Methylene Chloride and N-Methylpyrrolidone; Regulation of Certain Uses Under TSCA Section 6(a)

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 751

[EPA-HQ-OPPT-2016-0231; FRL-9958-57]

RIN 2070-AK07

Methylene Chloride and N-Methylpyrrolidone; Regulation of Certain Uses Under TSCA Section 6(a)

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Proposed rule.

SUMMARY:

Methylene chloride, also called dichloromethane, is a volatile chemical that has a variety of uses, including paint and coating removal. N-methylpyrrolidone (NMP) is a solvent used in a variety of applications, including paint and coating removal. For each of these chemicals, EPA has identified risks of concern associated with their use in paint and coating removal. EPA proposes a determination that these are unreasonable risks. EPA is proposing to prohibit the manufacture (including import), processing, and distribution in commerce of methylene chloride for consumer and most types of commercial paint and coating removal under section 6 of the Toxic Substances Control Act (TSCA). EPA is also proposing to prohibit the use of methylene chloride in these commercial uses; to require manufacturers (including importers), processors, and distributors, except for retailers, of methylene chloride for any use to provide downstream notification of these prohibitions throughout the supply chain; and to require recordkeeping. EPA is proposing an initial ten-year time-limited exemption from these proposed regulations on methylene chloride for coating removal uses critical for national security. First, EPA is proposing to prohibit the manufacture (including import), processing, and distribution in commerce of NMP for all consumer and commercial paint and coating removal; to prohibit the use of NMP for all commercial paint and coating removal; to require, consistent with methylene chloride restrictions, downstream notification of these prohibitions throughout the supply chain; to require recordkeeping; and to provide a time-limited exemption from these proposed regulations on NMP for coating removal uses critical for national security. For NMP, as an alternate proposal, EPA is proposing that (1) commercial users of NMP for paint and coating removal establish a worker protection program for dermal and respiratory protection and not use paint and coating removal products that contain greater than 35 percent NMP by weight (except for product formulations destined to be used by DoD or its contractors performing work only for DOD projects); and (2) processors of products containing NMP for paint and coating removal reformulate products such that these products do not exceed a maximum of 35 percent NMP by weight, identify gloves that provide effective protection for the formulation, and provide warning and instruction labels on the products.

DATES:

Comments must be received on or before April 19, 2017.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2016-0231, at

http://www.regulations.gov

. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or withdrawn. EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. EPA will generally not consider comments or comment contents located outside of the primary submission (

i.e.,

on the web, cloud, or other file sharing system). For additional submission methods (

e.g.,

mail or hand delivery), the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit

http://www2.epa.gov/dockets/commenting-epa-dockets

.

Docket.

Docket number EPA-HQ-OPPT-2016-0231 contains supporting information used in developing the proposed rule, comments on the proposed rule, and additional supporting information. A public version of the docket is available for inspection and copying between 8:30 a.m. and 4:30 p.m., Monday through Friday, excluding federal holidays, at the U.S. Environmental Protection Agency, EPA Docket Center Reading Room, WJC West Building, Room 3334, 1301 Constitution Avenue NW., Washington, DC 20004. A reasonable fee may be charged for copying.

FOR FURTHER INFORMATION CONTACT:

For technical information contact:

Ana Corado, Chemical Control Division, Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number 202-564-0140; email address:

corado.ana@epa.gov

.

For other information contact:

Niva Kramek, Chemical Control Division, Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 202-564-4830; email address:

kramek.niva@epa.gov

.

For general information contact:

The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address:

TSCA-Hotline@epa.gov

.

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

You may potentially be affected by this proposed action if you manufacture (defined under Toxic Substances Control Act (TSCA) to include import), process, distribute in commerce, or use methylene chloride or NMP for paint and coating removal. Paint and coating removal, also referred to as paint stripping, is the process of removing paint or other coatings from a surface. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Chemical and Allied Products Manufacturers (NAICS code 32411).

• Ship building and repairing (NAICS code 336611)

• Aircraft manufacturing (NAICS code 336411)

• Museums (NAICS code 712110)

• Independent Artists, Writers, and Performers (NAICS code 711510)

• Reupholster and furniture repair (NAICS code 811420)

• Automotive body, paint, and interior repair and maintenance (NAICS code 811121)

• Flooring contractors (NAICS code 238330)

• Painting and wall covering contractors (NAICS code 238320)

This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Persons who import any chemical substance governed by a final TSCA section 6(a) rule are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements and the corresponding regulations at 19 CFR

12.118 through 12.127; see also 19 CFR 127.28. Those persons must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of this proposed rule are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)), and must comply with the export notification requirements in 40 CFR part 707, subpart D.

If you have any questions regarding the applicability of this proposed action to a particular entity, consult the technical information contact listed under

FOR FURTHER INFORMATION CONTACT

.

B. What is the Agency's authority for taking this action?

Under TSCA section 6(a) (15 U.S.C. 2605(a)), if EPA determines after risk evaluation that 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, under the conditions of use, EPA must by rule apply one or more requirements to the extent necessary so that the chemical substance or mixture no longer presents such risk.

With respect to a chemical substance listed in the 2014 update to the TSCA Work Plan for Chemical Assessments for which a completed risk assessment was published prior to the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, TSCA section 26(l)(4) (15 U.S.C. 2625(l)(4)) expressly authorizes EPA to issue rules under TSCA section 6(a) that are consistent with the scope of the completed risk assessment and consistent with the other applicable requirements of TSCA section 6. Methylene chloride and NMP are such chemical substances (Ref. 1). They are listed in the 2014 update to the TSCA Work Plan and the completed risk assessments were published in 2014 and 2015, respectively. The scope of each completed risk assessment includes consumer and commercial paint and coating removal.

C. What action is the Agency taking?

EPA proposes a determination that the uses of methylene chloride or NMP in paint and coating removal present an unreasonable risk of injury to health. Accordingly, for methylene chloride, EPA is proposing under section 6 of TSCA to prohibit the manufacture (including import), processing, and distribution in commerce of methylene chloride for all consumer and for most types of commercial paint and coating removal uses. EPA is also proposing under TSCA section 6 to prohibit the use of methylene chloride for commercial paint and coating removal in the specified sectors, which include painting and decorating, floor refinishing, automotive refinishing, civilian aircraft refinishing, graffiti removal, renovations and contracting, bridge repair and repainting, and marine craft refinishing and repair. EPA is not proposing at this time to regulate the use of methylene chloride in commercial furniture refinishing, also referred to as furniture stripping or refinishing conducted by professionals or commercial workers. EPA is also proposing to exempt certain uses of methylene chloride for coating removal that EPA proposes are critical for national security.

EPA is also proposing to require that any paint or coating removal products containing methylene chloride that continue to be distributed be packaged in containers with a volume no less than 55 gallons, except for formulations specifically manufactured for the Department of Defense, which may be distributed in containers with volumes no less than 5 gallons. EPA is also proposing to require manufacturers (including importers), processors, and distributors, except for retailers, of methylene chloride for any use to provide downstream notification of these requirements and prohibitions throughout the supply chain; and to require limited recordkeeping. More details on this supply chain approach are in Unit VI.C.3.

EPA intends to issue a separate proposal on methylene chloride in paint and coating removal in commercial furniture refinishing, but plans to issue one final rule covering both this proposal and the future proposed rule on methylene chloride in paint and coating removal in commercial furniture refinishing. More information on such a future proposal that would directly address methylene chloride in paint and coating removal in furniture refinishing is in Unit XI.

For NMP, EPA is co-proposing two different options to reduce the unreasonable risks presented by NMP in paint and coating removal for consumers and commercial users. EPA is co-proposing these two options because the Agency is interested in public consideration of these approaches, and is soliciting comments regarding the extent to which these approaches could reduce the unreasonable risks the Agency has identified.

Under the first approach co-proposed for NMP (option 1), EPA is proposing to prohibit the manufacture (including import), processing, and distribution in commerce of NMP for all consumer and commercial paint and coating removal, with exemptions for certain coating removal uses that EPA proposes are critical to national security. EPA is also proposing to prohibit the commercial use of NMP for paint and coating removal, with exemptions for certain coating removal uses that EPA proposes are critical to national security. These exemptions include the condition that any exempt paint and coating removal products containing NMP be packaged in containers with a volume no less than 5 gallons. Unlike the option proposed for methylene chloride, these exemptions do not include the use of NMP in furniture refinishing. EPA is also proposing to require manufacturers (including importers), processors, and distributors, except for retailers, of NMP for any use to provide downstream notification of these prohibitions throughout the supply chain; and to require limited recordkeeping.

Under the second approach proposed for NMP, EPA is proposing a reformulation, PPE, and labeling approach. This would require product reformulation to limit the concentration of NMP in paint and coating removal products; testing of product formulations to identify specialized gloves that provide protection; relabeling of products to provide additional information to consumers; an occupational dermal and respiratory protection program for commercial use of NMP in paint and coating removal, downstream notification when distributing NMP for other uses, and limited recordkeeping. Under this approach, no exemption is proposed for coating removal identified as critical for national security because paint and coating removal products containing NMP would continue to be available for these national security uses under this option, even without establishing a national security exemption.

EPA is requesting public comment on these proposals.

D. Why is the Agency taking this action?

Based on EPA's analysis of worker and consumer populations' exposures to methylene chloride and NMP in paint and coating removal, EPA proposes a determination that methylene chloride and NMP in paint and coating removal present an unreasonable risk to human

health. For methylene chloride, the health impacts of its use in paint and coating removal include death (due to asphyxiation), liver toxicity, kidney toxicity, reproductive toxicity, specific cognitive impacts, and cancers such as brain cancer, liver cancer, certain lung cancers, non-Hodgkin's lymphoma, and multiple myeloma (Ref. 2). Some of these effects result from a very short, acute exposure; others follow years of occupational exposure. For NMP, these health effects include developmental toxicity (

e.g.,

fetal death or decreased infant birth weight), neurotoxicity, immunotoxicity, liver and kidney toxicity, and reproductive toxicity (Ref. 3).

It is important to note that while both methylene chloride and NMP are used in paint and coating removal, products containing NMP have in recent years become increasingly popular substitutes for users interested in avoiding the health effects or odors known to be associated with products containing methylene chloride. While exposures to these chemicals have been assessed using different health endpoints, EPA proposes a determination that the use of either methylene chloride or NMP in paint and coating removal presents unreasonable risks. For this reason, EPA proposes to address the unreasonable risks presented by both chemicals in one rule.

Although EPA proposes to determine that the identified risks to workers exposed to methylene chloride in commercial furniture refinishing are unreasonable, EPA is not proposing to regulate these risks at this time. EPA intends to issue a separate proposal addressing the use of methylene chloride in paint and coating removal in commercial furniture refinishing. See Unit XI.

As discussed in Unit V.C., EPA is not proposing to prohibit all manufacturing, processing, distribution in commerce, and use of methylene chloride or NMP, of which paint and coating removal is estimated to comprise 25% and 9% of the use of each chemical, respectively (Refs. 2 and 3).

E. What are the estimated incremental impacts of this action?

EPA proposes to determine that the identified risks from methylene chloride and NMP in paint and coating removal are unreasonable. Apart from that proposed determination, EPA has evaluated the potential costs of the proposed approach of (1) prohibiting the manufacture (including import), processing, and distribution in commerce of methylene chloride for all consumer paint and coating removal in the sectors specified in section I.C of this preamble, exempting specific uses critical to national security; (2) prohibiting the commercial use of methylene chloride for paint and coating removal in the specified sectors; (3) requiring any paint and coating removal products containing methylene chloride to be packaged for distribution in commerce in containers with volumes no less than 55 gallons so as to reduce diversion to restricted uses, except for formulations specifically manufactured for the Department of Defense; (4) requiring manufacturers (including importers), processors, and distributors, except for retailers, to provide downstream notification of these prohibitions throughout the supply chain; and (5) requiring associated recordkeeping requirements. EPA has also evaluated the costs of the two co-proposed options for NMP. Under the first option, this includes (1) prohibiting the manufacture (including import), processing, and distribution in commerce of NMP for all paint and coating removal, exempting specific uses critical to national security; (2) prohibiting the commercial use of NMP for paint and coating removal exempting specific uses critical to national security; (3) requiring any paint and coating removal products containing NMP to be packaged for distribution in commerce in containers with a volume no less than 5 gallons; (4) requiring manufacturers (including importers), processors, and distributors of NMP for any use, except for retailers, to provide downstream notification of these prohibitions throughout the supply chain; and (5) requiring associated recordkeeping requirements. Under the second option, this includes: (1) Prohibiting the manufacture, processing, and distribution in commerce of paint and coating removal products containing more than 35 percent NMP by weight except for products used for critical national security uses; (2) Requiring product formulators to test gloves for the product formulations being processed and distributed in commerce for other than exempt critical national security uses to identify specialized gloves that provide protection for users and keep records relevant to these tests; (3) Requiring product formulators to label products with information for consumers about the risks presented by the products and how to reduce these risks during use, including identifying which specialized gloves provide protection against the specific formulation; (4) Requiring product formulators to provide information for commercial users about reducing risks when using the product, via product labels, SDS, and other methods of hazard communication, and to keep records; (5) Prohibiting the commercial use of paint and coating removal products that contain more than 35 percent by weight of NMP, except for critical national security uses; and (6) Requiring commercial users to establish worker protection programs for dermal and respiratory protection, including hazard communication and training, and to require their employees to wear specialized gloves, impervious clothing that covers most of the body, and a respirator with an assigned protection fact (APF) of 10 or compliance with an alternative air exposure limit.

This analysis, which is available in the docket, is discussed in Units VII.A. and XVII.A., and is briefly summarized here.

Costs of the proposed approach and relevant alternate approaches for each chemical are discussed in Units VII.A. for methylene chloride and XVII.A. for NMP. Costs for the whole proposal follow. Costs to users of methylene chloride or NMP for paint and coating removal under the first co-proposed approach for NMP are $2,517,000 to $50,801,000 annualized for 20 years at a discount rate of 3% and $3,114,000 to $50,916,000 at a discount rate of 7%. Costs to users of methylene chloride or NMP for paint and coating removal under the second co-proposed approach for NMP are $114,164,860 to $124,893,000 annualized for 20 years at a discount rate of 3% and $114,658,000 to $125,438,000 at a discount rate of 7%. As described in more detail in the Economic Analysis (Ref. 4) and supplement to the Economic Analysis (Ref. 127), there are estimated to be approximately 13,000 commercial firms and 2,002,000 consumers who use methylene chloride or NMP in paint and coating removal that would be affected; costs per firm and for each household are estimated to include costs of alternative formulations of paint removal products, additional time spent applying or removing paint with alternative methods or substitute products, and other cost factors. For product processors and formulators, the costs of paint and coating removal product reformulations for methylene chloride and NMP under the first co-proposed approach for NMP are estimated to be approximately $17,000 to $34,000 per year (annualized at 3% over 20 years) and $23,000 to $43,000 (annualized at 7% over 20 years). For product processors and formulators, the costs of paint and coating removal product reformulations for methylene

chloride and NMP under the second co-proposed approach for NMP are estimated to be approximately $25,140 to $41,140 per year (annualized at 3% over 20 years) and $34,160 to $55,160 (annualized at 7% over 20 years). Only 17 firms are estimated to be affected. For manufacturers, processors, and distributors of methylene chloride or NMP under the first co-proposed approach for NMP, the costs of downstream notification and recordkeeping on an annualized basis over 20 years are $140 and $160 using 3% and 7% discount rates respectively. For manufacturers, processors, and distributors of methylene chloride or NMP under the second co-proposed approach for NMP, the costs of downstream notification and recordkeeping on an annualized basis over 20 years are $140 and $160 using 3% and 7% discount rates respectively (the same as under the first co-proposed approach). Approximately 30 firms are estimated to be affected. Agency costs for enforcement for each chemical, under the first co-proposed approach for NMP, are estimated to be approximately $114,401 and $111,718 annualized over 20 years at 3% and 7%, respectively (Ref. 4). Total Agency costs for enforcement, for both chemicals together under the first co-proposed approach for NMP, are estimated to be approximately $228,802 and $223,436 annualized over 20 years at 3% and 7%. Agency costs for enforcement for each chemical, under the second co-proposed approach for NMP, are estimated to be approximately $114,401 and $111,718 annualized over 20 years at 3% and 7%, respectively for methylene chloride and $1,024,144 and $998,711 annualized over 20 years at 3% and 7% respectively for NMP (Ref. 127). Total Agency costs for enforcement, for both chemicals together under the second co-proposed approach for NMP, are estimated to be approximately $1,138,545 and $1,110,429 annualized over 20 years at 3% and 7%.

