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The Program on Reproductive Health and the Environment (PRHE) at the University of California, San Francisco (UCSF) is part of the Department of Obstetrics, Gynecology & Reproductive Services located in UCSF’s School of Medicine. PRHE just published its "Recommendations for Addressing Potential Health Risks from Nanomaterials in California” which was commissioned by California's Office of Environmental Health Hazard Assessment  (OEHA).  The document is designed to provide the State with an overview of nanotechnology materials and their potential exposures and human health risks, and proposes a selection of policy options for addressing potential hazards and risks from nanotechnology.  We previously provided our comments on the May 2010 draft of this document here.  A year later, many of our same concerns still apply to the final document.

The new document makes a range of recommendations, which are set forth below:

Recommendations to address health risks from nanomaterials for OEHHA that can be achieved under the existing regulatory structure:

1. Develop a definition of nanomaterials that can be used to identify them.

2. Identify and define priority properties for risk characterization and collect information about them for each nanomaterial.

3. Develop characteristics by which to define, describe, and group nanomaterials according to conventional or unique properties.

4. Establish a publicly accessible clearinghouse and inventory of nanomaterial sources and products.

5. Identify and/or develop methods for monitoring nanomaterials in environmental media and through human biomonitoring.

6. Collect information on the fate and transport of nanomaterials, including through monitoring in environmental and biological media.

7. As for other chemicals, focus on identifying and addressing nanomaterials that are persistent, bioaccumulative, and toxic (PBT).

8. Use existing hazard traits from other chemicals and toxicological and environmental-health-related endpoints to assess potential adverse health outcomes from nanomaterial exposure.

9. Evaluate existing risk-assessment guidelines to determine whether they sufficiently cover nanomaterials, adjusting or incorporating nano-specific approaches as needed.

10. Integrate nanomaterials into current efforts to modernize toxicity testing.

11. Develop and maintain relationships with other governments and researchers to share relevant data and information on nanotechnology and nanomaterials’ use, applications, and toxicity.

12. Improve coordination and monitor communication among federal and state agencies, other countries’ governments, businesses, and NGOs.

13. Continue to include opportunities for public input and comment during decision-making processes.
 

Recommendations to support successful approaches to address potential health risks from nanomaterials that are currently outside the scope of OEHHA.

1. Require disclosure of where and what nanomaterials are manufactured, in what quantities, and for what new or existing products.

2. Require reporting of properties that can identify nanomaterials that are persistent,bioaccumulative, and toxic (PBT). Phase out uses consistent with approaches for other PBTs.

3. Develop a framework for making policy and regulatory decisions that balances the uses and benefits of nanomaterials with their toxicity and exposure potential.

4. Require testing of release and exposure potential for nanomaterials in consumer products for both existing and new products.

5. Increase efforts to protect and educate workers, researchers, and downstream users of nanomaterials

6. Require sufficient toxicological testing—preferably pre-market and also post-market as necessary—to assess risks to manufacturing and other workers and to downstream users, including consumers and susceptible subpopulations such as infants.

7. Implement a labeling system that requires labeling of products that contain nanomaterials.
 

8. Increase funding and support for targeted, nano-specific research to fill data gaps.
 

9. Conduct targeted research on the biological fate, transport, and distribution of nanomaterials, including sources, exposure routes, and internal distributions. Integrate this research with information gathered on exposure potential.
 

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On Friday, the United States Government Accountability Office issued its Report to the Chairman (Barbara Boxer) of the Committee on Environment and Public Works, US Senate, GAO-10-549:

Nanotechnology: Nanomaterials Are Widely used in Commerce, but EPA Faces Challenges in Regulating Risk.

Highlights from the report follow.  The report confirms speculation that EPA intends to issue certain new rules pertaining to select nanomaterials by the end of 2010.

Background

"EPA has taken a mulitpronged approach to understanding and regulating the risks of nanomaterials, including conducting further research and implementing a voluntary data collection program. Furthermore, under its existing statutory framework, EPA has regulated some nanomaterials but not others. Although the EPA is planning to issue additional regulations later this year, these changes have not yet gone into effect and products may be entering into the market without EPA review of all available information on their potential risk. Moreover, EPA faces challenges in effectively regulating nanomaterials that may be released in air, water, and waste because it lacks the technology to monitor and characterize these materials or the statutes include volume based regulatory thresholds that may be too high for effectively regulating the production and disposal of nanomaterials."

