Submitted via Regulations.gov

August 30, 2019

Administrator Andrew Wheeler U.S. Environmental Protection Agency 1200 Pennsylvania Ave SW Washington, DC 20460-0001

Re: Docket No. EPA-HQ-OPPT-2019-0238, Draft Risk Evaluation for 1,4-Dioxane Docket No. EPA-HQ-OPPT-2019-0237, Draft Risk Evaluation for Cyclic Aliphatic Bromide Cluster (“HBCD”)

Dear Administrator Wheeler:

Earthjustice and the Occupational Safety & Health Law Project submit these comments on the U.S. Environmental Protection Agency’s (“EPA’s”) draft risk evaluations for 1,4-dioxane and Cyclic Aliphatic Bromide Cluster (“HBCD”) on behalf of the American Federation of Labor and Congress of Industrial Organizations (AFL-CIO), the International Association of Fire Fighters (IAFF), the International Union, United Automobile, Aerospace, and Agricultural Implement Workers of America (UAW), and the United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial and Service Workers International Union (USW). These unions represent millions of workers across a range of economic sectors, many of whom are occupationally exposed to HBCD or 1,4-dioxane.

The Toxic Substances Control Act (“TSCA”) requires EPA to evaluate risks to workers as a “potentially exposed and susceptible subpopulation.” If a chemical presents unreasonable risks to workers under its known, intended or reasonably foreseen conditions of use, EPA must issue rules that eliminate such risks. EPA’s draft 1,4-dioxane and HBCD risk evaluations violate those requirements in three fundamental respects.

First, EPA cannot meaningfully evaluate risks to workers because it lacks reliable occupational exposure data. EPA has the authority under TSCA to order the production or generation of any information that it needs to conduct a risk evaluation. Yet EPA has not used that authority in these risk evaluations, relying instead on modeled exposure values, studies of foreign workplaces, and other data sources that EPA has no reason to believe are representative of the broad range of U.S. worker exposures. For existing chemicals that have been widely used for decades, this reliance on inappropriate surrogates in lieu of reasonably available and more reliable domestic monitoring data violates TSCA.

Second, EPA’s assumptions and methodology understate the risks posed by 1,4-dioxane and HBCD. EPA does not consider the total exposure to workers across routes of exposures and exposure settings; ignores foreseeable ingestion exposures at work; and miscalculates the risks posed by peak occupational exposures.

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Third, while both 1,4-dioxane and HBCD present unreasonable risks to workers, EPA improperly assumes that workers will protect themselves from those risks through the voluntary use of personal protective equipment (“PPE”). This conflates TSCA’s risk evaluation and risk management procedures and departs from well-established principles of occupational . EPA’s assumptions of universal PPE use are also factually and legally baseless. EPA has no evidence that manufacturers, processors, and users of 1,4-dioxane or HBCD consistently provide PPE to workers, and, contrary to EPA’s claims, there is no legal mandate under the Occupational Safety and Health Act that they do so. Moreover, not all employees can use respirators, as EPA itself has previously acknowledged. Consistent with Occupational Safety and Health Administration (“OSHA”) practice, EPA must evaluate worker risks without regard to the use of respirators and other PPE. Only then can EPA determine whether workers face unreasonable risks and require, in a subsequent risk management rule, the use of the most appropriate tools for addressing such risks.

Every year, millions of workers and occupational non-users (“ONUs”) are exposed to 1,4-dioxane or HBCD. EPA fails to adequately evaluate or characterize the risks caused by those exposures, leaving workers without the protections that TSCA demands. EPA should revise its risk evaluations by requiring the production or generation of reasonably available exposure data, adopting more realistic exposure estimates, and revising its risk determinations to eliminate the improper reliance on PPE.

I. TSCA REQUIRES EPA TO PROTECT WORKERS

TSCA requires EPA to conduct risk evaluations to “determine whether a chemical substance presents an unreasonable risk of injury to health or the environment . . . under the conditions of use.”1 The “conditions of use” are the circumstances under which a chemical “is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of.”2

In conducting a risk evaluation, EPA must consider all “reasonably available information,”3 including “information that EPA … can reasonably generate, obtain, and synthesize for use in risk evaluations.”4 TSCA thus requires EPA not only to rely on the information in its possession, but also to seek out and obtain relevant information about chemical exposures and risks. EPA must evaluate that information using the “best available science,”5 and EPA’s risk determinations must be supported by “substantial evidence.”6

When Congress amended TSCA in 2016, it added a requirement that risk evaluations analyze risks to “potentially exposed or susceptible subpopulation[s]” who, “due to either greater susceptibility or greater exposure, may be at greater risk than the general population of adverse

1 15 U.S.C. § 2605(b)(4)(A). 2 Id. § 2602(4). 3 Id. § 2625(k). 4 40 C.F.R. § 702.33. 5 15 U.S.C. § 2625(h). 6 Id. § 2618(c). 2

health effects from exposure to a chemical substance.”7 The statute specifically defines potentially exposed or susceptible subpopulations to include “workers,”8 reflecting Congress’ intent that EPA evaluate and address workplace risks under TSCA.

