Public comments due by October 15, 2012.
Under the Toxic Substances Control Act (TSCA), EPA is proposing to amend a significant new use rule (SNUR) for perfluoroalkyl sulfonate (PFAS) chemical substances to add PFAS chemical substances that have completed the TSCA new chemical review process but have not yet commenced production or import, and to designate (for all listed PFAS chemical substances) processing as a significant new use. EPA is also proposing a SNUR for long-chain perfluoroalkyl carboxylate (LCPFAC) chemical substances that would designate manufacturing, importing, or processing for use as part of carpets or for treating carpet (e.g., for use in the carpet aftercare market) as a significant new use. For this SNUR, EPA is also proposing to make the article exemption inapplicable to the import of LCPFAC chemical substances as part of carpets. Persons subject to these SNURs would be required to notify EPA at least 90 days before commencing any significant new use. The required notifications would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs…
B. What action has the agency previously taken on other PFAS chemical substances?
On October 18, 2000, EPA published in the Federal Register a proposed SNUR (65 FR 62319) (FRL-6745-5) to regulate perfluorooctyl sulfonate (PFOS). The structure and definition of the chemical substances affected by the proposed SNUR were described on page 62325, Unit IV.A. of that proposed rule. The final rule was published in the Federal Register on March 11, 2002 (67 FR 11008) (FRL-6823-6), for 13 PFAS chemical substances (Ref. 2). In response to comments, EPA decided to use the generic term perfluoroalkyl sulfonates (PFAS) for this category of perfluorinated compounds, which includes those with eight carbons as well as those with higher and lower amounts of carbon and the term PFOS to represent only those chemical substances that have predominantly eight carbons. A supplemental proposed SNUR for 75 other similar PFAS chemical substances was published in the Federal Register on March 11, 2002 (67 FR 11014) (FRL-6823-7) (Ref. 3). EPA promulgated a final rule for these 75 PFAS chemical substances on December 9, 2002 (67 FR 72854) (FRL-7279-1) (Ref. 4). On March 10, 2006 (71 FR 12311) (FRL-7740-6), EPA proposed to add 183 PFAS chemical substances to the SNUR at 40 CFR 721.9582, and published a final rule for these 183 PFAS chemical substances on October 9, 2007 (71 FR 12311) (FRL-8150-4) (Ref. 5).Show citation box
C. What are the uses and production levels of the PFAS chemical substances?
The Agency previously determined that the 271 PFAS chemical substances identified in 40 CFR 721.9582(a)(1) were no longer being manufactured or imported for any use in the United States, other than the uses listed under § 721.9582 (a)(3), (a)(4), and (a)(5) (67 FR 72858 and 72 FR 57225). In addition, since those chemicals are no longer manufactured or imported other than for the listed uses, EPA concluded that those chemical substances are also no longer processed other than for those listed uses.Show citation box
PFAS chemical substances included in § 721.9582 were previously used in a variety of products, which can be divided into three main use categories: Surface treatments, paper protection, and performance chemicals (Ref. 6). In the past, PFAS chemical substances in the performance chemicals category were used in a wide variety of specialized industrial, commercial, and consumer applications. Specific applications included fire fighting foams, mining and oil well surfactants, acid mist suppressants for metal plating and electronic etching baths, alkaline cleaners, floor polishes, inks, photographic film, denture cleaners, shampoos, chemical intermediates, coating additives, carpet spot cleaners, and as an insecticide in bait stations for ants (Ref. 7). In 2000, the domestic production volume of the PFAS chemical substances containing eight carbons for the performance chemicals use category was estimated to be approximately 1.5 million pounds (Ref. 16).Show citation box
PFAS chemical substances were also used for treating textiles, fabrics and carpet. These upholstery and fabric protectors were designed to protect rugs and carpets against soiling and restore their original look. Prior to 2003, these formulations were based on PFOS compounds, which contain eight perfluorinated carbons. After 2003, however, 3M, the primary manufacturer of these chemical substances, reformulated the product to be based on perfluorobutane sulfonate (PFBS) compounds containing four perfluorinated carbons (Ref. 8). In addition to domestic manufacture, articles treated with these PFAS chemical substances are also imported. EPA is continuing to evaluate these uses and may determine that regulatory action may be appropriate in the future.Show citation box
The PFAS chemical substances that EPA is proposing to add to the existing PFAS SNUR are chemical substances that have completed the TSCA new chemical review process but have not yet commenced production or import. Any person who commences the manufacture or import of a new chemical substance for which that person previously submitted a section 5(a) notice must submit a notice of commencement of manufacture or import (40 CFR 720.102). EPA has not received any notices of commencements for these chemical substances, and there is currently no production or import of these chemical substances. If commenced, these chemical substances could be used for the PFAS uses described above, significantly increasing the magnitude and duration of exposure to humans and the environment, constituting a significant new use.Show citation box
D. What are the potential health effects of these chemicals and the potential sources and routes of exposures to these chemicals?
