Federal Register
The following were published in the Federal Register, the daily newspaper of the U.S. federal government, and published every business day by the National Archives and Records Administration.
| Excerpts | |
| Date PublishedEPA Docket ID No. | Details |
| April 4, 1994 | Secondary Direct Food Additives Permitted in Food for Human Consumption; Perfluorinated Ion Exchange Membranes. FINAL RULE. Food and Drug Administration, HHS. SUMMARY: The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of a perfluorinated ion exchange membrane intended for repeated use in the treatment of bulk quantities of liquid foods at temperatures up to 70 deg.C (158 deg.C). The membrane is a copolymer of ethanesufonyl fluoride, 2-[1- [difluoro-[(trifluoroethenyl)oxy]methyl]-1,2,2,2-tetrafluoroethoxy]-1,1,2,2,-tetrafluoro- with tetrafluoroethylene that is subsequently treated to hydrolyze the sulfonyl fluoride group to the sulfonic acid. This action is in response to a petition filed by E. I. du Pont de Nemours and Co… |
| Oct 18, 2000 | 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: 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)… Surface treatment Paper protection Performance chemicals |
| Nov 21, 2000 | PFOS: 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 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. |
| Dec 1, 2000 | Forty-Sixth Report of the TSCA Interagency Testing Committee to the Administrator; Receipt of Report and Request for Comments. Notice. US EPA. –The Toxic Substances Control Act (TSCA) Interagency Testing Committee (ITC) transmitted its Forty- Sixth Report to the Administrator of the EPA on May 25, 2000. In the 46th Report, which is included with this notice, the ITC: Solicits information on uses, exposures, ecological effects, environmental fate, and health effects on 3 classes of structurally related chemicals (4 polychlorophenols and polychlorobenzenethiols, 8 chlorotrifluoromethylphenoxy benzenes, and 50 perfluorinated chemicals) that have potential to persist and bioconcentrate; requests more detailed exposure and use information be included in the TSCA Electronic Hazard and Safety Data Reporting Form… |
| Feb 23, 2001 | Perfluorooctyl Sulfonates; Notice of Public Meeting. |
| March 6, 2002 | Forty-Ninth Report of the TSCA Interagency Testing Committee. Request for Comments. |
| March 11, 2002 | 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… |
| March 11, 2002 | 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.See Comment from FAN’s Pesticide Director |
| April 5, 2002 | Perfluoroalkyl Sulfonates, Proposed Significant New Use Rule; Extension of Comment Period – EPA is extending the existing comment period for the proposed significant new use rule (SNUR) on perfluoroalkyl sulfonates published on March 11, 2002, in the Federal Register. In response to a request from the International Imaging Industry Association, the comment period is being extended by 90 days, until July 9, 2002. |
| Dec 9, 2002 | 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.Documents added to this Docket:- Sulfonated Perfluorochemicals in the Environment: Sources, Dispersion, Fate and Effects.- The Science of Organic Fluorochemistry- Fluorochemical Use, Distribution and Release Overview- 3M. Phase-out Plan for POSF-Based Products. Letter from William Weppner (3M) to Charles Auer (US EPA)- Hazard Assessment and Biomonitoring Data on Perfluorooctane Sulfonate – PFOS, with cover memo from Jennifer Seed, EPA OPPT to Charles Auer, EPA OPPT –EPA’s response to Waste Not [FAN’s Pesticide Director]: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. • Note: |
| April 16, 2003 | 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-2003-0012-0007Aug 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-2003-0012-0164Aug 1, 2003.Submission of Monitoring DataPursuant 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-2003-0012-0163March 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… |
| Sept 30, 2003 | PFOS / PFOAS. Candidate Chemicals for Possible Inclusion in Future Releases of the National Report on Human Exposure to Environmental Chemicals. September 30, 2003. Federal Register. DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and PreventionGroup 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) TrifluralinGroup 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) |
| March 4, 2004 | 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. Part A: Supporting Statement – EPA ICR Number: 2126.01 – 61 pages From Table 2: • Of 16 pesticides included in this study, 4 are fluorinated: Bifenthrin, Fipronil, Lambda-cyhalothrin, and Cyfluthrin I, II, III, IV, total • Perfluorinated chemicals: Perfluorooctanoic acid (PFOA) and Perfluorooctane sulfonate (PFOS)From Table 3: List of chemicals to be analyzed in biological media: • one is fluorinated: 4-fluoro-3-phenoxybenzoic acid (a breakdown product of Cyfluthrin) • Perfluorooctanoic acid/Perfluorooctane sulfonate |
| July 8, 2005 | 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: See the 159 documents attached to this Docket.Also see List of Fluoropolymer Chemicals to be used in incineration tests |
| March 7, 2006 | Proposed Rule: Premanufacture Notification Exemption for Polymers; Amendment of Polymer Exemption Rule to Exclude Certain Perfluorinated PolymersEPA 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. |
