FINAL REPORT of the Small Business Advocacy Review Panel on EPA's Planned Proposed Rule Toxic Substances Control Act (TSCA) Section 6(a) for N-Methylpyrrolidone (NMP) September 14, 2023 ------- Table of Contents 1. INTRODUCTION 4 2. BACKGROUND AND DESCRIPTION OF RULEMAKING 5 2.1 Risk Evaluation for NMP 5 2.2 Regulatory History 9 2.3. Estimates of Exposed Populations 10 2.4. Description of Section 6(a) Regulatory Options and Scope 11 2.5. Overview of Options under Consideration 12 2.5.1 Concentration limit 13 2.5.2 Prescriptive Engineering or Administrative Controls 14 2.5.3 Prescriptive Personal Protective Equipment (PPE) 14 2.5.4 Combination of Controls (non-prescriptive) 15 2.5.5 Prohibition of manufacturing (including import), processing, and/or distribution 15 2.5.6 Recordkeeping, downstream notification, and other support for implementation 16 3. APPLICABLE SMALL ENTITY DEFINITIONS 17 4. SMALL ENTITIES THAT MAY BE SUBJECT TO THE PROPOSED REGULATION 17 5. LIST OF SMALL ENTITY REPRESENTATIVES 28 6. SUMMARY OF SMALL ENTITY OUTREACH 29 7. SUMMARY OF COMMENTS FROM SMALL ENTITY REPRESENTATIVES 30 7.1. Summary of the Pre-Panel Outreach Meeting Discussion 30 7.1.1. Number and Types of Entities Affected 30 7.1.2. Potential Reporting, Recordkeeping, and Compliance Requirements 31 7.1.3. Related Federal Rules 33 7.1.4. Regulatory Flexibility Alternatives 33 7.2. Summary of Written Comments Following the Pre-Panel Outreach Meeting 33 7.2.1. Number and Types of Entities Affected 34 7.2.2. Potential Reporting, Recordkeeping, and Compliance Requirements 34 7.2.3. Related Federal Rules 35 7.2.4. Regulatory Flexibility Alternatives 35 7.3. Summary of the Panel Outreach Meeting Discussion 35 2 ------- 7.3.1. Number and Types of Entities Affected 35 7.3.2. Potential Reporting, Recordkeeping, and Compliance Requirements 36 7.3.3. Related Federal Rules 36 7.3.4. Regulatory Flexibility Alternatives 36 7.4. Summary of Written Comments Following the Panel Outreach Meeting 37 8. PANEL FINDINGS AND DISCUSSION 38 8.1. Number and Types of Entities Affected 38 8.2. Potential Reporting, Recordkeeping, and Compliance Requirements 38 8.3. Related Federal Rules 38 8.4. Regulatory Flexibility Alternatives 39 APPENDIX A: Materials Shared with Small Entity Representatives for the Pre-Panel and Panel Outreach Meetings 42 APPENDIX B: Written Comments Submitted by Small Entity Representatives following the Pre-Panel and Panel Outreach Meetings 43 3 ------- 1. INTRODUCTION This report is presented by the Small Business Advocacy Review Panel (SBAR Panel or Panel) that convened to review the planned proposed rulemaking by the U.S. Environmental Protection Agency (EPA) under section 6(a) of the Toxic Substances Control Act (TSCA) to regulate n-methylpyrrolidone (NMP), which was the subject of a TSCA risk evaluation under section 6(b). Section 6 of TSCA requires that EPA issue regulations to address identified unreasonable risks resulting from the manufacture (including import), processing, distribution in commerce, or use of the chemical, as well as any manner or method of disposal of NMP. Section 609(b) of the Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), requires EPA to convene a Panel prior to publication of the initial regulatory flexibility analysis (IRFA) that EPA may be required to prepare under the RFA. In addition to EPA's Small Business Advocacy Chairperson, the Panel consists of the Deputy Director of the Office of Pollution Prevention and Toxics, the Administrator of the Office of Information and Regulatory Affairs within the Office of Management and Budget, and the Chief Counsel for Advocacy of the Small Business Administration. This report includes the following: • Background information on the proposed rule being developed; • Information on the types of small entities that may be subject to the proposed rule; • A description of efforts made to obtain the advice and recommendations of representatives of those small entities; and • A summary of the comments that have been received to date from those representatives. Section 609(b) of the RFA directs the Panel to consult with and report on the comments of small entity representatives (SERs) and make findings on issues related to elements of an IRFA under section 603 of the RFA. Those elements of an IRFA are: • A description of, and where feasible, an estimate of the number of small entities to which the proposed rule will apply; • A description of projected reporting, record keeping, and other compliance requirements of the proposed rule, including an estimate of the classes of small entities which will be subject to the requirement and the type of professional skills necessary for preparation of the report or record; • An identification, to the extent practicable, of all relevant Federal rules which may duplicate, overlap, or conflict with the proposed rule; and • A description of any significant alternatives to the proposed rule which accomplish the stated objectives of applicable statutes and which minimize any significant economic impact of the proposed rule on small entities. This analysis shall discuss any significant alternatives such as: o the establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; o the clarification, consolidation, or simplification of compliance and reporting requirements under the rule for such small entities; o the use of performance rather than design standards; and o an exemption from coverage of the rule, or any part thereof, for such small entities. 4 ------- Once completed, the Panel report is provided to the agency issuing the proposed rule and is included in the rulemaking record. The agency is to consider the Panel's findings when completing the draft of the proposed rule. In light of the Panel report, and where appropriate, the agency is also to consider whether changes are needed to the IRFA for the proposed rule or the decision on whether an IRFA is required. The Panel's findings and discussion are based on the information available at the time the final report is drafted. Given EPA's ongoing consideration of exposure pathways such as ambient air and drinking water to the general population and fenceline communities, there is a chance that some impacts of the proposed rulemaking may not have been fully considered by the Panel during its work. If EPA considers additional requirements impacting small businesses related to exposure pathways that were not presented to Small Entity Representatives (SERs) during the Panel Outreach meeting, then EPA will determine whether those additional requirements may have a significant impact on a substantial number of small entities. Under these unique circumstances, EPA would organize a supplemental opportunity for the Panel to consult with the SERs and additional small entities that might be significantly impacted prior the rule's proposal. EPA continues to conduct analyses relevant to the proposed rule, and additional information may be developed or obtained during the remainder of the rule development process. Any options identified by the Panel for reducing the rule's regulatory impact on small entities may require further analysis and/or data collection to ensure that the options are practicable, enforceable, environmentally sound, and consistent with TSCA and its amendments. 2. BACKGROUND AND DESCRIPTION OF RULEMAKING 2,1 Risk Evaluation for NMP In December 2016, EPA selected NMP as one of the first 10 chemicals for risk evaluation under section 6 of TSCA. EPA published the risk evaluation for NMP in December 2020. The risk evaluation as conducted pursuant to TSCA, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which requires EPA to conduct risk evaluations "to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non- risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant to the risk evaluation by the Administrator, under the conditions of use." EPA published the scope of the risk evaluation document1 in July 2017 (82 FR 31592, July 7, 2017), the NMP problem formulation document2 in June 2018 (83 FR 26998, June 11, 2018), and the NMP draft risk evaluation3in November 2019 (84 FR 60087, November 11, 2019). EPA held a peer review meeting of the Science Advisory Committee on Chemicals (SACC) on the draft risk evaluation of NMP in December 2019. Public comments and external scientific peer review informed the development of the NMP risk evaluation4 (85 FR 86558, December 30, 2020). With input from comments and peer review, EPA published a draft revision to the risk determination for the NMP risk evaluation in July 2022 (87 FR 39511, July 1, 2022) and a final revised unreasonable risk determination for NMP as a whole chemical substance 1 Available at https://www.regulations.gov/document/EPA-HQ-OPPT-2016-0743-0061. 2 Available at https://www.regulations.gov/document/EPA-HQ-QPPT-2016-0743-0076. 3 Available at https://www.regulations.gov/document/EPA-HQ-QPPT-2019-0236-0017. "Available at https://www.regulations.gov/document/EPA-HQ-QPPT-2019-0236-0081. 5 ------- in December 2022s (87 FR 77596, December 19, 2020). In the 2020 Risk Evaluation for NMP, EPA evaluated risks associated with 37 conditions of use within the following categories: manufacture (including import), processing, distribution in commerce, industrial and commercial use, consumer use, and disposal. The 2020 Risk Evaluation for NMP identified significant adverse health effects associated with exposure to NMP, including risks of developmental toxicity from acute inhalation and dermal exposures and reproductive toxicity from chronic inhalation and dermal exposures. Additional risks associated with other adverse effects (e.g., liver toxicity, kidney toxicity, immunotoxicity, neurotoxicity, irritation and sensitization) were identified for acute and chronic inhalation and dermal exposures. The 2020 Risk Evaluation for NMP evaluated inhalation and dermal exposures together, rather than separately. The resulting risk characterization is described in section 4 of the 2020 Risk Evaluation. Section 4.3.7 provides details on how the unreasonable risk identified for NMP from the combined dermal, inhalation, and vapor-through-skin exposures are primarily driven by direct dermal contact with liquid NMP. Small business may be regulated under all conditions of use that drive EPA's unreasonable risk determination for NMP. EPA's unreasonable risk determination for NMP is based on unreasonable risk of injury to health for workers and to consumers from consumer use. EPA did not identify an unreasonable risk of injury to the environment from NMP under the conditions of use. On June 30, 2021, EPA announced policy indicating that EPA intends to move forward by revisiting the risk evaluations for the first ten chemical substances within a narrow scope that is supported by science and the law, including: • Consideration of exposure pathways such as ambient air and drinking water to the general population and fenceline communities; • Revisiting the assumption that personal protective equipment (PPE) is always used in occupational settings when making a risk determination for a chemical. Rather, EPA will no longer assume that PPE is always used when determining whether a chemical substance presents unreasonable risk; and • Making the determination of unreasonable risk for the whole chemical rather than on a condition of use basis. EPA will continue to provide risk calculations with no PPE and with various levels of PPE in the risk characterization section of the risk evaluation to help inform possible risk management options. EPA has moved forward with the final revised risk determination for NMP, which determines that NMP, as a whole chemical substance, presents an unreasonable risk of injury to health under the conditions of use. This revision, published on December 19, 2022 (87 FR 77596), supersedes the condition of use- specific risk determination in the December 2020 NMP risk evaluation. The final revised risk determination does not reflect an assumption that all workers always appropriately wear PPE. EPA understands that there could be adequate occupational safety protections in place at certain workplace locations; however, not assuming use of PPE reflects EPA's recognition that unreasonable risk may exist 5 The final risk evaluation and supplemental materials are in docket EPA-HQ-OPPT-2019-0236, with the July 2022 draft revised unreasonable risk determination, December 2022 final revised unreasonable risk determination, and additional materials supporting the risk evaluation process in docket EPA-HQ-OPPT-2016- 0743, on www.regulations.gov. 6 ------- for subpopulations of workers that may be highly exposed because they are not covered by OSHA standards. In the case of NMP, OSHA has not issued a chemical-specific permissible exposure limit (PEL). As a result of this revision, removing the assumption that workers always and appropriately wear PPE means that three additional conditions of use in addition to the original 26 drive the unreasonable risk for NMP, and for five conditions of use, acute effects in addition to chronic effects also drive the unreasonable risk to workers. As described in the final revised unreasonable risk determination, 29 conditions of use (three in addition to the 26 conditions of use identified in the December 2020 risk evaluation) drive the unreasonable risk determination for NMP, listed below: • Domestic manufacture • Manufacture: import • Processing: as a reactant or intermediate in plastic material and resin manufacturing and other non-incorporative processing • Processing: incorporation into a formulation, mixture or reaction product in multiple industrial sectors • Processing: incorporation into articles in lubricants and lubricant additives in machinery manufacturing • Processing: incorporation into articles in paint additives and coating additives not described by other codes in transportation equipment manufacturing • Processing: incorporation into articles as a solvent (which becomes part of product formulation or mixture), including in textiles, apparel and leather manufacturing • Processing: incorporation into articles in other sectors, including in plastic product manufacturing • Processing: repackaging in wholesale and retail trade • Processing: recycling • Industrial and commercial use in paints, coatings, and, adhesive removers • Industrial and commercial use in paints and coatings in lacquers, stains, varnishes, primers and floor finishes, and powder coatings, surface preparation • Industrial and commercial use in paint additives and coating additives not described by other codes in computer and electronic product manufacturing in electronic parts manufacturing • Industrial and commercial use in paint additives and coating additives not described by other codes in computer and electronic product manufacturing for use in semiconductor manufacturing • Industrial and commercial use in in paint additives and coating additives not described by other codes in several manufacturing sectors • Industrial and commercial use as a solvent (for cleaning or degreasing) use in electrical equipment, appliance and component manufacturing 7 ------- • Industrial and commercial use as a solvent (for cleaning or degreasing) in electrical equipment, appliance and component manufacturing for use in semiconductor manufacturing • Industrial and commercial use in ink, toner, and colorant products in printer ink and inks in writing equipment • Industrial and commercial use in processing aids, specific to petroleum production in petrochemical manufacturing, in other uses in oil and gas drilling, extraction and support activities, and in functional fluids (closed systems) • Industrial and commercial use in adhesives and sealants including binding agents, single component glues and adhesives, including lubricant adhesives, and two-component glues and adhesives including some resins • Industrial and commercial use in other uses in soldering materials • Industrial and commercial use in other uses in anti-freeze and de-icing products, automotive care products, and lubricants and greases • Industrial and commercial use in other uses in metal products not covered elsewhere, and lubricant and lubricant additives including hydrophilic coatings • Industrial and commercial use in other uses in laboratory chemicals • Industrial and commercial uses in other uses in lithium ion battery manufacturing • Industrial and commercial use in other uses in cleaning and furniture care products, including wood cleaners and gasket removers • Industrial and commercial use in other uses in fertilizer and other agricultural chemical manufacturing, processing aids and solvents • Consumer use in adhesives and sealants in glues and adhesives, including lubricant adhesives and sealants • Disposal The following conditions of use do not drive EPA's unreasonable risk determination for NMP: • Distribution in commerce • Consumer use in paint and coating removers • Consumer use in adhesive removers • Consumer use in paints and coatings in lacquers, stains, varnishes, primers and floor finishes • Consumer use in paint additives and coating additives not described by other codes in paints and arts and crafts paints • Consumer use in other uses in automotive car products • Consumer use in other uses in cleaning and furniture care products, including wood cleaners and gasket removers • Consumer use in other uses in lubricant and lubricant additives, including hydrophilic coatings 8 ------- 2,2 Regulatory History NMP is subject to several Federal laws and regulations in the United States and is also subject to regulatory actions by States and other countries. A summary of the regulatory history for NMP and a list of related regulations (EPA, Federal, State, and International) for NMP is provided in this section. Actions under EPA pertaining to NMP include: • Toxics Substances Control Act (TSCA) - Section 6(b): EPA is directed to identify and begin risk evaluations on 10 chemical substances drawn from the 2014 update of the TSCA Work Plan for Chemical Assessments. NMP is on the initial list of chemicals evaluated for unreasonable risk under TSCA (81 FR 91927, December 19, 2016). • Toxics Substances Control Act (TSCA) - Section 8(a): The TSCA Section 8(a) Chemical Data Reporting (CDR) Rule requires manufacturers (including importers) to give EPA basic exposure- related information on the types, quantities and uses of chemical substances produced domestically and imported into the United States. NMP manufacturing (including importing), processing, and use information is reported under the CDR rule (76 FR 50816, August 16, 2011). • Federal Food, Drug, and Cosmetic Act (FFDCA) and Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA): NMP is currently approved for use as a solvent and co-solvent inert ingredient in pesticide formulations for both food and non-food uses and is exempt from the requirements of a tolerance limit (40 CFR Part 180.920). • Clean Air Act (CAA): Clean Air Act (CAA): NMP is subject to CAA Section 111 Standards of Performance for New Stationary Sources of Air Pollutants for volatile organic compound (VOC) emissions from synthetic organic chemical manufacturing industry distillation operations (40 CFR Part 60, subpart NNN) and reactor processes (40 CFR Part 60, Subpart RRR). This rule applies only to sources constructed after 1983 and includes the production of NMP. EPA expects that facilities included in the risk evaluation already meet this standard. NMP is also listed under the National Volatile Organic Compound Emission Standards for Aerosol Coatings (40 CFR part 59, subpart E). This is a content-based limit confined to manufacturers of aerosol coating products. Under EPA's SNAP program, EPA listed NMP as an acceptable substitute for "straight organic solvent cleaning (with terpenes, C620 petroleum hydrocarbons, oxygenated organic solvents such as ketones, esters, alcohols, etc.)" for metals, electronics and precision cleaning and "Oxygenated organic solvents (esters, ethers, alcohols, ketones)" for aerosol solvents (59 FR, March 18, 1994). • Safe Drinking Water Act (SDWA): NMP was identified on both the Third (2009) and Fourth (2016) Contaminant Candidate Lists (74 FR 51850, October 8, 2009) (81 FR 81099 November 17, 2016). NMP was not identified on the proposed Fifth Contaminant Candidate List (86 FR 37948, July 19, 2021). Other Federal actions pertaining to NMP include: • FFDCA: Food and Drug Administration identifies NMP as an "Indirect Additive Used in Food Contact Substances" specifically as: 1) an adjuvant substance in the preparation of slimicides (21 CFR 176.300), 2) an adjuvant substance in the production of polysulfone resin authorized for use as articles intended for use in contact with food (21 CFR 177.1655) and 3) a residual solvent in polyetherone sulfone resins authorized as articles for repeated use in contact with food (21 CFR 177.2440). FDA also identifies NMP as a Class 2 solvent, namely a solvent that "should be limited in pharmaceutical products because of their inherent toxicity." 9 ------- • Federal Hazardous Material Transportation Act (HMTA): The Department of Transportation (DOT) has designated NMP as a hazardous material, and there are special requirements for marking, labeling and transporting it (49 CFR Part 171, 49 CFR 172, 40 CFR § 173.202 and 40 CFR § 173.242). State actions pertaining to NMP include: • Two states, New Hampshire and Vermont list NMP in state air regulations. New Hampshire lists NMP as a regulated toxic air pollutant (Env-A 1400: Regulated Toxic Air Pollutants) and Vermont lists NMP as a hazardous air contaminant (Vermont air Pollution Control Regulations, 5261). • California has a permissible exposure limit (PEL) for NMP of 1 part per million (ppm) as an 8- hr-time-weighted average (TWA) along with a skin notation for NMP (California Code of Regulations, title 8, section 5155). California also lists NMP on Proposition 65 due to reproductive toxicity (Cal. Code Regs. Title 27, Section 27001). California's Office of Environmental Health Hazard Assessment (OEHHA) lists a Maximum Allowable Dose Level (MADL) for inhalation exposure = 3,200 micrograms per day (ng/day) and MADLfor dermal exposure = 17,000 ng/day. The California Department of Toxic Substances Control (DTSC) Safer Consumer Products Program lists NMP as a Candidate Chemical for development toxicity and reproductive toxicity. In 2006, the California Department of Public Health's Hazard Evaluation System and Information Service (HESIS) issued a Health Hazard Advisory on NMP and updated the Advisory in June 2014. The Advisory is aimed at workers and employers at sites where NMP is used. • Several other states have adopted reporting laws for chemicals in children's products that include NMP. Minnesota has listed NMP as a chemical of concern to children (Minnesota Statutes 116.9401 to 116.9407). International actions pertaining to NMP include: • In 2011, NMP was listed on the Candidate list as a Substance of Very High Concern (SVHC) under regulation (EC) No 1907/2006 to the Regulation, Evaluation, Authorisation and Restriction of Chemicals (REACH). In 2018 the European Union added NMP to REACH Annex XVII, the restricted substances list. The restriction includes three conditions: that NMP shall not be placed on the market above 0.3% unless users have chemical safety reports and SDSs with set inhalation and dermal Derived No-Effect Levels (DNELs); NMP shall not be used above 0.3% unless appropriate risk management measures ensure that the exposure of workers is below the DNELs; and an exclusion from the regulation until May 9, 2024, for the use of NMP as a solvent or reactant in the process of coating wires. • Several countries, including Australia, Belgium, Canada, Finland, Poland, and Spain have occupational exposure limits (OELs) for NMP (GESTIS International limit values for chemical agents OELs database, Accessed April 12, 2023). 2,3, Estimates of Exposed Populations Populations exposed to NMP include workers and consumers using products containing NMP. EPA estimates the exposed population includes 199,428 workers. The number of consumers that use products containing NMP each year is unknown. For the conditions of use that drive the unreasonable risk, EPA has identified industry sectors that are 10 ------- likely affected (see Table 4.1), and the number of entities associated with those sectors (see Table 4.2). EPA estimates that the proposed rulemaking would affect approximately 63,748 small entities. Most (26,017) of these small entities are commercial users of NMP in fertilizer and other agricultural chemical manufacturing and application. EPA also estimates that 13,198 of these small entities use NMP in paints and coatings applications, 6,814 of these small entities use NMP in adhesives and sealants, 3,886 of these small entities use NMP in paint, coating, and adhesive removers, and 3,266 of these small entities use NMP for electronic product and semiconductor manufacturing. Additional estimates are provided in Table 4.2. 2,4, Description of Sectii sgulatory Options and Scope EPA is developing a proposed regulation under section 6(a) of TSCA to address the unreasonable risk of the chemical substance NMP so that NMP no longer presents an unreasonable risk under the conditions of use. As explained above, based on the December 2020 Risk Evaluation for NMP, on December 19, 2022 (87 FR 77596), EPA determined that NMP as a whole chemical substance presents an unreasonable risk, driven by 29 conditions of use. EPA is considering an array of approaches under TSCA section 6(a) to determine which option will address the unreasonable risk from NMP. Table 2.4.1 below summarizes regulatory requirements EPA can utilize, separately or in combination, under TSCA section 6(a). Table 2.4.1. Regulatory Requirements Available under TSCA Section 6(a) TSCA Section Option 6(a)(1) A requirement (A) prohibiting the manufacturing, processing, or distribution in commerce of such substance or mixture, or (B) limiting the amount of such substance or mixture which may be manufactured, processed, or distributed in commerce. 6(a)(2) A requirement (A) prohibiting the manufacture, processing, or distribution in commerce of such substance or mixture for (i) a particular use or (ii) a particular use in a concentration in excess of a level specified by the Administrator in the rule imposing the requirement, or (B) limiting the amount of such substance or mixture which may be manufactured, processed, or distributed in commerce for (i) a particular use or (ii) a particular use in a concentration in excess of a level specified by the Administrator in the rule imposing the requirement. 6(a)(3) A requirement that such substance or mixture or any article containing such substance or mixture be marked with or accompanied by clear and adequate warnings and instructions with respect to its use, distribution in commerce, or disposal or with respect to any combination of such activities. The form and content of such warnings and instructions shall be prescribed by the Administrator. 6(a)(4) A requirement that manufacturers and processors of such substance or mixture make and retain records of the processes used to manufacture or process such substance or mixture and monitor or conduct tests which are reasonable and 11 ------- TSCA Section Option necessary to assure compliance with the requirements of any rule applicable under this subsection. 