Sen. Lautenberg released the 2011 version of the Safe Chemicals Act for TSCA Reform April 14 here. I’ve blogged about it before and posted a summary pdf here.
The notable changes I see from last year’s version:
– References to mixtures and articles have been deleted here and there. No PMNs by new mixture makers. But mixture and article makers with new uses of “existing” chemicals will still have to submit essentially SNUNs (with minimum data set updates) or proof that the use meets the safety standard (if there is one). Mixture and article makers are still “processors” under SCA, so there still needs to be clarification in the bill. Oddly, the new bill drops allegations of adverse effects and information on substantial risk (old 8(c) and (e)) on mixtures.
- Some definitions were dropped or modified. "Adverse Effect" is gone, as is "Special Substance Characteristics" because they got incorporated into later language. "Reasonable Certainty of No Harm" definition is gone but is used in section 6 as a required finding by the Administrator for a determination that a chemical and its use meets a safety standard:
"6(b)(1)(C)(ii)(I)(bb) find that a chemical substance meets the safety standard only if the Administrator finds that there is a reasonable certainty that no harm will result to human health or the environment from aggregate exposure to the chemical substance."
[that in addition to required EPA review, but recognized as likely not available, of cumulative exposures. Reminder: "aggregate exposure" means all sources, whether or not TSCA "chemical substances" and "cumulative exposure" means all substances with a similar/same effect.]
The fun part is that manufacturers and processors have to provide EPA with "sufficient information" to make the above finding - with EPA left to decide when they have enough to agree something will have no harm. EPA manages to deal with no unreasonable risk in today's PMN calls, but this positive finding? Of course, the EPA can impose risk management actions to ensure no [aggregate] harm. How precautionary will they be?
- What is to prevent EPA from keeping chemicals and their uses in forever limbo by either failing to set a safety standard or agreeing a company has provided enough "proof"?
- New use notifications won't be required as long as someone got the use on the inventory of declarations under section 8(a)(2) instead of last year's version that you had to have declared it. Of course, it will depend on what gets defined as a significantly increased volume than was first reported. If there is a safety standard, you must declare you will meet the standard. If there is no safety standard, you will have to provide the data set to allow EPA to write one.
- The bill expects Minimum Data Sets (that will at a minimum support screening level risk assessment) on all chemicals within 5 years of the effective date of the law. Take that, REACH!
- The biggest change is setting up 3 priority classes of chemicals for safety determinations and risk management action instead of EPA coming up with a standing list of 300 priority chemicals:
Priority Class 1: Require Immediate Risk Management. EPA has to list 20 - 30 chemicals within the first year. 18 months after listing, EPA imposes conditions "necessary to achieve the greatest practicable reductions in human or environmental exposure." It gets a year after that to get rid of residual risk above the safety standard.
Priority Class 2: Chemical Substances That Require Safety Standards. This one puzzles me. EPA assigns as many chemicals as it can manage to this class based on
"...any more-than-theoretical concern, that there is uncertainty as to whether a chemical substance would satisfy the safety standard in a determination..."
But is this only for chemicals with safety standards already or those that would likely fail a not-yet-promulgated safety standard? Recall that a new "inventory" of safety declarations will be required for all chemicals; but no way is EPA churning out standards very fast. I assume this one is the corollary to REACH's Candidate List of Substances of Very High Concern.
Priority Class 3: No Immediate Action Required. The title doesn't match the criteria. This is a list of chemicals with intrinsic properties such that at no stage of their life cycle would there be "any risk of adverse effects" under existing, proposed or anticipated levels of exposure. I doubt there will be many chemicals that will qualify!
- It drops EPA publishing an inventory of chemicals by effects, exposure or lack of data at least. The agency also gets more time to publish data and decisions on the internet.
-Sneaky big change: Import requirements will apply to chemicals imported as part of articles as if the chemicals were imported in bulk under the revised bill, unless the EPA or Homeland Security exempts them. Holy cow! Since every chemical has some requirements - minimum data sets, safety declarations, eventual safety standards, import certification, etc. - this is going to be a nightmare. Not sure they thought this one through.
- Minor change on state preemption. TSCA preempts only if it is impossible to comply with both a state regulation and a TSCA requirement.
The safety standard-driven reporting requirements remain mind-boggling. The freedom for the Agency to require any information and institute any conditions it wants by order and without judicial review remains of considerable concern.
I assume we are still looking at continued dialog and little action in this Congress.