| March 21, 2008 | Submission for OMB Review; Comment Request; Longitudinal Investigation of Fertility and the Environment [LIFE]. National Institutes of Health….The purpose of the LIFE Study is to assess the impact of environmental factors, broadly defined to include lifestyle factors, on human reproduction and development.. The LIFE Study is consistent with the mission of the Eunice Kennedy Shriver National Institute of Child Health and Human Development that includes conducting basic, clinical and epidemiologic research focusing on factors and processes associated with human reproduction and development thereby, ensuring the birth of healthy infants capable of reaching full adult potential unimpaired by physical or mental disabilities. This study will assess the relation between select environmental factors and human reproduction and development. This research originally proposed to recruit 960 couples who are interested in becoming pregnant and willing to participate in a longitudinal study… The study’s primary environmental exposures include: Organochlorine pesticides; polychlorinated biphenyls; polybrominated diphenyl ethers; metals; perfluorinated compounds; cotinine; and phytoestrogens. A growing body of literature suggests these compounds may exert adverse effects on human reproduction and development; however, definitive data are lacking especially for sensitive endpoints… |
| January 27, 2010 | Premanufacture Notification Exemption for Polymers; Amendment of Polymer Exemption Rule to Exclude Certain Perfluorinated Polymers. FINAL RULE.US EPA.SUMMARY: EPA is amending the polymer exemption rule, which provides an exemption from the premanufacture notification (PMN) requirements of the Toxic Substances Control Act (TSCA), 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 sulfonates (PFAS), perfluoroalkyl carboxylates (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 (affected polymers). In general, any person who intends to manufacture (which is defined by TSCA to include import into the customs territory of the United States) any of these polymers not already on the TSCA Inventory (Inventory) must complete the TSCA PMN 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 Release and Exposure Exemption (LoREX), for affected polymers that they reasonably believe may qualify for such exemptions. Those persons who 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 TSCA section 5(h)(4) exemption or under a different TSCA section 5 authority, such as TSCA section 5(a)(1) or section 5(e). This change 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 TSCA section 5(h)(4). |
| April 27, 2012 | Significant New Use Rules on Certain Chemical Substances. Direct Final Rule. US EPA.EPA is promulgating significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 119 chemical substances which were the subject of premanufacture notices (PMNs). Four of these chemical substances are subject to TSCA consent orders issued by EPA. This action requires persons who intend to manufacture, import, or process any of these 119 chemical substances for an activity that is designated as a significant new use by this rule to notify EPA at least 90 days before commencing that activity…Chemical name: Potassium zinc fluoride (KZnF3). CAS number: 13827–02–6. Basis for action: The PMN states that the substance will be used as a flux for brazing aluminum. Based on EcoSAR analysis of test data on analogous zinc compounds, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 2 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii). Recommended testing: EPA has determined that results of a porous pot test (OPPTS Test Guideline 835.3220); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help to characterize the environmental effects of the PMN substance.Chemical name: Dimethyl siloxy- polyfluoro methyl siloxy- poly(oxyalkylenediyl) methyl siloxy copolymer (generic). CAS number: Not available. Effective date of TSCA section 5(e) consent order: April 20, 2011. Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the PMN substance will be as an open, non- dispersive carpet treatment. EPA has concerns for potential incineration or other decomposition products of the PMN substance. These perfluorinated products may be released to the environment from incomplete incineration of the PMN substance at low temperatures. EPA has preliminary evidence, including data on some fluorinated polymers that suggests that, under some conditions, the PMN substance could degrade in the environment. EPA has concerns that these degradation products will persist in the environment, could bioaccumulate or biomagnify, and could be toxic to people, wild mammals, and birds. These concerns are based on data on analog chemicals, including perfluorooctanoic acid (PFOA) and other perfluorinated alkyls, which include the presumed environmental degradant of the PMN substance. There is pharmacokinetic and toxicological data in animals on PFOA, as well as epidemiological and blood monitoring data in humans. Toxicity studies on PFOA indicate developmental, reproductive, and systemic toxicity in various species, as well as cancer. These factors, taken together, raise concerns for potential adverse chronic effects from the presumed degradation product in humans and wildlife. The order was issued under TSCA sections 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II), based on a finding that this substance may present an unreasonable risk of injury to the environment and human health, the substance may be produced in substantial quantities and may reasonably be anticipated to enter the environment in substantial quantities, and there may be significant (or substantial) human exposure to the substance and its potential degradation products. To protect against these risks, the consent order requires: No manufacture of the