6(a)(5) A requirement prohibiting or otherwise regulating any manner or method of commercial use of such substance or mixture. 6(a)(6) (A) A requirement prohibiting or otherwise regulating any manner or method of disposal of such substance or mixture, or of any article containing such substance or mixture, by its manufacturer or processor or by any other person who uses, or disposes of, it for commercial purposes.6 6(a)(7) A requirement directing manufacturers or processors of such substance or mixture (A) to give notice of such unreasonable risk of injury to distributors in commerce of such substance or mixture and, to the extent reasonably ascertainable, to other persons in possession of such substance or mixture or exposed to such substance or mixture, (B) to give public notice of such risk of injury, and (C) to replace or repurchase such substance or mixture as elected by the person to which the requirement is directed. EPA would consider regulatory options that would not duplicate other federal regulations. EPA has determined that current federal regulations discussed in Section 2.2 do not address the unreasonable risk that EPA has identified for NMP. 2,5. Overview of Options under Consideration EPA is considering a number of regulatory options under TSCA section 6(a) for NMP to reduce exposures such that the risk from NMP inhalation and dermal exposure is no longer unreasonable. The unreasonable risk is primarily driven by direct dermal contact for most but not all conditions of use. Therefore, to mitigate the unreasonable risk, EPA is considering a variety of options that are focused on preventing direct dermal contact. Additionally, for some conditions of use, EPA is also considering reducing inhalation risks as well; this includes conditions of use where dermal exposure may not be able to be completely eliminated. For this reason, EPA presented materials to SERs that included inhalation protection (respirators) and asked about all worker exposure reductions. The options under consideration would address the unreasonable risk identified for NMP, which includes dermal and inhalation exposures, including chronic inhalation exposures. The following options listed below, as presented to SERs, are currently being evaluated by EPA, and are not final at this time. Feedback from SERs on these options is in Section 7. EPA is considering the National Institute for Occupational Safety and Health (NIOSH) hierarchy of controls when developing risk management actions. As described by NIOSH, the hierarchy of controls can be used to implement feasible and effective controls to protect workers; it typically includes elimination, substitution, engineering controls, administrative controls, and PPE on a scale of most to least protective.7 Any regulatory option can be used alone or in combination so that NMP no longer presents an unreasonable 6 A requirement under subparagraph (A) may not require any person to take any action which would be in violation of any law or requirement of, or in effect for, a State or political subdivision, and shall require each person subject to it to notify each State and political subdivision in which a required disposal may occur of such disposal. 7 NIOSH Hierarchy of Controls Overview: https://www.cdc.gov/niosh/topics/hierarchv/default.html 12 ------- risk under the conditions of use. Additionally, under TSCA section 6(g), EPA may propose a time-limited exemption for specific conditions of use provided certain criteria are met.8 The 2020 risk evaluation for NMP and revised unreasonable risk determination found that the unreasonable risk of injury to human health is driven by direct dermal contact with liquid NMP for most but not all conditions of use. For this reason, EPA is not considering an airborne concentration limit for NMP and is focusing on dermal protection measures to prevent direct dermal contact. However, some conditions of use have particularly high air concentrations, such as from an aerosol application or liquid NMP used at an elevated temperature, and a high concentration of NMP in formulation based on publicly available information9. For these conditions of use EPA is considering regulatory options to reduce the unreasonable risk driven by both inhalation and dermal exposures, including considering if variations in formulation may help mitigate the unreasonable risk. For this reason, EPA presented materials to SERs that included inhalation protection (respirators), NMP weight fractions evaluated, and asked about all worker exposure reductions. The options under consideration will address the unreasonable risk identified for NMP, which includes dermal and inhalation exposures, including chronic inhalation exposures. When considering practicability and a reasonable transition period, EPA works to account for various factors such as supply chains, availability of alternatives, and time needed for recertification, testing, and retrofitting. 2,5,1 Concentration limit Under this option, EPA would restrict the concentration or weight fraction of NMP within a formulation. For example, if scientific analysis based on the 2020 Risk Evaluation supported it, EPA could limit the percentage amount of the chemical in the formulation if that percentage addressed the unreasonable risk and the formulation was still efficacious. In the 2020 Risk Evaluation for NMP, EPA identified the expected weight fraction of NMP in liquid products based on publicly available information, public comments, and available products on the market. If ranges of NMP in formulations were identified, EPA generally assessed the lower bound of the range as the central tendency and the upper bound of the range as the high end. There is uncertainty if lowering the concentration limit may impact efficacy of the products. For a concentration or weight fraction limit to address the unreasonable risk, it would need to be lower than those that drove the unreasonable risk in the risk evaluation. Costs of concentration limits could include reformulation of the product to reduce NMP concentration (with an estimated cost of $17,000 per product, reflecting a dilution reformulation approach) and 8 In order to propose an exemption under TSCA section 6(g), EPA must find that the specific condition of use is a critical or essential use for which no technically and economically feasible safer alternative is available; compliance with the rule would significantly disrupt the national economy, national security, or critical infrastructure; or the specific condition of use, as compared to alternatives, provides a substantial benefit to health, the environment, or public safety. In proposing the exemption, EPA must provide a time limit for the exemption; analyze the need for the exemption and make the analysis public; and include interim conditions to protect health and the environment. 9 Publicly available information about NMP concentrations in formulations are in the document "Information on Weight Fractions of NMP Evaluated in the 2020 Risk Evaluation" (see Appendix A) and the Uses and Market Profile for N-methylpyrrolidone (NMP) supplemental file found at https://www.regulations.gov/document/EPA-HQ-OPPT- 2016-0743-0060 13 ------- reformulation of a product to eliminate NMP (with an estimated cost ranging from $60,000 - $102,000 per product). Costs would vary by condition of use and would be dependent on the reformulation approach. 2.5.2 Prescriptive Engineering or Administrative Controls Under this option, EPA would require specific prescriptive controls to reduce the exposure to NMP to workers for manufacturing, processing, industrial, and commercial conditions of use. The requirements could include, but are not limited to: • Engineering controls that reduce worker exposure by requiring specific physical changes to the workplace to eliminate or reduce direct dermal contact. o Examples of engineering controls that could be installed to reduce exposure to NMP include: installing additional or different equipment, such as enclosed transfer liquid lines, closed loop container systems or a laboratory type fume hood, to reduce the exposure to the chemical. o EPA's confidence that the unreasonable risk from NMP can be addressed is highest for highly standardized and industrialized settings, such as where NMP is used in a closed-loop system. • Administrative controls could reduce exposures for workers by requiring processes or procedures in the workplace to eliminate or reduce direct dermal contact. An example of an administrative control could be to limit access to work areas (restricted areas) or confining operations (enclosed areas). Costs of implementing engineering and administrative controls would vary by control type and user needs and are dependent on the user's current practices. Potential impacts to small businesses could include (but may not be limited to) the cost of capital investments for engineering controls, maintenance, and other expenses related to implementing industrial hygiene practices, as well as potential costs associated with utilities and labor. Administrative controls could result in increased costs associated with developing and implementing new work practices. 2.5.3 Prescriptive Personal Protective Equipment (PPE) Under this option, EPA would require specific PPE to minimize exposure. This may limit flexibility for the regulated entity. EPA could require the use of specific gloves that meet certain standards such as providing an impervious barrier to the chemical during expected durations and normal conditions of exposure. Some examples of potential PPE that could contribute to reducing the unreasonable risk include both purifying and supplied-air respirators with an assigned protection factor varying from APF 10 - 10,000, and dermal protection such as reusable or disposable gloves or aprons. Additional examples are listed in Appendix F of the 2020 risk evaluation for NMP. Requiring the use of dermal or inhalation PPE that provides an impervious barrier in combination with a set concentration limit of NMP would allow more flexibility for regulated entities to mitigate unreasonable risk. EPA anticipates that PPE would need to be combined with training and other controls in order to address the unreasonable risk from NMP. Potential impacts to small businesses include (but may not be limited to) the cost of purchase of equipment, routine cleaning of equipment, training, fit-testing, and medical clearance for estimated baseline PPE use. Respirator costs are associated with the APF level and range from $1,100 - $2,000 per worker per year. For example, for APF 10 respiratory protection costs are estimated as $1,800 per worker 14 ------- per year and for APF 10,000 respiratory protection costs are estimated as $2,000. Total cost depends on the prevalence of current use, replace parts for the respirators, and number of workers required to use the respirators. For gloves or other dermal PPE, costs include purchase of equipment and EPA estimates these costs would be $6 - $55 per pair of gloves reusable butyl, laminated polyethylene, neoprene, and natural rubber/latex. For disposable gloves, estimated costs are $0.50 per pair of nitrile gloves and disposable nitrile gloves are not used alone but in combination with reusable gloves. Input from potentially regulated entities is needed regarding which glove material type would be used. For aprons, costs include purchase of equipment. EPA estimates costs for a reusable apron to be $25 - $34 per nitrile and neoprene apron and cost for a disposable apron to be $4 per polyethylene apron. 2.5.4 Combination of Controls (non-prescriptive) For processing, industrial, and commercial uses involving occupational exposures, a combination of risk management approaches could be used for conditions of use where strict industrial practices may already exist. This would enable users to determine how to most effectively separate, distance, physically remove, or isolate workers from direct handling of NMP or from contact with equipment/materials on which NMP may be present; users could determine what to do based on what works best for their workplace and the ability to combine prescriptive controls. This approach would eliminate direct dermal contact in accordance with the Pollution Prevention Act and NIOSH hierarchy of controls. This approach could include engineering and administrative controls to reduce exposure. If direct dermal contact could not be eliminated using elimination, substitution, engineering controls, or administrative controls, EPA could require personal protective equipment that provides an impervious barrier. The costs of a non-prescriptive approach would likely include development of an exposure control plan. Costs include costs for conducting regular inspections, PPE program plan documentation, records of plan implementation, and records of dermal exposure. Costs would include both per-facility and per-worker costs, and would depend on baseline PPE and dermal exposure control plan activities. Generally, costs would vary based on the complexity of the site. Annualized costs would include an exposure control plan ($560 - $630 per facility costs, with $35 per worker costs). Additionally, EPA estimates a one-time cost to develop an exposure control plan of $3,730 per facility, regular inspection costs of $370 per facility per year, and potential recordkeeping costs $40 per facility per year. Costs of engineering controls, monitoring, or PPE as part of the non-prescriptive controls would vary by control type and the needs of the user, so they are not captured in these estimates. 