{"id":12005,"date":"2023-11-03T15:31:53","date_gmt":"2023-11-03T20:31:53","guid":{"rendered":"https:\/\/blogs.edf.org\/health\/?p=12005"},"modified":"2023-12-21T10:37:51","modified_gmt":"2023-12-21T15:37:51","slug":"new-chemicals-rule-epa-must-require-more-info-from-industry","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2023\/11\/03\/new-chemicals-rule-epa-must-require-more-info-from-industry\/","title":{"rendered":"New Chemicals Rule: EPA must require more info from industry"},"content":{"rendered":"<p><em>By <\/em><a href=\"https:\/\/www.edf.org\/people\/maria-doa\"><em>Maria J. Doa<\/em><\/a><em>, PhD, Senior Director, Chemicals Policy, and Greg Schweer, Consultant<\/em><\/p>\n<p><strong>NOTE:<\/strong> This is the third in a series about EPA\u2019s regulation of new chemicals. See below under <strong>Go Deeper<\/strong> for links to other blogs in the series.<\/p>\n<h3><strong>What Happened?<\/strong><\/h3>\n<p>EPA recently<a href=\"https:\/\/www.regulations.gov\/document\/EPA-HQ-OPPT-2022-0902-0001\"> proposed regulations<\/a> to govern how it reviews companies\u2019 pre-manufacture notifications for new chemicals before those chemicals can go on the market.<\/p>\n<h3><strong>Why It Matters<\/strong><\/h3>\n<p>Industry often waits until late in the review process to submit information\u2014which means that EPA may spend a significant amount of time and effort to revise its risk assessments to incorporate the new information.<\/p>\n<p>EPA has a major opportunity to improve the New Chemicals Program as it crafts these revised regulations. Requiring industry to provide additional \u201cknown or reasonably ascertainable information\u201d <em>as required by the law<\/em> is an important component of this rule. This should reduce the amount of assessment \u201crework\u201d the agency currently conducts.<\/p>\n<p><!--more--><\/p>\n<h3><strong>Our Take<\/strong><\/h3>\n<p>EDF supports the aspects of EPA\u2019s proposal that clarify, strengthen, and expand on the information required in the initial industry submissions on potential uses, exposures, releases, etc. We also commend EPA for moving to increase efficiency by requiring a more robust submission at the <em>beginning<\/em> of the review process.<\/p>\n<p>The specific information EPA is proposing to require is information companies already have but generally don\u2019t include in their initial submissions. A company often submits this information only <em>after<\/em> EPA\u2019s review has identified a risk.<\/p>\n<p>While we support EPA\u2019s proposed requirement that industry submit more complete information, we noted in <a href=\"https:\/\/www.edf.org\/sites\/default\/files\/documents\/230808--EDF--New_Chemicals_Proposed_Rule_Comments_0.pdf\">our comments to EPA<\/a> [PDF, 721KB] that the proposal could go farther in implementing changes needed to ensure the safety of new chemicals and protect human health and the environment, including those people at greatest potential risk.<\/p>\n<p>We encourage EPA to strengthen these requirements further by adding additional information requirements to seven of the agency&#8217;s proposed changes:<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter\" src=\"https:\/\/www.edf.org\/sites\/default\/files\/2023-11\/New-Chemicals-recs_0.png\" alt=\"Image chart of EPA's proposed revisions of the New Chemical Rule, with EDF's recommended revisions and rationales for those recommendations. Screen-reader friendly version in downloadable PDF linked at end of the post.\" width=\"729\" height=\"912\" \/><\/p>\n<h3><strong>NOTES<\/strong><\/h3>\n<p><sup>1<\/sup> Organisation for Economic Co-operation and Development, Health and Safety Publications. (2017, May 17). <em>Internationally Harmonised Functional, Product and Article Use Categories<\/em>. Paris: OECD Environment, Series on Testing &amp; Assessment ENV\/JM\/MONO(2017)14, No. 262.<a href=\"https:\/\/one.oecd.org\/document\/ENV\/JM\/MONO(2017)14\/en\/pdf\">https:\/\/one.oecd.org\/document\/ENV\/JM\/MONO(2017)14\/en\/pdf<\/a><\/p>\n<p><sup>2<\/sup> Environmental Protection Agency, Office of Pollution Prevention and Toxics. (2018, June). <em>Points to Consider When Preparing TSCA New Chemical Notifications<\/em>.