EPA offices in Washington , DC
‣ administration , this construction has raised eyebrows , leading some to question whether this interpretation meets the requirements under TSCA Section 5 . Many in industry were of the view that , in issuing a SNUR to prohibit conditions of use that the EPA identifies as potentially leading to an unreasonable risk , the agency was deploying its discretion under TSCA to achieve the protective end ( the TSCA regulation ) without the inefficiency and delays associated with the development of a consent order . In other words , the non-order SNUR was an effective and efficient expedient . The EPA would only use this option when it concluded that the intended conditions of use were not likely to present an unreasonable risk . For reasons that will never be clear , a SNUR is viewed as being somehow less protective than an order , even though an order applies only to the PMN submitter and a SNUR applies to all entities in the supply chain . The EPA is required to promulgate a SNUR that conforms to an order , absent a reason otherwise . The belief that undertaking a condition of use that is defined in a SNUR as a significant new use “ requires only notification to EPA ” grossly misrepresents the scientific and regulatory rigour of the significant new use notice ( SNUN ) process .
A SNUN is functionally identical to a PMN , with a comparable level of effort required on the submitter ’ s and the EPA ’ s part and nearly identical determination outcomes ( a consent order , modification of the existing SNUR or revocation of the existing SNUR , if warranted ). Detractors might also assert that orders include testing , but that presumes that testing is required for the EPA to make an informed decision . If it can - as it routinely does - make a decision based on conservative assumptions with chemical analogues , models , and information provided by the submitter , the EPA can similarly make an informed decision about what measures are necessary to achieve its protective goal without new test data . Many fear that this policy change will require significant additional effort for both the EPA and the submitter , while bringing marginal , if any , protective benefit .
Use of PPE
The EPA ’ s decision that it no longer views use of PPE as reasonably foreseeable is an unwelcome and unprincipled development . At the request of the EPA ’ s Office of Pollution Prevention & Toxics ( OPPT ), chemical stakeholders presented a robust data set that demonstrated that the non-use of proper PPE is rare in an industrial or commercial setting .
Specifically , stakeholders identified a database of 40 years of OSHA violations that contained few glove , goggle or general dermal protection violations . This supports the view that standard PPE use is reasonably foreseeable , highly likely and , based on the data , demonstrably so . The EPA ’ s unexplained and unilateral policy reversal is difficult to align with the facts . If the agency is required to issue orders for every PMN that may present a risk if workers do not take routine protective measures , which in our view they can be reasonably foreseen to do , then it will be required to regulate nearly every PMN in which it identifies a hazard other than ‘ low ’ for health and ecotoxicity . This was the agency ’ s practice when the TSCA amendments were passed in 2016 . In those days , delays in new chemicals reviews were extraordinary and , to many innovators , intolerable . In short , it would mean that the EPA will be implementing TSCA as a hazardbased law , instead of the clearly riskbased law that it is . Chemical stakeholders may wish to urge the EPA to revisit its decision . Chemical innovation is needed now and this policy reversal will slow the commercialisation of more sustainable chemicals for years to come . •
Lynn L . Bergeson
MANAGING PARTNER
BERGESON CAMPBELL k + 1 202 557 3801 J lbergeson @ lawbc . com j www . lawbc . com
50 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981