Proposed Rule: Premanufacture Notification Exemption for Polymers; Amendment of Polymer Exemption Rule to Exclude Certain Perfluorinated Polymers

EPA believes that it can no longer conclude that polymers containing fluorotelomers as an integral part of the polymer composition ``will not present an unreasonable risk of injury to health or the environment'' as required for an exemption under section 5(h)(4) of TSCA. Therefore, EPA is proposing to exclude polymers that contain such fluorotelomers from the polymer exemption at 40 CFR 723.250.

... Although EPA does not have specific data demonstrating that polymers containing perfluoroalkyl moieties other than PFAS, PFAC, or fluorotelomers present the same concerns as those containing PFAS, PFAC, or fluorotelomers, EPA is nevertheless proposing to exclude polymers containing perfluoroalkyl groups, consisting of a CF3- or longer chain length, 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 from the polymer exemption. Based on available data which indicates that compounds containing PFAS or PFAC may degrade in the environment thereby releasing the PFAS or PFAC moiety, and that fluorotelomers may degrade in the environment to form PFAC, EPA believes that it is possible for polymers containing these other types of perfluoroalkyl moieties to also degrade over time in the environment thereby releasing the perfluoroalkyl moiety. EPA also believes that once released, such moieties may potentially degrade to form PFAS or PFAC. EPA does not believe, therefore, that it can continue to make the ``will not present an unreasonable risk of injury to health or the environment'' finding for such polymers and is proposing to exclude them from the polymer exemption. EPA is specifically requesting comment on this aspect of the proposed rule.

A. Polymers Containing PFAS or PFAC
... Animal test data for PFOS and PFOA have shown liver, developmental, and reproductive toxicity at very low exposure levels. Animal test data indicate that PFOA may cause cancer, and an epidemiologic study reported an increased incidence of bladder cancer mortality in a small number of workers at a plant that manufactures perfluorinated chemicals. The number of carbon atoms on the PFAS/PFAC component may influence the bioaccumulation potential and the toxicity. In particular, there is some evidence that PFAS/PFAC moieties with longer carbon chains may present greater concerns for bioaccumulation potential and toxicity than PFAS/PFAC moieties with shorter carbon chains (Refs. 5, 6, and 7)...

B. Polymers Containing Fluorotelomers or Other Perfluoroalkyl Moieties
EPA is also proposing to exclude from the polymer exemption rule polymers that contain fluorotelomers, or that contain perfluoroalkyl moieties of a CF3- or longer chain length that are covalently bound to either a carbon or sulfur atom where the carbon or sulfur atom is an integral part of the polymers molecule. EPA has concerns with respect to the potential health and environmental effects of these substances and the Agency believes that polymers containing such moieties should be subject to the premanufacture review process so that EPA can better evaluate and address these concerns. As discussed in Unit IV.E., there is a growing body of data demonstrating that fluorotelomer alcohols metabolize or degrade to generate PFOA. Initial studies have also demonstrated toxic effects of certain compounds containing fluorotelomers (derived from the 8-2 alcohol). Preliminary investigations have found that fluorotelomer alcohols were present in the air above several cities, indicating that these substances may be widely distributed and that air may be a route of exposure. EPA believes that polymers containing 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 polymers molecule may degrade in the environment thereby releasing fluorotelomer alcohols or other perfluoroalkyl-containing substances. Accordingly, EPA can no longer conclude that polymers containing fluorotelomers and these other perfluoroalkyl moieties ``will not present an unreasonable risk of injury to health or the environment'' as required for an exemption under section 5(h)(4) of TSCA. Therefore, EPA is proposing to exclude such polymers from the polymer exemption at
40 CFR 723.250.

... Canadian researchers found fluorotelomer alcohols in the air in six different cities is significant. This finding is indicative of widespread fluorotelomer alcohol distribution, and it further indicates that air may be a route of exposure to these chemicals, which can ultimately become PFOA.

