TSCA Reform:
On July 25, the U.S. Senate Committee on Environment & Public Works passed a 174-page, substantially revised version of Senator Lautenberg’s 2011 Safe Chemicals Act (S.847). The bill was approved along party lines, with all Republicans voting against it. It will now move to the full U.S. Senate for consideration. Since the bill moved out of committee, we are aware of no meaningful progress toward passage of the bill on the floor of the full Senate. Moreover, it is unlikely that a companion bill will be passed in the U.S. House of Representatives prior to the November election. Therefore, we continue to anticipate meaningful TSCA reform efforts in 2013, but not before then. We also expect this amended bill to remain a focal point of future negotiations in both houses.
- Summary of Proposed Changes – Although the bill would make significant revisions to the current TSCA statute, the law’s scope would remain largely unchanged in terms of persons and chemicals subject to regulation, as well as the range of risk management measures available to EPA. Compared to the existing statute, the bill would increase the regulatory burden of “processors,” making them subject to requirements similar to those imposed on manufacturers (e.g., notifications, risk management). Compared to the prior version of the bill, this version places greater reliance on existing information before requiring new data and information to be generated in a targeted manner as part of a tiered evaluation process. It limits the number of substances that must undergo a full safety determination. It also provides greater protection for confidential business information than the last version. Below is a short summary of some of the more noteworthy changes.
- Inventory Reset – Manufacturers and processors would submit declarations of current or potential commercial interest in “existing” chemical substances (i.e., those on the current TSCA Inventory), and EPA would use the declarations to establish an “Active” and an “Inactive” Inventory. The Active Inventory would list substances for which EPA received declarations of current commercial interest (basically manufacturing/ processing at the time of the new law’s enactment). The Inactive Inventory would list substances that might be used as a substitute for a substance currently manufactured or processed. Substances would be eliminated from the Inventory if no declaration was submitted.
- New Chemicals Notification and Categorization – Pre-manufacturing notices (PMN) would be required for substances not on either the Active or Inactive Inventory. (Certain exemptions would be available, but it does not appear the “articles” exemption would be based on its absence in the prior version or the current amendment. Many of the exemptions would require some form of notification to EPA.) More substantial data and information requirements would apply than under the current statute, even though “existing information” would be used initially. EPA would “categorize” substances and impose data generation requirements on substances in some of the categories. The five categories are listed below.
- Substances in the “SVHC category” would be PBTs and those that are “highly hazardous.” They could not be manufactured or processed except under very limited circumstances requiring an exemption application (e.g., critical uses). These would not be added to the either Inventory.
- “Substances to Undergo a Safety Determination” would be set into one of three “Priority Classes” and then undergo a risk assessment to confirm that their manufacturing, processing, use (including in articles), etc., would meet the safety standard discussed below. Risk management measures could be imposed in order to meet the standard. These substances would be added to the Active Inventory while awaiting assessment because it’s anticipated that they would satisfy the standard.
- “Substances of Very Low Concern” are not subject to risk management, and would not undergo further evaluation unless new information arose indicating a change was necessary. They would be added to the Active Inventory. They would be considered to have “intrinsic low-hazard properties.”
- “Substances with Insufficient Information” would need certain data submitted and could not be manufactured or processed until the EPA had re-categorized the substance into one of the other categories.
- “Substances Unlikely to Meet the Safety Standard” could not be manufactured or processed except under very limited circumstances requiring an exemption application. These would not be added to the either Inventory.
- Existing Chemicals Notification Requirements – Existing chemicals would be subject to certain advance notification requirements. Again, the “articles” exemption appears unavailable.
- Substances on the “Inactive Inventory” would require certain limited data and other information to be submitted before manufacturing or processing could occur.
- Substances on the “Active Inventory” that had not undergone a safety determination would require advance notification before (1) engaging in a use not ongoing at the time of the law’s enactment or (2) substantially increasing the volume of a substance. A submission akin to the current significant new use notification (SNUN) would be required – again certain existing data, etc., would be provided to EPA beforehand.
- Substances on the “Active Inventory” that had undergone a safety determination would require advance notification before undertaking a use that was not included in the determination. The applicant would have to establish with data that the use would also comply with the standard. EPA would impose any new risk management measures that might be necessary to meet the standard.
- Existing Chemicals Categorization – Every five years, EPA would select a “batch” of approximately 6,000 existing chemicals. It would then place them into “categories” very similar to the ones identified above for new chemicals. Substances identified for safety standard determinations would be placed into one of three different “priority” classes and then reviewed. EPA might require data generation to categorize or a substance or to conduct the safety standard determination. Risk management measures could result – again, SVHCs would be subject to expedited and highly restrictive risk management, but certain limited exceptions would be available. Other substances unable to meet the safety standard would be banned except for under limited circumstances (e.g., critical uses).
- Safety Standard – The safety standard proposed remains very rigorous and controversial. It’s the same standard found in the Food Quality Protection Act. Based solely on considering human health and the environment, including vulnerable populations, EPA must determine whether “there is a reasonable certainty that no harm will result to human health or the environment from aggregate exposure to the chemical substance.” The burden of proof rests on the company, however. Use in “articles” must meet the standard as well.
- Confidential Business Information – EPA would place information into one of three categories – (1) always eligible for protection, (2) never eligible, and (3) sometimes eligible. Most eligible information would be protected for 5 years, with a possible extension for another five years. Certain sensitive information would receive indefinite protection. Severe penalties would be imposed for release of protected information or for claiming protections that were unwarranted.
- Preemption of State Laws – the bill does not include a robust preemption provision.
A copy of the amendment to the bill is available here Final-Amendment-to-S.-847[1]. The original version is available here BILLS-112s847is. Senator Lautenberg’s summary is available here. And a webcast of the committee hearing is available here.