TSCA

"In the fall of 2009, EPA announced it would reconsider the policy described in its January 2008 document, TSCA Inventory Status of Nanoscale Substances -- General Approach, and subsequently announced it planned to develop a SNUR to regulate nanoscale versions of conventional scaled chemicals that are already on the TSCA inventory as a significant new use of that chemical. The agency intends to propose this rule in December 2010."

"TSCA also gives EPA authority to issue rules requiring companies to submit certain information about chemicals. EPA plans to issue one such rule for nanomaterials that would require manufacturers to provide information on production volume, methods of manufacture and processing, and exposure and release, as well as available health and safety studies. Evaluation of this information will provide EPA with an opportunity to consider appropriate action under TSCA to reduce unreasonable risks to human health or the environment, according to EPA. This rule may also help them collect information on nanomaterials not covered by the SNUR discussed above. EPA intends to propose this rule in December 2010."

"EPA officials told us they intend to propose a rule in December 2010 that would require companies to generate test data on the health effects of 15 to 20 different nanomaterials, including carbon nanotubes, nanoclays, and nano aluminum, and also on nanomaterials used in aerosol-applied products. This information will help EPA correlate the properties of these materials with specific health effects, manage or minimize risk and exposure, and help EPA determine the need for additional testing of these materials, according to EPA. EPA officials told us they will be working with the National Institute for Safety and Health Administration, and the Consumer Product Safety Commission on this effort."

FIFRA

"EPA officials told us that if a company replaces a conventionally sized active ingredient in a pesticide with a nanoscale version of that ingredient, it is mandatory for the company to amend its registration. Officials also noted, however, that the agency's position on this point needs to be made explicit to the regulated community and such a clarification could be made in EPA guidance. According to stakeholders, manufacturers of nanopesticides are required to obtain an amended registration in such a circumstance even without new EPA guidance explicitly requiring it since the registration requirement is based not only on questions of chemical identity, but also on claims made about the pesticide; its composition; and its chemistry, toxicology, and other information."

GAO's Recommendations

"We recommend that the Administrator of EPA, take the following three actions:

• Complete its plan to issue a Significant New Use rule for nanomaterials.
• Modify FIFRA pesticide registration guidelines to require applicants to identify nanomaterial ingredients in pesticides.
• Complete its plan to clarify that nanoscale ingredients in already registered pesticides, as well as in those products for which registration is being sought, are to be reported to EPA and that EPA will consider nanoscale ingredients to be new.

In addition, the Administrator of EPA should make greater use of the agency's authorities to gather information under existing environmental statutes. Specifically, EPA should

• complete its plan to use data gathering and testing authorities under TSCA to gather information on nanomaterials, including production volumes, methods of manufacture and processing, exposure and release, as well as available health and safety studies; and
• use information-gathering provisions of the Clean Water Act to collect information about potential discharges containing nanomaterials.

Finally, the Administrator of EPA should consider revising the Inventory Update under TSCA so that it will capture information on the production and use of nanomaterials and so that the agency will receive periodic updates on this material."

EPA's May 4, 2010 Response to GAO

Finally, attached as an exhibit to the report was a written response from EPA in which the agency largely agreed with all of GAO's recommendations. Regarding GAO's Clean Water Act recommendation, EPA stated that its Office of Research and Development is currently developing methods to detect nanomaterials in water and predict levels of concern. Once able to detect and measure nanomaterials in water, EPA will then consider whether reporting requirements should be amended.

We will continue to monitor these issues and provide timely updates to our readers.

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This article originally appeared on the National Nanomanufacturing Network's InterNano website on April 30, 2010.  It is licensed under Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported.

The Program on Reproductive Health and the Environment (PRHE) at the University of California, San Francisco (UCSF) is part of the Department of Obstetrics, Gynecology & Reproductive Services located in UCSF’s School of Medicine. PRHE recently published its draft “A Nanotechnology Policy Framework: Policy Recommendations for Addressing Potential Health Risks from Nanomaterials in California.1” The draft nanotechnology policy framework will be presented to Cal/EPA’s Office of Environmental Health Hazard Assessment once finalized to “better inform . . . risk assessment recommendations for decision makers and risk managers.” It was designed to provide the State “with an overview of nanotechnology materials and their potential exposures and human health risks, and proposes a selection of policy options for addressing potential hazards and risks from nanotechnology.”

