{"id":573,"date":"2010-05-09T22:31:51","date_gmt":"2010-05-10T03:31:51","guid":{"rendered":"http:\/\/blogs.edf.org\/nanotechnology\/?p=573"},"modified":"2024-02-12T11:00:56","modified_gmt":"2024-02-12T16:00:56","slug":"raising-the-bar-for-chemical-safety-will-spur-not-stifle-innovation","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2010\/05\/09\/raising-the-bar-for-chemical-safety-will-spur-not-stifle-innovation\/","title":{"rendered":"Raising the bar for chemical safety will spur, not stifle, innovation"},"content":{"rendered":"<p><em>Richard Denison, Ph.D., is a Senior Scientist.<\/em><\/p>\n<p>An emerging chemical industry talking point in TSCA reform is the claim that imposing new requirements on new chemicals will somehow stifle innovation.\u00a0 The milder manifestation of this perspective emanates from those who oppose requiring a safety determination for new chemicals unless they raise major red flags in an initial review.<\/p>\n<p>But some in the industry go further, arguing that even requiring safety data for new chemicals would put the big chill on development of new chemicals.<\/p>\n<p>I beg to differ with both arguments.\u00a0 This post will make the opposite case, and will also argue that true innovation embraces rather than shuns safety, and demands the information needed to demonstrate it.<!--more--><\/p>\n<p><strong>Doesn\u2019t safe mean \u2026 uh, safe?<\/strong><\/p>\n<p>The chemical industry has fought hard for a provision in TSCA reform legislation that would allow new chemicals onto the market without first having to undergo a safety determination. \u00a0That approach has crept into the <em><a href=\"http:\/\/lautenberg.senate.gov\/assets\/SCA2010.pdf\">Safe Chemicals Act of 2010<\/a><\/em>: \u00a0The new TSCA section 5(a)(1)(B)(ii) would allow a new chemical to enter the market and remain there for an indeterminate length of time, as long as EPA finds that it does not and is not expected to flag any of several criteria.<\/p>\n<p>These criteria include:<\/p>\n<ul>\n<li>high-volume production or environmental release;<\/li>\n<li>evidence that the chemical does or may possess certain toxicity;<\/li>\n<li>evidence that the chemical is both persistent and bioaccumulative; and<\/li>\n<li>detection of the chemical in biomonitoring or in food, drinking water, air, soil or house dust.<\/li>\n<\/ul>\n<p>Some of those criteria may sound reasonably tough, but applying them to new chemicals would be problematic: \u00a0A new chemical would not <em>yet<\/em> be in production and use, so obviously it wouldn\u2019t <em>yet<\/em> be present in people or the environment. EPA would have to project whether it would <em>later<\/em> be found there.\u00a0 I wish I had more confidence in our track record of predicting chemical exposures, but frankly, <a href=\"http:\/\/blogs.edf.org\/nanotechnology\/2009\/11\/11\/over-exposed-why-relying-on-exposure-to-prioritize-chemicals-is-dangerous\/\">it\u2019s pretty dismal<\/a>.<\/p>\n<p>As for toxicity, while the list of types of toxicity in the provision is pretty impressive, the question is whether the minimum data to be required for a new chemical will be sufficient to determine whether it has any of them (more on minimum data requirements in a moment).<\/p>\n<p><strong>A barefaced double standard<\/strong><\/p>\n<p>Ironically, this provision would do \u2013 but in reverse \u2013 exactly what the industry has gone apoplectic over in other contexts.\u00a0 It would decide what to do about a chemical based solely on its <em>hazard<\/em> or <em>exposure<\/em>, rather than by assessing its <em>risk<\/em>.<\/p>\n<p>The chemical industry staunchly opposes ever identifying \u201cbad\u201d chemicals via a solely hazard-based approach.\u00a0 And it never utters the word \u201cbiomonitoring\u201d without hastening to add, usually in the same sentence, that mere detection of a chemical in people says absolutely nothing about its risk.<\/p>\n<p>Yet here the industry is merrily endorsing giving a new chemical a free pass based solely on whether or not it meets certain decidedly non-risk-based criteria.<\/p>\n<p>Last time I recall, the <a href=\"http:\/\/www.americanchemistry.com\/s_acc\/sec_article_acc.asp?CID=2178&amp;DID=9939\">American Chemistry Council\u2019s first principle<\/a> for modernizing TSCA read as follows:\u00a0 \u201cChemicals should be safe for their intended use.\u201d\u00a0 Just checked again, and yes, it still reads that way.<\/p>\n<p>So why is the industry so willing to let new chemicals slip onto the market without a safety determination?\u00a0 I smell a double standard.<\/p>\n<p><strong>No data, no problem?<\/strong><\/p>\n<p>There is one small silver lining to the troubling provision noted above:\u00a0 It would at least require that the decision as to whether a new chemical meets the red-flag criteria be based on a minimum data set.