Part of a series of blogs on the House bill HR 5820 to reform TSCA.
TSCA reform bill HR 5820 sets up requirements for EPA to establish “safety standards” and a new twist on significant new use rules (SNURs). Here’s a quick summary that applies to scenarios described in related blogs on HR 5820 Implications here.
Safety Standards: EPA has to set a safety standard on the basis of life cycle risk aggregate and cumulative exposures and may set conditions (up to and including a total ban) that would ensure there is “reasonable certainty of no harm” to vulnerable populations throughout the life cycle of a chemical substance.
The number of safety standards will be driven by several prioritization edicts in the bill:
1. EPA must write safety standards for a set of politically identified priority chemicals (BPA, Formaldehyde, phthalates, brominated flame retardants, etc.)
2. EPA must create and work on a steady list of 300 existing chemicals for standards development
3. EPA must evaluate new chemicals and new uses declared by companies for whether a safety standard is needed
4. EPA will set significant volume triggers for what will become “new uses” for chemicals covered by safety standards. Those “new uses” will be considered for whether to modify the standard.
5. If a use is not listed in a standard, it will be a “new use” and subject to the same reporting as a new chemical. Safety standards may or may not have specific conditions that apply to manufacture, processing, use and disposal. Regardless, they will need to contain triggers for what would constitute a new use and require notice (e.g., unlisted uses, significant volume increases).
New Use Rules. Companies proposing to do a “new use” as triggered by the following must submit a notice to EPA that includes the declaration set described in Scenario A (#1) and also the minimum data set (#3) at least 90 days before commencing activity.
1. Significant New Uses Rules (current regulations) still apply
2. If there is a safety standard and a use is not listed in the standard, it is a “new use” and EPA has to decide if it will modify the safety standard or declare the use to be “critical.”
3. If there is a safety standard that lists the use, but the volume is significantly higher than considered, it will be a “new use.” This version of a SNUR would trump the timing of the declaration updates. [presumably, EPA would designate what would trigger this volume threshold in the standard]
The standard of "reasonable certainty of no harm" is not defined in the House bill. The Senate bill described it as: "...presents a negligible risk of any adverse effect on the general population or a vulnerable population." The term comes from pesticides in food tolerances, which doesn't make a lot of sense for the gamut of commercial chemicals.
But EPA will figure it out. And issue the safety standards without rulemaking or notice and comment of any kind, except to allow comment on the science it will use in setting standards in general.
But there will be exceptions for "critical uses." “Critical uses” are for chemicals that cannot meet the safety standard conditions if the EPA is convinced (the burden of proof is on the company) that the use is “critical or essential” and there is no feasible safer alternative or there is a net benefit to health or the environment compared to alternatives. Feasible conditions will still be set and purchasers must be informed that the supplied chemical is subject to a safety standard. These exemptions are good for 5 year periods. EPA will publish them for notice and comment, but not necessarily rulemaking.
Rulemaking is apparently just too cumbersome and such due process gives industry opportunities to challenge and delay EPA control of chemicals.