{"id":4382,"date":"2015-05-20T07:56:16","date_gmt":"2015-05-20T12:56:16","guid":{"rendered":"http:\/\/blogs.edf.org\/health\/?p=4382"},"modified":"2024-02-12T11:01:43","modified_gmt":"2024-02-12T16:01:43","slug":"tsca-reform-legislation-consideration-of-costs-and-other-non-risk-factors","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2015\/05\/20\/tsca-reform-legislation-consideration-of-costs-and-other-non-risk-factors\/","title":{"rendered":"TSCA reform legislation: Consideration of costs and other non-risk factors"},"content":{"rendered":"<p><em>Richard Denison, Ph.D.,\u00a0<\/em>is a Lead Senior Scientist<em>.<\/em><\/p>\n<p><a href=\"https:\/\/blogs.edf.org\/health\/2015\/04\/15\/tsca-reform-legislation-enhancing-epa-testing-authority\/\">Part 1<\/a>\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 <a href=\"https:\/\/blogs.edf.org\/health\/2015\/04\/16\/tsca-reform-legislation-epa-review-of-new-chemicals\/\">Part 2<\/a>\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 <a href=\"https:\/\/blogs.edf.org\/health\/2015\/04\/20\/tsca-reform-legislation-how-chemicals-are-selected-for-safety-evaluations\/\">Part 3<\/a>\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 <a href=\"https:\/\/blogs.edf.org\/health\/2015\/04\/23\/tsca-reform-legislation-confidential-business-information\/\">Part 4<\/a>\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Part 5<\/p>\n<p><em>[NOTES: \u00a0<\/em><em>(1) This post reflects the latest versions of TSCA reform legislation:<\/em><\/p>\n<ul>\n<li><a href=\"http:\/\/www.tomudall.senate.gov\/?p=press_release&amp;id=1943\"><em>the revised version of the Lautenberg Act<\/em><\/a><em> passed by the Senate Environment and Public Works Committee on April 28, 2015; and <\/em><\/li>\n<li><a href=\"http:\/\/energycommerce.house.gov\/markup\/markup-tsca-modernization-act\"><em>the revised version of the TSCA Modernization Act of 2015<\/em><\/a><em> [UDPATE 5-28-15: <span style=\"text-decoration: line-through\">passed by the House Subcommittee on Environment and the Economy on May 14, 2015 <\/span>introduced as <a href=\"https:\/\/www.congress.gov\/bill\/114th-congress\/house-bill\/2576\">H.R. 2576<\/a> on May 26, 2015].<\/em><\/li>\n<\/ul>\n<p><em>(2) All of the earlier posts in this series have been updated to reflect these latest versions.]<\/em><\/p>\n<p>This is the fifth in a series of blog posts looking at less talked-about, but critically important, elements of bipartisan legislative proposals to reform the Toxic Substances Control Act (TSCA).\u00a0 This post deals with how costs and other non-risk considerations factor into safety and regulatory risk management decisions. \u00a0<!--more--><\/p>\n<p><strong>The safety standard<\/strong><\/p>\n<p>Under <strong><em>current TSCA<\/em><\/strong>, EPA\u2019s determination of whether or not a chemical presents an \u201cunreasonable risk\u201d requires the agency to formally balance consideration of costs and other non-risk factors against the potential danger to human health or the environment.<\/p>\n<p><a href=\"https:\/\/www.congress.gov\/bill\/114th-congress\/senate-bill\/697\"><em><strong>The Lautenberg Act<\/strong><\/em><\/a>\u00a0retains the term \u201cunreasonable risk\u201d as its safety standard but, in defining the standard, explicitly precludes EPA from considering costs and other non-risk factors in making safety determinations.\u00a0 This same exclusion of costs and other non-risk factors is made in each relevant provision throughout TSCA where the term \u201cunreasonable risk\u201d is used, to make clear that EPA\u2019s decisions as to the safety of chemicals are based solely on considerations of risks to human health and the environment.<\/p>\n<p><a href=\"http:\/\/energycommerce.house.gov\/markup\/markup-tsca-modernization-act\"><strong><em>The TSCA Modernization Act of 2015<\/em><\/strong><\/a> <em>[UPDATE 5-28-15:\u00a0 <\/em><em><a href=\"https:\/\/www.congress.gov\/bill\/114th-congress\/house-bill\/2576\">H.R. 2576<\/a>] <\/em>also retains the term \u201cunreasonable risk\u201d as its safety standard, but does not define the safety standard. \u00a0The bill clarifies that <em>[UPDATE 5-28-15:\u00a0 in conducting a risk evaluation, EPA \u201cshall not include information on cost and other factors not directly related to health or the environment;\u201d and that]<\/em> \u201c[t]he Administrator shall not consider costs or other non-risk factors when deciding whether to initiate a rulemaking under subsection (a).