PFAS chemical substances degrade ultimately to perfluoroalkylsulfonic acid (PFASA), which can exist in the anionic form under environmental conditions. Further degradation of PFASA is not observed under normal environmental conditions. PFASA is highly persistent in the environment and has a tendency to bioaccumulate (Refs. 8 and 9). PFASA can continue to be formed by any PFAS containing chemical substances introduced into the environment.Show citation box
Studies have found PFAS chemical substances containing five to fourteen carbons (C5-C14) in the blood of the general human population, as well as in wildlife, indicating that exposure to these chemical substances is widespread (Refs. 1, 2, and 10). The widespread presence of PFAS chemical substances in human blood samples nationwide suggests other pathways of exposure, possibly including the release of PFAS treated articles. EPA’s Office of Research and Development (ORD) has conducted research on 116 articles of commerce documenting that PFCs contained in articles of commerce have the potential to be released from those articles and be transformed into PFAC (Ref. 1).Show citation box
Biological sampling has shown the presence of certain perfluoroalkyl compounds in fish and in fish-eating birds across the United States and in locations in Canada, Sweden, and the South Pacific (Ref. 2). The wide distribution of the chemical substances in high trophic levels is strongly suggestive of the potential for bioaccumulation and/or bioconcentration.Show citation box
Based on currently available information, EPA believes that while all PFAS chemical substances are expected to persist, the length of the perfluorinated chain may also have an effect on bioaccumulation and toxicity, which are also characteristics of concern for these chemical substances. PFAS chemical substances with longer carbon chain lengths may be of greater concern than those with shorter chain lengths (Refs. 11, 12, and 13).Show citation box
The hazard assessment published by the Organization for Economic Cooperation and Development (OECD) (Ref. 15) concluded that perfluorooctyl sulfonates (PFOS) are persistent, bioaccumulative and toxic to mammalian species. While most studies to date have focused primarily on PFOS, structure-activity relationship analysis indicates that the results of those studies are applicable to the entire category of PFAS chemical substances, which includes PFOS. Available test data have raised concerns about their potential developmental, reproductive, and systemic toxicity (Refs. 1, 2, and 3).Show citation box
For a more detailed summary of background information (e.g., chemistry, environmental fate, exposure pathways, and health and environmental effects), as well as references pertaining to PFAS chemical substances, please refer to EPA’s proposed SNURs on PFAS chemical substances issued in the Federal Register of October 18, 2000 (65 FR 62319) (FRL-6745-5) (Ref. 16) and March 10, 2006 (71 FR 12311) (FRL-7740-6) (Ref. 17), and also refer to December 30, 2009 Long-Chain Perfluorinated Chemicals Action Plan (Ref. 1).