In summary, total costs of the proposed rule under the first co-proposed approach for NMP are estimated to be $2,763,000 to $51,070,000 annualized over 20 years at 3% and $3,361,000 to $51,163,000 annualized over 20 years at 7% (Ref. 4). Total costs of the proposed rule under the second co-proposed approach for NMP are estimated to be $114,196,000 to $124,893,000 annualized over 20 years at 3% and $114,658,000 to $125,438,000 annualized over 20 years at 7% (Ref. 127).

Although methylene chloride in paint and coating removal can cause a wide range of non-cancer adverse effects, cancer, and death and NMP can cause a variety of developmental non-cancer adverse effects, monetized benefits included only the subset of benefits associated with reducing cancer risks or deaths that occur at a known rate among users or bystanders. Methodological limitations prevent EPA from being able to include a quantification or monetary valuation estimate of the other non-cancer benefits at this time, and thus there is not a quantification or monetary valuation estimate for the overall total benefits. Based on the costs and benefits that EPA can estimate, the monetized benefits for the proposed approach range from approximately $14,354,000 to $14,558,000 on an annualized basis over 20 years at 3% and $13,791,000 to $13,919,000 at 7% (Ref. 4). EPA also considered non-monetized benefits that would result from the prevention of non-cancer adverse effects associated with methylene chloride or NMP in paint and coating removal, including nervous system effects, liver toxicity, kidney toxicity, and reproductive effects from exposure to methylene chloride in paint and coating removal; and developmental toxicity, fetal death, fetal body weight reductions, kidney toxicity, liver toxicity, immunotoxicity, and reproductive toxicity from exposure to NMP in paint and coating removal (Refs. 2 and 3).

F. Children's Environmental Health

This action is consistent with the 1995 EPA Policy on Evaluating Health Risks to Children (

http://www.epa.gov/children/epas-policy-evaluating-risk-children

). In its risk assessments for methylene chloride and NMP, EPA identified risks to children from exposure to methylene chloride and NMP used in paint and coating removal. EPA has also identified women of childbearing age as a potentially exposed or susceptible subpopulation who may be at greater risk than the general population of adverse health effects from exposure to NMP. EPA has identified this subpopulation as relevant to EPA's risk assessment for NMP due to NMP's effects on the developing fetus. Therefore, the risk management standard under Section 6 of TSCA, with respect to NMP, is to reduce the risk posed by NMP so that it no longer presents an unreasonable risk (either to users in the general population or to users who are women of childbearing age). In its TSCA Work Plan Risk Assessment for methylene chloride, EPA identified risks from inhalation exposure to children who may be present as bystanders in homes where paint removal occurs. These risks include neurological effects such as cognitive impairment, sensory impairment, dizziness, incapacitation, and loss of consciousness (leading to risks of falls, concussion, and other injuries). The supporting non-cancer risk analysis of children as bystanders conducted in the TSCA Work Plan Risk Assessment for methylene chloride meets the 1995 EPA Policy on Evaluating Health Risks to Children. Supporting information on the health effects of methylene chloride exposure to children is available in the Toxicological Review of Methylene Chloride (Ref. 5) and the Final Risk Assessment on Methylene Chloride (Ref. 2), as well as Units VI.C.1. and VI.D.

In the TSCA Work Plan Risk Assessment for NMP, EPA identified developmental toxicity as the most sensitive endpoint for NMP exposure (

i.e.,

fetal death and decreased fetal birth weight) for the most sensitive human life stages (

i.e.,

women of childbearing age between the ages of 16 and 49 years and the fetus) (Ref. 3). The supporting non-cancer risk analysis of children and women of childbearing age conducted in the TSCA Work Plan Risk Assessment for NMP meets the 1995 EPA Policy on Evaluating Health Risks to Children.

II. Overview of Methylene Chloride and Uses Subject to This Proposed Rule

A. What chemical is included in the proposed rule?

This proposed rule would apply to methylene chloride (CASRN 75-09-2) when used in paint and coating removal except for several specified uses, including as part of commercial furniture refinishing and uses critical to national security.

B. What are the uses of methylene chloride?

Methylene chloride is a solvent used in a variety of industrial, commercial and consumer use applications, including (Ref. 2):

• Paint remover

• Adhesive

• Aerosol propellant

• Metal cleaner and degreaser

• Chemical processor for polycarbonate resins and cellulose triacetate (photographic film)

• Feedstock in the production of the refrigerant hydrofluorocarbon-32

Minor uses of methylene chloride include (Ref. 2):

• Extraction solvent for oils, waxes, fats, spices, and hops

• Tablet coating for pharmaceuticals

According to the 2012 Chemical Data Reporting (CDR) information, approximately 260 million pounds of

methylene chloride were produced or imported into the United States that year, with between 80% to 96% produced in the United States (Ref. 2). In terms of environmental releases, 277 facilities reported a total of 3.2 million pounds of releases of methylene chloride to the 2014 Toxics Release Inventory (Ref. 6).

Individuals, including workers, consumers, and the general population, are exposed to methylene chloride from industrial/commercial and consumer sources in different settings such as homes and workplaces, and through multiple routes (inhalation, dermal, and ingestion).

The use assessed by EPA that is the subject of this proposal, methylene chloride in paint and coating removal, represents about 25% of total use of methylene chloride. This is a decrease from the 1980s, when approximately 50% of the total methylene chloride market was composed of paint removal use (Ref. 2). Paint and coating removal is the application of a chemical or use of another method to remove, loosen, or deteriorate any paint, varnish, lacquer, graffiti, surface protectants, or other coatings from a substrate. Substrates can include objects, vehicles, architectural features, or structures. This use is discussed in detail in Unit VI.B.

Although the TSCA Work Plan Chemical risk assessment for methylene chloride focused on the chemical's use in paint and coating removal, EPA announced in December 2016 its designation of methylene chloride as one of the ten chemical substances that will undergo risk evaluation pursuant to section 6(b)(2)(A) of TSCA (81 FR 91927). The Agency is proceeding with this proposed rule addressing methylene chloride in paint and coating removal in accordance with TSCA section 26(l) and asks for comment on its decision to pursue risk management for specific conditions of use of methylene chloride while preparing to conduct a risk evaluation of remaining conditions of use of methylene chloride under TSCA section 6(b).

C. What are the potential health effects of methylene chloride?

Methylene chloride is a likely human carcinogen, a neurotoxicant, and acutely lethal. Acute and chronic exposures to methylene chloride are primarily associated with neurological and hepatic effects. The primary target organ of methylene chloride acute toxicity is the brain, and neurological effects result from either direct narcosis or the formation of carbon monoxide. Carbon monoxide is one of the metabolic byproducts of methylene chloride, and reversibly binds to hemoglobin as carboxyhemoglobin. Part of the effect of methylene chloride on the central nervous system comes from the accumulation of carboxyhemoglobin in the blood, which can lead to sensory impairment, dizziness, incapacitation, loss of consciousness, heart failure, and death (Ref. 2). Hemoglobin in the fetus has a higher affinity for carbon monoxide than does adult hemoglobin. Thus, the neurotoxic and cardiovascular effects may be exacerbated in fetuses and in infants with higher residual levels of fetal hemoglobin when exposed to high concentrations of methylene chloride (Ref. 2).

During acute exposures, methylene chloride primarily affects the brain, though effects on lung, liver, and kidney have also been reported in humans following acute exposures. Acute exposures to methylene chloride can be fatal; acute lethality in humans following inhalation exposure is related to central nervous system depressant effects. Effects include loss of consciousness and respiratory depression, resulting in irreversible coma, hypoxia, and eventual death. Acute non-lethal effects in humans are similarly related to the central nervous system and can include incapacitation, loss of consciousness, heart failure, and coma. Other acute non-lethal effects in humans include neurobehavioral deficits measured in psychomotor tasks, such as tests of hand-eye coordination, visual evoked response changes, and auditory vigilance (Ref. 2).

Since 1976, more than 40 deaths have been attributed to methylene chloride when used in paint and coating removal (Ref. 7); in some cases, two or more individuals have died during a single job when air concentrations quickly reached lethal levels, potentially in less than 10 minutes. In other situations, individuals have died when entering rooms or facilities in which paint or coating removal was previously conducted and air concentrations of methylene chloride remained dangerously high (Ref. 7).

Chronic exposures to methylene chloride are associated with cancer and non-cancer hepatic effects. Methylene chloride is likely to be carcinogenic in humans with a mutagenic mode of action. This mutagenic mode of action is supported by the weight of evidence from multiple

in vivo

and

in vitro

studies. There is a risk for some specific cancers, including brain cancer, liver cancer, non-Hodgkin lymphoma, and multiple myeloma. Additionally, several cancer bioassays in animals have identified the liver and lung as the most sensitive target organs for tumor development induced by methylene chloride (Ref. 2).

Non-cancer effects of chronic exposure to methylene chloride are primarily hepatic; the liver is the most sensitive target for non-cancer toxicity. Lifetime exposure in rats dosed with different concentrations is associated with hepatic vacuolation, degeneration, or liver necrosis. Other non-cancer effects of chronic methylene chloride exposure include renal tubular degeneration in rats and mice, testicular atrophy in mice, and ovarian atrophy in mice (Ref. 2).

D. What are the environmental impacts of methylene chloride?

Pursuant to TSCA section 6(c), EPA in this unit describes the effects of methylene chloride on the environment and the magnitude of the exposure of the environment to methylene chloride. The proposed unreasonable risk determination, however, is based solely on risks to human health since these risks are the most serious consequence of use of methylene chloride and are sufficient to support this proposed action.

1.

Environmental effects and impacts.

Methylene chloride is mainly released to the environment in air, and to a lesser extent in water and soil, due to industrial and consumer uses as a solvent, in aerosol products, and in paint and coating removal. Many chemical waste sites contain methylene chloride and these might act as additional sources of environmental contamination through spills, leaks, or evaporation. Because methylene chloride evaporates readily, most releases enter the air. In the air, it is broken down by sunlight and by reaction with other chemicals present in the air. In the air, methylene chloride's half-life is between 53 to 127 days (Ref. 8).

Ecotoxicity studies for methylene chloride have been conducted in fish, aquatic invertebrates, and aquatic plants. Based on available data, in the methylene chloride risk assessment EPA concluded that methylene chloride has low aquatic toxicity for fish, aquatic invertebrates, and aquatic plants (Ref. 2).

While methylene chloride is moderately persistent, given its low bioaccumulation and low hazard for aquatic toxicity, the magnitude of potential environmental impacts on ecological receptors is judged to be low for the environmental releases associated with methylene chloride in paint removal. This should not be misinterpreted to mean that methylene chloride does not pose environmental

concerns. Through other regulations, EPA is addressing methylene chloride releases to air and contamination of groundwater, drinking water, and contaminated soils. While the primary concern with this contamination has been human health, there is potential for methylene chloride exposures to ecological receptors in some cases (Ref. 2). More information about regulations to reduce environmental impacts of methylene chloride is in Unit III.

2.

What is the global warming potential of methylene chloride?

Global warming potential (GWP) measures the potency of a greenhouse gas over a specific period of time, relative to carbon dioxide, which has a high GWP of 1 regardless of the time period used. Due to its volatility, methylene chloride enters the atmosphere where it reacts slowly enough to undergo atmospheric transport and act as a greenhouse gas. Methylene chloride has been reported to the Intergovernmental Panel on Climate Change as a global warming potential chemical with a value of 8.7 GWP, or approximately 8.7 times more heat absorptive than carbon dioxide (Ref. 2).

3.

What is the ozone depletion potential of methylene chloride?

Methylene chloride is not an ozone-depleting substance and is listed as acceptable under the Significant New Alternatives Policy program for metal and electronic cleaning (degreasing), aerosol solvents, foam blowing agents, and other uses (59 FR 13044, March 18, 1994).

4.

Is methylene chloride a volatile organic compound (VOC)?

Though volatile, methylene chloride is exempt from being classified as a VOC as defined at 40 CFR 51.100(c). A VOC is any compound of carbon, excluding carbon monoxide, carbon dioxide, carbonic acid, metallic carbides or carbonates, and ammonium carbonate, which participates in atmospheric photochemical reactions. Because methylene chloride has negligible atmospheric photochemical reactions, it is not classified as a VOC (40 CFR 51.100(s)(1)).

5.

Does methylene chloride persist in the environment and bioaccumulate?

Due to its volatility, methylene chloride does not significantly partition to solid phases. Therefore, releases of methylene chloride to the environment are likely to evaporate to the atmosphere, or if released to soil, migrate to groundwater. Methylene chloride has been shown to biodegrade over a range of rates and environmental conditions. Measured bioconcentration factors for methylene chloride suggest its bioconcentration potential is low (Ref. 2).

III. Regulatory Actions Pertaining to Methylene Chloride

This section summarizes current state, federal, and international regulations and restrictions on methylene chloride, with a focus on its use in paint and coating removal. None of these actions imposes requirements to the extent necessary so that methylene chloride does not present the unreasonable risk described in this proposed rule.

A. Federal Actions Pertaining to Methylene Chloride

Methylene chloride has been the subject of U.S. federal regulations by EPA, the Consumer Product Safety Commission (CPSC), the Food and Drug Administration (FDA), and the Occupational Safety and Health Administration (OSHA). EPA and other agencies have taken actions (see below) to address the serious human health risks from specific sources and routes of methylene chloride exposure, but none of these actions sufficiently mitigate the risks that EPA is proposing to address under TSCA section 6(a).

EPA has issued several final rules and notices pertaining to methylene chloride under EPA's various authorities.

