The Impact of Toxicity Testing Costs on Nano Regulation - Paradigm Shift in the US?
Information about the toxicity of nanoparticles is important in determining how nanoparticles will be regulated. In the U.S., the burden of collecting this information and conducting risk assessment is placed on regulatory agencies without the budgetary means to carry out this mandate. The authors of a new paper analyze the impact of testing costs on society’s ability to gather information about nanoparticle toxicity and whether such costs can reasonably be borne by an emerging industry. The results support a tiered risk-assessment strategy similar to the EU’s REACH legislation for regulating toxic chemicals.
In order for the potential health risks associated with nanotechnology to be properly assessed, the current regulatory system in the US 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 British Columbia and the University of Minnesota (The Impact of Toxicity Testing Costs on Nanomaterial Regulation).
“Nanomaterials are unregulated in the United States, even though they are being manufactured and used in literally hundreds of products,” says Prof. Milind Kandlikar, of UBC’s Liu Institute for Global Issues 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 US 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.
Prof. Kandlikar, along with doctoral student Jae-Young Choi and Prof. Gurumurthy Ramachandran from the University of Minnesota, 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 US could range from $249 million to $1.18 billion, and might take decades to complete at current levels of investment in nano-hazard testing.
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, authorisation 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 Kandlikar.
Kandlikar 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 US chemical companies with businesses in Europe need to comply with REACH, the legislation is forcing them to change their behavior,” explains Kandlikar. However, requiring US 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,” notes Kandlikar, “the political economy barriers to a REACH-like system in the US remain.”
Adapted from Nanowerk (Original Source: UBC Centre for Health and Environment Research)