Finally, TSCA distinguishes between risk evaluation and risk management, a separate statutory process that follows a determination of unreasonable risk. During a risk evaluation, established industrial hygiene practice requires EPA to measure risk without regard to whether PPE is used. PPE is a poor risk management tool, which should be relied upon only when more effective risk management tools are inadequate and which EPA may consider only “[i]f the Administrator determines that a chemical substance presents an unreasonable risk” in a risk evaluation.9 By conflating risk evaluation with risk management, EPA impermissibly fails to find that employees are exposed to unreasonable risks. As a result, EPA cannot impose risk management under TSCA Section 6.

II. EPA MUST ACQUIRE AND CONSIDER REASONABLY AVAILABLE EXPOSURE DATA

According to EPA, millions of workers, including those who work directly with the chemicals and those who work nearby,10 are potentially exposed to 1,4-dioxane each year, and hundreds of thousands of workers are potentially exposed to HBCD.11 These workers manufacture, process, use, and dispose of those chemicals, and many of them are also exposed to 1,4-dioxane or HBCD in their drinking water supplies and homes as well. Between the two risk evaluations, EPA identifies at least 24 different occupational conditions of use.12 However, EPA does not have reliable occupational exposure data for any of them.

EPA acknowledges this deficiency in its risk evaluations, repeatedly stating that it lacks “inhalation exposure air pertaining to workers in the U.S.”13 and “did not have discrete data points” measuring worker exposures to HBCD and 1,4-dioxane.14 Such data would represent the “best available science” of workplace exposures.15 Instead of requiring the generation or production of the best available data, however, EPA relies upon:

7 Id. §§ 2605(b)(4)(A), 2602(12). 8 Id. § 2602(12). 9 Id. § 2605(c)(1). 10 EPA refers to workers who work directly with the chemical as “workers” and workers who do not work directly with the chemical but are exposed by virtue of their proximity to it as “occupational non-users” (“ONUs”). This distinction is arbitrary, and EPA’s assumption that ONUs are subject to limited exposure is baseless. 11 See 1,4-Dioxane Risk Evaluation at 167; HBCD Risk Evaluation at 208–209. 12 See 1,4-Dioxane Risk Evaluation at 47-74; HBCD Risk Evaluation at 174-214. 13 HBCD Risk Evaluation at 187; see also, e.g., HBCD Risk Evaluation at 197, 199, 205, 208, 214; 1,4-Dioxane Risk Evaluation at 67, 71. 14 HBCD Risk Evaluation at 175. See also 1,4-Dioxane Risk Evaluation at 60, 65 (acknowledging that EPA “mostly lacked specific descriptions of worker tasks, exposure sources, and possible ” and “[m]ost of the datasets were only presented in ranges … (i.e. median or average and 90th percentile).”) 15 15 U.S.C. § 2625(h). 3

• A report on “Workplace exposure to hexabromocyclododecane (HBCD) in the European Union” that did not contain the underlying monitoring data or describe how the average values that EPA relied upon were calculated;16 • Data reported by a U.S. manufacturer of 1,4-dioxane that “lack[ed] … descriptions of worker tasks [and] exposure sources;”17 • Predicted exposures from EPA models, based not on measured exposure levels but “assumed … process details;”18 • Exposure estimates from a European Union that “did not provide details about how these values were calculated” and did not contain the underlying data;19 • A published paper that reports a single data point measuring 1,4-dioxane exposure from 3-D printing.20

None of these sources provides a credible or scientifically justified substitute for the exposure monitoring that EPA could have obtained using its TSCA authorities. Without “discrete data from the original source[s],” EPA “could not verify” how the average values cited in the studies were calculated.21 EPA also lacks information about the conditions under which the European HBCD monitoring was conducted, and acknowledges that “HBCD exposure concentrations at manufacturing sites in Europe may not be representative of those at U.S. sites.”22 EPA does not even state which countries the HBCD inhalation data was taken from – a critical omission given that several European nations have lower occupational exposure limits than the United States. For instance, Germany’s standard for respirable dust (including HBCD) is between 0.3–1.5 mg/m3, compared to 5 mg/m3 in the United States.23 OSHA’s eight-hour exposure limit for 1,4-dioxane is 100 parts per million (ppm), five times higher than the European Union limit and ten times higher than some European nations.24 Exposure data taken from Europe are thus likely to understate worker exposures in the United States.

