Date: Jun 24, 2011
A series of stakeholder meetings on Toxic Substance Control Act (TSCA) (15 U.S.C. § 2601 et seq.) "reform" began in the Senate this week, on June 21, 2011. Billed as bipartisan stakeholder talks, these meetings may bring us closer to a viable TSCA reform proposal. Senate staff have advised us that the meetings are closed to the public, so while we await word on the fate of TSCA reform in this legislative session we provide this summary of key provisions in the most recent TSCA reform bill, the Safe Chemicals Act of 2011 (S. 847). S. 847 was introduced by Senator Frank Lautenberg (D-NJ) on April 14, 2011, and is co-sponsored by Senators Barbara Boxer (D-CA), Charles E. Schumer (D-NY), Amy Klobuchar (D-MN), and Al Franken (D-MN).
The Safe Chemicals Act of 2011 would implement a nearly toothless preemption provision that would allow for broad regulation of chemical substances by states and localities. The bill permits state and local governments to regulate chemicals unless it is impossible for regulated entities to comply with both the federal and the state or local standard. Under this provision, it would be quite challenging to make a case for preemption.
An Uncertain Future for Current TSCA Exemptions
The bill would significantly alter the scope of TSCA by eliminating important exemptions that exist under the current statute. The bill would eliminate the current "polymer exemption" by deleting section 5(h)(4). The bill would also repeal the "article exemption" under TSCA through provisions applying not only to chemical substances, but also to mixtures and articles containing those substances. Of particular interest, the bill prohibits the manufacture, processing, or distribution of a new chemical substance (a substance that does not appear on the TSCA Chemical Substance Inventory) that is found not to meet the safety standard, or any mixture or article containing such a substance. Additionally, chemicals and mixtures imported as part of an article would also be subject to the requirements of the legislation as if they were imported in bulk. The bill also broadens the definition of "distribution in commerce" to include export. Finally, the bill includes a provision clearly aimed at nanomaterials, viz., EPA may deem that a variant of a chemical substance (due to different size or shape) is a new chemical substance, despite having an identical molecular identity.
New Safety Standard Based on Pesticide Law
This bill creates a new safety standard for chemical substances under TSCA: a reasonable certainty that no harm will result to human health or the environment from aggregate exposure to the chemical substance. While this is similar to the existing safety standard for pesticides under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), it is not clear how it would be applied in practice. To calculate the "aggregate exposure" to a substance, EPA must consider sources of exposure not regulated under TSCA (such as drugs, which are regulated under the Federal Food, Drug, and Cosmetic Act (FFDCA)).
If EPA determines that a substance does not meet the safety standard, the Agency may prohibit the manufacture, processing, and distribution of the substance, or any mixture or article containing that substance. (Note that EPA's determination is not judicially reviewable.) To manage risks of a chemical substance, EPA may prohibit or limit certain uses of the substance or activities involving the substance (manufacture, process, distribution, disposal), among other actions. Should the Agency determine that a chemical substance meets the new safety standard, uses of the chemical will be limited to those uses outlined in the Agency's safety determination.
New Obligations of Downstream Users: Manufacturers and Processors Indistinguishable under TSCA Bill
The bill imposes certain new obligations on manufacturers and processors. The bill does not define "processing" or "manufacturing," nor does it differentiate these distinct parts of the supply chain. As a result, processors would essentially be in the same position as manufacturers in terms of their obligations under TSCA. Failure to distinguish the processing step means that only end users would be exempt from notification requirements that have traditionally applied only to manufacturers and importers under TSCA.
Prior to manufacturing or processing a new chemical substance, the manufacturer or processor would be required to submit a notice to EPA. The bill thus expands the existing concept of a pre-manufacture notification (PMN) to include a pre-processing notification. (The terms "pre-manufacture" and "pre-processing" are used here to describe the notification obligations, despite the bill not using these particular terms.) Along with a notification, a manufacturer or processor would be required to provide EPA with data sufficient to allow EPA to conduct a screening-level risk assessment on the substance. The data set must include information on the characteristics, toxicological properties, exposure, and use of the substance. EPA would make information and data submitted as part of this notification process publically available.
