^«^EZDy% United States LhI Environmental Protection Agency Office of Chemical Safety and Pollution Prevention Proposed Designation of 1,1 -Dichloroethane (CASRN 75-34-3) as a High-Priority Substance for Risk Evaluation August 22,2019 ------- Table of Contents List of Tables iii Acronyms and Abbreviations iv 1. Introduction 1 2. Production volume or significant changes in production volume 3 Approach 3 Results and Discussion 3 3. Conditions of use or significant changes in conditions of use 4 Approach 4 CDR and TRI Tables 4 CDR and TRI Summary and Additional Information on Conditions of Use 11 4. Potentially exposed or susceptible subpopulations 12 Approach 12 Results and Discussion 12 5. Persistence and bioaccumulation 13 Approach 13 Physical and Chemical Properties and Environmental Fate Tables 13 Results and Discussion 16 6. Storage near significant sources of drinking water 16 Approach 16 Results and Discussion 17 7. Hazard potential 17 Approach 17 Potential Human Health and Environmental Hazard Tables 17 8. Exposure potential 21 Approach 21 Results and Discussion 21 9. Other risk-based criteria that EPA determines to be relevant to the designation of the chemical substance's priority 25 10. Proposed designation and Rationale 25 11. References 26 li ------- List of Tables Table 1. 1986-2015 National Aggregate Production Volume Data (Production Volume in Pounds) 3 Table 2. 1,1-Dichloroethane (CASRN 75-34-3) Categories and Subcategories of Conditions of Use (2016 CDR reporting cycle) 5 Table 3. 1,1-Dichloroethane (75-34-3) Categories and Subcategories of Conditions of Use (2012 CDR reporting cycle) 5 Table 4. Activities and Uses Reported to TRI for 1,1-Dichloroethane, Reporting Year 2011 6 Table 5. Activities and Uses Reported to TRI for 1,1-Dichloroethane, Reporting Year 2015 7 Table 6. Activities and Uses Reported to TRI for 1,1-Dichloroethane, Reporting Year 2017 9 Table 7. Physical and Chemical Properties of 1,1-Dichloroethane 13 Table 8. Environmental Fate Characteristics of 1,1-Dichloroethane 15 Table 9. Potential Human Health Hazards Identified for 1,1-Dichloroethane 18 Table 10. Potential Environmental Hazards Identified for 1,1-Dichloroethane 19 Table 11. The TRI Data on 1,1-Dichloroethane from Reporting Years 2011, 2015, and 2017 and Used in this Document to Assess Exposure Potential 22 Table 12. Exposure Information for Consumers 23 Table 13. Exposure Information for the Environment and General Population 23 in ------- Acronyms and Abbreviations Term Description ACGIH American Conference of Governmental Industrial Hygienists ATSDR Agency for Toxic Substances and Disease Registry Biomon. Biomonitoring BOD Biochemical oxygen demand BP Boiling point CAA Clean Air Act CASRN Chemical Abstracts Service Registry Number CBI Confidential Business Information CDR Chemical Data Reporting CERCLA Comprehensive Environmental Response, Compensation, and Liability Act CFR Code of Federal Regulations Concen. Concentration CWA Clean Water Act CPDat Chemical and Products Database ECOTOX Ecotoxicology Database EPA U.S. Environmental Protection Agency EPCRA Emergency Planning and Community Right-to-Know Act FDA U.S. Food and Drug Administration FR Federal Register GC Gas chromatography HPLC High performance liquid chromatography IRIS Integrated Risk Information System IUR Inventory Update Rule K Thousand Koc Organic carbon-water partition coefficient Kow Octanol-water partition coefficient M Million iv ------- Term Description MITI Ministry of International Trade and Industry MP Melting point NAICS North American Industry Classification System NIH National Institute of Health NIOSH National Institute for Occupational Safety and Health NR Not reported OECD Organisation for Economic Co-operation and Development •OH Hydroxyl radical OPPT Office of Pollution Prevention and Toxics OSHA Occupational Safety and Health Administration PEL Permissible Exposure Limit POTW Publicly owned treatment works PPE Personal protective equipment PPM Parts per million RCRA Resource Conservation and Recovery Act REL Recommended Exposure Limit RY Reporting Year SOP Standard Operating Procedure SMILES Simplified Molecular-Input Line-Entry System T1/2 Half-life TG Test guidance TLV Threshold Limit Value TRI Toxics Release Inventory TSCA Toxic Substances Control Act TWA Time weighted average USGS United States Geological Survey VP Vapor pressure WS Water solubility V ------- 1. Introduction In section 6(b)(1)(B) of the Toxic Substances Control Act (TSCA), as amended, and in the U.S. Environmental Protection Agency's implementing regulations (40 CFR 702.3)1, a high-priority substance for risk evaluation is defined as a chemical substance that EPA determines, without consideration of costs or other non-risk factors, may present an unreasonable risk of injury to health or the environment because of a potential hazard and a potential route of exposure under the conditions of use, including an unreasonable risk to potentially exposed or susceptible subpopulations identified as relevant by EPA. Before designating prioritization status, under EPA's regulations at 40 CFR 702.9 and pursuant to TSCA section 6(b)(1)(A), EPA will generally use reasonably available information to screen the candidate chemical substance under its conditions of use against the following criteria and considerations: • the hazard and exposure potential of the chemical substance; • persistence and bioaccumulation; • potentially exposed or susceptible subpopulations; • storage near significant sources of drinking water; • conditions of use or significant changes in the conditions of use of the chemical substance; • the chemical substance's production volume or significant changes in production volume; and • other risk-based criteria that EPA determines to be relevant to the designation of the chemical substance's priority. This document presents the review of the candidate chemical substance against the criteria and considerations set forth in 40 CFR 702.9 for a may present risk finding. The information sources used are relevant to the criteria and considerations and consistent with the scientific standards of TSCA section 26(h), including, as appropriate, sources for hazard and exposure data listed in Appendices A and B of the TSCA Work Plan Chemicals: Methods Document (February 2012) (40 CFR 702.9(b)). EPA uses scientific information that is consistent with the best available science. Final designation of the chemical substance as a high-priority chemical substance would immediately initiate the risk evaluation process as described in the EPA's final rule, Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act (40 CFR 702). 1,1-Dichloroethane is one of the 40 chemical substances initiated for prioritization as referenced in the March 21, 2019 notice (84 FR 10491)2. EPA has determined that 1,1-dichloroethane is a suitable candidate for the proposed designation as a high-priority chemical substance. The proposed designation is based on the results of the review against the aforementioned criteria and considerations as well as review of the reasonably available information on 1,1-dichloroethane, including relevant information received from the public and other information as appropriate. 