Silver Nanotechnology Working Group A Program of The Silver Research Consortium LLC
1822 East NC Highway 54, Suite 120 Durham, NC 27713 Tel: (919) 361-4647 Fax: (919) 361-1957
Mr. James Laity Policy Analyst New Executive Office Building Room 10202 725-17th St., NW Washington, DC 20503 September 8, 2010 Dear Mr. Laity, Thank you again for making time on Thursday, August 19, to meet with me, Michael DiRienzo of The Silver Institute, and others to discuss the concerns of the Silver Nanotechnology Working Group (SNWG) with the U.S. Environmental Protection Agency’s (EPA’s) proposed Nanopesticide Policy. As I explained on August 19, the SNWG was initiated in January 2009 with the purpose of working directly with the EPA to define a reasonable regulatory approach toward nanosilver and currently is made up of five companies with interests in the field of silver nanotechnology. In writing this letter, I would like to reinforce some of the points that I made at our meeting. Nanosilver (also known as colloidal silver) is not a new material. It is one of the oldest man-made materials and has been used safely for decades as an antiseptic effect. Colloidal silver products with sizes ranging from 2 to 50 nanometers have been registered and used in the U.S. market for decades in a variety of applications, including pesticides, dietary supplements, photography, pigments, wound treatments, conductive/antistatic, catalysts, antimicrobials, and the list goes on. In fact, silver has been regulated as a biocide in the United States under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) since 1954. Every EPA silver registration between 1970 and 1990 was a colloidal nanosilver or nanosilver composite product. All such biocides have been subjected to a rigorous review prior to registration with the EPA to ensure that they do not pose an unreasonable risk to human health or the environment.
Furthermore, nanosilver products have been safely produced and used in the United States for over a hundred years and there are many important current and potential applications of silver nanoparticles as an antimicrobial (FIFRA) in common everyday products including textiles (e.g., sportsclothing, socks), medical articles & devices (e.g., plasters, wound care), coatings (e.g., wall paint), and plastics (e.g., keyboards). All nanopesticides, including nanosilver, are now emerging as the cornerstone of sustainable pesticide development, where the less-is-more nature of nanopesticides provides real benefits by, for example, allowing for more efficient and targeted application of pesticides, thus reducing the quantities of ingredients released into the environment from the level associated with traditional (bulk material) pesticidal products. In other words, nanopesticides should be embraced – by EPA and others – as beneficial, efficient, and environmentally safe, i.e., “green.” Unfortunately, this is not the case since EPA appears not to fully comprehend the benefits of nanopesticides versus the risk, and instead has moved in the direction of proposing a policy for regulating nanopesticides which could ultimately stigmatize not only the nanosilver industry, but the entire field of nanopesticides. SNWG’s immediate concern is a policy announced by EPA’s Office of Pesticide Programs on April 29, 2010, in which EPA stated that it intended to use the “adverse effects” reporting provision found in FIFRA Sec. 6(a)(2) to subject existing and even asof-yet unregistered nanopesticides to greater scrutiny based solely on the presence of nanomaterials in such products, despite there being no bona fide evidence that any registered pesticide containing nanomaterials is having adverse environmental or humanhealth effects. Under this policy, every pesticide containing nanomaterial will be treated as “new” and thus be subjected to the FIFRA registration process, even if the product is already registered. In other words, a registered pesticide containing silver will require registration anew if it contains nanosilver, i.e., silver measuring on the nanoscale. As I noted on August 19, the SNWG has five principal concerns with EPA’s new policy: 1. EPA is misusing the FIFRA Sec. 6(a)(2) authority. Section 6(a)(2) is intended to serve as a post-registration check on registrants by requiring them to report to EPA additional factual information about unreasonable adverse effects in order to ensure EPA remains current about a pesticide’s risk assessment.1 Importantly, it only applies where there is tangible evidence of some adverse effect, and it was never intended to apply to pesticides not yet registered. Regarding registered pesticides. The Section 6(2)(a) authority is factbased, i.e., it applies only where the registrant becomes aware of demonstrable 1
See 7 U.S.C. § 136d(a)(2) (“Information. If at any time after the registration of a pesticide the registrant has additional factual information regarding unreasonable adverse effects on the environment of the pesticide, the registrant shall submit such information to the Administrator.”).
