has virtually banned the commercialization of new chemical substances containing any perfluoroalkyl groups with a length of more than four contiguous carbons if the substances are the subjects of premanufacture notices (PMNs). PMN filers have chosen to withdraw premanufacture notices (PMNs) rather than carry out costly studies. Consequently, the appropriateness of the EPA's refusal to clear specific PMNs has not been challenged. Nonetheless, commercialization of polymers that incorporate perfluoroalkyl groups under the polymer exemption may continue at least until the polymer exemption is amended.
Will the EPA carefully craft an exclusion from the current terms of the exemption limited to only those larger perfluoroalkyl groups that pose the most concern? That seems unlikely. The statutory basis for the exemption requires a determination that the manufacture, processing, distribution in commerce, use, or disposal of a new chemical substance, or any combination of those activities, will not present an unreasonable risk of injury to health or the environment. Therefore, it is more likely that the EPA will assert that it can only make that finding if it excludes from the exemption all polymers that contain fluorine in any intentional form. In other words, if this prediction is accurate, a polymer that contains any perfluoroalkyl group would not be eligible under the terms of an amended exemption. For products that are already on the market on the basis of the exemption, it is anticipated that EPA will allow commercial activity to continue for some limited period of time while a PMN or some other exclusion or exemption is pursued. If such a polymer does not successfully pass through PMN review and no other exclusions or exemptions are applicable, the polymer would no longer be permitted in commerce. It is important to note that fluorine-containing chemical substances that are listed TSCA Chemical Substance Inventory (Inventory) will not be affected by any change to the polymer exemption.
One might well ask, how can the EPA revoke the status of polymers that are eligible and have relied on the current polymer exemption? There are no revocation provisions. Revocation provisions were included in the 1993 proposed amendments to the 1984 polymer exemption rule. 56 Fed. Reg. 7679 (Feb. 8, 1993). When the EPA finalized the amendments to the polymer exemption proposed in 1993, 60 Fed. Reg. 16316 (Mar. 29, 1995), the EPA withdrew the revocation provisions. The withdrawal was based on EPA's gauging the likelihood being low that eligible polymers would pose an unreasonable risk. The Agency offered the rationale that the revocation provisions were not needed to support the necessary statutory finding that polymers manufactured under terms of the exemption will not present an unreasonable risk of injury to human health or the environment. In this regard, the EPA said,
Should evidence be received by the Agency that casts reasonable doubt on the appropriateness of a criterion or set of criteria, the Agency has other regulatory options available, such as publication of a proposed amendment to the polymer exemption rule to either refine the criteria or impose new restrictions. . . .
60 Fed. Reg. at 16326 (emphasis added). We expect that this language will be cited in the proposed amendments to the current polymer exemption.
While there is a statutory basis for the EPA to claim the authority to force certain fluoropolymers off the market by amending the polymer exemption, the action might be viewed as depriving manufacturers of existing property rights. In that case, such government "takings" must also pass Constitutional muster. While the EPA has grown accustomed to not being challenged for decisions blocking commercialization of a new substance, it may discover that manufacturers will challenge EPA's actions when the effect is to ban an existing product.
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