For those who might wonder about PRHE’s focus, its “mission is to create a healthier environment for human reproduction and development through advancing scientific inquiry, clinical care and health policies that prevent exposures to harmful chemicals in our environment.” While its draft nanotechnology policy framework briefly touches upon reproductive issues, it provides a more general approach to what its authors see as difficulties presented by the potential regulation of nanotechnology (or lack thereof) in California.

The draft nanotechnology policy framework was written by three PRHE staff members with the assistance of an eleven member scientific advisory panel. Only one business – DuPont – had a representative on the scientific advisory panel, and there were no representatives from the federal government (FDA, EPA, NIOSH or otherwise). In fact, federal efforts to deal with nano-related environmental, health, and safety issues are summarily dismissed: “In light of the NRC’s analysis that the federal government is inadequately prepared to deal with strategic nanotechnology risk research, and given the current changing field of chemicals policy in California, it is an appropriate time to consider new ways of regulation in the area of nanotechnology.”

The first three chapters of PRHE’s draft nanotechnology policy framework provide a general introduction to nanotechnology including an overview of some of the science regarding nano-material toxicology; potential for exposure and assessing the alleged risks of nanotechnology; and fate, transport, and transformation of nanoscale materials in the environment and biological systems. It also contains several “case studies” covering previous chemical substances which PRHE believes may have been mishandled, and thus could provide some insight to California regulators regarding how to address some of the uncertainties presented by certain nanoscale materials. The overview provided by these chapters is unbalanced and somewhat skewed, but the general themes have been covered in depth by several other organizations. At the very least, these chapters of the draft nanotechnology policy framework show that PRHE is truly attempting to understand these complex issues.

Fifteen Policy Recommendations

For our readers, the most interesting part of the draft nanotechnology policy framework will likely be its fifteen specific policy recommendations appearing in Chapter 4:

1. Develop a description of nanomaterials that can be used to identify them.
2. Identify and define priority properties which could be used in risk characterization and collect these properties for each nanomaterial, including: "traditional" risk assessment or hazard identification properties, such as molecular formula, density, solubility, vapor pressure, melting point, etc. as applicable; "unique” nanomaterial-specific properties, such as size, shape, surface functionality, charge, stability, and reactivity.
3. Develop characteristics by which to define, describe, and group nanomaterials according to conventional or unique properties.
4. Gather information regarding what types of nanomaterials are being manufactured and in what products they are being used.
5. Support a publicly accessible clearing house and inventory of products and sources of nanomaterials. Require disclosure of where nanomaterials are manufactured, in what quantities and for what new or existing products such as through product labeling.
6. Collect information on fate and transport of nanomaterials, including monitoring in environmental and biological media. Require centralized reporting mechanisms, and maintain them in a systematic manner (could be incorporated into clearinghouse in recommendation 5 above).
7. Develop a framework for making policy and regulatory decisions based on nanomaterials’ use, exposure potential, and exposure to susceptible subpopulations, while weighing public health or societal benefit.
8. Require testing of release and exposure potential for nanomaterials in consumer products that have widespread use, such as titanium dioxide, silver nanoparticles and carbon nanotubes. Testing must be completed for products to remain on the market.
9. Integrate nanomaterial safe handling practices into standard lab safety training for academic, industrial and other laboratory workers and students.
10. Use existing hazard traits from other chemicals and toxicological and environmental health-related endpoints to assess potential adverse health outcomes from nanomaterial exposure.
11. Risk assessment guidelines should be evaluated to determine whether they sufficiently cover nanomaterials and if found to be lacking, adjust or incorporate accordingly to include them in decisions. Use existing data to evaluate and consider applying an adjustment factor to address enhanced risk for those nanomaterials that exhibit certain properties such as charge, certain size and certain surface functionalities.
12. Targeted research in the area of biological transport and distribution of nanomaterials including sources, routes of contact, and internal distributions. Integrate this with the information gathered on exposure potential.
13. Develop and maintain relationship with other governments (i.e. EU, Canada) and researchers (i.e. California NanoSystems Institute at University of California, Los Angeles) who conduct the research, to share relevant data and information.
14. Require sufficient toxicological testing information to assess safety of risks to consumers, including susceptible subpopulations such as infants preferable premarket, and post-market as necessary.
15. Implement a labeling system that requires labeling products that contain nanomaterials. Evaluate nanomaterials to determine if any should be placed on Prop 65 list.

Should California Reinvent the Wheel?