A. What LCPFAC chemical substances are subject to this proposed SNUR?
LCPFAC chemical substances are synthetic chemicals that do not occur naturally in the environment. The LCPFAC chemical substances are identified as follows, where n > 5 or m > 6:Show citation box
2. CF 3 (CF 2) n-CH = CH 2;Show citation box
3. CF 3 (CF 2) n-C(=O)-X where X is any chemical moiety;Show citation box
4. CF 3 (CF 2) m-CH 2-X where X is any chemical moiety;Show citation box
5. CF 3 (CF 2) m-Y-X where Y = non-S, non-N hetero atom and where X is any chemical moiety; andShow citation box
6. Structurally similar degradation products of any of the compounds in 2. through 5. above.Show citation box
This category definition of LCPFAC, based on the chemical structures above, refers to a large group of chemical substances containing perfluorooctanoic acid (PFOA) and its higher homologues. The category also includes the salts and precursors of these chemical substances. The precursors may be simple derivatives of PFOA and higher homologues or polymers that contain or may degrade to PFOA or higher homologues. These precursors include certain fluoropolymers and all fluorotelomers.Show citation box
B. What are the uses and production levels of LCPFAC chemical substances?
Currently, DuPont is the sole manufacturer of PFOA in the United States. In addition, PFOA, except possibly as part of articles, is not imported into the United States with the exception of the product manufactured by DuPont facilities overseas. According to EPA’s 2006 Inventory Update Reporting database, the aggregated production volume of PFOA and ammonium perfluorooctanoate (APFO) was less than 500,000 pounds for each. APFO is the ammonium salt of PFOA, which dissociates to PFOA in water (Ref. 1).Show citation box
Fluoropolymers such as polytetrafluoroethylene (PTFE), which may contain some PFAC contamination, or that use PFOA as an emulsion stabilizer in aqueous dispersions, are included in the LCPFAC definition and have a large U.S. market. The wire and cable industry is one of the largest segments of the fluoropolymer market, accounting for more than 35 percent of total U.S. fluoropolymer use. Apparel makes up about 10 percent of total fluoropolymer use, based on total reported production volume. Fluoropolymers are used in a wide variety of mechanical and industrial components, such as plastic gears, gaskets and sealants, pipes and tubing, O-rings, and many other products. Total U.S. demand for fluoropolymers in 2004 was between 50,000 and 100,000 metric tons. The United States accounted for less than 25 percent of the world consumption of PTFE in 2007, and between 25 and 50 percent of the world consumption of other fluoropolymers. PTFE is the most commonly used fluoropolymer, and the United States consumed less than 50,000 metric tons of PTFE in 2008 (Ref. 1).Show citation box
Fluorotelomers, oligomers of tetrafluoroethylene, are relatively small functionalized molecules used to make polymers. World-wide production of fluorotelomer-based polymers (FTBP), was estimated at 20 million pounds in 2006. Fluorotelomer monomers and FTBP are included in the LCPFAC category definition as potential LCPFAC precursors. The United States accounts for more than 50 percent of world-wide fluorotelomer/FTPB production. Textiles and apparel account for approximately 50 percent of the volume, with carpet and carpet care products accounting for the next largest share in consumer product uses. Polymeric coatings, including those for paper products, are the third largest category of consumer product uses (Ref. 1). Articles tested and found to contain the highest levels of PFAC were carpet and carpet treatment products, various types of apparel, home textiles, thread sealant tape, floor wax and other sealants, and food contact paper and paper coatings.Show citation box
LCPFAC chemical substances, including FTBP, were used in the textile market because of their thermo-stability, ability to adapt to a variety of surface characteristics, low refractive indexes, low dielectric constants, and high chemical stability. FTBP are used as soil retardants and stain repellents in carpets. FTBP are used to treat textiles which cannot be laundered, including carpets, by preventing or reducing the adhesion of liquid or solid contaminants to the textile fibers. Fluorotelomer carpet treatments are incorporated in polymers including fluorinated polyurethanes, fluorinated vinyl polymers and fluorinated acrylate and methacrylate polymers. Most of these fluorinated polymers have a non-fluorinated backbone with fluorinated alkyl chains which provide the desired physical characteristics. Fluorinated polyurethanes are noted to be tough but resilient and can withstand foot traffic on carpets (Ref. 18).Show citation box
