{"id":8606,"date":"2019-03-19T13:01:45","date_gmt":"2019-03-19T18:01:45","guid":{"rendered":"http:\/\/blogs.edf.org\/health\/?p=8606"},"modified":"2024-02-12T11:02:16","modified_gmt":"2024-02-12T16:02:16","slug":"part-2-busting-more-industry-perpetrated-myths-about-new-chemicals-and-worker-protection-under-tsca","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2019\/03\/19\/part-2-busting-more-industry-perpetrated-myths-about-new-chemicals-and-worker-protection-under-tsca\/","title":{"rendered":"PART 2: Busting more industry-perpetrated myths about new chemicals and worker protection under TSCA"},"content":{"rendered":"<p><em>Richard Denison, Ph.D.,\u00a0<\/em>is a Lead Senior Scientist.<\/p>\n<p><a href=\"https:\/\/blogs.edf.org\/health\/2019\/03\/15\/busting-industry-perpetrated-myths-about-new-chemicals-and-worker-protection-under-tsca\/\">Part 1<\/a>\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 Part 2\u00a0 \u00a0 \u00a0 \u00a0 \u00a0<a href=\"https:\/\/blogs.edf.org\/health\/2019\/04\/03\/part-3-busting-more-industry-perpetrated-myths-about-new-chemicals-and-worker-protection-under-tsca\/\">Part 3<\/a><\/p>\n<p>[pullquote]<strong><em>This post shows why the chemical industry has been so anxious to convince EPA to defer to OSHA rather than regulate worker risks from new chemicals under TSCA.<\/em><\/strong>[\/pullquote]<\/p>\n<p><a href=\"https:\/\/blogs.edf.org\/health\/2019\/03\/15\/busting-industry-perpetrated-myths-about-new-chemicals-and-worker-protection-under-tsca\/\">I started blogging last week<\/a> about myths the chemical industry is perpetrating when it comes to EPA\u2019s review of the risks new chemicals may present to workers.\u00a0 In this post, I address another such myth, one that the industry promotes to argue why the Environmental Protection Agency (EPA) can and should defer to the Occupational Safety and Health Administration (OSHA) in addressing the risks posed by new chemicals under the Toxic Substances Control Act (TSCA).\u00a0 This myth was on full display at last week\u2019s <a href=\"https:\/\/energycommerce.house.gov\/committee-activity\/hearings\/hearing-on-mismanaging-chemical-risks-epa-s-failure-to-protect-workers\">House Energy &amp; Commerce Committee hearing on EPA\u2019s failures to protect workers from chemical risks<\/a>.<\/p>\n<p><strong><em>Myth #2:\u00a0 OSHA regulations provide ample protection of workers from any exposures to new chemicals EPA is reviewing under TSCA.\u00a0\u00a0<\/em><\/strong><!--more--><\/p>\n<p>In his hearing testimony, Mark Duvall of Beveridge &amp; Diamond, currently a primary outside counsel to the chemical industry\u2019s main trade association, the American Chemistry Council (ACC), and before that a longtime Dow Chemical attorney, made both broad and specific assertions that OSHA regulations will protect workers \u2013 and do so to an extent that is sufficient to meet TSCA\u2019s requirements.\u00a0 He broadly asserted the following:<\/p>\n<p style=\"padding-left: 30px;\">EPA has apparently based its &#8220;not likely to present&#8221; finding in part on the reasonable assumption that employers will comply with applicable OSHA requirements, and that compliance with OSHA requirements means that the PMN [premanufacture notification] substance is not likely to present an unreasonable risk to workers.\u00a0 &#8230;<\/p>\n<p style=\"padding-left: 30px;\">In light of these applicable OSHA PPE [personal protective equipment] requirements, EPA concluded that the PMN substances for which it made &#8220;not likely to present&#8221; determinations were not likely to present an unreasonable risk even in the absence of a section 5(e) or section 5(f) order or a SNUR [Significant New Use Rule].<\/p>\n<p>Duvall then specified the OSHA regulations to which he was referring.\u00a0 These include:<\/p>\n<ul>\n<li>OSHA\u2019s hazard communication standard, <a href=\"https:\/\/www.osha.gov\/pls\/oshaweb\/owadisp.show_document?p_id=10099&amp;p_table=STANDARDS\">29 C.F.R. \u00a7 1910.1200<\/a><\/li>\n<li>OSHA&#8217;s general PPE standard, <a href=\"https:\/\/www.osha.gov\/pls\/oshaweb\/owadisp.show_document?p_id=9777&amp;p_table=STANDARDS\">29 C.F.R. \u00a7 1910.132<\/a><\/li>\n<li>OSHA\u2019s standard for respiratory protection, <a href=\"https:\/\/www.osha.gov\/pls\/oshaweb\/owadisp.show_document?p_id=12716&amp;p_table=standards\">29 C.F.R. \u00a7 1910.134<\/a><\/li>\n<li>OSHA&#8217;s standard for glove use, <a href=\"https:\/\/www.osha.gov\/pls\/oshaweb\/owadisp.show_document?p_id=9788&amp;p_table=STANDARDS\">29 C.F.R. \u00a7 1910.138<\/a><\/li>\n<\/ul>\n<p>This looks impressive at first glance.\u00a0 But the devil is in the details, in this case the major exceptions and caveats that apply to each regulation.