unreasonable adverse effects of its pesticide on the environment. EPA, however, is pursuing Section 6(a)(2) information-gathering and scrutiny, and the de facto re-registration requirement, based not on anything real and demonstrable, but on theoretical and generic “Potential Human Health Concerns” and “Potential Environmental Concerns,” even though no adverse environmental or health effects of nanopesticides have been documented. Focusing now on nanosilver, the scholarly scientific literature shows just the opposite: the overwhelming peerreviewed evidence examining the fate and transport of nanosilver particles and silver in the environment, indicates that nanosilver (indeed, all silver) is rendered innocuous to all life forms long before it comes into contact with ecosystems. Accordingly, there is no basis for subjecting registered nanosilver pesticides to further scrutiny under an “adverse effects” rubric, and no basis for classifying them as “new’ and thereby requiring registration anew. In fact, classifying registered pesticides as “new” directly contradicts the Pesticide Registration Improvement Act of 2003 (PRIA) which was enacted specifically to improve the speed and predictability of pesticide registration. Under PRIA, a “new active ingredient” means “an active ingredient that is not currently contained as an active ingredient in any registered pesticide product.” EPA’s policy contradicts both the intent of PRIA (predictability) and its terms (newness based on fact, not arbitrary and unsupported assumptions). Regarding products not yet registered. Furthermore, to subject as-of-yet unregistered products to an “adverse effects” reporting requirement is to put the cart before the horse – this policy essentially presumes adverse effects of a proposed product if it just lists one or more nanomaterials as an ingredient, and thus taints the product from the outset, depriving the manufacturer of a fair and objective review of the actual scientific documentation about the product. 2. EPA’s policy will foster a negative public perception of nanopesticides. By ascribing to all nanopesticides the taint of “adverse effects,” EPA’s new policy will stigmatize the use of nanopesticides (indeed, all nanomaterials) as commentators will tend to equate nanopesticides with “adverse effects” by sheer virtue of EPA’s policy. Consumers, in turn, may actively try to avoid all products containing nanomaterials because of this taint, and investors, too, will be leery of investing in new nanomaterial businesses out of this same fear, and the derivative fear that if a product is not safe, or even just perceived as not safe, it will not attract customers and become profitable. 3. EPA’s policy will stifle innovation and progress. EPA will also endanger innovation and progress in nanopesticides, which are on the cutting edge of the chemical industry and “green” technology. Absent any roadmap on the acceptable uses of nanopesticides, EPA’s policy threatens to bring research and development in this field to a grinding halt. The policy is like a black box, and in many (perhaps most) cases it will be simply too risky and too expensive to fund R&D for products that face such an uncertain fate.
4. EPA’s policy will costs jobs. Part and parcel to the stifling of research and development is the threat to the very livelihood of the small businesses responsible for innovation in this field and the professionals and staff they employ. As just one example of this, the manufacturer of the very first nanosilver biocide registered under FIFRA in 1954 expects that the new policy will put it out of business on account of EPA telling it that, under EPA’s new FIFRA Sec. 6(a)(2) policy, its product will have to undergo scrutiny and re-registration as a “new” product, notwithstanding the complete lack of any reported “adverse effects.” 5. EPA’s policy institutionalizes an arbitrary and unsupportable definition of nanotechnology. At the root of EPA’s ill-conceived policy is its definition of “nanoscale material,” a term it defines as “an ingredient that contains particles that have been intentionally produced to have at least one dimension that measures between approximately 1 and 100 nanometers.” By this definition, EPA misses the material concern of FIFRA: the environmental effects of a pesticide. Size by itself is immaterial, and by relying solely on size, EPA has fueled the concerns noted above without any concrete evidence of adverse effects by an actual product. Moreover, there is no legitimate basis for the “intentionality” component of the definition. All pesticide nanomaterials are intentionally manufactured and always have been. Intentionality was originally introduced into discussions about nanomaterials in order to contrast naturally occurring nanomaterials from materials purposely generated for a specific function. However, inasmuch as all pesticide nanomaterials are manufactured, the intentionality criterion is inappropriate. To be clear, SNWG’s concern is not with EPA’s desire to obtain additional information about nanopesticides or nanosilver in particular – we support EPA’s goal of increasing its knowledge of nanotechnology in general and recognize the importance of information-gathering to the agency’s mission of protecting the nation’s environment from harmful pollutants. But EPA can accomplish its aims through means that do not stigmatize, unjustifiably, an entire field. I discussed some of these alternative means of data collection at our meeting on August 19. They include:
EPA could modify the information that it requires as part of the pesticide registration or registration review processes. For instance, EPA could require that applications for pesticide products include information on active ingredient and inert ingredient particle size and distribution. Additionally, EPA can pursue modifying its Part 158 requirements to obtain this information without the “adverse effects” label. By focusing on methods that systematically obtain information from a particular category that is of real interest, EPA can avoid haphazard collection of only the information that registrants happen to obtain (including information that has no risk implications). In this way, EPA can also avoid the stigma associated with a policy that implies that all nanotechnology may be associated with adverse effects.
