Implications and Considerations for Manufacturers and Importers
Senior Consultant Jessica Onyshko and President of M8, Inc. Leslie MacDougall discuss the TSCA reforms.
According to the Toxic Substance Control Act (TSCA), ‘new’ chemicals are chemical substances that are not listed in their inventory. The chemical substance must then be evaluated to determine if it meets any exemption criteria, reduced notifications, or if a full pre-manufacture notification is required. And it’s the latter of these categories which we focus on below.
What does the reform involve?
The Lautenberg Chemical Safety Act was passed in June 2016, and is the first time the TSCA has been amended since its enactment in 1976. As a result of this amendment, the Environment Protection Agency (EPA) has expanded its review process on pre-manufacturing notifications (PMNs), citing requirements to make an ‘affirmative decision’ on PMNs. This means the EPA must reach a conclusion on whether a chemical substance presents ‘unreasonable risk’ under specific ‘conditions of use’. This ‘use’ includes manufacturing, processing, distribution, use, storage, and end of life scenarios. New chemical substances, as a result, are being evaluated for ‘all reasonably foreseen’ uses.
How does the reform affect your business?
The new review/evaluation process is making it increasingly difficult for manufacturers and importers to effectively move through the PMN process in the 90-day review timeline specified. In some cases, the initial review may be completed within the 90-day timeframe but, given the need for the EPA to make an ‘affirmative decision’ on a chemical substance, this is typically leading to a number of follow-ups and significant delay on the timeframe to place substances on the market. The new PMN review process has led to:
- further EPA option letters being issued, which in many cases contain 3 to 4 options, including withdrawal of the PMN;
- additional Consent Orders being issued to assist in making an affirmative decision of unreasonable risk, and,
- an increase in Significant New Use Rules (SNURs) being issued to ensure all reasonably foreseen uses – not just intended uses – are notified and considered for evaluation prior to authorizing the use.
The last of the three points above ensures that substances being listed on the TSCA Inventory are only authorized for a use that the EPA has evaluated and approved. Additionally, it appears the EPA will no longer be issuing “non-Section 5(e) SNURs” under the new risk determination provisions. In the case of initial EPA option letters, they may require significant testing to support a Consent Order or, in some cases, offer the notifier the ability to refute EPA’s findings by providing additional data on the substance or a close structural analog.
From another perspective, there was a significant push during TSCA reform activities to allow the EPA flexibility in determining what data is needed to support a PMN. However, the current approach is causing significant delays in bringing new chemical substances to the US market in a timely manner. Perhaps knowing the data requirements for certain substances in advance of submitting the PMN would better manage expectations from a timing perspective, provide the EPA with the data it needs upfront, and ultimately make the process quicker for your business. Being selective in data submitted could be viewed as controversial since the EPA desires to have as much exposure and release information as part of the notification as is possible, which is incredibly challenging given the ‘unforeseen uses’ evaluation.
In addition to the above, Confidential Business Information (CBI) must now be substantiated as part of exemptions/reduced notifications and full PMNs. It is critical to ensure that your PMN now contains significant information to ensure that CBI claims are substantiated. To ensure that CBI is appropriately substantiated, take a look at 40 CFR 720.85(b)(3)(iv). This legislation specifies questions that must be answered, and we recommend these accompany any PMN in which CBI is claimed.
In summary: considerations for your businesses
To help navigate some of the challenges/complexities of the EPA’s new review process, we offer some considerations for your business below:
- There’s longer lead time for bringing new substances to market… so be prepared (or be prepared to wait!). Of course, this may have significant implications for your business – especially when the timeframe for some substances to move through the review process can be a year. The EPA is requesting “suspension” of the review periods and issuing letters to further allow the notifier to select options for next steps.
- Submit high quality PMNs upon initial submission. This includes enhanced exposure and release information. If your operations include a problematic class of substance, you might therefore like to consider some initial testing (although the program does not require it).
- Consider data on analog substances for inclusion along with QSAR modeling.
- Consider Sustainable Futures Program evaluation.
- Maintain propriety information by substantiating CBI claims.
- Be aware your costs may increase. This is because additional testing may be required as part of EPA’s evaluation process (unless proven unnecessary by the notifier).
While the TSCA reform is itself impacting on business in number of ways, it has also highlighted the need for a data sharing mechanism in the US – and this is an issue of global relevance. As enhanced chemical management legislation is more broadly implemented on a global basis, access to existing data to support these programs is becoming critical. Anthesis’ Paul Ashford spoke on this topic at the recent “Safer Chemicals in Products” conference in San Francisco, CA and will be contributing an article to Chemical Watch in the coming months to share thoughts on potential strategies to address this global issue.
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