EPA recently announced some concerning changes to its approach to evaluating new and existing chemicals under the 2016 amendments to TSCA.
The continued implementation of the law according to the statute and congressional intent is critical to our industry’s ability to produce countless products essential to overcoming pressing issues such as climate change, the global pandemic, aging infrastructure, safe drinking water, and more.
There will always be political disagreements when implementing regulations, but the changes to the new chemicals and risk evaluations processes announced recently by EPA are a move backward and, importantly, could stifle innovation necessary to create more sustainable products and help build a more sustainable world.
EPA has been using non-5(e) significant new use rules (SNURs) for new chemicals since 1995. EPA has authority to use them, and this didn’t change in the 2016 amendments. Nothing in the legislative history indicates a Congressional intent to preclude EPA from issuing non-5(e) SNURs. And doing away with them and moving to section 5(e) orders across the board will result in a substantial increase in unnecessary work for EPA, added burden for PMN submitters, and lost economic benefit. Congress’ express policy set out in section 2 of TSCA is that EPA should not exercise its authority to impede innovation or create unnecessary economic barriers. The proposed action flies in the face of that policy.
Non-5(e) SNURs are a useful tool where EPA concludes that it does not have a concern with how the PMN submitter plans to handle a substance – so a section 5(e) order directed at the PMN submitter is not needed – but where EPA may nonetheless have a concern about how others might later handle the substance. The SNUR applies to everyone who might later want to manufacture a chemical in the way that EPA is concerned about, requiring notice to EPA and allowing EPA to intervene and impose additional restrictions if the situation arises.
Unfortunately, EPA seems poised to issue section 5(e) consent orders in the vast majority of PMN cases. The refusal to issue non-5(e) SNURs and instead issue orders means the agency is opting to return to the status quo before 1995, when it admitted it was issuing unnecessary orders. And this change will create a significant burden for both the agency and PMN submitters, covering the drafting, negotiation and adoption of orders.
But it gets worse. Consent orders require discussion and negotiation. At the same time, EPA has a requirement to finish PMN reviews in 90 days. Almost inevitably, this proposal thus means that EPA is suggesting it will move to non-negotiable, take-it-or-leave-it orders that aren’t informed by discussion and an exchange of information. We expect that some manufacturers will decide to take their business out of the U.S. rather than face delays and unilateral orders without the benefit of informed dialogue.
Section 5(e) orders have another important drawback: the section 5(e) order does not apply to anyone other than the PMN submitter. Only a SNUR can apply notification requirements to persons other than the PMN submitter. Nevertheless, the restrictions in a section 5(e) order almost always show up in a subsequent SNUR. That means that whatever the PMN submitter agrees to in its order will probably be applicable to all other manufacturers and processors once EPA adopts a SNUR for the PMN substance. Public comments on a proposed SNUR will likely receive little attention from EPA since its SNURs almost always essentially mirror related section 5(e) orders.
We urge the agency to consider carefully whether and when section 5(e) orders are justified under the statute, given that SNURs are highly effective with respect to providing notice of obligations to chemical manufacturers and processors. If EPA proceeds nonetheless, we urge it to be as transparent as possible with respect to such orders and clearly identify which specific uses may present an unreasonable risk. This will be particularly important if the agency is making assumptions about prospective future uses that are not intended or proposed by a PMN submitter.
It is also important that the Occupational Safety and Health Administration’s role as the lead regulator for workplace safety be maintained throughout EPA’s new chemical review process. When considering workplace exposures for new and existing chemical evaluations, the public should understand that OSHA comprehensively regulates these potential exposures and employers already are required to follow these laws. EPA activity here risks imposing unnecessary delay or possibly redundant or contradictory measures.
ACC is particularly concerned with EPA’s announced intention to identify the absence of worker safeguards as a “reasonably foreseen” condition of use. Adequate worker safeguards are already required under the Occupational Safety and Health Act of 1970to prescribe worker safety requirements, so EPA is essentially proposing that it will assume non-compliance with the law as a default. The agency should also be cautious of stepping into the shoes of OSHA to prescribe specific requirements for the workplace.
If EPA moves forward with these proposals, the agency should fully integrate appropriate OSHA personnel on a real time basis as part of EPA’s work teams to ensure this necessary coordination.
Actions that cause delays in the PMN review process will have a significant adverse impact on research and development expenditures, planning product launches, development of new sustainable chemistries, innovation and competitiveness.
We urge EPA to carefully consider any potential changes that may reverse the years of progress that have been made to effectively and efficiently implement TSCA as Congress intended.