<\/p>\n<p><strong>OSHA\u2019s hazard communication standard (HCS):<\/strong> \u00a0\u00a0The HCS requires a company making a chemical to provide a Safety Data Sheet (SDS) identifying the chemical\u2019s hazards and recommended precautions.\u00a0 The SDS is required to be made available to a company\u2019s workers and to accompany a chemical if it is sold to customers downstream in a supply chain.\u00a0 However, the HCS does not impose ANY requirements on employers to implement those recommended precautions.\u00a0 This is made clear in the <a href=\"https:\/\/www.osha.gov\/FedReg_osha_pdf\/FED20120326.pdf\">preamble to the final HCS (p. 17693, emphases added<\/a>):<\/p>\n<p style=\"padding-left: 30px;\">While the current HCS and this final standard require the provision of information on recommended control measures, including respiratory protection, personal protective equipment, and engineering controls, <em>there is no requirement for employers to implement the recommended controls<\/em>.\u00a0 An employer should use all available information when designing an appropriate protective program, but <em>a recommendation on a safety data sheet by itself would not trigger the need to implement new controls<\/em>.<\/p>\n<p><strong>OSHA\u2019s general and specific PPE regulations: <\/strong>\u00a0These regulations have two very important limitations as to when they are applicable and hence when use of PPE is mandatory:\u00a0 They apply only where the <em>employer<\/em> has determined that workers are subject to sufficient <em>hazards<\/em> from chemical exposures, and they apply only \u201c<em>where necessary<\/em>.\u201d<\/p>\n<p>To illustrate, here is what <a href=\"https:\/\/www.osha.gov\/pls\/oshaweb\/owadisp.show_document?p_id=9777&amp;p_table=STANDARDS\">OSHA\u2019s general PPE standard<\/a> states (emphases added):<\/p>\n<p style=\"padding-left: 30px;\">Protective equipment, including personal protective equipment for eyes, face, head, and extremities, protective clothing, respiratory devices, and protective shields and barriers, shall be provided, used, and maintained in a sanitary and reliable condition <em>wherever it is necessary by reason of hazards<\/em> of processes or environment, chemical hazards, radiological hazards, or mechanical irritants encountered in a manner capable of causing injury or impairment in the function of any part of the body through absorption, inhalation or physical contact.<\/p>\n<p>Similar caveats appear in the specific PPE standards.\u00a0 They mean that it is the employer who gets to decide both whether and what hazards exist and whether worker use of PPE is necessary.\u00a0 Let\u2019s look closer at each of these factors.<\/p>\n<p><strong><em>Deciding whether a hazard exists<\/em><\/strong><\/p>\n<p>Under OSHA\u2019s HCS, employers have considerable latitude in deciding whether a hazard exists in the workplace.\u00a0 Even a hazard classification of a chemical issued by an authoritative government body need not be relied on.\u00a0 That is, the employer can apply his\/her own weight-of-evidence (WoE) approach to decide a chemical does not present a hazard even if a government authority has determined that it does.\u00a0 The employer can do so even if that government authority applied a WoE approach to make its hazard determination.<\/p>\n<p>For example, for many chemicals, government authorities such as EPA\u2019s Integrated Risk Information System (IRIS) or the National Toxicology Program (NTP) have reached determinations as to which human health hazards are posed by a particular chemical, such as whether a chemical is known or suspected to cause cancer in people.\u00a0 They do so by applying WoE approaches that have been subject to independent peer-review.\u00a0 Yet even where such a government body has classified a chemical as a carcinogen, under OSHA\u2019s HCS and associated guidance a company can decide the chemical is not carcinogenic, by weighing the evidence differently using its own methodology.<\/p>\n<p>This issue figured prominently in 2016, when OSHA took public comment on its draft \u201c<a href=\"https:\/\/www.regulations.gov\/document?D=OSHA-2016-0004-0002\">Guidance on Data Evaluation for Weight of Evidence Determination<\/a>\u201d as it related to changes OSHA made in 2012 to the HCS.\u00a0 In that draft, OSHA proposed to give deference to decisions made by authoritative bodies:<\/p>\n<p style=\"padding-left: 30px;\">If a classifier reaches a final WoE conclusion that differs from that of the NTP or IARC [International Agency for Research on Cancer], OSHA would look, in the event of a compliance inspection, for a clear justification for the different classification. \u00a0If OSHA disagrees with the classifier\u2019s classification after evaluating the classifier\u2019s justification, OSHA may issue a citation.