1 NOTE: For all 40 CFR 702 citations, please refer to: https://www. regulations. gov/document?D=EP A-HO-OPPT -2016-0654-0108 2 https://www.federalregister.gov/documents/2019/03/21/2019-05404/initiation-of-prioritization-under-the-toxic- subsfances-eontrol-act-fsca 1 ------- EPA will take comment on this proposed designation for 90 days before finalizing its designation of 1,1-dichloroethane. The docket number for providing comments on 1,1-dichloroethane is EPA-HQ-OPPT-2018-0426 and is available at www.regulations.gov. The information, analysis, and basis for the review of the chemical is organized as follows: • Section 1 (Introduction): This section explains the requirements of the amended TSCA and implementing regulations - including the criteria and considerations — pertinent to the prioritization and designation of high-priority chemical substances. • Section 2 (Production volume or significant changes in production volume): This section presents information and analysis on national aggregate production volume of the chemical substance. • Section 3 (Conditions of use or significant changes in conditions of use): This section presents information and analysis regarding the chemical substance's conditions of use under TSCA. • Section 4 (.Potentially exposed or susceptible subpopulations): This section presents information and analysis regarding potentially exposed or susceptible subpopulations, including children, women of reproductive age, and workers, with respect to the chemical substance. • Section 5 {Persistence and bioaccumulation): This section presents information and analysis regarding the physical and chemical properties of the chemical substance and the chemical's fate characteristics. • Section 6 (Storage near significant sources of drinking water): This section presents information and analysis considered regarding the risk from the storage of the chemical substance near significant sources of drinking water. • Section 7 {HazardPotential): This section presents the hazard information relevant to the chemical substance. • Section 8 {Exposure Potential): This section presents information and analysis regarding the exposures to the chemical substance. • Section 9 (Other risk-based criteria): This section presents the extent to which EPA identified other risk-based criteria that are relevant to the designation of the chemical substance's priority. • Section 10 (Proposed designation): Based on the results of the review performed and the information and analysis presented, this section describes the basis used by EPA to support the proposed designation. 2 ------- 2. Production volume or significant changes in production volume Approach EPA considered current volume or significant changes in volume of the chemical substance using information reported by manufacturers (including importers). EPA assembled reported information for years 1986 through 2015 on the production volume for 1,1-dichloroethane reported under the Inventory Update Reporting (IUR) rule and Chemical Data Reporting (CDR) rule.3 Results and Discussion The national aggregate production volume, which is presented as a range to protect individual site production volumes that are confidential business information (CBI), is presented in Table 1. Table 1.1986-2015 National Aggregate Production Volume Data (Production Volume in Pounds) Chemical ID 1986 1990 1994 1998 2002 2006 2011 2012 2013 2014 2015 1,1- Dichloroethane (75-34-3) >100M to 500M >100M to 500M >500K to 1M >lMto 10M >500K to 1M >100M to 500M >lMto 10M Withheld4 Withheld Withheld Withheld Note: K = thousand, M = million Reference: U.S. EPA (201.3) and U.S. EPA (201. Production volume of 1,1-dichloroethane as reported to EPA decreased from 1986 to 2011. Production volume from 2012 to 2015 was withheld5 (Table 1). 3 Over time, the requirements for reporting frequency, production volume thresholds, and chemical substances under the Chemical Data Reporting (CDR) rule have changed. CDR was formerly known as the Inventory Update Rule (IUR). The first IUR collection occurred in 1986 and continued every four years through 2006. As part of two rulemakings in 2003 and 2005, EPA made a variety of changes to the IUR, including to change the reporting frequency to every five years to address burdens associated with new reporting requirements. Additional changes to reporting requirements were made in 2011, including to suspend and replace the 2011 submission period with a 2012 submission period, return to reporting every four years, and require the reporting of all years beginning with 2011 production volumes. The reporting of production volumes for all years was added because of the mounting evidence that many chemical substances, even larger production volume chemical substances, often experience wide fluctuations in production volume from year to year. In addition, also as part of the 2011 IUR Modifications final rule (76 FR 50816, Aug 16, 2011), EPA changed the name of the regulation from IUR to CDR to better reflect the distinction between this data collection (which includes exposure-related data) and the TSCA Inventory itself (which only involves chemical identification information). 4 This information is withheld, because EPA is releasing the 2016 CDR data in stages. EPA released the initial 2016 CDR data in May 2017. The initial data included national production volume (released in ranges), other manufacturing information, and processing and use information, except for information claimed by the submitter to be confidential business information (CBI) or information that EPA is withholding to protect claims of CBI. EPA anticipates releasing additional data after completion of an effort to obtain CBI substantiation required by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which amended the Toxic Substances Control Act. 5 This information is withheld, because EPA is releasing the 2016 CDR data in stages. EPA released the initial 2016 CDR data in May 2017. The initial data included national production volume (released in ranges), other manufacturing information, and processing and use information, except for information claimed by the submitter to be confidential business information (CBI) or information that EPA is withholding to protect claims of CBI. EPA anticipates releasing additional data after completion of an effort to obtain CBI substantiation required by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which amended the Toxic Substances Control Act. 3 ------- 3. Conditions of use or significant changes in conditions of use Approach EPA assembled information to determine conditions of use or significant changes in conditions of use of the chemical substance. TSCA section 3(4) defines the term "conditions of use" to mean the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of. A key source of reasonably available information that EPA considered for determining the conditions of use for 1,1-dichloroethane was submitted by manufacturers (including importers) under the 2012 and 2016 CDR reporting cycles. CDR requires manufacturers (including importers) to report information on the chemical substances they produce domestically or import into the United States greater than 25,000 lbs per site, except if certain TSCA actions apply (in which case the reporting requirement is greater than 2,500 lbs per site). CDR includes information on the manufacturing, processing, and use of chemical substances. Based on the known manufacturing, processing and uses of this chemical, EPA assumes distribution in commerce. CDR may not provide information on other life-cycle phases such as distribution or chemical end-of-life after use in products (i.e., disposal). While EPA may be aware of additional uses, CDR submitters