The bill establishes a system that avoids submission of multiple minimum data sets for the same chemical substance under the notification process. EPA can waive the data requirements for a new chemical substance if it previously received data on an "equivalent" substance, and it determines that additional data would be duplicative. To take advantage of this exemption, a manufacturer or processor must reimburse the original data submitter for use of the data.
Once EPA receives a notification, the Agency may approve an activity involving a new substance if either (1) the substance meets the new safety standard, or (2) the substance and activity meet all of the following criteria:
· The annual manufacturing volume for the substance is 1,000,000 pounds or less, or the substance will be released into the environment in quantities of less than 100,000 pounds annually;
· The substance is not a known, probable, or suspected reproductive, developmental, neurological, or immunological toxicant, carcinogen, mutagen, or endocrine disruptor;
· The substance is neither persistent nor bioaccumulative;
· The substance is not found in the human body at levels that exceed those at which it is normally present in the body; and
· The substance is not found in food, drinking water, air, residential soil, or house dust in excess of normal, medium-specific levels.
Under the bill, EPA has one year from receipt of a pre-manufacture or pre-processing notice to determine whether a substance meets the new safety standard. No later than 30 days after manufacture or processing of the new chemical substance begins, the manufacturer or processor must provide EPA with a Notice of Commencement (NOC).
New uses of an existing chemical substance (a substance listed on the TSCA Inventory) also require a filing with EPA. If EPA has already made a safety determination for the existing substance, the determination has the same impact as a TSCA section 5 significant new use rule (SNUR) under the existing statute: manufacture or processing of the substance for a "new use" is prohibited, unless the manufacturer or processor submits a notice to EPA and updates the minimum data set with information relevant to the new use. If EPA has not yet made a safety determination for the substance, a "declaration" and certain information must be submitted prior to manufacture or processing in significantly increased volumes, or for uses that were not ongoing at the time the bill was enacted.
Existing Substances Also Subject to Filing Requirements
The bill would upend the regulation of existing chemicals under TSCA through new notification and data requirements. For substances in commerce at the time the bill is passed, a minimum data set must be submitted within five years of the bill's passage. Also, every manufacturer and processor of an existing substance must submit to EPA a declaration providing the chemical identity of the substance and its uses; the annual production volume; all locations where the chemical is manufactured, processed, or distributed; and a list of health and safety studies on the substance. EPA will make available to the public any submitted information that the Agency deems significant.
Prioritization of Chemicals into Three Classes
Under the bill EPA will publish a list of chemicals warranting placement in one of three priority classes. A data set for a substance must be provided to EPA within 18 months of its assignment to a priority class.
Priority Class 1 is reserved for substances that are, or degrade or metabolize into, persistent, bioaccumulative, and toxic substances that could result in widespread exposure. Within 18 months of a substance being assigned to priority class 1, EPA must limit activities involving the substance to achieve the greatest practicable reduction in exposure.
A chemical substance will be placed into priority class 2 if EPA has more than a theoretical concern about the uncertainty of whether the substance will meet the safety standard. Within 30 months of assignment to priority class 2, manufacturers and processors of the substance must update its data set and provide EPA with any other required information. Within one year of this supplemental submission, EPA must determine whether the substance meets the new safety standard.
Priority Class 3 will consist of substances that will not pose any risk of adverse effects at any stage of their lifecycles, under existing or anticipated production, patterns of use, and levels of exposure. EPA's decision to assign a substance to any of the priority classes is not judicially reviewable.
EPA May Require Testing and Publish Results Online
The bill authorizes EPA to require manufacturers or processors to conduct tests and provide the results to the Agency. If data on a particular substance has already been submitted, others may be exempt from the requirement as long as they compensate the original data submitter. EPA will post to a publicly accessible internet site all data submitted pursuant to a test order.
Confidential Status Granted to Select Business Information
Finally, the bill proposes a completely new approach to handling confidential business information (CBI) under TSCA. The bill requires EPA to establish standards regarding the type of information that may be claimed as CBI. While some information (like health and safety studies for commercial chemicals) are automatically ineligible for CBI protection, information that discloses manufacturing or processing procedures and percentages of chemical substances in mixtures remains protected as CBI. Generally, information granted confidential status will remain confidential only for five years, but EPA may designate certain types of CBI for which confidentiality is not time-limited.
For up-to-the-minute coverage on TSCA Reform, visit Keller and Heckman's TSCA Reform Center at www.tsca-reform.com.
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