2.5.5 Prohibition of manufacturing (including import), processing, and/or distribution Under this option, EPA would prohibit the manufacturing (including import), processing, and/or distribution of NMP. Such prohibition would reduce exposures to NMP throughout the supply chain and possibly affect the distribution in commerce condition of use, which does not drive unreasonable risk. EPA may also prohibit conditions of use that have minimal ongoing use or have been or will be phased out. Under TSCA section 6(c)(2)(C), in deciding whether to prohibit or restrict in any manner that substantially prevents a specific condition of use, and in setting an appropriate transition period for such action, EPA is required to consider, to the extent practicable, whether technically and economically feasible alternatives that benefit health or the environment, compared to the use proposed to be prohibited or restricted, will be reasonably available as a substitute when the proposed prohibition or other restriction takes effect. 15 ------- Costs of prohibitions would vary by condition of use. Potential activities could include changes in process and equipment, costs of alternatives, reformulation, shutting down the operation and more. Costs would vary by price of NMP per ounce compared to substitutes, as well as the difference in efficacy of the substitute products, and would also include changes in equipment, technology, training, testing, and more in addition to the material cost. As described earlier, costs of reformulation of a product to eliminate NMP are estimated to range from $60,000 - $102,000 per product). More precise cost estimates will require input from potentially regulated entities. 2,5.6 Recordkeeping, downstream notification, and other support for implementation TheTSCA section 6(a) activities listed below are options that could support the implementation of the regulatory approaches outlined in the preceding sections. • Recordkeeping would require records and documentation for the purposes of demonstrating compliance with any option described above. Recordkeeping would aim to consist of ordinary business records already maintained to the extent possible. • Downstream notification would support any of the control options described above (e.g., prescriptive controls, prohibitions) to disseminate information about restrictions and requirements through the supply chain. • Monitoring, labeling, and container sizes - o For monitoring, EPA could require initial or periodic monitoring of occupational exposure or for concentration limits. o For labeling, EPA could require that a prominent label be securely attached to each container with specific directions, limitation, and precautions, or that describes the health endpoints. EPA could also require labeling products to indicate that they should not be used by consumers or to describe other regulatory requirements. o For container sizes, EPA could require a minimum or maximum container size (e.g., 32 ounce container, 55 gallon drum) to reduce likelihood of purchase by certain types of users (consumers or commercial users) • Limited access program: EPA could, for example, restrict distribution of a chemical or product only to certain users, under a limited access program that could require training and certification, or restrict distribution only to users with certain equipment or type of facilities. Potential impacts to small businesses associated with recordkeeping could include the annual labor and material costs associated with documentation of ordinary business records, estimated at $218 -$340 per firm. Downstream notification costs are per product (estimated cost $121 -$138) and include labor and material costs to update the product's safety data sheet (SDS). For labeling, EPA estimates that costs could range from $830 to $8,900 per product as a one-time cost. Costs would vary by condition of use. Potential activities may include graphic design changes, plate changes, discarded inventory, and labor. Due to uncertainties and variations in product types, this estimate does not include potential impacts on sales. For a limited access program, costs vary with condition of use and type of distributor; in general, the costs would vary by type of requirements for certification and any distribution processes or restrictions already in place. 16 ------- 3. IIIONS The Regulatory Flexibility Act (RFA) defines small entities as including "small businesses/' "small governments/' and "small organizations" (5 (JSC 601). The RFA references the definition of "small business" found in the Small Business Act, which authorizes the Small Business Administration to further define "small business" by regulation. The SBA definitions of small business by size standards using the North American Industry Classification System (NAICS) can be found at 13 CFR 121.201. The detailed listing of SBA definitions of small business for affected industries or sectors, by NAICS code, is included in Table 4.1 of Section 4, below. 4. SMALL ENirnrv V'ON RjTf r TO THE PROPOSED REGULATION Table 4.1 shows the SBA size standards by affected industry sector. Table 4.2 shows the estimated number of small firms by condition of use (COU). Table 4.1. Industry Sectors and Definitions NAICS NAICS Description SBA Size Standard 111110 Soybean Farming $2.3 million 111120 Oilseed (except Soybean) Farming $2.3 million 111130 Dry Pea and Bean Farming $2.8 million 111140 Wheat Farming $2.3 million 111150 Corn Farming $2.5 million 111160 Rice Farming $2.5 million 111191 Oilseed and Grain Combination Farming $2.3 million 111199 All Other Grain Farming $2.3 million 111211 Potato Farming $4.3 million 111219 Other Vegetable (except Potato) and Melon Farming $3.8 million 111310 Orange Groves $4.0 million 111320 Citrus (except Orange) Groves $4.3 million 111331 Apple Orchards $4.5 million 111332 Grape Vineyards $4.0 million 111333 Strawberry Farming $5.5 million 111334 Berry (except Strawberry) Farming $3.8 million 111335 Tree Nut Farming $3.8 million 111336 Fruit and Tree Nut Combination Farming $5.0 million 17 ------- NAICS NAICS Description SBA Size Standard 111339 Other Non-citrus Fruit Farming $3.5 million 111411 Mushroom Production $4.5 million 111419 Other Food Crops Grown Under Cover $4.5 million 111421 Nursery and Tree Production $3.3 million 111422 Floriculture Production $3.8 million 111910 Tobacco Farming $2.5 million 111920 Cotton Farming $3.3 million 111930 Sugarcane Farming $5.0 million 111940 Hay Farming $2.5 million 111991 Sugar Beet Farming $2.5 million 111992 Peanut Farming $2.5 million 111998 All Other Miscellaneous Crop Farming $2.5 million 236115 New Single-family Housing Construction (Except For-Sale Builders) $45.0 million 236116 New Multifamily Housing Construction (except For-Sale Builders) $45.0 million 236117 New Housing For-Sale Builders $45.0 million 236118 Residential Remodelers $45.0 million 236210 Industrial Building Construction $45.0 million 236220 Commercial and Institutional Building Construction $45.0 million 237110 Water and Sewer Line and Related Structures Construction $45.0 million 237120 Oil and Gas Pipeline and Related Structures Construction $45.0 million 237130 Power and Communication Line and Related Structures Construction $45.0 million 237310 Highway, Street, and Bridge Construction $45.0 million 237990 Other Heavy and Civil Engineering Construction $45.0 million 238110 Poured Concrete Foundation and Structure Contractors $19.0 million 238120 Structural Steel and Precast Concrete Contractors $19.0 million 238130 Framing Contractors $19.0 million 238190 Other Foundation, Structure, and Building Exterior Contractors $19.0 million 238210 Electrical Contractors and Other Wiring Installation Contractors $19.0 million 238220 Plumbing, Heating, and Air-Conditioning Contractors $19.0 million 18 ------- NAICS NAICS Description SBA Size Standard 238290 Other Building Equipment Contractors $22.0 million 238310 Drywall and Insulation Contractors $19.0 million 238320 Painting and Wall Covering Contractors $19.0 million 238330 Flooring Contractors $19.0 million 238910 Site Preparation Contractors $19.0 million 238990 All Other Specialty Trade Contractors $19.0 million 313210 Broadwoven Fabric Mills 1,000 employees 313320 Fabric Coating Mills 1,000 employees 316110 Leather and Hide Tanning and Finishing 800 employees 316210 Footwear Manufacturing 1,000 employees 321912 Cut Stock, Resawing Lumber, and Planing 500 employees 322220 Paper Bag and Coated and Treated Paper Manufacturing 750 employees 323111 Commercial Printing (except Screen and Books) 650 employees 323113 Commercial Screen Printing 500 employees 323117 Books Printing 1,250 employees 323120 Support Activities for Printing 550 employees 324110 Petroleum Refineries 1,500 employees 324191 Petroleum Lubricating Oil and Grease Manufacturing 900 employees 325110 Petrochemical Manufacturing 1,300 employees 325120 Industrial Gas Manufacturing 1,200 employees 325180 Other Basic Inorganic Chemical Manufacturing 1,000 employees 325199 All Other Basic Organic Chemical Manufacturing 1,250 employees 325211 Plastics Material and Resin Manufacturing 1,250 employees 325220 Artificial and Synthetic Fibers and Filaments Manufacturing 1,050 employees 325311 Nitrogenous Fertilizer Manufacturing 1,050 employees 325412 Pharmaceutical Preparation Manufacturing 1,300 employees 325510 Paint And Coating Manufacturing 1,000 employees 325520 Adhesive Manufacturing 550 employees 325611 Soap And Other Detergent Manufacturing 1,100 employees 19 ------- NAICS NAICS Description SBA Size Standard 325612 Polish and Other Sanitation Good Manufacturing 900 employees 325998 All Other Miscellaneous Chemical Product and Preparation Manufacturing 650 employees 326150 Urethane and Other Foam Product (except Polystyrene) Manufacturing 750 employees 326199 All Other Plastics Product Manufacturing 750 employees 327390 Other Concrete Product Manufacturing 500 employees 327910 Abrasive Product Manufacturing 900 employees 331110 Iron and Steel Mills and Ferroalloy Manufacturing 1,500 employees 331210 Iron and Steel Pipe and Tube Manufacturing from Purchased Steel 1,000 employees 331221 Rolled Steel Shape Manufacturing 1,000 employees 331222 Steel Wire Drawing 1,000 employees 331313 Alumina Refining and Primary Aluminum Production 1,300 employees 331314 Secondary Smelting and Alloying of Aluminum 750 employees 331315 Aluminum Sheet, Plate, and Foil Manufacturing 1,400 employees 331318 Other Aluminum Rolling, Drawing, and Extruding 750 employees 331410 Nonferrous Metal (except Aluminum) Smelting and Refining 1,000 employees 331420 Copper Rolling, Drawing, Extruding, and Alloying 1,050 employees 331491 Nonferrous Metal (except Copper and Aluminum) Rolling, Drawing, and Extruding 900 employees 331492 Secondary Smelting, Refining, and Alloying of Nonferrous Metal (except Copper and Aluminum) 850 employees 331511 Iron Foundries 1,000 employees 331512 Steel Investment Foundries 1,050 employees 331513 Steel Foundries (except Investment) 700 employees 331523 Nonferrous Metal Die-Casting Foundries 700 employees 331524 Aluminum Foundries (except Die-Casting) 550 employees 331529 Other Nonferrous Metal Foundries (except Die-Casting) 500 employees 332111 Iron and Steel Forging 750 employees 332112 Nonferrous Forging 950 employees 332114 Custom Roll Forming 600 employees 332117 Powder Metallurgy Part Manufacturing 550 employees 20 ------- NAICS NAICS Description SBA Size Standard 332119 Metal Crown, Closure, and Other Metal Stamping (except Automotive) 500 employees 332215 Metal Kitchen Cookware, Utensil, Cutlery, and Flatware (except Precious) Manufacturing 1,000 employees 332216 Saw Blade and Handtool Manufacturing 750 employees 332311 Prefabricated Metal Building and Component Manufacturing 750 employees 332312 Fabricated Structural Metal Manufacturing 500 employees 332313 Plate Work Manufacturing 750 employees 332321 Metal Window and Door Manufacturing 750 employees 332322 Sheet Metal Work Manufacturing 500 employees 332323 Ornamental and Architectural Metal Work Manufacturing 500 employees 332410 Power Boiler and Heat Exchanger Manufacturing 750 employees 332420 Metal Tank (Heavy Gauge) Manufacturing 750 employees 332431 Metal Can Manufacturing 1,500 employees 332439 Other Metal Container Manufacturing 600 employees 332510 Hardware Manufacturing 750 employees 332613 Spring Manufacturing 600 employees 332618 Other Fabricated Wire Product Manufacturing 500 employees 332710 Machine Shops 500 employees 332721 Precision Turned Product Manufacturing 500 employees 332722 Bolt, Nut, Screw, Rivet, and Washer Manufacturing 600 employees 332811 Metal Heat Treating 750 employees 332812 Metal Coating, Engraving (except Jewelry and Silverware), and Allied Services to Manufacturers 600 employees 332813 Electroplating, Plating, Polishing, Anodizing, and Coloring 500 employees 332911 Industrial Valve Manufacturing 750 employees 332912 Fluid Power Valve and Hose Fitting Manufacturing 1,000 employees 332913 Plumbing Fixture Fitting and Trim Manufacturing 1,000 employees 332919 Other Metal Valve and Pipe Fitting Manufacturing 750 employees 332991 Ball and Roller Bearing Manufacturing 1,250 employees 332992 Small Arms Ammunition Manufacturing 1,300 employees 21 ------- NAICS NAICS Description SBA Size Standard 332993 Ammunition (except Small Arms) Manufacturing 1,500 employees 332994 Small Arms, Ordnance, and Ordnance Accessories Manufacturing 1,000 employees 332996 Fabricated Pipe and Pipe Fitting Manufacturing 550 employees 332999 All Other Miscellaneous Fabricated