are not required to provide information on chemical uses that are not regulated under TSCA. For chemical substances under review that are included on the Toxics Release Inventory (TRI) chemical list, information disclosed by reporting facilities in Part II Section 3 ("Activities and Uses of the Toxic Chemical at the Facility") of their TRI Form R reports was used to supplement the CDR information on conditions of use (Tables 4, 5 and 6). There is not a one-to-one correlation between conditions of use reported under CDR and information reported in Part II Section 3 of the TRI Form R because facilities are not required to disclose in their Form R submissions the specific uses of TRI chemical substances they manufactured on-site or imported. In addition to the information disclosed in Part II Section 3 of the TRI Form R, the information pertaining to waste management activities (i.e., disposal/releases, energy recovery, recycling, and treatment) disclosed in other sections of the Form R was also used to supplement the CDR information on conditions of use as shown in Tables 4, 5 and 6. For purposes of this proposed prioritization designation, EPA assumed end-of-life pathways that include releases to air, wastewater, and solid and liquid waste based on the conditions of use. CDR and TRI Tables Based on the publicly available6 manufacturing information, industrial processing and use information, and consumer and commercial use information reported under CDR, EPA developed a list of conditions of use for the 2016 and 2012 reporting cycles (Table 2 and Table 3, respectively). 6 Some specific chemical uses may be claimed by CDR submitters as confidential business information (CBI) under section 14 of TSCA. In these cases, EPA has indicated that the information is CBI. 4 ------- Table 2.1,1-Dichloroethane (CASRN 75-34-3) Categories and Subcategories of Conditions of Use 7(2016 CD] i reporting cycle) Life-Cycle Stage Category Subcategory of Use Reference Manufacturing Domestic manufacturing Domestic manufacturing U.S. EPA (2019b) Processing As a reactant Intermediate in: - All other basic organic chemical manufacturing - All other chemical product and preparation manufacturing U.S. EPA (2019b) Processing Distribution in commerce Disposal Rec\cluiij Distribution in commerce Disposal ('1)1 a CDR includes information on the manufacturing, processing, and use of chemical substances. CDR may not provide information on other life-cycle phases such as distribution or chemical end-of-life after use in products (i.e., disposal). The table row is highlighted in gray to indicate that no information is provided for this life-cycle stage. b EPA is particularly interested in information from the public on distribution in commerce. Table 3.1,1-Dichloroethane (75-34-3) Categories and Subcategories of Conditions of Use9 (2012 CDR reporl ting cycle) Life-Cycle Stage Category Subcategory of Use Reference Manufacturing Domestic CBI10 U.S. EPA (2019b) manufacturing/Import Domestic manufacturing Domestic manufacturing U.S. EPA (2019b) Processing As a reactant Intermediate in all other basic organic chemical manufacturing U.S. EPA (2019b) Recycling CBI U.S. EPA (2019b) Distribution in Distribution in commerce commerce Disposal Disposal a CDR includes information on the manufacturing, processing, and use of chemical substances. CDR may not provide information on other life-cycle phases such as distribution or chemical end-of-life after use in products (i.e., disposal). The table row is highlighted in gray to indicate that no information is provided for this life-cycle stage. b EPA is particularly interested in information from the public on distribution in commerce. 7 Certain other uses that are excluded from TSCA are not captured in this table. 8 At this time, "CBI" indicates that a data element has been claimed CBI by the information submitter; it does not reflect the result of an EPA substantiation review. 9 Certain other uses that are excluded from TSCA are not captured in this table. 10 At this time, "CBI" indicates that a data element has been claimed CBI by the information submitter; it does not reflect the result of an EPA substantiation review. 5 ------- EPA used TRI data to identify additional conditions of use and to supplement CDR information about conditions of use. In addition, TRI information from 2017 is useful for demonstrating that a condition of use reported to CDR in 2015 is still ongoing. Table 4. Activities and Uses Reported to TRI for 1,1-Dichloroethane, Reporting Year 2011 Activity Type Activity Industry Group NAICS Code Manufacture Produce Basic Chemical Manufacturing 3251 Resin, Synthetic Rubber, and Artificial and Synthetic Fibers and Filaments Manufacturing 3252 Plastics Product Manufacturing 3261 Import Basic Chemical Manufacturing 3251 Produce or import for on-site use/processing Basic Chemical Manufacturing 3251 Resin, Synthetic Rubber, and Artificial and Synthetic Fibers and Filaments Manufacturing 3252 Produce or import for sale/distribution Basic Chemical Manufacturing 3251 Resin, Synthetic Rubber, and Artificial and Synthetic Fibers and Filaments Manufacturing 3252 Plastics Product Manufacturing 3261 Produce or import as a byproduct Basic Chemical Manufacturing 3251 Resin, Synthetic Rubber, and Artificial and Synthetic Fibers and Filaments Manufacturing 3252 Plastics Product Manufacturing 3261 Produce or import as an impurity Resin, Synthetic Rubber, and Artificial and Synthetic Fibers and Filaments Manufacturing 3252 Process Process as a reactant Basic Chemical Manufacturing 3251 Process as an impurity Resin, Synthetic Rubber, and Artificial and Synthetic Fibers and Filaments Manufacturing 3252 Otherwise Use Otherwise use - ancillary or other Basic Chemical Manufacturing 3251 use Resin, Synthetic Rubber, and Artificial and Synthetic Fibers and Filaments Manufacturing 3252 6 ------- Activity Type Activity Industry Group NAICS Code Cement and Concrete Product Manufacturing 3273 Waste Treatment and Disposal 5622 Waste Management Disposal/releases Basic Chemical Manufacturing 3251 Resin, Synthetic Rubber, and Artificial and Synthetic Fibers and Filaments Manufacturing 3252 Plastics Product Manufacturing 3261 Cement and Concrete Product Manufacturing 3273 Waste Treatment and Disposal 5622 Energy recovery Basic Chemical Manufacturing 3251 Resin, Synthetic Rubber, and Artificial and Synthetic Fibers and Filaments Manufacturing 3252 Cement and Concrete Product Manufacturing 3273 Waste Treatment and Disposal 5622 Recycling Basic Chemical Manufacturing 3251 Treatment Basic Chemical Manufacturing 3251 Resin, Synthetic Rubber, and Artificial and Synthetic Fibers and Filaments Manufacturing 3252 Plastics Product Manufacturing 3261 Waste Treatment and Disposal 5622 Reference: U.S. EPA. 201.9(1 Table 5. Activities and Uses Reported to TE J for 1,1-Dichloroethane, Reporting Year 2015 Activity Type Activity Industry Group NAICS Code Manufacture Produce Basic Chemical Manufacturing 3251 Resin, Synthetic Rubber, and Artificial and Synthetic Fibers and Filaments Manufacturing 3252 Import Basic Chemical Manufacturing 3251 Basic Chemical Manufacturing 3251 7 ------- Activity Type Activity Industry Group NAICS Code Produce or import for on-site use/processing Resin, Synthetic Rubber, and Artificial and Synthetic Fibers and Filaments Manufacturing 3252 Produce or import for sale/distribution Basic Chemical Manufacturing 3251 Resin, Synthetic Rubber, and Artificial and Synthetic Fibers and Filaments