The US Environmental Protection Agency’s (EPA) “whole chemical” approach to TSCA risk determinations means that it requires an unreasonable degree of information from small and medium-sized companies.

In the past, EPA used a tiered approach to require different levels of information from manufacturers depending on their size. With this approach, EPA could request a certain level of data from a large company and not extend information from a smaller company. 

The EPA has now moved away from this tiered approach to take a whole-chemical approach to all chemicals. This means that any manufacturer is required to provide the same amount of data as any other manufacturer, regardless of size. However, many challenges come with this new rule, such as time constraints and high costs, which disproportionately affect small and medium-sized companies.

Read on to learn about these challenges and how they can be mitigated by regulatory changes and incentives provided by the government

The EPA’s whole-chemical approach to TSCA risk determinations

The EPA’s whole-chemical approach to TSCA risk determinations means that it requires an unreasonable degree of information from small and medium-sized companies. Historically, the EPA relied on a tiered approach to require different levels of information from companies based on their size. The EPA would ask for fewer data from larger companies and more information from smaller ones.

However, the EPA has now moved away from this tiered approach to take a whole-chemical approach to all chemicals. This means that any manufacturer is required to provide the same amount of data as any other manufacturer, regardless of size. Many challenges come with this new rule, such as time constraints and high costs, which disproportionately affect small and medium-sized companies. These challenges can be mitigated by regulatory changes and incentives provided by the government.

Challenges faced by small and medium-sized companies

EPA’s “whole chemical” approach to TSCA risk determinations has been a burden to small and medium-sized companies because it requires an unreasonable degree of information from them.

In the past, EPA used a tiered approach to require different levels of information from manufacturers depending on their size. With this approach, EPA could request a certain level of data from a large company and not extend the same request to a smaller company.

The EPA has now moved away from this tiered approach to take a whole-chemical approach to all chemicals. This means that any manufacturer is required to provide the same amount of data as any other manufacturer, regardless of size. 

However, many challenges come with this new rule, such as time constraints and high costs, which disproportionately affect small and medium-sized companies. These challenges can be mitigated by regulatory changes and incentives provided by the government

Mitigating factors for small and medium-sized companies

There are several ways that the EPA can mitigate some of these challenges for small and medium-sized companies. One way is to provide incentives for companies to share data. This would make it less burdensome for both companies, as they would be able to get information from one another rather than having to gather all the data themselves. 

The EPA could also allow more time for smaller companies to comply with the rule. For example, if a company has less than 10 employees, then it could request an additional 12 months to comply with the whole-chemical approach. This would help them avoid time constraints that are common among smaller businesses, which are often unable to afford team members who specialize in toxicology or chemistry.

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Conclusion

The EPA’s “whole-chemical” approach to TSCA risk determinations places a burden on small and medium-sized companies. Despite the challenges faced by these businesses, there are mitigating factors that can be put in place to help them. As an example, the EPA has made certain exemptions for businesses that wish to use chemicals that have been grandfathered in. This exemption is a step in the right direction since it helps to lessen the regulatory burden on these companies and provides them with greater flexibility.