Clean Water Act Effluent Limitations Guidelines and Standards for the Organic Chemicals, Plastics and Synthetic Fibers Point Source Category, 14560-14567 [2021-05402]

Download as PDF 14560 Federal Register / Vol. 86, No. 50 / Wednesday, March 17, 2021 / Proposed Rules ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 414 [EPA–HQ–OW–2020–0582; FRL 10019–06– OW] RIN 2040–AG10 Clean Water Act Effluent Limitations Guidelines and Standards for the Organic Chemicals, Plastics and Synthetic Fibers Point Source Category Environmental Protection Agency (EPA). ACTION: Advance notice of proposed rulemaking. AGENCY: The U.S. Environmental Protection Agency (EPA or Agency) is initiating further data collection and analysis to support potential future rulemaking, under the Clean Water Act (CWA), relating to the effluent limitations guidelines, pretreatment standards and new source performance standards applicable to the Organic Chemicals, Plastics and Synthetic Fibers (OCPSF) point source category to address discharges from manufacturers of per- and polyfluoroalkyl substances (PFAS) and is considering revising the same for formulators of PFAS. PFAS are a group of man-made organic chemicals. Some PFAS compounds are persistent in the environment and in the human body. Analysis of animal studies and human epidemiological research suggest that exposure above certain levels to some PFAS may be associated with adverse human health effects. The Agency has identified several industries with facilities that are likely to be discharging PFAS in their wastewater, including OCPSF manufacturers and formulators. This advance notice of proposed rulemaking (ANPRM) provides for public review and comment on the information and data regarding PFAS manufacturers and formulators that EPA has collected to date. EPA is requesting public comment on the information and data presented in this ANPRM. EPA is also soliciting additional information and data regarding discharges of PFAS from these facilities to inform future revisions to the wastewater discharge requirements that apply to the OCPSF point source category. jbell on DSKJLSW7X2PROD with PROPOSALS SUMMARY: Comments must be received on or before May 17, 2021. ADDRESSES: You may send comments, identified by Docket ID No. EPA–HQ– OW–2020–0582, by any of the following methods: DATES: VerDate Sep<11>2014 17:42 Mar 16, 2021 Jkt 253001 • Federal eRulemaking Portal: https://www.regulations.gov/ (our preferred method). Follow the online instructions for submitting comments. • Mail: U.S. Environmental Protection Agency, EPA Docket Center, Office of Water, Office of Science and Technology Docket, Mail Code 28221T, 1200 Pennsylvania Avenue NW, Washington, DC 20460. • Hand Delivery or Courier (by scheduled appointment only): EPA Docket Center, WJC West Building, Room 3334, 1301 Constitution Avenue NW, Washington, DC 20004. The Docket Center’s hours of operations are 8:30 a.m.–4:30 p.m., Monday–Friday (except Federal Holidays). Instructions: All submissions received must include the Docket ID No. for this rulemaking. Comments received may be posted without change to https:// www.regulations.gov/, including any personal information provided. For detailed instructions on sending comments and additional information on the rulemaking process, see the ‘‘Public Participation’’ heading of the SUPPLEMENTARY INFORMATION section of this document. Out of an abundance of caution for members of the public and our staff, the EPA Docket Center and Reading Room are closed to the public, with limited exceptions, to reduce the risk of transmitting COVID–19. Our Docket Center staff will continue to provide remote customer service via email, phone, and webform. We encourage the public to submit comments via https:// www.regulations.gov/ or email, as there may be a delay in processing mail and faxes. Hand deliveries and couriers may be received by scheduled appointment only. For further information on EPA Docket Center services and the current status, please visit us online at https:// www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Ms. Samantha Lewis, Engineering and Analysis Division, Office of Science and Technology, Office of Water; telephone number: 202–566–1058; email address: lewis.samantha@epa.gov. I. Public Participation A. Written Comments Submit your comments, identified by Docket ID No. EPA–HQ–OW–2020– 0582, at https://www.regulations.gov (our preferred method), or the other methods identified in the ADDRESSES section. Once submitted, comments cannot be edited or removed from the docket. EPA may publish any comment received to its public docket. Do not submit to EPA’s docket at https:// www.regulations.gov any information PO 00000 Frm 00010 Fmt 4702 Sfmt 4702 you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. If you wish to submit such information, consult the person listed for additional information in the preceding FOR FURTHER INFORMATION CONTACT section. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. EPA will generally not consider comments or comment contents located outside of the primary submission (i.e., on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit https://www.epa.gov/dockets/ commenting-epa-dockets. EPA is temporarily suspending its Docket Center and Reading Room for public visitors, with limited exceptions, to reduce the risk of transmitting COVID–19. Our Docket Center staff will continue to provide remote customer service via email, phone, and webform. We encourage the public to submit comments via https:// www.regulations.gov/ as there may be a delay in processing mail and faxes. Hand deliveries or couriers will be received by scheduled appointment only. For further information and updates on EPA Docket Center services, please visit us online at https:// www.epa.gov/dockets. EPA continues to carefully and continuously monitor information from the Centers for Disease Control and Prevention (CDC), local area health departments, and our Federal partners so that we can respond rapidly as conditions change regarding COVID–19. B. Supporting Information This notice is supported by documents that are contained in the public docket. EPA has prepared an index of these materials to aid in the public’s review and comment. The index can be identified by searching the docket for DCN OCPSF00116. II. General Information A. Does this action apply to me? Entities potentially affected by any rulemaking following this notice include: E:\FR\FM\17MRP1.SGM 17MRP1 Federal Register / Vol. 86, No. 50 / Wednesday, March 17, 2021 / Proposed Rules Category Example of regulated entity Industry ..................... PFAS Manufacturers. PFAS Formulators. jbell on DSKJLSW7X2PROD with PROPOSALS This section is not intended to be exhaustive, but rather provides a guide regarding entities likely to be regulated by any future rulemaking activities following this notice. Other types of entities that are not included in the examples above could also be regulated. PFAS manufacturers are facilities that produce PFAS compounds or precursors through processes including, but not limited to, electrochemical fluorination (ECF) and telomerization. Facilities that manufacture PFAS are currently regulated under EPA’s national Effluent Limitations Guidelines and Standards (ELGs) for the OCPSF category (40 CFR part 414). EPA has also gathered more limited information about PFAS formulators. PFAS formulators are facilities that are the primary customers of the PFAS manufacturers, and that use raw PFAS feedstock to (a) produce commercial or consumer goods (e.g., weather-proof caulking), or (b) as intermediary products for use in the manufacture of commercial goods (e.g., a grease-proof coating for a pizza box). If you still have questions regarding the applicability of any future rulemaking activities following this notice to a particular entity, please consult the person listed for additional information in the preceding FOR FURTHER INFORMATION CONTACT section. B. What is the purpose of this notice? As part of EPA’s statutorily required Effluent Guidelines planning process, EPA has reviewed readily available information about PFAS surface water discharges to identify industrial sources that may warrant further study for potential regulation through national ELGs. Based on the limited data available at the time, in February of 2019, EPA published the PFAS Action Plan, in which it identified several industries with facilities that are likely to be discharging PFAS compounds in their wastewater and EPA began a more detailed study to evaluate the potential for PFAS presence in their wastewater discharges. Through the PFAS MultiIndustry Study, described in EPA’s Preliminary Effluent Guidelines Program Plan 14, EPA gathered a range of information about PFAS manufacturers and formulators, as well as the potential discharges of PFAS from these facilities (further details on these efforts are provided in Section V below). PFAS manufacturers are facilities that produce PFAS compounds or precursors VerDate Sep<11>2014 17:42 Mar 16, 2021 Jkt 253001 through processes including, but not limited to, ECF and telomerization. Facilities that manufacture PFAS are currently regulated under EPA’s national ELGs for the OCPSF category (40 CFR part 414). EPA has also gathered some information about PFAS formulators. PFAS formulators are facilities that are the primary customers of PFAS manufacturers, and that use raw PFAS feedstock to (a) produce commercial or consumer goods (e.g., weather-proof caulking), or (b) as intermediary products for use in the manufacture of commercial goods (e.g., a grease-proof coating for a pizza box). EPA’s data set for formulators is more limited than for manufacturers, as the Agency has identified little publicly available information on these facilities and their potential discharges. This notice provides for public review and comment on the information that EPA has collected to date on PFAS discharges from both PFAS manufacturers and formulators. In addition, as detailed in Section V below, EPA is soliciting additional information and data regarding PFAS manufacturers and formulators, including wastewater characteristics and treatability. EPA will use any information and data received to inform potential next steps, which could include developing new or revised ELGs for these categories of dischargers. Because formulators may be subject to national ELGs outside of the OCPSF category, future EPA actions to address PFAS discharges from these facilities may include revisions to ELGs other than the ELGs that apply to the OCPSF category or proposal of a new ELG. III. Background A. Clean Water Act Among its core provisions, the Clean Water Act (CWA) prohibits the discharge of pollutants from a point source to waters of the United States, except as authorized under the CWA. Under CWA Section 402, 33 U.S.C. 1342, discharges may be authorized through a National Pollutant Discharge Elimination System (NPDES) permit. The CWA outlines a dual approach for establishing discharge limits for these permits: (1) Technology-based effluent limitations that establish a floor of performance for categories of dischargers, and (2) water quality-based effluent limitations that are established where technology-based effluent limitations are insufficient to meet applicable state water quality standards (WQS) or site specific water quality goals. The CWA authorizes EPA to establish national technology-based PO 00000 Frm 00011 Fmt 4702 Sfmt 4702 14561 ELGs and new source performance standards for discharges to waters of the United States from categories of point sources (such as industrial, commercial, and public sources). These national ELGs are used by state permitting authorities to establish technologybased effluent limitations for NPDES permits. The CWA also authorizes EPA to promulgate nationally applicable pretreatment standards that control pollutant discharges from sources that discharge wastewater indirectly to waters of the United States through Publicly Owned Treatment Works (POTWs), as outlined in Sections 307(b) and (c) of the CWA, 33 U.S.C. 1317(b) and (c). EPA establishes national pretreatment standards for pollutants in wastewater from such indirect dischargers shown to pass through, to interfere with, or to be otherwise incompatible with POTW operations. Pretreatment standards are designed to ensure that wastewaters from indirect industrial dischargers are subject to similar levels of treatment as direct dischargers in the same industrial category. See CWA Section 301(b), 33 U.S.C. 1311(b). Technology-based effluent limitations in NPDES permits are derived from effluent limitations guidelines (CWA Sections 301 and 304, 33 U.S.C. 1311 and 1314) and new source performance standards (CWA Section 306, 33 U.S.C. 1316) promulgated by EPA. Where EPA has not promulgated an applicable ELG or new source performance standard, technology-based effluent limitations are based on the best professional judgment (BPJ) of the permitting authority. Additional limitations are also required in a permit where necessary to meet WQS. CWA Section 301(b)(1)(C), 33 U.S.C. 1311(b)(1)(C). The ELGs are established by EPA regulation for categories of industrial dischargers and are based on the degree of control that can be achieved using various levels of pollution control technology, as specified in the CWA (e.g., Best Practicable Control Technology Currently Available (BPT), Best Conventional Pollutant Control Technology (BCT), Best Available Technology Economically Achievable (BAT); see below). The EPA promulgates national ELGs for industrial categories for three classes of pollutants: (1) Conventional pollutants (total suspended solids (TSS), oil and grease, biochemical oxygen demand (BOD5), fecal coliform, and pH), as outlined in CWA Section 304(a)(4), 33 U.S.C. 1314(a)(4), and 40 CFR 401.16; (2) toxic pollutants (e.g., toxic metals such as arsenic, mercury, selenium, and E:\FR\FM\17MRP1.SGM 17MRP1 14562 Federal Register / Vol. 86, No. 50 / Wednesday, March 17, 2021 / Proposed Rules chromium; toxic organic pollutants such as benzene, benzo-a-pyrene, phenol, and naphthalene), as outlined in CWA Section 307(a), 33 U.S.C. 1317(a); 40 CFR 401.15 and 40 CFR part 423, appendix A; and (3) nonconventional pollutants, which are those pollutants that are not categorized as conventional or toxic (e.g., ammonia-N, phosphorus, and total dissolved solids (TDS)). PFAS compounds fall into the category of nonconventional pollutant, as they are not defined as a toxic or conventional pollutant in the CWA or the Code of Federal Regulations (CFR). B. Effluent Guidelines Program EPA establishes ELGs based on the performance of well-designed and welloperated control and treatment technologies. EPA is not to base technology-based requirements on their effects on the receiving water. See Weyerhaeuser Co. v. Costle, 599 F.2d 1011, 1028, 1042 (D.C. Cir. 1978). There are four levels of technologybased controls applicable to direct dischargers and two levels of controls applicable to indirect dischargers. These are described in detail below as general background information: jbell on DSKJLSW7X2PROD with PROPOSALS 1. Best Practicable Control Technology Currently Available (BPT) Consistent with the CWA, EPA establishes effluent limitations based on BPT by reference to the average of the best performances of facilities within the industry, grouped to reflect various ages, sizes, processes, or other common characteristics. EPA promulgates BPT effluent limitations for conventional, toxic, and nonconventional pollutants. In specifying BPT, EPA looks at a number of factors. EPA first considers the cost of achieving effluent reductions in relation to the effluent reduction benefits. The Agency also considers the age of equipment and facilities, the processes employed, engineering aspects of the control technologies, any required process changes, non-water quality environmental impacts (including energy requirements), and such other factors as the Administrator deems appropriate. See CWA Section 304(b)(1)(B), 33 U.S.C. 1314(b)(1)(B). 