Manufacturing 3252 Produce or import as a byproduct Basic Chemical Manufacturing 3251 Resin, Synthetic Rubber, and Artificial and Synthetic Fibers and Filaments Manufacturing 3252 Produce or import as an impurity Resin, Synthetic Rubber, and Artificial and Synthetic Fibers and Filaments Manufacturing 3252 Process Process as a reactant Basic Chemical Manufacturing 3251 Process as an article component Resin, Synthetic Rubber, and Artificial and Synthetic Fibers and Filaments Manufacturing 3252 Process as an impurity Resin, Synthetic Rubber, and Artificial and Synthetic Fibers and Filaments Manufacturing 3252 Otherwise Use Otherwise use - ancillary or other Basic Chemical Manufacturing 3251 use Resin, Synthetic Rubber, and Artificial and Synthetic Fibers and Filaments Manufacturing 3252 Cement and Concrete Product Manufacturing 3273 Other Nonmetallic Mineral Product Manufacturing 3279 Waste Treatment and Disposal 5622 Waste Management Disposal/releases Basic Chemical Manufacturing 3251 Resin, Synthetic Rubber, and Artificial and Synthetic Fibers and Filaments Manufacturing 3252 Cement and Concrete Product Manufacturing 3273 Other Nonmetallic Mineral Product Manufacturing 3279 Waste Treatment and Disposal 5622 8 ------- Activity Type Activity Industry Group NAICS Code Energy recovery Basic Chemical Manufacturing 3251 Resin, Synthetic Rubber, and Artificial and Synthetic Fibers and Filaments Manufacturing 3252 Cement and Concrete Product Manufacturing 3273 Other Nonmetallic Mineral Product Manufacturing 3279 Recycling Basic Chemical Manufacturing 3251 Other Nonmetallic Mineral Product Manufacturing 3279 Treatment Basic Chemical Manufacturing 3251 Resin, Synthetic Rubber, and Artificial and Synthetic Fibers and Filaments Manufacturing 3252 Other Nonmetallic Mineral Product Manufacturing 3279 Waste Treatment and Disposal 5622 Reference: U.S. EPA. 20.1.9(1 Table 6. Activities and Uses Reported to T il for 1,1-Dichloroethane, Reporting Year 2017 Activity Type Activity Industry Group NAICS Code Manufacture Produce Basic Chemical Manufacturing 3251 Resin, Synthetic Rubber, and Artificial and Synthetic Fibers and Filaments Manufacturing 3252 Import Basic Chemical Manufacturing 3251 Produce or import for on-site use/processing Basic Chemical Manufacturing 3251 Resin, Synthetic Rubber, and Artificial and Synthetic Fibers and Filaments Manufacturing 3252 Produce or import for sale/distribution Basic Chemical Manufacturing 3251 Resin, Synthetic Rubber, and Artificial and Synthetic Fibers and Filaments Manufacturing 3252 Produce or import as a byproduct Basic Chemical Manufacturing 3251 9 ------- Activity Type Activity Industry Group NAICS Code Resin, Synthetic Rubber, and Artificial and Synthetic Fibers and Filaments Manufacturing 3252 Produce or import as an impurity Resin, Synthetic Rubber, and Artificial and Synthetic Fibers and Filaments Manufacturing 3252 Process Process as a reactant Basic Chemical Manufacturing 3251 Process as an article component Resin, Synthetic Rubber, and Artificial and Synthetic Fibers and Filaments Manufacturing 3252 Process as an impurity Resin, Synthetic Rubber, and Artificial and Synthetic Fibers and Filaments Manufacturing 3252 Otherwise Use Otherwise use - ancillary or other use Basic Chemical Manufacturing 3251 Resin, Synthetic Rubber, and Artificial and Synthetic Fibers and Filaments Manufacturing 3252 Other Nonmetallic Mineral Product Manufacturing 3279 Waste Treatment and Disposal 5622 Waste Disposal/releases Basic Chemical Manufacturing 3251 Management Resin, Synthetic Rubber, and Artificial and Synthetic Fibers and Filaments Manufacturing 3252 Other Nonmetallic Mineral Product Manufacturing 3279 Waste Treatment and Disposal 5622 Energy recovery Basic Chemical Manufacturing 3251 Resin, Synthetic Rubber, and Artificial and Synthetic Fibers and Filaments Manufacturing 3252 Other Nonmetallic Mineral Product Manufacturing 3279 Recycling Basic Chemical Manufacturing 3251 Treatment Basic Chemical Manufacturing 3251 Resin, Synthetic Rubber, and Artificial and Synthetic Fibers and Filaments Manufacturing 3252 10 ------- Activity Type Activity Industry Group NAICS Code Other Nonmetallic Mineral Product Manufacturing 3279 Waste Treatment and Disposal 5622 Reference: U.S. EPA. 201.9(1 CDR and TRI Summary and Additional Information on Conditions of Use For the 2016 CDR, 1,1-dichloroethane was not reported as used in the manufacture of commercial or consumer products. Two sites reported use of 1,1-dichloroethane as a reactant in basic organic chemical manufacturing and in chemical product and preparation manufacturing. One site reported that 1,1-dichloroethane was not recycled (e.g., not recycled, remanufactured, reprocessed, or reused) and one site reported this information as CBI.11 Between 2012 and 2016, the functional uses of 1,1-dichloroethane included processing as a reactant in basic organic chemical manufacturing and in chemical product and preparation manufacturing, as well as use in non-incorporative activities. Information on industrial use of 1,1-dichloroethane was withheld between 2012 and 2016 to protect claims of CBI.12 No consumer and commercial uses for 1,1-dichloroethane were reported to 2012 and 2016 CDR. Consumer uses were also identified in additional databases, which are included in the Exposure Potential section (Section 8). TRI data reported in Part II Section 3 of the TRI Form R ("Activities and Uses of the Toxic Chemical at the Facility") were compiled for Reporting Years (RY) 2011, 2015, and 2017. RY 2011, RY 2015, and RY 2017 reflect the chemical activities at reporting facilities in calendar years 2011, 2015, and 2017, respectively. Each facility filing a TRI Form R discloses activities that apply to the TRI chemical at the facility. The TRI data presented above are from the TRI dataset updated in April 2019. Tables 4, 5 and 6 present the activities and uses reported to TRI by industry group for 2011, 2015, and 2017. Waste management activity type includes all industry groups that reported to TRI using each waste management activity for 1,1- dichloroethane. During the first public comment period for the draft high-priority designation of 1,1- dichloroethane, one public comment states that specific aerospace industrial uses include, but may not be limited to, heat resistant adhesives for primary and secondary structural and external metallic airframe parts, intermediates for the synthesis of organics, dispersants for plastics and elastomers, components of fumigants and insecticides, low friction and anti-knock coatings, bond primers, as a component in paint and varnish and paint removers, as a component of degreasing and cleaning solvents, and as a reagent. The commenter also stated that 1,1- dichloroethane can be used as a constituent in adhesives, intermediates, dispersants, fumigants 11 At this time, "CBI" indicates that a data element has been claimed CBI by the information submitter; it does not reflect the result of an EPA substantiation review. 12 At this time, "CBI" indicates that a data element has been claimed CBI by the information submitter; it does not reflect the result of an EPA substantiation review. 11 ------- and insecticides, coatings and paint, paint removers, solvents, reagents, and as a constituent in making high vacuum rubber. (EPA-HQ-OPPT-2018-0426-0005). Should the Agency decide to make a final decision to designate this chemical substance as a high-priority substance, further characterization of relevant TSCA conditions of use will be undertaken as part of the process of developing the scope of the risk evaluation. 