•

Clean Air Act:

Methylene chloride is designated as a hazardous air pollutant (HAP) under the Clean Air Act (42 U.S.C. 7412(b)(1))CAA). EPA issued a final rule in January 2008 that promulgated National Emission Standards for Hazardous Air Pollutants (NESHAP) for area sources engaged in paint stripping, surface coating of motor vehicles and mobile equipment, and miscellaneous surface coating operations. In this NESHAP, EPA listed “Paint Stripping,” “Plastic Parts and Products (Surface Coating),” and “Autobody Refinishing Paint Shops” as area sources of HAPs that contribute to the risk to public health in urban areas. The final rule included emissions standards that reflect the generally available control technology or management practices in each of these area source categories, and applies to paint stripping operations using methylene chloride (73 FR 1738, January 9, 2008). In 2014, EPA issued a final rule for Flexible Polyurethane Foam Manufacturing that banned the use of methylene chloride as a foam-blowing agent (79 FR 48073, August 15, 2014). In 2015, EPA issued a final rule for Aerospace Manufacturing and Rework Facilities, which updated a NESHAP from 1995 by adding limitations to reduce organic and inorganic emissions HAPs, including methylene chloride, from specialty coating application operations; and removed exemptions for periods of startup, shutdown and malfunction so that affected units would be subject to the emission standards at all times (80 FR 76152, December 7, 2015).

•

Solid Waste Disposal Act:

Methylene chloride is listed as a hazardous waste under the Resource Conservation and Recovery Act (RCRA) (Code U080) (Ref. 2).

•

Emergency Planning and Community Right-to-Know Act:

Methylene chloride is listed on the Toxics Release Inventory (TRI) pursuant to section 313 of the Emergency Planning and Community Right-to-Know Act (Ref. 2).

•

Safe Drinking Water Act:

The Safe Drinking Water Act (SDWA) requires EPA to determine the level of contaminants in drinking water at which no adverse health effects are likely to occur. EPA has set a maximum contaminant level goal of zero and an enforceable maximum contaminant level for methylene chloride at 0.005 mg/L or 5 parts per billion (57 FR 31776, July 17, 1992).

Regulation of methylene chloride by other agencies includes:

• In 1987, CPSC issued a statement of policy explaining that CPSC considers household products containing methylene chloride to be hazardous substances and providing guidance on labeling of such products. Labels of products containing methylene chloride are required to state that inhalation of methylene chloride vapor has caused cancer in certain laboratory animals, and the labels must specify precautions to be taken during use by consumers (52 FR 34698, September 14, 1987). In 2016, CPSC was petitioned by the Halogenated Solvents Industry Alliance to amend the statement of interpretation and enforcement policy regarding labeling of household products containing methylene chloride; CPSC published that petition for public comments (81 FR 60298, September 1, 2016).

• In 1989, FDA banned methylene chloride as an ingredient in all cosmetic products because of its animal carcinogenicity and likely hazard to human health (21 CFR 700.19). Before 1989, methylene chloride had been used in aerosol cosmetic products, such as hairspray (54 FR 27328 (June 29, 1989)).

• OSHA has taken steps to reduce exposure to methylene chloride in occupational settings. In 1997, OSHA lowered the permissible exposure limit (PEL) for methylene chloride from an eight-hour time-weighted average (TWA) of 500 parts per million (ppm) to an eight-hour TWA of 25 ppm and a 15-minute short-term exposure limit

(STEL) of 125 ppm. This standard also includes provisions for initial exposure monitoring, engineering controls, work practice controls, medical monitoring, employee training, personal protective equipment, and recordkeeping (29 CFR 1910.1052).

• The Department of Housing and Urban Development (HUD) has prohibited methylene chloride and other hazardous chemicals for use in removing lead-based paint by HUD contractors and anyone receiving grants or engaging in the HOME Program, which was created by the National Affordable Housing Act of 1990 (Ref. 9).

• The National Institute for Occupational Safety and Health (NIOSH) considers methylene chloride a potential occupational carcinogen and currently recommends an exposure limit of the “lowest feasible concentration” of methylene chloride (Ref. 10). NIOSH and OSHA in 2013 issued a hazard alert for bathtub refinishing with methylene chloride, warning that methylene-chloride based products are extremely dangerous and that the best way to prevent exposure is to use products that do not contain methylene chloride (Ref. 11).

B. State Actions Pertaining to Methylene Chloride

Several states have taken actions to reduce or make the public aware of risks from methylene chloride. For example, since 2011 methylene chloride has been prohibited from use in graffiti removal in the District of Columbia and 11 states (California, Connecticut, Delaware, Illinois, Indiana, Maine, Maryland, Michigan, New Jersey, New York, and Rhode Island) (Ref.12). Iowa, Indiana, South Carolina, and other states have established detection monitoring regulations for methylene chloride (567 IAC 113.15, 329 IAC 10-21-15, S.C. Code Regs. 16-107.198, Appx. III). In Alaska, methylene chloride is listed as a carcinogenic hazardous substance (18 AAC 75.341). Methylene chloride is listed on California's Safer Consumer Products regulations candidate list of chemicals that exhibit a hazard trait and are on an authoritative list of either chemical hazard traits or potential exposure concerns (Ref. 13). Methylene chloride is also listed on California's Proposition 65 list of chemicals known to cause cancer, birth defects, or reproductive harm (Ref. 13). In Minnesota, it has been found that methylene chloride may negatively affect the nervous system and cause cancer (Minn. R. 4717.8200, Minn. R. 4717.8100). The state of Washington has listed methylene chloride as a human carcinogen and a chemical of high concern to children (WAC 296-62-07473, WAC 173-334-130). In Pennsylvania, it is listed as an environmental and special hazardous substance (34 Pa. Code XIII, Ch. 323.2(a)).

All states have set PELs identical to the OSHA 25 ppm eight-hour time weighted average (TWA) PEL (79 FR 61384, October 10, 2014), however it is worth noting that California, Oregon, and Washington, which have a state PEL identical to the OSHA PEL, have slightly different requirements than OSHA for medical evaluation, fit testing for respirators, and implementation timelines related to methylene chloride (8 CCR 5502, OAR 437-002-1052, WAC 296-62-07470). The OSHA PEL is considerably higher than the levels at which EPA identified risks of concern for methylene chloride in paint and coating removal and would not be protective for the unreasonable risks identified.

C. International Actions Pertaining to Methylene Chloride

Methylene chloride is also regulated internationally and industrial and commercial sectors in certain other countries have moved to alternatives.

In Canada, the Canadian Minister of the Environment published in 2003 a Notice under Part 4 of the “Canadian Environmental Protection Act, 1999” requiring the preparation and implementation of pollution prevention plans for methylene chloride (Ref. 14). This Notice targets persons involved in the use of methylene chloride for the following activities: Aircraft paint stripping; flexible polyurethane foam blowing; pharmaceuticals and chemical intermediates manufacturing and tablet coating; industrial cleaning; and adhesive formulations. Also in 2003, Environment Canada published a Code of Practice for the reduction of methylene chloride emissions from the use of paint and coating removal products in commercial furniture refinishing and other stripping applications (Ref. 14). This Code of Practice was developed by a multi-stakeholder technical working committee, which consisted of industry representatives (

i.e.,

furniture refinishers, auto body shops, formulators of paint and coating removal products, solvent recovery firms), government personnel, and environmental non-governmental organizations.

In the European Union, the European Commission amended its Registration, Evaluation, Authorization, and Restriction of Chemical substances in 2010 to incorporate restrictions for the use of methylene chloride in paint removers. Methylene chloride is banned in the European Union from: (1) Placement on the market in a new product for consumers/professionals after December 2010; (2) placement on the market in any product for consumers/professionals after December 2011; and (3) use by professionals after June 2012. Member States could allow the use of methylene chloride if they have a program to license and train professionals in the following: Awareness; evaluation and management of risks; use of adequate ventilation; and use of appropriate personal protective equipment (Ref. 15). The United Kingdom has issued a derogation to allow professional use of methylene chloride (Ref. 16). In addition, industrial installations using methylene chloride must have effective ventilation, minimize evaporation from tanks, and have measures for safe handling of methylene chloride in tanks, adequate personal protective equipment, and adequate information and training for operators. Paint and coating removers containing methylene chloride in a concentration equal to or greater than 0.1% by weight must include a label: “Restricted to industrial use and to professionals approved in certain EU Member States—verify where use is allowed” (Ref. 15).

IV. Methylene Chloride Risk Assessment and Outreach

In 2013, EPA identified methylene chloride in paint and coating removal as a priority for risk assessment under the TSCA Work Plan. This unit describes the development of the methylene chloride risk assessment and supporting analysis and expert input on the uses that are the subject of this proposed rule. A more detailed discussion of the risks associated with methylene chloride in paint and coating removal can be found in Unit VI.C.1.

A. TSCA Work Plan for Chemical Assessments

In 2012, EPA released the “TSCA Work Plan Chemicals: Methods Document” in which EPA described the process the Agency intended to use to identify potential candidate chemicals for near-term review and assessment under TSCA (Ref. 17). EPA also released the initial list of TSCA Work Plan chemicals identified for further assessment under TSCA as part of its chemical safety program (Ref. 1).

The process for identifying these chemicals for further assessment under TSCA was based on a combination of hazard, exposure, and persistence and bioaccumulation characteristics, and is

described in the TSCA Work Plan Chemicals Methods Document (Ref. 17). Using the TSCA Work Plan chemical prioritization criteria, methylene chloride ranked high for health hazards and exposure potential and was included on the initial list of TSCA Work Plan chemicals for assessment. Methylene chloride appeared in the 2012 TSCA Work Plan for Chemical Assessments and in the 2014 update of the TSCA Work Plan for Chemical Assessments.

B. Methylene Chloride Risk Assessment

EPA finalized a TSCA Work Plan Chemical Risk Assessment for methylene chloride (methylene chloride risk assessment) in August 2014, following the 2013 peer review of the 2012 draft methylene chloride risk assessment. All documents from the 2013 peer review of the draft methylene chloride risk assessment are available in EPA Docket Number EPA-HQ-OPPT-2012-0725. The completed risk assessment is included in that docket.

The methylene chloride risk assessment evaluated health risks to consumers, workers, and bystanders from inhalation exposures to methylene chloride when used in paint and coating removal (Ref. 2). EPA assumes workers and consumers would be adults of both sexes 16 and older, including pregnant women. EPA assumes bystanders in commercial or occupational settings would be worker non-users or adjacent workers, while bystanders in residential settings would be individuals of any age group (

e.g.,

children, adults, the elderly) nearby during product application. During scoping and problem formulation for the risk assessment, EPA focused on paint and coating removal because it was expected to involve frequent or routine use of methylene chloride in high concentrations and/or have high potential for human exposure (Ref. 2). However, this does not mean that EPA found that other uses not included in the methylene chloride risk assessment present low risk.

The methylene chloride risk assessment characterized human health effects associated with paint removal with methylene chloride. Based on the physical-chemical properties of methylene chloride and the paint and coating removal use scenarios described in the assessment, EPA assessed inhalation as the predominant route of exposure to methylene chloride during paint removal. Though highly volatile compounds such as methylene chloride may also be absorbed through the skin, EPA does not have the data nor the methodology to assess methylene chloride dermal exposure during paint removal. As a result, the assessment may underestimate total exposures to methylene chloride during paint removal due to this inability to evaluate dermal exposure (Ref. 2).

The methylene chloride risk assessment identified risks of concern following acute (short-term) and chronic exposures for workers and consumers conducting paint removal with methylene chloride, as well as for exposed bystanders, including residents of homes in which paint removal is conducted and worker non-users adjacent to other workers conducting paint removal. The acute risks identified include death; neurological impacts such as coma, incapacitation, loss of consciousness, and dizziness; and liver effects. The chronic risks identified include brain, liver, lung, and hematopoietic cancers and liver damage (Ref. 2).

Margins of exposure (MOEs) were used in this assessment to estimate non-cancer risks for acute exposures (for consumers and workers) and chronic exposures (for workers). The MOE is the point of departure (an approximation of the no-observed adverse effect level (NOAEL)) for a specific health endpoint divided by the exposure concentration for the specific scenario of concern. The benchmark MOE accounts for the total uncertainty in a point of departure, including: (1) The variation in sensitivity among the members of the human population (

i.e.,

interhuman or intraspecies variability); (2) the uncertainty in extrapolating animal data to humans (

i.e.,

interspecies variability); (3) the uncertainty in extrapolating from data obtained in a study with less-than-lifetime exposure to lifetime exposure (

i.e.,

extrapolating from subchronic to chronic exposure); and (4) the uncertainty in extrapolating from a lowest observed adverse effect level rather than from a NOAEL (Ref. 18). MOEs provide a non-cancer risk profile by presenting a range of estimates for different non-cancer health effects for different exposure scenarios, and are a widely recognized method for evaluating a range of potential non-cancer health risks from exposure to a chemical. For non-cancer effects EPA estimated exposures that are significantly larger than the point of departure, thus resulting in MOEs that are significantly less than the benchmark MOE (Ref. 2). For methylene chloride, EPA identified acute or chronic non-cancer risks of concern if the MOE estimates were less than the benchmark MOE of 10 (Ref. 2). The health endpoint used for the benchmark MOE for acute exposure to methylene chloride is central nervous system effects, such as dizziness or incapacitation; the health endpoint used for the benchmark MOE for chronic exposure to methylene chloride is liver toxicity. These are the most sensitive adverse health effects from exposure to methylene chloride.

Methylene chloride is a likely human carcinogen; cancer risks determine the estimated incremental increased probability of an individual in an exposed population developing cancer over a lifetime following exposure to the chemical under specified use scenarios. Standard cancer benchmarks used by EPA and other regulatory agencies are an increased cancer risk of 1 in 1,000,000 ranging to 1 in 10,000 (

i.e.,

1 × 10

−6

to 1 × 10

−4

). For cancer effects, EPA estimated that workers and occupational bystanders exposed to methylene chloride in paint and coating removal have an increase in cancer risk that ranged from 10 times to almost 1,000 times greater than a cancer benchmark of 1 in 1,000,000, depending on the specific way paint or coating removal was conducted with methylene chloride (Ref. 2).

The levels of acute and chronic exposures estimated to present low risk for non-cancer effects also result in low risk for cancer.

The assessment identified the following risks from acute exposures to methylene chloride when used in paint and coating removal (Ref. 2):

• Acute risks of incapacitation, coma, or death in workers exposed to methylene chloride in paint removers when no respiratory protection is used. In some industries with high exposure scenarios, these risks of incapacitation or death are present even when respiratory protection is used.

• Acute risks of neurological effects for most workers. These risks are present even when respiratory protection is used.

• Acute risks of neurological effects for consumer users of methylene chloride as a paint remover.

• Acute risks of neurological effects for bystanders (including children and worker non-users) in the location in which paint removers containing methylene are used by either residents or commercial users. These risks are also present for exposures to methylene chloride in a location after the paint removal work is complete, because methylene chloride can remain in the air in spaces that are enclosed, confined, or lacking ventilation.

Based on the risk assessment scenarios, EPA identified the following non-cancer risks from chronic exposures to methylene chloride in paint and coating removal (Ref. 2):

• Non-cancer risks for liver effects for most workers (including worker non-users, or adjacent workers) in industries conducting paint removal.

• Non-cancer risks occur for most workers (including adjacent workers) when exposed to paint removers containing methylene chloride even when wearing respiratory protection in the exposure scenarios that predominantly demonstrate variations in exposure conditions (

i.e.,

exposure frequency and working years) in facilities reporting central tendency or high-end air levels of methylene chloride. Among all the occupational scenarios, the greatest risk of concern is for workers engaging in long-term use of or exposure to methylene chloride as a paint remover (

i.e.,

250 days/year for 40 years) with no respiratory protection.

The assessment identified the following cancer risks from chronic exposures to methylene chloride when used in paint removal (Ref. 2):

• Cancer risks for workers (including adjacent workers) exposed to methylene chloride as a paint remover in various industries. These cancer risks include liver cancer, lung cancer, brain cancer, non-Hodgkin lymphoma, and multiple myeloma.