<\/p>\n<p>The more extreme manifestation of the stifling-of-innovation argument says that even that requirement will cause the ever-churning wheels of new chemicals development to grind to a screeching halt.<\/p>\n<p>Perhaps the most vocal proponent of this viewpoint has been Charlie Auer, former Director of EPA\u2019s Office of Pollution Prevention and Toxics (OPPT), and now a chemical industry consultant.\u00a0 I heard this argument from Mr. Auer firsthand at a recent conference in DC, which was reported in the April 19, 2010 issue of the <em><a href=\"http:\/\/www.bna.com\/products\/ens\/bder.htm\">Daily Environment Report<\/a><\/em> (page A-11, subscription required).<\/p>\n<p>He points to the draft legislation\u2019s requirement for a minimum data set for new chemicals as evidence of a \u201cstrong bias\u201d against new chemicals.\u00a0 He says that imposing such a requirement would create a disincentive for companies to develop new chemicals, which he argues are safer than older chemicals as a rule.\u00a0 Finally, he points to experience in Europe, where far fewer new chemicals entered the market over the last few decades than in the U.S., as supporting his case.\u00a0 Let\u2019s take each of these lines of argument in turn.<\/p>\n<p><strong>Unlevel playing field?<\/strong><\/p>\n<p>The first argument maintains that there\u2019s an unlevel playing field, because new chemicals would have to provide their minimum data set before they could get on the market, whereas existing chemicals would be given some time to do so.<\/p>\n<p>During this transition, there would indeed be a tilt.\u00a0 That\u2019s a direct consequence of the fact that TSCA grandfathered in some 62,000 chemicals without requiring any safety testing.\u00a0 That\u2019s a deep hole, one that can\u2019t be climbed out of overnight.<\/p>\n<p>Auer points to a provision of the Senate bill that would allow makers of existing chemicals up to 14 years to provide their data.\u00a0 But it\u2019s the chemical industry, not those of us who think new chemicals need safety data, that successfully lobbied for that provision in the Senate bill.<\/p>\n<p>As <a href=\"http:\/\/blogs.edf.org\/nanotechnology\/2010\/04\/21\/a-minimum-data-set-why-what-how-much-and-when\/\">I noted in a recent post<\/a>, we want as short a transition as possible, and prefer the <a href=\"http:\/\/energycommerce.house.gov\/index.php?option=com_content&amp;view=article&amp;id=1956:chairmen-rush-waxman-release-discussion-draft-of-the-toxic-chemicals-safety-act&amp;catid=122:media-advisories&amp;Itemid=55\">House discussion draft<\/a>\u2019s version of this provision (see section 4(a)(2)).\u00a0 That version would require data sets on existing chemicals within either 18 months of priority listing or five years of enactment \u2013 <em>whichever comes first<\/em>.<\/p>\n<p>Of course, even if one accepts this line of argument, the status quo is even more tilted against new chemicals.\u00a0 Under current TSCA, new chemicals are subject to premanufacture notices, while existing chemicals have none.\u00a0 New chemicals are subject to EPA review, while existing chemicals have none.\u00a0 EPA can (and occasionally does) require testing of new chemicals through consent orders, while it virtually never requires testing of existing chemicals.<\/p>\n<p><em>The solution to this problem is to expedite the requirement for minimum data for existing chemicals \u2013 <span style=\"text-decoration: underline\">not<\/span> to do away with the requirement for safety data for new chemicals!<\/em><\/p>\n<p><strong>Should we presume new chemicals are safer?<\/strong><\/p>\n<p>Mr. Auer also claims new chemicals are safer as a rule, so we should readily allow them onto the market.\u00a0 I suppose the rationale is that they will somehow thereby supplant the older chemicals, improving the \u201caverage\u201d safety of chemicals on the market over time.<\/p>\n<p>Should we assume new chemicals are <em>a priori<\/em> safer?\u00a0 One very recent cautionary example ought to begin to dispel the wisdom of such a presumption: Multi-walled carbon nanotubes (MWCNTs).\u00a0 These new marvels hold all kinds of promise in applications ranging from stronger composites to superconductive materials to photodetection.\u00a0 It so happens <a href=\"http:\/\/en.wikipedia.org\/wiki\/Carbon_nanotube#Toxicity\">they are quite toxic<\/a>:\u00a0 The are potent inducers of lung inflammation and fibrotic responses, and also seem to have a great deal in common with asbestos fibers, having been shown capable of crossing from the lung into the surrounding tissue and there inducing mesothelioma-like symptoms.