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By Pat Rizzuto
June 12 --The Environmental Protection Agency should revise and re-propose a data collection rule proposed in April to address industry concerns and to provide needed clarifications, a toxicologist representing the American Chemistry Council's Nanotechnology Panel said June 11.
“Because of the substantial changes to the proposed rule that we feel are necessary and the complexity of the subject, we suggest that EPA re-propose the rule for comments after it has been revised,” Steven Gordon, a toxicologist with the 3M Co., said during a meeting the EPA held to discuss a data collection rule proposed in April (80 Fed. Reg. 18,330).
The proposed rule is too broad, some of its requirements are vague, and it would require companies to report certain physical-chemical data even though there are no agreed-upon protocols and methods for generating that data, Gordon and other industry representatives told the agency during a meeting it held to solicit comments on its proposed rule.
Gordon spoke on behalf of ACC's Nanotechnology Panel, which has a membership that in addition to 3M includes BASF Corp., Cabot Corp., DuPont, Evonik Corp., Lockheed Martin Corp. and Procter & Gamble.
The EPA proposed rule consisted of a one-time and an ongoing reporting obligation.
Jeff Morris, deputy director for programs in the EPA Office of Pollution Prevention and Toxics, said the rule is needed for the agency to understand what nanoscale chemicals are being commercialized and to give the public confidence that it is being developed in responsible ways.
Under the proposed rule, companies that make, import or process separate, or what the agency called “discrete,” nanoscale forms of existing chemicals--substances that already are on the Toxic Substances Control Act's inventory of chemicals that are or have been in commerce--would have a one-time obligation to submit basic production, volume and other information.
That other information would include much more extensive physical-chemical properties data about nanoscale chemicals than the agency typically receives from chemical manufacturers or processors.
A form the EPA posted in the rulemaking docket to illustrate the spectrum of information that companies would report includes up to 43 physical and chemical properties such as vapor pressure, solubility, flammability, crystal structure, particle size distribution, particle shape, surface area, porosity, surface chemical composition, surface charge and biodegradation rate.
In addition to the one-time reporting requirement, the proposed rule would require chemical manufacturers and processors to notify the agency 135 days before they intend to make, import or process a new discrete form of an existing nanoscale chemical. The requirement to submit these notifications would be ongoing, meaning the proposed rule didn't describe whether or when the obligation would end.
Companies providing the notifications would be asked to provide the same information as did companies that were subject to the one-time reporting obligation, the EPA's proposed rule said.
The EPA proposed the rule under Section 8(a) of TSCA, which provides the agency the authority to require the submission of certain types of data companies already have or that is reasonably ascertainable by them.
The proposed rule wouldn't require the generation of data, Jim Alwood, a program manager in the EPA Chemical Control Division, told the audience.
Alwood and Morris asked the audience to offer perspectives on at least six specific aspects of the proposed rule, including how the agency should define what constitutes a discrete form of a chemical.
For example, Morris said, an existing chemical could be made in 10, 50 and 80 nanometer sizes with slightly differing crystal structures.
“Are they all reportable as one [form of a nanoscale chemical] or are they all separate forms?” Morris asked. “These are the types of decisions people who will have to report will have to make.”
Gordon said “separate reporting on each discrete form as currently described in the proposed rule is not adequately justified on the basis of health or environmental risk and would place a large burden on many nanomaterial producers and processors.”
There isn't enough scientific evidence to conclude that any particular physical or chemical property of a nanoscale chemical is consistently associated with posing an increased hazard to people or the environment, he said.
“There is insufficient justification at the present time for using these [physical-chemical] properties as criteria for distinguishing 'discrete forms,' ” Gordon said.
Jo Anne Shatkin, founder of Vireo Advisors, a company that offers risk assessment expertise, market analysis and other services, raised a concern shared by other speakers about the proposed rule's definition of a chemical substance that would be subject to reporting requirements.
TSCA defines a chemical substance as “an organic or inorganic substance of a particular molecular identity.”
The proposed rule's definition of a chemical subject to reporting includes size parameters and the requirement the chemical exhibit “unique and novel characteristics or properties” because of its size.
How can a company measure whether its chemical has novel or unique characteristics or properties, Shatkin asked.
Various international and scientific organizations have described the physical-chemical property data identified in the agency's proposal as being of potential interest in understanding whether a nanoscale chemical would have the potential to harm human health or the environment, Shatkin said.
“However, we would need guidance,” Shatkin said.
If companies are going to provide useful information that could inform future EPA policies for nanoscale chemicals, the agency will need to provide guidance on issues, including how to measure the physical-chemical properties it is interested in and how to prepare chemical samples for such measurements, she said. “It is in EPA's interest, in our interest that we provide the best information.”
Martha Marrapese, a partner with Keller & Heckman LLP and general counsel for the NanoManufacturing Association, said the proposed rule “appears to be trying to expand the statutory definition of a chemical substance, when all EPA is actually interested in is receiving information on physical-chemical properties.”
Speakers also said they are concerned about:
The proposed rule would not apply to chemical substances that only have trace amounts of primary particles or particle clumps of particles, called “aggregates or agglomerates,” in the size range of one nanometer to 100 nanometers.
Gordon was among the speakers that urged the EPA to work with Canada to make their approaches to obtaining information on nanoscale chemicals more similar than their proposed approaches are.
“[ACC's Nanotechnology] Panel is extremely concerned that unless the U.S. and Canadian approaches are more closely aligned, the information requested will not be comparable and the reporting burden on industry will be very high,” Gordon said.
Gordon referred to a consultation Environment Canada and Health Canada launched in February to obtain information on nanoscale forms of chemicals.
Marrapese said Canada's approach is clearer and covers a narrower range of materials.
Canada's proposed approach consists of three phases:
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