2. Best Conventional Pollutant Control Technology (BCT) The 1977 amendments to the CWA require EPA to identify additional levels of effluent reduction for conventional pollutants associated with Best Conventional Pollutant Control Technology (BCT) for discharges from existing industrial point sources. In addition to other factors specified in Section 304(b)(4)(B), 33 U.S.C. VerDate Sep<11>2014 17:42 Mar 16, 2021 Jkt 253001 1314(b)(4)(B), the CWA requires that EPA establish BCT limitations after consideration of a two-part ‘‘cost reasonableness’’ test. EPA explained its methodology for the development of BCT limitations on July 9, 1986 (51 FR 24974). Section 304(a)(4) designates the following as conventional pollutants: BOD5, TSS, fecal coliform, pH, and any additional pollutants defined by the Administrator as conventional. The Administrator designated oil and grease as a conventional pollutant on July 30, 1979 (44 FR 44501; 40 CFR 401.16). 3. Best Available Technology Economically Achievable (BAT) BAT represents the second level of control for direct discharges of toxic and nonconventional pollutants. As the statutory phrase intends, EPA considers technological availability and the economic achievability in determining what level of control represents BAT. CWA Section 301(b)(2)(A), 33 U.S.C. 1311(b)(2)(A). Other statutory factors that EPA must consider in assessing BAT are the cost of achieving BAT effluent reductions, the age of equipment and facilities involved, the process employed, potential process changes, non-water quality environmental impacts (including energy requirements), and such other factors as the Administrator deems appropriate. CWA Section 304(b)(2)(B), 33 U.S.C. 1314(b)(2)(B); Texas Oil & Gas Ass’n v. EPA, 161 F.3d 923, 928 (5th Cir. 1998). The Agency retains considerable discretion in assigning the weight to be accorded each of these factors. Weyerhaeuser Co., 590 F.2d at 1045. Generally, EPA determines economic achievability based on the effect of the cost of compliance with BAT limitations on overall industry and subcategory (if applicable) financial conditions. BAT is intended to reflect the highest performance in the industry, and it may reflect a higher level of performance than is currently being achieved based on technology transferred from a different subcategory or category, bench scale or pilot studies, or foreign facilities. Am. Paper Inst. v. Train, 543 F.2d 328, 353 (D.C. Cir. 1976); Am. Frozen Food Inst. v. Train, 539 F.2d 107, 132 (D.C. Cir. 1976). BAT may be based upon process changes or internal controls, even when these technologies are not common industry practice. See Am. Frozen Food Inst., 539 F.2d at 132, 140; Reynolds Metals Co. v. EPA, 760 F.2d 549, 562 (4th Cir. 1985); Cal. & Hawaiian Sugar Co. v. EPA, 553 F.2d 280, 285–88 (2nd Cir. 1977). One way that EPA may consider differences within an industry when establishing BAT limitations is through PO 00000 Frm 00012 Fmt 4702 Sfmt 4702 subcategorization. The Supreme Court has recognized that the substantive test for subcategorizing an industry is the same as that which applies to establishing fundamentally different factor variances—i.e., whether the plants are different with respect to relevant statutory factors. See Chem. Mfrs. Ass’n v. EPA, 870 F.2d 177, 214 n.134 (5th Cir. 1989) (citing Chem. Mfrs. Ass’n v. NRDC, 470 U.S. 116, 119–22, 129–34 (1985)). Courts have stated that there need only be a rough basis for subcategorization. See Chem. Mfrs. Ass’n, 870 F.2d at 215 n.137 (summarizing cases). 4. Best Available Demonstrated Control Technology/New Source Performance Standards (NSPS) NSPS reflect ‘‘the greatest degree of effluent reduction’’ that is achievable based on the ‘‘best available demonstrated control technology’’ (BADCT), ‘‘including, where practicable, a standard permitting no discharge of pollutants.’’ CWA Section 306(a)(1), 33 U.S.C. 1316(a)(1). Owners of new facilities have the opportunity to install the best and most efficient production processes and wastewater treatment technologies. As a result, NSPS generally represent the most stringent controls attainable through the application of BADCT for all pollutants (that is, conventional, nonconventional, and toxic pollutants). In establishing NSPS, EPA is directed to take into consideration the cost of achieving the effluent reduction and any non-water quality environmental impacts and energy requirements. CWA Section 306(b)(1)(B), 33 U.S.C. 1316(b)(1)(B). 5. Pretreatment Standards for Existing Sources (PSES) Section 307(b) of the CWA, 33 U.S.C. 1317(b), authorizes EPA to promulgate pretreatment standards for discharges of pollutants to POTWs. PSES are designed to prevent the discharge of pollutants that pass through, interfere with, or otherwise are incompatible with the operation of POTWs. Categorical pretreatment standards are technologybased and are analogous to BPT and BAT effluent limitations guidelines, and thus the Agency typically considers the same factors in promulgating PSES as it considers in promulgating BPT and BAT. The General Pretreatment Regulations, which set forth the framework for the implementation of categorical pretreatment standards, are found at 40 CFR part 403. These regulations establish pretreatment standards that apply to all non-domestic dischargers. See 52 FR 1586 (January 14, 1987). E:\FR\FM\17MRP1.SGM 17MRP1 Federal Register / Vol. 86, No. 50 / Wednesday, March 17, 2021 / Proposed Rules 6. Pretreatment Standards for New Sources (PSNS) Section 307(c) of the CWA, 33 U.S.C. 1317(c), authorizes EPA to promulgate PSNS at the same time it promulgates NSPS. As is the case for PSES, PSNS are designed to prevent the discharge of any pollutant into a POTW that interferes with, passes through, or otherwise is incompatible with the POTW. In selecting the PSNS technology basis, the Agency generally considers the same factors it considers in establishing NSPS, along with the results of a passthrough analysis. Like new sources of direct discharges, new sources of indirect discharges have the opportunity to incorporate into their operations the best available demonstrated technologies. As a result, EPA promulgates pretreatment standards for new sources based on best available demonstrated control technology for new sources. See Nat’l Ass’n of Metal Finishers v. EPA, 719 F.2d 624, 634 (3rd Cir. 1983). C. Summary of the Existing OCPSF ELGs jbell on DSKJLSW7X2PROD with PROPOSALS The OCPSF ELGs (40 CFR part 414) were originally promulgated in 1987, and then amended in 1989, 1990, 1992, and 1993. The OCPSF category includes more than 1,000 chemical facilities producing over 25,000 end products. These include such products as benzene, toluene, polypropylene, polyvinyl chloride, chlorinated solvents, rubber precursors, rayon, nylon, and polyester. The OCPSF industry is large and diverse with complex operations and processes. Some plants produce chemicals in large volumes through continuous chemical processes, while others produce only small volumes of ‘‘specialty’’ chemicals through batch chemical processes. Only a small subset of the facilities that are currently regulated under the OCPSF ELGs manufacture or formulate PFAS. Although the OCPSF ELGs may apply to PFAS manufacturers and formulators, the OCPSF ELGs do not establish effluent limitations or pretreatment standards for any PFAS compounds. Rather, the revision to the OCPSF ELGs would address PFAS discharges from PFAS manufacturers and formulators. IV. The EPA’s PFAS Multi-Industry Study and Identification of PFAS Manufacturers and Formulators for Potential Regulation As described in the Preliminary Effluent Guidelines Program Plan 14 (Preliminary Plan 14), published in October 2019, EPA conducted an initial examination of readily available public VerDate Sep<11>2014 17:42 Mar 16, 2021 Jkt 253001 information about PFAS surface water discharges to identify industrial sources that may warrant further study. The Preliminary Plan 14 docket (EPA–HQ– OW–2018–0618) includes a summary of the information EPA reviewed and a report with a more thorough description of our review activities. Based on this initial review, EPA decided to conduct further studies to better understand and document facilities discharging PFAS compounds to surface waters and to POTWs. This was introduced in the Preliminary Plan 14 as the PFAS MultiIndustry Study. The goals of the PFAS Multi-Industry Study are to identify industries and specific facilities producing or using PFAS compounds; quantify—to the best of EPA’s ability—the amounts of PFAS being discharged; identify PFAS control practices and treatment technologies; document PFAS removal efficiency in wastewater; and estimate costs associated with PFAS treatment systems. EPA identified the following industrial point source categories as the primary focus of this study: OCPSF manufacturers; pulp and paper manufacturers; textiles and carpet manufacturers; and commercial airports.1 For the OCPSF manufacturers, EPA reviewed numerous data sources and identified six PFAS manufacturers and ten likely PFAS formulators. EPA is not sure that the ten facilities that it identified as ‘‘likely’’ PFAS formulators are actually PFAS formulators due to limited data available at this time. We discuss each of these data sources in greater detail below. EPA reviewed 2019 Discharge Monitoring Reports (DMRs) and obtained PFAS data for six PFAS manufacturers and three likely PFAS formulators (the other seven facilities do not report PFAS compounds in their DMRs or they do not have DMRs because they are indirect dischargers). These nine facilities combined reported a total of 17 PFAS compounds in their discharges. Based on the DMRs, effluent data detected a total of 15 PFAS compounds, and concentrations ranged from non-detect to 777 parts per billion (ppb). The ‘‘2019 Monitoring Period Level DMR PFAS Data’’ (DCN OCPSF00030) includes additional information on the compounds that were monitored, and the concentration ranges reported in DMRs. EPA reviewed NPDES permits for these PFAS manufacturers and formulators to evaluate whether their permits contain effluent limitations or 1 Military bases and airports are not included in the scope of this study. PO 00000 Frm 00013 Fmt 4702 Sfmt 4702 14563 monitoring requirements for PFAS compounds. One current NPDES permit in West Virginia contains effluent limitations for two PFAS compounds (Perfluorooctanoic acid (PFOA) and Hexafluoropropylene oxide dimer acid (HFPODA) that go into effect on September 1, 2021. Another facility in North Carolina is under a consent decree with requirements for no discharge of PFAS process wastewater. See DCN OCPSF00079 for consent decree. The North Carolina facility is currently hauling all PFAS process wastewater off-site for disposal. The consent decree went into effect on February 25, 2019 and ends on January 31, 2023. This North Carolina facility reported detections of PFOA for 9 of 12 reporting periods in 2019 DMRs, including periods after February 2019. Four of the other PFAS manufacturers and formulators have PFAS monitoring requirements, and no effluent limitations, in their NPDES permits. Two Alabama facilities and one Illinois facility are operating under expired, administratively continued NPDES permits. The NPDES permit materials collected and reviewed are available as DCNs OCPSF000008 to OCPSF00025. EPA also reviewed the Toxics Release Inventory (TRI), which is managed by EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) and tracks annual environmental waste management, including releases, of 767 individually listed chemicals and 33 chemical categories from industrial facilities that manufacture, process, or otherwise use these chemicals in amounts above their applicable reporting thresholds. Release of a TRI chemical refers to an emission to air, discharge to water, or placement in some type of land disposal. EPA has not yet received any information or data pertaining to the release of PFAS compounds through TRI reporting. However, the National Defense Authorization Act for Fiscal Year 2020 added 172 PFAS compounds to the TRI. TRI reporting for these PFAS will be due to EPA by July 1, 2021, for calendar year 2020 data. For additional information on the addition of 172 PFAS to TRI, see https://www.epa.gov/ toxics-release-inventory-tri-program/listpfas-added-tri-ndaa. EPA reviewed data from the Toxic Substances Control Act (TSCA) Inventory, which lists chemicals manufactured (including imported) or processed in the United States. The TSCA Inventory, managed by the Office of Pollution Prevention and Toxics (OPPT) within OCSPP, currently lists more than 86,000 chemicals, of which approximately half are currently in E:\FR\FM\17MRP1.SGM 17MRP1 14564 Federal Register / Vol. 86, No. 50 / Wednesday, March 17, 2021 / Proposed Rules jbell on DSKJLSW7X2PROD with PROPOSALS commerce or ‘‘active.’’ For PFAS specifically, the TSCA Inventory lists over one thousand compounds, of which approximately half are known to be commercially active within the last decade. The TSCA Inventory by itself cannot be used to identify dischargers. EPA also reviewed the Chemical Data Reporting (CDR) database, which compiles information collected under a TSCA Section 8(a) rule that requires chemical manufacturers (including importers) to provide EPA with production, import, and customer use information about chemicals in commerce. Manufacturers and importers must report to the CDR database if they meet certain annual volume thresholds, typically 25,000 pounds, but 2,500 pounds for chemicals subject to certain TSCA actions. EPA matched the chemicals in the 2016 CDR data (the most recent year available) 2 against EPA’s Cross-Agency Research List 3 and identified 118 PFAS compounds in the CDR database. See DCN OCPSF00032 for ‘‘2016 nonCBI CDR Data for PFAS Compounds’’ and DCN OCPSF00003 for ‘‘EPA’s CompTox Cross Agency PFAS List.’’ Using this list of CDR PFAS compounds, EPA summed the reported production volumes to calculate a total PFAS production and importation volume of approximately 608 million pounds for 2015. See DCN OCPSF00033 for ‘‘Review of 2015 non-CBI CDR Data for PFAS Compounds.’’ The CDR database contains data identifying which facilities produced PFAS compounds, but does not have any information on PFAS discharges. The six PFAS manufacturing facilities that reported 2019 DMR data also appear in the CDR data as domestic manufacturers of 76 separate PFAS compounds. An additional 55 facilities appear in the CDR dataset; however, EPA has no corresponding data on their potential PFAS discharges. The deadline for the CDR data for the 2020 reporting cycle is in January 2021. Additional PFASrelated data submitted by CDR sites can be assessed shortly thereafter. EPA collected and reviewed 15 treatment technology technical articles from a range of sources including EPA 2 The information for the CDR is collected every four years from manufacturers (including importers). The 2016 CDR data contains information reported in 2016 and covering 2012 to 2015. https://www.epa.gov/chemical-datareporting/basic-information-about-chemical-datareporting#what. 3 EPA’s Cross-Agency Research PFAS list, from the CompTox Chemicals Dashboard, is a manually curated listing of mainly straight-chain and branched PFAS compiled from various internal, literature and public sources by EPA researchers and program office representative (https:// comptox.epa.gov/dashboard). VerDate Sep<11>2014 17:42 Mar 16, 2021 Jkt 253001 publications, federal, state, and local government publications, PFAS manufacturers, and non-governmental organizations (NGOs). Through these articles, EPA identified eight potential technologies that can remove PFAS from wastewater. These include granular activated carbon, reverse osmosis filtration, and ion exchange. A full list of available technologies that EPA has identified to date is included in DCN OCPSF00096. EPA began stakeholder outreach in July 2019 by meeting with stakeholders to collect, on a voluntary basis, additional information such as supplementary effluent data, information on PFAS compounds being produced/used and discharged, and any information about treatment technologies being used, along with their effectiveness and costs, to augment the available information EPA reviewed. This information gathering effort was performed under the Multi-Industry Study noted above. The information provided by stakeholders is included in DCN OCPSF00042–OCPSF00078. EPA met with the FluoroCouncil of the American Chemistry Council,4 the primary trade association that represents PFAS manufacturers and formulators, and its members. See DCN OCPSF00054 for meeting notes. They provided EPA with technical literature concerning PFAS terminology and classification, a list of short chain fluorotelomers studies, an economic assessment of the U.S. fluoropolymer industry, and the names of contacts at entities that they identified as the sole three PFAS manufacturing companies in the United States. These three manufacturers (with a total of six facilities) mirrored the six facilities for which EPA found DMR data and an additional facility for which EPA received internal monitoring data. EPA met with representatives of one company that operates multiple facilities that manufacture PFAS in West Virginia, New Jersey and North Carolina. They provided EPA with a copy of the presentation they gave during their meeting with the Agency, a copy of a New Jersey facility’s NPDES permit, data for an internal outfall at that facility, a document addressing PFAS concerns at a North Carolina facility, and technical literature on fluoropolymers of low concern. See DCN OCPSF00061 for meeting notes and DCNs OCPSF00062 to OCPSF00064 for materials provided. 4 The FluoroCouncil of the American Chemistry Council has disbanded since EPA last spoke to them. PO 00000 Frm 00014 Fmt 4702 Sfmt 4702 EPA met with representatives of one company that operates multiple facilities that manufacture PFAS in Alabama, Illinois and Minnesota. Representatives of this company provided EPA with a PFAS production history in addition to current PFAS product categories, wastewater process flow diagrams, copies of their NPDES permits, documentation for a direct injection analytical method, sampling data for both PFAS manufacturing facilities and a formulating facility, and related published literature. See DCN OCPSF00042 for meeting notes and DCNs OCPSF00043 to OCPSF00052 for materials provided. EPA met with representatives of another PFAS manufacturing facility in Alabama. See DCN OCPSF00065 for meeting notes. EPA spoke to a representative of another company who stated that the company does not produce PFAS compounds in the United States. EPA learned that this company imports products from international manufacturing facilities and other manufacturers both inside and outside of the United States. Those materials are further processed at a domestic facility in Pennsylvania. See DCN OCPSF00060 for meeting notes. EPA is not aware of any PFAS discharge data from this facility, but EPA is requesting additional information regarding these and similar operations through this notice. EPA made attempts to contact the other PFOA/PFOS Stewardship Program https://www.epa.gov/assessing-andmanaging-chemicals-under-tsca/factsheet-20102015-pfoa-stewardshipprogram) companies but did not receive any additional information. EPA continues to coordinate with manufacturers to obtain additional information, including a list of PFAS compounds they manufacture, documentation for the analytical methods they use to analyze PFAS in waste streams, and PFAS analytical data collected from source water, process water, and effluent at their facilities. EPA spoke with representatives of the Michigan Department of Environment, Great Lakes, & Energy (MI EGLE). Michigan EGLE provided EPA with sampling data for 30 direct discharging facilities and 633 indirect discharging facilities across 44 industrial categories, mostly for PFOA and PFOS. See DCN OCPSF00067 for direct discharging data and DCN OCPSF00068 for indirect discharging data provided by MI EGLE. Four of these facilities were likely PFAS formulators based on the concentrations of PFAS in discharges and the operations of the facilities. EPA also reviewed an investigation report E:\FR\FM\17MRP1.SGM 17MRP1 Federal Register / Vol. 86, No. 50 / Wednesday, March 17, 2021 / Proposed Rules from EPA’s Region 3, looking for potential PFAS sources in Goose Creek, Pennsylvania. From this report, EPA was able to identify another likely PFAS formulator. See DCN OCPSF00038 for report and communications. jbell on DSKJLSW7X2PROD with PROPOSALS V. Request for Further Information on PFAS Manufacturers and Formulators A. PFAS Manufacturers EPA has identified six facilities (Alabama, North Carolina, West Virginia, New Jersey, Illinois) in the United States that currently manufacture PFAS compounds and have an associated wastewater discharge. Throughout the course of EPA’s PFAS Multi-Industry Study, the Agency worked collaboratively with stakeholders to obtain information regarding facilities that manufacture and formulate fluorochemicals in the United States. EPA appreciates the information that these entities have provided to the Agency to date.5 This information has greatly increased the Agency’s understanding of current manufacturing facilities, their operations, their production of fluorochemicals, their wastewater generation activities, and their wastewater treatment activities. After reviewing the information received to date, EPA is inviting stakeholders to review this information and provide comment and is seeking additional information and data to inform EPA’s next steps. Specifically, EPA is requesting the following information and data regarding PFAS manufacturers: 1. The identity of or suggestions for how to identify any other facilities in the United States currently manufacturing PFAS. 2. Descriptions of the manufacturing processes being employed at PFAS manufacturing facilities, including process flow diagrams. 3. Information and data on the specific PFAS compounds that are currently being produced (including as byproducts) at these facilities (including the product name, CAS number and class of each compound), the quantities that are being produced, the customers or industries that are purchasing these materials, and the quantities of materials sold to various customers. For sales, EPA is also interested in knowing the quantities of PFAS compounds that are exported outside of the United States. 4. Identification of the wastewater streams at manufacturing facilities that contain PFAS (e.g., process wastewater, 5 These data and information are contained in the docket supporting this notice. VerDate Sep<11>2014 17:42 Mar 16, 2021 Jkt 253001 cooling water, contaminated stormwater, wastewater from aqueous scrubbers or air pollution control equipment, off-specification products, equipment cleaning wastewater, spills and leaks), their volumes, characteristics, the identity (including CAS Number), and concentrations of PFAS compounds in those individual waste streams. 5. Information and data on the current wastewater treatment and management practices (including pollution prevention and product recovery practices) being utilized at existing PFAS manufacturers. Specific information requested includes descriptions of the treatment technologies, their size and flow rate, process flow diagrams, capital and operation and maintenance costs, treatment chemical utilization, and residuals generation and management. If wastewater storage ponds are used to hold PFAS wastewater, EPA also requests a description of the ponds, including purpose, age, capacity, design, wastewater characteristics, whether they are lined or unlined, and whether they have discharge outfalls. 6. If manufacturers are not treating PFAS containing wastewater onsite, EPA is requesting information on the management or disposal practices being utilized (e.g., zero liquid discharge, disposal wells, transfer to off-site centralized waste treatment facilities or transfer to POTWs), the volumes of wastewaters being managed via different practices, the name and location of the facilities receiving wastewaters, and their associated costs. 7. Information and data on future planned process changes at existing PFAS manufacturing facilities, any plans to change or phase-out manufacture of specific fluorinated compounds or to increase or decrease production of specific compounds, and any planned major upgrades to existing manufacturing facilities or construction of new PFAS manufacturing facilities in the United States. EPA is also requesting information regarding any potential changes in PFAS manufacturing processes, pollution prevention practices or chemicals used as PFAS substitution, or use and cost of specific technologies that can reduce the quantity of PFAS in wastewater from PFAS manufacturing operations. 8. EPA has collected existing publicly available DMR data and monitoring data from known manufacturers, as well as data from TRI and CDR databases, as indicated in the docket. These DMRs contain data on only a subset of the total PFAS that are potentially present in discharges from these facilities. EPA PO 00000 Frm 00015 Fmt 4702 Sfmt 4702 14565 requests additional monitoring data (see DCN OCPSF00115 for suggested data format and fields) on PFAS compounds in wastewater discharges from PFAS manufacturing facilities. Since there is currently no CWA-approved analytical method promulgated for analysis of PFAS compounds in wastewater, EPA requests that monitoring data that is submitted include information on the analytical methods used as well as associated information and data that can be used by EPA to determine the quality of the data. EPA also requests comment on whether additional PFAS compounds or precursors that are not reported in DMRs are found in wastewater discharges from these facilities, and the quantities of such PFAS compounds, precursors, and other organofluoride compounds found in untreated and treated wastewaters from these facilities. In addition to data on individual compounds, EPA is also particularly interested in data that would provide the total quantity of organofluorides present, such as would be provided by a Total Organic Fluorine (TOF) analysis or other assays. 9. In addition to treatment technologies being used at the six known PFAS manufacturing facilities, EPA is requesting additional information and data regarding treatment and destruction technologies for PFAS in industrial wastewater, including data on their performance, costs (both capital and operation and maintenance), and the types, quantities and management practices for any treatment residuals that are generated. Data from laboratory, bench, pilot, and full-scale facilities are requested. EPA also requests comment on the 15 treatment technology articles included in the docket. 10. Analytical methodologies used to monitor wastewater at PFAS manufacturing facilities, including in house SOPs and method performance data, including lists of specific PFAS compounds being monitored, and any aggregate procedures (e.g., adsorbable or extractable organic fluorine by combustion ion chromatography). 