<\/p>\n<p>However, this and other language in the draft still retained the HCS\u2019s approach of providing the company with the option of making its own determination that differs from that made by an authoritative body.\u00a0 And that determination would only be questioned in the rather unlikely event of a compliance inspection that focused in on this aspect of a company\u2019s SDS.<\/p>\n<p>An example of a company\u2019s SDS substituting the company\u2019s own conclusions about a chemical\u2019s hazards for those of authoritative government bodies is this <a href=\"http:\/\/208.112.58.204\/pridesol\/documents\/sds\/Methylene%20Chloride%20Tech%20-%20Dow%20-%202015-03-04.pdf\">2015 Dow Chemical SDS for methylene chloride<\/a>, which asserts:\u00a0 \u201cMethylene chloride is not believed to pose a measurable carcinogenic risk to humans when handled as recommended.\u201d<\/p>\n<p>This despite the following:<\/p>\n<ul>\n<li>EPA\u2019s IRIS program 2011 weight-of-evidence characterization determined that the chemical is \u201c<a href=\"https:\/\/cfpub.epa.gov\/ncea\/iris2\/chemicalLanding.cfm?substance_nmbr=70\">Likely to be carcinogenic to humans<\/a>.\u201d<\/li>\n<li>The National Toxicology Program\u2019s latest (2016) Report on Carcinogens classifies the chemical as \u201c<a href=\"https:\/\/ntp.niehs.nih.gov\/ntp\/roc\/content\/profiles\/dichloromethane.pdf\">Reasonably anticipated to be a human carcinogen<\/a>.\u201d<\/li>\n<li>The International Agency for Research on Cancer (IARC) classified the chemical in 2017 as \u201c<a href=\"https:\/\/monographs.iarc.fr\/list-of-classifications-volumes\/\">Probably carcinogenic to humans<\/a>.\u201d<\/li>\n<\/ul>\n<p><a href=\"https:\/\/www.regulations.gov\/document?D=OSHA-2016-0004-0035\">EDF<\/a> and <a href=\"https:\/\/www.regulations.gov\/docketBrowser?rpp=25&amp;so=DESC&amp;sb=commentDueDate&amp;po=0&amp;D=OSHA-2016-0004\">numerous other commenters<\/a> urged OSHA to require companies to rely on hazard classifications by authoritative bodies identified by OSHA for chemicals, where they exist.\u00a0 Unfortunately, it appears this guidance did not move forward.<\/p>\n<p>(Of more than passing interest is that Dr. Nancy Beck, at the time a senior official at the ACC, <a href=\"https:\/\/www.regulations.gov\/document?D=OSHA-2016-0004-0024\">authored ACC\u2019s extensive comments<\/a> on this draft OSHA guidance.\u00a0 ACC\u2019s comments urged OSHA to allow companies to apply their own WoE approaches and reach different hazard classifications even where authoritative government bodies had already done so. \u00a0Now that Beck is Principal Deputy Assistant Administrator in EPA\u2019s TSCA office, she is centrally involved in the agency\u2019s decisions that seek to defer worker risks to OSHA and that agency\u2019s regulations.)<\/p>\n<p><strong><em>Deciding whether PPE is \u201cnecessary\u201d<\/em><\/strong><\/p>\n<p>\u201cNecessary\u201d under OSHA\u2019s statute is a very different animal than \u201cnecessary\u201d under TSCA.<\/p>\n<p>This matters enormously because the <a href=\"https:\/\/blogs.edf.org\/health\/2019\/02\/21\/the-trump-epa-is-throwing-workers-facing-risks-from-new-tsca-chemicals-under-the-bus\/\">dangerous tack EPA has taken<\/a> deems regulations developed by OSHA to be sufficient and defers to them as a basis for greenlighting new chemicals.\u00a0 This has several major consequences.\u00a0 First, it means EPA itself will rarely impose any mandatory worker protections on companies.<\/p>\n<p>Second, an employer can decide that worker protections are not \u201cnecessary\u201d under OSHA standards unless it believes there is clear evidence of a hazard.\u00a0 Usually, with a new chemical such evidence of hazards is limited or lacking altogether. \u00a0In contrast, under TSCA the lack of sufficient information to evaluate a new chemical\u2019s hazards and risks \u2013 in and of itself \u2013 mandates that EPA issue an order to address any potential risks pending receipt of the information (see TSCA section 5(e)(1)).<\/p>\n<p>Third, in deciding whether a hazard necessitating protections exists, the company\u2019s point of reference will be OSHA\u2019s, not TSCA\u2019s, safety standard.\u00a0 Here is how the two standards differ:<\/p>\n<p><em>TSCA\u2019s safety standard<\/em>:\u00a0\u00a0 First, the 2016 amendments to TSCA explicitly preclude EPA from considering feasibility or other non-risk factors when determining whether a chemical presents an \u201cunreasonable risk,\u201d including to workers.