PFAS and LCPFAC chemical substances were used in carpets to impart stain, soil, and grease repellant properties (Ref. 18). There are four typical scenarios for chemical application that could lead to the presence of these chemical substances in carpet products, and this SNUR would apply to all of them. First, these chemical substances could be applied to carpet at a carpet and rug mill during the manufacturing process. Second, these chemical substances could be applied to carpet after the manufacturing process at a separate finishing facility. Third, treatment products containing these chemical substances could be applied to carpets in the aftermarket by consumers or professional carpet cleaners. In the described scenarios, LCPFAC chemical substances could have been domestically produced or imported. Fourth, treated carpet fabrics or treated carpet could be imported as articles. Domestically produced carpets could be made using imported fabrics that had been treated with PFAS or LCPFAC chemical substances or carpet containing these chemical substances could be imported into the United States as a final product.Show citation box
The Agency believes that the LCPFAC chemical substances included in this proposal are no longer being manufactured, processed, or imported for use as part of carpet or for treating carpet (e.g., for use in the carpet aftercare market) in the United States. The Agency also believes that LCPFAC chemical substances are not being imported as part of carpet. In January 2012, The Carpet and Rug Institute (CRI) informed EPA that all members of CRI have voluntarily discontinued the use of LCPFAC chemical substances and have switched to alternative compounds beginning prior to 2003 and completing sometime near the end of 2005 or beginning of 2006 (Ref. 19). CRI is a nonprofit trade association representing the manufacturers of more than 95 percent of all carpet made in the United States, as well as their suppliers and service providers. Although CRI does not track data from non-United States manufacturers or the few domestic manufacturers who are not members of CRI, EPA’s market analysis showed no indication that imported carpet products contain PFAS and LCPFAC chemical substances covered by this proposal, nor did it show any evidence that these chemical substances are manufactured or imported for use as part of carpets (Refs. 20 and 21). The Agency is concerned that LCPFAC chemicals may in the future be used again as part of carpet or for treating carpet, and is hence proposing to include these uses among the significant new uses to be designated for those chemical substances.Show citation box
D. What are the potential health and environmental effects of LCPFAC chemical substances and the potential sources and routes of exposure to these substances?
The following summary of chemistry, environmental fate, exposure pathways, and health and environmental effects of LCPFAC chemical substances is based on the December 30, 2009 Long-Chain Perfluorinated Chemicals Action Plan (Ref. 1), as well as references cited in the 2009 Action Plan.Show citation box
PFOA is the most studied chemical of the LCPFAC chemical substances. PFOA is manufactured for use primarily as an aqueous dispersion agent, as the ammonium salt, in the manufacture of fluoropolymers, such as PTFE, which have thousands of important manufacturing and industrial applications. PFOA can also be produced unintentionally by the degradation of some fluorotelomers, which are not manufactured using PFOA but could degrade to PFOA. Fluorotelomers are used to make polymers that impart soil, stain, grease, and water resistance to coated articles. Some fluorotelomer based products are also used as high performance surfactants in products where an even flow is essential, such as paints, coatings, cleaning products, and fire-fighting foams for use on liquid fuel fires.Show citation box
FTBP can be applied to articles both at the factory and by consumers and commercial applicators in after-market uses such as carpet treatments and water repellent sprays for apparel and footwear (Ref. 18). Therefore, exposure to carpet treatment chemicals may occur both during and after the carpet manufacturing process. In 2008, EPA’s ORD conducted research on 116 articles of commerce and found high levels of LCPFAC in carpet and carpet treatment products (levels were from 0.04-40,200 nanograms per gram) (Ref. 1). This is of particular concern for children since they engage in a variety of activities on carpets for longer periods of time in their earliest years and can be exposed to chemical substances in carpets via inhalation and dust ingestion (Ref. 1).Show citation box
PFOA and its higher homologues are highly persistent chemical substances that are resistant to degradation under environmental conditions. The chemical substances which degrade to form these chemicals are called LCPFAC precursors. These precursors may be present in the final polymer product as residuals and the amount present in the polymer as perfluoroalkyl group (R f) moieties. The availability of LCPFAC precursor from the content of residuals in fluorotelomer based polymer products (FTBP) would be small in comparison to the amount released should polymeric materials biodegrade in the environment. Potentially all monomeric and most if not all polymeric products, not just the small amounts of residual monomers and other monomer raw material and intermediates, could be LCPFAC precursors. LCPFAC can continue to be formed by LCPFAC precursors introduced into the environment as they biodegrade with time.Show citation box
