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Regulatory change at the federal level frequently takes a very long time. The sluggish wheels of the federal government have evolved to be more reactive than proactive and that's why important issues often have to reach a critical stage before any action is taken. When the federal government fails to take action states are often willing and sometimes better able to implement regulatory changes. This is true for most issues and when it comes to chemicals, and now nanomaterials, that change is already happening.
September 7th, 2010
We Should Have Seen It Coming: States Regulating Nanotechnology
We've heard a great deal in recent days about changes to national chemical regulatory policy through reform of TSCA, the Toxic Substances Control Act. The Safe Chemicals Act of 2010 represents the Senate's attempt to modernize TSCA which remains essentially unchanged since it went into effect in 1976. At the same time the Senate bill was introduced, the House of Representatives released a discussion draft of the Toxic Chemicals Safety Act of 2010.
The federal government has had a great deal on its plate this year and even though the highly-anticipated bills in the Senate and House are expected to bring about fundamental changes to chemical regulatory policy, it may not happen this year. With elections coming up in November there is an additional layer of complexity associated with any proposed changes at the national level. Many people feel this process is taking too long so they've been pressing their state and local governments to take action. This can be very effective in creating a national de facto regulatory policy and I have a good example to illustrate how local and regional regulations can become national solutions.
In this column I will address the collective power that states have when it comes to regulations, what the states have been doing with regard to traditional chemical substances and, importantly, which states already have nanotechnology regulation in their crosshairs.
Power in Numbers
You may recall that at one time phosphates were a key ingredient in our laundry detergents but they came under attack when it was shown that they were an unwelcome addition to an excess of nutrients being discharged in our nation's surface waters. Federal regulators were unable to put into place effective regulatory controls on phosphates so state governments began enacting bans on phosphates in laundry detergents. When close to 20 states had enacted a ban, manufacturers reformulated their laundry detergents to eliminate phosphates rather than make different products for each state.
One by one, slice by slice, phosphates in laundry detergents (next up, phosphates in dishwashing detergents) became a thing of the past. What the federal government regulatory machine couldn't do, the states accomplished by simply enacting individual state bans. When the geographic area was broad enough to make it no longer economically feasible the issue was resolved with a de facto national ban.
Let's take a look at where state chemical regulatory initiatives are taking place. Several states have enacted bans on the plasticizer Bisphenol-A (BPA). Bisphenol-A (BPA) is a chemical that is used in hard plastics and epoxy resins. It was first used in the 1930's as a synthetic estrogen. These days, it helps make plastics strong while staying lightweight, and coats metal food containers in order to preserve the food inside. BPA is one of the highest-volume chemicals produced in the world with approximately six pounds of BPA produced for every American per year but at least a dozen additional states are working toward limited or full-scale bans. Cadmium, discovered in children's toys has been the subject of bans and restrictions in dozens of states as has the brominated flame retardant Deca-BE. Mercury and arsenic have long been the target of regulators and the advent of Green Chemistry initiatives provides consumers with a strong voice shouting the need for safer alternatives.
An important thing to remember is that regulatory action can include more than outright bans. It could mean use restrictions, labeling requirements, reporting of manufacturing data, or, as in some states having your product on a list of chemicals of concern. The examples I provide here illustrate the ability of local and regional governments to take action when public confidence in the safety of products diminishes to a level warranting regulatory action. We've seen this with traditional chemical substances and now nanomaterials and products enhanced with nanotechnology are receiving similar scrutiny. The point is that the regulatory snowball is a chilly mesh of science and politics and its direction, velocity and force can be unpredictable.
He Who Forgets the Past is Doomed to Repeat It
This history lesson is instructive for nanomaterial producers and users. The federal and state level nanotechnology regulatory community is doing more than asking questions, they're imposing requirements. Regulatory requirements imposed at the state level have an impact that may not be seen immediately but at some point in the future. There are a few reasons why I've been writing so much about traditional chemicals rather than nanomaterials. First, nanomaterials are chemicals and they often don't need nano-specific laws or regulations to identify, evaluate for risk, evaluate for alternatives or to establish rules and regulations for their handling and use. Many state and federal laws are broad enough to capture nanomaterials within their respective regulatory frameworks. This doesn't mean that the laws and regulations won't need to be changed or at least reevaluated for nanomaterials because some changes are absolutely necessary to properly evaluate any potential risks associated with unique chemical substances.