\u00a0 Moreover, in implementing TSCA (even before the amendments) and its other environmental statutes, EPA has generally sought to reduce population risks from chemicals in commerce that are carcinogens to below about one case per one million people, or in some cases one case per 100,000 people (see Appendix B of <a href=\"https:\/\/www.nap.edu\/download\/10974\">this 2004 National Academy of Sciences report<\/a>).\u00a0 And the head of EPA\u2019s TSCA office at the time the new law was passed indicated she expected the same approach would be taken under amended TSCA in identifying chemicals in commerce that \u201cpresent an unreasonable risk\u201d (see <a href=\"https:\/\/ehp.niehs.nih.gov\/doi\/pdf\/10.1289\/ehp.124-A182\">p. 184 here<\/a>).<\/p>\n<p>In the present case, we are talking about new chemicals not yet in commerce.\u00a0 For them, TSCA requires EPA to regulate the chemical even if it \u201c<em>may<\/em> present an unreasonable risk\u201d \u2013 which means an even lower level of risk should trigger regulatory action.<\/p>\n<p><em>OSHA\u2019s safety standard<\/em>:\u00a0 In contrast, the Occupational Safety and Health Act allows OSHA to regulate only \u201csignificant\u201d risks in the workplace. \u00a0And as a result of the landmark 1980 <a href=\"https:\/\/en.wikipedia.org\/wiki\/Industrial_Union_Department_v._American_Petroleum_Institute\"><em>Benzene<\/em> <\/a>case, for carcinogenic chemicals OSHA has interpreted as \u201csignificant\u201d a risk of one or more cases per 1,000 workers (see Appendix B of the <a href=\"https:\/\/www.nap.edu\/download\/10974\">2004 NAS report<\/a>).\u00a0 This means that OSHA tolerates risks to workers from chemicals that are <em>several orders of magnitude<\/em> <em>higher <\/em>than are allowed under TSCA.<\/p>\n<p>In addition, OSHA can only regulate workplace exposures where it is \u201cfeasible\u201d to do so.\u00a0 In practice, OSHA has frequently concluded that it is infeasible to reduce workplace risks below or even down to the 1 in 1,000 level (again, see Appendix B of <a href=\"https:\/\/www.nap.edu\/download\/10974\">this 2004 National Academy of Sciences report<\/a>), leaving workers at even greater risk than contemplated by the <em>Benzene <\/em>decision.\u00a0 Indeed, <a href=\"https:\/\/energycommerce.house.gov\/sites\/democrats.energycommerce.house.gov\/files\/documents\/03.13.19_Witness%20Testimony_Finkel.pdf\">evidence cited <\/a>at last week\u2019s hearing indicated that actual workplace risks posed by many carcinogens are even higher than one case per 1,000 workers.<\/p>\n<p><strong><em>Now you can see why the chemical industry has been so anxious to convince EPA to defer to OSHA rather than regulate worker risks from new chemicals under TSCA.<\/em><\/strong><\/p>\n<p style=\"text-align: center;\"><strong><em>\u00a0<\/em><\/strong>***<\/p>\n<p>In my next post I will look at the industry\u2019s mythic claims that requirements for SDSs and use of PPE are effective and universally complied with.\u00a0 Stay tuned.<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Richard Denison, Ph.D.,\u00a0is a Lead Senior Scientist. Part 1\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 Part 2\u00a0 \u00a0 \u00a0 \u00a0 \u00a0Part 3 [pullquote]This post shows why the chemical industry has been so anxious to convince EPA to defer to OSHA rather than regulate worker risks from new chemicals under TSCA.[\/pullquote] I started blogging last week about myths &#8230;<\/p>\n","protected":false},"author":100,"featured_media":8618,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[44,56093,56096,77],"tags":[68,56107,113921,56108],"coauthors":[],"class_list":["post-8606","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-policy","category-industry-influence","category-omboira","category-worker-safety","tag-epa","tag-lautenberg-act","tag-myth-busting","tag-new-chemicals"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/8606","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/users\/100"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/comments?post=8606"}],"version-history":[{"count":1,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/8606\/revisions"}],"predecessor-version":[{"id":12868,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/8606\/revisions\/12868"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media\/8618"}],"wp:attachment":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media?parent=8606"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/categories?post=8606"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/tags?post=8606"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/coauthors?post=8606"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}