{"id":8816,"date":"2019-05-22T09:55:25","date_gmt":"2019-05-22T14:55:25","guid":{"rendered":"http:\/\/blogs.edf.org\/health\/?p=8816"},"modified":"2025-12-09T14:26:03","modified_gmt":"2025-12-09T19:26:03","slug":"company-safety-data-sheets-on-new-chemicals-frequently-lack-the-worker-protections-epa-claims-they-include","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2019\/05\/22\/company-safety-data-sheets-on-new-chemicals-frequently-lack-the-worker-protections-epa-claims-they-include\/","title":{"rendered":"Company safety data sheets on new chemicals frequently lack the worker protections EPA claims they include"},"content":{"rendered":"<p><em>Richard Denison, Ph.D.,\u00a0<\/em>is a Lead Senior Scientist.<\/p>\n<p>Readers of this blog know <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\/\">how concerned EDF is<\/a> over the Trump EPA\u2019s approval of many dozens of new chemicals based on its mere \u201cexpectation\u201d that workers across supply chains will always employ personal protective equipment (PPE) just because it is recommended in the manufacturer\u2019s non-binding safety data sheet (SDS).[pullquote]<strong><em>How much farther under the bus will the Trump EPA throw American workers?<\/em><\/strong>[\/pullquote]<\/p>\n<p>The typical course has been for EPA to identify risks to workers from a new chemical it is reviewing under the Toxic Substances Control Act (TSCA), but then \u2013 instead of issuing an order imposing binding conditions on the chemical\u2019s entry onto the market, as TSCA requires \u2013 to find that the chemical is \u201cnot likely to present an unreasonable risk\u201d and impose no conditions whatsoever on its manufacturer.\u00a0 This sleight of hand is pulled off by EPA stating that it:<\/p>\n<p style=\"padding-left: 30px;\">expects employers will require and workers will use appropriate personal protective equipment (PPE) \u2026 <em>consistent with the Safety Data Sheet<\/em> prepared by the new chemical submitter, in a manner adequate to protect them.<\/p>\n<p>We have detailed earlier the <a href=\"https:\/\/blogs.edf.org\/health\/tag\/myth-busting\/\">myriad ways<\/a> in which this approach strays from the law, is bad policy and won\u2019t protect workers.\u00a0 But here\u2019s yet another gaping problem:\u00a0 When we are able to look at the actual SDSs \u2013 that is, when EPA has made them available and when they are not totally redacted \u2013 we are frequently finding that <strong><em>the specific PPE that EPA claims to be specified in the SDSs \u2013 and that EPA asserts is sufficient to protect all workers handling the chemical \u2013 is not in the SDSs.<\/em><\/strong>\u00a0\u00a0<!--more--><\/p>\n<p>EDF recently examined the SDSs for each of five new chemicals where EPA has declared them \u201cnot likely to present an unreasonable risk\u201d and included the language I cited above.\u00a0 EPA has also included the five in a proposed Significant New Use Rule (SNUR) that would require companies to notify EPA if they intend to use chemical in a particular manner that EPA has defined as a \u201csignificant new use.\u201d\u00a0 On Monday, <a href=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2019\/05\/EDF-comments-on-4-19-19-proposed-SNURs-FINAL.pdf\">EDF filed extensive critical comments<\/a> on those proposed SNURs.<\/p>\n<p>The reason we are focusing here on these chemicals is because, by law, EPA had to establish a rulemaking docket for the SNUR and place in that docket certain supporting documents pertaining to each new chemical.\u00a0 Among those documents is (supposed to be) the chemical\u2019s corresponding SDS.<\/p>\n<p>Unfortunately, for two of the five chemicals (identified as P-18-0073 and P-19-0010, because the companies claimed their actual identities to be confidential), EPA failed to provide a copy of the SDS in its docket even though it is part of the documentation the company was required to submit to EPA.\u00a0 For another of the five (P-17-0239), the <a href=\"https:\/\/www.regulations.gov\/contentStreamer?documentId=EPA-HQ-OPPT-2018-0772-0003&amp;attachmentNumber=2&amp;contentType=pdf\">copy of the SDS<\/a> EPA included in the docket is <em>totally redacted<\/em> \u2013 even though much if not all of its content comprises health and safety information not eligible for confidential business information (CBI) protection under TSCA and, for the remainder, there is no evidence EPA has reviewed and approved any CBI claims the company asserted for the SDS.