Trichloroethylene; Regulation of Certain Uses Under TSCA SEC 6(a)
Proposed rule.
CFR Part: "40 CFR Part 751"
RIN Number: "RIN 2070-AK03"
Citation: "81 FR 91592"
Document Number: "
Page Number: "91592"
"Proposed Rules"
SUMMARY: Trichloroethylene (TCE) is a volatile organic compound widely used in industrial and commercial processes and has some limited uses in consumer and commercial products.
EFFECTIVE DATE: Comments must be received on or before
ADDRESSES: Submit your comments, identified by docket identification (ID) number
Docket. Docket number
FOR FURTHER INFORMATION CONTACT: For technical information contact:
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
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 TSCA to include import), process, or distribute in commerce TCE or commercially use TCE in aerosol degreasers or for spot cleaning in dry cleaning facilities. 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:
* All Other Miscellaneous Textile Product Mills (NAICS code 314999).
* Petroleum Refineries (NAICS code 324110).
* Petroleum Lubricating Oil and Grease Manufacturing (NAICS code 324191).
* Petrochemical Manufacturing (NAICS code 325110).
* Industrial Gas Manufacturing (NAICS code 325120).
* Other Basic Inorganic Chemical Manufacturing (NAICS code 325180).
* All Other Basic Organic Chemical Manufacturing (NAICS code 325199).
* Plastics Material and Resin Manufacturing (NAICS code 325211).
* Synthetic Rubber Manufacturing (NAICS code 325212).
* Paint and Coating Manufacturing (NAICS code 325510).
* Adhesive Manufacturing (NAICS code 325520).
* Soap and Other Detergent Manufacturing (NAICS code 325611).
* Polish and Other Sanitation Good Manufacturing (NAICS code 325612).
* All Other Miscellaneous Chemical Product and Preparation Manufacturing (NAICS code 325998).
* Unlaminated Plastics Film and Sheet (except Packaging) Manufacturing (NAICS code 326113).
* All Other Plastics Product Manufacturing (NAICS code 326199).
* Rubber and Plastics Hoses and Belting Manufacturing (NAICS code 326220).
* All Other Rubber Product Manufacturing (NAICS code 326299).
* Cement Manufacturing (NAICS code 327310).
* Ground or Treated Mineral and Earth Manufacturing (NAICS code 327992).
* Iron and Steel Pipe and Tube Manufacturing from Purchased Steel (NAICS code 331210).
* Steel Wire Drawing (NAICS code 331222).
* Copper Rolling, Drawing, Extruding, and Alloying (NAICS code 331420)
* Nonferrous Metal (except Copper and Aluminum) Rolling, Drawing, and Extruding (NAICS code 331491).
* Nonferrous Metal Die-Casting Foundries (NAICS code 331523).
* Powder Metallurgy Part Manufacturing (NAICS code 332117).
* Metal Crown, Closure, and Other Metal Stamping (except Automotive) (NAICS code 332119).
* Saw Blade and Hand Tool Manufacturing (NAICS code 332216).
* Metal Window and Door Manufacturing (NAICS code 332321).
* Power Boiler and Heat Exchanger Manufacturing (NAICS code 332410).
* Other Fabricated Wire Product Manufacturing (NAICS code 332618).
*
* Precision Turned Product Manufacturing (NAICS code 332721).
* Bolt, Nut, Screw, Rivet, and Washer Manufacturing (NAICS code 332722).
* Metal Heat Treating (NAICS code 332811).
* Metal Coating, Engraving (except Jewelry and Silverware), and Allied Services to Manufacturers (NAICS code 332812).
* Electroplating, Plating, Polishing, Anodizing, and Coloring (NAICS code 332813).
* Oil and
* Cutting Tool and Machine Tool Accessory Manufacturing (NAICS code 333515).
* Small Arms, Ordnance, and Ordnance Accessories Manufacturing (NAICS code 332994).
* Fluid Power Pump and Motor Manufacturing (NAICS code 333996).
* All Other Miscellaneous Fabricated Metal Product Manufacturing (NAICS code 332999).
* Oil and
* Industrial and Commercial Fan and Blower and Air Purification Equipment Manufacturing (NAICS code 333413).
* Cutting Tool and Machine Tool Accessory Manufacturing (NAICS code 333515).
* Pump and Pumping Equipment Manufacturing (NAICS code 333911).
* Fluid Power Pump and Motor Manufacturing (NAICS code 333996).
* Search, Detection, Navigation, Guidance, Aeronautical, and Nautical System and Instrument Manufacturing (NAICS code 334511).
* Automatic Environmental Control Manufacturing for Residential, Commercial, and Appliance Use (NAICS code 334512).
* Motor and Generator Manufacturing (NAICS code 335312).
* Primary Battery Manufacturing (NAICS code 335912).
* Carbon and Graphite Product Manufacturing (NAICS code 335991).
* Motor Vehicle Brake System Manufacturing (NAICS code 336340).
* Aircraft Manufacturing (NAICS code 336411).
* Other Aircraft Parts and Auxiliary Equipment Manufacturing (NAICS code 336413).
* Guided Missile and Space Vehicle Manufacturing (NAICS code 336414).
*
* Dental Equipment and Supplies Manufacturing (NAICS code 339114).
* Other Chemical and Allied Products Merchant Wholesalers (NAICS code 424690).
* Petroleum Bulk Stations and Terminals (NAICS code 424710).
* Hazardous Waste Treatment and Disposal (NAICS code 562211).
* Solid Waste Combustors and Incinerators (NAICS code 562213).
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 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
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 section 6(a) of TSCA (15 U.S.C. 2605(a)), if
Since the original enactment of TSCA in 1976,
When issuing a rule under TSCA section 6(a),
* Health effects of the chemical substance in question, TCE in this case, and the magnitude of human exposure to TCE;
* Environmental effects of TCE and the magnitude of exposure of the environment to TCE;
* Benefits of TCE for various uses; and the
* 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 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.
For 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) expressly recognizes that
C. What action is the Agency taking?
EPA has preliminarily determined that the use of TCE in aerosol degreasing and for spot cleaning in dry cleaning facilities presents an unreasonable risk of injury to health. Accordingly,
EPA's analysis of worker and consumer populations' exposures to TCE also preliminarily indicates that the use of TCE in vapor degreasing presents an unreasonable risk of injury to health.
D. Why is the Agency taking this action?
Based on
As discussed in Unit I.C,
E. What are the estimated incremental impacts of this action?
EPA has evaluated the potential costs of multiple regulatory options, including the proposed approach of prohibiting the manufacture (including import), processing, and distribution in commerce of TCE for use in aerosol degreasing and for spot cleaning in dry cleaning facilities; prohibiting the commercial use of TCE for aerosol degreasing and for spot cleaning in dry cleaning facilities; and requiring manufacturers, processors, and distributors, except for retailers, to provide downstream notification of these prohibitions throughout the supply chain as well as associated recordkeeping requirements. This analysis, which is available in the docket, is discussed in Units VI and VII, and is briefly summarized here.
Costs of the proposed approach are discussed in Units VI.C.1 and VII.C.1. Alternatives to TCE are readily available at similar cost and performance. Blenders of TCE aerosol degreasers and spot cleaners are expected to reformulate their products. Reformulation costs are expected to be incurred during the first year and
Although TCE causes a wide range of non-cancer adverse effects and cancer, monetized benefits included only benefits associated with reducing cancer risks. The Agency does not have sufficient information to include a quantification or valuation estimate in the overall benefits at this time. The monetized benefits for the proposed approach range from approximately
Another alternative regulatory option considered was a respiratory protection program requiring an air-supplied respirator with an APF of 10,000. The costs of implementing a respiratory protection program, including a supplied-air respirator and related equipment, training, fit testing, monitoring, medical surveillance, and related requirements, would far exceed the costs of switching to alternatives, on a per facility basis. The estimated annualized costs of switching to a respiratory protection program requiring personal protective equipment (PPE) of 10,000 are
F.
This action is consistent with the 1995
II. Overview of TCE and Uses Subject to This Proposed Rule
A. What chemical is included in the proposed rule?
This proposed rule would apply to TCE (Chemical Abstract Services Registry Number 79-01-6) for use in aerosol degreasing and for spot cleaning in dry cleaning facilities.
B. What are the uses of TCE and how can people be exposed?
In 2011, global consumption of TCE was 945 million pounds and consumption in
Individuals, including workers, consumers and the general population, are exposed to TCE from industrial/commercial, consumer, and environmental sources, in different settings such as homes and workplaces, and through multiple exposure pathways (air, water, soil) and routes (inhalation, ingestion, dermal).
The majority (about 83.6%) of TCE is used as an intermediate chemical for manufacturing refrigerant HFC-134a. This use occurs in a closed system that has low potential for human exposure (Ref. 1).
Based on the Toxics Release Inventory (TRI) data for 2012, 38 companies used TCE as a formulation component, 33 companies processed TCE by repackaging the chemical, 28 companies used TCE as a manufacturing aid, and 1,113 companies used TCE for ancillary uses, such as degreasing (Ref. 1). Based on the latest TRI data from 2014, the number of users of TCE has significantly decreased since 2012: 24 companies use TCE as a formulation component, 20 companies process TCE by repackaging the chemical, 20 companies use TCE as a manufacturing aid, and 97 companies use TCE for ancillary uses, such as degreasing.
The uses assessed by
C. What are the potential health effects of TCE?
A broad set of relevant studies including epidemiologic studies, animal bioassays, metabolism studies, and mechanistic studies show that TCE exposure is associated with an array of adverse health effects. TCE has the potential to induce developmental toxicity, immunotoxicity, kidney toxicity, reproductive and endocrine effects, neurotoxicity, liver toxicity, and several forms of cancer (Ref. 1).
TCE is fat soluble (lipophilic) and easily crosses biological membranes. TCE has been found in human maternal and fetal blood and in the breast milk of lactating women (Ref. 1).