Courts have previously held that foreign studies of occupational exposure and risk “do not constitute substantial evidence for OSHA's finding of a significant risk,” due to the differences in working conditions between the countries where the studies were conducted and the United States.25 Similarly, courts have previously recognized that aggregated exposure data is an inadequate basis for determining risk to workers.26 EPA’s reliance on summaries of foreign

16 See, e.g., HBCD Risk Evaluation at 189–191 (citing A. Searl &A. Robertson, Workplace Exposure to Hexabromocyclododecane (HBCD) in the European Union, Report for the European Brominated Flame Retardant Industry Panel (2005)). See also id. at 196. 17 1,4-Dioxane Risk Evaluation at 54. 18 Id. at 57. 19 Id. at 59. 20 Id. at 70. 21 HBCD Risk Evaluation at 216. 22 Id. at 187. 23 See GESTIS International Limit Values, IFA (last updated May 2019), http://limitvalue.ifa.dguv.de/ (standards for multiple types of Dust). For the non-respirable portion of inhalation dusts, Germany’s limit is 4–10 mg/m3, compared to 15 mg/m3 in the United States. See id. 24 Id. (standards for “1,4-Dioxane, tech. grade”). 25 Tex. Indep. Ginners Ass’n v. Marshall, 630 F.2d 398, 407 (5th Cir. 1980). 26 Am. Iron & Steel Inst. v. OSHA, 939 F.2d 975, 984–85 (D.C. Cir. 1991). 4

exposures does not provide substantial evidence for EPA’s determinations of no reasonable risk or satisfy EPA’s TSCA obligation to consider all reasonably available information.

EPA also lacks any data measuring exposures by workers who do not regularly handle or work with the chemical but work in or near areas where the chemical is handled, workers who EPA misleadingly characterizes as ONUs. The range of workers that EPA defines as ONUs is too large to support a single classification. Supervisors and managers have very different exposure patterns than skilled trade workers, yet all three are assumed to face similar risks under EPA’s overbroad ONU categorization.27 Moreover, EPA did not assess ONU exposures quantitatively in either risk evaluation “due to lack of data.”28

While EPA assumes that ONUs will be exposed to lower contaminant concentrations than direct users of HBCD or 1,4-dioxane, EPA has no factual basis for assuming that ONUs are exposed to levels that will not pose an unreasonable risk.29 Skilled trade workers and maintenance workers, for instance, frequently provide servicing and maintenance on equipment and as a result experience high short-term exposures to chemicals. In addition, fire fighters and other first responders are routinely exposed to high levels of HBCD and other flame retardants— as they regularly encounter consumer products and building materials containing HBCD, under extreme heat conditions, as part of their occupation. 30 These workers would also fall into EPA’s ONU category, although they should instead be evaluated as a susceptible subpopulation. Moreover, EPA found unreasonable risk to workers for many conditions in both risk evaluations but discounted that risk based on the (improper) assumption of PPE use. ONUs, which include supervisors, managers, and workers in adjoining areas, are even less likely to use PPE, and thus may face unreasonable risks even if their exposures are lower than those of other workers. EPA must measure ONU exposures based on reasonably available data for the specific type of worker.

EPA can “reasonably generate, obtain, and synthesize” actual monitoring data for 1,4- dioxane and HBCD, which EPA acknowledges is preferable to surrogate data or modeled exposures.31 OSHA requires employers to preserve and maintain employee exposure records— including “the sampling results, the collection methodology (sampling plan), a description of the analytical and mathematical methods used, and a summary of other background data relevant to interpretation of the results obtained”—for thirty years.32 OSHA has set a Permissible Exposure Limit (“PEL”) for 1,4-dioxane.33 Many employers will have measured employee exposures to ensure they are in compliance with that limit. Indeed, EPA has identified at least one manufacturer (BASF) that claims to have conducted workplace monitoring for 1,4-dioxane, and a number of and former manufacturers, processors, and users that may have worker

27 1,4-Dioxane Risk Evaluation at 47 (“ONUs for manufacturing include supervisors, managers, and tradesmen that may be in the manufacturing area.”). 28 HBCD Risk Evaluation at 216. See also 1,4-Dioxane Risk Evaluation at 55, 57, 60, 64, 71, 74, 277 (“Exposure data for ONUs were not available.”). 29 See note 28 supra. 30 Comments of the Int’l Ass’n of Fire Fighters on HBCD Risk Evaluation, EPA-HQ-OPPT-206-0735-0088 (Aug. 14, 2018). 31 See HBCD Risk Evaluation at 175–76; 1,4-Dioxane Risk Evaluation at 50. 32 29 C.F.R. § 1910.1020(d)(1)(ii). 33 Id. § 1910.1000, Table Z-1. 5

exposure records for both 1,4-dioxane and HBCD.34 EPA could have requested the production of this data voluntarily, ordered the production of such records under Section 8 of TSCA, or issued a subpoena under TSCA Section 11 requiring those companies to produce all available exposure data.35

If monitoring data is unavailable, EPA can order manufacturers and processors to conduct workplace sampling under TSCA Section 4.36 EPA also “may inspect any establishment, facility, or other premises in which chemical substances, mixtures, or products . . . are manufactured, processed, stored, or held” and gather its own data for use in the risk evaluations.37 Direct monitoring data is not only “reasonably available,” but is also the “best available science” for the measurement of occupational exposures and risks, routinely used by OSHA and required by the courts.38 EPA’s failure to rely upon reasonably available occupational exposure data in both risk evaluations violates TSCA.

