The new Lautenberg-Vitter Chemical Safety Improvement Act (CSIA) TSCA reform bill offers some interesting “fixes” to TSCA, but may fall short of NGO demands for more data and more bans. Here are my first pass impressions:
Safety Standard: The new TSCA standard would be compliance with a safety standard defined as: “a standard that ensures that no unreasonable risk of harm to human health or the environment will result from exposure to a chemical substance.’’ A safety determination that a chemical meets a safety standard is based on a “safety assessment” which means a risk-based assessment of the safety of a chemical substance that— (A) integrates hazard; use; and exposure information about a chemical substance; and (B) includes— (i) an assessment of exposure under the intended conditions of use; and (ii) reference parameters that may be appropriate with regard to a specific chemical substance (such as a margin of exposure).
Safety assessments are based only on health and environmental risk only. However, restrictions on chemicals that do not meet the safety standard must look at the costs, benefits and whether feasible alternatives exist and offer net benefit for safety.
New chemicals must meet the safety standard under “the intended conditions of use” and will likely be covered by SNURs and restrictions to bind them to a safe intention. EPA appears to maintain its current authority to ask for more data before making the safety determination or having restrictions until it is developed, but there is no required upfront test data set.
Priorities: A new inventory of existing chemicals that are “active” in commerce (the last 5 years) will be created and screened into two pots: “high” and “low” priority. “High ” priority is based on high hazard PLUS high exposure. EPA is to look at exposure to “vulnerable subpopulations” as well. EPA is to rank chemicals for action, based on existing data and recommendations from states, and systematically work through the high priorities to come up with safety standards and restrictions. No arbitrary deadlines or minimum number of chemicals on the hit list – but can EPA get its act together without them?
Mo Data: If EPA needs data it can collect existing data from manufacturers and processors as now, with an encouraging word on asking for voluntary info. EPA can issue orders to require new testing. However, EPA is to do 2 screening tiers using in silico, in vitro and “focused” in vivo for major effects first and then go for more, with minimization of animal testing.
The lists of high and low priority chemicals will be published, but no judicial review is allowed until rulemaking on restrictions are developed. The potential for a lot of de facto blacklisting by pending action is significant.
Restrictions: Section 6 is rewritten to be focused around determining whether a high priority chemical meets a safety standard and offering a gamut of restrictions up to a full or partial use ban as long as EPA considers the weight of evidence and magnitude of risk. If EPA wants to ban or phase out a chemical or uses, it has to show feasible and safer alternatives exist and the economic and social costs of proposed actions. Exemptions can be made for national security and “critical” chemicals where continued use provides a net benefit. All done by regular notice and comment rulemaking, which should ease EPA’s burden.
Good Science: CSIA is replete with language on using “best available science” “scientifically sound criteria” “quality” “reliable” “relevant” “objective” “weight of scientific evidence” “scientifically valid” Defining what this all means in practice will be an ongoing debate.
Transparency: Lots of publication of frameworks for decision-making and the basis for decisions and opportunity for comment, but not judicial review of screening results and safety determinations. Alternatively, confidential information is provided for specific information, as long as substantiation (with a time delineation) and generic information is released. States who have systems in place to manage confidential info can get it.
Preemption: Mostly. States can’t restrict use if EPA has done a safety determination, nor can they duplicate information collection. But if a state has water, air, waste issues they can do whatever.
Overall – if EPA and stakeholders can agree on the frameworks for determining “safety” and EPA devotes resources to plowing through the chemicals in commerce without designating everything as “high” – maybe there will be progress. There will continue to be lots of arguments on what constitutes sound scientific support for risk assessment and restrictions. WIll this bill induce constructive discussions? One can only hope….
But that was only my first pass. There are always hidden gotchas and changes will be made as this gets stakeholder input. Stay tuned.
UPDATE 9/2/13: See my post on Boxer and her issues. No clue on redrafting that may be going on behind the scenes, but likely California will get their preemption removed. Lynn Bergeson has a nice summary of CSIA here. Hard to believe anything will happen this year with all the hot national issues roiling Congress, but maybe TSCA reform will be seen as an easier vote-getter.