An evaluation of the overall weight of the evidence of the human and animal developmental toxicity data suggests an association between pre- and/or post-natal TCE exposures and potential adverse developmental outcomes. TCE-induced heart malformations and immunotoxicity in animals have been identified as the most sensitive developmental toxicity endpoints for TCE. Human studies examined the possible association of TCE with various prenatal effects. These adverse effects of developmental TCE exposure may include: Fetal death (spontaneous abortion, perinatal death, pre- or post-implantation loss, resorptions); decreased growth (low birth weight, small for gestational age); congenital malformations, in particular heart defects; and postnatal effects such as growth, survival, developmental neurotoxicity, developmental immunotoxicity, and childhood cancers. Some epidemiological studies reported an increased incidence of birth defects in TCE-exposed populations from exposure to contaminated water. As for human developmental neurotoxicity, studies collectively suggest that the developing brain is susceptible to TCE toxicity. These studies have reported an association with TCE exposure and central nervous system birth defects and postnatal effects such as delayed newborn reflexes, impaired learning or memory, aggressive behavior, hearing impairment, speech impairment, encephalopathy, impaired executive and motor function and attention deficit disorder (Ref. 1).
Immune-related effects following TCE exposures have been observed in adult animal and human studies. In general, these effects were associated with inducing enhanced immune responses as opposed to immunosuppressive effects. Human studies have reported a relationship between systemic autoimmune diseases, such as scleroderma, with occupational exposure to TCE. There have also been a large number of case reports in TCE-exposed workers developing a severe hypersensitivity skin disorder, often accompanied by systemic effects to the lymph nodes and other organs, such as hepatitis (Ref. 1).
Studies in both humans and animals have shown changes in the proximal tubules of the kidney following exposure to TCE (Ref. 1). The TCE IRIS assessment concluded that TCE is carcinogenic to humans based on convincing evidence of a causal relationship between TCE exposure in humans and kidney cancer (Ref. 3). A recent review of TCE by the
TCE metabolites appear to be the causative agents that induce renal toxicity, including cancer. S-dichlorovinyl-L-cysteine (DCVC), and to a lesser extent other metabolites, appears to be responsible for kidney damage and kidney cancer following TCE exposure. Toxicokinetic data suggest that the TCE metabolites derived from glutathione conjugation (in particular DCVC) can be systemically delivered or formed in the kidney. Moreover, DCVC-treated animals showed the same type of kidney damage as those treated with TCE (Ref. 1). The toxicokinetic data and the genotoxicity of DCVC further suggest that a mutagenic mode of action is involved in TCE-induced kidney tumors, although cytotoxicity followed by compensatory cellular proliferation cannot be ruled out. As for the mutagenic mode of action, both genetic polymorphisms (Glutathione transferase (GST) pathway) and mutations to tumor suppressor genes have been hypothesized as possible mechanistic key events in the formation of kidney cancers in humans (Ref. 1).
The toxicological literature provides support for male and female reproductive effects following TCE exposure. Both the epidemiological and animal studies provide evidence of adverse effects to female reproductive outcomes. However, more extensive evidence exists in support of an association between TCE exposures and male reproductive toxicity. There is evidence that metabolism of TCE in male reproductive tract tissues is associated with adverse effects on sperm measures in both humans and animals. Furthermore, human studies support an association between TCE exposure and alterations in sperm density and quality, as well as changes in sexual drive or function and altered serum endocrine levels (Ref. 1).
Neurotoxicity has been demonstrated in animal and human studies under both acute and chronic exposure conditions. Evaluation of multiple human studies revealed TCE-induced neurotoxic effects including alterations in trigeminal nerve and vestibular function, auditory effects, changes in vision, alterations in cognitive function, changes in psychomotor effects, and neurodevelopmental outcomes. These studies in different populations have consistently reported vestibular system-related symptoms such as headaches, dizziness, and nausea following TCE exposure (Ref. 1).
Animals and humans exposed to TCE consistently experience liver toxicity. Specific effects include the following structural changes: Increased liver weight, increase in DNA synthesis (transient), enlarged hepatocytes, enlarged nuclei, and peroxisome proliferation. Several human studies reported an association between TCE exposure and significant changes in serum liver function tests used in diagnosing liver disease, or changes in plasma or serum bile acids. There was also human evidence for hepatitis accompanying immune-related generalized skin diseases, jaundice, hepatomegaly, hepatosplenomegaly, and liver failure in TCE-exposed workers (Ref. 1).
TCE is characterized as carcinogenic to humans by all routes of exposure as documented in
D. What are the environmental impacts of TCE?
Pursuant to Section 6(c) of TSCA,
1. Environmental effects and impacts. TCE enters the environment as a result of emissions from metal degreasing facilities, and spills or accidental releases, and historic waste disposal activities. Because of its high vapor pressure and low affinity for organic matter in soil, TCE evaporates fairly rapidly when released to soil; however, where it is released onto land surface or directly into the subsurface, TCE can migrate from soil to groundwater (Ref. 1). Based on TCE's moderate persistence, 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 the use of TCE for spot cleaning in dry cleaning facilities and in aerosol degreasers. This should not be misinterpreted to mean that the fate and transport properties of TCE suggest that water and soil contamination is likely low or does not pose an environmental concern.
2. What is the global warming potential of TCE? 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 high variability in the atmospheric lifetime of greenhouse gases, the 100-year scale (GWP100) is typically used. TCE has relatively low global warming potential at a GWP100 of 140 and thus the impact is low (Ref. 1).
3. What is the ozone depletion potential of TCE? TCE is not an ozone-depleting substance and is listed as acceptable under the Significant New Alternatives Policy (SNAP) program for degreasing and aerosols. In 2007, TCE was identified as a substitute for two ozone depleting chemicals, methyl chloroform and CFC-113, for metals, electronics, and precision cleaning (72 FR 30142,
4. Is TCE a volatile organic compound (VOC)? TCE is 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.
5. Does TCE persist in the environment and bioaccumulate? TCE may be persistent, but it is not bioaccumulative. TCE is slowly degraded by sunlight and reactants when released to the atmosphere. Volatilization and microbial biodegradation influence the fate of TCE when released to water, sediment or soil. The biodegradation of TCE in the environment is dependent on a variety of factors and so a wide range of degradation rates have been reported (ranging from days to years). TCE is not expected to bioconcentrate in aquatic organisms based on measured bioconcentration factors of less than 1000 (Ref. 1).
III. Regulatory Actions Pertaining to TCE
Because of its potential health effects, TCE is subject to state, federal, and international regulations restricting and regulating its use, which are summarized in this section. None of these actions addresses the unreasonable risks under TSCA that
A. Federal Actions Pertaining to TCE
Since 1979,
* Safe Drinking Water Act:
* Clean Water Act:
* Clean Air Act: TCE is designated a hazardous air pollutant (HAP) under the Clean Air Act (42 U.S.C. 7412(b)(1)).
* Resource Conservation and Recovery Act (RCRA):
* Comprehensive Environmental Response, Compensation and Liability Act (CERCLA):
While many of the statutes that
The Occupational Safety and Health Administration (OSHA) established a permissible exposure limit (PEL) for TCE in 1971. The PEL is an 8-hour time-weighted average (TWA) TCE concentration of 100 ppm. In addition, the TCE PEL requires that exposures to TCE not exceed 200 ppm (ceiling) at any time during an eight hour work shift with the following exception: Exposures may exceed 200 ppm, but not more than 300 ppm (peak), for a single time period up to 5 minutes in any 2 hours (Refs. 7 and 8).
To provide employers, workers, and other interested parties with a list of alternate occupational exposure limits that may serve to better protect workers,
B. State Actions Pertaining to TCE
Many states have taken actions to reduce risks from TCE use. TCE is listed on
In Massachusetts, TCE is a designated high hazard substance, with an annual reporting threshold of 1,000 pounds (Ref. 13).
Most states have set PELs identical to the
C. International Actions Pertaining to TCE
TCE is also regulated internationally and the international industrial and commercial sectors have moved to alternatives. TCE is prohibited for use in the
Canada conducted a hazard assessment of TCE in 1993 and concluded that "trichloroethylene occurs at concentrations that may be harmful to the environment, and that may constitute a danger in
In Japan, the Chemical Substances Control Law considers TCE a Class II substance (substances that may pose a risk of long-term toxicity to humans or to flora and fauna in the human living environment, and that have been, or in the near future are reasonably likely to be, found in considerable amounts over a substantially extensive area of the environment) (Ref. 19).
TCE is listed in the Australian National Pollutant Inventory, a program run cooperatively by the Australian, State and Territory governments to monitor common pollutants and their levels of release to the environment.
IV. TCE Risk Assessment
In 2013,
A. TSCA Work Plan for Chemical Assessments
In 2012,
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. 21). Using the TSCA Work Plan chemical prioritization criteria, TCE ranked high for health hazards and exposure potential and was included on the initial list of TSCA Work Plan chemicals for assessment.
B. TCE Risk Assessment
EPA finalized a TSCA Work Plan Chemical Risk Assessment for TCE (TCE risk assessment) in
The TCE risk assessment evaluated health risks to consumers and workers, including occupational bystanders, from inhalation exposures to TCE. A summary of the peer review and public comments, along with
The TCE risk assessment identified acute non-cancer risks (i.e., developmental effects) for most occupational and consumer exposure scenarios, including commercial vapor degreasing, spot cleaning, and consumer aerosol degreasing exposure scenarios (Ref. 1). For chronic non-cancer risks there is a range of human health effects in both the occupational vapor degreasing and spot cleaning exposure scenarios with the greatest concern for developmental effects (i.e., fetal cardiac defects), as well as kidney effects and immunotoxicity. In addition, there are chronic non-cancer risks for adverse reproductive effects, neurotoxicity, and liver toxicity (Ref. 1).
Margins of exposure (MOEs) were used in this assessment to estimate non-cancer risks for acute and chronic exposures. The MOE is the health point of departure (an approximation of the no-observed adverse effect level (NOAEL) for a specific endpoint divided by the exposure concentration for the specific scenario of concern. The benchmark MOE accounts for the
The TCE risk assessment estimated acute non-cancer risks for consumers and residential bystanders from the use of TCE-containing aerosol degreasers and spray-applied protective coatings. Exposure scenarios with MOEs below the benchmark MOE have significant risks of concern and typically, non-cancer adverse effects are more likely to result from exposure scenarios with MOEs below the benchmark MOE. For non-cancer effects
The TCE risk assessment also estimated chronic non-cancer risk for workers and occupational bystanders for uses including spot cleaning in dry cleaning facilities. These include developmental toxicity, toxicity to the kidney, immunotoxicity, reproductive and endocrine effects, neurotoxicity, and toxicity to the liver.