<\/p>\n<p>More generally, while the results of EPA\u2019s new chemical reviews are held as top secret information, <a href=\"http:\/\/ec.europa.eu\/environment\/chemicals\/reach\/background\/docs\/eia-sec-2003_1171.pdf\">the European Union reports<\/a> that its review of new chemicals over the years before REACH found that about 70% of them possessed at least one dangerous property (page 27).<\/p>\n<p>There\u2019s no reason to presume that new chemicals are less safe than existing ones, <em>but the only way we\u2019ll know is to require data sufficient to determine their safety<\/em>.<\/p>\n<p>And even if one believes a new chemical poses less risk at least initially because it isn\u2019t used widely at the outset, the risk to workers making and handling it is present from day one.\u00a0 Safety data are essential to ensuring their protection.<\/p>\n<p><strong>More lessons from abroad<\/strong><\/p>\n<p>Finally, Mr. Auer points to the much lower rate of introduction of new chemicals in Europe than in the U.S. as evidence of the chilling effect of data requirements.<\/p>\n<p>It\u2019s true that only about 4,000 new chemicals entered the market in EU during the same time that nearly 20,000 new chemicals did so in the U.S.\u00a0 Mr. Auer argues that\u2019s because the EU (even before REACH) had the audacity to require some actual data for new chemicals as a condition for their entering the market.<\/p>\n<p>First, lest you think those tree-hugging Europeans are somehow uniquely anti-new chemical, the U.S. is virtually alone in the developed world in <em>not<\/em> requiring an up-front minimum data set to inform government\u2019s evaluation of new chemical safety; the <a href=\"http:\/\/ec.europa.eu\/environment\/chemicals\/reach\/reach_intro.htm\">EU does<\/a>, of course, and <a href=\"http:\/\/canadagazette.gc.ca\/archives\/p2\/2005\/2005-09-21\/html\/sor-dors247-eng.html\">Canada does<\/a>, and <a href=\"http:\/\/www.ilo.org\/safework_bookshelf\/english?content&amp;nd=857170404\">Japan does<\/a>.<\/p>\n<p>I\u2019ve noted in <a href=\"http:\/\/blogs.edf.org\/nanotechnology\/2009\/04\/16\/epas-new-chemicals-program-tsca-dealt-epa-a-very-poor-hand\/\">an earlier post<\/a> that TSCA <em>prohibits<\/em> EPA from requiring a minimum data set for new chemicals.\u00a0 As a result, 85% of the premanufacturing notices EPA reviews contain no health data, and 95% contain no ecotoxicity data.<\/p>\n<p>But more to the point, the differential rate of new chemical introduction in the U.S. versus the EU and its perceived implications for innovation was in fact a major motivation for the development of REACH; see <a href=\"http:\/\/eur-lex.europa.eu\/LexUriServ\/LexUriServ.do?uri=COM:2001:0088:FIN:EN:PDF\">White Paper, especially pp. 5, 8, 11-12 and 32<\/a>.<\/p>\n<p>And how did the EU go about leveling the playing field under REACH?\u00a0 Did it gut the data requirements for new chemicals?\u00a0 No; it raised the bar for existing chemicals, phasing in requirements over time that will require makers of all chemicals, whether new or existing, to provide data sufficient to demonstrate their safety.<\/p>\n<p><strong>Playing the China card<\/strong><\/p>\n<p>Unfortunately, there is a rather stale last stanza that\u2019s been added recently to the industry\u2019s song about innovation, a variation on an old theme:\u00a0 If you over-regulate us, you\u2019ll just push the industry overseas.<\/p>\n<p>In this case, it plays to the broader tune of the China blues:\u00a0 Innovation will still happen, the lyrics go, it\u2019ll just happen in China.<\/p>\n<p>First, it must be said that this refrain is rather hard to listen to, coming as it does from an industry that is already moving production overseas as fast as it can, and for reasons that have nothing to do with the environment or regulation.<\/p>\n<p>But it\u2019s also tone-deaf:\u00a0 It ignores the fact that the industry\u2019s own customers, more than anyone else, are demanding more and better information about the chemicals they buy, more, not less, evidence of their safety.<\/p>\n<p>Finally, it ignores the fact that the rest of the world is moving ahead faster than we are to address chemical safety.\u00a0 That includes even China, which <a href=\"http:\/\/www.edf.org\/documents\/9295_Denison_testimony_Toxics_Act.pdf\">bars domestic use of formaldehyde-laced plywood<\/a> that we allow to be imported, which has reportedly translated the REACH regulation into half a dozen dialects, and <a href=\"http:\/\/www.rsc.org\/chemistryworld\/News\/2010\/April\/01041001.asp\">which is modernizing its own laws along the lines of REACH<\/a>.<\/p>\n<p><strong>Innovation, yes, but to what end?