I’m sorry I wasn’t able to continue my analysis last week of the new Chemical Safety Improvement Act that is currently in committee. Lots of busy times, not enough sit-down-and-write times. I’ve talked about CSIA here, here, here and here if you’re not caught up.
CSIA almost entirely replaces the corresponding section of TSCA with some requirements for safety assessments and determinations of chemical substances. This is a fairly massive change, with a lot of groundwork to be done by the EPA if this part of the bill passes in its current form. It requires that the EPA conduct a safety assessment on high-priority chemical substances, and make a determination for each substance. This means that the EPA must “establish requirements for risk management of a high-priority substance,” based on the results of the safety assessment.
The requirements for the safety assessments include a schedule that will be established by the EPA, based on “considerations of risk to human health and the environment.” The EPA must also establish procedural rules for safety assessments and determinations, schedules for the submission of data and deadlines for the completion of said safety assessments.
These rules shall:
- Identify the basis upon which the EPA designates certain substances to be high-priority
- Require the EPA to inform the public about which substances are considered high-priority
- Allow interested parties (companies, members of the public, State governments, etc.) to submit information regarding the high-priority substances
- Require the EPA to make this information available, offer an opportunity for comment, and publish final safety assessments and determinations
CSIA allows the EPA a tiny bit of flexibility in the schedule for these safety assessments in the form of “reasonable” time extensions “after an adequate public justification.”
When conducting a safety assessment, the EPA is required to consider the data mentioned in Section 4 and any additional information that has been submitted. Each safety assessment will include a summary of the weight of the evidence and the relevant information, as well as a non-technical summary that explains what that information demonstrates in the context of intended conditions of use for the substance in question.
The EPA will be required to develop a “science-based methodology for conducting safety assessments.” This methodology must be made public for comment and peer review. The methodology will be reviewed and revised at least once every five years, and may be reviewed/revised more frequently as needed. The EPA must consider exposures or significant subsets of exposures, exposure duration, intensity, frequency and “the vulnerability of exposed populations.” The EPA is required to use the “best available science” when conducting safety assessments. If the EPA determines that more data or information is needed, the EPA must again provide an opportunity for interested parties to submit additional information and may “promulgate a rule, enter into a testing consent agreement, or issue an order under Section 4 to require development of the information.” Remember, the EPA would be allowed to leverage the manufacturer of the substance to gather more information and help with testing.
Under Section 6, a safety assessment shall not be considered final agency action, and is not subject to judicial review.
The EPA has a relatively wide range of restrictive actions it is allowed to take based on the outcomes of the safety assessments. They include labeling and warning requirements, recordkeeping and reporting requirements, data development obligations, production limits, and finally bans or phase-outs of a chemical use, distribution method, or any aspect of a chemical that does not meet the safety standard.
There is an entire subsection devoted exclusively to defining the “considerations” on which the EPA may take such restrictive actions. It lists economic and benefit factors that must be considered, which include the “availability of technically and economically feasible alternatives” for the substance under its intended condition of use, the risks posed by alternative substances compared to those of the original substance, and “the economic and social costs and benefits of the proposed regulatory action and options considered, and of potential alternatives.” Bergeson & Campbell PC’s reading of this section seems to imply that this section attempts to limit the consideration of cost/benefit in circumstances that involve a ban or phase-out action.
There are circumstances listed in Section 6 in which the EPA may consider an exemption from additional restrictions. The EPA is also authorized to potentially make determinations that involve national security, “significant disruption in the national economy”, critical or essential use for which no chemical substitution is possible, or circumstances in which the use of a chemical provides a net benefit (compared to available alternatives) to human health, the environment, or public safety.
Safety determinations shall be considered final agency action and is also subject to judicial review.
This section merely clarifies the corresponding section in TSCA, and not in any meaningful way.
CSIA keeps some things and changes some things in this corresponding section of TSCA. The changes include requiring the EPA to promulgate rules requiring reporting of information so that the EPA has the necessary information to carry out the mandates listed in Section 4 and Section 6. These reporting requirements include information that is known by or reasonably ascertained by the person making the report. This section makes an explicit mention of processors, rather than users, which seems significant considering the recent disasters in processing plants.
The rules may differ from manufacturers and processors, but these rules are limited to active substances or mixtures thereof, and only applies to the extent the EPA determines is necessary for the effective enforcement of CSIA. The EPA is required to develop guidance to assist processors and manufacturers with understanding these reporting requirements.
Section 8 confirms the continued use of nomenclature established in the Soap and Detergent Association Nomenclature System. It also discusses circumstances in which multiple nomenclature conventions might be used and the EPA must make a very clear establishment of equivalent conventions. It also requires the EPA to recognize chemical mixtures that have multiple Chemical Abstracts Service (CAS) number listings as a single substance, rather than separate substances (currently, this is a pain in the ass).
CSIA describes an approach to create and update a list of “active” versus “inactive” listed chemicals, and to make available a “candidate list of active substances in commerce.” It goes on to define “active” chemicals, citing the reporting rules to which those chemicals are subject.
Section 8 requires the EPA to update this updated list after each Chemical Data Reporting cycle. It also allows “any person” to submit information or data that reasonably supports the conclusion that a given chemical substance “does not present a substantial risk of injury.”
This section makes only conforming changes to the corresponding section in TSCA.