CU comments to EPA regarding risks in engineered nano-materials
Program Leader for Product Safety, Consumers Union
U.S. Environmental Protection Agency Office of Pollution Prevention and Toxics
Public Meeting on the Voluntary Nanoscale Materials Stewardship Program and Inventory of Nanoscale Substances under the Toxic Substances Control Act
August 2, 2007
My name is Carolyn Nunley Cairns, and I lead the Product Safety Program in the Technical Division at Consumers Union, non-profit publisher of Consumer Reports Magazine. I am an environmental health scientist who has worked on toxics issues for more than two decades. Like several of my predecessors at Consumers Union, I have spent most of my career working to assess and mitigate the harmful effects of hazardous chemicals that were dispersed through commerce before their risks to human and environmental health were considered. In fact, our very first issue of Consumers Reports, back in 1936, warned about the toxic effects of lead in consumer products, a chemical that continues to harm consumers some 75 years later, as we continue to find high levels in foods, children’s jewelry and even painted products.
Consumers Union appreciates the opportunity to comment on EPA’s plans concerning risks from engineered nano-materials. We feel strongly that EPA must fulfill its mission under TSCA to assure that all nanomaterials are safe for humans and the environment before they enter commerce, something EPA’s current proposals will not do.
My comments today can be summarized in three points:
1. A voluntary approach is grossly insufficient for the scope of the potential risks that consumers increasingly face from engineered nano-materials.
2. Thorough substantiation of, and public access to reported information about nanomaterials in commerce is critical to assessing and managing risk.
3. EPA must actively pursue a plan to regulate nanomaterials as “new”chemicals or “new uses” of existing chemicals under TSCA, to regulate their use in commerce based on demonstrated safety for humans and the environment prior to commercialization.
We are deeply concerned that the current proposals do not reflect the lessons that we have so painfully learned from our past failures to regulate chemical risks. Asbestos, PCBs, lead, mercury are just a few of the highly toxic chemicals that consumers unwittingly brought into their homes and into their bodies only to later suffer serious illness and even death, or at the very least, the huge financial burden to de-contaminate their homes after the science caught up with commerce to prove their harm.
EPA’s best, and virtually only tool to effectively manage chemical risks is Section 5 of TSCA – the New Chemicals Program. As the record shows EPA is much better equipped to address toxic chemical concerns prior to their manufacture than afterwards. In the years since TSCA was enacted, EPA has only regulated five existing chemicals, and many of those regulations came only after many, many years of legal battles. EPA will face similar hurdles to manage hazardous nanomaterials after they reach the marketplace. Though the window is quickly closing as the markets for nano-materials race forward, we have a critical opportunity to do things differently with nanotechnology. But to do so will require a much more proactive approach from EPA than is currently planned.
We urge EPA to reconsider its approach to anticipate risks and manage the use of this important new class of chemicals before they enter into commerce, before they expose consumers, workers and the environment, and before they are so widely dispersed that their risks cannot be mitigated.
Voluntary Initiatives are Insufficient to Manage Risks at the Nanoscale
The main shortcoming of the proposed Nanotechnology Materials Stewardship Program is that it is only a voluntary plan. We question how EPA can ensure participation of even a small portion of the growing number of companies that are using nanomaterials. Given the urgency that so many expert bodies including the Royal Society of London, the Council of State and Territorial Epidemiologists, and the American Public Health Association have put on evaluating and regulating risks from nanomaterials, it’s hard to see how developing a voluntary stewardship program could do anything but add more delay to the important business of regulating the use of these chemicals. Instead, we recommend that EPA develop a parallel process to take action under TSCA Section 5 that requires a minimum pre-market safety assessment for all nanomaterials.
Beyond its voluntary nature, we have a number of specific concerns about the NMSP proposal. Without the regulatory imperative, the information EPA receives through this program stands to be extremely limited, particularly given there is no apparent schedule for reporting and an open-ended opportunity for participants to contribute information. While it makes sense for EPA to continually gather new information as it becomes available, we strongly suggest that EPA develop a staged schedule for reporting to maximize the possibility for prompt reporting. We fear that by the time EPA waits for companies to report on their own and evaluates the outcome of the program, it will be too late to protect consumers from the many nano-materials that will have reached the marketplace, and consumers will be faced with another set of chemical hazards in their home and their environment. EPA should not wait to develop mandatory regulations.
Substantiation and Public Access Critical
It is not clear from the current plan that EPA or the public will be able to verify the information that is given. Participating companies should not only fill out the forms, but provide documentation supporting their claims and indicate whether or not studies have been done. We would also urge EPA to ensure that as much information as possible from these reports is made public and that it is reported in a clear and consistent manner, following standard measurement units and nomenclature so that the public can make informed comments and informed decisions about assessing and managing risks associated with these compounds.
We are also concerned about the two-track nature of the program. With some companies reporting much less information than others, the public could get a misleading picture of how much meaningful participation EPA garners from manufacturers. Our recent investigative report on nano-materials in consumer products found a disturbingly wide range of attitudes among companies using these materials about the importance of understanding and managing risks; attitudes ranging from serious concern and proactive risk analysis to complete denial of any safety concerns. In the absence of appropriate toxicity and exposure testing, many seem to be mistaking the lack of evidence of harm for certainty of safety. EPA should ensure that this voluntary reporting structure does not serve to institutionalize this perception.
We have only to look at the recent experience with perfluorinated compounds to see that existing voluntary approaches often fail to protect consumers. It was only after EPA discovered the huge body burden of PFCs that all Americans now carry that companies were forced to work with EPA in a long ultimately unsuccessful process to attempt to identify the most important sources of exposure. It’s clearly time for a change – time for EPA to get back to its primary mandate of establishing mandatory procedures for ensuring that chemicals that reach consumers are safe for human and environmental health. Period.
Inventory Status of Nanoscale Substances
Finally, we are extremely disappointed that EPA seems to be ignoring science that is accepted by the vast majority of experts and institutions studying the issue – namely, that chemicals do take on different biologically-relevant properties at the nanoscale. By ignoring this fact in regulating new chemicals EPA will quickly lose its ability to carry out the mission of the Toxic Substances Control Act, which is to assure that new substances are used in a manner that protects against unreasonable risks to human health.
As we’ve indicated earlier, lack of evidence of harm is no assurance of safety, and without evidence, EPA cannot do its job to assure against unreasonable risks from these new compounds. EPA clearly needs to adapt its program to the realities of new science and regulate nanomaterials as “new” chemicals under TSCA or “new uses” of existing chemicals through a Significant New Use Rule. Either way, the information that EPA is proposing to obtain voluntarily will be critical in order for EPA to fulfill its mission to manage chemical risks under TSCA ,and EPA should not allow chemicals to enter commerce without it.
In summary, we urge EPA undertake an accelerated program to begin regulating nanoscale materials as separate molecular entities or significant new uses under TSCA. Any voluntary reporting structure should be developed only as a parallel process, with a clear schedule that ensures rapid reporting in a manner that supports an accelerated regulatory process. Reported information should be verifiable and publicly available in a manner that supports accurate assessment and management of risks.