<\/strong><\/p>\n<p>In my view, one of the most egregious failings of TSCA has been its failure to incentivize innovation toward safer chemicals and products.\u00a0 Instead, it has perpetuated a chemicals industry that has little incentive <em>either<\/em> to replace existing chemicals \u2013 because they skate along without any scrutiny at all \u2013 or to ensure that new chemicals it does introduce are safe (or at least safer than the existing chemicals with which they will compete) \u2013 because the review they get is so cursory (data- and time-constrained) that it would catch and be able to stop only the most dangerous substances.<\/p>\n<p>I support provisions in the <em>Safe Chemicals Act of 2010<\/em> that would:<\/p>\n<ul>\n<li>provide an easier path onto the market for new chemicals the makers of which demonstrate their new chemicals are safer than other chemicals for the uses for which they are intended (see section 32 of the Act); and<\/li>\n<li>allow critical or essential use exemptions even for chemicals (whether new or existing) that fail the safety standard, where they fulfill vital purposes for which alternatives do not exist \u00a0or can be shown to provide a net health or environmental benefit compared to the alternatives (see section 6(e)(2)).<\/li>\n<\/ul>\n<p>Both of those provisions encourage the development of innovative new chemicals that are either demonstrably safer or meet an essential need.<\/p>\n<p>Can anyone seriously think that any sort of desirable innovation can happen without ensuring safety? \u00a0Safety ought to be at the core of innovation, rather than being seen as an impediment or afterthought.\u00a0 And in this, regulation can help rather than hurt.<\/p>\n<p>As the EU\u2019s White Paper made clear, stronger regulation through REACH was seen as vital not only to protecting health and the environment, but to shoring up the competitiveness of the EU\u2019s chemical industry (the world\u2019s largest), and putting it on a more sustainable footing.\u00a0 And smart companies made the connection.\u00a0 As REACH took effect in 2008, a DuPont spokesperson was quoted saying:<\/p>\n<p style=\"padding-left: 30px\">We are implementing REACH as a global program across DuPont, and the impact of REACH will be varied and widespread. <strong><em>We see it as potential to drive market innovation<\/em><\/strong><em>.<\/em> There are chemicals that may be restricted under REACH, and it&#8217;ll provide the opportunity for a science company like DuPont to develop replacement products to satisfy market needs. (emphasis added, <em>Greenwire<\/em>, 6\/23\/08)<\/p>\n<p>But the chemical industry\u2019s proposal \u2013 to allow new chemicals to enter commerce without being demonstrated to be safe, or in the more ominous version, without provision of even basic safety data \u2013 would do nothing more than compromise public health in the name of innovation.<\/p>\n<p>That notion of innovation rings hollow and confuses the means with the end.\u00a0 It is one we are better off without.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Richard Denison, Ph.D., is a Senior Scientist. An emerging chemical industry talking point in TSCA reform is the claim that imposing new requirements on new chemicals will somehow stifle innovation.\u00a0 The milder manifestation of this perspective emanates from those who oppose requiring a safety determination for new chemicals unless they raise major red flags in &#8230;<\/p>\n","protected":false},"author":100,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[44,56096,114108],"tags":[39168,641,39211,824,39153,39201,39171,39151,5021,39190,39173,39156,39595],"coauthors":[],"class_list":["post-573","post","type-post","status-publish","format-standard","hentry","category-policy","category-omboira","category-tsca","tag-biomonitoring","tag-canada","tag-carbon-nanotubes","tag-china","tag-data-requirements","tag-dupont","tag-exposure-vs-hazard","tag-high-production-volume-hpv","tag-chemical-industry-tactics","tag-japan","tag-office-of-pollution-prevention-and-toxics-oppt","tag-persistant-bioaccumulative-and-toxic-pbt","tag-safe-chemicals-acts"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/573","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=573"}],"version-history":[{"count":1,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/573\/revisions"}],"predecessor-version":[{"id":12573,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/573\/revisions\/12573"}],"wp:attachment":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media?parent=573"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/categories?post=573"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/tags?post=573"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/coauthors?post=573"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}