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February 20, 2008
Ask EPA is an online interactive forum where you can discuss a wide range of environmental and human health issues with EPA's senior officials.
Today's Session
Jim Gulliford, Assistant Administrator for Prevention, Pesticides and Toxic Substances, will discuss how their new Nanoscale Materials Stewardship Program will examine the human health and environmental risks and benefits of nanoscale chemical products.
Jim Gulliford: Thanks for joining me today to discuss our new Nanoscale Materials Stewardship Program (NMSP), which we initiated in January of this year. Ensuring the proper oversight of nanotechnology is a priority of mine. It is an area where we all need to work together to realize the potential benefits of the products of this promising technology while minimizing health and environmental risks.
The Nanoscale Materials Stewardship Program - or NMSP- was developed through a public consultative process over the last couple years. It is a voluntary program which complements EPA’s new and existing chemical regulatory programs under the Toxic Substances Control Act - TSCA. The NMSP will help to more quickly assemble key scientific information needed to assess and, where appropriate, make risk management decisions on chemical nanoscale materials - which are in production or contemplated for production. Therefore, it will help us to encourage responsible development of nanoscale materials by industry. Let’s get to your questions.
From: George
In: Washington, DC
Question: What does nanotechnology mean? Isn't it just molecules? I mean, everything is molecules, which are nanosized, so what's the deal?
Jim Gulliford: Nanotechnology is generally considered the understanding and control of matter at the atomic or molecular level to create structures with dimensions of roughly one to 100 nanometers -- a nanometer is about one ten-thousandth the diameter of a human hair. Most individual molecules are smaller than one nanometer in size and thus fall below the size range associated with nanotechnology. Nano-sized materials, or nanomaterials, can have properties that are fundamentally different than their larger-sized counterparts, and these differences often enable nanoscale materials to be used in new and valuable ways. Nanotechnology has the potential to change and improve many sectors of the global economy from consumer products to health care, transportation, energy, agriculture and the environment.
From: Eileen
In: New Jersey
Question: Recently, USEPA determined that nanoscale material is not different from its parent material under TSCA. Research shows that nanoparticles behave quite differently in the human body and in environmental systems than their larger cousins. Does EPA plan to conduct any research to prove its assumption that nanoscale particles are not differet from parent compounds?
Jim Gulliford: You're right - nanoparticles may have different characteristics than their macro counterparts. However, as discussed in EPA's paper, "TSCA Inventory Status of Nanoscale Substances – General Approach," we believe that under TSCA nanoscale materials need to be looked at based on molecular identity for the purpose of determining whether a nanoscale substance is a "new" or "existing" chemical substance under TSCA.
EPA will conduct research to learn more about the characteristics of nanoscale materials and assessing their hazards, exposures, and risks. A few weeks ago, we issued a draft Research Strategy describing how the Agency plans to research the potential health and environmental risks of nanoscale materials (see http://es.epa.gov/ncer/nano/publications/nano_strategy_012408.pdf) (76pp, 1.1M, About PDF)
From: Jean
In: Brecksville, OH
Question: Jim, Realistically, when do you think regulations will be promulgated? Some multiple of 5 years is ok.
Jim Gulliford: We've received several similar questions in this session. We're already regulating nanoscale materials that are new chemicals under TSCA, the law that regulates chemicals. Section 5 of TSCA requires that data on all new chemical substances are submitted to the Agency for review 90 days prior to manufacture and introduction into commerce. Since 2005, we've received over 30 new chemical notices for nanoscale materials. My office has taken steps to control or limit exposures to these chemicals, and has also required testing to generate health and environmental effects data where appropriate.
From: Jean
In: Cleveland
Question: Are polymers in the nano-scale?
Jim Gulliford: Yes, dendrimers are a type of polymer that can be in the nanoscale. They consist of polymer chains manufactured to have specific functions and properties different from regular polymers.
From: Chris
In: Arlington, VA
Question: What has the EU done in terms of regulating nanotechnology, and will the US follow suite? Thank you.
Jim Gulliford: We work with the EU and its member countries through the Organization for Economic Cooperation and Development (OECD). We collaborate on research and share approaches to risk assessment and oversight of nanomaterials. This partnership has been very helpful. The EU's approach to distinguishing new nanoscale materials from existing ones is fundamentally the same as ours.
From: rick
In: Boston, MA
Question: If I may ask three questions:
1. Will the research agenda investigate the biodegradability of released nanoparticles, such as whether fullerenes have a markedly different biodegradability than ordinary carbon?
2. Will the research agenda include examining the ability of microorganisms to metabolize such particles as buckyballs or carbon nanotubes?