III. EPA UNDERESTIMATES WORKER EXPOSURES AND RISKS

In addition to lacking necessary data, EPA’s occupational exposure assumptions and methodology understate worker risks. While EPA purports to calculate worker risks from inhalation and dermal exposures, it does not evaluate the combined risks to workers who both breathe and touch 1,4-dioxane and HBCD. Nor does EPA account for the fact that many exposed workers are also exposed to those same chemicals outside of work, via consumer products, drinking water, and other pathways. Fire fighters, for example, may be exposed to high levels of HBCD through multiple pathways - inhalation, dermal, and oral – yet EPA’s risk evaluation does not even consider fire fighters as a susceptible subpopulation. TSCA requires EPA to determine whether “a chemical substance presents an unreasonable risk of injury to health or the environment . . . including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant to the risk evaluation by the Administrator, under the conditions of use.”39 EPA’s piecemeal risk determinations, which focus on the risks associated with individual routes and pathways while ignoring the total risks facing exposed workers, fall short of this requirement.

EPA also fails to consider oral ingestion of HBCD or 1,4-dioxane in occupational settings. Studies have shown that nearly one in six workers inadvertently ingest hazardous substances through activities like biting their nails, touching their faces, or eating in an area where chemicals dusts can contaminate their food.40 Particularly for persistent, bioaccumulative, and toxic chemicals like HBCD, these ingestion exposures add up and contribute to workers’ risks. EPA cannot overlook those exposures in its occupational risk calculations.

34 See 1,4-Dioxane Risk Evaluation at 54. 35 15 U.S.C. § 2607(a). 36 Id. § 2603(a)(2). 37 Id. § 2610(a). 38 See Am. Petroleum Inst. v. OSHA, 581 F.2d 493, 507 (5th Cir. 1978), aff'd sub nom. Indus. Union Dep't, AFL-CIO v. Am. Petroleum Inst., 448 U.S. 607 (1980); Am. Iron & Steel Inst. v. OSHA, 939 F.2d 975 (D.C. Cir. 1991) 39 15 U.S.C. § 2605(b)(4)(a). 40 John W. Cherrie et al., How Important is Inadvertent Ingestion of Hazardous Substances at Work?, 50 Annals 693 (2006). 6

EPA calculates central tendency and high-end exposure scenarios for all occupational uses. Where the high-end scenario does not result in findings of unreasonable risk (assuming the use of PPE), EPA relies on that scenario for its risk determinations. In at least two instances, however, EPA discounts high-end scenarios where the calculating margin of exposure fell outside EPA’s acceptable range and relied on central tendency assumptions in order to avoid finding unreasonable risk.41 EPA offers no rationale for this inconsistent approach.

The central tendency scenario is not protective of workers. It assumes a 31-year career (nine fewer than the OSHA default level), and exposure durations and concentrations that are not supported by the record. EPA measures acute occupational inhalation risks using eight-hour time weighted average values, which are not reflective of peak exposures and impacts.42 Instead, there are frequently times during the workday where normal work activities can result in exposures far greater than the eight-hour average, and even brief exposures to those peak levels can have acute adverse health effects. For that reason, standard practice in industrial hygiene, as recommended by American Conference of Governmental Industrial Hygienists (“ACGIH”), is to identify the activity that generates the greatest peak exposure and to collect a fifteen-minute sample to evaluate short-term impacts.43 In its risk evaluations, EPA must similarly evaluate and account for the risks posed by intermittent peak exposures.

IV. EPA IMPROPERLY ASSUMES THE USE OF PPE TO AVOID DETERMINATIONS OF UNREASONABLE RISK

Both draft risk evaluations acknowledge that workers face “greater exposure” to HBCD and 1,4-dioxane than the general public.44 Further, EPA finds that workers’ inhalation and dermal margins of exposure (“MOE”) are far below the benchmark MOEs for both chemicals, indicating unreasonable risk. Occupational inhalation of 1,4-dioxane causes risks up to 48 times greater than levels EPA deems acceptable.45 Occupational inhalation of HBCD is responsible for risks up to 37 times greater than are acceptable, and dermal exposure results in worker risks up to 300 times above acceptable levels.46

However, EPA concludes that most of these risks are not unreasonable because workers would be able to protect themselves using PPE.47 This assumption is flawed for at least four reasons. First, EPA’s assumptions violate foundational industrial hygiene principles by measuring exposure after taking PPE into account. This conflates risk evaluation with risk management, which TSCA does not permit. Second, EPA has no evidence that workers have access to, or consistently use, adequate PPE. Third, even when it is available and is used, PPE does not effectively protect all workers. Fourth, EPA misconstrues OSHA regulations which do not require that PPE be provided to employees exposed to 1,4-dioxane and HBCD.

