Nanotechnology promises to alter almost every industry in the world today. It provides the ability to measure, see, predict and make things on a scale of atoms and molecules, typically in the realm of 1-100 nanometers. A nanometer is one billionth of a meter. For comparison, a human hair is about 100,000 nanometers wide.
The potential for improvement of products could breathe new life into manufacturing, product life-cycles and applications. Those applications extend to many sectors of the American economy, from consumer products to agriculture. According to some estimates, the nanotechnology industry is expected to grow to $2.6 trillion in manufactured goods by the year 2014.1
While the properties of nanotechnology materials have great potential for use in a wide range of new products, these same exciting properties may pose new and different risks for humans and the environment. Regulatory agencies in the U.S. (including the Environmental Protection Agency (EPA) and the Food and Drug Administration) are focusing in earnest on nanotechnology issues. In December 2004, EPA's Science Policy Council formed a cross-Agency Nanotechnology Work group to examine the potential environmental and human health implications of nanotechnology. A week or so ago, that group issued a final white paper on nanotechnology that lays out the science and policy issues it believes the Agency must address across all of its programs.2
These developments are encouraging, but the market is already outpacing the Agency in at least one regulatory area - EPA's oversight and regulation of pesticides. A wide range of consumer products containing nanoparticles of active pesticide ingredients, such as silver, are already available to consumers. (The silver nanoparticles typically are claimed to impart antimicrobial attributes.) At the same time, agricultural chemical manufacturers are working on enhanced nanotechnology delivery systems and other new products. These products, like traditional pesticides and treated articles, almost certainly will fall within EPA's existing authority under the Federal Insecticide Fungicide and Rodenticide Act (FIFRA).
Under FIFRA Section 3, no person may distribute or sell an unregistered pesticide in the U.S.3 In order to register a pesticide, EPA must first determine whether the benefits of it outweigh any risks to human health and the environment, and if so, to set the conditions under which the product may be used so as to limit potential risks.4
Distribution and sale of a registered pesticide is also prohibited if the pesticide is distributed, sold or used in a manner that departs from the conditions imposed with registration. This includes making claims in the sale of the product that are substantially different than those approved in registration; selling a product with a composition that is different from the composition approved as part of its registration; selling an adulterated product; or using a product in a manner inconsistent with the product's labeling.5 Violators of these prohibitions are subject to civil or criminal penalties. EPA also may stop the sale and order the removal from the channels of trade of offending products, and even suspend or cancel the registration of a product.6
But applying EPA's FIFRA authority to nanopesticides raises a host of issues that are now settled for conventional pesticides. For example, when (if at all) are new registrations and product risk assessments required for nanoscale versions of already-registered conventional pesticides? If new registrations are necessary, how does this affect data compensation and exclusive use protections under FIFRA? What would be the impact of EPA's identification of different data requirements for assessing the potential risks of nanopesticides, or new registration requirements specifically for nanopesticides or articles treated with nanoscale active ingredients?
The adoption of nanotechnology to conventional pesticides seems likely to be relatively straightforward. At least initially, nanotechnology may be applied to extend existing crop protection technologies to smaller scales. Many currently registered pesticide microemulsion formulations are already at nanoscale. Other microencapsulation formulations are still at microscopic scale, but have great potential for being taken down to nanoscale.
Moreover, nanoencapsulation would seem to offer many potential benefits in the application of conventional pesticides. For example, it has the potential to allow for controlled delivery, in which the pesticide is only released in response to certain conditions, such as temperature or other environmental factors. One current manufacturer has developed microcapsules that either break open when they hit plant leaves or stay intact after impact for a period of time, thus allowing control over how quickly the pesticide is released to the plant leaves. Many scientists and researchers believe that reducing microencapsulation down to the nanoscale will enhance this benefit.
But experience teaches that complications will arise. This already has been demonstrated with respect to anti-microbial pesticides. About a year ago, Samsung launched a new "Silver Wash" washing machine for clothes that utilizes nanosilver particles. Silver has been used for centuries as an anti-microbial substance. In marketing the product, Samsung stated that the machine injects silver ions into the wash and rinse cycle to penetrate fabric and kill bacteria without the need for hot water and bleach. The anti-bacterial claim seemed to put the product squarely within the scope of FIFRA, and EPA ultimately determined that the washing machine indeed was a "pesticide product" that required registration. It is now working to determine what types of environmental and efficacy data are required to support the anti-microbial claims Samsung seeks to make.