• The greatest cancer risks occur for workers exposed to methylene chloride when used as a paint remover who have no respiratory protection and are exposed for an extended period.

C. Supplemental Analysis Consistent With the Methylene Chloride Risk Assessment

Following the methylene chloride risk assessment, EPA conducted supplemental analyses to inform risk management. These analyses are consistent with the scope of the methylene chloride risk assessment and were based on the peer-reviewed methodology used in the methylene chloride risk assessment. They included identification of baseline and central tendency exposure scenarios, impacts of reduced methylene chloride content in paint removers, addition of local exhaust ventilation (LEV), use of personal protective equipment (PPE), additional consumer exposure scenarios, and methods of monitoring to determine workplace exposures. The results of EPA's analyses are available in this rulemaking docket (Refs. 19, 20, and 21). Prior to promulgation of the final rule, EPA will peer review the “Respirator and Glove Specifications for Workers Exposed to Methylene Chloride in Paint and Coating Removal,” “Supplemental Consumer Exposure and Risk Estimation Technical Report for Methylene Chloride in Paint and Coating Removal”, and “Recommendation for an Existing Chemical Exposure Concentration Limit (ECEL) for Occupational Use of Methylene Chloride and Workplace Air Monitoring Methods for Methylene Chloride” (Refs. 19, 20, 21).

D. Outreach

In addition to the consultations described in Unit XXIII.C., EPA engaged in discussions with experts on and users of paint removers (Ref. 22). The purpose of these discussions was to hear from users, academics, manufacturers, and members of the public health community about practices related to paint removal in various industries and by consumers; the importance of methylene chloride and NMP in paint removal; frequently-used substitute chemicals or alternative paint removal methods; engineering control measures and personal protective equipment currently in use or feasibly adoptable for paint removal; and other risk reduction approaches that may have already been adopted or considered for commercial or consumer paint removal. Informed by these discussions and by industry and other governmental research, EPA has concluded that alternatives to methylene chloride and NMP are available for nearly all paint removal uses.

EPA is continuing to gather information, to the extent practicable, regarding the availability of alternatives to methylene chloride for furniture refinishing. EPA plans to continue to engage stakeholders to identify what methods may be available as alternatives to methylene chloride. After collecting the information, EPA expects to address this use of methylene chloride so that the substance no longer poses an unreasonable risk and intends to issue separately a proposal in the future. Also see Unit XI.

V. Regulatory Approach for Methylene Chloride in Paint and Coating Removal

A. TSCA Section 6(a) Unreasonable Risk Analysis

Under TSCA section 6(a), if the Administrator determines that 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 Agency's risk evaluation, under the conditions of use, EPA must by rule apply one or more requirements to the extent necessary so that the chemical substance no longer presents such risk.

TSCA section 6(a) requirements can include one or more, or a combination of, the following actions:

• Prohibit or otherwise restrict the manufacturing, processing, or distribution in commerce of such substances (§ 6(a)(1)).

• Prohibit or otherwise restrict the manufacturing, processing, or distribution in commerce of such substances for particular uses or for uses in excess of a specified concentration (§ 6(a)(2)).

• Require minimum warning labels and instructions (§ 6(a)(3)).

• Require recordkeeping or testing (§ 6(a)(4)).

• Prohibit or regulate any manner or method of commercial use (§ 6(a)(5)).

• Prohibit or otherwise regulate any manner or method of disposal (§ 6(a)(6)).

• Direct manufacturers and processors to give notice of the determination to distributors and the public and replace or repurchase substances (§ 6(a)(7)).

EPA analyzed a wide range of regulatory options under section 6(a) for each use in order to select the proposed regulatory approach (Refs. 23 and 24). For each use, EPA considered whether a regulatory option (or combination of options) would address the identified unreasonable risks so that the chemical substance no longer presents such risks. EPA found that an option that could reduce exposures such that they would achieve the benchmark MOE for the most sensitive non-cancer endpoint would address the risk of concern for other non-cancer endpoints. Additionally, EPA's assessments for methylene chloride in paint and coating removal found that exposures that meet the benchmark MOE for the most sensitive non-cancer endpoint would also not result in cancer risks of concern.

After the technical analysis, which represents EPA's assessment of the potential for the regulatory options to achieve risk benchmarks based on analysis of exposure scenarios, EPA then considered how reliably the regulatory options would actually reach these benchmarks. For the purposes of this proposal, EPA found that an option addressed the risk so that it was no longer unreasonable if the option could achieve the benchmark MOE or cancer benchmark for the most sensitive endpoint. In considering whether a regulatory option would ensure the chemical no longer presents the unreasonable risk, the Agency considered whether the option could be realistically implemented or whether there were practical limitations on how well the option would mitigate the risks

in relation to the benchmarks, as well as whether the option's protectiveness was influenced by concerns related to environmental justice, children's health, and potentially exposed or susceptible subpopulations identified as relevant to the Agency's risk evaluation.

B. TSCA Section 6(c)(2) Considerations

TSCA section 6(c)(2) requires EPA to consider and publish a statement based on reasonably available information with respect to the:

• Health effects of the chemical substance or mixture (in this case, methylene chloride) and the magnitude of human exposure to methylene chloride;

• Environmental effects of methylene chloride and the magnitude of exposure of the environment to methylene chloride;

• Benefits of methylene chloride for various uses;

• Reasonably ascertainable economic consequences of the rule, including: The likely effect of the rule on the national economy, small business, technological innovation, the environment, and public health; the costs and benefits of the proposed and final rule and of the one or more primary alternatives that EPA considered; and the cost-effectiveness of the proposed rule and of the one or more primary alternatives that EPA considered.

In addition, in selecting among prohibitions and other restrictions available under TSCA section 6(a), EPA must factor in, to the extent practicable, these considerations. Further, in deciding whether to prohibit or restrict in a manner that substantially prevents a specific condition of use of a chemical substance or mixture, and in setting an appropriate transition period for such action, EPA must also consider, to the extent practicable, whether technically and economically feasible alternatives that benefit health or the environment will be reasonably available as a substitute when the proposed prohibition or other restriction takes effect.

EPA's analysis of the health effects and magnitude of exposure to methylene chloride can be found in Units IV.B., VI.C.1. and VI.D., which discuss the methylene chloride risk assessment and EPA's regulatory assessment of methylene chloride in paint and coating removal. A discussion of the environmental effects of methylene chloride is in Unit II.D.

With respect to the costs and benefits of this proposal and the alternatives EPA considered, as well as the impacts on small businesses, the full analysis is presented in the Economic Analysis (Ref. 4). To the extent information was reasonably available, EPA considered the benefits realized from risk reductions (including monetized benefits, non-monetized quantified benefits, and qualitative benefits), offsets to benefits from countervailing risks (

e.g.,

risks from chemical substitutions and alternative practices), the relative risk for environmental justice populations and children and other potentially exposed or susceptible subpopulations (as compared to the general population), the cost of regulatory requirements for the various options, and the cost effectiveness of the proposed action and the one or more primary alternate regulatory options. A discussion of the benefits EPA considered can be found in Units VI.D. and VII.B. as well as in the Economic Analysis (Ref. 4).

EPA considered the estimated costs to regulated entities as well as the cost to administer and enforce the options. For example, an option that includes use of a respirator would include inspections to evaluate compliance with all elements of a respiratory protection program (Ref. 25). In understanding the burden, EPA took into account reasonably available information about the functionality and performance efficacy of the regulatory options and the ability to implement the use of chemical substitutes or other alternatives. Reasonably available information included the existence of other Federal, state, or international regulatory requirements associated with each of the regulatory options as well as the commercial history for the options. A discussion of the costs EPA considered and a discussion of the cost-effectiveness of the proposal and the primary alternate regulatory options that EPA considered is in Units VI.F. and VII.A. In addition, a discussion of the impacts on small businesses is in Unit XXIII. and in the Initial Regulatory Flexibility Analysis and Report from the Small Business Advocacy Review Panel (Refs. 26 and 27).

With respect to the anticipated effects of this proposal on the national economy, EPA considered the number of businesses and workers that would be affected and the costs and benefits to those businesses and workers. In addition, EPA considered the employment impacts of this proposal, as discussed in section 9.2 of the Economic Analysis (Ref. 4). EPA found that the direction of change in employment is uncertain, but EPA expects the short term and longer-term employment effects to be small.

The benefits of methylene chloride in paint and coating removal are discussed in Unit VI.B., along with the availability of alternatives. The dates that the proposed restrictions would take effect are discussed in Unit X. The availability of alternatives to methylene chloride in paint and coating removal on those dates is discussed in Unit VI.E.

Finally, with respect to this proposal's effect on technological innovation, EPA expects this action to spur innovation, not hinder it. An impending prohibition on this use of methylene chloride is likely to increase demand for alternatives, which EPA expects would result in the development of new alternatives. See also section 9.3 in the Economic Analysis (Ref. 4).

C. Regulatory Options Receiving Limited Evaluation

EPA analyzed a wide range of regulatory options under TSCA section 6(a). There are a range of regulatory options under TSCA; only those pertaining to these risks were evaluated in detail. An overview of the regulatory options not evaluated in detail follows.

First, EPA reasoned that the TSCA section 6(a)(1) regulatory option to prohibit the manufacture, processing or distribution in commerce of methylene chloride or limit the amount of methylene chloride which may be manufactured, processed or distributed in commerce is not germane because EPA is not proposing to ban or limit the manufacture, processing or distribution in commerce of methylene chloride for uses other than paint and coating removal.

In addition, EPA determined that the TSCA section 6(a)(6) regulatory option to prohibit or otherwise regulate any manner or method of disposal of the chemical is not applicable since EPA did not assess risks associated with methylene chloride disposal.

Another option EPA evaluated would require warning labels and instructions on paint and coating removal products containing methylene chloride, pursuant to TSCA section 6(a)(3) (Ref. 28). However, EPA reasoned that warning labels and instructions alone could not significantly mitigate the unreasonable risks presented by methylene chloride in paint and coating removal. EPA based its reasoning on an analysis of 48 relevant studies or meta-analyses, which found that consumers and professionals do not consistently pay attention to labels for hazardous substances; consumers, particularly those with lower literacy levels, often do not understand label information; consumers and professional users often base a decision to follow label information on previous experience and perceptions of risk; even if consumers

and professional users have noticed, read, understood, and believed the information on a hazardous chemical product label, they may not be motivated to follow the label information, instructions, or warnings; and consumers and professional users have varying behavioral responses to warning labels, as shown by mixed results in studies (Ref. 28). Additionally, workers being exposed may not be in a position to influence their employer's decisions about the type of paint removal method, or ensure that their employer provides appropriate PPE and an adequate respiratory protection program.

These conclusions are based on the weight-of-evidence analysis that EPA conducted of the available literature on the efficacy of labeling and warnings. This analysis indicates that a label's effectiveness at changing user behavior to comply with instructions and warnings depends on the attributes of the label and the user, and how those interact during multiple human information processing stages, including attention, comprehension, judgement, and action (Ref. 28).

Numerous studies have found that product labels and warnings are effective to some degree. However, the extent of the effectiveness has varied considerably across studies and some of the perceived effectiveness may not reflect real-world situations. This is because interactions among labels, users, the environment, and other factors greatly influence the degree of a label's effectiveness at changing user behavior (Ref. 28). In addition, while some studies have shown that certain components of labels and warnings tend to have some influence, it is less clear how effective labels and warnings are likely to be over time, as users become habituated to both the labels and the products.

Presenting information about methylene chloride on a product label would not adequately address the unreasonable risk presented by this use of this chemical because the nature of the information the user would need to read, understand, and act upon is extremely complex. When the precaution or information is simple or uncomplicated (

e.g.,

do not mix this cleaner with bleach or do not mix this cleaner with ammonia), it is more likely the user will successfully understand and follow the direction. In contrast, it would be challenging to most users to follow the complex product label instructions required to explain how to reduce exposures to the extremely low levels needed to minimize the risk from methylene chloride. Rather than a simple message, the label would need to explain a variety of inter-related factors, including but not limited to the use of local exhaust ventilation, respirators and assigned protection factor, and effects to bystanders. Currently, though some paint removers containing methylene chloride are labeled with information about its fatal effects if used without “adequate ventilation” (Ref. 28) and this information appears on the product safety data sheet, deaths continue to occur. It is unlikely that label language changes for this use of methylene chloride will result in widespread, consistent, and successful adoption of risk reduction measures by users.

Any use of labels to promote or regulate safe product use should be considered in the context of other potential risk reduction techniques. As highlighted by a 2014 expert report for the Consumer Product Safety Commission (CPSC), “safety and warnings literature consistently identify warnings as a less effective hazard-control measure than either designing out a hazard or guarding the consumer from a hazard. Warnings are less effective primarily because they do not prevent consumer exposure to the hazard. Instead, they rely on persuading consumers to alter their behavior in some way to avoid the hazard” (Ref. 29). Specifically regarding methylene chloride, effective personal protection resulting in risk reduction would require this altered behavior to include the appropriate use of a supplied-air respirator. Consumer users are particularly unlikely to acquire and correctly use such an apparatus in response to reading a warning label (Ref. 19). Any labeling aiming to reduce risks to consumer or commercial users of these products would need to sufficiently and clearly explain the importance of the supplied-air respirator, and would still leave the user with the problem of obtaining and properly using the supplied-air respirator, which is a particularly expensive piece of equipment (Ref. 4). Further, for the effective use of a respirator, particularly an air-supplied respirator, there would need to be fit-testing of the respirator and training in its use.

While EPA reasons that revised labeling will not address the unreasonable risk presented by methylene chloride in paint and coating removal, as a result of recommendations from the Small Business Advocacy Review (SBAR) Panel to solicit information from the public about the potential efficacy of labeling, following advice from the small entity representatives who participated in the SBAR process (Ref. 27), EPA requests public comments on enhanced labeling requirements for consumer paint and coating removal products containing methylene chloride as a method for reducing exposure to methylene chloride in these products. More information about the SBAR process, the Panel recommendations, and advice from small businesses related to this proposal are in Unit XXIII. and in the Panel Report (Ref. 27).

While this regulatory option alone would not adequately address the unreasonable risks, EPA recognizes that the TSCA section 6(a)(3) warnings and instruction requirement can be an important component of an approach that addresses unreasonable risks associated with a specific use prohibition. EPA has included a downstream notification requirement as part of the proposed rule to ensure that users would be made aware of the prohibition on the use of methylene chloride in paint and coating removal.

An additional regulatory option receiving limited evaluation was a training and certification program for commercial paint and coating removers, similar to the certification process required under EPA's Lead-Based Paint Renovation, Repair, and Painting Rule (73 FR 21692, April 22, 2008). This option was recommended by the small entity representatives as part of the SBAR process (Ref. 27). EPA considered this option as an approach to reducing risks from methylene chloride in paint and coating removal. However, unlike the process for training and certification of commercial workers required under the Lead-Based Paint Renovation, Repair, and Painting Rule, effective risk reduction from commercial use of methylene chloride for paint and coating removal would require additional regulation of distributors of these products. When considering this approach, given the Agency's experience with the training and certification program under the Lead-Based Paint Renovation, Repair, and Painting Rule, EPA viewed the costs and challenges involved in regulating distributors and ensuring that only trained and certified commercial users are able to access these paint and coating removal products as a significant limitation for this approach. EPA seeks public comment on the feasibility of such a program and its potential to reduce risks of exposure to methylene chloride for workers and bystanders so that those risks are no longer unreasonable.