A limited number of studies on the degradation of fluorotelomers have been submitted in support of PMN submissions and existing chemical substances, and they have been published in the open literature. Based on studies, some fluorotelomer-based polymers are subject to hydrolysis, photolysis and biodegradation to some extent. Studies have shown half-lives of a few days to hundreds of years. In addition, existing research on degradation of fluorotelomers has shown that some urethanes and acrylates biodegrade; however, half-lives and kinetics of the fluorotelomers are not yet well defined (Ref. 22). Nevertheless, these studies have shown unambiguously that the perfluorinated portion of some polymers is released as the polymer is degraded by microbial or abiotic processes to form telomer alcohols or other intermediates and that they eventually form LCPFAC.Show citation box
LCPFAC have been detected in biota, air, water, dust, and soil samples collected throughout the world. Some LCPFAC chemical substances have the potential for long-range transport. They are transported over long distances by a combination of dissolved-phase ocean and gas-phase atmospheric transport; however, determining which is the predominant transport pathway is complicated by many factors including the uncertainty over water to atmosphere partitioning. Furthermore, there is evidence that transport and subsequent oxidation of volatile alcohol LCPFAC precursors contribute to the levels of LCPFAC in the environment.Show citation box
LCPFAC chemical substances have been detected in human blood samples throughout the United States and the world. These compounds have also been detected in human breast milk, liver, umbilical cord blood, and seminal plasma. Individual samples collected on perfluorinated chemical substances in the most recent National Health and Nutrition Examination Survey (NHANES) 1999-2009 are similar across teens and adults (Ref. 1); however, pooled data from NHANES 2001-2002 indicate that most of the levels of perfluorinated compounds are higher in children ages 3-11 years compared to adults. In addition, a 2009 Texas survey of 300 children reported PFOS, PFOA, perfluorohexanesulfonate (PFHS) and perfluorononanoic acid (PFNA) at higher levels in children 9 to 13 years than in 0 to 2 years (Ref. 1).Show citation box
Multiple studies have reported a global distribution of LCPFAC in wildlife tissue and blood samples. LCPFAC have also been found in a variety of aquatic organisms. In general, the highest concentrations in wildlife have been found in the livers of fish-eating animals close to industrialized areas.Show citation box
Animal studies of the straight-chain LCPFAC have shown that these compounds are well absorbed orally, but poorly eliminated; they are not metabolized, and they undergo extensive uptake from enterohepatic circulation. Studies of PFOA have shown that these compounds are distributed mainly to the serum, kidney, and liver, with liver concentrations being several times higher than serum concentrations; the distribution is mainly extracellular. PFOA has a high affinity for binding to B-lipoproteins, albumin, and liver fatty acid-binding protein. Studies have reported several LCPFAC chemical substances in umbilical cord blood, in amniotic fluid, and in blood samples from infants and toddlers (Ref. 1).Show citation box
In general, the rate of elimination decreases with increasing chain length. Elimination in humans takes years (elimination half-life of PFOA is 2.3-3.8 years). These compounds will persist and bioaccumulate in humans, which means that comparatively low exposures may result in large body burdens.Show citation box
LCPFAC bioaccumulate and persist in protein-rich compartments of fish, birds, and marine mammals, such as carcass, blood, and liver. Studies have found fish bioconcentration factor (BCF) values for C8 to C14 LCPFAC ranging from 4-40,000 in rainbow trout. Available evidence shows the likely potential for bioaccumulation or biomagnifications in marine or terrestrial species. Additional evidence that C14 and C15 LCPFAC bioaccumulate and are bioavailable is their presence in fish, invertebrates, and polar bears. The bioaccumulation of LCPFAC is thought to represent biomagnification due to high gastrointestinal uptake and slow elimination.Show citation box
The toxicity of PFOA has been extensively studied and available data have raised concerns about LCPFAC chemical substances’ potential developmental, reproductive, and systemic toxicity (Ref. 1). Although there is an extensive database for PFOA, few studies have examined the toxicity of other LCPFAC chemical substances. However, the data suggest that the toxicity profile is quite similar to that of PFOA, albeit at different dose levels.