41 1,4-Dioxane Risk Evaluation at 160–161. 42 HBCD Risk Evaluation at 217; 1,4-Dioxane Risk Evaluation at 50. 43 ACGIH, TLV® Chemical Substances Introduction (Mar. 1, 1988), https://www.acgih.org/tlv-bei-guidelines/tlv- chemical-substances-introduction. 44 HBCD Risk Evaluation at 382; 1,4-Dioxane Risk Evaluation at 21. 45 1,4-Dioxane Risk Evaluation at 136. 46 HBCD Risk Evaluation at 358, 362. 47 Unreasonable risks were reported only for those 1,4-dioxane uses where, even with PPE, calculated inhalation MOEs were still below benchmark levels. 7

A. EPA’s Assumption of PPE Violates TSCA and Contradicts Established OSHA Practice.

TSCA separates risk evaluation from risk management, a distinct statutory process that begins after EPA has already completed a risk evaluation and made a determination of unreasonable risk.48 This separation is necessary, since the selection of appropriate risk management tools requires the consideration of numerous non-risk factors—including costs— that cannot be considered during the risk evaluation process.49

For chemicals that undergo TSCA risk evaluations, EPA may issue risk management rules only after it makes a determination of unreasonable risk.50 Assuming the voluntary use of PPE to avoid determinations of unreasonable risk, as EPA has done in both the 1,4-dioxane and HBCD risk evaluations, eliminates EPA’s ability to issue rules that ensure the chemicals’ unreasonable risks will, in fact, be adequately controlled.

OSHA and NIOSH consistently measure employee exposure, and hence risk, without regard to respirator use. The principle that exposure is measured without regard to respirator use has been incorporated into every OSHA health standard promulgated since 1970.51 If exposures in the absence of respirators pose a significant risk, then OSHA requires, and NIOSH recommends, reducing exposures through reliance on the “hierarchy of controls,” under which elimination, substitution, engineering and are all prioritized over the use of personal protective equipment.52 The hierarchy of controls has been endorsed by OSHA, NIOSH, the American Society of Safety Engineers, the American Industrial Hygiene Association, the American Conference of Governmental Industrial Hygienists, the American Association, the American Federation of Labor and Congress of Industrial Organizations and many others. As explained by NIOSH, “[t]he hierarchy of controls normally

48 Compare 15 U.S.C. § 2605(c) (governing risk management) with id. § 2605(b) (governing risk evaluation). 49 See note 47 supra. 50 15 U.S.C. § 2605(c)(1). 51 See, e.g., 29 C.F.R. § 1910.1053(b) (defining employee exposure as exposure “that would occur if the employee were not using a respirator.”). 52 Nat’l Inst. for Occupational Safety & Health, Ctrs. for Disease Control & Prevention, Hierarchy of Controls (last updated Jan. 13, 2015), https://www.cdc.gov/niosh/topics/hierarchy/. The hierarchy of controls has also been incorporated into every OSHA health standard and endorsed by EPA. See, e.g., Occupational Exposure to Respirable Crystalline Silica, 81 Fed. Reg. 16,286, 16,779–83 (Mar. 25, 2016) (silica preamble) (explaining OSHA’s longstanding policy of rejecting reliance on respirators to protect employees from health ); 29 C.F.R. § 1926.55 (to prevent employee exposure to inhalation, ingestion, skin absorption or contact with substances above safe levels, “engineering controls must first be implemented whenever feasible. When such controls are not feasible to achieve full compliance, protective equipment or other protective measures shall be used . . . .”); Id. § 1910.134(a)(1) (the prevention of due to “shall be accomplished as far as feasible by accepted engineering control measures (for example, enclosure or confinement of the operation, general and local ventilation, and substitution of less toxic materials). When effective engineering controls are not feasible, or while they are being instituted, appropriate respirators shall be used . . . .”); Significant New Use Rules on Certain Chemical Substances, 78 Fed. Reg. 38,210, 38,214 (June 26, 2013) (expressing EPA’s “agree[ment] that a hierarchy of controls should be applied and that personal protective equipment is the last resort to prevent exposures.”). 8

leads to the implementation of inherently safer systems” because chemical regulation and substitution are “more effective and protective” than PPE.53

Under the hierarchy of controls, employers must use engineering and work practice controls to eliminate hazards to the extent they are feasible. Respirators may be used only as an interim measure while other controls are being installed or when engineering controls cannot reduce exposures to the level necessary to eliminate the hazard.54 Under no circumstances does OSHA policy permit sole reliance on across-the-board respirator use as a method of reducing chemical exposure risks. EPA’s assumption to the contrary is incompatible with established occupational health policy and practice.

Among the many reasons that OSHA and NIOSH have rejected reliance on respirator use to protect workers are the facts that respirators are only effective when they are properly fitted; they can cause discomfort, skin , heat stress, communication difficulties, and vision limitations; and they often create other hazards for workers, such as trips, falls, and “struck by” hazards.55 For these reasons, and other, OSHA has found “only a nominal possibility that respirators will be properly worn at all times.”56

While EPA pays lip service to the hierarchy of controls—stating that “[r]espirators, and any other personal protective equipment, are the last means of worker protection … and should only be considered when process design and engineering controls cannot reduce workplace exposure to an acceptable level”57 —the risk evaluations’ PPE assumptions prevent EPA from even reaching the risk management stage where that hierarchy could be applied. By assuming across-the-board use of PPE to avoid all findings of unreasonable risk for HBCD, and most unreasonable risk findings for 1,4-dioxane, EPA starts with the control of “last resort”58 and bypasses the consideration of the non-PPE risk management measures recommended by OSHA, NIOSH, and EPA itself.