<\/p>\n<p>That leaves us with the SDSs for the remaining two cases (<a href=\"https:\/\/www.regulations.gov\/contentStreamer?documentId=EPA-HQ-OPPT-2018-0772-0005&amp;attachmentNumber=3&amp;contentType=pdf\">P-18-0048<\/a> and <a href=\"https:\/\/www.regulations.gov\/contentStreamer?documentId=EPA-HQ-OPPT-2018-0772-0006&amp;attachmentNumber=4&amp;contentType=pdf\">P-18-0122<\/a>), which are unredacted. \u00a0Now we can compare what they specify by way of PPE to the specific PPE that EPA relied on in determining these chemicals are \u201cnot likely to present an unreasonable risk.\u201d<\/p>\n<p><strong><u>P-18-0048<\/u><\/strong>:\u00a0 Here is what the <a href=\"https:\/\/www.epa.gov\/reviewing-new-chemicals-under-toxic-substances-control-act-tsca\/tsca-section-5a3c-determination-183\">\u201cnot likely\u201d determination document for P-18-0048<\/a> states:<\/p>\n<p><strong><em>Risks to workers<\/em><\/strong>:\u00a0 Reproductive toxicity via dermal exposure; corrosion to all tissues via dermal and inhalation exposures.<\/p>\n<p><strong><em>PPE EPA relies on<\/em><\/strong>:\u00a0 EPA identifies as \u201cappropriate PPE\u201d the use of \u201cimpervious gloves and a respirator.\u201d EPA goes on to state:<\/p>\n<p style=\"padding-left: 30px;\">EPA expects that employers will require and workers will use appropriate personal protective equipment, including dermal and <em>respiratory protection with an Assigned Protection Factor <\/em>[APF]<em> of 50, consistent with the Safety Data Sheet submitted with the PMN <\/em>[premanufacture notice], in a manner adequate to protect them. (p. 6, emphasis added)<\/p>\n<p>The <a href=\"https:\/\/www.regulations.gov\/contentStreamer?documentId=EPA-HQ-OPPT-2018-0772-0005&amp;attachmentNumber=3&amp;contentType=pdf\">associated SDS<\/a> does recommend wearing \u201cprotective gloves,\u201d \u201csuitable protective equipment,\u201d and \u201cappropriate chemical resistant gloves.\u201d\u00a0 Its only reference to respiratory protection, however, is this:<\/p>\n<p style=\"padding-left: 30px;\">[I]n the case of insufficient ventilation, wear suitable respiratory equipment.<\/p>\n<p>Nowhere does the SDS specify use of a respirator with an APF of 50.\u00a0 The SDS is clearly not consistent with EPA\u2019s own description of it.<\/p>\n<p><strong><u>P-18-0122<\/u><\/strong>:\u00a0 Here is what the <a href=\"https:\/\/www.epa.gov\/reviewing-new-chemicals-under-toxic-substances-control-act-tsca\/tsca-section-5a3c-determination-190\">\u201cnot likely\u201d determination document for P-18-0122<\/a> states:<\/p>\n<p><strong><em>Risks to workers<\/em><\/strong>:\u00a0 Lung toxicity via inhalation; irritation to skin, eyes, lung and GI tract.<\/p>\n<p><strong><em>PPE EPA relies on<\/em><\/strong>:<\/p>\n<p style=\"padding-left: 30px;\">Risks will be mitigated if exposures are controlled by the use of appropriate PPE, <em>including respiratory protection with an APF of 10<\/em>.\u00a0 Risks could not be quantified for irritation hazards, but appropriate PPE, including impervious gloves and protective eye wear, would mitigate concerns.\u00a0 EPA expects that employers will require and workers will use appropriate personal protective equipment (i.e., impervious gloves, protective eye wear, and a respirator), <em>consistent with the Safety Data Sheet prepared by the PMN submitter<\/em>, in a manner adequate to protect them.\u00a0 (pp. 5-6, emphases added)<\/p>\n<p>While the <a href=\"https:\/\/www.regulations.gov\/contentStreamer?documentId=EPA-HQ-OPPT-2018-0772-0006&amp;attachmentNumber=4&amp;contentType=pdf\">corresponding SDS<\/a> does recommend certain types of gloves and safety glasses, it specifically states:<\/p>\n<p style=\"padding-left: 30px;\">Other protective equipment is not generally required under normal working conditions.<\/p>\n<p>The only mention of use of a respirator anywhere in the SDS is where an OSHA regulatory workplace standard is exceeded \u2013 which is clearly not the case here, as no such standards exist for the new chemical.\u00a0 Nowhere does the SDS specify use of a respirator with an APF of 10.