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KELLER AND HECKMAN ALERT

Jun 24, 2011

Bipartisan Meetings on The Safe Chemicals Act of 2011

A series of stakeholder meetings on Toxic Substance Control Act (TSCA) (15 U.S.C. § 2601 et seq.) "reform" beganin the Senate this week, on June 21, 2011. Billed as bipartisan stakeholder talks, these meetings may bring uscloser 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 keyprovisions in the most recent TSCA reform bill, the Safe Chemicals Act of 2011 (S. 847). S. 847 was introduced bySenator Frank Lautenberg (D-NJ) on April 14, 2011, and is co-sponsored by Senators Barbara Boxer (D-CA), CharlesE. Schumer (D-NY), Amy Klobuchar (D-MN), and Al Franken (D-MN).

Limited Preemption

The Safe Chemicals Act of 2011 would implement a nearly toothless preemption provision that would allow forbroad regulation of chemical substances by states and localities. The bill permits state and local governments toregulate chemicals unless it is impossible for regulated entities to comply with both the federal and the state orlocal 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 thecurrent statute. The bill would eliminate the current "polymer exemption" by deleting section 5(h)(4). The billwould 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 themanufacture, processing, or distribution of a new chemical substance (a substance that does not appear on theTSCA Chemical Substance Inventory) that is found not to meet the safety standard, or any mixture or articlecontaining such a substance. Additionally, chemicals and mixtures imported as part of an article would also besubject to the requirements of the legislation as if they were imported in bulk. The bill also broadens thedefinition of "distribution in commerce" to include export. Finally, the bill includes a provision clearly aimed atnanomaterials, viz., EPA may deem that a variant of a chemical substance (due to different size or shape) is a newchemical 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 harmwill result to human health or the environment from aggregate exposure to the chemical substance. While this issimilar 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 theFederal 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'sdetermination is not judicially reviewable.) To manage risks of a chemical substance, EPA may prohibit or limitcertain 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, usesof 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 wouldessentially be in the same position as manufacturers in terms of their obligations under TSCA. Failure to distinguishthe processing step means that only end users would be exempt from notification requirements that havetraditionally applied only to manufacturers and importers under TSCA.

Prior to manufacturing or processing a new chemical substance, the manufacturer or processor would be requiredto submit a notice to EPA. The bill thus expands the existing concept of a pre-manufacture notification (PMN) toinclude a pre-processing notification. (The terms "pre-manufacture" and "pre-processing" are used here to describethe notification obligations, despite the bill not using these particular terms.) Along with a notification, amanufacturer or processor would be required to provide EPA with data sufficient to allow EPA to conduct ascreening-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 aspart of this notification process publically available.

The bill establishes a system that avoids submission of multiple minimum data sets for the same chemicalsubstance under the notification process. EPA can waive the data requirements for a new chemical substance if itpreviously received data on an "equivalent" substance, and it determines that additional data would beduplicative. To take advantage of this exemption, a manufacturer or processor must reimburse the original datasubmitter for use of the data.

Once EPA receives a notification, the Agency may approve an activity involving a new substance if either (1) thesubstance 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 releasedinto the environment in quantities of less than 100,000 pounds annually;

· The substance is not a known, probable, or suspected reproductive, developmental, neurological, orimmunological 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 thebody; and