Blog Home | TSCA /? Php the_category (‘|’); ?>
The EPA recently announced some changes to its approach to evaluating new and existing chemicals as part of the 2016 TSCA changes.
Continued implementation of the law in accordance with the law and the intent of Congress is critical to the ability of our industry to manufacture myriad products that are essential to overcoming pressing issues such as climate change, global pandemic, aging infrastructure, safe drinking water and more.
There will always be political disagreements on how to implement regulations, but the changes recently announced by the EPA to the new chemicals and risk assessment processes are a step backwards and, most importantly, could stifle the innovations required to create more sustainable products and build a more sustainable world are.
The EPA has been using non-5 (e) significant New Use Rules (SNURs) for new chemicals since 1995. The EPA is empowered to use these and this has not changed in the 2016 amendments. Nothing in legislative history indicates the intention of Congress to prevent the EPA from issuing non-5 (e) SNURs. If they are abolished and the orders in Section 5 (e) are broadly changed, it will result in a significant increase in unnecessary work for the EPA, an additional burden on PMN filers and a loss of economic benefit. The express policy of Congress, as set out in Section 2 of the TSCA, is that the EPA should not use its powers to hinder innovation or create unnecessary economic barriers. The proposed measure contradicts this policy.
Non-5 (e) SNURs are a useful tool where the EPA concludes that it does not care how the PMN submitter is going to handle a substance – therefore an order directed to the PMN submitter is in accordance Section 5 (e) not required – but where the EPA may still have concerns about how others might deal with the substance later. The SNUR applies to anyone who may later want to manufacture a chemical in the manner affected by the EPA, need a notification to the EPA and allow the EPA to intervene and, should the situation arise, impose additional restrictions.
Unfortunately, the EPA appears ready to issue consent decisions under Section 5 (e) in the vast majority of PMN cases. The refusal to issue non-5 (e) SNURs and issue assignments instead means the agency is choosing to revert to the status quo before 1995 when it admitted to placing unnecessary assignments. This change will be a significant burden for both the agency and the PMN submitter as it involves drafting, negotiating and accepting orders.
But it’s getting worse. Requests for approval require discussion and negotiation. At the same time, the EPA must complete the PMN reviews in 90 days. Almost inevitably, this proposal means that the EPA is proposing to move to non-negotiable take-it-or-leave-it orders that are not informed through discussion and exchange of information. We anticipate that some manufacturers will choose to move their business out of the US instead of experiencing delays and unilateral orders without the benefit of an informed dialogue.
Orders according to Section 5 (e) have another important disadvantage: The order according to Section 5 (e) is only valid for the PMN submitter. Only a SNUR can apply notification requests to anyone other than the PMN submitter. Nevertheless, the restrictions in an order according to Section 5 (e) are almost always indicated in a subsequent SNUR. This means that whatever the PMN submitter agrees on in their order will likely apply to all other manufacturers and processors once the EPA adopts a SNUR for the PMN substance. Public comments on a proposed SNUR are unlikely to receive much attention from the EPA as their SNURs almost always largely mirror the relevant provisions in Section 5 (e).
We urge the Agency to carefully examine whether and when orders under Section 5 (e) are legally justified, as SNURs are highly effective in communicating obligations to chemical manufacturers and processors. However, if the EPA does proceed, we urge them to be as transparent as possible with respect to such orders and clearly identify which specific uses may pose an unreasonable risk. This is especially important when the agency is making assumptions about potential future uses that are not intended or suggested by a PMN submitter.
It is also important that the Occupational Safety and Health Agency’s role as the lead regulator for occupational safety is maintained throughout the EPA’s new chemical review process. When considering workplace exposure for new and existing chemical assessments, the public should understand that OSHA fully regulates these potential exposures and employers already have an obligation to comply with these laws. The EPA’s activities can lead to unnecessary delays or potentially redundant or contradicting measures.
ACC is particularly concerned about the announced intention of the EPA to identify the lack of worker protection as a “reasonably foreseeable” condition of use. Under the Occupational Health and Safety Act of 1970, adequate safety precautions are already required for workers to prescribe occupational safety requirements. Therefore, the EPA is essentially proposing to adopt non-compliance as the standard. The agency should also be careful about following in OSHA’s footsteps to prescribe specific requirements for the workplace.
As the EPA moves these proposals forward, the Agency should fully integrate appropriate OSHA personnel into the EPA’s work teams in real time to ensure this necessary coordination.
Actions that cause delays in the PMN review process have a material adverse effect on research and development spending, planning product launches, developing new sustainable chemicals, innovation and competitiveness.
We urge the EPA to carefully consider possible changes that could undo years of progress in the effective and efficient implementation of the TSCA in accordance with the intentions of Congress.