The New TSCA and PMNs: Lessons Learned Since Passage of the Lautenberg Act
TSCA legislation was enacted 40 years ago to regulate any chemicals not regulated by other statutes. In June, 2016, it was finally updated, with a focus on evaluating and regulating existing chemicals. Adrienne Timmel, an attorney at Keller and Heckman, talked about some of the updates most relevant to product stewards during a presentation at Product Stewardship 2017, including changes to Premanufacture Notices (PMN).
First, what hasn’t changed is the timing. You still submit PMNs 90 days before non-exempt commercial manufacture or importation. Also, when you submit a PMN, you only submit information known to you or easily obtained by you.
So what has changed? Timmel noted that companies thought the updates codified what EPA was already doing in practice, but it turns out the changes have real business implications. Among the most notable is that EPA is required to make an affirmative risk determination, and it has to consider ‘conditions of use.’ This refers not only to the applications and PPE and engineering controls. It also has to consider reasonably foreseeable uses.
When EPA makes an affirmative risk determination, it’s compelled to take certain actions. “They had more discretion earlier,” said Timmel. Now they have to do one of the following: Determine there’s a reasonable risk; determine they have insufficient information and trigger a Section 5 order; or determine there is no unreasonable risk likely.
“The consequences of these changes is that many more chemicals trigger Section 5 risk management actions,” said Timmel, because it’s typical not to have enough information to perform a full evaluation of health and environmental effects. The result has been a slowdown in PMN reviews, causing a backlog.
Timmel offered some ideas on improving the chances that your PMN will be successful. One is to use EPA models to characterize the substance. Another idea is to document when there’s no spray application and provide specific information on the type of PPE required: gloves, respirators, protective clothing, etc.
On the client side, she suggested managing expectations by informing customers that the new PMN requirements take longer than they used to.