Nanotechnology Update: EPA Makes a Move
April 16, 2008
Robert Rhodes - Atlanta
Since our last update on this topic,1 the United States Environmental Protection Agency (EPA) has finalized its “Nanoscale Materials Stewardship Program” (the program). On January 28, 2008, EPA published a notice of the design and format of the program.2 The program is intended to facilitate the collection of data on various aspects of nanoscale materials through the voluntary cooperation of entities that manufacture, import, use or process nanomaterials or that engage in nanotechnology research and development.
EPA acknowledged that some commenters on the draft version of the program3 had urged the immediate development of a mandatory regulatory program for nanoscale materials under the Toxic Substances Control Act (TSCA). Others urged the agency to at least use the threat of its mandatory information gathering power under TSCA as a possible incentive to complement the voluntary program. EPA demurred but stated: “While implementing the [program], EPA will continue to consider, as appropriate, the timing and use of all of its authority under TSCA for nanoscale materials.”4
There are two elements of the program: (1) the “basic” program and (2) the “in-depth” program. The basic program element involves the voluntary submittal of all known or reasonably ascertainable existing data on nanoscale materials. Such data would include information on material characterization, hazard, use, potential exposures and risk management practices. EPA has developed a form that can be used to submit data but use of the form is not mandatory. The agency is asking that any submittals under the basic program be made within six months of the publication of the notice.
The in-depth program element will once again involve the voluntary participation of entities to engage in the development of new data. The precise aspects of any future data development efforts will be influenced by review of the data collected in the basic program phase as well as through the joint development of study plans with the participants.
EPA intends to issue an interim report approximately one year after the notice of the program, i.e., by January 28, 2009. This report would essentially summarize (subject to restrictions on the use of data that is considered confidential business information) the data collected during the initial six months of the basic program element. EPA also intends to issue a more detailed report by approximately January 28, 2010.
When Is a Substance “New”?
On a related issue, contemporaneously with the publication of the draft program in July 2007, EPA also issued a draft document titled: TSCA Inventory Status of Nanoscale Substances –General Approach.5 Boiled down, this document stated that, for the most part, EPA will not change its basic approach to determining whether a substance is to be considered a “new” substance for the purposes of the pre-manufacture notice requirements of TSCA. This basic approach is that if a substance has the same molecular structure as a substance listed on the TSCA list of existing substances, the substance will be considered to be existing.
Numerous public comments have urged a different approach that would allow for the consideration of the physical characteristics of a nanoscale version of an existing substance in making the “new versus existing” determination. In the notice issued announcing the program, EPA rejected these comments and announced that it would follow the general approach set forth in the draft.6
As with any controversial policy decision, the January 28 notice has triggered a wide range of public reaction from interested parties. Some have decried the program as too little, too late while others found it to reflect an appropriate balanced approach.
We will report further on this topic as news unfolds.
For more information, email Robert L. Rhodes, Jr. at rob.rhodes@hklaw.com or call toll free, 1.888.688.8500.
1 “Nanotechnology Update: And the Beat Goes On,” Holland & Knight Environment Newsletter, Second Quarter 2007, available at
http://www.hklaw.com/id24660/PublicationId1860/ReturnId31/contentid48297/
2 73 Fed. Reg. 4861 (January 28, 2008).
3 72 Fed. Reg. 38,083 (July 12, 2007).
4 73 id. 4862.
5 Note 3 supra.
6 73 Fed. Reg. 4862 (January 28, 2008).