\u201d\u00a0 The bill does not explicitly state, however, whether the determination of \u201cunreasonable risk\u201d is to be based solely on risks to human health or the environment.<\/p>\n<p>The House bill, like the earlier drafts, includes the requirement that EPA show a chemical \u201cmay present an unreasonable risk\u201d in order to initiate a risk evaluation of the chemical.\u00a0 While the bill\u00a0has been modified to indicate the finding can be made \u201cbecause of potential hazard and a potential route of exposure under the intended conditions of use,\u201d the language still requires EPA to make a risk finding in advance of and as a condition for initiating a risk evaluation, a potential <em>Catch-22<\/em>.<\/p>\n<p><strong>Regulatory requirements<\/strong><\/p>\n<p>Under <strong><em>current TSCA<\/em><\/strong>, EPA is required to conduct a formal analysis of costs and benefits of any proposed restriction of a chemical, and to show that the benefits of the restriction outweigh its costs. It also must demonstrate that any restrictions it chooses to impose are the \u201cleast burdensome\u201d among those able to address the identified risks, a showing that in practice has proven excessively onerous. These requirements have proven to be fatal flaws in TSCA, imposing evidentiary and analytic burdens on EPA so severe that it could not meet them even for the deadly human carcinogen asbestos.<\/p>\n<p><strong><em>The Lautenberg Act<\/em><\/strong> strikes the \u201cleast burdensome\u201d language and clarifies that a balancing test for costs and benefits is not required.\u00a0 It goes further to make clear that cost considerations cannot override the requirement that restrictions be sufficient to ensure chemical safety:\u00a0 Where a chemical does not meet the safety standard, EPA \u201cshall promulgate a rule establishing restrictions necessary to ensure that the chemical substance meets the safety standard.\u201d<\/p>\n<p>In deciding what restrictions to impose on a chemical found not to meet the safety standard, EPA is to consider \u201cto the extent practicable based on reasonably available information, quantifiable and nonquantifiable costs and benefits of the proposed regulatory action and of the 1 or more primary alternative regulatory actions considered by the Administrator.\u201d \u00a0EPA is also to review alternatives to the chemical it deems relevant and technically and economically feasible.<\/p>\n<p>In the case of a ban or phase-out, in deciding whether any exemptions should be allowed EPA must also consider \u201cto the extent practicable based on reasonably available information, the quantifiable and nonquantifiable costs and benefits of the 1 or more technically and economically feasible alternatives to the chemical substance most likely to be used in place of the chemical substance under the conditions of use if the rule is promulgated.\u201d<\/p>\n<p><strong><em>The TSCA Modernization Act of 2015<\/em><\/strong> <em>[UPDATE 5-28-15:\u00a0 <a href=\"https:\/\/www.congress.gov\/bill\/114th-congress\/house-bill\/2576\">H.R. 2576<\/a>] <\/em>also strikes the \u201cleast burdensome\u201d language of current TSCA. \u00a0Where EPA determines a chemical presents an unreasonable risk, it is to impose requirements \u201cto the extent necessary <em>[UPDATE 5-28-15:\u00a0 so that the chemical substance no longer presents or will present an unreasonable risk, including an identified unreasonable risk to a potentially exposed subpopulation<span style=\"text-decoration: line-through\">to protect adequately against such risk<\/span>.\u201d]<\/em>\u00a0 In deciding what restrictions to impose, EPA must consider the \u201creasonably ascertainable economic consequences of the rule, including the likely effect of the rule on the national economy, small business, technological innovation, the environment, and public health.\u201d This broad language would place substantial evidentiary and analytic burdens on the EPA in order to regulate a chemical.