Second, there are multiple mechanisms available to regulators at all levels of government. Legislative action, directives from the Governor, regulatory additions of substances to a "chemicals of concern" list, identification of nanomaterials as an emerging contaminant and incorporation into Green Chemistry initiatives are just a few examples of how nanomaterials can be treated within existing regulatory frameworks. There is another regulatory tool that government officials have at their disposal -- reinterpretation of existing policy. EPA officials are trying to do so with antimicrobials and may soon be implementing a new policy with a very broad impact on previously-registered antimicrobials and on how new antimicrobials that are nano-enhanced will be evaluated for risk.
Third, it's important not to discount the activist element I mentioned in my last column What Drives the Regulation of Nanomaterials?. It's largely due to their efforts that we are on the precipice of TSCA reform and there is no limit to any organized movement at the grass roots level. So, what I'm saying is that any action taken to regulate a traditional chemical substance can be used to regulate nanomaterials.
Where's the Nano Action?
Many states have enacted their own chemical control regulations with at least seven states specifically calling out nanomaterials for treatment as "chemicals of concern." While this hints at the breadth of nanotechnology regulation at the state level it pales in comparison to the potential impact of the State of California regulatory initiatives. California is further down the regulatory path than all of the other states. Last year it conducted a data call-in for carbon nanotubes and additional data call-ins on metal oxides and other nanoscale materials can be expected. The Draft Regulation for Safe Consumer Products specifically identifies nanomaterials and I can tell you from personal experience that the nano-related definitions have stimulated a great deal of discussion with the nanomaterial producers and users.
Nanomaterials are the subject of regulatory activity at the Office of Environmental Health Hazard Assessment (OEHHA) and the Department of Toxic Substances Control (DTSC). Under the Green Chemistry initiative both agencies are in the process of developing nano-specific regulations. At the DTSC the major issue revolves around a preliminary decision to consider materials under 1,000 nm to be nanoscale rather than the more commonly accepted 100 nm. OEHHA has taken a different approach by indicating that all nanomaterials will be considered a toxicity "trait." In essence all nanomaterials will be considered hazardous and subject to a broad range of regulations. These issues are currently on the table and there has been no lack of stakeholder involvement but, as of this writing, they are still "under discussion."
Maine is interesting because it developed an Air Toxics Priority List in 2007 that includes particulate matter from nanotechnology. Little has happened since the list was created but those of us that follow regulatory policy expect some action in the not-too-distant future.
The Massachusetts Department of Environmental Protection has taken the step of adding nanomaterials to the list of emerging contaminants of concern. In 2007, the Massachusetts Department of Environmental Protection joined with other Massachusetts agencies, the Department of Public Health, Division of Occupational Safety, Office of Technical Assistance, Toxic Use Reduction Institute and the Office of Business Development, to establish the Massachusetts Interagency Committee on Nanotechnology. To this point the Committee has had some workshops and continues to gather information on how to promote the safe development of nanotechnology in Massachusetts. Recently the Massachusetts Office of Technical Assistance (MOTA) released a guidance document "Nanotechnology -- Considerations for Safe Development," with recommendations on how to enhance the safety of nanotechnology.
Two states, Pennsylvania and South Carolina have taken similar steps by identifying nanoparticles as "emerging chemicals of concern." This provides the states with an opportunity to further evaluate nanoscale materials and allow them to take action based on risks associated with the use or disposal of these substances.
The Washington Department of Ecology also considers nanomaterials an emerging contaminant of concern. While not yet taking any specific regulatory action involving nanomaterials, the state has revised the manual used by hazardous waste inspectors to include collection of specific information on nanomaterials. Largely a data-gathering effort at this point, the information will be used to inform regulatory officials as they determine an appropriate course of action for nanomaterials.
Wisconsin is also trying to gather information through proposed legislation designed to create a nanomaterial registry of specific nanoscale substances and products containing nanomaterials. The legislation has been proposed several times over the last few years and proponents are confident that it's only a matter of time before a bill gets passed. Since registries are generally meant to be used for some purpose one can only assume that once such a reporting mechanism is put in place that regulators will find a use for it.
All Politics Are Local
It's important not to underestimate the collective power of the states. Regulatory approaches don't need to be the same in each state to have a collective effect on the further growth and development of nanomaterials. When stakeholders (producers, government and the public) are out of sync, regulatory steps by state and federal officials are to be expected. In today's regulatory climate, producers and users of nanomaterials can expect to be more deeply engaged in the safety debate than ever before. With so many unanswered questions on the safe use of nanomaterials the chorus of those expressing concern about potential risks will grow louder and the delicate balance of science and politics will tip toward office-holders reacting to emotional arguments made by vocal constituents. The result is inevitable -- legislation and regulation.