A large class of consumer items impregnated with nanosilver is also receiving attention from EPA and state enforcement agencies. Nanosilver is now being incorporated into a variety of consumer products from food containers, socks, shoe liners, pillows, hair dryers, slippers and cutting boards. Manufacturers of these products have touted - or come close to touting - the anti-microbial properties imparted by these products. Thus, like Samsung's washing machine, these claims potentially bring the products within EPA's regulatory authority over pesticides.
This is because antimicrobial substances like silver are considered to be pesticides under FIFRA. Consumer products impregnated with these substances are known as "treated articles." Under FIFRA, treated articles are "pesticides" that may require registration.
Historically, pesticides were added to articles during manufacture to protect the article or product itself. Several years ago, EPA issued guidance that provides a narrow exemption from registration for products making only such claims.7 Increasingly, however, marketers are making implied or explicit claims that go beyond protection of the product and can be read to mean that the treated article supposedly offers health-related qualities to the user or consumer.
Such claims can put products outside the scope of the exemption, and thus require registration. There are essentially two requirements that must be met to fall within the exemption - the pesticide incorporated into the product must be specifically registered for the protective use being asserted, and the claims made must be limited to statements that go to protection of the article itself. That is, the claims cannot express or imply any public health protection to the user.
Conventional silver pesticides have been registered with EPA for a wide variety of uses in plastics and other substrates that are used in making consumer products. However, at the moment, it is not clear whether nano versions of conventional silver require new registrations before they can be used in these products. Unofficially, EPA staff claim that new registrations are required but, so far, EPA has not registered a nanosilver product for a treated article use. Thus, in the current context, EPA would likely take the view that consumer products containing nanosilver are not eligible for the treated article exemption.
But even if that issue was settled, companies marketing impregnated consumer products must still meet the second requirement of the policy - i.e., their marketing claims must be limited to protection of the article itself. Under EPA's guidance, this means that the claims should go no further than statements such as "this product contains a pesticide (or silver) built-in only to protect the product from the growth of microbes." Public health related claims, such as assertions that the products inherently control germs and microorganisms, are prohibited.8 The guidance also prohibits claims that the product is "anti-bacterial/germicidal" or reference in any context to activity against germs implying public health related protection.9
The bottom line is that EPA views treated articles with implied or explicit public health claims, or which otherwise fail to qualify for the exemption, as pesticide products subject to all requirements of FIFRA, including registration. But, the Agency currently lacks sufficient protocols for the development of data to support public health claims on treated articles for which registration is sought.
A quick search on the Web pulls up a wide range of nanosilver impregnated consumer products that are being marketed with "anti-microbial" and germicidal claims. Many of these products are marketed by non-traditional pesticide manufacturers and retailers who may not understand the nuances of FIFRA and EPA's regulation of treated articles. Many of these marketers may not even realize that FIFRA applies to their products. EPA recently announced that it will publish an updated policy on the types of claims that can be made for products containing nanopesticides and how they will be registered. As of today, however, it is unclear how long it will take EPA to develop this guidance.
Companies contemplating the sale of nanopesticides and consumer products containing them thus must keep a close watch on EPA's development of regulations and guidance in this area. They also should realize that under EPA's current FIFRA authority, the sale and distribution of products that utilize nanomaterials could expose them to enforcement actions. Thus, it is wise to carefully consider whether those products are subject to regulation under FIFRA and ensure that the marketing claims being made for them do not run afoul of EPA's current requirements.1 The Nanotech Report 4th Edition. New York, NY: Lux Research, Inc., 2006, p. iii.
2 U.S. Environmental Protection Agency Nanotechnology White Paper, Science Policy Council, EPA, Washington, DC, February 2007, EPA 100/B-01/001.
3 FIFRA 3, 7 U.S.C. 136a.
4 FIFRA 3(c)(5), 7 U.S.C. 136a(c)(5).
5 FIFRA 12(a)(1), 7 U.S.C. 136j(a)(1).
6 FIFRA 14(a) and (b), 7 U.S.C. 136l(a) and (b).
7 PR Notice 2000-1, Applicability of the Treated Articles Exemption to Antimicrobial Products, U.S. Environmental Protection Agency (March 6, 2000).
Tracy Heinzman, a Partner in Wiley Rein's Chemicals, Safety & Environment Practice, has been representing clients for more than a dozen years in a broad range of environmental, health and safety matters. She is nationally recognized for her strategic representation of businesses that manufacture and market chemicals, pesticides, biocides and other highly regulated products. Ms. Heinzman can be reached at (202) 719-7106.