There are also cancer risks for persons occupationally exposed to TCE when using TCE-containing spot cleaners in dry cleaning facilities. For users of TCE-containing spot cleaning products, these cancer risks are 1.35 x 10-2 for spot cleaning. In the supplemental analysis following the TCE risk assessment,
The levels of acute and chronic exposures estimated to present low risk for non-cancer effects also result in low risk for cancer.
Given the risks identified in the TCE risk assessment, the agency undertook further analysis to help determine whether the use of TCE for spot cleaning in dry cleaning facilities and in aerosol degreasers poses an unreasonable risk.
C. Supplemental Analysis Using the Methodology of the TCE Risk Assessment
Because the TCE risk assessment concentrated on consumer use of aerosol degreasers and because the aerosol degreaser products available to consumers are also available to commercial users, following release of the TCE risk assessment,
D. Expert Meeting on TCE
On
V. Regulatory Approach
A. TSCA Section 6 Unreasonable Risk Analysis
Under section 6(a) of TSCA, 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,
The 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 (
* Prohibit or otherwise restrict manufacturing, processing, or distribution in commerce of such substances for particular uses or for uses in excess of a specified concentration (
* Require minimum warning labels and instructions (
* Require record keeping or testing (
* Prohibit or regulate any manner or method of commercial use (
* Prohibit or otherwise regulate any manner or method of disposal (
* Direct manufacturers and processors to give notice of the determination to distributors and the public and replace or repurchase substances (
EPA analyzed a wide range of regulatory options under section 6(a) for each use in order to determine the proposed regulatory approach (Refs. 28 and 29). For each use,
After the technical analysis, which represents
B. Section 6(c)(2) considerations. As noted previously, TSCA section 6(c)(2) requires
* Health effects of TCE and the magnitude of human exposure to TCE;
* Environmental effects of TCE and the magnitude of exposure of the environment to TCE;
* Benefits of TCE 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
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's analysis of the regulatory options and consideration of the TSCA section 6(c)(2) factors are discussed in more detail in Unit VI for aerosol degreasing and in Unit VII for spot cleaning in dry cleaning facilities.
To the extent information was available,
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. 30).
C. Regulatory Options Receiving Limited Evaluation
As discussed previously,
Another option
These conclusions are based on the weight-of-evidence analysis that
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. 37). In addition, while some studies have shown that different components of labels and warnings tend to have some influence, the evidence does not suggest that labels alone would be sufficient to ensure that users take the steps needed to protect themselves.
The Agency further determined that presenting information about TCE on a label would not adequately address the identified unreasonable risks 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 TCE. 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 window periods during pregnancy when the developing fetus is susceptible to adverse effects from acute exposures, as well as effects to bystanders. It is unlikely that label language changes will for this use result in widespread, consistent, and successful adoption of risk reduction measures by users.
Additionally, 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
While this regulatory option alone does not address the risks,
VI. Regulatory Assessment of TCE Use in Aerosol Degreasing
This Unit describes the current use of TCE in aerosol degreasing, the unreasonable risks presented by this use, and how
A. Description of the Current Use
Aerosol degreasing is a process that uses aerosol spray products, typically applied from a pressurized can, to remove residual contaminants from parts. The aerosol droplets bead up on the fabricated part and then drip off, carrying away any contaminants and leaving behind a clean surface. Components of an item can be cleaned in place or removed from the item for more thorough cleaning. Aerosol degreasers can also be sprayed onto a rag that is used to wipe components clean.
Aerosol degreasers are primarily used for niche industrial or manufacturing uses and some commercial service uses, such as degreasing of metals, degreasing of electrical motors, and electronic cleaners. One example of a commercial setting for the aerosol degreaser use is repair shops, where service items are cleaned to remove any contaminants that would otherwise compromise the item's operation. Internal components may be cleaned in place or removed from the item, cleaned, and then re-installed once dry.
Consumer use of TCE in aerosol degreasers is similar to commercial use but occurs in consumer settings. The aerosol products used in consumer settings are the same as those used in commercial settings. TCE use is very limited in products intended for consumers due to existing VOC regulations in
There are currently TCE alternatives available on the market for all of the existing uses of aerosol degreasing that are similar in efficacy and cost (Refs. 2, 32). The most likely substitute products would be products with hydrocarbon/mineral spirits, products that are acetone or terpene based, and some that contain perchloroethylene or 1-bromopropane. All substitutes are expected to be less hazardous than TCE. Substitutes that are hazardous but at dose levels higher than the dose levels at which TCE causes adverse effects include perchloroethylene and 1-bromopropane.
B. Analysis of Regulatory Options
In this section,
1. Risks associated with the current use. a. General impacts. The TCE risk assessment identified acute non-cancer risks for consumers and residential bystanders from the use of TCE-containing aerosol degreasers (Ref. 1).
b. Impacts on minority populations. There is no known disproportionate representation of minority populations in occupations using aerosol degreasers. All employees and consumers using aerosol degreasers would benefit from risk reduction.
c. Impacts on children.
EPA also examined acute risks for consumer exposures in residential settings.
d. Exposures for this use. For consumer exposures,
The high-end inhalation exposure estimates for the consumer scenarios were 2 ppm for users of TCE-containing aerosol degreasers and 0.8 ppm for bystanders of TCE-containing solvent degreasers (Ref. 1).
For exposures in commercial settings,
EPA assumed that a worker applies aerosol degreasers 260 days a year, once per hour, and that no applications occur during the first hour of the 8-hour work day.
e. Risks for this use. As discussed in Unit IV.B, TCE is associated with a range of non-cancer adverse health effects in humans and animals and is carcinogenic to humans. MOEs were used in this assessment to estimate non-cancer risks for acute and chronic exposures. Exposure scenarios with MOEs below the benchmark MOE for the individual toxicity endpoints have risks of concern, as explained in detail in the TCE risk assessment (Ref. 1). Cancer risks express the incremental probability of an individual developing cancer over a lifetime as a result of exposure to TCE under specified use scenarios.
The acute inhalation risk assessment used developmental toxicity data to evaluate the acute risks for the TCE use scenarios. As indicated in the TSCA Work Plan Risk Assessment on TCE,
Acute inhalation risks were estimated for all residential exposure scenarios of aerosol degreasing based on concerns for developmental effects. Risks of concern were identified for consumer users and bystanders, regardless of the type of exposure (typical vs. worst case scenario) and whether room ventilation was used. For acute consumer aerosol degreasing exposures, the high end MOE is 0.002 for fetal heart malformations. This means that exposures are estimated to be 5,000 times greater than exposures used to calculate the benchmark MOE of 10. All of the residential use scenarios resulted in MOE values significantly below the benchmark MOE of 10 irrespective of the percentile HEC value used to estimate the MOEs (Refs. 1, 24). Given this significant difference between the benchmark MOEs and the MOEs from the residential use scenarios,
For occupational aerosol degreasing exposures the MOE is 0.003 for fetal heart malformation and is also representative of MOEs for kidney toxicity and immunotoxicity. This equates to estimated exposures that are more than 3,000 times greater than those needed to achieve the benchmark MOE. For chronic occupational aerosol degreasing exposures the baseline cancer risk is 1.6 x 10-2> exceeding standard cancer benchmarks of 10-6 to 10-2 (Refs. 1, 23).
2. Initial analysis of potential regulatory options. Having identified unreasonable risks from the use of TCE in aerosol degreasing,
EPA assessed a number of exposure scenarios associated with risk reduction options in order to determine variations in TCE exposure from aerosol degreasing, including: Material substitution, engineering controls, and use of PPE.
EPA's inhalation exposure modeling estimated exposures to characterize the range of workplace scenarios. Inhalation exposure level estimate for facilities without local exhaust ventilation ranged from 1.00 ppm to 14.36 ppm as 8-hour TWAs for workers and 0.21 ppm to 13.58 ppm for bystanders. For facilities with local exhaust ventilation which was estimated to have an effectiveness of 90%,
Overall,
3. Assessment of regulatory options to determine whether they address the identified unreasonable risks to the extent necessary so that TCE no longer presents such risks. As discussed in Unit V,
The options that had the potential to address the identified unreasonable risks for consumer use, commercial use, or both uses of TCE in aerosol degreasing included: (a) Prohibiting the manufacturing, processing, and distribution in commerce of TCE for use in aerosol degreasing under section 6(a)(2) plus prohibiting the use of TCE in commercial aerosol degreasing under section 6(a)(5) and requiring downstream notification when distributing TCE for other uses under section 6(a)(3); (b) variations on such a supply-chain approach (such as just prohibiting the manufacturing, processing, and distribution in commerce of TCE for use in aerosol degreasing products under section 6(a)(2) or just prohibiting the commercial use of TCE in aerosol degreasing under section 6(a)(5)); (c) prohibiting the manufacturing, processing, and distribution in commerce of TCE for use in consumer aerosol degreasing products under section 6(a)(2) and requiring downstream notification (e.g., via a Safety Data Sheet (SDS)) when distributing TCE for other uses under section 6(a)(3); and (d) requiring the use of PPE in commercial aerosol degreasing operations in which TCE is used under section 6(a)(5) or requiring the use of PPE and engineering controls (local exhaust ventilation) in commercial aerosol degreasing operations in which TCE is used under section 6(a)(5).
The full range of regulatory options considered under section 6(a) is reflected in
a. Proposed approach to prohibit manufacturing, processing, distribution in commerce, and use of TCE for aerosol degreasing and require downstream notification. As noted previously, the proposed regulatory approach for TCE use in aerosol degreasing would prohibit the manufacturing, processing, and distribution in commerce of TCE for aerosol degreasing under TSCA section 6(a)(2), prohibit the commercial use of TCE for aerosol degreasing under TSCA section 6(a)(5), and require manufacturers, processors, and distributors, except for retailers, to provide downstream notification, e.g., via a Safety Data Sheet (SDS), of the prohibitions under TSCA section 6(a)(3).