Final Enforceable Consent Agreement and Testing Consent Order for Four Formulated Composites of Fluoropolymer Chemicals; Export Notification.

EPA has issued a testing consent order (Order) that incorporates an enforceable consent agreement (ECA) with AGC Chemicals Americas, Inc.; Daikin America, Inc.; Dyneon, LLC; and E.I. du Pont de Nemours and Company (the Companies)...

... Data developed from the ECA testing will contribute to the Agency's [EPA] efforts to determine whether municipal and/or medical waste incineration of fluoropolymer (FP) chemicals is a potential source and/or pathway of environmental and human exposure to perfluorooctanoic acid (PFOA)...

NOTE: There were 159 documents attached to this Docket. FAN has downloaded each document and they are available at http://www.fluorideaction.org/pesticides/pfoa-eca/index.html

Also see List of Fluoropolymer Chemicals to be used in incineration tests

Announcement: Longitudinal Study of Young Children's Exposures in their Homes to Selected Pesticides, Phthalates, Brominated Flame Retardants, and Perfluorinated Chemicals (A Children's Environmental Exposure Research Study--CHEERS).

Abstract: The U.S. EPA's Office of Research and Development's National Exposure Research Laboratory proposes to conduct a two-year longitudinal field measurement study of young children's (aged 0 to 3 years) potential exposures to current-use pesticides and selected phthalates, polybrominated diphenyl ethers, and perfluorinated
compounds that may be found in residential environments. The study will be conducted in Duval County, Jacksonville, Florida over a two-year period from 2004 to 2006. Sixty young children will be recruited into this study in two cohorts: (1) infants recruited into the study soon after birth, and, (2) children recruited into the study at approximately 12 months of age. The study involves up to six monitoring events to each home during the two-year study period during which environmental, personal, biological, and activity pattern data will be collected. Each monitoring event consists of four visits to each participant's home. Aggregate exposure estimates will be conducted for the current-use pesticides and selected phthalates in the study. The data collected on the polybrominated diphenyl ethers and the perfluorinated compounds will provide valuable information on concentrations of these compounds in residential environments, the potential magnitude for exposure, and the temporal and spatial variability of these chemicals in residences.
The data collected in this study is very important to the EPA's Program Offices. The reasons for collecting this data are to better identify the exposure factors, routes, and pathways of exposure for these chemicals, thus improving the Agency's ability to regulate these chemicals, conduct meaningful risk assessments, and develop future studies.

Sept 30, 2003

None

PFOS / PFOAS. September 30, 2003. Federal Register.
Candidate Chemicals for Possible Inclusion in Future Releases of the National Report on Human Exposure to Environmental Chemicals.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Group 1
N-methyl perfluorooctanesulfonamidoacetate (M570)
Perfluorinated carboxylic acid metabolites of telomer alcohol or
telomer acrylate (n = 3)
Perfluorobutane sulfonate (PFBS)
Perfluorooctanoic acid fluoride
Perfluorooctanoic acid (PFOA) ammonium salt*
PFOA ethyl ester
PFOA free acid
PFOA methyl ester
PFOA potassium salt*
PFOA silver salt*
PFOA sodium salt*
Perfluorooctane sulfonate (PFOS) ammonium salt*
PFOS diethanolamine salt*
PFOS lithium salt*
PFOS potassium salt*
* PFOA and PFOS measured as a consequence of exposure to any PFOA or
PFOS salt.

Group 2
Lambda cyhalothrin
Perfluorodecanesulfonate (PFDS) ammonium salt
Perfluorooctanesulfonamidoacetate (M556)
Trifluralin

