{"id":9313,"date":"2019-12-16T14:14:32","date_gmt":"2019-12-16T19:14:32","guid":{"rendered":"http:\/\/blogs.edf.org\/health\/?p=9313"},"modified":"2024-02-12T11:02:24","modified_gmt":"2024-02-12T16:02:24","slug":"more-words-minced-this-time-but-epas-science-advisors-raise-serious-concerns-with-its-draft-risk-evaluation-of-1-bromopropane","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2019\/12\/16\/more-words-minced-this-time-but-epas-science-advisors-raise-serious-concerns-with-its-draft-risk-evaluation-of-1-bromopropane\/","title":{"rendered":"More words minced this time, but EPA\u2019s science advisors raise serious concerns with its draft risk evaluation of 1-bromopropane"},"content":{"rendered":"

Richard Denison, Ph.D.,\u00a0<\/em>is a Lead Senior Scientist.<\/p>\n

The peer review report by the Scientific Advisory Committee on Chemicals (SACC) on EPA\u2019s draft risk evaluation of 1-bromopropane (1-BP) has been released<\/a>.\u00a0 This carcinogenic solvent is one of the first 10 chemicals undergoing risk evaluation under the amended Toxic Substances Control Act (TSCA), and the new SACC report covers the fourth of EPA\u2019s draft risk evaluations (DREs) to be peer-reviewed.\u00a0 We\u2019ve blogged earlier about the SACC\u2019s reports on EPA\u2019s draft risk evaluations for 1,4-dioxane and HBCD<\/a> and Pigment Violet 29<\/a>.<\/p>\n

At first blush, the new report reads less harshly than the last one, and the SACC notes clear improvements in the content and organization of the 1-BP draft over earlier ones.\u00a0 But even the Executive Summary raises quite scathing criticisms that go to the heart of whether EPA has developed sufficient data to support its risk determinations for this chemical.\u00a0 Here is a telling excerpt (p. 17, emphases added):<\/p>\n

Overall, the Committee concurred that even though data provided in the DRE underestimated risk<\/em>, these data did support the finding of unreasonable risk to consumers and occupational conditions, including occupational non-users<\/em>. Conversely, inadequate data were presented<\/em> for a robust risk characterization for the environmental assessment, and the information provided did not support the conclusion of \u201cno unreasonable risk to the environment.\u201d<\/em><\/p>\n

These conclusions mirror those drawn by EDF<\/a> in the comments we submitted to EPA on the 1-BP DRE.<\/p>\n

Themes sounded by the SACC in its earlier peer reviews came up again here.\u00a0 <\/p>\n

Exclusion of exposures from environmental releases<\/u>:\u00a0 With regard to EPA\u2019s wholesale exclusion of exposures to the general population from 1-BP\u2019s releases to air, water, and land, the SACC had this to say (p. 17, emphases added):<\/p>\n

The lack of consideration for general population exposures excludes a vast extent of the US population (workers, consumers, school children, and other populations) who are exposed to 1-BP, perhaps on a daily basis<\/em>. The lack of consideration of the general population exposure is concerning given the strong evidence of widespread exposure to a chemical that may be 1-BP based (from biomonitoring data). Many of these problems stemmed from a reduction in the Scope of this assessment during the time since the 2016 Draft Problem Formulation. Many members of the Committee found this reduction in scope troubling.<\/em><\/p>\n

Unwarranted assumptions underestimating risk to workers<\/u>:\u00a0 EPA\u2019s assumption of universal, effective use of personal protective equipment (PPE) by workers as a basis to ignore the risks workers face was again heavily criticized by the SACC:\u00a0 \u201c[T]he assumption that Personal Protective Equipment (PPE) would be used consistently and by all workers is overly optimistic and the draft risk evaluation provided no data to support these assumptions\u201d (p. 16).<\/p>\n

The SACC particularly took EPA to task for its failure to consider the combined exposures to the same individuals, which EPA only considered in isolation from each other.\u00a0 Said the SACC:\u00a0 \u201c[A] worker who is occupationally exposed may also be exposed through other conditions of use in the home. Yet, these exposures are decoupled in the draft risk evaluation\u201d (p. 16).\u00a0 And, in a case of being about as nice as it could possibly be, the SACC noted that \u201cinclusion of an estimate of combined oral and dermal exposure would be welcome\u201d (p. 14).<\/p>\n

Inadequate evaluation of risks to vulnerable subpopulations<\/u>:\u00a0 The SACC notes that \u201cconsideration of potentially exposed or susceptible subpopulations (PESS) under TSCA is new and challenging\u201d but makes clear that it \u201cconsiders the approach in this draft risk evaluation to be inadequate to address PESS risk\u201d (p. 15).<\/p>\n

Omission of key hazards and risks<\/u>:\u00a0 The SACC flagged EPA\u2019s omission of any consideration of neurotoxicity and immunotoxicity, indicating EPA had not provided sufficient justification for excluding these human health endpoints (p. 15).\u00a0 Likewise, the SACC flagged EPA\u2019s failure to consider cancer risks from short term exposures (p. 15).<\/p>\n

The SACC also noted the \u201cpaucity of data for the environmental assessment\u201d (p. 16), including no data on reproductive or developmental toxicity, and recommended EPA at a minimum include additional uncertainty factors.<\/p>\n

Systematic review<\/u>:\u00a0 The SACC identified numerous inconsistencies in evaluating, and inadequate justifications for excluding, many studies evaluated using the TSCA systematic review approach (pp. 12, 16, 19-26).\u00a0 The SACC noted that \u201c[f]ewer than 25% of the references cited in the DRE were evaluated for data quality\u201d (p. 23).\u00a0 Once again the SACC urged EPA to submit its approach for third-party review, a step EPA finally took late last week<\/a>.<\/p>\n

_____<\/p>\n

The SACC did note the hard work that EPA career staff have been devoting to these draft risk evaluations, and noted the challenges they entail, a sentiment we certainly echo.\u00a0 At the same time, the SACC\u2019s report again makes clear that unfounded assumptions, questionable policy decisions, and suspect methodological choices are leading EPA to systematically underestimate risks of the chemicals it is evaluating under TSCA.<\/p>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

Richard Denison, Ph.D.,\u00a0is a Lead Senior Scientist. The peer review report by the Scientific Advisory Committee on Chemicals (SACC) on EPA\u2019s draft risk evaluation of 1-bromopropane (1-BP) has been released.\u00a0 This carcinogenic solvent is one of the first 10 chemicals undergoing risk evaluation under the amended Toxic Substances Control Act (TSCA), and the new SACC …<\/p>\n","protected":false},"author":100,"featured_media":8516,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[68,44,5009,114108],"tags":[113939,68,91722,113963],"coauthors":[],"class_list":["post-9313","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-epa","category-policy","category-health-science","category-tsca","tag-1-bromopropane","tag-epa","tag-risk-evaluation","tag-sacc-dre"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/9313","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=9313"}],"version-history":[{"count":1,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/9313\/revisions"}],"predecessor-version":[{"id":12897,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/9313\/revisions\/12897"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media\/8516"}],"wp:attachment":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media?parent=9313"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/categories?post=9313"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/tags?post=9313"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/coauthors?post=9313"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}