As discussed in Unit VI.B.1, the baseline risk for exposure to workers and consumers for aerosol degreasing departs from non-cancer MOE benchmarks for all non-cancer effects (e.g., developmental effects, kidney toxicity, and immunotoxicity) and standard cancer benchmarks. Under this proposed approach, exposures to TCE from use in aerosol degreasing would be completely eliminated. As a result, both non-cancer and cancer risks would be eliminated (Refs. 23 and 24).
The proposed approach would ensure that workers and consumers are no longer at risk from TCE exposure associated with this use. Prohibiting the manufacturing, processing and distribution in commerce of TCE for use in aerosol degreasing would minimize the availability of TCE for aerosol degreasing. The prohibition of the use of TCE in commercial aerosol degreasing would eliminate commercial demand for TCE aerosol degreasing products and significantly reduce the potential for consumer use of commercial products. These complementary provisions would protect both workers and consumers; workers would not be exposed to TCE and the risk to consumers would be minimized because commercial aerosol degreasing products containing TCE would not be available, so consumers would not be able to divert commercial-use products from the supply chain. The downstream notification of these restrictions ensures that processors, distributors, and other purchasers are aware of the manufacturing, processing, distribution in commerce and use restrictions for TCE in aerosol degreasing, and helps to ensure that the rule is effectively implemented by avoiding off-label use as an aerosol degreaser of TCE manufactured for other uses. Downstream notification also streamlines and aids in compliance and enhances enforcement. Overall, downstream notification facilitates implementation of the rule. This integrated supply chain proposed approach minimizes the risk from TCE in aerosol degreasing. In addition, the proposed approach would provide staggered compliance dates for implementing the prohibition of manufacturing, processing, distribution in commerce, and commercial use in order to avoid undue impacts on the businesses involved.
b. Options that are variations of the proposed approach to prohibit manufacturing, processing, distribution in commerce, and use of TCE for aerosol degreasing and require downstream notification. One variation of the proposed approach would be to prohibit manufacture, processing, and distribution in commerce for the consumer and commercial aerosol degreasing uses alone. This option could reach the risk benchmarks for TCE. However, while this option could address the identified unreasonable risks, in practice given the continued availability of TCE for other uses, it would not do so. Without the accompanying prohibition on commercial use and downstream notification that is included in the proposed approach, this option would leave open the likelihood that commercial users or consumers could obtain off-label TCE for aerosol degreasing. For example, if only manufacturing, processing and distribution in commerce for the aerosol degreasing use were prohibited without also prohibiting the commercial use and providing the downstream notice, commercial users or consumers could more easily acquire TCE for degreasing from sources that make it available for other uses. This would be particularly easy for commercial users given that a company may buy a chemical substance for one use and also use it for another. Without downstream notification, unsophisticated purchasers, in particular, are likely to be unfamiliar with the prohibitions regarding this use and mistakenly use TCE for aerosol degreasing and thereby expose themselves and bystanders to unreasonable risks. Thus, under these variations,
Another regulatory option that
c. Prohibit the manufacturing, processing, and distribution in commerce of TCE for use in consumer aerosol degreasing products under section 6(a)(2) or prohibit the manufacturing, processing, and distribution in commerce of TCE for use in consumer aerosol degreasing products under section 6(a)(2) and require downstream notification when distributing TCE for other uses section 6(a)(3).
d. Require the use of personal protective equipment in commercial aerosol degreasing operations in which TCE is used under section 6(a)(5) or require the use of personal protective equipment and engineering controls in commercial aerosol degreasing operations in which TCE is used under section 6(a)(5). Another regulatory option that
Although respirators could reduce exposures to levels that are protective of non-cancer and cancer risks, there are many documented limitations to successful implementation of respirators with an APF of 10,000. Not all workers can 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 a tight fitting full-face piece respirators to provide the required protection. Also, difficulties associated with selection, fit, and use often render them ineffective in actual application, preventing the assurance of consistent and reliable protection, regardless of the assigned capabilities of the respirator. Individuals who cannot get a good face piece fit, including those individuals whose beards or sideburns interfere with the face piece seal, would be unable to wear tight fitting respirators. In addition, respirators may also present communication problems, vision problems, worker fatigue and reduced work efficiency (63 FR 1156,
In addition,
Also for commercial aerosol degreasing uses,
Furthermore, neither of these variations of relying upon PPE for commercial aerosol degreasing use would do anything to reduce the risks to consumer users. Therefore, considering the practical limitations of PPE for this scenario as well as the unmitigated risks to consumers, this option would not address the unreasonable risks presented by these uses.
Even if either of these approaches were coupled with a section 6(a)(2) prohibition on the manufacture, processing and distribution in commerce of TCE for use in consumer aerosol degreasing products, this would not protect consumers because they would be able to buy and use commercial aerosol degreasing products, e.g., via the
EPA could also require that TCE products be distributed with a respirator with an appropriate assigned protection factor to protect for the risks from TCE.
C. Availability of Substitutes and Impacts of the Proposed and Alternative Regulatory Options
This Unit examines the availability of substitutes for TCE in aerosol degreasing and describes the estimated costs of the proposed and alternative regulatory actions that
Overall,
TCE is also prohibited in the
1. Proposed approach to prohibit manufacturing, processing, distribution in commerce, and use of TCE for aerosol degreasing and require downstream notification. The costs of the proposed approach are estimated to include product reformulation costs, downstream notification costs, recordkeeping costs, and Agency costs. The
2. Options that require personal protective equipment. Given equipment costs and the requirements associated with establishing a respiratory protection program which involves training, respirator fit testing and the establishment and maintenance of a medical monitoring program,
3. Options that exclude downstream notification.
D. Summary
The proposed approach to prohibit manufacturing, processing, distribution in commerce, and use of TCE for aerosol degreasing and require downstream notification is necessary to ensure that TCE no longer presents unreasonable risks for all users. This option does not pose an undue burden on industry because comparably effective and priced substitutes to TCE for aerosol degreasing are readily available. The supply chain approach ensures protection of consumers from the identified unreasonable risks by precluding the off-label purchase of commercial products by consumers. The downstream notification (e.g., via SDS) component of the supply chain approach provides notice of the prohibition throughout the supply chain and, while slightly more costly to upstream entities, helps to ensure that the use no longer presents unreasonable risks because it streamlines and aids in compliance and enhances enforcement.
VII. Regulatory Assessment of TCE Use for Spot Cleaning in Dry Cleaning Facilities
This Unit describes the current use of TCE for spot cleaning in dry cleaning facilities, the unreasonable risks presented by this use, and how
A. Description of the Current Use
TCE was first introduced as a dry cleaning solvent in
EPA estimates that there are approximately 61,000 dry cleaning facilities in
There are currently a wide variety of comparably effective substitutes on the market and in use in dry cleaning operations that are similarly priced to TCE (Ref. 2), including substitute water-based cleaners (Ref. 44), methyl esters (soy) cleaners, hydrocarbon/mineral spirits, glycol ethers, perchloroethylene, methylene chloride, and 1-bromopropane (Ref. 32). Chemical substitutes that would most likely be used are water-based cleaners, methyl esters (soy) cleaners, hydrocarbon/mineral spirits, glycol ethers, perchloroethylene, 1-bromopropane, methylene chloride, and others.
B. Analysis of Regulatory Options
In this Unit,
1. Risks associated with the current use. a. General impacts. The TCE risk assessment identified non-cancer risks and cancer risks for chronic exposures of workers and occupational bystanders in dry cleaning facilities that use TCE for spot cleaning (Ref. 1).
b. Impacts on minority populations. In dry cleaning facilities, Asian and Hispanic populations are over-represented. 13% of dry cleaning workers are Asian, compared to 5% of the national population. Also, 30% of dry cleaning workers are Hispanic (of any race) compared to 16% of the national population (Ref. 2). Because minority populations are disproportionately over-represented in this industry they are disproportionately exposed; thus, there would be disproportionately positive benefits for these populations from the regulatory approach set forth in this proposal.
c. Impacts on children.
d. Exposures for this use. TCE exposures for this use are through the inhalation route.
e. Risks for this use. As discussed in Unit IV.B, TCE is associated with a range of non-cancer health effects in humans and animals and is also carcinogenic to humans.
As discussed in Unit IV.B, MOEs were used in this assessment to estimate non-cancer risks for acute and chronic exposures. Exposure scenarios with MOEs below the benchmark MOE have risks of concern and typically, non-cancer adverse effects are more likely to result from exposure scenarios with MOEs below the benchmark MOE. For the use of TCE as a spot cleaner in dry cleaning facilities, the risk estimates for a range of non-cancer effects were below the benchmark MOE of 10 for developmental effects. The MOE for acute developmental effects is 0.002 for fetal heart malformation (Refs. 1, 25). For chronic occupational spot cleaning exposures, the MOE is 0.003 for fetal heart malformation and is similar to MOEs for kidney toxicity and immunotoxicity. In the baseline exposure scenarios, the MOEs are 3,000 times less than the benchmark MOEs (Refs. 1, 25).
Cancer risks determine the incremental probability of an individual developing cancer over a lifetime as a result of exposure to TCE. For chronic occupational spot cleaning exposures the baseline cancer risk is 1 x 10-2 which exceeds the standard cancer benchmarks of 10-6 to 10-4 (Refs. 1 and 25). Accordingly,
2. Initial analysis of potential regulatory options. Having identified unreasonable risks from the use of TCE in spot cleaning in dry cleaning facilities,
EPA assessed a number of exposure scenarios associated with risk reduction options in order to determine variations in TCE exposure when spot cleaning in dry cleaning facilities: Material substitution, engineering controls, and use of PPE, as well as combinations. The materials substitution scenarios involved reducing the concentration of TCE in the spot cleaning formulation, with concentrations varying from 5% to 95%
EPA's site-specific inhalation exposure level estimate for facilities without local exhaust ventilation ranged from 0.08 to 19 ppm as 8-hour TWAs. Although relevant exposure monitoring data were limited,
For facilities with local exhaust ventilation,
The results indicate that alternate regulatory options such as reducing the concentration of TCE in spot cleaners for dry cleaning facilities and using local exhaust ventilation to improve ventilation near worker activity could not achieve the target MOE benchmarks for non-cancer endpoints for acute and chronic exposures and standard cancer risk benchmarks for chronic exposures. The results also demonstrate that all risk reduction options require the use of a respirator, whether used alone or in conjunction with additional levels of protection, in order to meet the non-cancer and cancer risk benchmarks (Ref. 25). Therefore,
3. Assessment of regulatory options to determine whether they address the identified unreasonable risks to the extent necessary so that TCE no longer presents such risks. As discussed in Unit V.,
The full range of regulatory options considered under section 6(a) is reflected in
a. Proposed approach to prohibit manufacturing, processing, distribution in commerce, and use of TCE for spot cleaning in dry cleaning facilities and require downstream notification. As noted previously, the proposed regulatory approach uses several elements of TSCA section 6(a) to address the risk of TCE use for spot cleaning in dry cleaning facilities throughout the supply chain. The proposed regulatory approach would prohibit the manufacturing, processing, and distribution in commerce of TCE for spot cleaning in dry cleaning facilities under TSCA SEC 6(a)(2), prohibit the commercial use of TCE for spot cleaning in dry cleaning facilities under TSCA SEC 6(a)(5), and require manufacturers, processors, and distributors, except for retailers, to provide downstream notification, e.g., via a SDS, of the prohibitions under TSCA SEC 6(a)(3).