4. Potentially exposed or susceptible subpopulations Approach In this review, EPA considered reasonably available information to identify potentially exposed or susceptible subpopulations, such as children, women of reproductive age, workers, consumers or the elderly. EPA analyzed processing and use information included on the CDR Form U. These data provide an indication about whether children or other susceptible subpopulation may be potentially exposed. EPA also used human health hazard information to identify potentially exposed or susceptible subpopulations. Results and Discussion At this stage, EPA identified children, women of reproductive age, workers and consumers as subpopulations who may be potentially exposed or susceptible subpopulations for 1,1 -dichloroethane. Children EPA used data reported to the 2012 and 2016 CDR to identify uses in products and articles intended for children over time for 1,1 dichloroethane. The 2012 and 2016 CDR did not report any use in children's products. In the existing assessments reviewed, there was no discussion on the susceptibility of children to 1,1-dichloroethane. EPA also identified potential developmental hazards that would impact any stage of children's development. Women of reproductive age (e.g., pregnant women per TSCA statute) EPA identified studies that observed developmental effects following exposure to 1,1- dichloroethane (Section 7, Table 9). Although no reproductive hazards were identified, EPA considers women of reproductive age as potentially exposed. During the scoping and risk evaluation process, reproductive hazards will be considered again following a systematic search of the relevant scientific literature. Consideration of women of reproductive age as a potentially exposed or susceptible subpopulation was also based on exposure because women of reproductive age are potential workers in the manufacturing, processing, distribution in commerce, use, or disposal of the chemical substance. Workers Please refer to the Exposure Potential section (Section 8) for a summary of potential occupational exposures, which EPA indicates that workers are potentially exposed or susceptible subpopulations based on greater exposure. 12 ------- Consumers Please refer to the Exposure Potential section (Section 8) for a summary of potential consumer exposures, which EPA indicates that consumers are potentially exposed or susceptible subpopulations based on greater exposure. 5. Persistence and bioaccumulation Approach EPA reviewed reasonably available information, such as physical and chemical properties and environmental fate characteristics, to understand 1,1-dichloroethane's persistence and bioaccumulation. Physical and Chemical Properties and Environmental Fate Tables Tables 7 and 8 summarize the physical and chemical properties and environmental fate characteristics of 1,1-dichloroethane, respectively. Table 7. Physical and Chemical Properties of 1,1-Dichloroethane Property or Endpoint Value3 Reference Molecular Formula C2H4CI2 CRC Handbook (Rumble, 2018) Molecular Weight 98.959 g/mol CRC Handbook (Rumble, 2018) Physical State Liquid CRC Handbook (Rumble, 2018) Physical Form Colorless, oily liquid HSDB. 2018 citins NIOSH (2010) Purity Impurities include 0.02% ethyl chloride; 0.08% butylene oxide; 0.08%trichloroethylene; 0.01% ethylene dichloride; 0.14% unknown for reagent grade preparations HSDB. 2018 citins ITC (1980) Melting Point -96.9 °C PhvsProD Database (U.S. EPA. 2012c): ATSDR (2015) Boiling Point 57.4 °C PhvsProD Database (U.S. EPA. 2012c): ATSDR (20.1.5) 56.3 °C CRC Handbook (Rumble, 2018) Density 1.175 g/mL ATSDR (20.1.5) 1.1757 g/mL at 20 °C CRC Handbook (Rumble, 2018) Vapor Pressure 227.3 mm Hg at 25 °Cb Daubert and Danner (1989) 230 mm Hg at 25 °C ATSDR (20.1.5) 13 ------- Property or Endpoint Value3 Reference Vapor Density 3.44 (relative to air) HSDB (2018) citing Water Solubility 5,040 mg/L at 25 °Cb HSDB (2018) citing Horvath (1999) 0.55 g/100 g at 20 °C ATSDR (20.1.5) Log Kow 1.79 Hansch (1995); ATSDR (20.1.5) Henry's Law Constant 5.62 x 10 3 atm-m3/mol at 25 °Cb ATSDR (20.1.5); HSDB (20.1.8) citins Gossett (1987) 5.51 x 10 3 atm-m3/mol at 25 °C ATSDR (20.1.5) Flash Point -12 °C (closed cup); 14 °C (open cup) ATSDR (20.1.5) -17 °Cb (closed cup) HSDB (20.1.8) citins NFPA (2010) 14 °Cb (open cup) HSDB (20.1.8) citins Bingham (2001) Auto Flammability 457.8 °C (autoignition temperature)13 ATSDR (20.1.5); NFPA (2010) 470 °C (autoignition temperature) HSDB (20.1.8) citins Lewis and Sax (2004) Viscosity 0.464 mPa second at 25 °C; 0.362 mPa second at 50 °C HSDB (20.1.8) citins Haynes (2014) Refractive Index 1.4167 at 20 °C HSDB (20.1.8) citins Haynes (2014) Dielectric Constant 10.9 at 20 °C HSDB (20.1.8) citins Dreher (2014) Surface Tension 24.07 mN/m at 20 °C HSDB (20.1.8) citins Haynes (2014) Notes: "Measured unless otherwise noted; bSelected value Reference: (U.S. EPA. 20.1..9d) 14 ------- Table 8. Environmental Fate Characteristics of 1,1-Dichloroethane Property or Endpoint Value3 Reference Direct Photodegradation Not expected to be susceptible to direct photolysis by sunlight because 1,1- dichloroethane does not contain chromophores that absorb at wavelengths >290 nm HSDB (2018) citine Lvman (1990) Indirect Photodegradation ti/2 = 39 days (based on 12-hour day; 1.5 x 106 •OH/cm3 from -OH rate constant of 2.74 x 10" 13 cm3/molecules-second at 25 °C) PhvsProt) Database (U.S. EPA 2012c) citing Kwok and Atkinson (1994) Hydrolysis ti/2 = 61.3 years at 25 °C and pH 7 HSDB (20.1.8) citing Jeffers (1989) Biodegradation 31. l%/25 days reductive dechlorination to mainly chloroethane (14.5%) in sludge (anaerobic water) ATSDR (20.1.5) ti/2 >30-60 days (anaerobic soil) ATSDR (20.1.5): Wood (1985) 50%/7 days degradation and 19%/7 days evaporation at 5 ppm 1,1-dichloroethane and 29%/7 days degradation and 4%/7 days evaporation at 10 ppm (aerobic static- screening-flask test method with a municipal wastewater sewage inoculum) HSDB (20.1.8) citing Tabak (1981) Wastewater Treatment 72% total removal (9% by biodegradation, 62% by volatilization to air, 1% to sludge; estimated)13 U.S. EPA (20.1.2a) Bioconcentration Factor 7 (estimated)13 U.S. EPA (20.1.2a) Bioaccumulation Factor 6.8 (estimated)13 U.S. EPA (20.1.2a) Soil Organic Carbon:Water Partition Coefficient (Log Koc) 1.48 HSDB (20.1.8) citing Sabljic (1995) Notes: "Measured unless otherwise noted; bEPI Suite™ physical property inputs: Log K0w = 1.79, BP = 57.4 °C, MP = -96.9 °C, VP = 227 mmHg, WS = 5,040 mg/L, BioP = 120, BioA = 30 and BioS = 30, SMILES C(C1)(C1)C •OH = hydroxyl radical; OECD: Organisation for Economic Co-operation and Development; TG = test guideline; GC = gas chromatography; MITI = Ministry of International Trade and Industry; BOD = biochemical oxygen demand; HPLC = high performance liquid chromatography 15 ------- Results and Discussion 1,1-Dichloroethane is a volatile, highly water-soluble liquid (5,040 mg/L). Measured Henry's Law constant (5.62 x 10"3 atm-m3/mol) and vapor pressure (227.3 mm Hg) data indicate that this chemical will not be persistent in surface water and soil as it will likely volatilize upon release. In the air, 1,1-dichloroethane will likely exist in the vapor phase where it may react with photochemically produced hydroxyl radicals with an estimated half-life of 39 days. Given that the measured hydrolysis half-life for 1,1-dichloroethane is 61.3 years at pH 7, hydrolysis is not expected to be an important fate process for this chemical. 