<\/p>\n<p>The House bill also adds to these two mandatory cost-related evidentiary and analytic requirements not in current TSCA:<\/p>\n<ul>\n<li>EPA must show that any requirements it imposes on a chemical are \u201ccost-effective, except where the Administrator determines that <em>[UPDATE 5-28-15:\u00a0 additional or different requirements &#8230; are necessary<span style=\"text-decoration: line-through\">it is not practicable to protect against the identified risk using cost-effective requirements<\/span>.\u201d]<\/em><\/li>\n<li>In deciding whether to impose a ban or effective ban on specific uses of a chemical, and in setting compliance dates, EPA must \u201cdetermine whether technically and economically feasible alternatives that benefit health or the environment, compared to the use so proposed to be prohibited or restricted, will be reasonably available as a substitute when the proposed prohibition or restriction takes effect.\u201d<\/li>\n<\/ul>\n<p>While the latter of these two requirements does not expressly preclude EPA from banning a use of a chemical if a safer, viable alternative is not available, it comes close, raising concerns similar to those <a href=\"https:\/\/blogs.edf.org\/health\/2014\/03\/04\/house-tsca-reform-discussion-draft-major-problem-1\/\">I raised about a House discussion draft introduced in the last Congress<\/a>.<\/p>\n<p>Collectively, these requirements that must be met for EPA to regulate a chemical would appear to place burdens on EPA comparable to the requirement under current TSCA (struck in the draft) that EPA demonstrate its regulation imposes the \u201cleast burdensome requirements.\u201d<\/p>\n<p><strong>Relationship to other Federal laws<\/strong><\/p>\n<p>Under <strong><em>current TSCA<\/em><\/strong> (Section 9), EPA must consider whether any risks it identifies could be addressed either by another federal agency or by EPA acting under another statute.\u00a0 Various procedures must be followed where EPA so determines.<\/p>\n<p><strong><em>The Lautenberg Act<\/em><\/strong> retains these requirements of current TSCA.<\/p>\n<p><strong><em>The TSCA Modernization Act of 2015<\/em><\/strong>\u00a0<em>[UDPATE 5-28-15: \u00a0<a href=\"https:\/\/www.congress.gov\/bill\/114th-congress\/house-bill\/2576\">H.R. 2576<\/a>] <\/em>retains these requirements but adds a new cost-related requirement that EPA would have to meet before taking any regulatory action under TSCA instead of another law EPA administers:\u00a0 \u201c[T]he Administrator shall compare the relative risks, estimated costs, and efficiencies of the action to be taken under this title and an action to be taken under such other law to protect against such risk.\u201d<\/p>\n<p>This new set of analytic and evidentiary requirements is in addition to TSCA\u2019s existing requirement that EPA show that acting under TSCA is \u201cin the public interest\u201d (which currently is determined at the Administrator\u2019s discretion).<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Richard Denison, Ph.D.,\u00a0is a Lead Senior Scientist. Part 1\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Part 2\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Part 3\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Part 4\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Part 5 [NOTES: \u00a0(1) This post reflects the latest versions of TSCA reform legislation: the revised version of the Lautenberg Act passed by the Senate Environment and Public Works Committee on April 28, 2015; and the revised version of the &#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":[68,56107,56109],"coauthors":[],"class_list":["post-4382","post","type-post","status-publish","format-standard","hentry","category-policy","category-omboira","category-tsca","tag-epa","tag-lautenberg-act","tag-tsca-modernization-act"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/4382","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=4382"}],"version-history":[{"count":1,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/4382\/revisions"}],"predecessor-version":[{"id":12740,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/4382\/revisions\/12740"}],"wp:attachment":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media?parent=4382"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/categories?post=4382"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/tags?post=4382"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/coauthors?post=4382"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}