As discussed in Unit VII.B.1, the MOEs for occupational exposure for spot cleaning in dry cleaning facilities are below the non-cancer MOE benchmarks for all non-cancer effects (e.g., developmental effects, kidney toxicity, and immunotoxicity) and standard cancer benchmarks. Under this proposed approach, exposures to TCE from this use would be completely eliminated. As a result, both non-cancer and cancer risks from exposure to TCE from this use would be eliminated (Ref. 39). All employees in dry cleaning facilities would benefit; and Asian and Hispanic populations, which are over-represented in dry cleaning facilities, would disproportionally benefit from the proposed approach.
The proposed approach would ensure that workers and occupational bystanders are no longer at risk from TCE exposure associated with this use throughout the supply chain. By proposing to prohibit the manufacture, processing and distribution in commerce of TCE for use as a spot cleaner in dry cleaning facilities,
b. Options that are variations of the proposed approach to prohibit manufacturing, processing, distribution in commerce, and use of TCE for spot cleaning in dry cleaning facilities and require downstream notification. Another regulatory option that
Due to the large number of dry cleaning facilities in
Another regulatory option that
c. Require the use of personal protective equipment in commercial dry cleaning facilities in which TCE is used as a spot cleaner under section 6(a)(5) or require the use of personal protective equipment and engineering controls in commercial dry cleaning facilities in which TCE is used as a spot cleaner under section 6(a)(5). Another regulatory option that
EPA also considered requiring the combination of the use of local exhaust ventilation which achieves 90% reduction in airborne concentrations to improve ventilation near the worker activity and a supplied-air respirator with an APF of 1,000 with a performance based option using an air exposure limit.
C. Availability of Substitutes and Impacts of the Proposed and Alternative Regulatory Options
This Unit examines the availability of substitutes for TCE as a spot cleaner in dry cleaning facilities and describes the estimated costs of the proposal and the alternatives that
Overall,
1. Proposed approach to prohibit manufacturing, processing, distribution in commerce, and use of TCE for spot cleaning in dry cleaning facilities and require downstream notification. The costs of the proposed approach are estimated to include product reformulation costs, downstream notification and recordkeeping costs, and Agency costs. The
2. Options that require personal protective equipment. The costs of implementing a respiratory protection program, including a supplied-air respirator and related equipment, training, fit testing, monitoring, medical surveillance, and related requirements, would far exceed the costs of switching to alternatives, on a per facility basis. The estimated annualized costs of switching to a respiratory protection program requiring PPE of 10,000 are
3. Options that exclude downstream notification.
D. Summary
The proposed approach to prohibit manufacturing, processing, distribution in commerce, and use of TCE for spot cleaning in dry cleaning facilities and require downstream notification is necessary to ensure that TCE no longer presents unreasonable risks for this use. This option does not pose an undue burden on industry because comparable substitutes to TCE for spot cleaning in dry cleaning facilities are readily available. This approach also protects workers and occupational bystanders from the identified unreasonable risks by providing downstream notification of the prohibition throughout the supply chain and avoiding off-label purchase and use of TCE for the prohibited use. Downstream notification streamlines compliance and aids in compliance and enhances enforcement.
VIII. Other Factors Considered
When issuing a rule under TSCA section 6(a),
* Health effects of the chemical substance in question, TCE in this case, and the magnitude of human exposure to TCE;
* Environmental effects of TCE and the magnitude of exposure of the environment to TCE;
* Benefits of TCE for various uses; and the
* 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, benefits, and cost-effectiveness of the rule and of the one or more primary alternatives that
TSCA section 6(c)(2)(B) instructs
As discussed in Unit IV.B, TCE exposure is associated with a wide array of adverse health effects. These health effects include developmental toxicity (e.g., cardiac malformations, developmental immunotoxicity, developmental neurotoxicity, fetal death), toxicity to the kidney (kidney damage and kidney cancer), immunotoxicity (such as systemic autoimmune diseases e.g., scleroderma) and severe hypersensitivity skin disorder, non-Hodgkin's lymphoma, endocrine and reproductive effects (e.g., decreased libido and potency), neurotoxicity (e.g., trigeminal neuralgia), and toxicity to the liver (impaired functioning and liver cancer) (Ref. 1). TCE may cause fetal cardiac malformations that begin in utero. In addition, fetal death, possibly resulting from cardiac malformation, can be caused by exposure to TCE. Cardiac malformations can be irreversible and impact a person's health for a lifetime. Other effects, such as damage to the developing immune system, may first manifest when a person is an adult and can have long-lasting health impacts. Certain effects that follow adult exposures, such as kidney and liver cancer, may develop many years after initial exposure. The point during a lifetime when the effect manifests itself and the expected impacts to a person during her/his lifetime are important factors in determining the benefits of mitigating and preventing TCE exposure.
Based on
The number of people at risk for the developmental effects is estimated to be up to approximately 5,400 pregnant women in dry cleaning operations and approximately 900 pregnant women exposed to TCE during the use of aerosol degreasers. The potential for exposure is significant because approximately half of all pregnancies are unintended. If a pregnancy is not planned before conception, a woman may not be in optimal health for childbearing (Ref. 33).
Given the large differential between the benchmark MOE and the MOEs resulting from
The risk reduction from preventing TCE exposure cannot be comprehensively quantified or monetized even though the adverse effects are well-documented, the TCE risk assessment estimating these risks has been peer-reviewed, and the benefits of reducing the risk of these health endpoints can be described. It is relatively straightforward to monetize the benefits of reducing the risk of cancer (kidney cancer, liver cancer, non-Hodgkin's lymphoma) due to TCE exposure. The estimated value of the annualized benefit is estimated to be
The health endpoints associated with TCE exposure are serious. The following is a discussion of the impacts of the most significant cancer and non-cancer effects associated with TCE exposure, including the severity of the effect, the manifestation of the effect, and how the effect impacts a person during their lifetime. While TCE can cause a variety of adverse health effects, the general population incidences of these adverse health outcomes are not due solely to TCE.
A. Benefits of the Proposed Rule and the Alternatives That
1. Developmental effects. The TCE risk assessment (and
Cardiac defects, which can result from very low level exposure to TCE, affect the structural development of a baby's heart and how it works. The defects impact how blood flows through the heart and out to the rest of the body. The impact can be mild (such as a small hole in the heart) or severe (such as missing or poorly formed septal wall and valves of the heart). While diagnosis for some cardiac defects can occur during pregnancy, for other cardiac defects, detection may not occur until after birth or later in life, during childhood or adulthood. These cardiac defects can be occult or life- threatening with the most severe cases causing early mortality and morbidity. While the incidences in the following paragraphs reflect adverse health outcomes beyond just exposure to TCE, the general population numbers provide a context for understanding the impact of the adverse health effects that TCE can cause.
Nearly 1% or about 40,000 births per year in
Infant deaths resulting from cardiac defects often occur during the neonatal period. One study indicated that cardiac defects accounted for 4.2% of all neonatal deaths. Of infants born with a non-critical cardiac defect, 97% are expected to survive to the age of one, with 95% expected to survive to 18 years of age. Of infants born with a critical cardiac defect, 75% are expected to survive to one year of age, with 69% expected to survive to 18 years of age (Ref. 47). A child with a cardiac defect is 50% more likely to receive special education services compared to a child without birth defects (Ref. 46).
Treatments for cardiac defects vary. Some affected infants and children might need one or more surgeries to repair the heart or blood vessels. In other instances, a heart defect cannot be fully repaired, although treatments have advanced such that infants are living longer and healthier lives. Many children are living into adulthood and lead independent lives with little or no difficulty. Others, however, may develop disability over time which is hard to predict and for which it is difficult to quantify impacts.
Even though a person's heart defect may be repaired, for many people this is not a cure. They can still develop other health problems over time, depending on their specific heart defect, the number of heart defects they have, and the severity of their heart defect. For example, some related health problems that might develop include irregular heart beat (arrhythmias), increased risk of infection in the heart muscle (infective endocarditis), or weakness in the heart (cardiomyopathy). In order to stay healthy, a person needs regular checkups with a cardiologist. They also might need further operations after initial childhood surgeries (Ref. 46).
Depending upon the severity of the defect, the costs for surgeries, hospital stays, and doctor's appointments to address a baby's cardiac defect can be significant. The costs for the defects may also continue throughout a person's lifetime. In 2004, hospital costs in
Beyond the monetary cost, the emotional and mental toll on parents who discover that their child has a heart defect while in utero or after birth will be high (Ref. 47). They may experience anxiety and worry over whether their child will have a normal life of playing with friends and participating in sports and other physical activities, or whether their child may be more susceptible to illness and be limited in the type of work and experiences they can have. In addition, parents can be expected to experience concerns over potential unknown medical costs that may be looming in the future, lifestyle changes, and being unable to return to work in order to care for their child.
The emotional and mental toll on a person throughout childhood and into adolescence with a heart defect also should be considered (Ref. 47). Cardiac patients who are children may feel excluded from activities and feel limited in making friends if they have to miss school due to additional surgeries, or may not be able to fully participate in sports or other physical exercise. Children may feel self-conscious of the scars left by multiple surgeries. This, in turn, adds emotional and mental stress to the parents as they observe their child's struggles.
