Study: New approach need to govern nanotechnology risks

(March 5, 2009) — In order for the potential health risks associated with nanotechnology to be properly assessed, the current regulatory system in the U.S. must be changed. That’s the conclusion of a new paper, published in the peer-reviewed journal Environmental Science and Technology, by researchers from the University of Minnesota and the University of British Columbia.

Nanomaterials are designed at the molecular level to have special properties, such as enhanced heat conductivity or strength, that are very different from the bulk forms of the same material. Thus, they have many promising applications, from handheld electronic devices to drug delivery techniques. However, because of the tiny size and distinctive qualities of nanomaterials, concern exists about their potential to damage the environment and the human body.

How the Current System Works

“Nanomaterials are essentially unregulated in the United States, even though they are being manufactured and used in lots of products,” says Gurumurthy Ramachandran, Ph.D., University of Minnesota School of Public Health Division of Environmental Health Sciences professor and co-author of the new study. “What’s more, the current regulatory system for chemicals is broken. Most chemicals present in workplace and community environments have not been subjected to health and safety risk assessments. We run the risk of repeating this situation for nanomaterials if the same processes are used.”

The current regulatory system in the U.S. places the burden for conducting risk assessments on the Occupational Safety and Health Administration (OSHA) for occupational risks, and the Environmental Protection Agency (EPA) for non-occupational risks. However, these agencies do not have the budgetary means to adequately test nanomaterials. Nor do they have sufficient toxicity or exposure information from nanotechnology firms, since industry is not required to divulge this information.

Ramachandran along with doctoral student Jae-Young Choi, University of Minnesota School of Public Health Division of Health Policy and Management, and Milind Kandlikar, Ph.D., University of British Columbia, set out to assess the feasibility of shifting the responsibility for testing nanomaterials onto industry. The budgetary and time investments necessary to complete the testing process depend on the stringency of tests used and the amount invested by nanotechnology firms as a portion of their yearly research and development budget. The researchers estimate that costs associated with nanomaterial risk assessment in the U.S. could range from $249 million to $1.18 billion, and might take decades to complete at current levels of investment in nano-hazard testing.

Study Supports Tiered Risk Assessment

In order to avoid crippling the burgeoning nanotechnology industry, which is dominated by startups and small companies, the study supports a tiered risk assessment strategy similar to the REACH (registration, evaluation, authorization, and restriction of chemicals) legislation used in the European Union. “Although REACH places the burden of proof on industry, it uses a tiered toxicity testing strategy to efficiently and effectively use scarce resources,” says Ramachandran.

Ramachandran and colleagues suggest that testing tiers for nanomaterials be based on information including potential human exposures, as well as the toxicity of the material in question. By using such a tiered system to prioritize nanomaterial risk assessment, the task would become more time- and cost-effective for industry, while freeing regulatory agencies to monitor industry rather than be asked to do the research without the funding.

The REACH legislation has already changed how traditional chemicals have been produced, traded, and released. “Because U.S. chemical companies with businesses in Europe need to comply with REACH, the legislation is forcing them to change their behavior,” explains Ramachandran. However, requiring U.S. companies to test, monitor, and mitigate the potential impacts of nanomaterials is likely to remain a challenge. “Because unregulated and voluntary oversight programs have been the norm for so many years, the political barriers to a REACH-like system in the U.S. remain,” Ramachandran adds.