11. Any studies that have been conducted concerning environmental or human health impacts (e.g., toxicity, risk, fate and transfer, cross media) of PFAS discharges from PFAS manufacturers. B. PFAS Formulators EPA has identified limited publicly available information regarding the universe of PFAS formulators. To date, EPA has identified ten facilities (in Ohio, Virginia, Michigan, Minnesota, Pennsylvania and New Jersey) that are E:\FR\FM\17MRP1.SGM 17MRP1 jbell on DSKJLSW7X2PROD with PROPOSALS 14566 Federal Register / Vol. 86, No. 50 / Wednesday, March 17, 2021 / Proposed Rules potential formulators, but requests additional details regarding formulator facilities. As with manufacturers, EPA is interested in obtaining additional information and data regarding discharges of PFAS from formulators in order to inform the Agency’s decisionmaking regarding the need for new or revised ELGs for these types of facilities. EPA is requesting the following information and data from PFAS formulators: 1. Identification of all known PFAS formulators in the United States. 2. Descriptions of the manufacturing processes occurring at formulating facilities, including descriptions of how PFAS compounds are utilized at these facilities. 3. The SIC or NAICS codes of formulating facilities. 4. Information and data on the PFAS compounds that are currently being used at these facilities (including the product name, CAS number and class of each compound), the quantities that are being used, the quantities that are being sold or transferred for further processing or as materials for incorporation into finished products, and the customers or industries that are purchasing these materials and products. 5. Information on whether PFAS is being imported by formulators from outside the United States, and if any formulators are exclusively utilizing imported PFAS. 6. The locations and number of formulating facilities, as well as whether process wastewater associated with PFAS formulating is being discharged at these facilities. 7. Whether facilities have current monitoring requirements for PFAS or other fluorocarbons. 8. Information and data on the current wastewater treatment and management practices (including pollution prevention and product recovery practices) being utilized at existing PFAS formulators. Specific information requested includes descriptions of the treatment technologies, their size and flow rate, process flow diagrams, capital and operation and maintenance costs, treatment chemical utilization, and residuals generation and management. If wastewater storage ponds are used to hold PFAS wastewater, provide a description of the ponds including purpose, age, capacity, design, wastewater characteristics, whether they are lined or unlined, and whether they have discharge outfalls. 9. For facilities that discharge process wastewater, whether facilities are subject to national ELGs, and if so, identification of the applicable part(s) VerDate Sep<11>2014 17:42 Mar 16, 2021 Jkt 253001 and subpart(s) (e.g., 40 CFR 414 Subpart H) and the wastewater discharge permit identification numbers. EPA is also requesting copies of NPDES permits and fact sheets (or statement of basis) for direct discharging facilities, and copies of control agreements for indirect discharging facilities. 10. Process flow diagrams showing where wastewater is generated. 11. Identification of the wastewater streams at formulating facilities that contain PFAS (e.g., process wastewater, cooling water, contaminated stormwater, wastewater from aqueous scrubbers or air pollution control equipment, off-specification products, equipment cleaning wastewater, spills and leaks), their volumes, characteristics, and concentrations of PFAS compounds in those individual waste streams. 12. If formulators are not treating PFAS containing wastewater onsite, EPA is requesting information on the management or disposal practices being utilized (e.g., zero liquid discharge, disposal wells, transfer to off-site centralized waste treatment facilities or transfer to POTWs), the volumes of wastes being managed via different practices, and their associated costs. 13. Information and data on future planned process changes at formulators, any plans to change or phase-out use of specific fluorinated compounds or to increase or decrease production of specific compounds, and any planned major upgrades to existing formulating facilities or construction of new formulating facilities in the United States. 14. EPA has collected existing publicly available DMR data and monitoring data from potential PFAS formulators, as well as data from TRI and CDR databases, as indicated in the docket. These DMRs contain data on only a subset of the total PFAS that are potentially present in discharges from these facilities. EPA requests additional monitoring data (see DCN OCPSF00115 for suggested data format and fields) on PFAS compounds in wastewater discharges from PFAS formulating facilities. Since there is currently no CWA-approved analytical method promulgated for analysis of PFAS compounds in wastewater, EPA requests that monitoring data that is submitted include information on the analytical methods used as well as associated information and data that can be used by EPA to determine the quality of the data. EPA also requests comment on whether additional PFAS compounds or precursors that are not reported in DMRs are found in wastewater discharges from these facilities, and the PO 00000 Frm 00016 Fmt 4702 Sfmt 4702 quantities of such PFAS compounds, precursors and other organofluoride compounds found in untreated and treated wastewaters from these facilities. In addition to data on individual compounds, EPA is also particularly interested in data that would provide the total quantity of organofluorides present, such as would be provided by a Total Organic Fluorine (TOF) analysis or other assays. 15. EPA is interested in information regarding any potential changes in PFAS formulating processes, pollution prevention practices or product substitution, or use and cost of specific technologies that can reduce the quantity of PFAS in wastewater from PFAS formulating operations. 16. Analytical methodologies used to monitor wastewater at PFAS formulating facilities, including in house SOPs and method performance data, including lists of specific PFAS compounds being monitored, and any aggregate procedures (e.g., adsorbable or extractable organic fluorine by combustion ion chromatography). 17. Any studies that have been conducted concerning environmental or human health impacts (e.g., toxicity, risk, fate and transfer, cross media) of PFAS discharges from formulators. VI. Statutory and Executive Order Reviews Under Executive Order 12866, titled Regulatory Planning and Review (58 FR 51735, October 4, 1993), this is a ‘‘significant regulatory action’’ ‘‘because the action raises novel legal or policy issues.’’ Accordingly, EPA submitted this action to the Office of Management and Budget (OMB) for review under Executive Order 12866, and any changes made in response to OMB recommendations have been documented in the docket for this action. Because this action does not propose or impose any requirements, other statutory and Executive Order reviews that apply to rulemaking do not apply. Should EPA subsequently determine to pursue a rulemaking, EPA will address the statutes and Executive Orders that apply to that rulemaking. EPA welcomes comments and/or information that would help the Agency to assess any of the following: The potential impact of a rule on small entities pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.); potential impacts on federal, state, or local governments pursuant to the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1531–1538); federalism implications pursuant to Executive Order 13132, entitled Federalism (64 FR 43255, November 2, E:\FR\FM\17MRP1.SGM 17MRP1 Federal Register / Vol. 86, No. 50 / Wednesday, March 17, 2021 / Proposed Rules 1999); availability of voluntary consensus standards pursuant to Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104– 113; tribal implications pursuant to Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000); environmental health or safety effects on children pursuant to Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997); energy effects pursuant to Executive Order 13211, entitled Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001); Paperwork burdens pursuant to the Paperwork Reduction Act (PRA) (44 U.S.C. 3501); or human health or environmental effects on minority or low-income populations pursuant to Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994). The Agency will consider such comments during the development of any subsequent rulemaking. List of Subjects in 40 CFR Part 414 Environmental protection, Chemicals, Plastics materials and synthetics, Waste treatment and disposal, Water pollution control. Jane Nishida, Acting Administrator. [FR Doc. 2021–05402 Filed 3–16–21; 8:45 am] BILLING CODE 6560–50–P DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR Part 100 RIN 0906–AB24 National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice of proposed withdrawal; request for comments. jbell on DSKJLSW7X2PROD with PROPOSALS AGENCY: HHS proposes rescinding the final rule entitled ‘‘National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table,’’ published in the Federal Register on January 21, 2021. That final rule, if it were to go into effect, would amend our SUMMARY: VerDate Sep<11>2014 17:42 Mar 16, 2021 Jkt 253001 regulations by removing Shoulder Injury Related to Vaccine Administration (SIRVA), vasovagal syncope, and the new vaccines category (Item XVII) from the Vaccine Injury Table (Table). HHS seeks comments on this proposed rescission. The final rule published January 21, 2021, at 86 FR 6249, delayed February 23, 2021, at 86 FR 10835, is proposed to be withdrawn. Written comments and related material to this proposed withdrawal must be received on or before April 16, 2021. ADDRESSES: You may submit written comments electronically by the following method: Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions on the website for submitting comments. Instructions. Include the HHS Docket No. HRSA–2021–0001 in your comments. All comments received will be posted without change to https:// www.regulations.gov. Please do not include any personally identifiable or confidential business information you do not want publicly disclosed. FOR FURTHER INFORMATION CONTACT: Please visit the National Vaccine Injury Compensation Program’s website, https://www.hrsa.gov/ vaccinecompensation/, or contact Tamara Overby, Acting Director, Division of Injury Compensation Programs, Healthcare Systems Bureau, HRSA, Room 08N146B, 5600 Fishers Lane, Rockville, MD 20857; by email at vaccinecompensation@hrsa.gov; or by telephone at (855) 266–2427. SUPPLEMENTARY INFORMATION: This is a notice of proposed rulemaking by which HHS proposes to rescind the final rule titled ‘‘National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table,’’ (final rule), January 21, 2021, 86 FR 6249, delayed February 23, 2021, 86 FR 10835, which, if it were to go into effect, would amend the provisions of 42 CFR 100.3 by removing Shoulder Injury Related to Vaccine Administration (SIRVA), vasovagal syncope, and the new vaccines category (Item XVII) from the Table. DATES: I. Background and Purpose The National Childhood Vaccine Injury Act of 1986, title III of Public Law 99–660 (42 U.S.C. 300aa–10 et seq.) (Vaccine Act), established the National Vaccine Injury Compensation Program (VICP) to ensure an adequate supply of vaccines, stabilize vaccine costs, and establish and maintain an accessible and efficient forum for individuals found to be injured by certain vaccines PO 00000 Frm 00017 Fmt 4702 Sfmt 4702 14567 to be compensated. The Vaccine Act has been amended several times since 1986. Petitions for compensation under this Program are filed in the United States Court of Federal Claims (Court), with a copy served on the Secretary, who is the ‘‘Respondent.’’ The Court, acting through judicial officers called Special Masters, makes findings as to eligibility for, and the amount of, compensation. To be found entitled to an award under the VICP, a petitioner must establish a vaccine-related injury or death, either by proving that a vaccine actually caused or significantly aggravated an injury (causation-in-fact) or by demonstrating the occurrence of what has been referred to as a Table injury. That is, a petitioner may show that the vaccine recipient suffered an injury of the type enumerated in the regulations at 42 CFR 100.3—the Vaccine Injury Table—corresponding to the vaccination in question, and that the onset of such injury took place within a time period also specified in the Table. The Table is accompanied by, among other provisions, the Qualifications and Aids to Interpretation (QAI), which defines the injuries and conditions listed on the Table. If these criteria are met, the injury is presumed to have been caused by the vaccination, and the petitioner is entitled to compensation (assuming that other requirements are satisfied), unless the respondent affirmatively shows that the injury was caused by some factor other than the vaccination (see 42 U.S.C. 300aa–11(c)(1)(C)(i), 300aa–13(a)(1)(B)), and 300aa–14(a)). Currently, cases are often resolved by negotiated settlements between the parties and approved by the Court. In such situations, HHS and the Court have not concluded, based upon review of the evidence, that the vaccine caused the alleged injury. Revisions to the Table are authorized under the Vaccine Act (42 U.S.C. 300aa– 14(c)–(e)). The Vaccine Act prohibits the Secretary of HHS from proposing a revision to the Table ‘‘unless the Secretary has first provided to the [Advisory] Commission [on Childhood Vaccines] a copy of the proposed regulation or revision, requested recommendations and comments by the Commission, and afforded the Commission at least 90 days to make such recommendations’’ (42 U.S.C. 300aa–14(d)). Further, once the proposed revision is published, the Secretary must afford the public at least 180 days of public comment (42 U.S.C. 300aa–14(c)(1)). HHS added SIRVA and vasovagal syncope to the Table in March 2017, following an extensive, multi-year process that involved nine HHS workgroups, including HRSA and the E:\FR\FM\17MRP1.SGM 17MRP1

