{"id":8059,"date":"2018-08-01T13:58:10","date_gmt":"2018-08-01T18:58:10","guid":{"rendered":"http:\/\/blogs.edf.org\/health\/?p=8059"},"modified":"2024-02-12T11:02:11","modified_gmt":"2024-02-12T16:02:11","slug":"epa-rams-through-its-reckless-review-scheme-for-new-chemicals-under-tsca-your-health-be-damned","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2018\/08\/01\/epa-rams-through-its-reckless-review-scheme-for-new-chemicals-under-tsca-your-health-be-damned\/","title":{"rendered":"PART 1: EPA rams through its reckless review scheme for new chemicals under TSCA, your health be damned"},"content":{"rendered":"

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

Part 1\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0Part 2<\/a>\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0Part 3<\/a><\/p>\n

Overruling the recommendations of its own longtime professional staff, political appointees at EPA have begun green-lighting new chemicals to enter commerce using an approach that shows contempt for the letter and intent of the 2016 reforms to the Toxic Substances Control Act (TSCA).<\/p>\n

EDF blogged recently <\/a>about the new approach and how it drastically deviates from what the law requires.[pullquote]Now any company will be free to produce, import and use the chemical in any manner it chooses and without any obligation to inform EPA of its activities.<\/em><\/strong>[\/pullquote]<\/p>\n

Today EPA posted the first decision <\/a>made under the new scheme:\u00a0 It issued a \u201cnot likely to present an unreasonable risk\u201d determination<\/a> for a chemical that, according to its manufacturer International Flavors and Fragrances Inc., is to be imported for use \u201cto reduce malodors. \u00a0It will be sold to industrial and commercial customers for their incorporation into industrial, commercial, and household consumer products such as floor cleaners, cat litters, fabric refresher sprays, Etc.\u201d<\/p>\n

The \u201cnot likely\u201d finding means that International Flavors and Fragrances Inc. can commence manufacture and sale of the chemical, and will not be subject to any conditions or limits.\u00a0 Once manufacture starts, the chemical will be placed on the TSCA Inventory, and that company or any other will be free to produce, import and use the chemical in any manner it chooses and without any obligation to inform EPA of its activities.\u00a0\u00a0<\/p>\n

The company submitted a premanufacture notice (PMN) for the chemical in August 2016<\/a> and EPA assigned it the number P-16-0510.\u00a0 Based on its original review of the PMN, EPA\u2019s staff made this initial recommendation<\/a>:<\/p>\n

\"\"<\/a><\/p>\n

EPA\u2019s decision today is a dramatic departure from that initial recommendation.\u00a0 Based on the new approach EPA is taking, not only will no consent order be developed, but EPA will also not pursue promulgation of a Significant New Use Rule (SNUR) for the chemical.\u00a0 Consent orders and SNURs are the two means by which EPA can place limits or require testing or more information on a new chemical.\u00a0 EPA is forgoing those options.<\/p>\n

Unlike the great majority of new chemicals submitted under TSCA, however, in this case the identity of the chemical was disclosed.\u00a0 The chemical and its Chemical Abstract Service (CAS) number are as follows:<\/p>\n

Oxirane, 2-methyl-, polymer with oxirane, bis[2-[(1-oxo-2-propen-1-yl)amino]propyl] ether<\/p>\n

CAS 1792208-65-1<\/p>\n

EPA has established a set of \u201cchemical categories<\/a>\u201d it uses to flag new chemicals that could pose serious health or environmental concerns without conditions placed on their production or use.\u00a0 EPA\u2019s determination document notes that this chemical falls into its \u201cacrylamides\u201d category. \u00a0This likely reveals why EPA staff raised concerns from the start.\u00a0 Here is EPA\u2019s description of the hazard concerns for this category:<\/p>\n

Based on analogy to acrylamide per se, members of the class are considered potential carcinogens, heritable mutagens, reproductive and developmental toxicants, and toxic to aquatic organisms. \u00a0Acrylamides are also potential neurotoxins based on data for a number of low molecular weight acrylamides.<\/p>\n

In its own determination document, EPA identifies these toxicities and more, noting \u201cthe potential for the following human health hazards: irritation, mutagenicity, developmental\/reproductive toxicity, neurotoxicity, and carcinogenicity.\u201d<\/p>\n

So, using its new scheme, it appears that the first chemical EPA has cleared to enter commerce without any restrictions or testing to address the health concerns whatsoever is one that:<\/p>\n