Group 3
PFOS-related compounds (n = 11; a heterogeneous group)
Fluoroalkyl ethers (n = 6)
Fluoroalkyl iodides (n = 3)
Other phased-out PFCs related to PFOS chemistries (n = 13)
Perfluorinated carboxylic acid metabolites of telomer alcohol or
telomer acrylate (n = 3)
Perfluorinated chemicals not assigned to a structural class (n = 2)
Perfluorinated homologues of <strong>PFOS</strong> and PFOA (n = 2)
Perfluorinated quaternary ammonium chemicals (n = 2)
Perfluoroalkanes (n = 3)
Perfluoroalkyl acids and salts (n = 6)
Perfluoroalkyl alcohols (n = 4)
Perfluoroalkyl carboxylic acid fluorides (n = 2)
Perfluoroalkyl esters (n = 5)
Perfluoroalkyl iodides (n = 6)
Perfluoroalkyl sulfonamides (n = 10)
Perfluoroalkyl sulfonates (n = 75)
Perfluoroalkyl sulfonyl fluorides (n = 4)
Perfluoroglycol acid fluorides (n = 5)

Group 4
Fluoroalkyl ethers (n = 6)
Fluoroalkyl iodides (n = 3)
Gamma, omega-perfluoroalkyl alcohols (n = 3)
Other phased-out PFCs related to PFOS chemistries (n = 13)
Perfluorinated carboxylic acid metabolites of telomer alcohol or
telomer acrylate (n = 3)
Perfluorinated chemicals not assigned to a structural class (n = 2)
Perfluorinated homologues of PFOS and PFOA (n = 2)
Perfluorinated quaternary ammonium chemicals (n = 2)
Perfluoroalkanes (n = 3)
Perfluoroalkyl acids and salts (n = 6)
Perfluoroalkyl alcohols (n = 4)
Perfluoroalkyl carboxylic acid fluorides (n = 2)
Perfluoroalkyl esters (n = 5)
Perfluoroalkyl iodides (n = 6)
Perfluoroalkyl sulfonamides (n = 10)
Perfluoroalkyl sulfonates (n = 75)
Perfluoroalkyl sulfonyl fluorides (n = 4)
Perfluoroglycol acid fluorides (n = 5)

Group 5
Perfluorinated compounds that the U.S. Food and Drug Administration
has approved as indirect food additives (n = 16)
Perfluoroalkyl acids and salts (n = 2)

PFOA: Perfluorooctanoic Acid, Fluorinated Telomers; Request for Comment, Solicitation of Interested Parties for Enforceable Consent Agreement Development, and Notice of Public Meeting.
-- EPA has prepared a preliminary risk assessment (Ref. 1) on perfluorooctanoic acid (PFOA) (Octanoic acid, pentadecafluoro-; (CAS No.) 335-67-1) and its salts, predominantly ammonium perfluorooctanoate (APFO) (Octanoic acid, pentadecafluoro-, ammonium salt (CAS No. 3825-26-1)). This preliminary
assessment indicates potential nationwide human exposure to low levels of PFOA...
-- The major fluoropolymers manufactured using PFOA salts are polytetrafluoroethylene (PTFE) and polyvinylidine fluoride (PVDF). PTFE has hundreds of uses in many industrial and consumer products, including soil, stain, grease, and water resistant coatings on textiles and carpet; uses in the automotive, mechanical, aerospace, chemical, electrical, medical, and building/construction industries; personal care products; and non-stick coatings on cookware. PVDF is used primarily in three major industrial sectors: Electrical/electronics, building/ construction, and chemical processing.
-- EPA has also received data which indicate that the 8-2 telomer alcohol (1-Decanol, 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-heptadecafluoro- (CAS No. 678-39-7)) although not itself made with PFOA, can be metabolized by living organisms or biodegrade under environmental conditions to produce PFOA ... anecdotal evidence of the atmospheric presence of telomer alcohols in a multi-city North American survey
suggests that telomers may be one source of environmental PFOA ...
-- PFOA exposures and releases to the environment may also come from the distribution of PFOA in aqueous dispersions of fluoropolymers used by processors to apply coatings to metals and textiles, a topic which industry is also attempting to resolve.
-- Preliminary data suggest that only higher perfluorinated homologues (chemicals with carbon chain lengths of eight and higher) would be converted into PFOA via normal environmental pathways.

