Opinion ID: 513179
Heading Depth: 2
Heading Rank: 1

Heading: Evidence of Exposure to EHA

Text: 69 EPA ultimately concluded that there is a more-than-theoretical probability that workers are exposed to EHA. After revising its estimate of the likely amount of exposure downward in response to industry comments, the Agency estimated that workers are likely to be exposed on infrequent occasions as a result of accidental spillage and that such exposure could amount to 60 milligrams of EHA per kilogram of body weight for each incident. Final Test Rule, 51 Fed.Reg. 40,320 (exposure believed to be incidental rather than routine). 70 Before issuing the Proposed Test Rule, EPA adduced a number of facts from which it could reasonably have inferred potential exposure. Although industry representatives presented rebuttal evidence purporting to show widespread use of gloves and purporting to show the effectiveness of gloves in preventing dermal exposure, EPA rationally concluded in the Final Test Rule that this evidence did not overcome its finding of potential exposure. First, weaknesses in testing methods suggested that the purported facts averred by industry had not been established reliably. Second, and more importantly, the very facts averred by industry (even assuming their truth) tended to support rather than refute a finding of potential exposure. 71 A number of facts supported EPA's initial inference of potential exposure. First, the number of employees involved in handling EHA is not small: approximately 400 are potentially exposed. Proposed Test Rule, 50 Fed.Reg. at 20,680; Final Test Rule, 51 Fed.Reg. at 40,319-20. Second, a large amount of EHA is produced and used: some 20 to 25 million pounds annually. Proposed Test Rule, 50 Fed.Reg. at 20,679; Final Test Rule, 51 Fed.Reg. at 40,319. Increases in production are expected to raise this amount substantially. Id. at 40,322; S.J.A. 516. Cf. Shell Chemical Co. v. EPA, 826 F.2d 295, 298 (5th Cir.1987) (in review of a TSCA section 4 test rule, remand to EPA is appropriate where EPA asserts post-promulgation increases in use not anticipated at time of rulemaking). Third, EHA is handled not at one or a small number of plants with uniform practices: rather, it is handled at two manufacturing plants and approximately 100 processing plants nationwide, giving rise to legitimate doubts by EPA about the uniformity of safety practices. Proposed Test Rule, 50 Fed.Reg. at 20,680; Final Test Rule, 51 Fed.Reg. at 40,319. Fourth, certain actions (e.g., drumming and undrumming, cleaning, sampling) were deemed likely by EPA to subject workers to dermal exposure. Proposed Test Rule, 50 Fed.Reg. at 20,68 0; Final Test Rule, 51 Fed.Reg. at 40,319. Fifth, EPA inferred potential exposure from the fact that glove use is not required by existing federal regulations. Proposed Test Rule, 50 Fed.Reg. at 20,681. Sixth, EPA noted that the physicochemical properties of EHA do not force workers to avoid contact with EHA--it is a colorless liquid with a mild odor. Final Test Rule, 51 Fed.Reg. at 40,319. From these facts, EPA logically could have reached the initial conclusion that there was a more-than-theoretical probability of human exposure to EHA. 72 As the record must be viewed as a whole, contrary evidence--such as that purportedly contained in the industry Glove Use Survey and Glove Permeability Study--should be given careful attention. The industry studies, however, did not weaken the EPA finding of potential exposure. Indeed, the Glove Use Survey lent significant support to that finding. 73 First of all, EPA convincingly discredited the Glove Use Survey, to the extent that it purported to show widespread use of gloves. As EPA pointed out in the rulemaking record, the survey entailed no on-site visits or inspections to facilities producing or using EHA. Final Test Rule, 51 Fed.Reg. at 40,320. The independent researchers conducting the survey did not in any way verify the responses of company managers. Id. Nor did the researchers audit glove use themselves--a noteworthy weakness of the survey, in view of the 20 percent of respondent employers who indicated that they did not monitor glove use either. J.A. 39. The researchers obtained no exposure information from workers, whose incentives to detail non-use would presumably be greater than those of management. Final Test Rule, 51 Fed.Reg. at 40,320. The candor of responses was also diluted by telling survey participants that their responses would be used as the basis for comments on a proposed EPA test rule. J.A. 434. 19 74 In addition to its skepticism of the Glove Use Survey, EPA discredited the Glove Permeability Study, to the extent that it purported to show the effectiveness of gloves in preventing exposure to EHA. In the study, gloves were immersed for seven hours continuously, with no resultant breakthrough of EHA. J.A. 68. EPA contends it is possible that an employee would wear a pair of EHA-doused gloves for longer than seven hours. Final Test Rule, 51 Fed.Reg. at 40,320. Indeed, the testing standards do not indicate a seven-hour time limit, but indicate rather that immersion should continue until breakthrough occurs. J.A. 448. Additionally, continuous immersion testing does not address the possibility of intermittent exposure over a period of time, especially with reused gloves. J.A. 320-21. Thirdly, the immersion test evaluated only two types of gloves, while workers in fact use five different types of gloves. Compare J.A. 68 (nitrile and neoprene gloves tested) with J.A. 36 (neoprene, rubber, polyvinyl chloride, latex and leatherpalmed cotton gloves used). Final Test Rule, 51 Fed.Reg. at 40,320. Finally, the study tested only the permeation of pure EHA, while EHA is often presented in mixtures with mineral spirits during processing operations. Id. Permeation of some substances in mixtures has been found greater than in pure form. J.A. 452, 455. Thus, the Glove Permeability Study did not succeed in effectively rebutting EPA's inference of potential exposure so as to dissipate any serious concerns about the likelihood of exposure. 75 More importantly, however, the Glove Use Survey lent positive evidentiary support to the Agency's exposure finding. Survey respondents stated that dermal contact with EHA is possible in several situations, including the emptying and filling of drums, sampling, and maintenance. J.A. 36. They indicated the use of five different types of gloves, J.A. 36, only one of which was included in the Glove Permeability Study. J.A. 68. (Leather-palmed cotton gloves, J.A. 36, could be expected to differ substantially from the neoprene and nitrile gloves used in the test.) Survey respondents indicated the use of half a dozen different procedures for ensuring the use of gloves. J.A. 37. Because no measurements were made of actual glove use, there is no basis for determining the extent to which any of these methods succeeded. Since only 15 percent of respondents used all the listed methods, J.A. 37, there exists a real possibility that some companies do not use the most effective method or combination of methods for ensuring glove use. Five percent of the respondents reported that gloves are not routinely worn during equipment maintenance, J.A. 38, and 20 percent indicated they do not monitor glove use, J.A. 39. Eight percent of the respondents do not even instruct their employees to wear gloves. J.A. 36. Most importantly, fully 25 percent of the respondents reported that there are 'occasional' situations in which dermal contact occurs. J.A. 39 (emphasis added). Company managers specifically mentioned small spills, accidental leaks and minor splashes that occur when employees do not wear protective gloves provided. J.A. 39. 20 Cumulatively, these data are sufficient to support the conclusion that there is a more-than-theoretical probability of human exposure to EHA. Where one fourth of the companies making or using EHA report occasional dermal contact, the likelihood of exposure cannot be characterized as speculative or theoretical. Cf. Ausimont U.S.A., Inc. v. EPA, 838 F.2d 93, 97 (3d Cir.1988) (evidence of exposure sufficient where not all workers exposed to fugitive gases wear respirators routinely). In sum, EPA has pointed to sufficient evidence of dermal exposure to warrant the promulgation of a test rule.