\u00a0 Here again, the SDS is clearly not consistent with EPA\u2019s own description of it.<\/p>\n<p><strong>Other recent cases found<\/strong><\/p>\n<p>This finding spurred us to look further at other \u201cnot likely\u201d determinations and the corresponding SDSs.\u00a0 This is slower-going, because there is no electronically accessible docket. \u00a0That\u2019s not only because EPA has not proposed a SNUR for other new chemicals to which it recently gave the green light; it\u2019s also because EPA has failed to comply with its own regulations requiring it to provide electronic access to all new chemical submissions it receives.<\/p>\n<p>As we <a href=\"https:\/\/blogs.edf.org\/health\/tag\/cbi-pmn-series\/\">have described elsewhere<\/a>, EDF has had no choice but to request the \u201cpublic files\u201d for these chemicals through EPA\u2019s Docket Center, which can take several weeks (they come by snail mail on a CD-ROM).<\/p>\n<p>I looked at a number of recent new chemicals EPA has green-lighted for which we have received public files.\u00a0 In one case no SDS was provided in the public file, while in two others the SDS was there but again totally redacted.\u00a0 In some of the remaining cases the SDS recommended PPE that matched that EPA described in its \u201cnot likely\u201d document, or at least came close.<\/p>\n<p>But in other cases, there was not a match.\u00a0 Here are two examples:<\/p>\n<p><strong><u>P-19-0021\/22<\/u><\/strong>:\u00a0 Here is what the <a href=\"https:\/\/www.epa.gov\/reviewing-new-chemicals-under-toxic-substances-control-act-tsca\/tsca-section-5a3c-determination-160\">\u201cnot likely\u201d determination document for P-19-0021 and P-19-0022<\/a> states:<\/p>\n<p><strong><em>Risks to workers<\/em><\/strong>:\u00a0 Lung overload via inhalation.<\/p>\n<p><strong><em>PPE EPA relies on<\/em><\/strong>:<\/p>\n<p style=\"padding-left: 30px;\">Risks will be mitigated if exposures are controlled by the use of appropriate PPE, <em>including a respirator with APF of 50<\/em>. \u00a0EPA expects that workers will use appropriate PPE <em>consistent with the SDS prepared by the PMN submitter<\/em>, in a manner adequate to protect them. (p. 5, emphases added)<\/p>\n<p>The <a href=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2019\/05\/SDS-CNTOP-Pigment-ink-Yellow.pdf\">associated SDS<\/a> makes only this reference to respiratory protection:<\/p>\n<p style=\"padding-left: 30px;\"><strong>Respiratory protection<\/strong> Mist respirator, include single use respirator<\/p>\n<p>Nowhere does the SDS specify use of a respirator with an APF of 50.\u00a0 The SDS is clearly not consistent with EPA\u2019s own description of it.<\/p>\n<p><strong><u>P-18-0212<\/u><\/strong>:\u00a0 Here is what the <a href=\"https:\/\/www.epa.gov\/reviewing-new-chemicals-under-toxic-substances-control-act-tsca\/tsca-section-5a3c-determination-134\">\u201cnot likely\u201d determination document for P-18-0212<\/a> states:<\/p>\n<p><strong><em>Risks to workers<\/em><\/strong>:\u00a0 Systemic effects via inhalation exposure; portal of entry\/contact effects to the eyes, lungs and skin following ocular, inhalation, and dermal exposures<\/p>\n<p><strong><em>PPE EPA relies on<\/em><\/strong>:<\/p>\n<p style=\"padding-left: 30px;\">The risks and hazards identified will be mitigated if exposures are controlled by the use of appropriate PPE, including impervious gloves, <em>respirators with an APF of at least 10<\/em>, and eye protection. \u00a0EPA expects that workers will use appropriate personal protective equipment (i.e., impervious gloves, <em>respirator with an APF of at least 10<\/em>, and eye protection),\u00a0<em>consistent with the Safety Data Sheet submitted with the PMN<\/em>, in a manner adequate to protect them. (p. 5, emphases added)<\/p>\n<p>The <a href=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2019\/05\/RESYDROL-AY-6838-US-SDSRevised.pdf\">associated SDS<\/a> makes this reference to respiratory protection:<\/p>\n<p style=\"padding-left: 30px;\"><strong>Respiratory Protection:\u00a0\u00a0<\/strong>For operations where inhalation exposure can occur use an approved respirator.\u00a0 Recommendations are listed below.\u00a0 Other protective respiratory equipment may be used based on user&#8217;s own risk assessment.\u00a0 Recommended respirators include those certified by NIOSH.