VI. Regulatory Assessment of Methylene Chloride in Paint and Coating Removal

This unit describes the current use of methylene chloride in paint and coating removal, the unreasonable risks presented by this use, and how EPA identified which regulatory options reduce the risks so that they are no longer unreasonable.

A. Methylene Chloride Uses That Are the Focus of This Regulation

The methylene chloride uses that are the focus of this action are:

1. Any consumer use of methylene chloride for paint and coating removal, and

2. Any commercial use of methylene chloride for paint and coating removal except for commercial furniture refinishing, which EPA intends to address in a separate proposal, as described in Unit XI. While EPA proposes to determine that the identified risks from methylene chloride in commercial furniture refinishing are unreasonable, EPA plans to continue public engagement before proposing regulations for methylene chloride in this industry. Additional information is in Unit XI. This is one of the recommendations from SBAR Panel (Ref. 27),

EPA proposes to exempt specific paint and coating removal with methylene chloride from critical corrosion-sensitive components of military aviation and vessels, which the Department of Defense identified as critical for national security purposes. The details of this national security use are in Unit VIII.

B. Methylene Chloride in Paint and Coating Removal

Methylene chloride has been used for decades in paint and coating removal in products intended for both commercial and consumer uses. Paint and coating removal, also referred to as paint stripping, is the process of removing paint or other coatings from a surface. Coatings can include paint, varnish, lacquer, graffiti, polyurethane, or other coatings sometimes referred to as high-performance or specialty coatings; surfaces may be the interior or exterior of buildings, structures, vehicles, aircraft, marine craft, furniture, or other objects. Paint and coating removal can be conducted in occupational or consumer settings. These surfaces, or substrates, include a variety of materials, such as wood, metals, plastics, concrete, and fiberglass. A variety of industries include paint and coating removal in their business activities, including professionals involved in renovations, bathtub refinishing, automotive refinishing, furniture refinishing, art restoration and conservation, aircraft repair, marine craft repair, and graffiti removers (Ref. 3).

Paint and coatings can be removed by chemical, mechanical, or thermal means. Chemical paint removers can include solvents, such as methylene chloride or NMP, caustic chemicals, or other categories of chemicals. Solvents aid in removing paints and coatings by permeating the top of the coating and dissolving the bond between the coating and the substrate (Ref. 30). Following the application of the chemical paint remover, the coating can be more easily peeled, scraped, or mechanically removed from the substrate. Techniques for applying the paint remover chemical include manual coating or brushing, tank dipping, flow-over systems, and spray applications (manually or through automation). Pouring, wiping and rolling are also possible application techniques and application can be manual or automated (Ref. 3).

In the construction trades, methylene chloride is used to remove paint and coatings from walls, trim, architectural features, patios or decks, ceilings, bathtubs, floors, etc. to prepare them for new coatings during residential and commercial building renovation. Methylene chloride is typically applied to the surface using a hand-held brush. It is then left on to soften the old coating (Ref. 4). Once curing has occurred, the old coating is scraped or brushed off and the surface is cleaned. For bathtub refinishing, methylene chloride is poured and brushed onto a bathtub using a paintbrush and then scraped from the bathtub after leaving the remover to cure for 20 to 30 minutes (Ref. 4). Consumers use methylene chloride in similar ways.

Commercially, methylene chloride is also used to remove paint and coatings from civilian aircraft, marine craft, cars, trucks, railcars, tankers, storage vessels, and other vehicles or their component parts to prepare for new coatings. Similar to the constructions trades, applications in the transportation industry tend to be brushed on and scraped off. More information on specific techniques for commercial paint removal and by consumers are in the methylene chloride risk assessment and supplemental materials (Refs. 2, 19, 20, 21, and 31).

Though many users are switching to substitutes and alternative methods, methylene chloride use persists because it is readily available and works quickly on nearly all coatings without damaging most substrates. In addition, some users may prefer methylene chloride because it is less flammable than some other solvents. However, it is extremely volatile, has strong fumes, and evaporates quickly so that it must be reapplied for each layer of paint or coating to be removed. Additionally, paint and coating removal products formulated with methylene chloride tend to contain high concentrations of co-solvents that are flammable, reducing one perceived advantage of methylene chloride products.

Chemical products for paint and coating removal are used across several industries as well as by consumers or hobbyists, and products intended for one type of use—such as aircraft renovation—have been used in other situations, such as bathtub refinishing (Refs. 11, 32, and 33). Products intended for one specific type of paint removal project can be easily used in a different setting. Additionally, consumers can easily use products intended for or marketed to professional users since paint removal products are readily available at big box and local hardware stores, as well as paint specialty stores.

EPA has identified 59 different products for paint and coating removal that contain methylene chloride, formulated by 10 different firms. This is approximately 54% of the total number of paint and coating removal products EPA identified (109 products) (Ref. 34). Commercial uses of these products include automotive refinishing, furniture refinishing, art conservation and restoration, pleasure craft building and repair, aircraft paint removal, graffiti removal, bathtub refinishing, and renovations in residences or other buildings. Though the number of workers and consumers exposed to methylene chloride during paint and coating removal is uncertain, EPA has several estimates based on industry data and information gathered for rulemakings promulgated previously under other statutes, such as the Clean Air Act, intended to address different risks. As described in more detail in the Economic Analysis, EPA estimates that 32,600 workers annually are exposed to methylene chloride during paint and coating removal activities (Ref. 4). Of them, 15,000 are estimated to be exposed during furniture refinishing; 17,600 are estimated to be exposed during other commercial paint and coating removal processes (Ref. 4).

Consumer use of methylene chloride in paint and coating removal is similar to commercial use but is carried out by do-it-yourself (DIY) consumers and occurs in consumer settings, such as homes, workshops, basements, garages,

and outdoors. Paint and coating removal products containing methylene chloride are the same as those used in many commercial settings, and the process consumers use is similar to commercial methods of brushing or spraying on the paint and coating removal product, allowing time to pass for the product to penetrate the coating, and then scraping the loosened coating from the surface. Manufacturers and retailers of paint and coating removal products containing methylene chloride frequently sell them to consumers in small containers with marketing language or labeling that state they are easy to use and work on a variety of paints, coatings, and surfaces (Ref. 35). Products intended for consumers containing methylene chloride must meet minimum labeling requirements prescribed by CPSC that the product contains methylene chloride and that it may cause cancer (52 FR 34698, September 14, 1987). Information about risks of death as a result of acute exposure or methods to reduce exposure through personal protective equipment or ventilation are not required and frequently are not present on products containing methylene chloride (Refs. 35 and 36). Paint and coating removers containing methylene chloride are frequently sold at home improvement retailers or automotive supply stores that sell products to consumers as well as professional users. Additionally, due to the wide availability of products available on the Internet and through various additional suppliers that serve commercial and consumer customers, consumers may foreseeably purchase a variety of paint and coating removal products containing methylene chloride. EPA estimates that a large percentage of users of paint and coating removal products containing methylene chloride are consumers, rather than occupational users. EPA estimates that approximately 1.3 million consumers annually use paint removal products containing methylene chloride (Ref. 4).

C. Analysis of Regulatory Options

In this unit, EPA explains how it evaluated whether the regulatory options considered would address the risks presented by this use as necessary so that the risks are no longer unreasonable. First, EPA characterizes the unreasonable risks associated with the current use of methylene chloride in paint and coating removal. Then, EPA describes its initial analysis of which regulatory options have the potential to achieve standard non-cancer and cancer benchmarks. The levels of acute and chronic exposures estimated to present no risks of concern for non-cancer effects also result in no risks of concern for cancer. Lastly, this section evaluates how well those regulatory options would address the unreasonable risk in practice.

1.

Risks associated with the current use.

a. General impacts.

The methylene chloride risk assessment and supplemental analyses identified acute and chronic risks from inhalation of methylene chloride during paint and coating removal by consumers and bystanders in residences; and commercial users and occupational bystanders in workplaces (individuals not using the paint and coating remover but nearby a user) (Refs. 2 and 19). EPA estimates, having refined the numbers since the risk assessment, that, annually, there are approximately 17,600 direct users at 8,600 commercial operations conducting paint and coating removal with methylene chloride for the uses proposed for regulation that will potentially benefit from the risk reduction resulting from this proposed regulation. EPA estimates that approximately 1.3 million consumers who use paint and coating removal products containing methylene chloride each year that will also potentially benefit from risk reduction resulting from this proposal (Ref. 4).

b. Impacts on minority and other populations.

While all consumers and workers using paint and coating removal products containing methylene chloride would benefit from risk reduction, some populations are currently at disproportionate risk for the health effects associated with use of methylene chloride in paint and coating removal. In the construction trades, Hispanic workers (of all races) and foreign-born workers are over-represented (Ref. 4). In the U.S. population, 16% of adults are Hispanic, whereas in the construction trades, 35% of workers are Hispanic (Ref. 4). Due to their overrepresentation in the construction trades, Hispanic workers are disproportionately at risk of exposure to methylene chloride when used in paint and coating removal.

Similarly, foreign-born workers are overrepresented in the construction trades. In the U.S. population overall, 17% of workers in all industries are foreign-born, whereas in the construction trades, 28% of workers are foreign-born (Ref. 4). As a result, they may primarily speak a language other than English and could be characterized as having limited English proficiency. Under Executive Order 13166, EPA and other agencies are charged with examining and identifying the needs of individuals with limited English proficiency (65 FR 50121, August 11, 2000). Like Hispanic workers, foreign-born workers are disproportionately at risk of exposure to methylene chloride when used in paint and coating removal in the construction trades.

EPA's identification of the current disproportionate risks of methylene chloride exposure faced by Hispanic and foreign-born workers in the construction trades is part of the analysis conducted as part of EPA's efforts towards environmental justice. Executive Order 12898 (59 FR 7629, February 16, 1994) establishes federal executive policy on environmental justice; EPA's compliance with this executive order is detailed in Unit XXIII.

c. Impacts on children.

In the methylene chloride risk assessment, EPA examined acute risks for bystanders to consumer use of methylene chloride in paint and coating removal in residential settings. Although EPA expects that users of methylene chloride in paint and coating removal would be adult individuals (16 years old and older), bystanders could be individuals of any age group (

e.g.,

children, adults, and the elderly) who are elsewhere in the house during product application and in the hours following application (Ref. 2). In most scenarios, EPA found acute risks of concern for central nervous system effects for other residents of the house, including children, in which paint and coating removal with methylene chloride was conducted (Ref 2). EPA found risks of concern not only during the application of the product, but also for several hours following (Ref. 2).

Although EPA anticipates that most consumers conducting paint and coating removal with methylene chloride would likely exclude children from the room in which the project was being carried out, it is unclear if they would exclude them from the house overall during and after the product application. Additionally, if the project involved removing the coating from a bathtub, households with only one bathroom would present challenges for bystander exclusion for several hours. As a result, children present in homes where paint and coating removal is being conducted, by family members or by professionals, face acute risks of central nervous system impacts.

EPA was not able to model scenarios in which paint and coating removal was conducted in an apartment building, hotel, or other residence or place in which children may be present other than single-family homes. However, the findings related to bystander exposure suggest risks for children and other

residents of apartments or hotel rooms adjacent to units in which paint and coating removal is being conducted. In these situations, it is even less likely that children would be excluded from all affected areas in order to protect them from acute risks. As a result, methylene chloride is likely to present acute risks to children as bystanders to paint and coating removal with methylene chloride, even if they are excluded from the areas in which work is conducted (Ref. 2).

d. Exposures for this use.

Exposures assessed for this use include acute exposures to methylene chloride in paint and coating removal by consumers and residential bystanders, and acute and chronic exposures by commercial workers and occupational bystanders, as described in the methylene chloride risk assessment (Ref. 2). In some cases where commercial paint and coating removal is conducted, such as in workshops or facilities that are within residences (for example, in the case of some small businesses) (Ref. 27), exposed bystanders may include family members, such as children. The exposures assessed included some commercial furniture refinishing, which is not proposed for regulation. Different exposure scenarios were evaluated for workers, occupational bystanders, consumers, and residential bystanders (Ref. 2)

For exposures in commercial settings, EPA assessed acute risks and chronic risks, including cancer risks. For acute risks, EPA assessed four occupational scenarios based on eight-hour TWA exposure concentrations and different variations in exposure conditions, such as presence or absence of respirators and the protection factor of any respirator used. For each commercial use evaluated in the assessment, EPA modeled scenarios using assumed parameters similar to typical use conditions within those industries, such as whether work was conducted indoors or outdoors and what quantity of methylene chloride was estimated to be used. For these acute workplace estimates, the acute methylene chloride exposure concentration evaluated for risk was the eight-hour TWA air concentration in milligrams per cubic meter reported for the various relevant industries. In the risk assessment, EPA assumed that some workers could be rotating tasks and not necessarily carrying out paint and coating removal tasks using methylene chloride on a daily basis. This type of exposure was characterized as acute in this assessment because the worker's body was estimated to have sufficient time to remove methylene chloride and its metabolites before the next encounter with methylene chloride during paint and coating removal (Ref. 2).

For chronic exposure scenarios, EPA varied not only the parameters described above, but also the number of working days exposed to methylene chloride during paint and coating removal (ranging from 125 to 250 days per year) and exposed working years (varying the number of years the worker was assumed to be exposed) (Ref. 2). Overall, EPA evaluated cancer and chronic non-cancer risks for 16 occupational scenarios.

Worker inhalation exposure data were taken from peer-reviewed literature sources, as cited in the risk assessment (Ref. 2). These data sources often did not indicate whether monitored exposure concentrations were for occupational users or bystanders. Therefore, EPA assumed that these exposure concentrations were for a combination of users and bystanders. EPA evaluated scenarios both with and without respirator use and a range of respirator assigned protection factors (APFs), but did not estimate the overall frequency of respirator use because supporting data on the prevalence of respirator use for these commercial uses was unavailable. Similarly, EPA made assumptions about the exposure frequencies and working years because data were not found to characterize these parameters, and estimated various exposure frequencies (125 and 250 days per year) and working years (20 and 40 years). Thus, EPA evaluated occupational risks by developing hypothetical scenarios under the varying exposure conditions described previously (Ref. 2).

It is important to note that EPA relied on monitoring data for these occupational exposure estimates. Many air concentrations reported and used in the risk assessment exceeded the current OSHA PEL of 25 ppm; in some industries where paint and coating removal was conducted by immersion in tanks or vats of methylene chloride, air concentrations were measured at above 7,000 milligrams per cubic meter, or 2,016 ppm. Even in industries with lower expected exposures, air concentrations frequently were reported in excess of 250 milligrams per cubic meter, or 72 ppm, such as during graffiti removal and automotive refinishing (Ref. 2). The risks associated with these dramatically high air concentrations are discussed in Unit VI.C.1.e.

For consumer and residential bystander exposures, EPA assessed exposure scenarios under which the individual user was presumed to work on one of several types of paint and coating removal projects (coffee table, chest of drawers, or bathtub). These scenarios take into account that consumers do not reliably use personal protective equipment (respirators) or have access to engineering controls (

e.g.,

exhaust ventilation), since these methods are costly, technically challenging, and not easily available to consumers (Ref. 2). EPA used product label information to establish the time durations (in minutes) that the user would require to complete each step of the paint or coating removal process. User breaks during wait periods were assumed; the scenarios varied the location of where the user rested (in the work space or elsewhere). In addition, back-to-back projects were modeled because it is likely that the user would take breaks during the wait periods specified on product labels. It was further assumed that the paint scrapings were removed from the house as soon as scraping was completed. In each scenario, the bystander was assumed to be somewhere else in the house, and exposed via inhalation to some of the methylene chloride from the workspace (Ref. 2).