Several of these recommendations have been voiced by other groups including the federal government, ISO, OECD, etc. PRHE’s draft nanotechnology policy framework could benefit from a detailed analysis of the effectiveness of existing programs already in place in the US and globally to achieve many of the recommendations urged by the authors. It is difficult to imagine that California has the desire (or funds) to replicate the same research being undertaken by hundreds of top researchers already in the field.

For example, should California develop its own definition of “nanomaterials,” or is it better and more effective to rely upon definitions promulgated by standard setting bodies such as ASTM, ANSI, and ISO? Similarly, these bodies are already developing methods to determine the “characteristics by which to define, describe, and group nanomaterials according to conventional or unique properties.” Should California join their efforts, or pursue its own independent path?

As another example, should California come up with its own policy and guidelines to “integrate nanomaterial safe handling practices into standard lab safety training for academic, industrial and other laboratory workers and students,” or should it defer to NIOSH’s excellent existing guidelines on this issue?2 - or even the Department of Energy’s?3

As a third example, there is already a large amount of research ongoing regarding the “biological transport and distribution of nanomaterials including sources, routes of contact, and internal distributions.” One need only search the International Council on Nanotechnology’s Virtual Journal of Nanotechnology Environment, Health and Safety4 to see what has already been published on these issues. OECD also has a nice online database covering these areas.5 Should California reinvent the wheel in this regard?

Perhaps the answer to all of the above-questions is “Yes.” Maybe California should undertake all of these efforts because they are not being effectively addressed by others. However, before making such recommendations the authors should at least evaluate and critique ongoing efforts in these areas so California’s policy makers can better prioritize their efforts.

Disconnect Between Science, Existing Regulation, and Policy Recommendations

Another major issue with PRHE’s draft nanotechnology policy framework is the disconnect between the science overview set forth in its first three chapters and the 15 policy recommendations appearing in its fourth chapter. It would be interesting for PRHE to develop the linkage, if any, between what it sees as the main gaps or deficiencies in the existing science and regulation surrounding nanoscale materials and PRHE’s specific policy recommendations. Simply put, how do PRHE’s 15 specific policy recommendations works towards solving the problems it identifies? Of course, the document is only a draft and perhaps PRHE will address these issues in its final version.

Two Most Controversial Recommendations

Perhaps the two most controversial recommendations in PRHE’s draft nanotechnology policy framework are its proposals to require pre-market testing for consumer products containing nanoscale materials and the mandatory labeling of such products. Both approaches have been considered and rejected (for the time being) by the federal government. Unfortunately, little effort is taken to develop the factual, logical, scientific, or legal support for these recommendations. This is particularly frustrating because the two major groups of effected stakeholders -- consumers and consumer product manufacturers/distributors -- appear to have had little, if any, input into the draft nanotechnology policy framework. However, quite a bit has already been written on these subjects, and authors have plenty of source material to assist in their analysis before the draft is finalized.

Public Comments and Meeting

PRHE has invited public comments regarding the draft nanotechnology policy framework and is holding a conference on May 5, 2010 which will include presentations from the science advisory panel who worked on the document, as well as time for public comment.6 Given the scope of the report, it will be interesting to see what comments and analysis can be pulled together by interested stakeholders in the relatively short time allotted by PRHE for review.

References

1. A Nanotechnology Policy Framework: Policy Recommendations for Addressing Potential Health Risks from Nanomaterials in California, http://prhe.ucsf.edu/prhe/nanoreportDRAFT.pdf (last visited Apr. 29, 2010).
2. Approaches to Safe Nanotechnology: Managing the Health and Safety Concerns Associated with Engineered Nanomaterials, http://www.cdc.gov/niosh/docs/2009-125/pdfs/2009-125.pdf (last visited Apr. 29, 2010).
3. Department of Energy, Nanoscale Science Research Centers, Approach to Nanomaterial ES&H, http://orise.orau.gov/ihos/nanotechnology/files/NSRCMay12.pdf (last visited Apr. 29, 2010).
4. The International Council on Nanotechnology, Virtual Journal of Nanotechnology Environment, Health and Safety, http://icon.rice.edu/virtualjournal.cfm (last visited Apr. 29, 2010).
5. OECD Database on Research into Safety of Manufactured Nanomaterials, http://webnet.oecd.org/NanoMaterials/Pagelet/Front/Default.aspx? (last visited Apr. 29, 2010).
6. PRHE Announcement, http://prhe.ucsf.edu/prhe/nanoannouncement.pdf (last visited Apr. 29, 2010).

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