I remember a few years ago when we were discussing a new regulatory approach being proposed in Europe that would put more of the burden of ensuring chemical safety on industry. It was touted by environmental groups around the world as being a model for chemicals policy. Because of the difference in legal and regulatory systems, it is unlikely that the European model would be appropriate for the United States. There is, however, another way we can achieve a similar shift of burden so that the chemical industry takes a greater role in ensuring the safety of its chemicals.

Both the House and Senate passed bills to update the Toxic Substances Control Act (TSCA). Although the two bills are different from each other, in terms of scope and complexity, they both contain provisions that allow industry to shoulder more of a burden by preparing risk-based evaluations using the same third-party scientific contractors and services that EPA uses. What I find perplexing, though, is the sudden change of heart within the environmental community to limit the amount of burden that industry can shoulder through an arbitrary cap on industry submissions.

It’s common knowledge that many chemicals sold in Europe are also sold here in the US. Groups of companies have been working together to prepare full risk assessments, also called dossiers, under the European regulatory system. Those comprehensive documents could easily be submitted for evaluation by US officials and made publicly available, which is also one of the desired outcomes that used to be expressed by environmental groups.

A report prepared by a former Office of Management and Budget (OMB) official, John Graham, found that risk assessments prepared and reviewed by EPA without assistance is a slow, burdensome and in some ways painstaking process. The report asserts that allowing industry to shoulder more of a burden, by preparing risk evaluations and submitting them to scientifically qualified third parties, would save EPA enormous amounts of work and make more information on chemical hazards, exposures and risks available more quickly than anything EPA could do on its own. So, why the sudden change of heart and the arbitrary cap on industry submissions?

The main reason given was that industry would somehow be able to control the risk assessment process at EPA by overwhelming EPA resources with risk assessments. That point was quickly countered by the fact that industry would be covering all of the costs, so it wouldn’t interfere with EPA’s budget for assessments of the chemicals on its work plan.

So, let’s recap the positive aspects of industry-initiated risk evaluations. The burden for ensuring chemical safety shifts more to industry than if EPA tries to go it alone. It will also result in more information about chemicals being made publicly available much more quickly. The one potential downside is the possibility of EPA not being able to effectively manage the overall risk evaluation process. Appropriate funding from the Agency’s multi-billion dollar budget should help alleviate that concern.

There must be a better way to allow EPA to manage the risk evaluation process, other than an arbitrary cap on industry efforts, while allowing industry the opportunity to voluntarily shoulder more of the burden associated with chemical safety. The consequences of an arbitrary cap on industry-initiated risk evaluations will be a continuation of the glacial pace at which EPA gathers information and conducts the assessments. The benefits of industry shouldering more of the burden and making information publicly available at a faster pace will never be realized.

Jim Cooper

Posted by Jim Cooper

Jim Cooper is the Senior Petrochemical Advisor for AFPM. To learn more about AFPM, visit AFPM.org.