Metal Product Manufacturing 750 employees 333111 Farm Machinery and Equipment Manufacturing 1,250 employees 333112 Lawn and Garden Tractor and Home Lawn and Garden Equipment Manufacturing 1,500 employees 333120 Construction Machinery Manufacturing 1,250 employees 333131 Mining Machinery and Equipment Manufacturing 900 employees 333132 Oil and Gas Field Machinery and Equipment Manufacturing 1,250 employees 333241 Food Product Machinery Manufacturing 500 employees 333242 Semiconductor Machinery Manufacturing 1,500 employees 333243 Sawmill, Woodworking, and Paper Machinery Manufacturing 550 employees 333244 Printing Machinery and Equipment Manufacturing 750 employees 333249 Other Industrial Machinery Manufacturing 750 employees 333314 Optical Instrument and Lens Manufacturing 1,000 employees 333316 Photographic and Photocopying Equipment Manufacturing 1,000 employees 333318 Other Commercial and Service Industry Machinery Manufacturing 1,000 employees 333413 Industrial and Commercial Fan and Blower and Air Purification Equipment Manufacturing 500 employees 333414 Heating Equipment (except Warm Air Furnaces) Manufacturing 500 employees 333415 Air-Conditioning and Warm Air Heating Equipment and Commercial and Industrial Refrigeration Equipment Manufacturing 1,250 employees 333511 Industrial Mold Manufacturing 500 employees 333514 Special Die and Tool, Die Set, Jig, and Fixture Manufacturing 500 employees 333515 Cutting Tool and Machine Tool Accessory Manufacturing 500 employees 333517 Machine Tool Manufacturing 500 employees 333519 Rolling Mill and Other Metalworking Machinery Manufacturing 500 employees 333611 Turbine and Turbine Generator Set Units Manufacturing 1,500 employees 333612 Speed Changer, Industrial High-Speed Drive, and Gear Manufacturing 750 employees 333613 Mechanical PowerTransmission Equipment Manufacturing 750 employees 22 ------- NAICS NAICS Description SBA Size Standard 333618 Other Engine Equipment Manufacturing 1,500 employees 333912 Air and Gas Compressor Manufacturing 1,000 employees 333914 Measuring, Dispensing, and Other Pumping Equipment Manufacturing 750 employees 333921 Elevator and Moving Stairway Manufacturing 1,000 employees 333922 Conveyor and Conveying Equipment Manufacturing 500 employees 333923 Overhead Traveling Crane, Hoist, and Monorail System Manufacturing 1,250 employees 333924 Industrial Truck, Tractor, Trailer, and Stacker Machinery Manufacturing 900 employees 333991 Power-Driven Handtool Manufacturing 950 employees 333992 Welding and Soldering Equipment Manufacturing 1,250 employees 333993 Packaging Machinery Manufacturing 600 employees 333994 Industrial Process Furnace and Oven Manufacturing 500 employees 333995 Fluid Power Cylinder and Actuator Manufacturing 800 employees 333996 Fluid Power Pump and Motor Manufacturing 1,250 employees 333997 Scale and Balance Manufacturing 700 employees 333999 All Other Miscellaneous General Purpose Machinery Manufacturing 700 employees 334111 Electronic Computer Manufacturing 1,250 employees 334112 Computer Storage Device Manufacturing 1,250 employees 334118 ComputerTerminal and Other Computer Peripheral Equipment Manufacturing 1,000 employees 334210 Telephone Apparatus Manufacturing 1,250 employees 334220 Radio and Television Broadcasting and Wireless Communications Equipment Manufacturing 1,250 employees 334290 Other Communications Equipment Manufacturing 800 employees 334310 Audio and Video Equipment Manufacturing 750 employees 334413 Semiconductor And Related Device Manufacturing 1,250 employees 334510 Electromedical and Electrotherapeutic Apparatus Manufacturing 1,250 employees 334511 Search, Detection, Navigation, Guidance, Aeronautical, and Nautical System and Instrument Manufacturing 1,350 employees 334512 Automatic Environmental Control Manufacturing for Residential, Commercial, and Appliance Use 650 employees 334513 Instruments and Related Products Manufacturing for Measuring, Displaying, and Controlling Industrial Process Variables 750 employees 23 ------- NAICS NAICS Description SBA Size Standard 334514 Totalizing Fluid Meter and Counting Device Manufacturing 850 employees 334515 Instrument Manufacturing for Measuring and Testing Electricity and Electrical Signals 750 employees 334516 Analytical Laboratory Instrument Manufacturing 1,000 employees 334517 Irradiation Apparatus Manufacturing 1,200 employees 334519 Other Measuring and Controlling Device Manufacturing 600 employees 334613 Blank Magnetic and Optical Recording Media Manufacturing 1,250 employees 334614 Software and Other Prerecorded Compact Disc, Tape, and Record Reproducing 1,250 employees 335110 Electric Lamp Bulb and Part Manufacturing 1,250 employees 335121 Residential Electric Lighting Fixture Manufacturing 750 employees 335122 Commercial, Industrial and Institutional Electric Lighting Fixture Manufacturing 600 employees 335129 Other Lighting Equipment Manufacturing 1,250 employees 335210 Small Electrical Appliance Manufacturing 1,500 employees 335220 Major Household Appliance Manufacturing 1,500 employees 335311 Power, Distribution, and Specialty Transformer Manufacturing 800 employees 335312 Motor and Generator Manufacturing 1,250 employees 335313 Switchgear and Switchboard Apparatus Manufacturing 1,250 employees 335314 Relay and Industrial Control Manufacturing 750 employees 335911 Storage Battery Manufacturing 1,250 employees 335912 Primary Battery Manufacturing 1,250 employees 335921 Fiber Optic Cable Manufacturing 1,000 employees 335929 Other Communication and Energy Wire Manufacturing 1,000 employees 335931 Current-Carrying Wiring Device Manufacturing 600 employees 335932 Noncurrent-Carrying Wiring Device Manufacturing 1,000 employees 335991 Carbon and Graphite Product Manufacturing 900 employees 335999 All Other Miscellaneous Electrical Equipment and Component Manufacturing 600 employees 336111 Automobile Manufacturing 1,500 employees 336112 Light Truck and Utility Vehicle Manufacturing 1,500 employees 24 ------- NAICS NAICS Description SBA Size Standard 336120 Heavy Duty Truck Manufacturing 1,500 employees 336211 Motor Vehicle Body Manufacturing 1,000 employees 336212 Truck Trailer Manufacturing 1,000 employees 336213 Motor Home Manufacturing 1,250 employees 336214 Travel Trailer and Camper Manufacturing 1,000 employees 336310 Motor Vehicle Gasoline Engine and Engine Parts Manufacturing 1,050 employees 336320 Motor Vehicle Electrical and Electronic Equipment Manufacturing 1,000 employees 336330 Motor Vehicle Steering and Suspension Components (except Spring) Manufacturing 1,000 employees 336340 Motor Vehicle Brake System Manufacturing 1,250 employees 336350 Motor Vehicle Transmission and Power Train Parts Manufacturing 1,500 employees 336360 Motor Vehicle Seating and Interior Trim Manufacturing 1,500 employees 336370 Motor Vehicle Metal Stamping 1,000 employees 336390 Other Motor Vehicle Parts Manufacturing 1,000 employees 336411 Aircraft Manufacturing 1,500 employees 336412 Aircraft Engine and Engine Parts Manufacturing 1,500 employees 336413 Other Aircraft Parts and Auxiliary Equipment Manufacturing 1,250 employees 336414 Guided Missile and Space Vehicle Manufacturing 1,300 employees 336415 Guided Missile and Space Vehicle Propulsion Unit and Propulsion Unit Parts Manufacturing 1,250 employees 336419 Other Guided Missile and Space Vehicle Parts and Auxiliary Equipment Manufacturing 1,050 employees 336510 Railroad Rolling Stock Manufacturing 1,500 employees 337110 Wood Kitchen Cabinet and Countertop Manufacturing 750 employees 337122 Nonupholstered Wood Household Furniture Manufacturing 750 employees 339112 Surgical and Medical Instrument Manufacturing 1,000 employees 339113 Surgical Appliance and Supplies Manufacturing 800 employees 339114 Dental Equipment and Supplies Manufacturing 750 employees 339115 Ophthalmic Goods Manufacturing 1,000 employees 339116 Dental Laboratories 500 employees 339950 Sign Manufacturing 500 employees 25 ------- NAICS NAICS Description SBA Size Standard 339999 All Other Miscellaneous Manufacturing 550 employees 423120 Motor Vehicle Supplies and New Parts Merchant Wholesalers 200 employees 423220 Home Furnishing Merchant Wholesalers 100 employees 423330 Roofing, Siding, and Insulation Material Merchant Wholesalers 225 employees 423390 Other Construction Material Merchant Wholesalers 100 employees 423490 Other Professional Equipment and Supplies Merchant Wholesalers 150 employees 423610 Electrical Apparatus and Equipment, Wiring Supplies, and Related Equipment Merchant Wholesalers 200 employees 423620 Electrical And Electronic Appliance, Television, And Radio Set Merchant Wholesalers 225 employees 423840 Industrial Supplies Merchant Wholesalers 125 employees 423850 Service Establishment Equipment and Supplies Merchant Wholesalers 125 employees 423990 Other Miscellaneous Durable Goods Merchant Wholesalers 100 employees 424690 Other Chemical And Allied Products Merchant Wholesalers 175 employees 424710 Petroleum Bulk Stations and Terminals 225 employees 424720 Petroleum and Petroleum Products Merchant Wholesalers (except Bulk Stations and Terminals) 200 employees 424910 Farm Supplies Merchant Wholesalers 200 employees 441110 Automobile Dealers 200 employees 441110 New Car Dealers 200 employees 441120 Used Car Dealers $30.5 million 441310 Automotive Parts and Accessories Stores $28.5 million 442110 Furniture Stores $25 million 453310 Used Merchandise Stores $14 million 453920 Art Dealers $16.5 million 453998 All Other Miscellaneous Store Retailers (Except Tobacco Stores) $11.5 million 488410 Motor Vehicle Towing $9.0 million 523930 Investment Advice $47 million 531190 Lessors of Other Real Estate Property $34.0 million 541330 Engineering Services $25.5 million 541380 Testing Laboratories $19.0 million 26 ------- NAICS NAICS Description SBA Size Standard 561110 Office Administrative Services $12.5 million 561210 Facilities Support Services $47.0 million 561720 Janitorial Services $22.0 million 561740 Carpet and Upholstery Cleaning Services $8.5 million 562211 Hazardous Waste Treatment and Disposal $47.0 million 562212 Solid Waste Landfill $47.0 million 562213 Solid Waste Combustors and Incinerators $47.0 million 562219 Other Nonhazardous Waste Treatment and Disposal $47.0 million 562920 Materials Recovery Facilities $25.0 million 711510 Independent Artists, Writers, and Performers $9.0 million 712110 Museums $34.0 million 811111 General Automotive Repair $9.0 million 811112 Automotive Exhaust System Repair $9 million 811113 Automotive Transmission Repair $9 million 811118 Other Automotive Mechanical and Electrical Repair and Maintenance $9 million 811121 Automotive Body, Paint, and Interior Repair and Maintenance $9.0 million 811122 Automotive Glass Replacement Shops $17.5 million 811191 Automotive Oil Change and Lubrication Shops $11.0 million 811192 Car Washes $9.0 million 811198 All Other Automotive Repair and Maintenance $10.0 million 811412 Appliance Repair and Maintenance $19.0 million 811420 Reupholstery and Furniture Repair $9.0 million 811430 Footwear and Leather Goods Repair $9.0 million 811490 Other Personal and Household Goods Repair and Maintenance $9.0 million 812310 Coin-Operated Laundries and Drycleaners $13.0 million 812320 Drycleaning and Laundry Services (except Coin-Operated) $8.0 million 812331 Linen Supply $40.0 million 812332 Industrial Launderers $47.0 million Source: U.S. Small Business Administration Table of Small Business Size Standards available at: https://www.sba.gov/document/support--table-size-standards 27 ------- Table 4.2. Estimated Number of Small Firms by Condition of Use (CPU) Use Category Estimated Percent of Firms Estimated Number of That Are Small Number of Firms Using Small Firms NMP Using NMP Manufacture/Import 49 24% 12 Repackaging 32 95% 30 Processing: incorporation into a formulation, mixture or reaction product 70 59% 41 Lithium ion battery manufacturing 55 91% 50 Waste handling, disposal, treatment, and recycling 1,787 91% 1,620 Plastic and resin product manufacturing 983 93% 917 Textiles, leather, and apparel manufacturing 33 95% 31 Processing aids in petrochemical manufacturing, oil and gas activities, and functional fluids (closed systems) 479 89% 427 Laboratory use 56 93% 51 Paints and coatings 13,574 97% 13,198 Paint, coating, and adhesive removers 4,296 90% 3,886 Electronic product and semiconductor manufacturing 3,473 94% 3,266 Adhesives and sealants 7,012 97% 6,814 Cleaning and furniture care products 2,702 99% 2,665 Ink, toner, and colorant products 114 99% 113 Soldering 2,768 98% 2,711 Fertilizer and other agricultural chemical manufacturing 26,265 99% 26,017 Lubricants and lubricant additives - - - Anti-freeze and de-icing - - - Total 63,748 97% 61,850 5. LIST OF SMALL ENTITY REPRESENTATIVES EPA consulted with Advocacy to develop the list of small entity representatives (SERs) in Table 5.1. EPA issued a press release inviting self-nominations by affected small entities to serve as potential SERs. The press release directed interested small entities to a web page where they could indicate their interest in serving as a SER. EPA launched the website January 5, 2021, and accepted self-nominations until January 19, 2021. EPA recruited additional potential SERs during and after the self-nomination process to address potential underrepresentation from certain affected industries. EPA sent Advocacy a Formal 28 ------- Notification with the suggested list of potential SERs on August 24, 2022, and Advocacy responded on September 7, 2022. Table 5.1: List of Small Entity Representatives Entity Contact MOC Products Company, Inc. Nasim Bagheri GreenChem Industries Leo Hernandez American Distillation, Inc. Donald Outlaw PICO Chemical