As discussed in Units III and IV, PFAS and LCPFAC chemical substances are found world-wide in the environment, wildlife, and humans. They are bioaccumulative in wildlife and humans, and are persistent in the environment. They are toxic to laboratory animals, producing reproductive, developmental, and systemic effects in laboratory tests. The exact sources and pathways by which these chemicals move into and through the environment and allow humans and wildlife to become exposed are not fully understood, but are likely to include releases from manufacturing of the chemicals, processing of these chemicals into products like carpets and textiles, and aging and wear of products containing them.Show citation box
Since the manufacture, import, and processing of PFAS and LCPFAC chemical substances for the proposed uses have been discontinued, EPA expects their presence in humans and the environment to decline over time as has been observed in the past when production and use of other persistent chemicals has ceased. EPA is concerned that the manufacturing, import (including import as part of certain articles), or processing of these chemical substances for the proposed new uses could be reinitiated in the future. If reinitiated, EPA believes that such use would increase the magnitude and duration of exposure to humans and the environment to these chemical substances, constituting a significant new use.Show citation box
EPA is concerned about the potential for PFAS or LCPFAC chemical substances (manufactured or imported for an ongoing use) to be redirected to other uses without prior notice to the Agency. For example, a chemical substance may be initially manufactured or imported for a uses listed under § 721.9582(a)(3), (a)(4), or (a)(5), and then redirected for another use after its initial manufacture or import. EPA is therefore proposing to add the processing of a PFAS chemical substances (for any use in the United States, other than the uses listed under § 721.9582(a)(3), (a)(4), and (a)(5)) to the significant new uses of those chemical substances. For similar reasons, EPA is proposing to include the processing of LCPFAC chemical substances (for use as part of carpets or to treat carpet) among the significant new uses to be designated for those chemical substances. While the processing of articles containing PFAS and LCPFAC would remain exempt from notice requirements, pursuant to § 721.45(f), persons who otherwise process PFAS or LCPFAC for a use other than the above-listed uses where applicable would be required to first notify EPA, even if they are not themselves manufacturers or importers of the chemical substance.Show citation box
Accordingly, EPA wants the opportunity to evaluate and control, where appropriate, activities associated with those uses, if such manufacturing, importing, or processing were to start or resume. The required notification provided by a SNUN would provide EPA with the opportunity to evaluate activities associated with a significant new use and an opportunity to protect against unreasonable risks, if any, from exposure to PFAS and LCPFAC chemical substances.Show citation box
Consistent with EPA’s past practice for issuing SNURs under TSCA section 5(a)(2), EPA’s decision to propose a SNUR for a particular chemical use need not be based on an extensive evaluation of the hazard, exposure, or potential risk associated with that use. Rather, the Agency’s action is based on EPA’s determination that if the use begins or resumes, it may present a risk that EPA should evaluate under TSCA before the manufacturing or processing for that use begins. Since the new use does not currently exist, deferring a detailed consideration of potential risks or hazards related to that use is an effective use of resources. If a person decides to begin manufacturing or processing the chemical for the use, the notice to EPA allows EPA to evaluate the use according to the specific parameters and circumstances surrounding that intended use.Show citation box
While the Agency is currently only proposing as significant new uses of LCPFAC chemical substances use as part of carpet or to treat carpet, the Agency believes the 2010/2015 PFOA Stewardship Program will eliminate many other ongoing uses of LCPFAC chemical substances. As those uses are phased out in the United States, EPA anticipates taking additional regulatory actions to prevent resumption of the uses without prior notice to EPA.Show citation box
Based on the considerations in Unit V.A., EPA wants to achieve the following objectives with regard to the significant new use(s) that are designated in this proposed rule:Show citation box
1. EPA would receive notice of any person’s intent to manufacture, import, or process PFAS or LCPFAC chemicals for the described significant new use before that activity begins.Show citation box
2. EPA would have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing, importing, or processing PFAS or LCPFAC chemicals for the described significant new use.Show citation box
3. EPA would be able to regulate prospective manufacturers, importers, or processors of PFAS or LCPFAC chemicals before the described significant new use of the chemical substance occurs, provided that regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6 or 7.