EPA developed seven consumer exposure scenarios for the assessment. Similar to the worker exposure assessment, the following factors were considered in developing the exposure scenarios (Ref. 2):

• The type of application (

i.e.,

brush-on or spray-on), weight fraction of methylene chloride in the paint and coating removal product, application rate by the user, surface area of object from which the paint or coating was being removed, and emission rate of the chemical, which can affect the amount of methylene chloride that ultimately is released to the indoor environment;

• The location where the product is applied, which relates to exposure factors such as the room volume and its air exchange rate with outdoor air;

• The house volume and air exchange rate, for reasons similar to those for the product use location; and

• Precautionary behaviors such as opening windows in the application room, the user leaving the application room during the wait period, related changes to the air exchange rates, and the proximity of the user to the source of methylene chloride emissions.

In the absence of representative air monitoring data for consumer users and residential bystanders using paint and coating removal products containing methylene chloride, EPA used the Multi-Chamber Concentration and Exposure Model to estimate consumer and bystander inhalation exposure concentrations (Ref. 2).

EPA's estimates of the exposures during paint and coating removal with methylene chloride experienced by commercial users and bystanders and consumer users and bystanders were used to assess the risks of this use of methylene chloride. The full exposure estimates and risk findings are described in the methylene chloride risk assessment; risk findings are also summarized in Unit VI.C.1.e.

In addition to estimating likely exposures under current use patterns (baseline exposures), for both commercial and consumer users, EPA assessed a number of exposure scenarios associated with risk reduction options in order to identify variations in methylene chloride exposure during paint and coating removal. All variations in the scenarios were applied to industry-specific exposure inputs and evaluated with exposure parameters that were modified to reflect either a reasonable worst-case scenario (also called the baseline) or a scenario in which exposures were moderated by several factors (also called the central tendency scenario). The risk reduction options that varied between scenarios included engineering controls, use of PPE, and well as combinations of these options (Ref. 19).

• Under the PPE risk reduction option exposure scenarios, EPA evaluated respirators with APF 10 to 10,000 for acute and chronic risks, including cancer risks.

• For the engineering controls risk reduction option exposure scenarios, EPA evaluated exposures using local exhaust ventilation (LEV) to improve ventilation near the activity of workers (using furniture refinishing operations as a model), with an assumed 90% reduction in exposure levels.

Overall, EPA evaluated dozens of distinct exposure scenarios for commercial paint and coating removal with methylene chloride; exposure reductions for consumer users are expected to be similar to the acute risk evaluations for professional contractors or workers in furniture refinishing operations, since these commercial activities are most similar to the types of projects in which consumers would engage (Refs. 19 and 20).

e. Specific risks for this use.

The acute inhalation risk assessment used central nervous system effects to evaluate the acute risks for occupational, consumer, and bystander exposure during paint and coating removal with methylene chloride. In the risk assessment, a risk of concern was identified if the MOE estimate was less than the benchmark MOE of 10 for acute central nervous system effects (Ref. 2).

EPA assessed acute risks for central nervous system effects from inhalation for all consumer, occupational, and bystander exposure scenarios of paint and coating removal with methylene chloride. For consumers, EPA identified risks of concern for all scenarios, with some consumer scenarios demonstrating risks within the first hour of product use when paint and coating removal was conducted indoors (such as in a workshop or bathroom), regardless of whether the product formulation was brush or spray. Risks for incapacitating nervous system effects were found in some indoor scenarios (such as in a bathroom) within four hours of product use. MOEs for consumer acute risks from exposures of one hour or less ranged from 1.6 to 0.2; this equates to estimated exposures that are between six and 50 times greater than those that are expected to produce no risks of concern (Ref. 2).

For residential bystanders, EPA identified risks of concern for all scenarios, even assuming that any bystander in the house was not in the room where the paint and coating removal occurred. Depending on the parameters of the scenario, MOEs for acute risks ranged from 2.9 to 0.5, or between three and 20 times greater than those that are expected to produce no risks of concern (Ref. 2).

For commercial users, the occupational scenarios in which acute risks for central nervous system effects were identified included nearly all occupational scenarios, irrespective of the absence or presence of respirators, and in both the central-tendency and worst-case assumed air concentrations of methylene chloride. Additionally, EPA found acute risks for incapacitating central nervous system effects for workers who had no respiratory protection in most industries, or with respirators with APFs of 10 or 25 in the industries with highest likely exposures, such as professional contractors, aircraft refinishers, and workers using immersion methods for paint and coating removal in several industries. MOEs for acute risks ranged from an average of 0.11 (automotive refinishing) to 0.037 (graffiti removal), with a lowest end of 0.0063 (workplaces engaged in paint and coating removal using immersion methods). In general, these workplaces are estimated to present exposure levels between 100 times to greater than 1,000 times more than those that are of concern. Not only workers, but also occupational bystanders, or workers engaged in tasks other than paint and coating removal, would be at acute risk for central nervous system effects (Ref. 2). Therefore, EPA's proposed determination is that acute methylene chloride exposures during paint and coating removal present unreasonable risks.

In the risk assessment, EPA also assessed risks of chronic exposure to methylene chloride during paint and coating removal by commercial users and occupational bystanders (Ref. 2). The methylene chloride risk assessment used liver toxicity as the critical endpoint for chronic exposure. EPA assessed risks for liver toxicity for occupational and bystander exposure scenarios of paint and coating removal with methylene chloride.

Workers and occupational bystanders in most industries evaluated were identified as at risk for non-cancer liver toxicity as a result of chronic exposure to methylene chloride during paint and coating removal under typical exposure scenarios. When workers were exposed repeatedly at facilities they were at risk, even for scenarios evaluated with workers wearing respiratory protection with APF 50 (Ref. 2). The concern is for workers engaging in long-term use of the product (

i.e.,

250 days/year for 40 years) with no respiratory protection.

For commercial users and bystanders, EPA also assessed cancer risks as a result of chronic exposure to methylene chloride in paint and coating removal. Workers and occupational bystanders showed were estimated to have an excess cancer risk greater than 1 in 1,000,000 for all of the commercial scenarios evaluated if exposed to paint and coating removal with methylene chloride for 250 days per year for 40 years with no respiratory protection. Depending on industry, cancer risks ranged from 6 in 10,000 (graffiti removal) to 2.5 in 1,000 (aircraft refinishing), with a maximum of 4 in 1,000 (workplaces using immersion methods, such as dip tanks for miscellaneous metal items). Workers in all industries showed a relative reduction in cancer risks when estimated to be working for 125 days per year for 20 years with a respirator with APF 50, with cancer risks in some industries estimated to be below benchmark levels in these scenarios. Therefore, EPA's proposed determination is that chronic methylene chloride exposures during paint and coating removal present unreasonable risks.

The SBAR Panel convened in support of this action heard from several SERs who expressed concerns about the underlying methylene chloride risk assessment (Ref. 27). Many of the concerns expressed by these SERs were already expressed in the public comments and the peer review

comments on the methylene chloride risk assessment. The Summary of External Peer Review and Public Comments and Disposition document in the risk assessment docket (EPA-HQ-OPPT-2012-0725) explains how EPA responded to the comments received.

2.

Initial analysis of potential regulatory options.

Having determined that the risks from methylene chloride in paint and coating removal were unreasonable, EPA evaluated whether regulatory options under section 6(a) could reduce the risk (non-cancer and cancer) so that it is no longer unreasonable.

The results of EPA's assessment of consumer uses, exposures, and risks indicate that regulatory options for consumer uses such as reducing the concentration of methylene chloride or advising the use of respirators could not achieve the target MOE benchmarks for acute exposures (benchmark MOE is 10). Similarly, the results of EPA's evaluation indicate that regulatory options for occupational exposures such as reducing the concentration of methylene chloride in products used for paint and coating removal and using local exhaust ventilation to improve ventilation, in the absence of PPE, could not achieve the target MOE benchmarks (benchmark MOE is 10) for non-cancer endpoints for acute and chronic exposures and common cancer risk benchmarks for chronic exposures (Refs. 19 and 20). The results also demonstrate that all risk reduction options meeting the benchmark MOEs and common cancer benchmarks for methylene chloride in paint and coating removal require the use of a respirator, whether used alone or in conjunction with additional levels of protection or the use of an air exposure limit. Therefore, EPA found the options of setting a maximum concentration of methylene chloride in products under TSCA section 6(a)(2) unable to reduce exposures to the risk benchmarks. Options found not to meet the risk benchmarks and, for the purposes of this proposal, found unable to address the unreasonable risk, are documented in EPA's supplemental technical reports on methylene chloride in paint and coating removal (Refs. 19 and 20).

3.

Assessment of whether regulatory options address the identified unreasonable risk so that methylene chloride in paint and coating removal no longer presents such risk.

As discussed earlier, EPA considered a number of regulatory options under TSCA section 6(a) for methylene chloride in paint and coating removal for the uses proposed for regulation. In assessing these options, EPA considered a wide range of exposure scenarios (Refs. 19, 20, and 38). These include both baseline and risk reduction scenarios involving varying factors such as exposure concentration percentiles, LEV use, respirator use, working lifetimes, etc. As part of this analysis, EPA considered the impacts of regulatory options on consumer users and commercial users separately. However, EPA is proposing to address paint and coating removal with methylene chloride for consumer uses together with many commercial uses, rather than as separate consumer and commercial uses. As described earlier, in Unit VI.B., paint and coating removal products containing methylene chloride frequently are available in the same distribution channels to consumers and professional users. Products are marketed for a variety of projects, and cannot be straightforwardly restricted to a single type of project or user. As highlighted in the investigation into recent deaths among bathtub refinishers using methylene chloride, “ten different products were associated with the 13 deaths [from 2000-2011]. Six of the products were marketed for use in the aircraft industry, the rest for use on wood, metal, glass, and masonry. None of the product labels mentioned bathtub refinishing” (Ref. 33).

The options that had the potential to address the unreasonable risks presented by methylene chloride when used for paint and coating removal by consumers, or within the commercial uses proposed for regulation, or for both consumer and these commercial uses included:

a. A supply-chain approach, which would include prohibiting the manufacturing (including import), processing, and distribution in commerce of methylene chloride for paint and coating removal under TSCA section 6(a)(2) for the consumer and commercial uses proposed for regulation; prohibiting the commercial use of methylene chloride in paint and coating removal under TSCA section 6(a)(5) for the commercial uses proposed for regulation; requiring that all paint and coating removers containing methylene chloride be distributed in volumes no less than 55-gallon containers under TSCA section 6(a)(2); requiring downstream notification when distributing methylene chloride under TSCA section 6(a)(3); and limited recordkeeping under TSCA section 6(a)(4);

b. Variations on such an approach, such as just prohibiting the manufacturing, processing, and distribution in commerce of methylene chloride for paint and coating removal under TSCA section 6(a)(2) for consumer use and for the commercial uses proposed for regulation or just prohibiting the commercial use of methylene chloride for paint and coating removal under TSCA section 6(a)(5) for the commercial uses proposed for regulation;

c. Additional variations on such an approach, such as prohibiting the manufacturing, processing, and distribution in commerce of methylene chloride for paint and coating removal under TSCA section 6(a)(2) for the consumer and commercial uses proposed for regulation and requiring downstream notification (

e.g.,

via a Safety Data Sheet (SDS)) when distributing methylene chloride for other uses under TSCA section 6(a)(3); and

d. Requiring a respiratory protection program, including PPE (a supplied-air respirator with APF 1,000 or 10,000) with an alternative air exposure limit of 1 part per million (ppm) achieved through engineering controls or ventilation alone or in combination with a supplied-air respirator at a lower APF, in commercial facilities where methylene chloride is used for paint and coating removal under TSCA section 6(a)(5) for the commercial uses proposed for regulation.

A discussion of the regulatory options that could potentially reach the risk benchmarks for consumer use, commercial uses proposed for regulation, or both is in this unit, along with EPA's evaluation of how well those regulatory options would address the unreasonable risks in practice.

a. Proposed approach.

The proposed regulatory approach for methylene chloride in paint and coating removal for the uses proposed for regulation would prohibit the manufacturing, processing, and distribution in commerce of methylene chloride for paint and coating removal under TSCA section 6(a)(2) for consumer uses and for the commercial uses proposed for regulation; would prohibit the commercial use of methylene chloride for paint and coating removal under TSCA section 6(a)(5) for the uses proposed for regulation; would require any remaining paint and coating removal products containing methylene chloride to be distributed in packaged volumes no less than 55-gallon containers, under TSCA section 6(a)(2); would require manufacturers, processors, and distributors to provide downstream notification of the prohibitions under TSCA section 6(a)(3), and would require recordkeeping relevant to these

prohibitions under TSCA section 6(a)(4).

As discussed in Unit VI.C.1., the risks for exposure to consumers, workers, and bystanders for methylene chloride in paint and coating removal vary. The MOEs for non-cancer endpoints range from 50 to 1,000 times below the benchmark MOEs for central nervous system effects (the acute health impact) or liver toxicity (the chronic health impact). Similarly, the increased risk of cancer (including brain, liver, and lung cancer) in some industries is 100 to nearly 1,000 times greater than common cancer benchmarks (Ref. 2). Under this proposed option, exposures to methylene chloride during paint and coating removal would be completely eliminated. As a result, non-cancer and cancer risks would be eliminated.

The proposed approach would reduce the risks to workers, consumers, and bystanders from methylene chloride in paint and coating removal for the uses proposed for regulation so that those risks are no longer unreasonable. Prohibiting the manufacturing, processing and distribution in commerce of methylene chloride for paint and coating removal for the uses proposed for regulation would minimize the overall availability of methylene chloride for paint and coating removal for these uses. Importantly, this proposed regulation is protective of consumer users. EPA cannot regulate consumer use under TSCA section 6(a)(5). The prohibition of the commercial use of methylene chloride for paint and coating removal in the uses proposed for regulation would reduce commercial demand for methylene chloride paint and coating removal products, reduce the likelihood that other types of products formulated with methylene chloride would be used for paint and coating removal, and significantly reduce the potential for consumer use of commercial paint and coating removal products containing methylene chloride. Workers and occupational bystanders would not be exposed to methylene chloride for paint and coating removal in the uses proposed for regulation, and the risk to consumers and residential bystanders would be minimized because commercial paint and coating removal products containing methylene chloride would not be available in volumes smaller than 55-gallon containers. This large volume requirement would ensure that consumers, who typically buy products in much smaller volumes, would not be able to easily divert products from the supply chain intended for commercial furniture refinishing or uses proposed to be critical to national security. EPA seeks comment on the impact to commercial furniture refinishers of a requirement that paint and coating removal products containing methylene chloride be sold only in 55-gallon containers for commercial paint and coating removal. This request for comment is one of the recommendations of the SBAR Panel, described earlier in Unit V.C. and in more detail in Unit XXIII.C. (Ref. 27). Based on the recommendations from the SBAR Panel, EPA is requesting comment on whether the rule should allow paint and coating removal products containing methylene chloride to be sold in 30-gallon containers, rather than limiting the volume to 55-gallon containers. EPA is also requesting comment on the feasibility of implementing appropriate industrial hygiene controls associated with 30- or 55-gallon containers in order to minimize potential disruptive impacts to those industrial processes where technically feasible substitutes are currently unavailable. The downstream notification of these restrictions ensures that processors and distributors are aware of the manufacturing, processing, distribution in commerce and use restrictions for methylene chloride in paint and coating removal, and enhances the likelihood that the risks associated with this use of methylene chloride are addressed throughout the supply chain. Downstream notification also streamlines compliance and enhances enforcement, since compliance is improved when rules are clearly and simply communicated (Ref. 39). This integrated supply chain proposed approach mitigates the risk to consumers and commercial workers and occupational bystanders in the uses proposed for regulation from methylene chloride in paint and coating removal.

b. Options that are variations of elements of the proposed approach.