As a person with a heart defect enters adulthood, the emotional or mental toll of a cardiac defect may continue or in other instances the problem may only surface as the person becomes an adult. If a cardiac defect impacts a person's ability to enter certain careers, this could take a monetary as well as emotional toll on that person and on their parents or families who may need to provide some form of financial support. The monetary, emotional, and mental costs of heart defects can be considerable, and even though neither the precise reduction in individual risk of developing a cardiac defect from reducing TCE exposure or the
2. Kidney toxicity. The TCE risk assessment identified kidney toxicity as a significant concern for non-cancer risk from TCE exposure with the risk being from chronic exposure. There are increased health risks for kidney toxicity to the approximately 10,800 workers and occupational bystanders at commercial aerosol degreasing operations and the up to approximately 168,000 workers and occupational bystanders in dry cleaning operations (Ref. 2).
Exposure to TCE can lead to changes in the proximate 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(s) 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(s) is impaired over a long period of time, the kidney(s) could be damaged to the point that it no longer functions. When a kidney(s) no longer functions, a person needs dialysis and ideally a kidney transplant. In some cases, a non-functioning kidney(s) can result in death. Kidney dialysis and kidney transplantation are expensive and incur long-term health costs if kidney function fails (Ref. 48).
Approximately 31 million people, or 10% of the adult population, in
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
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 TCE exposure or the
Chronic exposure to TCE can also lead to kidney cancer. The estimated value of the annualized benefit is
3. Immunotoxicity. a. Non-cancer chronic effects. The TCE risk assessment identified immunotoxicity as a chronic non-cancer risk from TCE exposure. There are increased health risks for immunotoxicity to the approximately 10,800 workers and occupational bystanders at commercial aerosol degreasing operations and the up to approximately 168,000 workers and occupational bystanders in dry cleaning operations (Ref. 1).
Human studies have demonstrated that TCE exposed workers can suffer from systemic autoimmune diseases (e.g., scleroderma) and severe hypersensitivity skin disorder. Scleroderma is a chronic connective tissue disease with autoimmune origins. The annual incidence is estimated to be 10 to 20 cases per 1 million persons (Ref. 51), and the prevalence is four to 253 cases per 1 million persons (Ref. 52). About 300,000 Americans are estimated to have scleroderma. About one third of those people have the systemic form of scleroderma. Since scleroderma presents with symptoms similar to other autoimmune diseases, diagnosis is difficult. There may be many misdiagnosed or undiagnosed cases (Ref. 52).
Localized scleroderma is more common in children, whereas systemic scleroderma is more common in adults. Overall, female patients outnumber male patients about 4-to-1. Factors other than a person's gender, such as race and ethnic background, may influence the risk of getting scleroderma, the age of onset, and the pattern or severity of internal organ involvement. The reasons for this susceptibility are not clear. Although scleroderma is not directly inherited, some scientists believe there is a slight predisposition to it in families with a history of rheumatic diseases (Ref. 53).
The symptoms of scleroderma vary greatly from person-to-person with the effects ranging from very mild to life threatening. If not properly treated, a mild case can become much more serious. Relatively mild symptoms are localized scleroderma, which results in hardened waxy patches on the skin of varying sizes, shapes and color. The more life threatening symptoms are from systemic scleroderma, which can involve the skin, esophagus, gastrointestinal tract (stomach and bowels), lungs, kidneys, heart and other internal organs. It can also affect blood vessels, muscles and joints. The tissues of involved organs become hard and fibrous, causing them to function less efficiently.
Severe hypersensitivity skin disorder includes exfoliative dermatitis, mucous membrane erosions, eosinophilia, and hepatitis. Exfoliative dermatitis is a scaly dermatitis involving most, if not all, of the skin. Eosinophilia on the other hand is a chronic disorder resulting from excessive production of a particular type of white blood cells. If diagnosed and treated early a person can lead a relatively normal life (Ref. 51).
The monetary costs for treating these various immunotoxicity disorders will vary depending upon whether the symptoms lead to early diagnosis and early diagnosis can influence whether symptoms progress to mild or life threatening outcomes. For mild symptoms, doctors' visits and outpatient treatment could be appropriate while more severe immunotoxicity disorders, may require hospital visits. Treatments for these conditions with immune modulating drugs also have countervailing risks.
These disorders also take an emotional and mental toll on the person as well as on their families. Their quality of life may be impacted because they no longer have the ability to do certain activities that may affect or highlight their skin disorder, such as swimming. Concerns over doctor and hospital bills, particularly if a person's ability to work is impacted, may further contribute to a person's emotional and mental stress. While neither the precise reduction in individual risk of developing this disorder from TCE exposure or the
b. Non-Hodgkin's Lymphoma.
NHL is a form of cancer that originates in a person's lymphatic system. For
Symptoms are painless, 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
Treatment for
4. Reproductive and endocrine effects. The TCE risk assessment identified chronic non-cancer risks for reproductive effects for workers and bystanders exposed to TCE. There are increased health risks for reproductive effects for the approximately 10,800 workers and occupational bystanders at commercial aerosol degreasing operations and the up to approximately 168,000 workers and occupational bystanders in dry cleaning operations (Ref. 2).
The reproductive effect for both females and males can be altered libido. The prevalence of infertility is estimated at about 10-15% of couples with a decreased libido among the factors of infertility (Ref. 56). For females, there can be reduced incidence of fecundability (6.7 million women ages 15 to 44 or 10.9% affected) (Ref. 57), increase in abnormal menstrual cycle, and amenorrhea (the absence of menstruation). Reproductive effects on males can be decreased potency, gynaecomastia, impotence, and decreased testosterone levels, or low T levels. Approximately 2.4 million men age 40 to 49 have low T levels, with a new diagnosis of about 481,000 androgen deficiency cases a year. Other estimates propose a hypogonadism prevalence of about 13 million American men (Ref. 58). Low T levels are associated with aging; an estimated 39% of men 45 or older have hypogonadism, resulting in low T levels (Ref. 59). Hormone therapy and endocrine monitoring may be required in the most severe cases. Low T levels are associated with aging; an estimated 39% of men 45 or older have hypogonadism, resulting in low T levels (Ref. 59). Hormone therapy and endocrine monitoring may be required in the most severe cases.
The monetary costs of these potential reproductive effects involve doctor's visits in order to try to determine why there is a change. In some instances, a person or couple may need to visit a fertility doctor.
The impact of a reduced sex drive can take an emotional and mental toll on single people as well as couples. For people trying to get pregnant, decreased fertility can add stress to a relationship as the cause is determined and avenues explored to try to resolve the difficulties in conceiving. A person or couples' quality of life can also be affected as they struggle with a reduced sex drive. Similar to effects discussed previously, while neither the precise reduction in individual risk of developing this disorder from reducing TCE exposure or the
5. Neurotoxicity. The TCE risk assessment identified chronic risks for neurotoxicity for workers and bystanders. There are increased health risks for neurotoxicity to the approximately 10,800 workers and bystanders at commercial aerosol degreasing operations and the up to approximately 168,000 workers and bystanders in dry cleaning operations (Ref. 2).
Studies have also demonstrated neurotoxicity for acute exposure. Neurotoxic effects observed are alterations in trigeminal nerve and vestibular function, auditory effects, changes in vision, alterations in cognitive function, changes in psychomotor effects, and neurodevelopmental outcomes. Developmental neurotoxicity effects are delayed newborn reflexes, impaired learning or memory, aggressive behavior, hearing impairment, speech impairment, encephalopathy, impaired executive and motor function and attention deficit (Ref. 3).
The impacts of neurotoxic effects due to TCE exposure can last a person's entire lifetime. Changes in vision may impact a person's ability to drive, which can create difficulties for daily life. Impaired learning or memory, aggressive behavior, hearing impairment, speech impairment, encephalopathy, impaired executive and motor function and attention deficit can impact a child's educational progression and adolescent's schooling and ability to make friends, which in turn can impact the type of work or ability get work later in life.
Neurotoxicity in adults can affect the trigeminal nerve, the largest and most complex of the 12 cranial nerves, which supplies sensations to the face, mucous membranes, and other structures of the head. Onset of trigeminal neuralgia generally occurs in mid-life and known causes include multiple sclerosis, sarcoidosis and
The monetary health costs can range from doctor's visits and medication to surgeries and hospital stays. Depending upon when the neurotoxic effect occurred, the monetary costs may encompass a person's entire lifetime or just a portion.
The personal costs (emotional, mental, and impacts to a person's quality of life) cannot be discounted. Parents of a child with impaired learning, memory, or some other developmental neurotoxic effect may suffer emotional and mental stress related to worries about the child's performance in school, ability to make friends, and quality of the child's life because early disabilities can have compounding effects as they grow into adulthood. The parent may need to take off work unexpectedly and have the additional cost of doctor visits and/or medication.
For a person whose trigeminal nerve is affected there is an emotional and mental toll as they wonder what is wrong and visit doctors in order to determine what is wrong. Depending on the severity of the impact to the nerve they may be unable to work. Doctor visits and any inability to work will have a monetary impact to the person. There are varying costs (emotional, monetary, and impacts to a person's quality of life) from the neurotoxicity effects due to TCE exposure. However, while neither the precise reduction in individual risk of developing this disorder from reducing TCE exposure or the
6. Liver toxicity. The TCE risk assessment identified liver toxicity as an adverse effect of chronic TCE exposure. There are increased health risks for liver toxicity to the approximately 10,800 workers occupational bystanders at commercial aerosol degreasing operations and the up to approximately 168,000 workers and occupational bystanders in dry cleaning operations (Ref. 1).
Specific effects to the liver can include increased liver weight, increase in DNA synthesis (transient), enlarged hepatocytes, enlarged nuclei, and peroxisome proliferation (Ref. 1). In addition, workers exposed to TCE have shown hepatitis accompanying immune-related generalized skin diseases, jaundice, hepatomegaly, hepatosplenomegaly, and liver failure (Ref. 1).