B. EPA’s PPE Assumptions are Unsupported and Self-Contradictory.

EPA cites no evidence that workers exposed to 1,4-dioxane and HBCD are provided with, or consistently use, PPE. The studies that EPA relies on to determine occupational exposure levels do not mention PPE use.59 EPA then ignores these studies and discounts the exposure levels they report based on the assumption that all workers are provided with, and use, appropriate PPE. There is simply no factual basis for this assumption.

53 See Nat’l Inst. for Occupational Safety & Health, Ctrs. for Disease Control & Prevention, Hierarchy of Controls (last updated Jan. 13, 2015), https://www.cdc.gov/niosh/topics/hierarchy/. 54 29 C.F.R. § 1910.134(a). 55 See Occupational Exposure to Respirable Crystalline Silica, 81 Fed. Reg. 16,286, 16,779–83 (Mar. 25, 2016). 56 Occupational Exposure to , Tremolite, Anthophyllite, and Actinolite, 51 Fed. Reg. 22,612, 22,693 (June 20, 1986). 57 1,4-Dioxane Risk Evaluation at 52; see also HBCD Risk Evaluation at 180. 58 Significant New Use Rules on Certain Chemical Substances, 78 Fed. Reg. 38,210, 38,214 (June 26, 2013). 59 See, e.g., 1,4-Dioxane Risk Evaluation at 78 (“Actual use of gloves in this use is uncertain.”); id. at 53 (“[I]t cannot be assumed that employers have or will implement comprehensive respiratory protection programs for their employees.”). 9

EPA’s risk evaluations not only assume the use of PPE but also speculate as to the specific types and protectiveness of such equipment. For 1,4-dioxane, EPA assumes that workers will wear respirators with an average assigned protection factor (“APF”) of at least 50 and impervious gloves with a protectiveness factor (“PF”) of at least 20.60 The Safety Data Sheets (“SDS”) referenced by EPA—which, as described below, are not binding on employers— belie these assumptions. According to EPA, “a specific glove material or protection factor rating was not provided” in the 1,4-dioxane SDSs.61 An SDS for a chemical reagent which is 50-60% 1,4-dioxane by states that “the use of this product should not require respiratory protection,”62 and other SDSs referenced in the draft risk evaluation recommend unspecified respirators only “if workplace exposure limit(s) of product or any component is exceeded.”63 In other words, EPA is assuming the use of very specific PPE that 1,4-dioxane’s manufacturers and users are not recommending, much less requiring.

For HBCD, EPA assumes that workers will use respirators with an APF of at least 5 and impervious gloves that eliminate any possibility of worker exposures.64 This one premise renders large parts of EPA’s risk evaluation superfluous; by relying on PPE to eliminate any possibility of exposure, EPA ensures that HBCD cannot present unreasonable dermal risks no matter what EPA’s detailed risk calculations show. Here too, EPA’s position is not supported by the SDSs cited in the risk evaluation, many of which “do not recommend specific glove materials.”65 Given their lack of specificity, EPA has no reason to believe that any gloves which may be provided to workers will be as effective as EPA assumes.

EPA’s PPE assumptions are self-contradictory. In the HBCD risk evaluation, EPA “assume[d] workers are properly trained and fitted on respirator use, and that they wear respirators for the entire duration of the work activity … throughout their career.”66 On the very same page, however, EPA notes that “regular use of respirators in chronic scenarios may not always be feasible.”67 In the 1,4-dioxane risk evaluation, EPA cautions that “it cannot be assumed that employers have or will implement comprehensive respiratory protection programs for their employees.”68 EPA makes no effort to explain why, if EPA cannot assume that all employers will provide respiratory protection, both risk evaluations rely on the use of respirators to find that worker risks will not be unreasonable. Nor is there any data in either risk evaluation that supports EPA’s PPE assumptions.

60 1,4-Dioxane Risk Evaluation at 158-173. 61 Id. at 75 62 Lumigen, forLumigen ECL Plus Chemiluminescent Reagent 5 (May 28, 2015), http://www.lumigen.com/sites/default/files/Additional%20documents/ps3-100-msdsc-ps3-100_english.pdf. 63 GAF, Safety Data Sheet for OlyBond Part B, at 4 (Oct. 2013), https://sweets.construction.com/swts_content_files/1772/714412.pdf. 64 HBCD Risk Evaluation at 359 (“EPA does not expect any level of dermal exposure to HBCD following proper use of impervious gloves.”). 65 HBCD Risk Evaluation at 182. 66 HBCD Risk Evaluation at 381. 67 Id. 68 1,4-Dioxane Risk Evaluation at 53. 10

C. Even When Provided, PPE Does Not Protect All Exposed Workers.

As noted above, even when PPE is available to workers, it is often insufficient to eliminate chemicals’ unreasonable risks. In a 2017 proposed ban on methylene chloride and N- Methyl-2-Pyrrolidone paint strippers, EPA found that respirators and other PPE were inadequate to comply with TSCA’s worker protection mandate because “not all workers may be able to wear respirators.”69 In particular, EPA explained that “[i]ndividuals with impaired lung function due to asthma, emphysema, or chronic obstructive pulmonary disease … may be physically unable to wear a respirator.”70 Workers’ facial hair, including beards and sideburns, can also interfere with the seal of a respirator, rendering it ineffective.71 Other workers forego respirators because they “may also present communication problems, vision problems, worker fatigue, and reduced work efficiency.”72 For all of these reasons, the OSHA previously informed EPA that it “consider[s] the use of respirators to be the least satisfactory approach to exposure control.”73 Notably, EPA has not published the results of OSHA’s review of the draft 1,4-dioxane or HBCD risk evaluations.