Agencies

[Federal Register Volume 86, Number 50 (Wednesday, March 17, 2021)]
[Proposed Rules]
[Pages 14560-14567]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05402]



[[Page 14560]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 414

[EPA-HQ-OW-2020-0582; FRL 10019-06-OW]
RIN 2040-AG10


Clean Water Act Effluent Limitations Guidelines and Standards for 
the Organic Chemicals, Plastics and Synthetic Fibers Point Source 
Category

AGENCY: Environmental Protection Agency (EPA).

ACTION: Advance notice of proposed rulemaking.

-----------------------------------------------------------------------

SUMMARY: The U.S. Environmental Protection Agency (EPA or Agency) is 
initiating further data collection and analysis to support potential 
future rulemaking, under the Clean Water Act (CWA), relating to the 
effluent limitations guidelines, pretreatment standards and new source 
performance standards applicable to the Organic Chemicals, Plastics and 
Synthetic Fibers (OCPSF) point source category to address discharges 
from manufacturers of per- and polyfluoroalkyl substances (PFAS) and is 
considering revising the same for formulators of PFAS. PFAS are a group 
of man-made organic chemicals. Some PFAS compounds are persistent in 
the environment and in the human body. Analysis of animal studies and 
human epidemiological research suggest that exposure above certain 
levels to some PFAS may be associated with adverse human health 
effects. The Agency has identified several industries with facilities 
that are likely to be discharging PFAS in their wastewater, including 
OCPSF manufacturers and formulators. This advance notice of proposed 
rulemaking (ANPRM) provides for public review and comment on the 
information and data regarding PFAS manufacturers and formulators that 
EPA has collected to date. EPA is requesting public comment on the 
information and data presented in this ANPRM. EPA is also soliciting 
additional information and data regarding discharges of PFAS from these 
facilities to inform future revisions to the wastewater discharge 
requirements that apply to the OCPSF point source category.

DATES: Comments must be received on or before May 17, 2021.

ADDRESSES: You may send comments, identified by Docket ID No. EPA-HQ-
OW-2020-0582, by any of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov/ 
(our preferred method). Follow the online instructions for submitting 
comments.
     Mail: U.S. Environmental Protection Agency, EPA Docket 
Center, Office of Water, Office of Science and Technology Docket, Mail 
Code 28221T, 1200 Pennsylvania Avenue NW, Washington, DC 20460.
     Hand Delivery or Courier (by scheduled appointment only): 
EPA Docket Center, WJC West Building, Room 3334, 1301 Constitution 
Avenue NW, Washington, DC 20004. The Docket Center's hours of 
operations are 8:30 a.m.-4:30 p.m., Monday-Friday (except Federal 
Holidays).
    Instructions: All submissions received must include the Docket ID 
No. for this rulemaking. Comments received may be posted without change 
to https://www.regulations.gov/, including any personal information 
provided. For detailed instructions on sending comments and additional 
information on the rulemaking process, see the ``Public Participation'' 
heading of the SUPPLEMENTARY INFORMATION section of this document. Out 
of an abundance of caution for members of the public and our staff, the 
EPA Docket Center and Reading Room are closed to the public, with 
limited exceptions, to reduce the risk of transmitting COVID-19. Our 
Docket Center staff will continue to provide remote customer service 
via email, phone, and webform. We encourage the public to submit 
comments via https://www.regulations.gov/ or email, as there may be a 
delay in processing mail and faxes. Hand deliveries and couriers may be 
received by scheduled appointment only. For further information on EPA 
Docket Center services and the current status, please visit us online 
at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Ms. Samantha Lewis, Engineering and 
Analysis Division, Office of Science and Technology, Office of Water; 
telephone number: 202-566-1058; email address: [email protected].

I. Public Participation

A. Written Comments

    Submit your comments, identified by Docket ID No. EPA-HQ-OW-2020-
0582, at https://www.regulations.gov (our preferred method), or the 
other methods identified in the ADDRESSES section. Once submitted, 
comments cannot be edited or removed from the docket. EPA may publish 
any comment received to its public docket. Do not submit to EPA's 
docket at https://www.regulations.gov any information you consider to 
be Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. If you wish to submit such 
information, consult the person listed for additional information in 
the preceding FOR FURTHER INFORMATION CONTACT section. Multimedia 
submissions (audio, video, etc.) must be accompanied by a written 
comment. The written comment is considered the official comment and 
should include discussion of all points you wish to make. EPA will 
generally not consider comments or comment contents located outside of 
the primary submission (i.e., on the web, cloud, or other file sharing 
system). For additional submission methods, the full EPA public comment 
policy, information about CBI or multimedia submissions, and general 
guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.
    EPA is temporarily suspending its Docket Center and Reading Room 
for public visitors, with limited exceptions, to reduce the risk of 
transmitting COVID-19. Our Docket Center staff will continue to provide 
remote customer service via email, phone, and webform. We encourage the 
public to submit comments via https://www.regulations.gov/ as there may 
be a delay in processing mail and faxes. Hand deliveries or couriers 
will be received by scheduled appointment only. For further information 
and updates on EPA Docket Center services, please visit us online at 
https://www.epa.gov/dockets.
    EPA continues to carefully and continuously monitor information 
from the Centers for Disease Control and Prevention (CDC), local area 
health departments, and our Federal partners so that we can respond 
rapidly as conditions change regarding COVID-19.

B. Supporting Information

    This notice is supported by documents that are contained in the 
public docket. EPA has prepared an index of these materials to aid in 
the public's review and comment. The index can be identified by 
searching the docket for DCN OCPSF00116.

II. General Information

A. Does this action apply to me?

    Entities potentially affected by any rulemaking following this 
notice include:

[[Page 14561]]



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                 Category                   Example of  regulated entity
------------------------------------------------------------------------
Industry..................................  PFAS Manufacturers.
                                            PFAS Formulators.
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    This section is not intended to be exhaustive, but rather provides 
a guide regarding entities likely to be regulated by any future 
rulemaking activities following this notice. Other types of entities 
that are not included in the examples above could also be regulated. 
PFAS manufacturers are facilities that produce PFAS compounds or 
precursors through processes including, but not limited to, 
electrochemical fluorination (ECF) and telomerization. Facilities that 
manufacture PFAS are currently regulated under EPA's national Effluent 
Limitations Guidelines and Standards (ELGs) for the OCPSF category (40 
CFR part 414). EPA has also gathered more limited information about 
PFAS formulators. PFAS formulators are facilities that are the primary 
customers of the PFAS manufacturers, and that use raw PFAS feedstock to 
(a) produce commercial or consumer goods (e.g., weather-proof 
caulking), or (b) as intermediary products for use in the manufacture 
of commercial goods (e.g., a grease-proof coating for a pizza box).
    If you still have questions regarding the applicability of any 
future rulemaking activities following this notice to a particular 
entity, please consult the person listed for additional information in 
the preceding FOR FURTHER INFORMATION CONTACT section.

B. What is the purpose of this notice?

    As part of EPA's statutorily required Effluent Guidelines planning 
process, EPA has reviewed readily available information about PFAS 
surface water discharges to identify industrial sources that may 
warrant further study for potential regulation through national ELGs. 
Based on the limited data available at the time, in February of 2019, 
EPA published the PFAS Action Plan, in which it identified several 
industries with facilities that are likely to be discharging PFAS 
compounds in their wastewater and EPA began a more detailed study to 
evaluate the potential for PFAS presence in their wastewater 
discharges. Through the PFAS Multi-Industry Study, described in EPA's 
Preliminary Effluent Guidelines Program Plan 14, EPA gathered a range 
of information about PFAS manufacturers and formulators, as well as the 
potential discharges of PFAS from these facilities (further details on 
these efforts are provided in Section V below). PFAS manufacturers are 
facilities that produce PFAS compounds or precursors through processes 
including, but not limited to, ECF and telomerization. Facilities that 
manufacture PFAS are currently regulated under EPA's national ELGs for 
the OCPSF category (40 CFR part 414). EPA has also gathered some 
information about PFAS formulators. PFAS formulators are facilities 
that are the primary customers of PFAS manufacturers, and that use raw 
PFAS feedstock to (a) produce commercial or consumer goods (e.g., 
weather-proof caulking), or (b) as intermediary products for use in the 
manufacture of commercial goods (e.g., a grease-proof coating for a 
pizza box). EPA's data set for formulators is more limited than for 
manufacturers, as the Agency has identified little publicly available 
information on these facilities and their potential discharges.
    This notice provides for public review and comment on the 
information that EPA has collected to date on PFAS discharges from both 
PFAS manufacturers and formulators. In addition, as detailed in Section 
V below, EPA is soliciting additional information and data regarding 
PFAS manufacturers and formulators, including wastewater 
characteristics and treatability. EPA will use any information and data 
received to inform potential next steps, which could include developing 
new or revised ELGs for these categories of dischargers. Because 
formulators may be subject to national ELGs outside of the OCPSF 
category, future EPA actions to address PFAS discharges from these 
facilities may include revisions to ELGs other than the ELGs that apply 
to the OCPSF category or proposal of a new ELG.

