{"id":1615,"date":"2011-11-02T15:30:07","date_gmt":"2011-11-02T20:30:07","guid":{"rendered":"http:\/\/blogs.edf.org\/nanotechnology\/?p=1615"},"modified":"2024-02-12T11:01:18","modified_gmt":"2024-02-12T16:01:18","slug":"epa-proposes-yet-another-tsca-workaround-creative-yes-but-why-not-just-give-it-the-authority-it-needs","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2011\/11\/02\/epa-proposes-yet-another-tsca-workaround-creative-yes-but-why-not-just-give-it-the-authority-it-needs\/","title":{"rendered":"EPA proposes yet another TSCA workaround: Creative, yes, but why not just give it the authority it needs?"},"content":{"rendered":"

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

One thing I\u2019ve learned in observing EPA try to operate under the Toxic Substances Control Act (TSCA) over the years is that \u2013 faced with limited authority and significant evidentiary and resource burdens \u2013 the Agency often has to resort to a <\/span>workaround<\/span><\/em><\/a> to get something it needs to do done. <\/span><\/p>\n

Can\u2019t ban a nasty chemical?\u00a0 Wait until it\u2019s voluntarily withdrawn and then pounce on it with a Significant New Use Rule (SNUR) to try to wedge the door closed.\u00a0 Witness <\/span>PFOS<\/span><\/a> and <\/span>penta and octaBDE<\/span><\/a>.\u00a0 (Under TSCA, without a SNUR in place on a chemical, a new producer or importer could start up without even letting EPA know; where EPA has issued a SNUR for a chemical, advance notification is required and EPA least has a chance to weigh in before production or import proceeds.)<\/span><\/p>\n

Can\u2019t require an up-front minimum data set for new chemicals?\u00a0 Recommend to companies that for certain chemicals they submit such a data set along with the pre-manufacturing notice (PMN) they\u2019re required to file, or risk having EPA extend the review of their new chemical or negotiate with them to do the testing.\u00a0 EPA has made such \u201crecommendations\u201d for those relatively few new chemicals where the company \u201canticipates\u201d at the outset <\/span>producing it in large amounts in the first three years or where significant release or exposure is projected<\/span><\/a>.<\/span>\u00a0<\/span><\/p>\n

The latest such workaround?\u00a0 EPA\u2019s <\/span>simultaneous issuance of a proposed test rule and a proposed SNUR<\/span><\/a> for a batch of high production volume (HPV) \u201corphan\u201d chemicals that no company agreed to sponsor under the Agency\u2019s voluntary HPV Challenge Program.<\/span><\/p>\n

Necessity is the mother of invention, they say, and these creative new proposals are a case in point.\u00a0 But, my oh my, there\u2019s gotta be a better way\u2026. <\/span><\/p>\n

EPA bears a heavy cross to require testing<\/span><\/strong>\u00a0<\/span><\/p>\n

Now, to justify requiring testing under TSCA, EPA has a number of substantial burdens it must meet.\u00a0 First, EPA must first make one of the following <\/span>statutory findings<\/span><\/a>:<\/span><\/p>\n

1.\u00a0 The substance \u201cmay present an unreasonable risk of injury to health or the environment\u201d and the probability of exposure to it is more than just theoretical.\u00a0<\/span><\/p>\n

OR<\/span><\/p>\n

2.\u00a0 The substance is produced in \u201csubstantial quantities\u201d and either enters the environment in \u201csubstantial quantities\u201d or there is \u201csubstantial or significant\u201d human exposure.<\/span><\/p>\n

In practice, EPA is rarely able to make the first, \u201crisk-based finding\u201d because it lacks the very data that testing would provide.\u00a0 In virtually all cases where it has issued test rules, EPA has relied on making the second \u201cexposure-based finding.\u201d\u00a0\u00a0<\/span>\u00a0<\/span><\/p>\n

Here are the criteria EPA uses to <\/span>define \u201csubstantial\u201d production and environmental release<\/span><\/a>:<\/span><\/p>\n