One variation of the proposed approach would be to prohibit manufacture, processing, and distribution in commerce of methylene chloride for consumer and commercial paint removal for the uses proposed for regulation without the prohibition on commercial use of methylene chloride for paint and coating removal and without the downstream notification of any prohibitions. Without the accompanying prohibition on commercial use and downstream notification that is included in the proposed supply chain approach, this option would leave open the likelihood that commercial users falling within the scope of this proposed rule and consumer users could obtain methylene chloride (which would continue to be available for other uses, such as degreasing or solvent purposes) and use it for paint and coating removal.

Without downstream notification, unsophisticated purchasers in particular are likely to be unfamiliar with the prohibitions regarding this use and mistakenly use methylene chloride for paint and coating removal, thereby exposing themselves and bystanders to unreasonable risks. Thus, under these variations, EPA anticipates that many users would not actually realize the risk benchmarks. Therefore, these variations fail to protect against the unreasonable risks.

Another regulatory option that EPA considered was to prohibit only the commercial use of methylene chloride for paint and coating removal in the uses proposed for regulation. This approach would reduce both non-cancer and cancer risks for commercial settings, but it would not reduce risks to consumers so that they are no longer unreasonable. By prohibiting use in the commercial sector alone, without a prohibition on the manufacture, processing, and distribution in commerce of paint and coating removal products containing methylene chloride for consumer and commercial use in the uses proposed for regulation, this approach would not address consumer risks as distributors of paint and coating removal products containing methylene chloride could continue to distribute to consumers methylene chloride marked as a paint and coating remover, including products labeled and marketed as “professional strength” or “commercial grade” products. Since it is foreseeable that consumers would continue to purchase products labeled and marketed in this fashion, and consumers would continue to be exposed far above the health benchmarks, they would not be protected from the unreasonable risks posed by methylene chloride.

c. Prohibit the manufacturing, processing, and distribution in commerce of methylene chloride for consumer paint and coating removal under TSCA section 6(a)(2) or prohibit the manufacturing, processing, and distribution in commerce of methylene chloride for consumer paint and coating removal under TSCA section 6(a)(2) and require downstream notification when distributing methylene chloride for other uses under TSCA section 6(a)(3).

EPA considered prohibiting the manufacturing, processing, and distribution in commerce of methylene chloride for consumer paint and coating removal including an option with a requirement for downstream

notification of such prohibition. If such a prohibition were effective, this option would mitigate the risks to consumers from methylene chloride in paint and coating removal. However, EPA recognizes that consumers can easily obtain products labeled for commercial use. Indeed, for many consumers, identifying a product as being for commercial use may imply greater efficacy. Coupled with the fact that many products identified as commercial or professional are readily obtainable in a variety of venues (

e.g.,

the Internet, general retailers, and specialty stores, such as automotive stores), EPA does not find that this option would protect consumers. In addition, this option alone would not address the risks to workers from methylene chloride in paint and coating removal.

d. Requiring a respiratory protection program, including PPE, air monitoring, and either a supplied-air respirator of APF 1,000 or 10,000 or an air exposure limit of 1 part per million (ppm) achieved through engineering controls or ventilation, in commercial facilities where methylene chloride is used for paint and coating removal under TSCA section 6(a)(5) for the commercial uses proposed for regulation.

Another regulatory option that EPA considered for the commercial uses of methylene chloride for paint and coating removal proposed for regulation was to require risk reduction through an occupational respiratory protection program, which would include air monitoring, medical monitoring, and respiratory protection through use of a supplied-air respirator with an APF of 1,000 or 10,000, depending on the methods used for paint and coating removal with methylene chloride and other workplace characteristics, with a performance-based alternative of meeting an air concentration level of 1 ppm as an exposure limit for methylene chloride. A full-facepiece (or helmet/hood) self-contained breathing apparatus (SCBA) when used in the pressure demand mode or other positive pressure mode has an APF of 10,000. EPA's analysis showed that use of a SCBA with an APF of 10,000 would, in all scenarios evaluated, control the exposure of methylene chloride to levels that allow for meeting the benchmarks for non-cancer and cancer risks. Exposures in most workplaces proposed for regulation could be reduced with an APF of 1,000 to exposure levels that reduce risks to benchmark levels (Ref. 19). It is important to note that current OSHA requirements for dermal and eye protection when using methylene chloride in any way would be maintained under this approach, in addition to other requirements for work practices, training, and hazard communication put forth in OSHA's Methylene Chloride Standard (29 CFR 1910.1052). It is also important to note that any respirator used would need to be a supplied-air respirator, since methylene chloride can clog or damage filters or cartridges for air-purifying respirators, rendering them non-protective (Ref. 19).

Although respirators, specifically SCBAs, could reduce exposures to levels that are protective of non-cancer and cancer risks, not all workers may be able to wear respirators. Individuals with impaired lung function due to asthma, emphysema, or chronic obstructive pulmonary disease, for example, may be physically unable to wear a respirator. Determination of adequate fit and annual fit testing is required for tight fitting full-face piece respirators to provide the required protection. Individuals with facial hair, like beards or sideburns that interfere with a proper face-to-respirator seal, cannot wear tight fitting respirators. In addition, respirators may also present communication problems, vision problems, worker fatigue, and reduced work efficiency (63 FR 1152, January 8, 1998). According to OSHA, “improperly selected respirators may afford no protection at all (for example, use of a dust mask against airborne vapors), may be so uncomfortable as to be intolerable to the wearer, or may hinder vision, communication, hearing, or movement and thus pose a risk to the wearer's safety or health.” (63 FR 1189-1190). Nonetheless, OSHA views respiratory protection as a backup method which is used to protect employees from toxic materials in those situations where feasible engineering controls and work practices are not available or are insufficient to protect employee health (63 FR 1156-1157). The OSHA respiratory protection standard (29 CFR 1910.134) requires employers to establish and implement a respiratory protection program to protect their respirator-wearing employees. This OSHA standard contains several requirements,

e.g.,

for program administration; worksite-specific procedures; respirator selection; employee training; fit testing; medical evaluation; respirator use; respirator cleaning, maintenance, and repair; and other provisions.

In addition, OSHA adopted a hierarchy of controls established by the industrial hygiene community and used to protect employees from hazardous airborne contaminants, such as methylene chloride (29 CFR 1910.1052). According to this hierarchy, substitution of less toxic substances, engineering controls, administrative controls, and work practice controls are the preferred method of compliance for protecting employees from airborne contaminants and are to be implemented first, before respiratory protection is used. OSHA permits respirators to be used where engineering controls are not feasible or during an interim period while such controls are being implemented.

Given equipment costs and the costs of establishing a respiratory protection program, which involves training, respirator fit testing, and the establishment of a medical monitoring program, EPA anticipates that most companies would choose to switch to substitutes instead of adopting a program for this type of PPE to continue using methylene chloride for paint and coating removal because this type of PPE program is not cost-effective. Further, even if cost were not an impediment, there are many limitations to the successful implementation of respirators with an APF of 1,000 or 10,000 in a workplace. As recommended by the SBAR panel, EPA is requesting comment on and information about workplace experience with respiratory protection programs and air monitoring for methylene chloride (Ref. 27). Specifically, EPA seeks comment on whether companies would opt to substitute an alternate chemical or process instead of implementing a worker protection program for PPE. EPA also requests comment on the scientific and technical support used for development of the 1 ppm air exposure limit (Ref. 21) for methylene chloride and the feasibility of implementing and enforcing this performance-based approach. Additionally, EPA is requesting comment on the cost to achieve reduced exposures in the workplace or to transition to alternative chemicals or technologies.

EPA also considered requiring a combination of local exhaust ventilation and supplied-air respirators with APF of 1,000 or 50, with a performance-based alternative to the respirator of an air exposure limit of 1 ppm as an eight-hour TWA. When properly executed, this option would reduce risks to the health benchmarks for workers and bystanders (Refs. 19, 21, and 38). However, while this option has the benefit of incorporating engineering controls and the use of respirators with a lower APF, the limitations to successful implementation of the use of supplied-air respirators in the workplace discussed previously are still present. EPA is requesting comment on

whether this alternate option of allowing industrial use at specified exposure levels and with appropriate personal protective equipment should be adopted. Specifically, EPA seeks information on whether this alternative approach would incentivize industry to eliminate methylene chloride use in paint and coating removal wherever technically feasible while minimizing disruptive impacts to those processes where technically feasible substitutes are currently unavailable.

Furthermore, neither of the variations of relying upon respiratory protection for commercial paint and coating removal with methylene chloride addresses consumer risks. EPA does not have the authority to require that consumers change use practices or wear PPE. Even if this approach were coupled with a TSCA section 6(a)(2) prohibition on the manufacture, processing and distribution in commerce of methylene chloride for consumer use in paint and coating removal, this would not protect consumers because they would foreseeably continue to buy and use paint and coating removal products containing methylene chloride intended for commercial users,

e.g.,

via the Internet or home improvement or automotive supply retailers. Consumers would continue to be exposed far above the established health benchmarks when using methylene chloride for paint and coating removal (Ref. 20).

Therefore, considering the increased complexity of a respiratory protection program involving supplied-air respirators as well as the general inability to require that consumers adhere to a respiratory protection program resulting in little mitigation of risks to consumers, an option focusing on respiratory protection would not address the unreasonable risks presented by these uses.

D. Adverse Health Effects and Related Impacts That Would Be Prevented by the Proposed Option

The proposed option would prevent exposure to methylene chloride from paint and coating removal and thus would prevent the risks of adverse effects and associated impacts. As discussed in Unit II.C., the range of adverse health effects includes effects on the nervous system, liver, respiratory system, kidneys, and reproductive systems (Ref. 2). These health effects associated with exposure to methylene chloride are serious and can have impacts throughout a lifetime. The following is a discussion of the impacts of significant acute, chronic non-cancer, and cancer effects associated with methylene chloride exposure during paint and coating removal, including the severity of the effect, the manifestation of the effect, and how the effect impacts a person during their lifetime.

1. Nervous system effects—acute exposures.

The methylene chloride risk assessment and EPA's 2011 IRIS assessment identified nervous system effects as the critical effect of greatest concern for acute exposure to methylene chloride. Specifically, these assessments identified sensory impairment and incapacitation (loss of consciousness) as the critical effect of acute exposures (Refs. 2 and 5). Exposure to methylene chloride can rapidly cause death as a result of nervous system depression, but even exposures that may in some cases result only in dizziness or fainting can be fatal if the individual who is disoriented or has fainted is alone. Several individuals have died after becoming incapacitated during paint and coating removal with methylene chloride; after losing consciousness, their nervous system is overcome by the continued accumulation of volatile fumes. As described in a recent report on deaths caused by methylene chloride, “. . . the danger posed by methylene chloride is its one-two punch when fumes accumulate. Because it turns into carbon monoxide in the body, it can starve the heart of oxygen and prompt an attack. The chemical also acts as an anesthetic at high doses: Its victims slump over, no longer breathing, because the respiratory centers of their brains switch off.” (Ref. 7).

There are increased risks of death and nervous system effects for many of the approximately 17,600 workers in 8,600 commercial facilities or companies that use methylene chloride for paint and coating removal for the commercial uses proposed to be regulated, as well as for the estimated 1.3 million consumers and residential bystanders who use or are exposed to paint and coating removers containing methylene chloride each year (Ref. 4).

Although the fact that deaths occur as a result of exposure to methylene chloride is well documented, the exact number of deaths specifically attributable to methylene exposure is unclear. In 2012, the Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report (MMWR) published results of an investigation into deaths among bathtub refinishers using methylene chloride. The authors of the investigation and the MMWR editors emphasized that the reported number of deaths due to methylene chloride is an underestimate and subject to at least three limitations: A lack of reporting to the OSHA incident database by self-employed individuals, no equivalent database to track consumer incidents and fatalities, and the likelihood that deaths due to methylene chloride exposures are misattributed to heart disease, since the pathology is similar (Ref. 33).

Based on data from OSHA, CPSC, state records, and publicly reported information, EPA has identified 49 fatalities since 1976 resulting from consumer or commercial worker exposure to methylene chloride during paint and coating removal, including for uses not proposed for regulation. However, as described earlier, this is likely an underestimate of the deaths that have occurred. As highlighted in the MMWR report from 2012 and OSHA alert from 2016, health effects from methylene chloride exposure are often misattributed to other causes (Refs. 32 and 33). For example, in several cases, workers were seen in hospital emergency rooms with symptoms of solvent exposure, were not properly diagnosed, and were sent back to the same work that ultimately killed them (Ref. 32).

Thus, EPA is unable to quantify the precise number or frequency of deaths that occur as a result of exposure to methylene chloride during paint and coating removal. However, the sporadically-occurring deaths outside of bathtub refinishing that have been documented as caused by methylene chloride, and the undocumented deaths that have been misattributed to heart disease should not be ignored merely because they cannot be monetized. Death following exposure to methylene chloride during paint and coating removal are characterized by family members as suddenly tragic, particularly when the deceased is young. In 1986 in Colorado, a worker died two hours into his first day on the job using methylene chloride to remove coatings from furniture (Ref. 40). In 2014 in New York, a 20-year old worker died while helping his father with a job refinishing a hotel bathtub (Ref. 41).

Fatalities have also occurred among more experienced workers. In 1990 in Georgia, a worker died while repairing a plastic-coated metal rack; he was found to have fainted and fallen into the tank of methylene chloride the company used to strip rack coatings (Ref. 7). In several instances, pairs of workers were killed while working on the same paint removal project with methylene chloride, such as renovating a squash court or the floor tile of a bathroom in a federal office building (Ref. 40).

In other cases, workers died when helping co-workers in distress. In South Carolina, in 1986, several workers were

killed or hospitalized in one incident: Two workers went to check on a colleague in a basement using a paint remover with methylene chloride; all three died. Five emergency responders arrived at the scene, and three were hospitalized due to inhalation of fumes (Ref. 7).

These sudden, unexpected deaths are not limited to commercial users or occupational bystanders exposed to methylene chloride during paint and coating removal. Consumer fatalities have been recorded, such as the woman who died in her house in 1990 in Ohio after removing paint from furniture with methylene chloride, as reported to the American Association of Poison Control Centers (Ref. 7). Consistent with the underreporting of commercial deaths, EPA estimates there are unreported consumer deaths due to exposure to methylene chloride during paint and coating removal.