III. Background

A. Clean Water Act

    Among its core provisions, the Clean Water Act (CWA) prohibits the 
discharge of pollutants from a point source to waters of the United 
States, except as authorized under the CWA. Under CWA Section 402, 33 
U.S.C. 1342, discharges may be authorized through a National Pollutant 
Discharge Elimination System (NPDES) permit. The CWA outlines a dual 
approach for establishing discharge limits for these permits: (1) 
Technology-based effluent limitations that establish a floor of 
performance for categories of dischargers, and (2) water quality-based 
effluent limitations that are established where technology-based 
effluent limitations are insufficient to meet applicable state water 
quality standards (WQS) or site specific water quality goals. The CWA 
authorizes EPA to establish national technology-based ELGs and new 
source performance standards for discharges to waters of the United 
States from categories of point sources (such as industrial, 
commercial, and public sources). These national ELGs are used by state 
permitting authorities to establish technology-based effluent 
limitations for NPDES permits.
    The CWA also authorizes EPA to promulgate nationally applicable 
pretreatment standards that control pollutant discharges from sources 
that discharge wastewater indirectly to waters of the United States 
through Publicly Owned Treatment Works (POTWs), as outlined in Sections 
307(b) and (c) of the CWA, 33 U.S.C. 1317(b) and (c). EPA establishes 
national pretreatment standards for pollutants in wastewater from such 
indirect dischargers shown to pass through, to interfere with, or to be 
otherwise incompatible with POTW operations. Pretreatment standards are 
designed to ensure that wastewaters from indirect industrial 
dischargers are subject to similar levels of treatment as direct 
dischargers in the same industrial category. See CWA Section 301(b), 33 
U.S.C. 1311(b).
    Technology-based effluent limitations in NPDES permits are derived 
from effluent limitations guidelines (CWA Sections 301 and 304, 33 
U.S.C. 1311 and 1314) and new source performance standards (CWA Section 
306, 33 U.S.C. 1316) promulgated by EPA. Where EPA has not promulgated 
an applicable ELG or new source performance standard, technology-based 
effluent limitations are based on the best professional judgment (BPJ) 
of the permitting authority. Additional limitations are also required 
in a permit where necessary to meet WQS. CWA Section 301(b)(1)(C), 33 
U.S.C. 1311(b)(1)(C). The ELGs are established by EPA regulation for 
categories of industrial dischargers and are based on the degree of 
control that can be achieved using various levels of pollution control 
technology, as specified in the CWA (e.g., Best Practicable Control 
Technology Currently Available (BPT), Best Conventional Pollutant 
Control Technology (BCT), Best Available Technology Economically 
Achievable (BAT); see below).
    The EPA promulgates national ELGs for industrial categories for 
three classes of pollutants: (1) Conventional pollutants (total 
suspended solids (TSS), oil and grease, biochemical oxygen demand 
(BOD5), fecal coliform, and pH), as outlined in CWA Section 
304(a)(4), 33 U.S.C. 1314(a)(4), and 40 CFR 401.16; (2) toxic 
pollutants (e.g., toxic metals such as arsenic, mercury, selenium, and

[[Page 14562]]

chromium; toxic organic pollutants such as benzene, benzo-a-pyrene, 
phenol, and naphthalene), as outlined in CWA Section 307(a), 33 U.S.C. 
1317(a); 40 CFR 401.15 and 40 CFR part 423, appendix A; and (3) 
nonconventional pollutants, which are those pollutants that are not 
categorized as conventional or toxic (e.g., ammonia-N, phosphorus, and 
total dissolved solids (TDS)). PFAS compounds fall into the category of 
nonconventional pollutant, as they are not defined as a toxic or 
conventional pollutant in the CWA or the Code of Federal Regulations 
(CFR).

B. Effluent Guidelines Program

    EPA establishes ELGs based on the performance of well-designed and 
well-operated control and treatment technologies. EPA is not to base 
technology-based requirements on their effects on the receiving water. 
See Weyerhaeuser Co. v. Costle, 599 F.2d 1011, 1028, 1042 (D.C. Cir. 
1978).
    There are four levels of technology-based controls applicable to 
direct dischargers and two levels of controls applicable to indirect 
dischargers. These are described in detail below as general background 
information:
1. Best Practicable Control Technology Currently Available (BPT)
    Consistent with the CWA, EPA establishes effluent limitations based 
on BPT by reference to the average of the best performances of 
facilities within the industry, grouped to reflect various ages, sizes, 
processes, or other common characteristics. EPA promulgates BPT 
effluent limitations for conventional, toxic, and nonconventional 
pollutants. In specifying BPT, EPA looks at a number of factors. EPA 
first considers the cost of achieving effluent reductions in relation 
to the effluent reduction benefits. The Agency also considers the age 
of equipment and facilities, the processes employed, engineering 
aspects of the control technologies, any required process changes, non-
water quality environmental impacts (including energy requirements), 
and such other factors as the Administrator deems appropriate. See CWA 
Section 304(b)(1)(B), 33 U.S.C. 1314(b)(1)(B).
2. Best Conventional Pollutant Control Technology (BCT)
    The 1977 amendments to the CWA require EPA to identify additional 
levels of effluent reduction for conventional pollutants associated 
with Best Conventional Pollutant Control Technology (BCT) for 
discharges from existing industrial point sources. In addition to other 
factors specified in Section 304(b)(4)(B), 33 U.S.C. 1314(b)(4)(B), the 
CWA requires that EPA establish BCT limitations after consideration of 
a two-part ``cost reasonableness'' test. EPA explained its methodology 
for the development of BCT limitations on July 9, 1986 (51 FR 24974). 
Section 304(a)(4) designates the following as conventional pollutants: 
BOD5, TSS, fecal coliform, pH, and any additional pollutants 
defined by the Administrator as conventional. The Administrator 
designated oil and grease as a conventional pollutant on July 30, 1979 
(44 FR 44501; 40 CFR 401.16).
3. Best Available Technology Economically Achievable (BAT)
    BAT represents the second level of control for direct discharges of 
toxic and nonconventional pollutants. As the statutory phrase intends, 
EPA considers technological availability and the economic achievability 
in determining what level of control represents BAT. CWA Section 
301(b)(2)(A), 33 U.S.C. 1311(b)(2)(A). Other statutory factors that EPA 
must consider in assessing BAT are the cost of achieving BAT effluent 
reductions, the age of equipment and facilities involved, the process 
employed, potential process changes, non-water quality environmental 
impacts (including energy requirements), and such other factors as the 
Administrator deems appropriate. CWA Section 304(b)(2)(B), 33 U.S.C. 
1314(b)(2)(B); Texas Oil & Gas Ass'n v. EPA, 161 F.3d 923, 928 (5th 
Cir. 1998). The Agency retains considerable discretion in assigning the 
weight to be accorded each of these factors. Weyerhaeuser Co., 590 F.2d 
at 1045. Generally, EPA determines economic achievability based on the 
effect of the cost of compliance with BAT limitations on overall 
industry and subcategory (if applicable) financial conditions. BAT is 
intended to reflect the highest performance in the industry, and it may 
reflect a higher level of performance than is currently being achieved 
based on technology transferred from a different subcategory or 
category, bench scale or pilot studies, or foreign facilities. Am. 
Paper Inst. v. Train, 543 F.2d 328, 353 (D.C. Cir. 1976); Am. Frozen 
Food Inst. v. Train, 539 F.2d 107, 132 (D.C. Cir. 1976). BAT may be 
based upon process changes or internal controls, even when these 
technologies are not common industry practice. See Am. Frozen Food 
Inst., 539 F.2d at 132, 140; Reynolds Metals Co. v. EPA, 760 F.2d 549, 
562 (4th Cir. 1985); Cal. & Hawaiian Sugar Co. v. EPA, 553 F.2d 280, 
285-88 (2nd Cir. 1977).
    One way that EPA may consider differences within an industry when 
establishing BAT limitations is through subcategorization. The Supreme 
Court has recognized that the substantive test for subcategorizing an 
industry is the same as that which applies to establishing 
fundamentally different factor variances--i.e., whether the plants are 
different with respect to relevant statutory factors. See Chem. Mfrs. 
Ass'n v. EPA, 870 F.2d 177, 214 n.134 (5th Cir. 1989) (citing Chem. 
Mfrs. Ass'n v. NRDC, 470 U.S. 116, 119-22, 129-34 (1985)). Courts have 
stated that there need only be a rough basis for subcategorization. See 
Chem. Mfrs. Ass'n, 870 F.2d at 215 n.137 (summarizing cases).
4. Best Available Demonstrated Control Technology/New Source 
Performance Standards (NSPS)
    NSPS reflect ``the greatest degree of effluent reduction'' that is 
achievable based on the ``best available demonstrated control 
technology'' (BADCT), ``including, where practicable, a standard 
permitting no discharge of pollutants.'' CWA Section 306(a)(1), 33 
U.S.C. 1316(a)(1). Owners of new facilities have the opportunity to 
install the best and most efficient production processes and wastewater 
treatment technologies. As a result, NSPS generally represent the most 
stringent controls attainable through the application of BADCT for all 
pollutants (that is, conventional, nonconventional, and toxic 
pollutants). In establishing NSPS, EPA is directed to take into 
consideration the cost of achieving the effluent reduction and any non-
water quality environmental impacts and energy requirements. CWA 
Section 306(b)(1)(B), 33 U.S.C. 1316(b)(1)(B).
5. Pretreatment Standards for Existing Sources (PSES)
    Section 307(b) of the CWA, 33 U.S.C. 1317(b), authorizes EPA to 
promulgate pretreatment standards for discharges of pollutants to 
POTWs. PSES are designed to prevent the discharge of pollutants that 
pass through, interfere with, or otherwise are incompatible with the 
operation of POTWs. Categorical pretreatment standards are technology-
based and are analogous to BPT and BAT effluent limitations guidelines, 
and thus the Agency typically considers the same factors in 
promulgating PSES as it considers in promulgating BPT and BAT. The 
General Pretreatment Regulations, which set forth the framework for the 
implementation of categorical pretreatment standards, are found at 40 
CFR part 403. These regulations establish pretreatment standards that 
apply to all non-domestic dischargers. See 52 FR 1586 (January 14, 
1987).

[[Page 14563]]

6. Pretreatment Standards for New Sources (PSNS)
    Section 307(c) of the CWA, 33 U.S.C. 1317(c), authorizes EPA to 
promulgate PSNS at the same time it promulgates NSPS. As is the case 
for PSES, PSNS are designed to prevent the discharge of any pollutant 
into a POTW that interferes with, passes through, or otherwise is 
incompatible with the POTW. In selecting the PSNS technology basis, the 
Agency generally considers the same factors it considers in 
establishing NSPS, along with the results of a pass-through analysis. 
Like new sources of direct discharges, new sources of indirect 
discharges have the opportunity to incorporate into their operations 
the best available demonstrated technologies. As a result, EPA 
promulgates pretreatment standards for new sources based on best 
available demonstrated control technology for new sources. See Nat'l 
Ass'n of Metal Finishers v. EPA, 719 F.2d 624, 634 (3rd Cir. 1983).

C. Summary of the Existing OCPSF ELGs

    The OCPSF ELGs (40 CFR part 414) were originally promulgated in 
1987, and then amended in 1989, 1990, 1992, and 1993. The OCPSF 
category includes more than 1,000 chemical facilities producing over 
25,000 end products. These include such products as benzene, toluene, 
polypropylene, polyvinyl chloride, chlorinated solvents, rubber 
precursors, rayon, nylon, and polyester. The OCPSF industry is large 
and diverse with complex operations and processes. Some plants produce 
chemicals in large volumes through continuous chemical processes, while 
others produce only small volumes of ``specialty'' chemicals through 
batch chemical processes.
    Only a small subset of the facilities that are currently regulated 
under the OCPSF ELGs manufacture or formulate PFAS. Although the OCPSF 
ELGs may apply to PFAS manufacturers and formulators, the OCPSF ELGs do 
not establish effluent limitations or pretreatment standards for any 
PFAS compounds. Rather, the revision to the OCPSF ELGs would address 
PFAS discharges from PFAS manufacturers and formulators.