Corporation Richard Pisarski, Jr. Bulk Chemicals Incorporated Harry Adams ReGen III Rowena Smith TRInternational Inc. Marjalena Santos Franmar Chemical, Inc. Dan Brown Hentzen Coatings Inc. George Curry Hillyard Industries Terry Hall Leather Magic, Inc. Danny Yunker OWOSSO Graphic Arts, Inc. Craig Ellenberg; Devin Ellenberg Chemsynergy, Inc. Aaislinn Chalecki Celanese (Fortron) Phil Brondsema AMVAC Chemical Corporation Jennifer Kelley Knox Fertilizer Company Randy Fritz Turf Care Supply Corporation Brain Kolesar After identifying a list of potential SERs, EPA conducted a Pre-Panel Outreach meeting with potential SERs on March 28, 2023. To help SERs prepare for the virtual meeting/teleconference, EPA sent materials to each of the potential SERs via email on March 14, 2023. A list of the materials shared with the potential SERs during the pre-Panel outreach meeting is contained in Appendix A. For the March 28 Pre-Panel outreach meeting with the potential SERs, EPA also invited representatives from the Office of Advocacy of the Small Business Administration and the Office of Information and Regulatory Affairs within the Office of Management and Budget. A total of 9 potential SERs participated in the meeting. EPA presented an overview of the SBAR Panel process, section 6 of TSCA, an explanation of the forthcoming rulemaking, potential regulatory approaches, and cost estimates. EPA also provided opportunities for questions and feedback, with a meeting structure that aimed to provide productive discussion by grouping conditions of use. 29 ------- The Pre-Panel outreach meeting was held to solicit feedback from the potential SERs on their suggestions for the upcoming rulemaking. EPA asked the potential SERs to provide written comments by April 11, 2023. Comments raised during the March 28 outreach meeting and written comments submitted by the potential SERS are summarized in sections 7.1 and 7.2, respectively, of this document. Written comments submitted after the meeting appear in Appendix Bl. The Panel conducted an outreach meeting with the SERs via a virtual meeting/teleconference on May 24, 2023. To help SERs prepare for the virtual meeting/teleconference, EPA sent materials to each of the SERs via email on May 10, 2023. A list of the materials shared with the SERs during the Panel outreach meeting is contained in Appendix A2. A total of 6 SERs participated in the meeting. EPA summarized SER comments during the pre-Panel outreach meeting and presented an overview of the SBAR Panel process, section 6 of TSCA, an explanation of the forthcoming rulemaking, potential regulatory approaches, and cost estimates. This Panel outreach meeting was held to solicit feedback from the SERs on their suggestions for the upcoming rulemaking. EPA asked the SERs to provide written comments by June 7, 2023, and the deadline was later extended to June 12, 2023. Comments raised during the May 24, 2023, Panel outreach meeting are summarized in sections 7.3 of this document. No written comments were received. 7. SUm OMMENTS FROM SMALL ENTITY REPRESENTATIVES 7,1, Summary of the Pre-Panel Outreach Meeting Discussion At the Pre-Panel outreach meeting, SERs provided information on the number and type of entities that would be affected (including how their products are used); potential compliance requirements (including current exposure monitoring and reduction practices, and anticipated impacts of potential prohibitions); related Federal rules; and potential regulatory flexibility alternatives (including considerations for substitute chemicals). Verbal comments from the meeting are summarized in the following subsections. 7,1,1, Number and Types of Entities Affected SERs discussed their import, manufacturing, processing or use of NMP, their customer base and how their products are used. Specifically, SERs described: • One SER described their business as a lawn care and agricultural fertilizer business that sells several products that contain NMP. The SER indicated they were looking to phase NMP out of their products. • A chemical processor SER described their use of NMP in industrial cleaners. The SER described how, generally, NMP is blended into industrial cleaners with a final concentration of 1.5 to 15% NMP in the formula by weight. The SER also described how they can formulate products to specific consumer requests. The SER estimated that on a monthly basis, they process about four drums, or 2,000 lbs of NMP. • Another chemical processor SER described their use of NMP in herbicides, fungicides, and pesticides. The SER provided an example of how they use NMP in six products registered 30 ------- under FIFRA with concentrations of NMP in formulation of some products up to 10% by weight. For other products, the NMP may be present in the formulation in small amounts. Several of these products are applied in the field in water-based solutions. The SER described how they test small volume formulations in a laboratory to complete specified consumer requests. • A third chemical processor SER described their patented planned use of NMP as an extraction solvent in re-refining used motor oil. The SER is a start-up company and described their investment in the process that will use NMP; the investment described was over $50 million dollars and the SER emphasized how critical NMP is to the planned re- refining process, in order to yield a higher purity of re-refined oil. 7,1,2, Potential Reporting, Recordkeeping, and Compliance Requirements SERs described their exposure monitoring and reduction practices, anticipated changes due to potential requirements from EPA, and considerations for substitute chemicals or processes. Specifically, SERs described, for themselves or their customers: • One SER who processes NMP into industrial cleaners described their exposure control practices, which include PPE and engineering controls. o PPE: The SER described how workers receiving and unloading the NMP (in 55- gallon drums), wear PPE to reduce exposures. The SER described this PPE as an industrial uniform with standard boots, safety glasses and gloves for NMP. For other chemicals, the SER described how PPE may include face shields and chemically-resistant elbow-length gloves. o Engineering controls: The SER described how, once received, the NMP is pumped through tubes or vacuum suction devices (such as a diaphragm pump) into large mixing vessels/tanks (approximately 800 gallons). Once blended, the formulations are then pumped into totes (standard size is 275 gallons) or drums (55 gallons). The SER noted that outgoing products are checked with Fourier transform infrared when necessary to identify the components in the mixture and measure NMP concentration by weight, rather than manual sampling by workers. This SER indicated their pumps are cleaned after use by water rinse or emulsifier to remove any remaining NMP. • One SER who formulates herbicides, fungicides, and pesticides with NMP described exposure reduction practices that include PPE, engineering controls, and administrative controls. The SER also provided insight on potential challenges for reformulation, and their feedback on potential compliance requirements. o Exposure controls: The SER described how they receive NMP in 55-gallon drums. The NMP is transferred to a blending tank that has vents that lead to carbon scrubbing filters. The SER described how worker protection is guided by SDS sheets, and that this provides guidance on chemically resistant material (e.g., barrier PPE) to NMP. The SER explained how within their internal laboratories, staff use standard PPE such as gloves, glasses, and lab coats, as well as additional control measures such as fume hoods. Staff are trained to follow good laboratory practices, and workers all have undergraduate degrees and experience working in labs. The SER also described how annual retraining is required. 31 ------- o Compliance requirements: This SER indicated PPE requirements would be the least burdensome option for their operations, because engineering control requirements would incur capital costs. This SER indicated that reformulating to avoid use of NMP would require additional laboratory testing and internal document revisions, which would require potentially one to two years. They indicated concern over the length of time required for EPA FIFRA registration, which they stated would need to be updated if their formulation changed. • One SER who plans to use NMP as an extraction solvent in re-refining used motor oil described their planned use of pure NMP in what they characterized as a closed loop system. They expect to achieve this through engineering controls, operations staff training, reduced entry to the area where NMP is used and the use of warning signs. They expect to have operations that run continuously unless routine maintenance is required. The SER described how the NMP would be received in a large truck, held in a small onsite storage tank, and recycled within their system. o This SER stated that prohibitions on NMP would have significant negative impacts on their business, and would require an additional 10 to 15 years of testing and investment to identify an alternative. • Several SERs discussed alternatives to NMP, and the challenges of using those alternatives if NMP were prohibited: o Two SERs (a chemical processor of industrial cleaners, and a chemical processor of herbicides, fungicides, and pesticides) each identified l-butyl-2-pyrrolidone (or n- butylpyrrolidone (NBP), CASRN 3470-98-2) as an alternative chemical for NMP but noted that it was less effective than NMP and required more product, degraded faster than NMP, and is subject to a TSCA section 5 premanufacture notice, consent order, and significant new use rule (SNUR), which would likely include the uses of interest to the SERs (the use in industrial cleaners and as a solvent for production and formulation of active ingredients for agriculture). Both SERs indicated that while they had used this alternative, they returned to using NMP. o A chemical processor SER also identified dimethyl sulfoxide (DMSO) (CASRN 67-68- 5) as an alternative to NMP in herbicide and fungicide formulations, and stated their view that it is not as good as NMP at carrying chemicals across barriers or solubilizing organic chemicals. DMSO is actively listed in the TSCA inventory. This SER noted it would be challenging to phase out of NMP because it would require lab work to develop a replacement formulation, two to three years of field and toxicology testing, and additional time if the reformulated products would need to be registered under FIFRA. This SER said their products are intended to have two to three year service lives. The SER estimated the cost of reformulation could be around $500,000. o A chemical processor SER noted that generally NMP was the chemical many processors in the industry had transitioned to as a replacement for other solvents they described as presenting higher hazards or other concerns (regrettable substitutes). 32 ------- 7,1,3, Related Federal Rules Two SERs mentioned FIFRA approval requirements for NMP as an inert ingredient in pesticide formulations. EPA notes that a substance intended for use as an inert ingredient in a registered pesticide product is subject to TSCA, not FIFRA, until it is actually formulated into the pesticide. The SERs indicated that if the manufacturing or processing of NMP were prohibited, there would be cost and testing requirements associated with pesticide product reformulation, and the required registration amendment would be subject to EPA review and approval before the product could be offered for sale under FIFRA. 7,1,4, Regulatory Flexibility Alternatives SERs identified several potential regulatory flexibility alternatives, challenges for small businesses, questions for EPA regarding the Agency's regulatory approach, and provided recommendations: • One SER that processes NMP into industrial cleaners stated that they expected six to eight months to transition to a known substitute chemical due to compliance with additional requirements for that chemical (it is subject to a Significant New Use rule under TSCA section 5). • A SER that formulates herbicides, fungicides, and pesticides with NMP stated a preference for PPE requirements to address unreasonable risks; the SER described how PPE changes would be less burdensome for their business, because engineering control requirements would incur capital costs. • In contrast, a SER who plans to use NMP as an extraction solvent in re-refining used motor oil stated that administrative or engineering controls would be possible and preferable. This SER expressed a strong preference for exposure controls that would prevent a need for prohibition or reductions in concentration. • SERs described considerations for timeframes for implementation of regulatory restrictions: o One SER that processes NMP as an inert ingredient in pesticides stated that reformulating to avoid use of NMP would require additional laboratory testing and internal document revisions, which would require potentially one to two years. They indicated concern over the length of time required for EPA FIFRA registration, which they stated would need to be updated if their formulation changed. o A different SER that processes NMP into pesticides provided a separate estimate of time that would be needed to reformulate products, which would include lab work to develop a replacement formulation, two to three years of field and toxicology testing, and additional time if the reformulated products would need to be registered under FIFRA. o One SER who plans to use NMP as an extraction solvent in re-refining used motor oil stated that in the event of a prohibition on NMP for this use, they expected that 10 to 15 years of testing and investment would be needed to identify an alternative. 