<\/p>\n<p style=\"padding-left: 30px;\"><strong>Recommended:\u00a0\u00a0<\/strong>Full Face Mask with a combination particulate\/organic vapor cartridge.<\/p>\n<p>Nowhere does the SDS specify use of a respirator with an APF of 10.\u00a0 The SDS is clearly not consistent with EPA\u2019s own description of it.<\/p>\n<p><strong>Conclusion<\/strong><\/p>\n<p>In each of these cases, EPA identified a particular type of respirator as necessary for its finding that the chemical is not likely to present an unreasonable risk, and in each case, EPA asserted that the corresponding SDS specified that type of equipment.\u00a0 But in fact, in each case, the SDS does <em>not<\/em> specify that type of respirator.\u00a0 EPA\u2019s decisions run counter to the actual evidence before the agency, and EPA has actually mischaracterized that evidence.\u00a0 That amounts to arbitrary decision-making.\u00a0 Practically speaking, this mismatch means that workers could follow the SDS to a T and be using a respirator that is not sufficient to protect them against the chemical\u2019s identified risks.<\/p>\n<p><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\/\">As we have noted before<\/a>, EPA\u2019s reliance on SDS-recommended PPE flouts the law and falls vastly short of what TSCA requires EPA to do to protect workers.\u00a0 Amended TSCA requires EPA to issue binding orders to mitigate identified risks posed to workers by new chemicals, which it has identified in each of the cases we cite above.\u00a0 EPA\u2019s mere \u201cexpectation\u201d that PPE will universally be available, used and effective is wholly insufficient to address the identified risks.\u00a0 The recommendations in an SDS are not binding on employers, neither on manufacturers nor on other companies downstream in supply chains.\u00a0 Failure to always use PPE or for it always to be effective is clearly reasonably foreseeable, and EPA is required to mitigate risks from \u201creasonably foreseen conditions of use\u201d of a new chemical.\u00a0 PPE is the option of last resort under the longstanding Industrial Hygiene Hierarchy of Controls adopted by OSHA and embraced by the industrial hygiene community.\u00a0 Reliance on expected use of PPE shifts the burden of protection off of EPA and employers and onto the backs of workers.<\/p>\n<p>Now, we find that even the PPE EPA identifies as necessary to be in an SDS in order to determine that a new chemical is not likely to present an unreasonable risk is frequently absent from the SDS.\u00a0 Even under its own flawed theories, EPA is utterly failing to protect workers from the risks of these chemicals.<\/p>\n<p>How much farther under the bus will the Trump EPA throw American workers?<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Richard Denison, Ph.D.,\u00a0is a Lead Senior Scientist. Readers of this blog know how concerned EDF is over the Trump EPA\u2019s approval of many dozens of new chemicals based on its mere \u201cexpectation\u201d that workers across supply chains will always employ personal protective equipment (PPE) just because it is recommended in the manufacturer\u2019s non-binding safety data &#8230;<\/p>\n","protected":false},"author":100,"featured_media":8820,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[68,44,56093,56096,114108,77],"tags":[68,56108],"coauthors":[],"class_list":["post-8816","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-epa","category-policy","category-industry-influence","category-omboira","category-tsca","category-worker-safety","tag-epa","tag-new-chemicals"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/8816","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=8816"}],"version-history":[{"count":2,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/8816\/revisions"}],"predecessor-version":[{"id":13455,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/8816\/revisions\/13455"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media\/8820"}],"wp:attachment":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media?parent=8816"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/categories?post=8816"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/tags?post=8816"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/coauthors?post=8816"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}