\u00a0 Washington, DC: OMB Control No.: 2070-0012. <a href=\"https:\/\/www.epa.gov\/sites\/default\/files\/2018-06\/documents\/points_to_consider_document_2018-06-19_resp_to_omb.pdf\">https:\/\/www.epa.gov\/sites\/default\/files\/2018-06\/documents\/points_to_consider_document_2018-06-19_resp_to_omb.pdf<\/a><\/p>\n<p><sup>3<\/sup> This information should be known or reasonably ascertainable and is similar to what EPA has long required for Toxics Release Inventory reporting.<\/p>\n<p><sup>4<\/sup> Although such information may be available to EPA from the Clean Water Act and Clean Air Act permit number(s) identified by the submitter, it would require extra effort on EPA\u2019s part to find that information and it may not be obvious from the permit.<\/p>\n<h3>Go Deeper<\/h3>\n<p><a href=\"https:\/\/blogs.edf.org\/health\/?s=New+Chemicals&amp;searchsubmit=Search&amp;source=direct+%28blogs.edf.org%29&amp;sub_source=%28blank%29&amp;custom_string16=blogs.edf.org%2Fhealth%2F&amp;custom_string17=blogs.edf.org%2Fhealth%2F\">Read our previous blogs on EPA&#8217;s New Chemicals program<\/a>.<\/p>\n<p>Follow these links to read the other blogs in the series:<\/p>\n<ul>\n<li>#1: <a href=\"https:\/\/blogs.edf.org\/health\/2023\/09\/20\/time-for-a-new-age-for-new-chemicals\/\">Time for a New Age for New Chemicals<\/a><\/li>\n<li>#2: <a href=\"https:\/\/blogs.edf.org\/health\/2023\/10\/10\/epa-nows-your-chance-to-get-foxes-out-of-the-henhouse\/\">EPA: Now\u2019s Your Chance to Get Foxes Out of the Henhouse<\/a><\/li>\n<li>#4: <u><a href=\"https:\/\/blogs.edf.org\/health\/2023\/11\/09\/epas-new-chemical-regulations-industry-bias-must-be-fixed\/\">EPA\u2019s New Chemical Regulations: Industry Bias Must Be Fixed<\/a><\/u><\/li>\n<li>#5: <a href=\"https:\/\/edforg.sharepoint.com\/sites\/SaferChemicals\/Shared%20Documents\/Media_and_Communications\/00--General_communications\/Newsletter\/2023--12--Newsletter\/EPA\u2019s%20New%20Chemical%20Regulations:%20Backtracking%20on%20PBTs\">EPA\u2019s New Chemical Regulations: Backtracking on PBTs<\/a><\/li>\n<li>#6: <a href=\"https:\/\/blogs.edf.org\/health\/2023\/12\/21\/epas-new-chemical-review-process-a-thought-experiment\/\">EPA\u2019s New Chemical Review Process: A Thought Experiment<\/a><\/li>\n<\/ul>\n<p><strong><a href=\"https:\/\/www.edf.org\/sites\/default\/files\/2023-11\/2023-11-03--EDF_Health_blog--New_Chemicals_recommendations.pdf\">Download a PDF of this blog post<\/a>. <\/strong>(PDF, 256KB)<\/p>\n","protected":false},"excerpt":{"rendered":"<p>By Maria J. Doa, PhD, Senior Director, Chemicals Policy, and Greg Schweer, Consultant NOTE: This is the third in a series about EPA\u2019s regulation of new chemicals. See below under Go Deeper for links to other blogs in the series. What Happened? EPA recently proposed regulations to govern how it reviews companies\u2019 pre-manufacture notifications for &#8230;<\/p>\n","protected":false},"author":1,"featured_media":12105,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[114078,56093,114076],"tags":[68,5021,56108,5017],"coauthors":[114087],"class_list":["post-12005","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-chemical-regulation","category-industry-influence","category-risk-assessment","tag-epa","tag-chemical-industry-tactics","tag-new-chemicals","tag-risk-assessment"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/12005","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\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/comments?post=12005"}],"version-history":[{"count":1,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/12005\/revisions"}],"predecessor-version":[{"id":13419,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/12005\/revisions\/13419"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media\/12105"}],"wp:attachment":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media?parent=12005"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/categories?post=12005"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/tags?post=12005"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/coauthors?post=12005"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}