3 of several documents in Docket:
March 13, 2003. Environmental, Health and Safety Measures Relating to Perfluorooctanoic Acid and its Salts (PFOA). Letter to US EPA from Dr. Larry Wendling, VP, Performance Materials Division, 3M Company (9 pages). Federal Register Docket OPPT-2003-0012-0007

Aug 1, 2003. Perfluorooctanoic Acid. Physiochemical Properties and Environmental Fate Data. Submitted to US EPA from Michael A. Santoro, Director, Environmental Health Safety and Regulatory Affairs, 3M; and George H. Millet, Director - Quality, Environmental, Health & Safety, Dyneon LLC, 3M Company. Federal Register Docket OPPT-2003-0012-0164

Aug 1, 2003. Submission of Monitoring Data Pursuant to the 3M LOI dated March 13, 2003 and APFO Users LOI dated March 14, 2003. Letter to US EPA from Michael A. Santoro, Director, Environmental Health Safety and Regulatory Affairs. 3M. Federal Register Docket OPPT-2003-0012-0163

March 1, 2000. Sulfornated Perfluorochemicals in the Environment: Sources, Dispersion, Fate and Effects. Prepared by 3M. This report is part of Federal Register Docket OPPT-2002-0043; for US EPA's Dec 9, 2002, Final Rule on Perfluoroalkyl Sulfonates; Significant New Use Rule.

Dec 9, 2002

OPPT-2002-0043

Perfluoroalkyl Sulfonates; Significant New Use Rule. FINAL RULE. EPA is issuing a significant new use rule (SNUR) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for 75 substances including perfluorooctanesulfonic acid (PFOSH) and certain of its salts (PFOSS), perfluorooctanesulfonyl fluoride (POSF), certain higher and lower homologues of PFOSH and POSF, and certain other chemical substances, including polymers, that are derived from PFOSH and its homologues. These chemicals are collectively referred to as perfluoroalkyl sulfonates, or PFAS. This rule requires manufacturers and importers to notify EPA at least 90 days before commencing the manufacture or import of these chemical substances for the significant new uses described in this document.

-- Manufacture or import of any chemical listed in Table 1, Unit I.A., solely for one or more of the following specific uses shall not be considered as a significant new use subject to reporting under this section:

i. Use as an anti-erosion additive in fire-resistant phosphate ester aviation hydraulic fluids.

ii. Use as a component of a photoresist substance, including a photo acid generator or surfactant, or as a component of an anti-reflective coating, used in a photomicrolithography process to produce semiconductors or similar components of electronic or other miniaturized devices.

iii. Use in coatings for surface tension, static discharge, and adhesion control for analog and digital imaging films, papers, and printing plates, or as a surfactant in mixtures used to process imaging films.

iv. Use as an intermediate only to produce other chemical substances to be used solely for the uses listed in Unit II.A.2.i., ii., or iii.

EPA's response to Waste Not:
Waste Not questioned whether PFAS chemicals previously on the list of pesticide inerts would continue to be listed, whether one named chemical on the inerts list was included in the SNUR, and whether its understanding of the status of sulfluramid products was correct. Waste Not also asked whether EPA would identify crops on which these products were used. EPA confirms that none of the PFAS chemicals on the inerts list identified by Waste Not, including the named chemical without a CAS number provided, are currently formulated into pesticide products, and they will all be removed from the EPA List 3 Inerts list the next time that list is updated. EPA notes that, although these PFAS chemicals will remain on the List 3 Inerts list until that list is updated, the manufacture or import of chemicals listed in this rule for use as inert ingredients in pesticide products would be a significant new use subject to this rule. Although TSCA does not regulate chemicals manufactured for use solely as pesticide active ingredients, chemical intermediates and pesticide inert ingredients are subject to regulation under TSCA. With respect to Waste Not's comment concerning the current status of registered insecticide products containing sulfluramid, EPA concurs with the list of active and cancelled products provided by Waste Not. There are currently 16 products listed as active and 3 products cancelled. Three of the four products listed as transferred, EPA Registration Nos. 11540-21, 1812-330, and 1812-329, are the same as the three products listed as cancelled. The fourth product listed as transferred, EPA Registration No. 11540-20, is the same as the active product under EPA Registration No. 499-45. All pesticide products containing sulfluramid are under a specific timeline to be phased out by 2016. The pesticide products that are registered are for use in a variety of enclosed termite, ant, and roach bait stations. These products are pre-filled and sold only in child-resistant packaging•. Products containing sulfluramid have not been registered for food or crop uses.

