New Chemical Review of Alternatives for PFOA and Related Chemicals
- Regulatory Approach
- Regulatory Approach for Shorter Chain-Length Telomer Alternatives
- Regulatory Approach for Alternatives for Certain PFOA Uses
- Polymer Exemption Rule Amendment
EPA is reviewing substitutes for PFOA, PFOS and other long-chain perfluorinated substances as part of its review process for new chemicals under EPA's New Chemicals Program (NCP). EPA established the program under Section 5 of the Toxic Substances Control Act (TSCA) to help manage the potential risk from chemicals new to the marketplace.
EPA's review of alternatives to perfluorinated chemical substances has been ongoing since 2000 and is consistent with the approaches to alternatives encouraged under the 2010/15 PFOA Stewardship Program. Through June 2008, over 100 alternatives of various types have been received and reviewed by EPA. EPA reviews the new substances against the range of toxicity, fate and bioaccumulation issues that have caused past concerns with perfluorinated substances, as well as any issues that may be raised by new chemistries.Regulatory Approach
EPA's regulatory approach is intended to ensure that the new substances are safer alternatives. In addition to requiring testing under TSCA §5(e) Consent Orders, EPA also restricts uses pending development of an adequate understanding of the chemical's fate and effects and, consistent with the PFOA Stewardship Program, requires that the substitutes not be contaminated significantly with longer chain-length perfluorinated substances of concern.
EPA's review of a significant number of new chemical notices on alternative substances has provided the opportunity to develop and apply a strategic and integrated approach to obtaining test data on the alternatives. This approach seeks to obtain a basic and confirmatory understanding of the health and environmental hazards and the environmental fate of the alternatives through the recognition of structural relationships among the alternatives. EPA strategically applies testing requirements to gain the needed understanding in a way that distributes the testing burdens among related chemicals to provide an authoritative understanding of the members in a given grouping of related chemicals.Regulatory Approach for Shorter Chain-Length Telomer Alternatives
Shorter chain-length perfluorinated telomeric substances have been notified as alternatives for a variety of uses including, for example, textile, carpet and paper additive uses and tile surface treatments. To date, over 75 premanufacture notices (PMNs) have been received for telomers based on shorter chain alternatives.
EPA's regulatory approach involves use of TSCA §5(e) Consent Orders to require testing while allowing production and use, with control measures where appropriate. EPA is requiring the possible ultimate degradation products from telomers to be tested to demonstrate that they are less bioaccumulative and less toxic than PFOA and other longer-chain perflourinated substances. These degradation products are being tested for the following endpoints: developmental and reproductive effects, subchronic toxicity (e.g. liver toxicity), pharmacokinetics and carcinogenicity and avian reproductive effects and chronic aquatic toxicity. In addition, EPA is requiring that the telomeric products be tested to determine their fate in the environment with a battery for each structural class of telomers, which includes biodegradability (water, soil, and sewage), photolysis, and hydrolysis testing. The total cost of such testing is expected to exceed $25 million.Regulatory Approach for Alternatives for Certain PFOA Uses
The Agency has begun receiving notices for and is carefully reviewing substitutes for certain PFOA uses. EPA's regulatory strategy is to consider appropriate management controls and testing to characterize the substances' toxicity and bioaccumulation. EPA will consider similar testing to characterize developmental and reproductive effects, subchronic toxicity, pharmacokinetics, and carcinogenicity and possibly chronic aquatic toxicity and avian reproductive effects.Polymer Exemption Rule Amendment
TSCA §5(h)(4) gives EPA the authority to exempt manufacturers from some or all of the requirements of TSCA §5 upon a determination by EPA that the intended activities associated with the substances will not present an unreasonable risk to health or the environment. In 1984 (modified in 1995), the Agency established eligibility criteria for exemptions for certain polymers based on §5(h)(4). The Polymer Exemption Rule (implementing regulations at 40 CFR 723.250) exempts eligible polymers from having to go through the full Premanufacture Notification (PMN) review process.
On March 7, 2006, EPA published a proposed rule (71 FR 11484) to amend the polymer exemption rule to exclude from eligibility for the exemption polymers containing certain perfluoroalkyl moieties. Under this proposal, polymers containing these perfluoroalkyl moieties would need to go through the PMN review process so that EPA can better evaluate these polymers for potential effects on human health and the environment.
On January 27, 2010, EPA published the final rule (75 FR 4295) that amends the Polymer Exemption Rule to exclude 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: PFAS; 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.
Any person who intends to manufacture (or import) any of these polymers not already on the TSCA Inventory must complete the TSCA premanufacture notification 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 Environmental Release and Human Exposure Exemption (LoREX), for affected polymers that they reasonably believe may qualify for such exemptions.
However, EPA is providing an extended compliance date for those who, prior to the effective date of this final rule (February 26, 2010), 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 section 5(h)(4) exemption or under a different section 5 authority, such as section 5(a)(1) or section 5(e).
This change to the current regulation 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 section 5(h)(4) of TSCA.
As of January 28, 2012, the manufacture or import of these polymers is no longer authorized under the polymer exemption rule. This means that all the manufacture or import of these polymers that was still dependant on the polymer exemption for TSCA compliance was required to cease by that date. To the extent that the manufacture or import of these polymers is otherwise compliant with TSCA section 5 and implementing regulations, it is unaffected by the close of this extended compliance period.