3. Will the research agenda evaluate the impact of released nanosilver on aquatic organisms?
Jim Gulliford: EPA's research on nanoscale materials focuses in the near and medium term on understanding the environmental fate and effects of nanoscale materials in the environment. Nanoscale material research falls under EPA's Office of Research and Development. The President's FY 09 proposal continues the Agency's increase in resources applied to nanoscale materials environmental health and safety research. For more details, see our Draft Nanomaterial Research Strategy and expert peer review meeting on April 11, 2008 - see http://www.epa.gov/fedrgstr/EPA-RESEARCH/2008/February/Day-13/r2697.htm. As I mentioned earlier, the draft Nanomaterial Research Strategy is at: http://es.epa.gov/ncer/nano/publications/nano_strategy_012408.pdf (PDF) (76pp, 1.1M, About PDF)
From: Nancy
In: Middletown, DE
Question: What influence will EPA's recommendations for chemical products have on consumer chemical products using nano-particles? I ask because of interest in chemical products used in clothing and other consumer productsm health care, personal care, etc.
Jim Gulliford: EPA shares responsibility for consumer products with other federal agencies, such as the Consumer Product Safety Commission and the U.S. Food and Drug Administration. My office would review the potential risk of nanoscale materials used in clothing, but FDA handles health care and personal care products. We would also be involved in the review of other consumer products such as cleaners and disinfectants. The information developed under the NMSP will help improve understanding of chemical nanoscale materials - their uses, properties, potential risks and benefits - and will hopefully be useful to other federal agencies as well.
From: Warren
In: Washington, DC
Question: What kind of response has EPA received to the Stewardship Program from industry so far?
How many companies does EPA anticipate will be particating in the Stewardship Program by the end of 2008?
On the regulatory side, does EPA expect to amend its PMN form to require information on particle size?
Jim Gulliford: The first answer is: very positive. Many US trade associations support the program and encourage their members to participate. In fact, DuPont has already submitted information for a nanoscale titanium dioxide.
I expect widespread participation in the NMSP because it will help us all better understand nanomaterials and implement a more effective oversight program.
Finally, information from the program will help us determine whether any changes to the PMN form are needed.
From: Stacey
In: Corvallis, OR
Question: The NanoHealth Enterprise Initiative recently formed several project groups to address health and safety aspects of nanotechnology, both implications and applications. Our group – the Informatics Science Project Group - aims to consolidate and integrate data on nanomaterial characterization and their interactions with biological systems. I am interested in finding out where the data from the Nanoscale Materials Stewardship Program will be housed and who will serve as a contact for that information. Thank you for your time.
Jim Gulliford: Thank you Stacey for your efforts! Our goal is to make as much of the information available to the public as we can, consistent with rules protecting confidential business information. We've also encouraged industry to submit as much as they can non-confidentially. We're considering how best to provide access; check our Web site as we make progress: http://www.epa.gov/oppt/nano/
From: Gina
In: Gloucester, VA
Question: Are engineered nanoscale chemical products that are being produced on an R&D basis subject to Premanufacturing Notice requirements?
Jim Gulliford: R&D activities under TSCA are not subject to PMN requirements. Commercial R&D activity is subject to TSCA regulations, which require that researchers manufacture the chemical in small quantities solely for R&D; notify anyone who handles the chemical of any known health risks; and ensure that the chemical is used by or directly under the supervision of a technically qualified individual.
I also encourage researchers to participate in the NMSP.
From: Christie
In: Hillsdale, MI
Question: What are the primary human and environmental risks that EPA is concerned about with regard to nanoscale chemical products?
Jim Gulliford: Our goal under the NMSP and EPA's research program is to develop the information needed to assess health and environmental risks of nanoscale materials. We'll look at acute and chronic risks to workers and consumers, as well as to the environment.
From: N. Luke
In: Edison, NJ
Question: Will we expect the regulations for the nomaterials soon? if so, when? Also does EPA plan to publish guidelines on how to conduct human health and ecological risk assessments on nanomaterials? Thank you.
Jim Gulliford: As I have mentioned in my response to Jean, EPA is already using its authorities to regulate nanoscale materials that are new chemicals under TSCA.
EPA will evaluate the NMSP data received during the first six months and after two years of implementation to determine whether any refinements are needed during or at the end of the program, including any needed TSCA regulations.
Regarding guidelines for risk assessments, EPA is working on various fronts which could inform whether we may need to adjust risk assessment approaches for nanoscale materials. These efforts include the NMSP, EPA research and case studies, working with other federal agencies and with our international partners through the OECD, among others. It will likely take several years of effort to develop the scientific understanding and assessment experience needed to support development of guidelines for risk assessment.
Jim Gulliford: Thanks for the great questions and for joining me today to discuss this exciting area. As I mentioned earlier, EPA's Nanoscale Materials Stewardship Program will help to encourage responsible development of nanoscale materials by industry. We hope that forums like this continue to showcase this effort and foster active participation in the NMSP.
EPA will be discussing the NMSP at a number of upcoming conferences and industry association meetings, including the Global Chemical Regulation Conference where I will lead a nanotechnology session on the afternoon of March 18th in Baltimore, Maryland.
Join us for the next Ask EPA session on Wednesday, March 12, at 1:00 pm eastern time. Dr. George Gray, Assistant Administrator for Research and Development, and the Agency's Science Advisor, will discuss the diversity of science careers at EPA. From engineers, chemists and toxicologists in the lab to ecologists in the field, he'll cover how EPA scientists and engineers are protecting human health and the environment.