7,2, Summary of Written Comments Following the Pre- reach Meeting SERs provided written responses to the Pre-Panel outreach questions for discussion, which aimed to seek feedback on NMP processing and use, workplace-specific practices, and experiences with NMP, 33 ------- importance of NMP to the individual business, and current risk management controls. One SER provided written comments: ReGen III Corp. 7.2.1, Number and Types of Entities Affected The written comment from the SER pertained to their planned use of NMP as an extraction solvent in their patented technology that will enable used motor oil to be re-refined to produce base oils of high purity. The SER described their business as a "cleantech" company advancing sustainability. The SER in their comment quantified expected benefits from their technology to re-refine used motor oil based on expected reductions in carbon dioxide emissions from used motor oil currently being disposed of improperly or burned as a fuel. The SER described that in their patented process, NMP is critical, and they are expecting that it would be used at any future facilities. 7.2.2, Potential Reporting, Recordkeeping, and Compliance Requirements While the SER did not describe the impact of potential reporting, recordkeeping, and compliance requirements, the SER did provide information on expected exposures and plans for minimization of worker risk. In the written comment, the SER detailed their expected operations and maintenance manual to track how many employees would be exposed to NMP and for how long. Re-refinery equipment, including a 60,000-gallon storage tank, are outside with open ventilation. The SER described how NMP is used in a Scheibel extraction column to extract low-quality products, aromatics and polar components from the used motor oil; these components are then distilled and separated from the desired output. The NMP is regenerated for storage and reuse. The SER expects the facility to have four persons per shift with two outside operators, and that one person per shift would be in the area with the tank containing NMP. The SER estimated that the person in the area with the tank would be in that area for no more than one hour a day, and did not expect inhalation or dermal exposures during normal operations. The SER also plans to maintain industrial hygiene programs and regular occupational exposure evaluations as part of their worker health and safety protection plan. The comment further detailed expected protocols for engineering controls, which would be focused on a closed loop design using vapor recovery and spill containment systems. Additional engineering controls would include fully automated processing equipment. Administrative controls would be implemented through a standard operating procedure and written instructions for any activity with NMP to restrict access to the area where NMP is being used. PPE would be fitted and available to workers, and industrial hygiene programs and regular occupational exposure evaluations implanted. Regarding use of alternatives in the event of prohibitions on NMP, in the written comment, the SER stated that their use of NMP as an extraction solved used to upgrade crude oil to base oil could be replaced with other solvents like furfural (CASRN 98-01-1) or phenol (hydroxy benzene) (CASRN 108-95- 2). The SER described how these alternatives are less effective than NMP at extracting polar and aromatic compounds, as well as how, compared to those chemicals, NMP has a lower flammability, lower volatility, and greater thermal stability. For these reasons, according to the SER, NMP is essential for their planned process. The SER described extensive development of their unique process, during which they have been testing NMP for fifteen years at a cost of over $50 million. Similar to their comments at the pre-Panel outreach meeting, in written comments the SER described how prohibition or restriction in concentration of NMP for this use would severely impair their planned business, and would require 10 to 15 years to identify and integrate alternative chemical into their extraction and re- refining process. 34 ------- 7,2,3, Related Federal Rules In the written comment the chemical processing SER did not mention related Federal rules. The SER indicated they expect health and safety practices to be enforced as part of typical health and safety protocols at refineries. 7,2,4, Regulatory Flexibility Alternatives In the written comment, the SER advised that EPA should focus the proposed regulation of NMP on engineering and administrative controls and PPE requirements instead of prohibitions, imposed concentration limits, or volume restrictions. This SER stated they did not believe additional requirements for their facility were needed, due to site specific operating protocols for health and safety practices including a closed loop system, engineering controls, rigorous operating procedures, employee/contractor training, appropriate PPE (including chemically impervious gloves), warning signs, restrictions for at-risk personnel. 7,3, Summary of the Panel Outreach Meeting Discussion At the Panel outreach meeting, SERs provided information on the number and type of entities that would be affected (including descriptions of their processing and use of NMP, their customer base, and how their products are used); potential compliance requirements (including current exposure reduction practices and anticipated impacts of potential prohibitions); related Federal rules; and potential regulatory flexibility alternatives (including descriptions of challenges for small businesses and questions for EPA regarding the regulatory approach). Verbal comments from the meeting are summarized in the following subsections. 7,3,1, Number and Types of Entities Affected SERs discussed their import, manufacturing, processing or use of NMP, their customer base and how their products are used. Specifically, SERs described: • A SER who uses NMP in formulating crop protection products described how NMP is polar solvent used for anti-crystallization. The SER estimated that their use of NMP is increasing. o The formulating SER described use of NMP in their laboratory and also a different use in product formulation. o The SER stated they have eight to ten products developed with NMP, and described their need for soluable, efficacious, aromatic solvents, with a preference for polar solvents. • A SER who uses NMP in paint and powder removal products described how their products are used and some of their business practices. Specifically, the SER described: o Their products are used in industrial settings, at ambient temperatures. The SER described how their paint and powder removal products are used in metal finishing (preparing metals for subsequent coatings), and architectural coating removal (such as appliances, lighting, electronics, and machinery). The SER specified that their products are not used in automotive refinishing. o The SER described how, in the past, they formulated the products themselves, but now, due to cost considerations, they have outsourced their product line to a Canadian 35 ------- company and import the formulated product at a more cost-effective price. The SER described importing products in 55-gallon drums or 275-gallon totes. • A SER that plans to use of NMP as an extraction solvent briefly described how they will be using NMP in their patented technology to re-refine used motor oil to produce base oils of high purity. The SER described how they intend to maintain a closed system to recycle back into the process as much NMP as possible (stripping it out of the final product, which may contain trace amounts of NMP (approximately 20 ppm)). 7.3.2, Potential Reporting, Recordkeeping, and Compliance Requirements SERs described their exposure monitoring and reduction practices, anticipated changes due to potential requirements from EPA, and considerations for substitute chemicals or processes. Specifically, SERs described, for themselves or their customers: • A SER who uses NMP to formulate crop protection products described their current exposure controls in their laboratory, in which they use NMP, and in their chemical manufacturing processes. Specifically, the SER described: o In the laboratory: Small number of workers (four or five staff), use of PPE (long sleeves and lab coat, butyl rubber gloves, goggles), engineering controls (fume hoods), and small amounts of NMP, not heated (ambient temperatures). o In the manufacturing part of their facilities: engineering controls (enclosed 2,000-gallon tanks with exhaust scrubbers, drums or totes directly connected to the tanks for mixing), PPE (Tyvek suits, full-face cartridge respirators). The SER described how the PPE was necessary due to other chemicals (organophosphates), rather than the NMP. • The SER who plans to use NMP to re-refine used motor oil described engineering controls, administrative controls, and PPE that they said were consistent with a refinery environment. They described how they aim to limit the number of workers in the facilities. 7.3.3, Related Federal Rules One SER mentioned FIFRA approval requirements for NMP as an inert ingredient in pesticide formulations. SERs were provided with a document in the Panel materials (included in Appendix A2) that summarizes EPA's longstanding interpretation of TSCA § 3(2)(B)(ii) that pesticide inert ingredients are subject to TSCA jurisdiction until becoming part of the pesticide product. See 42 Fed. Reg. 64,572, 64,586 (Dec. 23, 1977). The SER indicated that if the manufacturing or processing of NMP were prohibited there would be significant costs and testing requirements associated with pesticide product reformulation, and the required registration amendment subject would be to EPA review and approval before the product could be offered for sale under FIFRA. 7.3.4, Regulatory Flexibility Alternatives SERs identified several potential regulatory flexibility alternatives, challenges for small business, questions for EPA regarding the regulatory approach, and provided recommendations: • SERs described how prohibitions on their use of NMP would present significant challenges: o A SER who uses NMP to formulate other chemical products described how they have researched several potential alternatives and have not yet found a chemistry that provides the solubility and anti-crystallization properties provided by NMP. 36 ------- ¦ The SER noted that one potential alternative, NBP, is limited under TSCA section 5 to no more than 30% in the type of formulation that they would be developing, or else a pre-manufacture notice would need to be reviewed and approved by EPA. ¦ The SER also described how they prefer not to reformulate their products once the customers have gotten used to them, and that costs of reformulation include research of new alternatives, development time, registration for any pesticides, and relabeling. ¦ The SER stated that they do not have alternative products for the same applications as their NMP products. o A SER who uses NMP in paint and powder removal products described how they had identified a substitute chemical in the past (which they identified only by a proprietary trade name), but that the chemical had significant supply chain challenges and they could no longer purchase it. The SER described their preference to continue using NMP. o The SER who plans to use NMP to re-refine used motor oil stated that NMP is essential to their company, and if they are unable to use it, their planned company would close. The SER described how they have invested over $50 million over the last 15 years in developing the facility. The SER also described early experience with a potential alternative chemical (furfural) but the resulting re-refined base oils could not meet the viscosity standards set by the American Petroleum Institute, a trade association. • Regarding concentration limits, a SER described the concentrations at which they use NMP. Specifically, a SER who uses NMP to formulate other chemical products described some formulated products that contain 10-12% NMP, while a small number of their products contain 60-70% NMP. • SERs expressed a preference for exposure controls: o The SER who plans to use NMP to re-refine used motor oil described how they could retrofit their facility if needed, and could meet requirements for administrative and PPE changes if needed. The SER stated that engineering control changes could potentially be implemented within a year of being required. o The SER who uses NMP to formulate other chemicals described how their facility has a small number of employees in the laboratory and manufacturing areas, and how they could supplement currently Good Laboratory Practices (GLP) with additional administrative controls. 7,4, Summary of Written Comments Following the Panel Outreach Meeting SERs had the opportunity to provide written responses to the Panel outreach questions for discussion, which aimed to seek feedback on NMP processing and use, workplace-specific practices, and experiences with NMP, importance of NMP to the individual business, and current risk management controls. No written comments were provided. 