substance beyond an annual aggregate manufacture and importation volume; recording and reporting of certain fluorinated impurities in the starting raw material; and manufacture of the PMN substance not to exceed the maximum established impurity levels of certain fluorinated impurities. The SNUR designates as a ‘‘significant new use’’ the absence of these protective measures. Recommended testing: EPA has determined that the results of certain fate and physical/chemical property testing identified in the TSCA 5(e) consent order would help characterize possible effects of the substance and its degradation products. The order does not require submission of the testing at any specified time or production volume. However, the order’s restrictions on manufacture, import, processing, distribution in commerce, use and disposal of the PMN will remain in effect until the order is modified or revoked by EPA based on submission of that or other relevant information.Chemical names: Alkyl acrylate- polyfluoro methacrylate- poly(oxyalkylenediyl)- methacrylates (generic). CAS numbers: Not available. Effective date of TSCA section 5(e) consent order: April 20, 2011. Basis for TSCA section 5(e) consent order: The consolidated PMN states that the generic (non-confidential) use of the PMN substances will be as open, non- dispersive additives. EPA has concerns for potential incineration or other decomposition products of the PMN substances. These perfluorinated products may be released to the environment from incomplete incineration of the PMN substances at low temperatures. EPA has preliminary evidence, including data on some fluorinated polymers that suggests that, under some conditions, the PMN substances could degrade in the environment. EPA has concerns that these degradation products will persist in the environment, could be PBT chemicals, based on data on analog chemicals, including PFOA and other perfluorinated alkyls, which include the presumed environmental degradant of the PMN substances. There is pharmacokinetic and toxicological data in animals on PFOA, as well as epidemiological and blood monitoring data in humans. Toxicity studies on PFOA indicate developmental, reproductive, and systemic toxicity in various species, as well as cancer. These factors, taken together, raise concerns for potential adverse chronic effects from the presumed degradation product in humans and wildlife. The order was issued under TSCA sections 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II), based on a finding that these substances may present an unreasonable risk of injury to the environment and human health, the substances may be produced in substantial quantities and may reasonably be anticipated to enter the environment in substantial quantities, and there may be significant (or substantial) human exposure to the substances and their potential degradation products. To protect against these risks, the consent order requires: No manufacture of the substances beyond an annual aggregate manufacture and importation volume; recording and reporting of certain fluorinated impurities in the starting raw materials; and manufacture of the PMN substances not to exceed the maximum established impurity levels of certain fluorinated impurities. The SNUR designates as a ‘‘significant new use’’ the absence of these protective measures. Recommended testing: EPA has determined that the results of certain fate and physical/chemical property testing identified in the TSCA 5(e) consent order would help characterize possible effects of the substances and their degradation products. The order does not require submission of the testing at any specified time or production volume. However, the order’s restrictions on manufacture, import, processing, distribution in commerce, use, and disposal of the PMNs will remain in effect until the order is modified or revoked by EPA based on submission of that or other relevant information. § 721.10340 Potassium zinc fluoride (KZnF3). § 721.10396 Dimethyl siloxy-polyfluoro methyl siloxy-poly(oxyalkylenediyl) methyl siloxy copolymer (generic). § 721.10397 Alkyl acrylate-polyfluoro methacrylate-poly(oxyalkylenediyl)- methacrylates (generic). § 721.10409 Poly(oxyalkylenediyl), .alpha.- [[[methyl-3-[[[(polyfluoroalkyl)oxy] carbonyl]amino]phenyl]amino]carbonyl]- .omega.-methoxy-(generic). |
| May 2, 2012 | Revisions to the Unregulated Contaminant Monitoring Regulation (UCMR 3) for Public Water Systems. FINAL RULE. US EPA.The 1996 amendments to the Safe Drinking Water Act (SDWA) require that the United States Environmental Protection Agency (EPA or the agency) establish criteria for a program to monitor unregulated contaminants and publish a list of up to 30 contaminants to be monitored every five years. This final rule meets the SDWA requirement by publishing the third Unregulated Contaminant Monitoring Regulation (i.e., UCMR 3), listing the unregulated contaminants to be monitored and addressing the requirements for such monitoring. This final rule describes analytical methods to monitor for 28 chemical contaminants and describes the monitoring for two viruses…Final Contaminant Lists include: perfluorooctanesulfonic acid (PFOS) perfluorooctanoic acid (PFOA). perfluorononanoic acid (PFNA). perfluorohexanesulfonic acid (PFHxS). perfluoroheptanoic acid (PFHpA). perfluorobutanesulfonic acid (PFBS). |
| August 15, 2012 | Perfluoroalkyl Sulfonates and Long-Chain Perfluoroalkyl Carboxylate Chemical Substances; Proposed Significant New Use Rule.SUMMARY: 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. |
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