The Toxic Substances Control Act and resulting regulations are the federal regulatory structure for chemicals management. TSCA (tah-ska) authorizes the US EPA to review and regulate chemicals. For many existing chemicals, TSCA requires manufacturers to work with EPA to fill in data gaps on risk, and new chemicals must undergo pre-market screening.
If EPA determines a chemical poses an unreasonable risk to human health or the environment, it can place restrictions on the manufacture, import, processing, distribution, use, and disposal of the chemical. This can include bans, warning labels, and dissemination of hazard information. Whatever the action, it must be the “least burdensome” restriction to reduce the risk.
A failed system
TSCA is generally considered outdated and ineffectual. Congress enacted TSCA in 1976, and it grandfathered in chemicals already in use. Between this and the “least burdensome” requirement, TSCA is seen by both industry and activists as toothless.
This opened the door, in part, to state chemical management regimes, like California’s Proposition 65, which cropped up as states determined that the federal government was not doing enough.
As a result, TSCA reform has been at the top of many Congresspersons’ lists, but until recently, reform legislation never made it over the hump.
After many years of failed attempts, reform appears to be imminent.
In a Congress seemingly incapable of governing, the House passed H.R. 2576, the “TSCA Modernization Act,” on June 23, 2015, and the Senate passed S. 697, the “Lautenberg Chemical Safety for the 21st Century Act,” on December 18, 2015. The houses will now need to work together to reconcile the differences in the legislation.
Bridging the gap
While the competing bills have significant differences, supporters in both houses have suggested that they can be reconciled. Key issues revolve around:
- the process EPA must undertake to evaluate a chemical and impose a restriction;
- the extent to which a cost/benefit analysis plays a role in evaluating risk or regulatory measures;
- preemption of state chemical management laws; and
- treatment of confidential business information protection
The House bill requires EPA to evaluate a chemical’s risk of injury to human health or environment prior to any restriction or ban, and it establishes procedures for EPA or a manufacturer to initiate the risk evaluation. Under the bill, EPA may not consider cost or other non-health or environment factors in evaluating risk, but must consider costs and economic impacts in restricting or banning a chemical. This includes whether technically and economically feasible alternatives exist. EPA must also provide reasonable transition time if regulating a chemical, and exemptions are permitted to avoid “significant disruptions” to the economy, national security, or critical infrastructure.
H.R. 2576 preempts new state laws after EPA takes action on a chemical (determines there is or is not an unreasonable risk), but it grandfathers in state laws existing as of August 1, 2015 – no relief from Prop 65! The bill also contains strong CBI protections to prevent information manufacturers provide to EPA from becoming public.
The Senate bill is structurally similar to the H.R. 2576, but it contains much more detail (the House bill seems more like a framework with lots of room for EPA regulations to implement, while S. 697 is fleshed out).
Substantive differences involve EPA risk determinations, CBI, and preemption. For example, S. 697 requires EPA to evaluate the risk of a new chemical prior to manufacture, meaning it can only be manufactured if EPA determines it is unlikely the chemical will present an unreasonable risk of harm to human health or the environment. The Senate bill requires EPA to review existing CBI claims (H.R. 2576 leaves these undisturbed) for legitimacy, and it will not preempt any state law requiring reporting, monitoring, or disclosure. This includes Prop 65 and the California, Washington, Vermont, Oregon, and Maine green chemistry laws. States will also be able to regulate chemicals under EPA evaluation until EPA makes a determination. Despite the savings clauses in both bills, we expect that once/if meaningful federal chemical management legislation is in place, many states contemplating their own green chemistry laws may abandon these efforts.
We will keep you posted on reconciliation of the two bills.