37 ------- 8. PANEL FINDINGS AND DISCUSSION 8.1, Number and Types of Entities Affected The proposed rule potentially affects businesses that manufacture (including import), process, use distribute, or dispose of NMP which impacts industries that include fertilizer and other agricultural chemical manufacturing, chemical processors (including oil re-refiners), and formulators of paint and coating removal products. During the Panel outreach meeting, SERs discussed the types of small entities affected and included information on their use of NMP, with a focus on chemical processing and use of NMP in agricultural chemicals and oil re-refining. SERs commented on the approximate concentration of NMP in their products, the challenges of using alternative chemicals, the number of employees exposed, the number of product lines they had, and how their formulated products are used in lawn care and other agricultural sectors, architectural and equipment coating removal, and oil re-refining. EPA estimates of the small entities to which the proposed rule may apply are described in Section 4 of this document. As shown in Table 4.2, 61,850 small entities, or 97% of the estimated number of firms using NMP, could potentially be impacted by the rule. Not all of the small firms indicated in the Table, however, are expected to be impacted by the proposed rule as elaborated on in Section 4. 8.2, Potential Reporting, Recordkeeping, and ( iance Requirements SERs described their exposure monitoring and reduction practices, anticipated changes due to potential requirements from EPA, and considerations for substitute chemicals or processes. Specifically, SERs described engineering controls (in laboratories, fume hoods; in manufacturing facilities, valves and direct connections between drums or totes and mixing tanks; ventilation and exhaust scrubbers; systems for stripping NMP out of the finished product and reusing it; and remote sampling devices (such as infrared)); PPE (full-face cartridge respirators, due to the presence of other chemicals; goggles and face-shields; long-sleeves, lab coats, orTyvek suits; gloves including butyl rubber gloves, sometimes elbow-length); and administrative controls (such as limiting the number of personnel in an area where NMP is used, training in GLP, and other training). Regarding alternative chemicals, SERs described how several alternative chemicals did not yield the results they were seeking in terms of product efficacy or purity, could not perform the functions of NMP, or were chemicals the SERs had previously used prior to the transition to NMP that the SERs identified as presenting concerns (such as DMSO). Most SERs described their preference for continuing to use NMP, and provided their rationales, with one SER describing how NMP was a key part of their planned business for re-refining used motor oil. SERs also described how, for pesticides formulated with NMP, if the manufacturing or processing of NMP were prohibited or restricted under TSCA it would result in changes to their products under FIFRA. SERs described how without NMP available as an inert ingredient, they would need an alternative ingredient, which would require pesticide product reformulation, and the required registration amendment subject to EPA review and approval before the product could be offered for sale, under FIFRA. Overall, SERs expressed a preference for exposure controls and described current efforts to limit worker exposure to NMP. 8.3, Related Federal Rules SERs discussed FIFRA approval requirements for NMP as an inert ingredient in pesticide formulations. SERs were provided with a document in the Panel materials (included in Appendix A2) that summarizes EPA's longstanding interpretation of TSCA § 3(2)(B)(ii) that pesticide inert ingredients are subject to 38 ------- TSCA jurisdiction until becoming part of the pesticide product. See 42 Fed. Reg. 64,572, 64,586 (Dec. 23, 1977).The SERs indicated that if the manufacturing or processing of NMP were prohibited there would be significant costs and testing requirements associated with pesticide product reformulation, and the required registration amendment would be subject to EPA review and approval before the product could be offered for sale, under FIFRA. More information about the FIFRA inert ingredients overview and guidance is at https://www.epa.gov/pesticide-registration/inert-ingredients-overview-and-guidance. Review time for FIFRA approval depends on the type of petition as seen in the Pesticide Registration Improvement Act fee table found online at https://www.epa.gov/pria-fees/pria-fee-categorv-table- inert-ingredients. 8.4, Regulatory Flexibility Alternatives Regarding regulatory flexibilities to reduce the impact of a potential regulation on NMP under section 6 of TSCA, SERs suggested that EPA require exposure controls such as engineering controls, administrative controls, or PPE requirements. Some SERs stated a preference for PPE requirements (which would not incur capital costs) while others said engineering controls could be implemented. The Panel recommends that EPA consider additional activities listed below to determine if they are appropriate to provide flexibility to lessen impacts to small entities. Many of the recommended flexibilities may lessen impacts to all entities, and not only small entities: Regulatory Options Based on SER comments: 1. The Panel recommends that EPA describe in the NPRM how the inhalation and dermal exposures contribute to the identified unreasonable risk for NMP, including the importance of direct dermal contact in the unreasonable risk determination and special considerations for inhalation exposures for any particular conditions of use. 2. The Panel recommends that EPA consider and request comment on whether to allow the use of NMP by entities that could, based on demonstrated ability through recordkeeping and utilization of a combination of controls (including engineering controls, administrative controls, and PPE requirements), eliminate direct dermal contact with NMP to address the unreasonable risk. 3. The Panel recommends that EPA provide and request comment in the NPRM on reasonable compliance timeframes for small businesses. Specifically, the Panel recommends that EPA request comment on whether and how to provide longer compliance timeframes for transitioning to alternatives for uses requiring reformulation. As part of this effort, the Panel recommends that EPA seek comment on and consider compliance timelines based on the expected availability of technically and economically feasible alternatives, as well as any information that could be provided based on requirements for certification or standards relevant to pesticides, or as a solvent in products such as industrial cleaners, paint strippers, and oil refining. The Panel also recommends that EPA request comment in the NPRM on differing compliance or reporting requirements or timetables that account for the resources available to small entities. Additionally, the Panel recommends that EPA seek comment on and consider reasonable compliance timeframes for prohibitions or phase-outs on use of NMP in chemical processing and formulation, in response to SER input and other appropriate factors, such as the lifespan of equipment, capital costs for new equipment and certification, time to research alternatives, and time to reformulate products. In 39 ------- addition, the Panel recommends that EPA take comment on any additional appropriate factors for identifying reasonable compliance timeframes and how to weigh the factors for chemical processing, agricultural product manufacturing, petrochemical refining, and other industries. 4. The Panel recommends that EPA provide readily available information on potential costs that could be incurred using strategies to meet requirements for any proposed exposure controls, such as engineering, administrative, or prescriptive controls (e.g., use of specialized systems, cost of new equipment, PPE, etc.), or concentration limit, as they apply to each relevant COU. The Agency should also provide its analysis on whether it is feasible to implement these strategies for the regulated entities. 5. The Panel recommends that EPA provide details and request public comment in the NPRM about the feasibility of use of alternatives to NMP and their availability for conditions of use that drive the unreasonable risk. Specifically, the Panel recommends that EPA provide, to the extent practicable, costs for the use of alternatives and information on the hazard profile of the alternatives. The Panel recommends that EPA should ensure that entities, with emphasis on small entities, are provided as much information as is available to the Agency about suitable alternatives for these conditions of use, potentially through the form of information generated as part of the rulemaking process (such as an alternatives assessment). 6. The Panel recommends that EPA provide an analysis for each use identified by SERs that would be subject to prohibition to demonstrate whether technically and economically feasible alternatives to NMP that benefit health or the environment, compared to the use proposed to be prohibited or restricted, would be reasonably available as a substitute when the proposed prohibition or other restriction takes effect. 7. The Panel recommends that EPA consider and request public comment in the NPRM on a de minimis level in the case of an impurity or trace amounts of NMP in products. 8. The Panel recommends that EPA's RFA and cost-benefit analyses consider the impact of excluding, as viable alternatives, any chemicals identified by the Agency as part of the TSCA risk evaluation process as presenting an unreasonable risk of injury to health or the environment. The Panel recommends that EPA request comment on whether these chemicals as well as chemicals undergoing risk evaluation would be likely to be considered as viable alternatives and, if so, in which circumstances. 9. Based on SER comments providing diverse perspectives on preferences for exposure control technologies and methods, the Panel recommends that EPA consider and request comment on a regulatory approach for those conditions of use where EPA has confidence that exposures to NMP can be effectively controlled, would provide flexibility for regulated entities to incorporate the hierarchy of controls and reduce exposures so that the unreasonable risk is no longer present. 10. The Panel recommends that EPA explain in the NPRM the relationship of TSCA and FIFRA with regard to NMP conditions of use subject to the proposed rule. 11. The Panel recommends that EPA provide an overview of information reasonably available to EPA regarding engineering or administrative controls that could address dermal exposures expected for NMP. The panel recommends that EPA seek comment on state of the art equipment, engineering and administrative controls, and monitoring 40 ------- for dermal exposures. 12. The Panel recommends that EPA consider and request public comment on a limited access program for the sale of products containing NMP that could require training and certification, or restrict distribution only to users with certain equipment that could reduce or eliminate dermal exposures or type of facilities. Advocacy only recommendation In addition, Advocacy specifically recommends that EPA allow the use of NMP by entities who, based on demonstrated ability through recordkeeping and utilization of a combination of controls (including engineering controls, administrative controls, and PPE requirements), can eliminate direct dermal contact with NMP to address the unreasonable risk. 41 ------- APPENDIX A: Materials Shared with Small Entity Representatives for the Pre-Panel and Panel Outreach Meetings Appendix A1 (separate document) is a compilation of all outreach materials shared with SERs for the Pre-Panel Outreach meeting held on March 28, 2023. Below is a list of those materials. • Agenda • Panel Process Presentation • Pre-Panel Rulemaking Presentation • Industry Sectors with Small Entities Potentially Affected by the Rulemaking Document • Related Regulations (EPA, Federal, State, and International) Document • Pre-Panel Outreach SER Questions for Discussion • Personal Protective Equipment Respirator System Per Worker Unit Cost Breakdown Document • Potential Regulatory Options and Estimated Costs Document • Information on Weight Fractions of NMP Evaluated in the 2020 Risk Evaluation Appendix A2 (separate document) is a compilation of all outreach materials shared with SERs for the Panel Outreach meeting held on May 24, 2023. Below is a list of those materials. • Agenda (updated from pre-panel version) • Panel Rulemaking Presentation (updated from pre-panel version) • Industry Sectors with Small Entities Potentially Affected by the Rulemaking Document (updated from pre-panel version) • Related Regulations (EPA, Federal, State, and International) Document (same as pre-panel version) • Panel Outreach SER Questions for Discussion (same as pre-panel version) • Personal Protective Equipment Respirator System Per Worker Unit Cost Breakdown Document (same as pre-panel version) • Potential Regulatory Options and Estimated Costs Document (updated from pre-panel version) • Information on Weight Fractions of NMP Evaluated in the 2020 Risk Evaluation (same as pre- panel version) • Key Takeaways from Pre-Panel Outreach Meeting (updated from pre-panel version) • Pesticide Inert Ingredients interpretation TSCA and FIFRA Document (New material) 42 ------- APPEK' * nten Comments Submitted by Small Entity Representati\ ach Meetings Appendix B is a compilation of all written comments submitted by SERs following the Pre-Panel Outreach meeting on March 28, 2023, contained in a separate attachment. One SER submitted written comments: ReGen III Corp. No written comments were received following the Panel Outreach meeting. 43 ------- |