1,1-Dichloroethane may undergo some biodegradation under certain conditions. Under aerobic conditions, 29-50 percent 1,1-dichloroethane degraded over 7 days, and 4-19 percent was lost to evaporation in a static-screening-flask test using a municipal wastewater sewage inoculum. In anaerobic sludge, 31.1 percent 1,1-dichloroethane underwent reductive dichlorination over 25 days to yield chloroethane as the primary degradation product. Based on these results, 1,1-dichloroethane undergoes some biodegradation, but may persist in subsurface environments, groundwater, or enclosed pipes when volatilization is not an option. This chemical is expected to have low bioaccumulation potential based on its estimated bioconcentration factor and bioaccumulation factor of 7 and 6.8, respectively, along with its measured log Kow of 1.79. 6. Storage near significant sources of drinking water Approach To support the proposed designation, EPA screened each chemical substance under its conditions of use with respect to the seven criteria in TSCA section 6(b)(1)(A) and 40 CFR 702.9. The statute specifically requires the Agency to consider the chemical substance's storage near significant sources of drinking water, which EPA interprets as direction to focus on the chemical substance's potential human health hazard and exposure. EPA reviewed reasonably available information, specifically looking to identify certain types of existing regulations or protections for the proposed chemical substances. EPA considered the chemical substance's potential human health hazards, including to potentially exposed or susceptible subpopulations, by identifying existing National Primary Drinking Water Regulations under the Safe Drinking Water Act (40 CFR Part 141) and regulations under the Clean Water Act (CWA) (40 CFR 401.15). In addition, EPA considered the consolidated list of chemical substances subject to reporting requirements under the Emergency Planning and Community Right-to-Know Act (EPCRA; Section 302 Extremely Hazardous Substances and Section 313 Toxic Chemicals), the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA; Hazardous Substances), and the Clean Air Act (CAA) Section 112(r) (Regulated Chemicals for Accidental Release Prevention). Regulation by one of these authorities is an indication that the substance is a potential health or environmental hazard which, if released near a significant source of drinking water, could present an unreasonable risk of injury to human health or the environment. 16 ------- Results and Discussion 1,1-Dichloroethane is a Priority Pollutant under the CWA and is subject to reporting requirements under the EPCRA. It is also considered a CERCLA hazardous substance and releases in quantities equal to or greater than 1,000 pounds are subject to reporting to the National Response Center under CERCLA. 1,1-Dichloroethane is subject to the CAA 112(r) for storage near significant sources of drinking water. 1,1-Dichloroethane is also subject to the Resource Conservation and Recovery Act (RCRA; hazardous waste number U076). RCRA directs EPA to develop and promulgate criteria for identifying the characteristics of hazardous waste, and for listing hazardous waste, taking into account toxicity, persistence, and degradability in nature, potential for accumulation in tissue and other related factors such as flammability, corrosiveness, and other hazardous characteristics. 7. Hazard potential Approach EPA considered reasonably available information from peer-reviewed assessments and databases to identify potential human health and environmental hazards for 1,1-dichloroethane (Tables 9 and 10, respectively). Because there are very few publicly available assessments for 1,1-dichloroethane with cited environmental hazard data, EPA used the infrastructure of ECOTOXicology knowledgebase (ECOTOX) to identify single chemical toxicity data for aquatic and terrestrial life (U.S. EPA. 2018c). It used a comprehensive chemical-specific literature search of the open literature that was conducted according to the Standard Operating Procedures (SOPs)13. The environmental hazard information was populated in ECOTOX and available to the public. In comparison to the approach used to survey human health hazard data, EPA also used a read-across approach to identify additional environmental hazard data for isomers of 1,1-dichloroethane, if available, to fill in potential data gaps when there were no reported observed effects for specific taxa exposed to the 1,1-dichloroethane (Table 10). Potential Human Health and Environmental Hazard Tables EPA identified potential human health and environmental hazards based on a review of the reasonably available information for 1,1-dichloroethane (Tables 9 and 10, respectively). 13 The ECOTOX Standard Operating Procedures (SOPs) can be found at: https://cfpub.epa.gov/ecotox 17 ------- Table 9. Potential Human Health Hazards Identified for 1,1-Dichloroethane Human Health Hazards Tested for Specific Effect Effect Observed Data Source Acute Toxicity X X ATSDR (2015). NICNAS (2015). OEHHA (2003) Repeated Dose Toxicity X X ATSDR (2015). U.S. EPA (2006). NICNAS (2015). OEHHA (2003) Genetic Toxicity X X ATSDR (20.1.5). NICNAS (20.1.5). OEHHA (2003) Reproductive Toxicity Developmental Toxicity X X ATSDR (20.1.5). NICNAS (20.1.5). OEHHA (2003) Toxicokinetic X ATSDR (20.1.5). NICNAS (20.1.5). OEHHA (2003) Irritation/ Corrosion X X NICNAS (20.1.5) Dermal Sensitization X NICNAS (20.1.5) Respiratory Sensitization Carcinogenicity X X ATSDR (20.1.5). U.S. EPA (.1.990). U.S. EPA (2006). NICNAS (20.1.5). OEHHA (.1.992) OEHHA (2003). OEHHA (20.1.1). Immunotoxicity Neurotoxicity X X ATSDR (20.1.5). NICNAS (20.1.5). OEHHA (2003) Epidemiological Studies or Biomonitoring Studies X ATSDR (20.1.5) Note: The "X" in the "Effect Observed" column indicates when a hazard effect was reported by one or more of the referenced data sources. Blank rows indicate when information was not identified during EPA's review of reasonably available information to support the proposed designation. 18 ------- Table 10. Potential Environmental Hazards Identified for 1,1-Dichloroethane Isomers of 1,1-Dichloroethane High-Priority Chemical Candidate (CASRN 75-34-3) 1,2-Dichloroethane (CASRN 107-06-2) Media Study Duration Taxa Groups 1,1-Dichloroethane (CASRN 75-34-3) Data Sources Dichloroethane (CASRN 1300-21-6) Number Observed Number of Observed of Studies Effects Studies Effects Aquatic Acute Vegetation 1 X 2 X Tsai and Chen (2007); Wu et al. (2014) exposure Invertebrate Call et al. (1980); Foster and Tullis (1984); Foster and Tullis (1985); Freitag et al. (1994); Great Lakes Environment Center (2005); 1 X 14 X Kramer et al. (1983); LeBlanc (1980); Mayer and Ellersieck (1986); Price et al. (1974); Qureshi et al. (1982); Sanchez-Fortun et al. (1997); Sauvant et al. (1995a); Sauvant et al. (1995b); Sauvant et al. (1995c) Fish 1 X £ X Buccafusco et al. (1981); Geiger et al. (1985); Great Lakes Environment Center (2005); Heitmuller et al. (1981); Mayer and Ellersieck (1986); Walbridge et al. (1983) Non-Fish Vertebrates (i.e., amphibians, reptiles, mammals) - - Chronic Vegetation - - exposure Invertebrate - 1 X Call et al. (1980) Fish A X Ahmad et al. (1984); Barrows et al. (1980); Benoit et al. (1982); Black et al. (1982) Non-Fish Vertebrates Black etal. (1982) (i.e., amphibians, reptiles, mammals) - 2 X 19 ------- Isomers