Richard Denison, Ph.D., is a Senior Scientist.
[Links to posts in this series: Part 1, Part 2, Part 3, Part 4, Part 5]
This final post in this series goes to the ultimate question, where the nanorubber really hits the road: Can EPA regulate an “existing” nanomaterial’s production, use, or disposal under TSCA?
EPA’s authority to regulate a chemical in commerce is provided in Section 6 of TSCA. In principle, EPA has broad authority to impose any of a diverse range of controls on a chemical. It can:
- require labeling, monitoring, or compliance testing of a chemical or a product containing it;
- require communication of instructions on appropriate use to customers;
- prohibit or regulate disposal of the chemical or any product containing it;
- prohibit or regulate its commercial use;
- prohibit or regulate specific uses or the use above a specified concentration of the chemical; or
- prohibit or limit all production or use of a chemical.
But once again there’s a big catch: For EPA to take any regulatory action, it must first find that the chemical “presents or will present an unreasonable risk of injury to health or the environment.”
To make such a finding, EPA must consider more than whether the chemical is harmful and if there are significant exposures to it. EPA must also consider the economic and social costs of imposing controls on the chemical, including the benefits of the chemical, the availability of alternatives, and the impact of regulation on the economy, small businesses and innovation. It must demonstrate that the proposed control is the least burdensome it could have proposed. Finally, it must demonstrate that no other statute could address the concern.
Not surprisingly, this authority has seldom been used: Since adoption of TSCA in 1976, EPA has succeeded in developing Section 6 rules for specific uses of only five substances:
- fully halogenated chlorofluoroalkanes used as aerosol propellants;
- dioxin in certain wastes;
- hexavalent chromium used in water treatment chemicals in comfort cooling towers;
- polychlorinated biphenyls (PCBs), by virtue of a mandate from the U.S. Congress; and
- asbestos (limited to products no longer in commerce, because the initial rule was vacated by U.S. courts after legal challenge).
None of these constraints are specific to nanomaterials, of course. Nonetheless, all of them would apply to any nanomaterial or use of a nanomaterial EPA tried to regulate – even, for example, if it were simply to seek to require labeling of products containing a nanomaterial.
Series Conclusion
In this series of posts, I’ve described some of the serious limits to EPA’s ability to apply its authorities under TSCA to address the potential for nanomaterials to harm human health or the environment. These limits pertain both to EPA’s ability to obtain information sufficient to effectively assess potential risks, and its ability to act on such information when it indicates there are significant risks.
While in some cases EPA could use its existing authorities to do more than it has done, a number of the problems I’ve identified will clearly require changes to TSCA. And, of course, many of these problems extend well beyond nanomaterials to affect all chemicals that fall under the purview of TSCA.
The latter fact is one of the reasons EDF does not favor developing a new nano-specific law. Rather, careful consideration of the special features of nanomaterials and provision for their appropriate regulation must be incorporated into the broader process of bringing TSCA into the 21st century.
[Links to posts in this series: Part 1, Part 2, Part 3, Part 4, Part 5]