The UCSF Program on Reproductive Health and the Environment

UCSF National Center of Excellence in Women's Health

Summary of Policy Recommendations for Addressing Potential Health Risks from Nanomaterials in California

A report by the University of California, San Francisco's Program on Reproductive Health and the Environment

University of California, San Francisco’s Program on Reproductive Health and the Environment announces the publication of “Recommendations for Addressing Potential Health Risks from Nanomaterials in California”. The report provides recommendations for addressing potential health risks from nanomaterials to the Office of Environmental Health Hazard Assessment (OEHHA), under the California Environmental Protection Agency (CalEPA), and to the State of California.

Once just an ambitious goal, nanotechnology is today both a rapidly growing economic sector and is expected to be 15% of the global market by 2014. Nanotechnology is the manipulation of matter and the creation of new materials on an extremely small scale. Due to their small size, nanomaterials have unique physical and chemical properties, which in turn yield unique functionalities.

However, the very same properties that yield these unique functionalities also raise concerns about whether existing public policies to address industrial chemicals is sufficient to address potential health implications of engineered nanotechnology materials and their applications. With rising use of nanomaterials in the marketplace, and subsequent exposures to the population, it is an opportune time to enhance our approaches to address potential health risks from nanomaterials.

To meet this need, the California's OEHHA contracted with the University of California, San Francisco to prepare this report, which provides the State of California an overview of nanotechnology materials, potential exposures, and human-health risks, and recommendations for addressing potential health hazards and risks from nanotechnology.

Effective health protections are needed to guide the development of the nanotech industry. The report makes:

Recommendations that can be implemented under the existing regulatory structure of OEHHA to:

characterize nanomaterials;
identify sources and understand exposure to nanomaterials;
prioritize and characterize health effects; and
communicate the findings among government agencies, industry, NGOs, and the public.

Recommendations that are outside the scope of OEHHA are also needed to fully address potential health risks of nanomaterials. Many of these are likely to require legislative changes. These recommendations primarily focus on requiring information on potential exposures and health hazards for nanomaterials used in the marketplace.

California has been a leader in progressive chemicals policy, and the growing field of nanotechnology presents a new opportunity for the State to develop innovative technologies and policies that will simultaneously enhance public health and economic growth.

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.