of 1,1-Dichloroethane High-Priority Chemical Candidate (CASRN 75-34-3) 1,2-Dichloroethane (CASRN 107-06-2) Media Study Duration Taxa Groups 1,1-Dichloroethane (CASRN 75-34-3) Data Sources Dichloroethane (CASRN 1300-21-6) Number Observed Number of Observed of Studies Effects Studies Effects Terrestrial Acute Vegetation 1 X 1 X Crebelli et al. (1988) exposure Invertebrate - 4 X Neuhauser et al. (1985); Bhatia and Bansode (1971); Bang and Telford (1966); Leesch (1984) Vertebrates A X Kitchin et al. (1993); Sasaki et al. (1998), Crebelli et al. (1999); Crebelli et al. (1995) Chronic Vegetation 1 X 2 X Lewis et al. (1979); Dietz and Schnoor (2001) exposure Invertebrate - 15 X Lindgren et al. (1954); Bang and Telford (1966); Punj (1970); Shivanandappa and Rajendran (1987); Jefferson (1942) Vertebrates - 1 X Witt et al. (2000) The dash indicates that no studies relevant for environmental hazard were identified during the initial review and thus the "Observed Effects" column is left blank. The "X" in the "Observed Effects" column indicates when a hazard effect was reported by one or more of the referenced studies. The "N/A" in the "Observed Effects" column indicates when a hazard effect was not reported by one of the referenced studies' abstract (full reference review has not been conducted). 20 ------- 8. Exposure potential Approach EPA considered reasonably available information to identify potential environmental, worker/occupational, consumer and general population exposures to 1,1-dichloroethane. Release potential for environmental and human health exposure In addition to other required information, a submission of a TRI Form R report must include the quantities of a TRI chemical the facility released on-site to air, water, or land, and the quantities it transferred off-site to another facility for further waste management. On-site release quantities are reported in Part II Section 5 of the TRI Form R, and off-site transfers are reported in Part II Section 6. Waste management activities include: transfers of a TRI chemical in wastewater to a publicly owned treatment works (POTW) facility or to a non-POTW wastewater treatment facility for the purpose of treatment for destruction or removal; combustion for energy recovery; treatment (treatment includes treatment via incineration for destruction and waste stabilization); recycling; and release, including disposal. During treatment, combustion for energy recovery, or recycling activities, it is possible that some of the quantities of the TRI chemical will be released to the environment. Worker/Occupational and consumer exposure EPA's approach for assessing exposure potential was to review the physical and chemical properties, conditions of use reported in CDR, and information from the National Institutes of Health Consumer Product Database and the Chemical and Products Database (CPDat) for 1,1- dichloroethane to inform occupational and consumer exposure potential. The results of this review are detailed in the following tables. General population exposure EPA identified environmental concentration, human and environmental biomonitoring data to inform 1,1-dichloroethane's exposure potential to the general population (Table 13). Results and Discussion Release potential for environmental and human health exposure Aggregated quantities of 1,1-dichloroethane released on-site to air, water, and land, and aggregated quantities of 1,1-dichloroethane transferred off-site to POTW and other wastewater treatment facilities (non-POTW) are presented in Table 11 for RY 2011, 2015, and 2017. The table does not include any of the reported quantities pertaining to other waste management activities (e.g., recycling, combustion for destruction) that occurred on-site or off-site during RY 2011, 2015, and 2017. The "Number of Facilities" is the count of unique facilities that filed a TRI Form R report for 1,1-Dichloroethane for RY 2011, 2015, and 2017. The TRI data presented were obtained from the TRI dataset following its update in April 2019. 21 ------- Table 11. The TRI Data on 1,1-Dichloroethane from Reporting Years 2011, 2015, and 2017 and Used in this Document to Assess Exposure Potential Year Number of Facilities That Reported Total Quantities Released On-Site to Air (pounds) Total Quantities Released On- Site to Water (pounds) Total Quantities Released (Disposed of) On-Site to Land (pounds) Total Quantities Transferred to POTW (pounds) Total Quantities Transferred to Other (Non- POTW) Wastewater Treatment Facilities (pounds) 2011 15 9,026 5 415 0 0 2015 18 9,361 2 1 0 0 2017 16 8,599 0 0 0 5 POTW = publicly owned treatment works Reference: U.S. EPA. 201.9(1 For RY 2017, sixteen facilities reported to TRI for 1,1-dichloroethane. The total quantities of 1,1-dichloroethane these facilities released on-site to air (as fugitive and stack emissions), surface water, and land are: 8,599 pounds; 0 pounds; and 0 pounds, respectively. These facilities reported zero pounds of the chemical transferred to POTW and 5 pounds transferred off-site to other non-POTW wastewater treatment facilities for the purpose of wastewater treatment. These transfer categories represent two types of off-site transfers for wastewater treatment that may lead to releases from the receiving facilities. They do not include quantities sent off-site for other types of waste management activities that include, or may lead to, releases of the chemical. Quantities transferred off-site represent the amount of a toxic chemical a facility sent off-site prior to any waste management (e.g., treatment) at a receiving facility. Some of the quantities of 1,1-dichloroethane received by the non-POTW wastewater treatment facilities may have been released to surface waters or to air during treatment processes at the facilities. 1,1-Dichloroethane has a vapor pressure of around 230 mm Hg at 25 °C. This chemical's vapor pressure indicates potential for air releases from volatilization during manufacturing, processing and use. Worker/Occupational exposure Worker exposures to this chemical may be affected by many factors, including but not limited to volume produced, processed, distributed, used and disposed of; physical form and concentration; processes of manufacture, processing, and use; chemical properties such as vapor pressure, solubility, and water partition coefficient; local temperature and humidity; and exposure controls such as engineering controls, administrative controls, and the existence of a personal protective equipment (PPE) program. 1,1-dichloroethane has an Occupational Safety and Health Administration (OSHA) Permissible Exposure Limit (PEL) 14 The PEL is 100 parts per million (ppm) or 450 milligrams (mg)/cubic 14 OSHA, 2009. Occupational Safety and Health Administration (OSHA) Permissible Exposure Limits (PELs). https://www.osha.gov/dsg/annotated-peis/tablez-l.html 22 ------- meter (m3) over an 8-hour work day, time weighted average (TWA). This chemical also has a National Institute for Occupational Safety and Health (NIOSH) Recommended Exposure Limit (REL)15 of 100 ppm (450 mg/m3) TWA. The American Conference of Governmental Industrial Hygienists (ACGIH) set the Threshold Limit Value (TLV) at 100 ppm TWA. 1,1-Dichloroethane has a vapor pressure of approximately 230 mm Hg at 25 °C/77 F. 1,1- Dichloroethane's vapor pressure indicates the potential for inhalation exposure to vapors generated by the liquid at ambient room temperature conditions. Consumer exposure The 2012 CDR, 2016 CDR, and the National Institutes of Health Consumer Product Database did not report on the use of 1,1-dichloroethane in consumer products. However, according to the Chemical and Products Database (CPDat) and ATSDR (20.1.5). 