Report from the Front - EPA Meeting

Sorry, I've been kind of busy so here's my review of the EPA meeting from yesterday. I will blog more this week.

Report from the Front
U.S. Environmental Protection Agency
Office of Pollution Prevention and Toxics

June 23, 2005
Public Meeting on Nanoscale Materials
Washington Plaza Hotel

The meeting of about 200 people from academia, industry, NGOs, etc., examined regulatory modalities appropriate for nanoscale materials. The distinction between new and existing materials becomes important since the materials may face different regulatory regimes. For example, existing materials may be subject to a voluntary pilot program, like HPV, DfE, Green Suppliers Network, etc. New materials would be subject to current mechanisms including exemptions for LVE, LORex, polymers, etc. As such, there was much interest expressed in whether nanomaterials were existing or new. There was recurring interest in characterization and nomenclature, esp. methodologies for measurement. Interest to share efforts with countries, esp. OECD, was expressed. Overall, there was interest in collecting information on production, use, exposure and release, health and environmental effect, and life cycle fate if products.

Speakers included:
First session
• David Jones of Nanoscale Materials who described his company’s products based on an active agent derived from magnesium oxide. I particularly enjoyed his remarks that everyone was a stakeholder.
• Fred Klaessig of Degussa discussed fumed silica and how it appears on the CAS. He commented on agglomeration and aggregate nature of nanoparticles and discussed some of the parameters for definitions.
• Jo Anne Shatkin of Cadmus encouraged a better understanding of persistence, mobility, and bioaccumulation in characterization.
In questioning, it was noted that most of the toxicological research deals with acute rather than chronic toxicity. The criterion of porosity was added to definition list. A brief discussion over safety protocols ensued and concern was expressed about new entrants.

Second session
• Karluss Thomas discussed the ILSI-ELSI reports.
• Julie Fitzpatrick from RSI recommended a toxicity screening strategy for nanoscale materials, including the need for testing protocols. Definitions need to include size distribution, agglomeration state, shape, crystal structure, chemical composition, surface area, surface chemistry, and surface charge.
• Sherry Ward from PCRM seemed exceedingly concerned on including animal rights groups as stakeholders.
• Phil Radford spoke and claimed to speak for over a dozen groups, including Greenpeace and the NRDC. Advocating the precautionary principle, he claimed the UK and Swiss RE reports called for releases into the environment should be minimized and materials should be treated as toxic. He also suggested Swiss RE called for a moratorium on same applications until more is known [sorry, I read that report and Hett calls for an active application rather than a strict application of the precautionary principle]. He made a long list of normative recommendations including: treating all materials as new. He called for “adequate” toxicity testing, an inventory for “all” engineered nanoscale materials, an export notification and tracking system, all testing be undertaken by independent bodies, “adequately” funded public dialogues, “equitable” impact analysis, increased federal funding for toxicity, bio-accumulation, and development of methodologies.
In questioning, there was agreement for broad stakeholder dialogues being a high priority. There was a case made for co-development or co-evolution along with a voluntary pilot program which should not be viewed as mutually exclusive with other regimens.

Third session
• Richard Dennison and Larry Andrews co-presented some fundamental principles of agreement between SCC and Environmental Defense.
• Denison called for increased government spending for EHS research, open and transparent rule making, appropriate protecting measures, etc. He called to extend rules to all such materials, existing and new, to collect and produce sufficient data for hazard and exposure potential, to study material across full life cycles, to identify appropriate safety measures, and to work within the existing regulatory framework. He warned against reliance on estimation methods for lack of data. He chided VPP on existing-new materials definitions, how it sidesteps current regulatory frameworks, was ineffective in terms of encouraging participation, and had unclear reporting methods. He wants rebuttal presumption to rest on “new” material status. He called for pro-active risk management.
• Andrews supported the VPP proposal and called for global harmonization of nomenclature, information gathering, transparency, and increasing EHS funding. He called for assessment data from testing proposals, opportunities for public education and communication, and steps in the VPP.
In open discussion, EPA admitted $5 million a year was spent for EHS funding. There was some discussion on transitioning beyond the VPP. A question arose on who should pay for research and there seemed to be consensus the government should pay for developing platform methodologies, but EHS research should be supported by government and industry. An advisory panel was discussed and some concern was expressed over the exclusion of CBI. A discussion ensued over requirements in a VPP including a minimum data set, obligation to notify, scope, schedules, checkpoints, etc. A representative from the Science Committee said some effort to limit dispersive uses might decrease some of the urgency expressed by the body. It was agreed start-ups may be especially challenged by nature of their budgets and time commitments when it comes to programs, like VPP, and would benefit greatly from stewardship. I complained about the deficit model of science communication with lay persons and how toxicology is more intuitive and how risk algorithms fail to value benefits across the range of nanomaterials activities.

The inventory of information called for by the body should include:
• toxicological data, both health and ecological for the full cycle of the materials,
• exposure data, test methods,
• lab safety standards of care and protocols,
• appropriate protective equipment and best practices inventories,
• stewardship procedures and risk management schemes.