Some form of liver disease impacts at least 30 million people, or 1 in 10 Americans (Ref. 61). Included in this number is at least 20% of those with nonalcoholic fatty liver disease (NAFLD) (Ref. 61). NAFLD tends to impact people who are overweight/obese or have diabetes. However, an estimated 25% do not have any risk factors (Ref. 61). 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. 61). The most common known causes to this disease burden are attributable to alcoholism and viral infections, such as hepatitis A, B, and C. In 2013, there were 1,781 reported acute cases of viral hepatitis A and the estimated actual cases were 3,500 (Ref. 62). For hepatitis B in 2013 there were 3,050 reported acute cases, while the estimated actual incidence was 19,800, and the estimated chronic cases in
Effects from TCE exposure to the liver can occur quickly. Liver weight increase has occurred in mice after as little as 2 days of inhalation exposure (Ref. 3). Human case reports from eight countries indicated symptoms of hepatitis, hepatomegaly and elevated liver function enzymes, and in rare cases, acute liver failure developed within as little as 2-5 weeks of initial exposure to TCE (Ref. 3).
Chronic exposure to TCE can also lead to liver cancer. There is strong epidemiological data that reported an association between TCE exposure and the onset of various cancers, including liver cancer. The estimated value of the annualized benefit is
Additional medical and emotional costs are associated with non-cancer liver toxicity from TCE exposure, although they cannot be quantified. These costs include doctor and hospital visits and medication costs. In some cases, the ability to work can be affected, which in turn impacts the ability to get proper ongoing medical care. Liver toxicity can lead to jaundice, weakness, fatigue, weight loss, nausea, vomiting, abdominal pain, impaired metabolism, and liver disease. Symptoms of jaundice include yellow or itchy skin and a yellowing of the whites of the eye, and a pale stool and dark urine. These symptoms can create a heightened emotional state as a person tries to determine what is wrong with them.
Depending upon the severity of the jaundice, treatments can range significantly. Simple treatment may involve avoiding exposure to the TCE; however, this may impact a person's ability to continue to work. In severe cases, the liver toxicity can lead to liver failure, which can result in the need for a liver transplant, if a donor is available. Liver transplantation is expensive (with an estimated cost of
7. Disproportionate impacts on environmental justice communities. An additional factor that cannot be monetized is the disproportionate impact on environmental justice communities. Asian and Hispanic populations are disproportionately represented in dry cleaning facilities. 13% of dry cleaning workers are Asian, compared to 5% of the national population, and 30% of dry cleaning workers are Hispanic (of any race), compared to 16% of the national population, indicating that these two populations are over-represented. Because they are disproportionately over-represented in the dry cleaning industry, these populations are disproportionately exposed to TCE during spot cleaning in dry cleaning facilities and disproportionately at risk to the range of adverse non-cancer effects and cancer.
B. Monetized Benefits of the Proposed Rule and the Alternatives That
The benefits that can be monetized from risk reductions due to the proposed prohibitions on manufacture, processing, and distribution in commerce of TCE for aerosol degreasing, and the prohibition on commercial use of TCE in aerosol degreasing are estimated to be
C. Costs of the Proposed Rule and the Alternatives That
The details of the costs of the proposed approach for use of TCE in aerosol degreasing are discussed in Unit VI.C.1 and the details of the costs of the proposed approach for spot cleaning in dry cleaning facilities are discussed in Unit VII.C.1. Under the proposed option, costs to users of aerosol degreasers are negligible as substitute products are currently available on the market and are similarly priced.
Under the proposed approach, dry cleaners are expected to switch to alternatives because they are readily available at similar cost and performance. Blenders of TCE spot cleaners are expected to reformulate their products.
Total costs of the proposed rule for both uses are estimated to be
Alternatives that
D. Comparison of Benefits and Costs
The monetized benefits for preventing the risks resulting from TCE exposure from both these uses significantly outweigh the estimated costs. Even though simply comparing the costs and monetized benefits of prohibiting the manufacture, processing, and distribution in commerce of TCE as an aerosol degreaser; prohibiting its use as an aerosol degreaser; and requiring downstream notification demonstrates that the monetized benefits of this proposed action outweigh the costs,
While the risk of non-cancer health effects associated with TCE exposure cannot be quantitatively estimated, the qualitative discussion highlights how some of these non-cancer effects occurring much earlier in life from TCE exposure may be as severe as cancer's mortality and morbidity and thus just as life-altering. These effects include not only medical costs but also personal costs such as emotional and mental stress that are impossible to accurately measure.
While the impacts of non-cancer effects cannot be monetized,
Thus, considering costs, benefits that can be monetized (risk of cancer), and benefits that cannot be quantified and subsequently monetized (risk of developmental toxicity, kidney toxicity, immunotoxicity, reproductive toxicity, neurotoxicity, and liver toxicity), including benefits related to the severity of the effects and the impacts on a person throughout her/his lifetime in terms of medical costs, effects on earning power and personal costs, emotional and psychological costs, and the disproportionate impacts on Asian and Hispanic communities, the benefits of preventing TCE exposure outweigh the costs. Further, if
IX. Overview of Uncertainties
A discussion of the uncertainties associated with this proposed rule can be found in the TCE risk assessment (Ref. 1) and in the supplemental analysis (Refs. 23, 24, 25) for use of TCE in aerosol degreasing and use of TCE for spot cleaning in dry cleaning facilities. A summary of these uncertainties follows.
EPA used a number of assumptions in the TCE risk assessment and supporting analysis to develop estimates for occupational and consumer exposure scenarios and to develop the hazard/dose-response and risk characterization.
In addition to the uncertainties in the risks, there are uncertainties in the cost and benefits. The uncertainties in the benefits are most pronounced in estimating the benefits from preventing the non-cancer adverse effects because these benefits generally cannot be monetized due to the lack of concentration response functions in humans leading to the ability to estimate the number of population-level non-cancer cases and limitations in established economic methodologies. Additional uncertainties in benefit calculations include the reliance on professional judgment to estimate the alternatives that users might choose to adopt and the potential risks for adverse health effects that the alternatives may pose. While there are some products that have comparable risks, there are a number of alternatives that are likely to be of lower risk, although
There are also uncertainties in the estimates of the number of affected facilities, particularly those for the aerosol degreasing use and for numbers of processors and distributors of TCE-containing products not prohibited by the proposed rule who are required to provide downstream notification and/or maintain records. The estimate for number of facilities using TCE-containing aerosol degreasers is based on
Another uncertainty concerns the estimate for the cost of reblending products and the time required to reblend those products.
EPA also assumes that companies are generally able to reblend products within 6 months following publication of the final rule; however, it is not certain whether they may experience additional costs if they are not able have a product available to market at that time.
EPA will consider additional information received during the public comment period, including comments on implementation timeframes. This includes public comments, scientific publications, and other input submitted to
X. Analysis Under Section 9 of TSCA (Other Authorities) for Aerosol Degreasing and Spot Cleaning in Dry Cleaning Facilities and TSCA Section 26(h) Considerations
A. Section 9 Analysis
1. Section 9(a) analysis. Section 9(a) of TSCA provides that, if the Administrator determines in her discretion that unreasonable risks may be prevented or reduced to a sufficient extent by action taken under a Federal law not administered by
Section 9(d) of TSCA instructs the Administrator to consult and coordinate TSCA activities with other Federal agencies for the purpose of achieving the maximum enforcement of TSCA while imposing the least burden of duplicative requirements. For today's proposed rule,
CPSC protects the public from unreasonable risks of injury or death associated with the use of consumer products under the agency's jurisdiction. There are no CPSC regulations on use of TCE in aerosol degreasers and for spot cleaning at dry cleaning facilities (Ref. 64).
OSHA assures safe and healthful working conditions for working men and women by setting and enforcing standards and by providing training, outreach, education and assistance.
EPA has determined that risks from the use of TCE in aerosol spray degreasers and as a spot cleaner in dry cleaning facilities are best managed by regulation under TSCA rather than by referral to other agencies. Today's proposed rule addresses risk from TCE exposure to populations in both workplaces and consumer settings. With the exception of TSCA, there is no Federal law that provides authority to prevent or sufficiently reduce these cross-cutting exposures. No other Federal regulatory authority, when considering the exposures to the populations and within the situations in its purview, can evaluate and address the totality of the risk that
Moreover, recent amendments to TSCA, Public Law 114-182, alter both the manner of identifying unreasonable risk under TSCA and
TSCA is the only regulatory authority able to prevent or reduce risk from these uses of TCE to a sufficient extent across the range of uses and exposures of concern. In addition, these risks can be addressed in a more coordinated, efficient and effective manner under TSCA than under two or more different laws implemented by different agencies. Accordingly,
2. Section 9(b) analysis. If
Although several
B. Section 26(h) Considerations
In proposing this rule under section 6 of TSCA, the
The scientific information and technical measures and models used in the risk assessment and supplemental analyses are consistent with the intended use for risk reduction by regulation under section 6 of TSCA. The degree of clarity and completeness of the science used in the risk assessment and supplemental analyses are described in the risk assessment (Ref. 1) and Unit IX. Similarly, the variability and uncertainty in the information or models and methods used are described in the risk assessment (Ref. 1) and Unit IX.
XI. Major Provisions of the Proposed Rule
A. Prohibitions on TCE Manufacturing, Processing, Distribution in Commerce, and Commercial Use
The rule would prohibit (1) the manufacture, processing, distribution in commerce, and commercial use of TCE in aerosol degreasers; and (2) the manufacture, processing, distribution in commerce, and use of TCE for spot cleaning in dry cleaning facilities.
B. Downstream Notification
EPA has authority under section 6 of TSCA to require that a substance or mixture or any article containing such substance or mixture be marked with or accompanied by clear and adequate minimum warnings and instructions with respect to its use, distribution in commerce, or disposal or with respect to any combination of such activities. Many TCE manufacturers and processors are likely to manufacture or process TCE or TCE containing products for other uses that would not be regulated under this proposed rule. Other companies may be strictly engaged in distribution in commerce of TCE, without any manufacturing or processing activities, to customers for uses that are not regulated.
C. Enforcement
Section 15 of TSCA makes it unlawful to fail or refuse to comply with any provision of a rule promulgated under section 6 of TSCA. Therefore, any failure to comply with this proposed rule when it becomes effective would be a violation of section 15 of TSCA. In addition, section 15 of TSCA makes it unlawful for any person to: (1) Fail or refuse to establish and maintain records as required by this rule; (2) fail or refuse to permit access to or copying of records, as required by TSCA; or (3) fail or refuse to permit entry or inspection as required by section 11 of TSCA.