1,1-dichloroethane may be present in consumer products such as paint removers and fragrances (Table 12). Table 12. Exposure Information for Consumers Chemical Identity Consumer Product Database Consumer Uses (List) 1,1-Dichloroethane (75-34-3) Fragrance Reference: CPDat General population exposure 1,1-dichloroethane was reported in air, water, and soil/sediment environmental concentrations, as well as in human blood and aquatic, non-mammalian ecological biomonitoring data. A summary of the studies from peer-reviewed databases is presented in Table 13. Table 13. Exposure Information for the Environment and General Population Database Name Env. Concen. Data Present? Human Biomon. Data Present? Ecological Biomon. Data Present? Reference California Air Resources Board no no no C.ARB (2005) Comparative Toxicogenomics Database no no no MDI (2002) EPA Ambient Monitoring Technology Information Center - Air Toxics Data yes no no U.S. EPA (1.990b) EPA Discharge Monitoring Report Data yes no no U.S. EPA (2007) EPA Unregulated Contaminant Monitoring Rule yes no no U.S. EPA (.1.996) FDA Total Diet Study no no no FDA (199.1.) Great Lakes Environmental Database yes no no U.S. EPA (20.1.8d) 15 NIOSH, 2005. NIOSH Pocket Guide to Chemical Hazards. https://www.cdc.gov/niosIi/npg/npgdcas.html 23 ------- Database Name Env. Concen. Data Present? Human Biomon. Data Present? Ecological Biomon. Data Present? Reference Information Platform for Chemical Monitoring Data yes no no mmm International Council for the Exploration of the Sea no no no ICES (20.1.8) OECD Monitoring Database no no no OECD (20.1.8) Targeted National Sewage Sludge Survey no no no U.S. EPA (2006b) The National Health and Nutrition Examination Survey no yes no C°C .20.31 USGS Monitoring Data -National Water Quality Monitoring Council no no no USGS (1991a) USGS Monitoring Data -National Water Quality Monitoring Council, Air yes no no USGS (1991b) USGS Monitoring Data -National Water Quality Monitoring Council, Ground Water yes no no USGS (1991c) USGS Monitoring Data -National Water Quality Monitoring Council, Sediment yes no no USGS (.1.99.1.(1) USGS Monitoring Data -National Water Quality Monitoring Council, Soil yes no no USGS (1991e) USGS Monitoring Data -National Water Quality Monitoring Council, Surface Water yes no no USGS (199If) USGS Monitoring Data -National Water Quality Monitoring Council, Tissue no no yes USGS (1991 e) a Concen.= concentration b Biomon.= biomonitoring EPA anticipates releases of 1,1-dichloroethane into the environment because of the conditions of use for 1,1-dichloroethane, particularly activities associated with its production and use as a solvent, cleaning agent, degreaser and its use as an intermediate in the manufacturing of 1,1,1- trichloroethane, vinyl chloride, and high-vacuum rubber. Releases of 1,1-dichloroethane from certain conditions of use, such as manufacturing, disposal, or hazardous waste treatment activities, may result in general population exposures, mostly via inhalation of ambient air and ingestion of contaminated drinking water near emission sources, whereas presence in food sources is considered very unlikely ( PR 20.1.5, CalEPA 20031 Based on fate properties, such as vapor pressure, Henry's Law constant, soil mobility and water solubility, EPA anticipates possible presence of 1,1-dichloroethane in ambient air, and to a lesser extent in surface water, groundwater, and soil (ATSDR20.1.5. RIVM 20071 Existing assessments reported 1,1-dichloroethane in ambient air, waste gas from garbage dumps, surface water, groundwater, drinking water, and other environmental media (ATSDR 20.1.5. CalEPA 20031 24 ------- 9. Other risk-based criteria that EPA determines to be relevant to the designation of the chemical substance's priority EPA did not identify other risk-based criteria relevant to the designation of the chemical substance's priority. 10. Proposed designation and Rationale Proposed designation: High-priority substance Rationale: EPA identified and analyzed reasonably available information for exposure and hazard and is proposing to find that 1,1-dichloroethane may present an unreasonable risk of injury to health and/or the environment, including potentially exposed or susceptible subpopulations, (e.g., workers, consumers, women of reproductive age, children). This is based on the potential hazard and potential exposure of 1,1-dichloroethane under the conditions of use described in this document to support the prioritization designation. Specifically, EPA expects that the manufacturing, processing, distribution, use and disposal of 1,1-dichloroethane may result in presence of the chemical in surface water and groundwater, ingestion of the chemical in drinking water, inhalation of the chemical from air releases, and exposure to workers and exposure to the general population, including exposure to children. In addition, EPA identified potential environmental (e.g., aquatic toxicity, terrestrial toxicity), and human health hazards (e.g., acute toxicity, repeated dose toxicity, genetic toxicity, developmental toxicity, irritation/corrosion, carcinogenicity, and neurotoxicity). 25 ------- 11. References *Note: All hyperlinked in-text citations are also listed below * Ahmad, N; Benoit, D; Brooke, L; Call, D; Carlson, A; Defoe, D; Huot, J; Moriarity, A; Richter, J; Shubat, P; Veith, G; Wallbridge, C. (1984). Aquatic toxicity tests to characterize the hazard of volatile organic chemicals in water: A toxicity data summary—Parts I and II (pp. 103). (EPA 600/3-84-009). Duluth, MN: U.S. Environmental Protection Agency. ATSDR (Agency for Toxic Substances and Disease Registry). (2015). Toxicological profile for 1,1-dichloroethane. Atlanta, GA: U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry. https ://www.atsdr. cdc. gov/T oxProftk f Bang, YH; Telford, HS. (1966). Effect of sublethal doses of fumigants on stored-grain insects (pp. 22 p.). Pullman, WA: Washington University. Barrows, ME; Petrocelli, SR; Macek, KJ; Carroll, JJ. (1980). Bioconcentration and elimination of selected water pollutants by bluegill sunfish (Lepomis macrochirus). In R Haque (Ed.), (pp. 379-392). Ann Arbor, MI: Ann Arbor Science. Benoit, DA; Puglisi, FA; Olson, DL. (1982). A fathead minnow Pimephales promelas early life stage toxicity test method evaluation and exposure to four organic chemicals. Environmental Pollution - Series A: Ecological and Biological 28: 189-197. http://dx.doi.ore _ >143- 190075-7 Bhatia, SK; Bansode, PC. (1971). Studies on resistance to insecticides in Tribolium castaneum (Herbst). IV. Susceptibility of p,p'-DDT-resistant strain to some fumigants. Indian Journal of Entomology 33: 45-49. Bingham, E; Cohrssen, B; Powell, CH. (2001). Patty's toxicology. In E Bingham; B Cohrssen; CH Powell (Eds.), (5th ed.). Hoboken, NJ: John Wiley & Sons. http://dx.doi.ore *PQ2/0 i I II 5474 Black, JA; Birge, WJ; McDonnell, WE; Westerman, AG; Ramey, BA; Bruser, DM. (1982). The aquatic toxicity of organic compounds to embryo-larval stages of fish and amphibians. (Research Report No. 133). Lexington, KY: University of Kentucky. Buccafusco, RJ; Ells, SJ; LeBlanc, GA. (1981). Acute toxicity of priority pollutants to bluegill (Lepomis macrochirus). 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