March 11, 2002

OPPTS-50639C

PFAS: Perfluoroalkyl Sulfonates; Proposed Significant New Use Rule. EPA is proposing a supplemental significant new use rule (SNUR) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the following 75 substances: Perfluorooctanesulfonic acid (PFOSH) and certain of its salts (PFOSS), perfluorooctanesulfonyl fluoride (POSF), certain higher and lower homologues of PFOSH and POSF, and certain other chemical substances, including polymers, that are derived from PFOSH and its homologues. These chemicals are collectively referred to as perfluoroalkyl sulfonates, or PFAS. This proposed rule would require manufacturers and importers to notify EPA at least 90 days before commencing the manufacture or import of these chemical substances for the significant new uses described in this document. EPA believes that this action is necessary because the PFAS component of these chemical substances may be hazardous to human health and the environment.

-- In the original proposed SNUR (65 FR 62319, October 18, 2000), these chemicals had been referred to collectively as perfluorooctylsulfonates, or PFOS, but commenters noted that this generic usage of PFOS was inconsistent with 3M's use of PFOS to refer only to chemicals with an eight-carbon, or C8, chain length. Many of the chemicals in the proposed SNUR included a range of carbon chain lengths, although they all did include C8 within the range. Accordingly, EPA will use the generic term PFAS to refer to any chain length, including higher and lower homologues as well as C8, and the term PFOS to represent only those chemicals which are predominantly C8.

-- PFAS not subject to a significant new use determination:
-- As a component of a photoresist substance, including a photo acid generator or surfactant, or as a component of an anti-reflective coating, used in a photomicrolithography process to produce semiconductors or similar components of electronic or other miniaturized devices.

-- specific use of the 3M formulations FC93 and FC98, which contain three of the PFAS chemicals (CAS Nos. 2795-39-3, 67584-42-3, and 68156-01-4) listed in Table 2, Unit I.A, as an anti-erosion additive in fire- resistant phosphate ester aviation hydraulic fluids, was critical to the safe performance of large cargo and passenger aircraft, and that there are at present no viable alternatives to PFAS for this use... the total aggregate use of PFAS in this application by all aviation consumers is less than 5,000 lbs per year (2,273 kg), and that because these systems are sealed at the time of manufacture, worker exposures and releases to the environment are minimal.

-- Under consideration for exemption:
Commenters in the photography industry, in addition to raising the semiconductor applications addressed earlier in this section, also identified as critical the use of certain PFAS chemicals in surface tension and static discharge control coatings on films, papers, and printing plates, and as surfactants and defoamers in solutions used to process films and papers, particularly in both traditional and laser medical imaging and in some industrial and consumer film products. The industry estimated the total annual use of these PFAS chemicals in medical imaging for disease diagnosis at 30,600 kg (67,320 lbs), with another 5,400 kg (11,880 lbs) used per year in industrial (i.e., oil pipeline x-ray; aerial reconnaissance photography) and some consumer applications. Some information on specific chemicals used in these applications, as well as on the sources of those chemicals, was claimed as confidential.