Violators may be subject to both civil and criminal liability. Under the penalty provision of section 16 of TSCA, any person who violates section 15 could be subject to a civil penalty for each violation. Each day of operation in violation of this proposed rule when it becomes effective could constitute a separate violation. Knowing or willful violations of this proposed rule when it becomes effective could lead to the imposition of criminal penalties for each day of violation and imprisonment. In addition, other remedies are available to
Individuals, as well as corporations, could be subject to enforcement actions. Sections 15 and 16 of TSCA apply to "any person" who violates various provisions of TSCA.
XII. References
The following is a listing of the documents that are specifically referenced in this document. The docket includes these documents and other information considered by
1.
2.
3.
4.
5. National Toxicology Program. 13th Report on Carcinogens. 2014. Available at http://ntp.niehs.nih.gov/annualreport/2015/glance/roc/index.html.
6.
7.
8.
9.
10.
11.
12. Cal. Code Regs. tit. 17,
13.
14. Minnesota
15. LawAtlas: The Policy Surveillance Portal. http://lawatlas.org/. Retrieved
16.
17. Environment
18. Environment
19.
20.
21.
22.
23.
24.
25.
26.
27.
28.
29.
30.
31.
32.
33. Unintended pregnancy in
34.
35.
36. Johnson, P.D.,
37.
38.
39.
40. Hindin, David A., and
41.
42.
43.
44.
45. NIOSH (
46.
47.
48. Mayo clinic. Chronic kidney disease. http://www.mayoclinic.org/diseases-conditions/kidney-disease/basics/definition/con-20026778.
49.
50. The Kidney Boy. The Cost of Dialysis. http://thekidneyboy.blogspot.com/2011/01/cost-of-dialysis.html.
51. Silman AJ, Hochberg MC. Cooper C, et al. Epidemiology of the Rheumatic Diseases.
52. Lawrence RC, Helmick CG, Arnett FC, et al. Estimates of the prevalence of arthritis and selected musculoskeletal disorders in
53.
54.
55. Morton LM, Curtis RE, Linet MS, et al. Second Malignancy Risks After Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia: Differences by Lymphoma Subtype.
56. Sharma R, Biedenharn KR, Fedor JM, Agarwal A. Lifestyle factors and reproductive health: Taking control of your fertility. Reproductive Biology and Endocrinology: RB&E. 2013;11:66. doi:10.1186/1477-7827-11-66.
57.
58. Gruenewald DA, Matsumoto AM. Testosterone supplementation therapy for older men: Potential benefits and risks. J Am Geriatr Soc. 2003;51(1):101-115.
59. Dadona P, Rosenberg MT. A practical guide to male hypogonadism in the primary care setting. Int J Clin Pract. 2010;64(6):682-696.
60.
61.
62.
63.
64.
65.
66.
67.
XIII. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review
This action is a significant regulatory action because it may raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in Executive Order 12866 (58 FR 51735,
B. Paperwork Reduction Act (PRA)
The information collection requirements in this proposed rule have been submitted to OMB for review and comment under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. The Information Collection Request (ICR) document prepared by the
The information collection activities required under the proposed rule include a downstream notification requirement and a recordkeeping requirement. The downstream notification would require companies that ship TCE to notify companies downstream in the supply chain of the prohibitions of TCE in the proposed rule. The proposed rule does not require the regulated entities to submit information to
Respondents/affected entities: TCE manufacturers, processors, and distributors.
Respondent's obligation to respond: Mandatory.
Estimated number of respondents: 697.
Frequency of response: On occasion.
Total estimated burden: 348.5 hours (per year). Burden is defined at 5 CFR 1320.3(b).
Total estimated cost:
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for the
Submit your comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden to
C. Regulatory Flexibility Act (RFA)
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA, 5 U.S.C.
Comparing the
D. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of
E. Executive Order 13132: Federalism
The
F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments
This action does not have tribal implications, as specified in Executive Order 13175 (65 FR 67249,
EPA met with tribal officials in a national informational webinar held on
G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks
This action is not subject to Executive Order 13045 because it is not economically significant as defined in Executive Order 12866. This action's health and risk assessment of TCE exposure on children are contained in Units VI.B.1.c and VII.B.1.c of this preamble. Supporting information on the exposures and health effects of TCE exposure on children is also available in the Toxicological Review of Trichloroethylene (Ref. 3) and the TCE risk assessment (Ref. 1).
H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution in Commerce, or Use
This proposed rule is not subject to Executive Order 13211 (66 FR 28355,
I. National Technology Transfer and Advancement Act (NTTAA)
This proposed rulemaking does not involve technical standards.
J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations
Executive Order 12898 (59 FR 7629,
List of Subjects in 40 CFR Part 751
Environmental protection, Chemicals, Export notification, Hazardous substances, Import certification, Trichloroethylene, Recordkeeping.
Dated:
Administrator.
Therefore, it is that 40 CFR chapter I, subchapter R, is proposed to be amended by adding a new part 751 to read as follows:
PART 751--REGULATION OF CERTAIN CHEMICAL SUBSTANCES AND MIXTURES UNDER SECTION 6 OF THE TOXIC SUBSTANCES CONTROL ACT
Subpart A--General Provisions
Sec.
751.1 Purpose.
751.5 Definitions.
751.7 Exports and imports.
751.9 Enforcement and Inspections.
Subpart B--[Reserved]
Subpart C--[Reserved]
Subpart D--Trichloroethylene
751.301 General.
751.303 Definitions.
751.305 Aerosol Degreasing.
751.307 Spot Cleaning in Dry Cleaning Facilities.
751.309 [Reserved].
751.311 Downstream Notification.
751.313 Recordkeeping.
Authority: 15 U.S.C. 2605.
Subpart A--General Provisions
This part sets forth requirements, such as prohibitions concerning the manufacture (including import), processing, distribution in commerce, uses, and/or disposal of certain chemical substances and mixtures under section 6(a) of the Toxic Substances Control Act, 15 U.S.C. 2605(a).
The definitions in section 3 of the Toxic Substances Control Act, 15 U.S.C. 2602, apply to this part except as otherwise established in any subpart under this part.
Act or TSCA means the Toxic Substances Control Act, 15 U.S.C.
CASRN means Chemical Abstracts Service Registry Number.
EPA means the
Person means any natural person, firm, company, corporation, joint venture, partnership, sole proprietorship, association, or any other business entity; any State or political subdivision thereof; any municipality; any interstate body; and any department, agency, or instrumentality of the Federal Government.
(a) Exports. Persons who intend to export a chemical substance identified in any subpart under this part, or in any proposed rule which would amend any subpart under this part, are subject to the export notification provisions of section 12(b) of the Act. The regulations that interpret section 12(b) appear at 40 CFR part 707, subpart D.
(b) Imports. Persons who import a substance identified in any subpart under this part are subject to the import certification requirements under section 13 of the Act, which are codified at 19 CFR 12.118 through 12.127. See also 19 CFR 127.28.
(a) Enforcement. (1) Failure to comply with any provision of this part is a violation of section 15 of the Act (15 U.S.C. 2614).
(2) Failure or refusal to establish and maintain records or to permit access to or copying of records, as required by the Act, is a violation of section 15 of the Act (15 U.S.C. 2614).
(3) Failure or refusal to permit entry or inspection as required by section 11 of the Act (15 U.S.C. 2610) is a violation of section 15 of the Act (15 U.S.C. 2614).
(4) Violators may be subject to the civil and criminal penalties in section 16 of the Act (15 U.S.C. 2615) for each violation.
(b) Inspections.
Subpart B--[Reserved]
Subpart C--[Reserved]
Subpart D--Trichloroethylene
This subpart sets certain restrictions on the manufacture (including import), processing, distribution in commerce, and uses of trichloroethylene (TCE) (CASRN 79-01-6) to prevent unreasonable risks to health associated with human exposure to TCE for the specified uses.
The definitions in subpart A of this part apply to this subpart unless otherwise specified in this section. In addition, the following definitions apply:
Aerosol degreasing means the use of a chemical in aerosol spray products applied from a pressurized can to remove contaminants.
Distribute in commerce has the same meaning as in section 3 of the Act, except that the term does not include retailers for purposes of
Dry cleaning facility means an establishment with one or more dry cleaning systems.
Dry cleaning system means a dry-to-dry machine and its ancillary equipment or a transfer machine system and its ancillary equipment.
Retailer means a person who distributes in commerce a chemical substance, mixture, or article to consumer end users.
Spot cleaning means use of a chemical to clean stained areas on materials such as textiles or clothing.
(a) After [ Date 180 calendar days after the date of publication of the final rule ], all persons are prohibited from manufacturing, processing, and distributing in commerce TCE in aerosol degreasing products and TCE for use in aerosol degreasing products.
(b) After [ Date 270 calendar days after the date of publication of the final rule ], all persons are prohibited from commercial use of TCE in aerosol degreasing products.
(a) After [ Date 180 calendar days after the date of publication of the final rule ], all persons are prohibited from manufacturing, processing, and distributing in commerce TCE for spot cleaning at dry cleaning facilities.
(b) After [ Date 270 calendar days after the date of publication of the final rule ], all persons are prohibited from commercial use of TCE for spot cleaning at dry cleaning facilities.
Each person who manufactures, processes, or distributes in commerce TCE for any use after [ Date 45 calendar days after the date of publication of the final rule ] must, prior to or concurrent with the shipment, notify companies to whom TCE is shipped, in writing, of the restrictions described in this subpart.
(a) Each person who manufactures, processes, or distributes in commerce any TCE after [ Date 45 calendar days after the date of publication of final rule ] must retain in one location at the headquarters of the company documentation of:
(1) The name, address, point of contact, and telephone number of companies to whom TCE was shipped; and
(2) The amount of TCE shipped.
(3) Downstream notification.
(b) The documentation in (a) must be retained for 2 years from the date of shipment.
[FR Doc. 2016-30063 Filed 12-15-16;
BILLING CODE 6560-50-P
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