With respect to dermal exposures, EPA assumes that workers will be provided and will consistently use gloves “impervious to the hazardous chemical … worn on clean hands and replaced when contaminated or compromised.”74 EPA does not provide any support for this multi-part assumption, and it concedes that “[d]ata about the frequency of effective glove use – that is, the proper use of effective gloves – is very limited in industrial settings.”75 Permeable glove materials can absorb chemicals and increase worker exposures. Improper glove use (e.g., taking gloves off and putting them back on during a work shift) can also trap contaminants close to the skin and exacerbate dermal risks.

D. EPA Misconstrues OSHA Requirements.

TSCA requires EPA to evaluate risks “without consideration of costs and other non-risk factors,” and to determine whether a chemical presents unreasonable risks to “potentially any exposed and susceptible subpopulations.”76 Those risk evaluation requirements are not replicated in the Occupational Safety and Health Act. Rather, OSHA standards are aimed at eliminating “significant risk”—a term the Supreme Court has interpreted to permit risks that EPA would consider unreasonable—where “feasible.”77 Compliance with OSHA standards is thus insufficient to establish the absence of unreasonable risk under TSCA.

69 Methylene Chloride and N-Methylpyrrolidone; Regulation of Certain Uses Under TSCA Section 6(a), 82 Fed. Reg. 7464, 7481 (Jan. 19, 2017). 70 Id. 71 Id. 72 Id. 73 Letter from David Michaels, OSHA Administrator, to Jim Jones, EPA Assistant Administrator for the Office of Chemical Safety and Pollution Prevention, re: Docket No. EPA-HQ-OPPT-2014-0650, at 2 (Oct. 25, 2016). 74 HBCD Risk Evaluation at 181. 75 1,4-Dioxane Risk Evaluation at 293. 76 15 U.S.C. § 2605(b)(14)(A). 77 See Indus. Union Dep’t, AFL-CIO v. Am. Petroleum Inst., 448 U.S. 607 (1980); see also 1,4-Dioxane Risk Evaluation at 155 n.12. 11

EPA’s risk evaluations make several flawed assumptions about OSHA regulatory obligations. For example, EPA assumes that “existing OSHA regulations for … hazard communication will result in use of appropriate PPE consistent with the applicable [Safety Data Sheets] in a manner adequate to protect workers.”78 But OSHA does not require compliance with SDS recommendations. The preamble to OSHA’s Hazard Communication Standard expressly states that “while the … final standard require[s] the provision of information on recommended control measures, including respiratory protection, personal protective equipment, and engineering controls, there is no requirement for employers to implement the recommended controls.”79

Even if compliance with control measures recommended in an SDS were mandatory, EPA ignores factual information in the record showing that SDSs do not include recommendations adequate to protect workers. In his comments on the Pigment Violet 29 draft risk evaluation, Dr. Michaels references a published, 24-study survey that documented widespread “inaccuracies, incompleteness, incomprehensibility and overall low use of []SDSs.”80 EPA’s own analyses supporting the proposed methylene chloride ban rely on a study of 100 unionized workers across several manufacturing facilities which concluded that “information on … []SDSs was found to be about one-third incomprehensible.”81 Despite EPA’s assumption that workers will wear impervious, chemical-resistant gloves, many of the SDSs referenced in the HBCD and 1,4-dioxane risk evaluations “do not recommend specific glove materials.”82 Given the absence of any binding PPE requirements, the lack of details in the applicable SDSs, and the established limitations of SDSs more broadly, it is unreasonable for EPA to assume that all workers exposed to 1,4-dioxane and HBCD will be adequately protected from exposure by PPE.

EPA badly misstates OSHA requirements governing respirator use. EPA claims that “[r]espirators are required when effective engineering controls are not feasible,”83 and that, for 1,4-dioxane, respirators “[r]espirators must meet or exceed the required level of protection … to meet NIOSH recommended a 1 ppm ceiling …”84 That is simply not true. Under section 5 of the OSH Act, employers have a duty to comply with OSHA standards or to prevent exposure to “recognized hazards.”85 In the absence of actual harm to an employee, OSHA “must prove that the amount [of a chemical] to which employees are exposed presents a significant risk of harm” before it can require any risk management.86 That is already high bar, which would be made virtually insurmountable by EPA’s proposed determinations that all uses of HBCD and many uses of 1,4-dioxane present no unreasonable risk.