PFAS: Perfluoroalkyl Sulfonates; Significant New Use Rule. FINAL RULE. EPA is issuing a significant new use rule (SNUR) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for 13 chemicals, including polymers, that are derived from perfluorooctanesulfonic acid (PFOSH) and its higher and lower homologues. These chemicals are collectively referred to as perfluoroalkyl sulfonates, or PFAS. This rule requires manufacturers and importers to notify EPA at least 90 days before commencing the manufacture or import of these chemical substances for the significant new uses described in this document. EPA believes that this action is necessary because the PFAS component of these chemical substances may be hazardous to human health and the environment. The required notice will provide EPA with the opportunity to evaluate an intended new use and associated activities and, if necessary, to prohibit or limit that activity before it occurs. This action promulgates a portion of the proposed SNUR originally published in the Federal Register of October 18, 2000. This action also removes from the SNUR two chemicals that were listed erroneously in that original proposal. Published elsewhere in today's issue [see below] of the Federal Register is a supplemental proposed rule which addresses the remainder of the chemicals listed in the original proposed SNUR.

Perfluorooctyl Sulfonates, Proposed Significant New Use Rule; Extension of Comment Period. SUMMARY: EPA is extending the existing comment period for the proposed significant new use rule (SNUR) on perfluorooctyl sulfonates published on [[Page 69890]] October 18, 2000, in the Federal Register. In response to several requests, the comment period is being extended by 45 days, until January 1, 2001. The comment period was scheduled to close on November 17, 2000. The proposed SNUR under section 5(a)(2) of the Toxic Substances Control Act (TSCA) applies to the following chemical substances: perfluorooctanesulfonic acid (PFOSA) and certain of its salts (PFOSS), perfluorooctanesulfonyl fluoride (PFOSF), certain higher and lower homologues of PFOSA and PFOSF, and certain other chemical substances, including polymers, that contain PFOSA and its homologues as substructures. All of these chemical substances are referred to collectively in the proposed rule as perfluorooctyl sulfonates, or PFOS. The proposed rule would require manufacturers and importers to notify EPA at least 90 days before commencing the manufacture or import of these chemical substances for the significant new uses described in this document.

Perfluorooctyl Sulfonates. Proposed Significant New Use Rule.

This Notice provides highly disturbing data on significant and severe health effects from animal studies that used very low exposure levels. It also provides the list of the chemicals to be phased out of production by 3M. Due to the severity of effects EPA is proposing a zero production level of these chemicals by 2003.

The Notice states:
EPA is proposing a significant new use rule (SNUR) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the following chemical substances: Perfluorooctanesulfonic acid (PFOSA) and certain of its salts (PFOSS), perfluorooctanesulfonyl fluoride (PFOSF), certain higher and lower homologues of PFOSA and PFOSF, and certain other chemical substances, including polymers, that contain PFOSA and its homologues as substructures. All of these chemical substances are referred to collectively in this proposed rule as perfluorooctyl sulfonates, or PFOS...

All of these chemical substances have the potential to degrade back to PFOSA in the environment, and PFOSA does not degrade further. PFOSA is highly persistent in the environment and has a strong tendency to bioaccumulate. Studies have found PFOS in very small quantities in the blood of the general human population as well as in wildlife, indicating that exposure to the chemicals is widespread, and recent tests have raised concerns about their potential developmental, reproductive, and systemic toxicity (Refs. 1, 2, and 3). These factors, taken together, raise concerns for long term potential adverse effects in people and wildlife over time if PFOS should continue to be produced, released, and built up in the environment.

This proposed rule would require manufacturers and importers to notify EPA at least 90 days before commencing the manufacture or import of these chemical substances for the significant new uses described in this document. EPA believes that this action is necessary because the chemical substances included in this proposed rule may be hazardous to human health and the environment. The required notice would provide EPA with the opportunity to evaluate an intended new use and associated activities and, if necessary, to prohibit or limit that activity before it occurs.

Environmental Fate. The basic building block of all of the PFOS chemicals is PFOSF, which is used as an intermediate in the production of the PFOS chemicals. PFOSA results from the chemical or enzymatic hydrolysis of PFOSF. Current information strongly supports that PFOSA is an extremely stable substance which resists breakdown by chemical or biological processes. Therefore PFOSA is the ultimate degradation product from PFOS chemicals and will persist in that form (Refs. 1 and 2)...