Richard Denison, Ph.D., is a Lead Senior Scientist.
For years, the concept of prioritization as an element of TSCA reform has enjoyed support from a broad array of stakeholders. The number of chemicals in active commerce is large, if uncertain: surely less than the 85,000 listed on the TSCA Inventory, but still in the tens of thousands. That sheer number demands that EPA develop and apply a process to decide where to start and how to sequence the enormous task of reviewing the safety of those chemicals.
There has also been widespread agreement that EPA should make an initial pass using available information to identify three groups of chemicals: a) those that present significant hazard or exposure potential or both; b) those for which existing information doesn’t raise such concerns; and c) those that need more information to determine their level of concern.
As conceived, prioritization was to be a low-stakes proposition for the various stakeholders, simply the means to get the new system up and running. Prioritization decisions would not be final actions; rather, they were expressly designed to minimize dispute, and would be barred from legal challenge. Chemicals identified as high priority and in need of immediate scrutiny would get a more thorough assessment before any decision as to whether they posed significant risk and required a regulatory response. Chemicals identified as low-priority would be so designated provisionally based on less than a thorough assessment, and could be revisited if and when new information arose. And chemicals lacking sufficient information to be prioritized would be subject to further data collection and generation, and then funneled back into the prioritization process.
These concepts are well-established both in the outcomes of industry-NGO negotiations and in heavily negotiated provisions of the more recent incarnations of the Safe Chemicals Act.
But then some folks got greedy. They broke apart a strong consensus on the need and role for prioritization, by insisting on three specific changes that raise the stakes dramatically by transforming prioritization from a sorting and sequencing mechanism into a means of skirting a thorough assessment and avoiding regulation by any level of government. This sleight of hand was accomplished by:
- Forcing EPA to make prioritization decisions using only existing information, no matter how insufficient that information is.
- Preempting states from imposing new requirements on any chemical EPA designated low-priority, immediately upon such designation.
- Preempting states from imposing new requirements on any chemical EPA designated high-priority long before EPA has completed a safety assessment and determination for the chemical.
While it contained other positive elements, all three of these changes are in the introduced version of the Senate’s Chemical Safety Improvement Act (CSIA, S. 1009). In the House’s original discussion draft of the Chemicals in Commerce Act (CICA):
- #1 is included.
- #2 is even worse than in CSIA, in that low-priority designations would preempt pre-existing as well as new State requirements.
- #3 is better than in CSIA, in that preemption of either pre-existing or new State requirements for high-priority chemicals would not be triggered until a final safety determination has been made, or for a chemical found not to meet the standard, a final risk management rule has been promulgated.
A few improvements have been proposed in the context of ongoing negotiations on both legislative proposals, but as of this writing the fundamental problems remain.
Let’s look in more detail at each of these moves away from the consensus on prioritization:
1. Forcing EPA to make prioritization decisions using only existing information, no matter how insufficient that information is.
Under no circumstances could EPA require development of new information for purposes of prioritization. Where EPA found available data were insufficient, it would have three options – each of which represents truly bad policy. EPA could:
- Designate the chemical low-priority despite the data gaps, undermining confidence in the viability of such decisions.
- Designate the chemical high-priority in order to trigger testing authority to fill the data gaps. This decision would also trigger a mandatory safety assessment and safety determination. If the data then showed the chemical was low-priority, EPA’s resources would be wasted assessing a chemical that didn’t warrant it.
- Defer the decision, and ask for voluntary submissions of information. No deadline or even a timeframe is specified for such submissions, nor for subsequent prioritization decisions by EPA – which, even if made, would still be limited to the two unsatisfactory options just noted. Deferral decisions and the basis for them would not even have to be made public.
2. Preempting states from imposing new [or in CICA, new or pre-existing] requirements on any chemical EPA designated low-priority, immediately upon such designation.
Suddenly, a decision meant to be provisional and based on less than a full safety assessment – one using only already available information and against less than a definitive safety standard – would have sweeping consequences. The decision would amount to a final agency action, yet would not be judicially reviewable (CICA is ambiguous on this point). [Senate negotiations have led to a proposal that these decisions be able to be judicially challenged by a State if it first requested EPA to re-prioritize a low-priority chemical and EPA refused. But that change would hardly address the real problem here, which is that a process meant to broadly sort chemicals would effectively lead to definitive, binding determinations of chemicals’ safety.]
3. Preempting states from imposing new requirements on any chemical EPA designated high-priority, long before EPA has completed a safety assessment and determination for the chemical [in CSIA but not in CICA].
Under this provision, simply emerging from the prioritization process would trigger preemption – well before any actual determination as to a chemical’s safety had been made. And because high-priority chemicals must undergo safety assessments and determinations, the consequences of such an early preemptive effect could be even more perverse than for low-priority chemicals: Companies making such chemicals would have a major incentive to drag out the assessment and determination process for as long as possible, especially if they were concerned it could lead to testing requirements, restrictions or new conditions. That’s because States would have already been taken out of the picture, and the longer the federal process took, the longer the chemical could be marketed without new requirements. (Conversely, delaying any preemptive effect until the end of the safety assessment, determination, and where needed risk management rulemaking would provide incentives to efficiently complete that process.)
CSIA and CICA, as introduced, have no deadlines for completion of assessments, determinations and risk management rules. Negotiations have led to some proposed deadlines, but they would still allow many years for these processes; the last thing we need are incentives to drag things out even longer.
Beyond the shockingly bad policy these provisions represent, there is considerable hypocrisy in those who insist on them. The chemical industry has long argued that decisions on chemicals should be made only after a full risk assessment is conducted based on robust hazard and exposure information. Yet it supports provisions that would not only stymie EPA’s ability to get the information it needs to make sound prioritization decisions, but would dramatically restrict States’ ability to act to protect their citizens – all in the absence or far in advance of definitive risk-based decisions by EPA.
How can this be fixed?
Restoring the prior consensus and ensuring an effective role for prioritization under a reformed TSCA require the following:
- EPA should have the authority to require development of new information to fill critical gaps needed to support robust prioritization decisions.
- Any deferrals of prioritization decisions to collect additional information must be subject to clear deadlines, and the basis for such deferrals must be made publicly available.
- Low-priority designations must be based on robust information on chemicals' hazards, exposures and uses. Because such chemicals are to effectively be set aside for an indefinite period of time, it is essential that such decisions be fully informed.
- Low-priority designations should not be preemptive of State authority, as they are not based on a full safety assessment and are made against less than a definitive safety standard.
- High-priority designations should likewise not have any preemptive effect; any preemption should ensue only after EPA has completed safety assessments and determinations, and where needed, risk management rules, for a chemical.
- With the removal of preemptive effects from low- or high-priority designations, such decisions should not be judicially reviewable.
As a practical matter, a strong federal system will have a strong preemptive effect without legally mandating it: Few states will undertake to regulate chemicals EPA has designated low-priority through a process in which they have confidence. Nor would states be likely to target chemicals EPA has designated high-priority if they are confident EPA will be able to complete their safety assessments and determinations in a timely manner.
The good news is that the issues I’ve raised in this post are under active discussion in both houses of Congress. It is vital that we restore the original vision for a prioritization process under a reformed TSCA, and with it the strong consensus supporting that vision.