78 1,4-Dioxane Risk Evaluation at 175 n.1. 79 Hazard Communication, 77 Fed. Reg. 17,574, 17,693 (Mar. 26, 2012) (emphasis added). 80 Comment of David Michaels re: Draft Risk Evaluation for Pigment Violet 29, Docket No. EPA-HQ-OPPT-2018- 0604-0011, at 4 (Jan. 14, 2019) (citing Anne-Marie Nicol et al., Accuracy, Comprehensibility, and Use of Material Safety Data Sheets: A Review, 51 Am. J. Indus. Med. 861 (2008). 81 EPA, RIN 2070-AK07, The Effectiveness of Labeling on Hazardous Chemicals and Other Products, EPA-HQ- OPPT-2016-0231-0146 at 9 (Mar. 2016) (citing Paul Kolp et al., Comprehensibility of Material Safety Data Sheets, 23 Am. J. Indus. Med. 135 (1993)). 82 HBCD Risk Evaluation at 182; 1,4-Dioxane Risk Evaluation at 75. 83 1,4-Dioxane Risk Evaluation at 48; see also HBCD Risk Evaluation at 180. 84 1,4-Dioxane Risk Evaluation at 53. 85 29 U.S.C. § 654(a)(1). 86 Kastalon, Inc., 12 BNA OSHC 1928, at *4 (No. 79-5543, 1986). 12

Similarly, OSHA’s Respiratory Protection Standard87 does not require employers to provide PPE to workers exposed to 1,4-dioxane and HBCD at the levels that EPA projects may pose unreasonable risks. Instead, that standard requires that employers implement engineering controls, and when they are not feasible, provide respiratory protection only to the level required by OSHA exposure limits (in the case of 1,4 dioxane) or where significant risks exist. The OSHA exposure limit for 1,4-dioxane is woefully out of date; it was established in 1971 based on a consensus standard set years earlier.88 Moreover, in the absence of an OSHA PEL or an EPA finding of unreasonable risk for HBCD, there is little to no chance that OSHA would cite an employer for failing to provide respiratory protection to worker exposed HBCD at any level. Moreover, the method for determining the appropriate respirator required by OSHA’s standards involves measuring employee exposure to a chemical and comparing it to a respirator’s effectiveness in reducing those exposures to a specified level. In the absence of mandatory exposure limits for HBCD, there is no reference point for gauging the effectiveness of any given respirator.

OSHA’s PPE standard requires employers to assess the hazards workers face but to provide PPE only when the employer deems such measures “necessary.”89 Absent a regulatory requirement mandating exposure limits, employers are free to determine when PPE use is necessary to protect workers, using their own hazard standards that bear no relationship to TSCA’s requirements.90 Moreover, employers are not required to use the same regulatory thresholds as EPA. Under OSHA precedent, they could determine that increased cancer risks affecting up to 1 in 1,000 workers do not rise to the level of requiring PPE, even though under TSCA EPA would consider those same risks to be unreasonable.91

OSHA standards also do not protect public sector workers or construction workers who are classified as independent contractors, and are therefore not covered by OSHA. EPA’s risk evaluations indicate that such contractors would be exposed to both HBCD92 and 1,4-dioxane,93 yet EPA does not discuss how their status as workers affects EPA’s PPE analyses and assumptions.

In short, EPA’s belief that OSHA will ensure the use of PPE sufficient to eliminate HBCD and 1,4-dioxane’s unreasonable risks is based on a fundamental misunderstanding of OSHA’s organic statute and regulations. To comply with TSCA’s worker protection mandate, EPA must evaluate both 1,4-dioxane and HBCD without assuming any PPE use and consider all

87 29 C.F.R. § 1910.134. 88 OSHA, Permissible Exposure Limits, https://www.osha.gov/dsg/annotated-pels/ (last visited Aug. 22, 2019) (“OSHA recognizes that many of its permissible exposure limits (PELs) are outdated and inadequate for ensuring protection of worker health. Most of OSHA’s PELs were issued shortly after adoption of the Occupational Safety and Health (OSH) Act in 1970, and have not been updated since that time.”). 89 29 C.F.R. § 1910.132(a). 90 29 C.F.R. § 1910.134(a)(2). 91 See note 77 supra. 92 See HBCD Risk Evaluation at 206. 93 1-4-Dioxane Risk Evaluation at 288.

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other management tools before the use of PPE in EPA’s subsequent risk management rulemaking. Thank you for considering these comments. Respectfully submitted,

s/ Jonathan Kalmuss-Katz s/ Randy Rabinowitz Jonathan Kalmuss-Katz Randy Rabinowitz Staff Attorney Executive Director Earthjustice Occupational Safety & Health Law Project 48 Wall Street, 15th Floor P.O. Box 3769 New York, NY 10005 Washington, DC 20027 (212) 823-4989 (202) 256-4080 [email protected] [email protected]

On behalf of: American Federation of Labor and Congress of Industrial Organizations International Association of Fire Fighters International Union, United Automobile, Aerospace, and Agricultural Implement Workers of America United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial and Service Workers International Union

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