EPA should consider its regulatory authority as outlined by the American Bar Association (ABA) in the article “The Adequacy of FIFRA to Regulate Nanotechnology Based Pesticides,” published May 2006. This is a very
important document that articulates a coherent regulatory approach to regulating nanopesticides. For example, where a registrant of a conventional pesticide applies for registration of a nanoscale version of that pesticide, an application for an amended registration of the corresponding macroscale pesticide, under FIFRA Sec. 3(c)(2)(C) (7) and 40 C.F. R. Sec. 152.44, might be appropriate. In an amended registration application, the registrant could be required to provide additional information specific to the nanopesticide’s risks and benefits.
To perform the statutorily mandated risk assessment for a nanopesticide, EPA needs information on the potential risks and benefits of the nanopesticide. Under FIFRA Section 3, EPA may obtain the necessary data from prospective registrants, new registrants. Under FIFRA, EPA can ensure that it has all the data on the specific nanopesticide necessary to perform its risk assessment.
FIFRA offers ample authority to regulate nanopesticides. This authority covers the entire scope of regulatory interest, from pre-registration research and development, to registration, through post-registration marketing and use. EPA’s most powerful tool for controlling the potential risks posed by nanopesticides is the registration requirement. Registration provides EPA the opportunity to prohibit, condition, or allow the manufacture and use of nanopesticides and prescribes the conditions of that manufacture or use. The registration requirement in FIFRA Section 3 is bolstered by the strong enforcement powers that EPA can exercise over unregistered pesticides under Sections 12, 13, 14, and 19. EPA’s authority to regulate nanopesticides under FIFRA continues post-registration as well. After a period of years, review and re-registration is required under FIFRA Sections 3(g) and 4. Nanopesticide registrants remain under an obligation to notify EPA of adverse effects discovered after registration under FIFRA Sec. 6(a)(2). If EPA should determine that the balance of risk and benefits of a nanopesticide has shifted since its original risk assessment, it has a variety of tools to halt further use of the nanopesticides under Sections 12, 13, 14, and 19. Thus, in summary the SNWG recommends the following:
Use FIFRA’s pesticide registration and re-registration process as discussed above to obtain information about the current and historical uses of intentional and unintentional nanomaterials in pesticide products, and include this data in any risk assessment conducted by EPA and considered during policymaking;
Consider an alternative regulatory approach to nanopesticides such as that thoughtfully outlined in the article “The Adequacy of FIFRA to Regulate Nanotechnology-Based Pesticides,” published May 2006 by the ABA Section of Environment, Energy, and Resources, which avoids arbitrary definitions and the stigma of “adverse effects” reporting; and
Commission a study on the green-chemistry benefits of nanomaterials, including analyzing the relative risks and benefits to implementing the regulations.
The bottom line is that nanopesticides in general, and nanosilver more specifically, offer incredible promise, and SNWG believes strongly that EPA should not pursue a policy that, without demonstrable evidence, assumes a nexus between nanopesticides and adverse environmental or health effects. Such a policy is certain to create a negative perception in the public’s eye about the nanopesticides field, which in turn will stifle innovation and cause unnecessary hardships to many small businesses and their employees working in the field. Adopting an alternative approach, on the other hand – one that does not depend on the faulty “adverse effects” premise – would provide EPA with the same information without the social and economic cost. At the very least, EPA should put a hold on adopting any particular policy until it has had time to consider in greater depth these important issues with the various stakeholders. Thank you again for your attention to the concerns of SNWG. Please do not hesitate to contact me with any follow-up questions you may have.
Sincerely,
Rosalind Volpe, D.PH Director, SNWG Silver Nanotechnology Working Group
[email protected] cc: Travis Earles, Office of Science and Technology Policy, White House