IV. The EPA's PFAS Multi-Industry Study and Identification of PFAS 
Manufacturers and Formulators for Potential Regulation

    As described in the Preliminary Effluent Guidelines Program Plan 14 
(Preliminary Plan 14), published in October 2019, EPA conducted an 
initial examination of readily available public information about PFAS 
surface water discharges to identify industrial sources that may 
warrant further study. The Preliminary Plan 14 docket (EPA-HQ-OW-2018-
0618) includes a summary of the information EPA reviewed and a report 
with a more thorough description of our review activities. Based on 
this initial review, EPA decided to conduct further studies to better 
understand and document facilities discharging PFAS compounds to 
surface waters and to POTWs. This was introduced in the Preliminary 
Plan 14 as the PFAS Multi-Industry Study.
    The goals of the PFAS Multi-Industry Study are to identify 
industries and specific facilities producing or using PFAS compounds; 
quantify--to the best of EPA's ability--the amounts of PFAS being 
discharged; identify PFAS control practices and treatment technologies; 
document PFAS removal efficiency in wastewater; and estimate costs 
associated with PFAS treatment systems. EPA identified the following 
industrial point source categories as the primary focus of this study: 
OCPSF manufacturers; pulp and paper manufacturers; textiles and carpet 
manufacturers; and commercial airports.\1\
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    \1\ Military bases and airports are not included in the scope of 
this study.
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    For the OCPSF manufacturers, EPA reviewed numerous data sources and 
identified six PFAS manufacturers and ten likely PFAS formulators. EPA 
is not sure that the ten facilities that it identified as ``likely'' 
PFAS formulators are actually PFAS formulators due to limited data 
available at this time. We discuss each of these data sources in 
greater detail below.
    EPA reviewed 2019 Discharge Monitoring Reports (DMRs) and obtained 
PFAS data for six PFAS manufacturers and three likely PFAS formulators 
(the other seven facilities do not report PFAS compounds in their DMRs 
or they do not have DMRs because they are indirect dischargers). These 
nine facilities combined reported a total of 17 PFAS compounds in their 
discharges. Based on the DMRs, effluent data detected a total of 15 
PFAS compounds, and concentrations ranged from non-detect to 777 parts 
per billion (ppb). The ``2019 Monitoring Period Level DMR PFAS Data'' 
(DCN OCPSF00030) includes additional information on the compounds that 
were monitored, and the concentration ranges reported in DMRs.
    EPA reviewed NPDES permits for these PFAS manufacturers and 
formulators to evaluate whether their permits contain effluent 
limitations or monitoring requirements for PFAS compounds. One current 
NPDES permit in West Virginia contains effluent limitations for two 
PFAS compounds (Perfluorooctanoic acid (PFOA) and Hexafluoropropylene 
oxide dimer acid (HFPODA) that go into effect on September 1, 2021. 
Another facility in North Carolina is under a consent decree with 
requirements for no discharge of PFAS process wastewater. See DCN 
OCPSF00079 for consent decree. The North Carolina facility is currently 
hauling all PFAS process wastewater off-site for disposal. The consent 
decree went into effect on February 25, 2019 and ends on January 31, 
2023. This North Carolina facility reported detections of PFOA for 9 of 
12 reporting periods in 2019 DMRs, including periods after February 
2019. Four of the other PFAS manufacturers and formulators have PFAS 
monitoring requirements, and no effluent limitations, in their NPDES 
permits. Two Alabama facilities and one Illinois facility are operating 
under expired, administratively continued NPDES permits. The NPDES 
permit materials collected and reviewed are available as DCNs 
OCPSF000008 to OCPSF00025.
    EPA also reviewed the Toxics Release Inventory (TRI), which is 
managed by EPA's Office of Chemical Safety and Pollution Prevention 
(OCSPP) and tracks annual environmental waste management, including 
releases, of 767 individually listed chemicals and 33 chemical 
categories from industrial facilities that manufacture, process, or 
otherwise use these chemicals in amounts above their applicable 
reporting thresholds. Release of a TRI chemical refers to an emission 
to air, discharge to water, or placement in some type of land disposal. 
EPA has not yet received any information or data pertaining to the 
release of PFAS compounds through TRI reporting. However, the National 
Defense Authorization Act for Fiscal Year 2020 added 172 PFAS compounds 
to the TRI. TRI reporting for these PFAS will be due to EPA by July 1, 
2021, for calendar year 2020 data. For additional information on the 
addition of 172 PFAS to TRI, see https://www.epa.gov/toxics-release-inventory-tri-program/list-pfas-added-tri-ndaa.
    EPA reviewed data from the Toxic Substances Control Act (TSCA) 
Inventory, which lists chemicals manufactured (including imported) or 
processed in the United States. The TSCA Inventory, managed by the 
Office of Pollution Prevention and Toxics (OPPT) within OCSPP, 
currently lists more than 86,000 chemicals, of which approximately half 
are currently in

[[Page 14564]]

commerce or ``active.'' For PFAS specifically, the TSCA Inventory lists 
over one thousand compounds, of which approximately half are known to 
be commercially active within the last decade. The TSCA Inventory by 
itself cannot be used to identify dischargers.
    EPA also reviewed the Chemical Data Reporting (CDR) database, which 
compiles information collected under a TSCA Section 8(a) rule that 
requires chemical manufacturers (including importers) to provide EPA 
with production, import, and customer use information about chemicals 
in commerce. Manufacturers and importers must report to the CDR 
database if they meet certain annual volume thresholds, typically 
25,000 pounds, but 2,500 pounds for chemicals subject to certain TSCA 
actions. EPA matched the chemicals in the 2016 CDR data (the most 
recent year available) \2\ against EPA's Cross-Agency Research List \3\ 
and identified 118 PFAS compounds in the CDR database. See DCN 
OCPSF00032 for ``2016 nonCBI CDR Data for PFAS Compounds'' and DCN 
OCPSF00003 for ``EPA's CompTox Cross Agency PFAS List.'' Using this 
list of CDR PFAS compounds, EPA summed the reported production volumes 
to calculate a total PFAS production and importation volume of 
approximately 608 million pounds for 2015. See DCN OCPSF00033 for 
``Review of 2015 non-CBI CDR Data for PFAS Compounds.'' The CDR 
database contains data identifying which facilities produced PFAS 
compounds, but does not have any information on PFAS discharges. The 
six PFAS manufacturing facilities that reported 2019 DMR data also 
appear in the CDR data as domestic manufacturers of 76 separate PFAS 
compounds. An additional 55 facilities appear in the CDR dataset; 
however, EPA has no corresponding data on their potential PFAS 
discharges. The deadline for the CDR data for the 2020 reporting cycle 
is in January 2021. Additional PFAS-related data submitted by CDR sites 
can be assessed shortly thereafter.
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    \2\ The information for the CDR is collected every four years 
from manufacturers (including importers). The 2016 CDR data contains 
information reported in 2016 and covering 2012 to 2015. https://www.epa.gov/chemical-data-reporting/basic-information-about-chemical-data-reporting#what.
    \3\ EPA's Cross-Agency Research PFAS list, from the CompTox 
Chemicals Dashboard, is a manually curated listing of mainly 
straight-chain and branched PFAS compiled from various internal, 
literature and public sources by EPA researchers and program office 
representative (https://comptox.epa.gov/dashboard).
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    EPA collected and reviewed 15 treatment technology technical 
articles from a range of sources including EPA publications, federal, 
state, and local government publications, PFAS manufacturers, and non-
governmental organizations (NGOs). Through these articles, EPA 
identified eight potential technologies that can remove PFAS from 
wastewater. These include granular activated carbon, reverse osmosis 
filtration, and ion exchange. A full list of available technologies 
that EPA has identified to date is included in DCN OCPSF00096.
    EPA began stakeholder outreach in July 2019 by meeting with 
stakeholders to collect, on a voluntary basis, additional information 
such as supplementary effluent data, information on PFAS compounds 
being produced/used and discharged, and any information about treatment 
technologies being used, along with their effectiveness and costs, to 
augment the available information EPA reviewed. This information 
gathering effort was performed under the Multi-Industry Study noted 
above. The information provided by stakeholders is included in DCN 
OCPSF00042-OCPSF00078.
    EPA met with the FluoroCouncil of the American Chemistry 
Council,\4\ the primary trade association that represents PFAS 
manufacturers and formulators, and its members. See DCN OCPSF00054 for 
meeting notes. They provided EPA with technical literature concerning 
PFAS terminology and classification, a list of short chain 
fluorotelomers studies, an economic assessment of the U.S. 
fluoropolymer industry, and the names of contacts at entities that they 
identified as the sole three PFAS manufacturing companies in the United 
States. These three manufacturers (with a total of six facilities) 
mirrored the six facilities for which EPA found DMR data and an 
additional facility for which EPA received internal monitoring data.
---------------------------------------------------------------------------

    \4\ The FluoroCouncil of the American Chemistry Council has 
disbanded since EPA last spoke to them.
---------------------------------------------------------------------------

    EPA met with representatives of one company that operates multiple 
facilities that manufacture PFAS in West Virginia, New Jersey and North 
Carolina. They provided EPA with a copy of the presentation they gave 
during their meeting with the Agency, a copy of a New Jersey facility's 
NPDES permit, data for an internal outfall at that facility, a document 
addressing PFAS concerns at a North Carolina facility, and technical 
literature on fluoropolymers of low concern. See DCN OCPSF00061 for 
meeting notes and DCNs OCPSF00062 to OCPSF00064 for materials provided.
    EPA met with representatives of one company that operates multiple 
facilities that manufacture PFAS in Alabama, Illinois and Minnesota. 
Representatives of this company provided EPA with a PFAS production 
history in addition to current PFAS product categories, wastewater 
process flow diagrams, copies of their NPDES permits, documentation for 
a direct injection analytical method, sampling data for both PFAS 
manufacturing facilities and a formulating facility, and related 
published literature. See DCN OCPSF00042 for meeting notes and DCNs 
OCPSF00043 to OCPSF00052 for materials provided.
    EPA met with representatives of another PFAS manufacturing facility 
in Alabama. See DCN OCPSF00065 for meeting notes.
    EPA spoke to a representative of another company who stated that 
the company does not produce PFAS compounds in the United States. EPA 
learned that this company imports products from international 
manufacturing facilities and other manufacturers both inside and 
outside of the United States. Those materials are further processed at 
a domestic facility in Pennsylvania. See DCN OCPSF00060 for meeting 
notes. EPA is not aware of any PFAS discharge data from this facility, 
but EPA is requesting additional information regarding these and 
similar operations through this notice.
    EPA made attempts to contact the other PFOA/PFOS Stewardship 
Program https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/fact-sheet-20102015-pfoa-stewardship-program) companies but did 
not receive any additional information. EPA continues to coordinate 
with manufacturers to obtain additional information, including a list 
of PFAS compounds they manufacture, documentation for the analytical 
methods they use to analyze PFAS in waste streams, and PFAS analytical 
data collected from source water, process water, and effluent at their 
facilities.
    EPA spoke with representatives of the Michigan Department of 
Environment, Great Lakes, & Energy (MI EGLE). Michigan EGLE provided 
EPA with sampling data for 30 direct discharging facilities and 633 
indirect discharging facilities across 44 industrial categories, mostly 
for PFOA and PFOS. See DCN OCPSF00067 for direct discharging data and 
DCN OCPSF00068 for indirect discharging data provided by MI EGLE.
    Four of these facilities were likely PFAS formulators based on the 
concentrations of PFAS in discharges and the operations of the 
facilities. EPA also reviewed an investigation report

[[Page 14565]]

from EPA's Region 3, looking for potential PFAS sources in Goose Creek, 
Pennsylvania. From this report, EPA was able to identify another likely 
PFAS formulator. See DCN OCPSF00038 for report and communications.

