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Assessing and Managing Chemicals under TSCA

New Chemicals Program Review of Alternatives for PFOA and Related Chemicals

Overview

EPA is reviewing substitutes for perfluorooctanoic acid (PFOA), perfluorooctane sulfonic acid (PFOS) and other long-chain per- and polyfluoroalkyl substances (PFASs) for new chemicals under EPA's New Chemicals Program (NCP). EPA's review of alternatives to PFASs has been ongoing since 2000. Through September 2015, hundreds of alternatives of various types have been received and reviewed by EPA. EPA reviews the new substances to identify whether the range of toxicity, fate and bioaccumulation issues that have caused past concerns with perfluorinated substances may be present, as well as any issues that may be raised by new chemistries, in order to ensure that the new chemical may not present an unreasonable risk to health or the environment.

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), 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.

Regulatory Approach for Shorter Chain-Length Telomer Alternatives

Shorter chain-length PFAS telomeric substances have been submitted to EPA for review as alternatives for a variety of uses including, for example, textile, carpet and paper additive uses and tile surface treatments.

For many PFAS chemicals, 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. For a subset of PFAS chemicals, EPA requires environmental degradation testing before the chemicals may be commercialized. 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 perfluorinated 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.

Regulatory Approach for Alternatives for Certain PFOA Uses

The Agency has begun receiving notices for and is carefully reviewing substitutes for certain direct uses of PFOA itself. 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

On January 27, 2010, EPA published a 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: perfluoroalkyl carboxylic acids (PFCAs); perfluoroalkane sulfonates (PFSAs); 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. This change to the regulation was 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  manufacture (including import) of these polymers that was still dependent on the polymer exemption for TSCA compliance was required to cease by that date.  Any person who intends to manufacture (including import) any of these perfluoroalkyl polymers not already on the TSCA Inventory must complete the TSCA premanufacture notification review process prior to commencing the manufacture of such polymers. Alternatively, manufacturers 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.