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There are many influences on regulatory policies for chemicals and nanomaterials and it's important for us to understand the dynamics affecting the regulatory process. Regulatory policy and the development of science-based regulations can often be a complex give and take among producers and users, government regulators and the public.
July 26th, 2010
What Drives the Regulation of Nanomaterials?
I see the issue in a rather simple formula: Safe Products plus Government Oversight equals Public Confidence. This is a bit simplistic but it highlights a very important point. When products are inherently safe, government regulation and oversight can be minimized because the public, or consumers if you wish, can feel confident about safety. This approach can work regardless of the industry or product. If nanotechnology-related products can be made safe, there will be little need for regulatory intervention and the marketplace will decide which products become a success. Conversely, when nano-enhanced products represent a hazard to workers or consumers, regulations will play a more important role in establishing product safety. Failure on the part of manufacturers in developing safe products or failure by regulators to effectively monitor and evaluate product safety diminishes public confidence and often results in political solutions rather than those based on sound science.
Let's explore for a moment these key elements of nanotechnology regulatory policy. Manufacturers don't set out to create unsafe products but it isn't unusual to identify product hazards once the product has been in the marketplace and real-world uses show a side of the product unimagined by product designers. That doesn't, however, mean that nanomaterial manufacturers are off the hook. They have a clear ethical responsibility to create products that are safe for their intended use. In the chemical industry it isn't unusual to develop hazard information when developing new products but that information isn't always made publicly available. Regardless of the reason, it is often construed as the industry hiding something and more often than not it has a negative impact on consumer confidence. Another complicating factor is the sale of chemical substances like nanomaterials to other manufacturers who change the substance or include it in a formulation. Any changes along these lines can cause changes in the hazard characteristics which makes it difficult for the original manufacturers to reveal information about hazards once it is incorporated into other products.
Another important factor is the government because it plays a pivotal role in overseeing product safety. It doesn't matter if we are talking about cities, states, regions or countries and it doesn't matter what product we're talking about. In the case of chemical substances such as nanomaterials there are several agencies actively monitoring product safety and establishing regulations when necessary to ensure product safety. However, given the lack of detailed safety information on nanomaterials the safety issues are magnified despite the many reports of nanotechnology benefits to our society.
For example, NIOSH, the National Institute for Occupational Safety and Health, has done an excellent job evaluating the safe handling of nanomaterials in the workplace. Although not regulatory in nature, their field investigations generated valuable information that can be used by other agencies to develop regulations based on the scientific evidence gathered during the field investigations. In terms of regulatory agencies, the Environmental Protection Agency is the primary guardian and overseer regarding chemical safety, but the Food and Drug Administration will play a key role as well in its evaluations of nano-enabled pharmaceuticals, cosmetics and medical devices. The Occupational Safety and Health Administration will certainly use the NIOSH data to establish worker safety guidelines and the Consumer Product Safety Commission has an important role to play in evaluating the safety of nano-enhanced consumer products.
When scientific evidence is unavailable, inadequate, or inconclusive, regulatory officials tend to establish rules that err on the side of safety. Those of you in the antimicrobials arena get to see this firsthand because the Environmental Protection Agency often makes use of a 10X factor to set a regulatory standard when the data cannot correlate directly to risks to the environment or humans. For example, test data on rats showing an adverse effect at 1 part per million oftens ends up as a regulatory standard of 0.1 parts per million to take into account the differences between rats and humans. Again, the tendency is to err on the side of safety and when there are multiple issues of data correlation it isn't unusual to see a 10X factor become a 100X or 1,000X factor.
Unlike traditional chemical substances, nanomaterial testing doesn't even enjoy the safe harbor of verifiable standardized tests that are accepted globally by government regulators. The issues are complex and even when important safety data is available it may be difficult to establish the value of the data. When all else fails and scientific evidence doesn't provide enough information to adequately characterize nanomaterial hazards politics will come into play and as we all know when it gets to that point all bets are off. The political process favors vocal constituents and politicians are generally not scientists so the most expedient way to deal with the issue is to enact bans, prohibitions and restrictions on substance development and use. Clearly, the real danger here is an over-stimulated, political regulatory process that results in a reduction in the research and development of nanomaterials and one that provides a chilling effect on the growth of nano-enabled products.
For nanomaterials I think it's safe to say that there has been a breakdown in the first two key areas. Some people feel that nanomaterial producers are making unsafe products at the expense of consumers just for the money while others believe that oversight has been lax and the federal government is simply unable to regulate industry because it lacks sufficient authority to do so. It doesn't matter how we got here but what's important is that change is in the wind and the public is driving it.
Too many people have expressed concern about the safety of nanomaterials used in the enhancement of consumer products to ignore the rising tide of sentiment against nanomaterials. There is widespread acknowledgment that more safety data is needed and until a more robust data set on nanomaterials can be developed we will continue to hear calls for prohibitions and bans for new products containing nanomaterials, labeling of products with nanomaterials and withdrawal from the marketplace of products containing nanomaterials. That said, there is no easy fix here but a concerted effort to address the need for safety data which can be shared with a wary public will go a long way to build the public's confidence in nanotechnology.