V. Request for Further Information on PFAS Manufacturers and 
Formulators

A. PFAS Manufacturers

    EPA has identified six facilities (Alabama, North Carolina, West 
Virginia, New Jersey, Illinois) in the United States that currently 
manufacture PFAS compounds and have an associated wastewater discharge.
    Throughout the course of EPA's PFAS Multi-Industry Study, the 
Agency worked collaboratively with stakeholders to obtain information 
regarding facilities that manufacture and formulate fluorochemicals in 
the United States. EPA appreciates the information that these entities 
have provided to the Agency to date.\5\ This information has greatly 
increased the Agency's understanding of current manufacturing 
facilities, their operations, their production of fluorochemicals, 
their wastewater generation activities, and their wastewater treatment 
activities. After reviewing the information received to date, EPA is 
inviting stakeholders to review this information and provide comment 
and is seeking additional information and data to inform EPA's next 
steps.
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    \5\ These data and information are contained in the docket 
supporting this notice.
---------------------------------------------------------------------------

    Specifically, EPA is requesting the following information and data 
regarding PFAS manufacturers:
    1. The identity of or suggestions for how to identify any other 
facilities in the United States currently manufacturing PFAS.
    2. Descriptions of the manufacturing processes being employed at 
PFAS manufacturing facilities, including process flow diagrams.
    3. Information and data on the specific PFAS compounds that are 
currently being produced (including as byproducts) at these facilities 
(including the product name, CAS number and class of each compound), 
the quantities that are being produced, the customers or industries 
that are purchasing these materials, and the quantities of materials 
sold to various customers. For sales, EPA is also interested in knowing 
the quantities of PFAS compounds that are exported outside of the 
United States.
    4. Identification of the wastewater streams at manufacturing 
facilities that contain PFAS (e.g., process wastewater, cooling water, 
contaminated stormwater, wastewater from aqueous scrubbers or air 
pollution control equipment, off-specification products, equipment 
cleaning wastewater, spills and leaks), their volumes, characteristics, 
the identity (including CAS Number), and concentrations of PFAS 
compounds in those individual waste streams.
    5. Information and data on the current wastewater treatment and 
management practices (including pollution prevention and product 
recovery practices) being utilized at existing PFAS manufacturers. 
Specific information requested includes descriptions of the treatment 
technologies, their size and flow rate, process flow diagrams, capital 
and operation and maintenance costs, treatment chemical utilization, 
and residuals generation and management. If wastewater storage ponds 
are used to hold PFAS wastewater, EPA also requests a description of 
the ponds, including purpose, age, capacity, design, wastewater 
characteristics, whether they are lined or unlined, and whether they 
have discharge outfalls.
    6. If manufacturers are not treating PFAS containing wastewater 
onsite, EPA is requesting information on the management or disposal 
practices being utilized (e.g., zero liquid discharge, disposal wells, 
transfer to off-site centralized waste treatment facilities or transfer 
to POTWs), the volumes of wastewaters being managed via different 
practices, the name and location of the facilities receiving 
wastewaters, and their associated costs.
    7. Information and data on future planned process changes at 
existing PFAS manufacturing facilities, any plans to change or phase-
out manufacture of specific fluorinated compounds or to increase or 
decrease production of specific compounds, and any planned major 
upgrades to existing manufacturing facilities or construction of new 
PFAS manufacturing facilities in the United States. EPA is also 
requesting information regarding any potential changes in PFAS 
manufacturing processes, pollution prevention practices or chemicals 
used as PFAS substitution, or use and cost of specific technologies 
that can reduce the quantity of PFAS in wastewater from PFAS 
manufacturing operations.
    8. EPA has collected existing publicly available DMR data and 
monitoring data from known manufacturers, as well as data from TRI and 
CDR databases, as indicated in the docket. These DMRs contain data on 
only a subset of the total PFAS that are potentially present in 
discharges from these facilities. EPA requests additional monitoring 
data (see DCN OCPSF00115 for suggested data format and fields) on PFAS 
compounds in wastewater discharges from PFAS manufacturing facilities. 
Since there is currently no CWA-approved analytical method promulgated 
for analysis of PFAS compounds in wastewater, EPA requests that 
monitoring data that is submitted include information on the analytical 
methods used as well as associated information and data that can be 
used by EPA to determine the quality of the data. EPA also requests 
comment on whether additional PFAS compounds or precursors that are not 
reported in DMRs are found in wastewater discharges from these 
facilities, and the quantities of such PFAS compounds, precursors, and 
other organofluoride compounds found in untreated and treated 
wastewaters from these facilities. In addition to data on individual 
compounds, EPA is also particularly interested in data that would 
provide the total quantity of organofluorides present, such as would be 
provided by a Total Organic Fluorine (TOF) analysis or other assays.
    9. In addition to treatment technologies being used at the six 
known PFAS manufacturing facilities, EPA is requesting additional 
information and data regarding treatment and destruction technologies 
for PFAS in industrial wastewater, including data on their performance, 
costs (both capital and operation and maintenance), and the types, 
quantities and management practices for any treatment residuals that 
are generated. Data from laboratory, bench, pilot, and full-scale 
facilities are requested. EPA also requests comment on the 15 treatment 
technology articles included in the docket.
    10. Analytical methodologies used to monitor wastewater at PFAS 
manufacturing facilities, including in house SOPs and method 
performance data, including lists of specific PFAS compounds being 
monitored, and any aggregate procedures (e.g., adsorbable or 
extractable organic fluorine by combustion ion chromatography).
    11. Any studies that have been conducted concerning environmental 
or human health impacts (e.g., toxicity, risk, fate and transfer, cross 
media) of PFAS discharges from PFAS manufacturers.

B. PFAS Formulators

    EPA has identified limited publicly available information regarding 
the universe of PFAS formulators. To date, EPA has identified ten 
facilities (in Ohio, Virginia, Michigan, Minnesota, Pennsylvania and 
New Jersey) that are

[[Page 14566]]

potential formulators, but requests additional details regarding 
formulator facilities.
    As with manufacturers, EPA is interested in obtaining additional 
information and data regarding discharges of PFAS from formulators in 
order to inform the Agency's decision-making regarding the need for new 
or revised ELGs for these types of facilities. EPA is requesting the 
following information and data from PFAS formulators:
    1. Identification of all known PFAS formulators in the United 
States.
    2. Descriptions of the manufacturing processes occurring at 
formulating facilities, including descriptions of how PFAS compounds 
are utilized at these facilities.
    3. The SIC or NAICS codes of formulating facilities.
    4. Information and data on the PFAS compounds that are currently 
being used at these facilities (including the product name, CAS number 
and class of each compound), the quantities that are being used, the 
quantities that are being sold or transferred for further processing or 
as materials for incorporation into finished products, and the 
customers or industries that are purchasing these materials and 
products.
    5. Information on whether PFAS is being imported by formulators 
from outside the United States, and if any formulators are exclusively 
utilizing imported PFAS.
    6. The locations and number of formulating facilities, as well as 
whether process wastewater associated with PFAS formulating is being 
discharged at these facilities.
    7. Whether facilities have current monitoring requirements for PFAS 
or other fluorocarbons.
    8. Information and data on the current wastewater treatment and 
management practices (including pollution prevention and product 
recovery practices) being utilized at existing PFAS formulators. 
Specific information requested includes descriptions of the treatment 
technologies, their size and flow rate, process flow diagrams, capital 
and operation and maintenance costs, treatment chemical utilization, 
and residuals generation and management. If wastewater storage ponds 
are used to hold PFAS wastewater, provide a description of the ponds 
including purpose, age, capacity, design, wastewater characteristics, 
whether they are lined or unlined, and whether they have discharge 
outfalls.
    9. For facilities that discharge process wastewater, whether 
facilities are subject to national ELGs, and if so, identification of 
the applicable part(s) and subpart(s) (e.g., 40 CFR 414 Subpart H) and 
the wastewater discharge permit identification numbers. EPA is also 
requesting copies of NPDES permits and fact sheets (or statement of 
basis) for direct discharging facilities, and copies of control 
agreements for indirect discharging facilities.
    10. Process flow diagrams showing where wastewater is generated.
    11. Identification of the wastewater streams at formulating 
facilities that contain PFAS (e.g., process wastewater, cooling water, 
contaminated stormwater, wastewater from aqueous scrubbers or air 
pollution control equipment, off-specification products, equipment 
cleaning wastewater, spills and leaks), their volumes, characteristics, 
and concentrations of PFAS compounds in those individual waste streams.
    12. If formulators are not treating PFAS containing wastewater 
onsite, EPA is requesting information on the management or disposal 
practices being utilized (e.g., zero liquid discharge, disposal wells, 
transfer to off-site centralized waste treatment facilities or transfer 
to POTWs), the volumes of wastes being managed via different practices, 
and their associated costs.
    13. Information and data on future planned process changes at 
formulators, any plans to change or phase-out use of specific 
fluorinated compounds or to increase or decrease production of specific 
compounds, and any planned major upgrades to existing formulating 
facilities or construction of new formulating facilities in the United 
States.
    14. EPA has collected existing publicly available DMR data and 
monitoring data from potential PFAS formulators, as well as data from 
TRI and CDR databases, as indicated in the docket. These DMRs contain 
data on only a subset of the total PFAS that are potentially present in 
discharges from these facilities. EPA requests additional monitoring 
data (see DCN OCPSF00115 for suggested data format and fields) on PFAS 
compounds in wastewater discharges from PFAS formulating facilities. 
Since there is currently no CWA-approved analytical method promulgated 
for analysis of PFAS compounds in wastewater, EPA requests that 
monitoring data that is submitted include information on the analytical 
methods used as well as associated information and data that can be 
used by EPA to determine the quality of the data. EPA also requests 
comment on whether additional PFAS compounds or precursors that are not 
reported in DMRs are found in wastewater discharges from these 
facilities, and the quantities of such PFAS compounds, precursors and 
other organofluoride compounds found in untreated and treated 
wastewaters from these facilities. In addition to data on individual 
compounds, EPA is also particularly interested in data that would 
provide the total quantity of organofluorides present, such as would be 
provided by a Total Organic Fluorine (TOF) analysis or other assays.
    15. EPA is interested in information regarding any potential 
changes in PFAS formulating processes, pollution prevention practices 
or product substitution, or use and cost of specific technologies that 
can reduce the quantity of PFAS in wastewater from PFAS formulating 
operations.
    16. Analytical methodologies used to monitor wastewater at PFAS 
formulating facilities, including in house SOPs and method performance 
data, including lists of specific PFAS compounds being monitored, and 
any aggregate procedures (e.g., adsorbable or extractable organic 
fluorine by combustion ion chromatography).
    17. Any studies that have been conducted concerning environmental 
or human health impacts (e.g., toxicity, risk, fate and transfer, cross 
media) of PFAS discharges from formulators.

VI. Statutory and Executive Order Reviews

    Under Executive Order 12866, titled Regulatory Planning and Review 
(58 FR 51735, October 4, 1993), this is a ``significant regulatory 
action'' ``because the action raises novel legal or policy issues.'' 
Accordingly, EPA submitted this action to the Office of Management and 
Budget (OMB) for review under Executive Order 12866, and any changes 
made in response to OMB recommendations have been documented in the 
docket for this action. Because this action does not propose or impose 
any requirements, other statutory and Executive Order reviews that 
apply to rulemaking do not apply. Should EPA subsequently determine to 
pursue a rulemaking, EPA will address the statutes and Executive Orders 
that apply to that rulemaking.
    EPA welcomes comments and/or information that would help the Agency 
to assess any of the following: The potential impact of a rule on small 
entities pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 
et seq.); potential impacts on federal, state, or local governments 
pursuant to the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1531-
1538); federalism implications pursuant to Executive Order 13132, 
entitled Federalism (64 FR 43255, November 2,

[[Page 14567]]

1999); availability of voluntary consensus standards pursuant to 
Section 12(d) of the National Technology Transfer and Advancement Act 
of 1995 (NTTAA), Public Law 104-113; tribal implications pursuant to 
Executive Order 13175, entitled Consultation and Coordination with 
Indian Tribal Governments (65 FR 67249, November 6, 2000); 
environmental health or safety effects on children pursuant to 
Executive Order 13045, entitled Protection of Children from 
Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 
1997); energy effects pursuant to Executive Order 13211, entitled 
Actions Concerning Regulations that Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001); Paperwork burdens 
pursuant to the Paperwork Reduction Act (PRA) (44 U.S.C. 3501); or 
human health or environmental effects on minority or low-income 
populations pursuant to Executive Order 12898, entitled Federal Actions 
to Address Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994). The Agency will consider 
such comments during the development of any subsequent rulemaking.

List of Subjects in 40 CFR Part 414

    Environmental protection, Chemicals, Plastics materials and 
synthetics, Waste treatment and disposal, Water pollution control.

Jane Nishida,
Acting Administrator.
[FR Doc. 2021-05402 Filed 3-16-21; 8:45 am]
BILLING CODE 6560-50-P


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