These deaths clearly have a significant impact on families, workplaces, and communities, and yet not all of them can be monetized. Similarly, the serious health effects and lifetime impacts on workers who do not die but who are hospitalized with heart failure, coma, or other effects also cannot be quantified or monetized. However, the impacts of these effects should not be ignored. One example is a case in 2012 in California, where one man attempted to save a co-worker who had collapsed while cleaning a paint-mixing tank. The collapsed worker died, and the man attempting to rescue him was incapacitated within several seconds and lost consciousness. Though he survived, he required resuscitation, hospitalization for four days, and lengthy follow-up treatments (Ref. 7). The impacts on workers with severe but non-fatal nervous system impacts include monetary, personal health, and emotional suffering costs that cannot be quantified or monetized, but again, should not be ignored. These severe nervous system impacts can include coma and heart failure (Ref. 2).

Even when less severe, the nervous system effects of acute exposure to methylene chloride can have considerable adverse consequences on an individual, particularly if one is exposed as a bystander who is unaware of why these nervous system effects are occurring. Commercial and consumer users as well as bystanders in workplaces and residences are at risk of dizziness and sensory impairment during most uses of methylene chloride for paint and coating removal. Similarly, chronic exposure to methylene chloride presents risks to the nervous system of commercial users, consumer users, and bystanders exposed to methylene chloride in paint and coating removal.

2. Nervous system effects—chronic exposures.

The methylene chloride risk assessment identified nervous system effects as adverse effects of chronic exposure to methylene chloride exposure in paint and coating removal. There are increased health risks for nervous system effects for many of the approximately 17,600 workers in 8,600 commercial facilities or companies that use methylene chloride for paint and coating removal for the commercial uses proposed to be regulated (Ref. 4).

Chronic exposures in occupational settings put users and bystanders at risk of cognitive impairment (affecting eye-hand coordination, tracking tasks, auditory vigilance); adverse effects on autonomic, neuromuscular, and sensorimotor functions (Ref. 2); and long-term effects on specific cognitive-neurological measures (

i.e.,

attention and reaction time) (Ref. 5).

3. Liver toxicity.

The methylene chloride risk assessment identified liver toxicity and liver cancer as adverse effects of chronic exposure to methylene chloride exposure in paint and coating removal. There are increased health risks for liver toxicity and liver cancer for many of the approximately 17,600 workers in 8,600 commercial facilities or companies that use methylene chloride for paint and coating removal for the commercial uses proposed to be regulated (Ref. 4).

Specific effects to the liver include hepatic vacuolation and non-alcoholic fatty liver disease (NAFLD) (Ref. 2). Some form of liver disease impacts at least 30 million people, or 1 in 10 Americans. Included in this number is at least 20% of those with NAFLD. NAFLD tends to impact people who are overweight/obese or have diabetes. However, an estimated 25% do not have any risk factors. The danger of NAFLD is that it can cause the liver to swell, which may result in cirrhosis over time and could even lead to liver cancer or failure (Ref. 42). The most common known causes to this disease burden are attributable to alcoholism and viral infections, such as hepatitis A, B, and C. These known environmental risk factors of hepatitis infection may result in increased susceptibility of individuals exposed to organic chemicals such as methylene chloride.

Chronic exposure to methylene chloride can also lead to liver cancers including hepatocellular carcinomas (HCC), hepatocellular adenomas, and biliary tract cancer (Ref. 2). The monetizable benefits associated with reducing the risk of liver cancers associated with methylene chloride exposure are discussed in Unit VII.B. However, the impacts of these cancers should not be measured only as dollar valuations. For example, because HCC is frequently diagnosed only after an individual's health has deteriorated, survival is usually measured in months. As a result, “HCC is responsible for a large proportion of cancer deaths worldwide . . . HCC classically arises and grows in silent fashion, making its discovery challenging prior to the development of later stage disease” (Ref. 43). Recommended treatments are aggressive interventions such as the removal of the tumors or sections of the liver; the life expectancy of patients with HCC is a mean survival rate of 6 to 20 months. Advanced cases can metastasize to any organ system, and tends to spread to bones and lungs. Bone pain related to metastasis is frequently the initial presenting symptom of HCC (Ref. 43).

Additional medical and emotional costs are associated with cancer and non-cancer liver toxicity following chronic exposure to methylene chloride in paint and coating removal, although these costs cannot be quantified. These costs include medical visits and medication costs. In some cases, the ability to work can be affected, which in turn impacts the ability to get proper medical care. Liver toxicity can lead to jaundice, weakness, fatigue, weight loss, nausea, vomiting, abdominal pain, impaired metabolism, and liver disease.

Depending upon the severity of the jaundice, treatments can range significantly. Simple treatment may involve avoiding exposure to methylene chloride and other solvents; however, this may impact an individual's ability to continue to work. In severe cases, liver toxicity can lead to liver failure, which can result in the need for a liver transplant. Even if a donor is available, liver transplantation is expensive (with an estimated cost of $575,000) and there are countervailing risks for this type of treatment (Ref. 44). The mental and emotional toll on an individual and their family as they try to identify the cause of sickness and possibly experience an inability to work, as well as the potential monetary cost of medical treatment required to regain health, are significant.

4.

Hematopoietic cancers.

EPA's 2011 IRIS assessment for methylene chloride found that it is a likely human carcinogen. Chronic inhalation exposure to methylene chloride such as during paint and coating removal has been shown to result in increased risk for non‐Hodgkin's lymphoma (NHL) or multiple myeloma in workers (Ref. 5). There are increased risks for NHL or

multiple myeloma for many of the approximately 17,600 workers in 8,600 commercial facilities or companies that use methylene chloride for paint and coating removal for the commercial uses proposed to be regulated (Ref. 4).

NHL is a form of cancer that originates in the lymphatic system. Approximately 19 new cases per 100,000 adults per year are diagnosed, with approximately 6.2 deaths per 100,000 adults annually (Ref. 45). NHL is the seventh most common form of cancer (Ref. 46). Other factors that may increase the risk of NHL are medications that suppress a person's immune system, infection with certain viruses and bacteria, or older age (Ref. 47).

Symptoms of NHL are swollen lymph nodes in the neck, armpits or groin, abdominal pain or swelling, chest pain, coughing or trouble breathing, fatigue, fever, night sweats, and weight loss. Depending on the rate at which the NHL advances, treatment may consist of monitoring, chemotherapy, radiation, stem cell transplant, medications that enhance the immune system's ability to fight cancer, or medications that deliver radiation directly to cancer cells (Ref. 47).

Multiple myeloma is a related hematopoietic cancer, formed by malignant plasma cells. Multiple myeloma is characterized by low blood counts, bone and calcium problems, infections, kidney problems, light chain amyloidosis, and various forms of abnormal plasma cell growth. Often, multiple myeloma has no clinical symptoms until it reaches an advanced stage (Ref. 48).

Treatments for NHL or multiple myeloma result in substantial costs for hospital and doctors' visits in order to treat the cancer. Treatments for NHL or multiple myeloma can also have countervailing risks and can lead to patients' higher susceptibility for secondary malignancies (Refs. 47 and 48). The emotional and mental toll from wondering whether a treatment will be successful, going through the actual treatment, and inability to do normal activities, or work will most likely be high (Ref. 49). This emotional and mental toll could extend to the person's family and friends as they struggle with the diagnosis and success and failure of a treatment regime.

5. Brain cancer.

EPA's 2011 IRIS assessment for methylene chloride found that it is a likely human carcinogen. Chronic inhalation exposure to methylene chloride has been shown to result in brain cancer (Ref. 5). There are increased risks for brain cancer for many of the approximately 17,600 workers in 8,600 commercial facilities or companies that use methylene chloride for paint and coating removal for the commercial uses proposed to be regulated (Ref. 4).

Researchers at the National Cancer Institute found that “associations of astrocytic brain cancer were observed with likely exposure to carbon tetrachloride, methylene chloride, tetrachloroethylene, and trichloroethylene, but were strongest for methylene chloride. . . . Risk of astrocytic brain tumors increased with probability and average intensity of exposure, and with duration of employment in jobs considered exposed to methylene chloride . . . These trends could not be explained by exposures to the other solvents” (Ref. 50).

Cancers that originate in the brain, which include astrocytic brain cancers, are relatively rare. Astrocytic brain cancers are estimated to have an incidence of approximately 10 cases per 1 million people per year, depending on how these types of cancers are defined (Ref. 51). Astrocytic tumors are characterized by varying degrees of growth potential and infiltration into nearby tissues. They include tumors that can spread quickly through the brain stem (brain stem gliomas); affect the pineal gland, which controls the sleeping and waking cycle (pineal astrocytic tumors); grow slowly and can be relatively easily cured (pilocytic astrocytoma); grow slowly but often spread into nearby tissues (diffuse astrocytoma); grow quickly and spread into nearby tissues (anaplastic astrocytoma); and grow quickly, spread quickly into nearby tissues, and usually cannot be cured (glioblastoma) (Ref. 51).

For astrocytic brain cancers, like other primary malignant brain tumors, initial clinical symptoms are frequently headaches and seizures. Lower-grade tumors may persist undetected for years, whereas the faster-growing or faster-spreading tumors may rapidly provoke neurological decline. Other symptoms may include nausea, vomiting, headache, and confusion as a result of increased intracranial pressure (Ref. 51).

Treatment for astrocytic brain cancers varies by the type and stage of the tumor; it can include pharmacological treatment (for many patients, this includes steroids and anti-convulsants if they are experiencing seizures), surgery (depending on location of the tumor, they may be removed or separated from the brain), chemotherapy, hormone modulation, or combinations of these treatments (Ref. 51). Like most cancer treatments, these can have countervailing risks. Additionally, the emotional and mental tolls described in earlier sections are relevant to these cancer treatments as well (Ref. 49).

6. Lung cancer.

EPA's 2011 IRIS assessment for methylene chloride found that it is a likely human carcinogen. Chronic inhalation exposure to methylene chloride has been shown to result in bronchoalveolar carcinomas (BAC) or bronchoalveolar adenomas, which are forms of lung cancer (Ref. 5). There are increased risks for these lung cancers for many of the approximately 17,600 workers in 8,600 commercial facilities or companies that use methylene chloride for paint and coating removal for the commercial uses proposed to be regulated (Ref. 4).

BAC is a small percent of lung cancers (between 2% to 4%) and has unique characteristics. It is notable for its weak relationship with cigarette smoking; about one-third of patients in the United States with BAC were never smokers. Additionally, because it rarely spreads outside the lungs, it is often initially diagnosed as pneumonia or other lung inflammations (Ref. 52). Most patients do not present clinical symptoms (Ref. 52) and are only diagnosed following radiography or biopsy. Treatment requires surgery (Ref. 52). This has clear countervailing risks, and even if successful in removing any tumors present, the BAC may return.

7. Mammary tumors.

Exposure to methylene has been shown to result in significant increases in the incidence of adenomas, fibroadenomas, or fibromas in or near the mammary gland (Refs. 2 and 5). These are largely benign tumors (Ref. 2). Though many benign tumors do not require invasive procedures, doctors recommend removing fibroadenomas. Patients need to undergo a biopsy to identify the carcinogenic risk of the tumor, and have the tumors removed if they continue to grow, change the shape of the breast, or are carcinogenic (Ref. 53). If removal is necessary, the procedure may also require the removal of nearby healthy mammary tissue, resulting in scarring and changed shape and texture of the breast (Ref. 53). Women with fibroadenomas and adenomas also have an increased risk of breast cancer, estimated to be approximately 1.5 to 2.0 times the risk of women with no breast changes (Ref. 54).

8. Reproductive effects.

EPA's 2011 IRIS assessment for methylene chloride found that exposure can have reproductive effects that include testicular and ovarian atrophy (Ref. 5). At very high exposures, chronic inhalation of methylene chloride during paint and coating removal can result in these reproductive effects, which are related to decreased fertility (Ref. 55).

There are increased risks for these reproductive effects for many of the approximately 17,600 workers in 8,600 commercial facilities or companies that use methylene chloride for paint and coating removal for the commercial uses proposed to be regulated (Ref. 4). Similar to effects discussed previously, while neither the precise reduction in individual risk of developing this disorder from reducing exposure to methylene chloride or the total number of cases avoided can be estimated, EPA still considers their impact.

9.

Kidney toxicity.

EPA's 2011 IRIS assessment for methylene chloride identified kidney effects from exposure to methylene chloride; these effects include renal tubular degeneration (Ref. 5). At very high exposures, chronic inhalation exposure to methylene chloride during paint and coating removal can result in kidney toxicity. There are increased risks for these kidney effects for many of the approximately 17,600 workers in 8,600 commercial facilities or companies that use methylene chloride for paint and coating removal for the commercial uses proposed to be regulated (Ref. 4).

Exposure to methylene chloride can lead to changes in the proximal tubules of the kidney. This damage may result in signs and symptoms of acute kidney failure that include; decreased urine output, although occasionally urine output remains normal; fluid retention, causing swelling in the legs, ankles or feet; drowsiness; shortness of breath; fatigue; confusion; nausea; seizures or coma in severe cases; and chest pain or pressure. Sometimes acute kidney failure causes no signs or symptoms and is detected through lab tests done for another reason.

Kidney toxicity means the kidney has suffered damage that can result in a person being unable to rid their body of excess urine and wastes. In extreme cases where the kidney is impaired over a long period of time, the kidney could be damaged to the point that it no longer functions. When a kidney no longer functions, a person needs dialysis and ideally a kidney transplant. In some cases, a non-functioning kidney can result in death. Kidney dialysis and kidney transplantation are expensive and incur long-term health costs if kidney function fails (Ref. 56).

The monetary cost of kidney toxicity varies depending on the severity of the damage to the kidney. In less severe cases, doctor visits may be limited and hospital stays unnecessary. In more severe cases, a person may need serious medical interventions, such as dialysis or a kidney transplant if a donor is available, which can result in high medical expenses due to numerous hospital and doctor visits for regular dialysis and surgery if a transplant occurs. The costs for hemodialysis, as charged by hospitals, can be upwards of $100,000 per month (Ref. 57).

Depending on the severity of the kidney damage, kidney disease can impact a person's ability to work and live a normal life, which in turn takes a mental and emotional toll on the patient. In less severe cases, the impact on a person's quality of life may be limited while in instances where kidney damage is severe, a person's quality of life and ability to work would be affected. While neither the precise reduction in individual risk of developing kidney toxicity from reducing exposure to methylene chloride during paint or coating removal or the total number of cases avoided can be estimated, these costs must still be considered because they can significantly impact those exposed to methylene chloride.

10. Disproportionate impacts on environmental justice communities.

An additional factor that cannot be monetized is the disproportionate impact on environmental justice communities. As described in Unit VI.C.1.b., Hispanic and foreign-born workers, who may have limited English proficiency, are disproportionately over-represented in construction trades (Ref. 4), in which methylene chloride is used for paint and coating removal. Because they are disproportionately over-represented in this industry, these populations are disproportionately exposed to methylene chloride during paint and coating removal, and are disproportionately at risk to the range of adverse health effects described in this unit.

E. Availability of Alternatives

For almost every situation in which methylene chloride is used to remove paints or coatings, EPA is aware of technically and economically feasible chemical substitutes or alternative methods that are reasonably available. The two situations for which EPA does not know of technically and economically feasible alternatives are the uses that EPA proposes are critical for national security, described in more detail in Unit VIII., and commercial furniture refinishing, discussed in more depth in Unit XI. With respect to the specific coating removal uses that EPA proposes are critical for national security, described in Unit VIII., EPA does not believe that technically and economically feasible alternatives

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