What are the challenges and opportunities for businesses with the newly updated TSCA law?
Rose Passarella
Senior scientific regulatory manager
Intertek
Ahead of this year's sixth annual Regulatory Summit USA, which took place on 31 October-1 November in Arlington, Virginia, we took the opportunity to catch up with Dr Rose Passarella, senior scientific regulatory manager at Intertek, to find out more about the ongoing implementation of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA) in 2016, which has brought in major changes to the original Toxic Substances Control Act (TSCA).
Q: Two years in, how is implementation of the updated TSCA law progressing? If there have been significant challenges, are these to be expected?
The implementation of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the TSCA reform, is going well. The EPA is meeting the statutory deadlines. We would be remiss if we did not mention consent orders and Snurs, Significant New Use Rules, that the EPA is promulgating. It appears that more of these are being issued than in the past. The EPA stated that this is the new norm.
With the reform, the EPA must make a conclusive statement as part of the new substance review. There is no longer the process that if you don’t hear from the EPA in 90 days, you are able to proceed. To make this conclusion, it takes extensive risk evaluation. The EPA is very transparent and discusses all aspects with the notifier. However, consent orders and Snurs are not the only decisions the EPA is making. The EPA is also concluding that the notifiable substance does not present an unreasonable risk for some files.
There are always challenges when something new is being implemented. The EPA is doing it under the microscope and caught between the desires of the Non-Government Organizations (NGOs) and Industry. Ultimately, all groups, the EPA, NGOs and Industry want the best for the protection of health and the environment.
Q: What are the biggest challenges facing companies under the reformed TSCA law?
I believe the biggest challenge facing companies is the time it takes for a new substance review. Companies spend time compiling the pre-manufacture notice (PMN) dossier under Section 5 concerning new substances.
The EPA immediately starts the process. The good news is that there are usually a lot of questions from the EPA agent and thus there are a lot of opportunities to interact with the EPA. This sometimes has the effect of suspending the process timeline. Also, there is an additional step of a senior review called the Ad Hoc review that is not officially part of the process. While it is always good to have another review, the additional time and the uncertainty of the total time for the Ad Hoc review could adversely affect business.
Another possible challenge is the increase in fees. While is it understandable that the EPA’s activities do represent a large amount of work and while it is also understandable that the fees have not increased for quite some time, the jump from $2,500 to $16,000 represents a sizeable change. These fees are not the highest fees with respect to global regulations, but we now fall at the top end of the scale rather than the lower where we landed before. We are also very interested in the revised definition of a small business in the reform structure. It will be critical for entrepreneurs to understand if they qualify for a small business fee reduction so that they have the greatest opportunity to innovate.
Q: How did businesses find the 'inventory reset' reporting process? Do you think the exercise will result in the EPA having an accurate representation of the chemicals active in commerce?
Industry found the reset reporting process slightly more onerous than it seemed the EPA may have expected. Having worked in Industry, when it is expected that the company “must have that data”, it is not always the case. The information from a 10-year look back may not have been as readily available as thought. The EPA did change the reporting of the “dates of commercial use” requirement after hearing from the public. This is always welcome when requirements are reassessed as to the value of the information versus the work required to obtain the information. Also ensuring that your supplier reported the information and getting trade secrets information was more complicated that anticipated for larger companies.
The EPA is analysing for accuracy in the active list, especially when incorporating the submissions from the processors. This is critical since it is the subset of active chemicals on the inventory that is the source for the prioritisation into high and low priority chemicals. It is also important to remember an inactive substance is not removed from the inventory. If you want to use an inactive substance, you do need to notify the EPA, but you do not need to submit a new PMN.
Q: The inventory reset and framework rules are all subject to ongoing litigation. How is the regulated community managing the uncertainty that comes with these pending lawsuits?
Much of the US legal system is based on precedent. Decisions, on a controversy, help shape the law. The other aspect of law in the US is that decisions take time. With discovery, litigation and appeals, it could take months to years to resolve. The process is good, but the regulated community must continue to develop new chemicals and work safely with existing chemicals. This means the regulated community must follow the regulations as they are now. Of course, the regulated community must be aware of the challenges for possible future planning. From my experiences in working in industry for a number of years, you cannot wait for everything to be settled law. The community must move to develop new and more sustainable products with new and improved chemical substances. They must be compliant now, be aware of law litigation, but they must innovate.
Q: Does the newly reformed law present any opportunities for businesses?
I believe there are always opportunities if you focus on the positive. The opportunities include working with the EPA to get the best regulations that will safeguard health and the environment and foster innovation. There is another opportunity to open a discussion with other branches of government to collaborate. For example, the companies may open discussions with OSHA especially concerning safety data sheets (SDSs). OSHA has rules and a company creates a compliant SDS; however, the EPA has specific wording that it would like to see as a result of a risk evaluation. There may be an opportunity for more collaboration.
Another opportunity may be in a company requesting a risk evaluation for a specific existing substance. This may be a valuable part of the marketing plan to show that the company is willing to aid in the evaluation of their chemical substance. Working together aids the EPA and helps the company. The public benefits from having had the evaluation completed.
Q: Why are you looking forward to speaking at the US Regulatory Summit? What can delegates expect?
I am looking forward to speaking at Regulatory Summit USA because Chemical Watch provides, not only global multi-topic conferences like this one, but also a series of single-focus webinars and meetings. This helps those who need to pick and choose the best method to enhance their personal training. The delegates can expect to learn new things and receive updates; and to network with government agents, consultants that see a variety of situations, and other companies that can share their experiences.