(Beyond Pesticides, June 14, 2011) The U.S. Environmental Protection Agency (EPA) announced plans to obtain information on nanoscale materials in pesticide products, while the Food and Drug Administration (FDA) released draft guidelines to industries about when the use of nanomaterials might trigger regulatory interest. These two actions announced last week will aim to clarify the role that extremely small materials can play in items such as cosmetics and food production and packaging and gather environmental and human health related data.
According to EPA, the agency will gather information on what nanoscale materials are present in pesticide products to determine whether the registration of a pesticide may cause unreasonable adverse effects on the environment and human health. The proposed policy will soon be open for public comment.
“We want to obtain timely and accurate information on what nanoscale materials may be in pesticide products,“ said Steve Owens assistant administrator for EPA’s Office of Chemical Safety and Pollution Prevention. “This information is needed for EPA to meet its requirement under the law to protect public health and the environment.”
EPA states that it recognizes that nanoscale materials have a range of potentially beneficial public and commercial applications, including pest control products. However, nanosized materials, now incorporated into many consumer products, including paper wrapping, clothing and cosmetics, are currently not regulated and have not been assessed for hazards that have the potential to impact public health and the environment.
The new guidance will propose a new approach for how EPA will determine whether a nanoscale ingredient is a “new” active or inert ingredient for purposes of scientific evaluation under the pesticide laws, when an identical, non-nanoscale form of the nanoscale ingredient is already registered under the Federal Insecticide Fungicide and Rodenticide Act (FIFRA). This approach, according to the agency, will help ensure that EPA is informed about the presence of nanoscale ingredients in pesticide products and allows a more thorough review of the potential risks. Comments on the Federal Register notice will be accepted until 30 days after publication. The notice will be available at www.regulations.gov in docket number EPA—HQ—OPP—2010-0197.
EPA’s new guidance on nanotechnology has been delayed for almost one year after the agency first submitted its draft proposal to the Office of Management and Budget (OMB). Environmental advocates have attributed the holdup to industry lobbying against an interpretation of FIFRA Section 6(a)(2) that would require the presence of a nanoscale material to be reported to the agency under FIFRA Section 6(a)(2) for environmental effects. The requirement would apply to already registered products, as well as products pending registration. However, pesticide manufacturers routinely fail to inform EPA when their products contain nanoscale particles. Consumers are left in the dark about their potential exposure since these products are currently being marketed under ambiguous labels.
The Food and Drug Administration (FDA) named certain characteristics, such as the size of nanomaterials used and their properties, that may be considered when trying to identify applications of nanotechnology in products. A number of organizations, as well as government, academic and private sector scientists, have considered whether the small size of nanoscale materials or the unique or enhanced properties of nanoscale materials may, under specific conditions, pose new or increased hazards to humans and the environment. FDA’s draft guidance, “Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology,” is available online and open for public comment. According to the FDA, it represents the first step toward providing regulatory clarity on the FDA’s approach to nanotechnology. For products subject to premarket review, FDA intends to apply the points contained in the draft guidance, when finalized, to better understand the properties and behavior of engineered nanomaterials. For products not subject to premarket review, the FDA will urge manufacturers to consult with the agency early in the product development process.
“With this guidance, we are not announcing a regulatory definition of nanotechnology,” said Margaret A. Hamburg, MD, Commissioner of Food and Drugs. “However, as a first step, we want to narrow the discussion to these points and work with industry to determine if this focus is an appropriate starting place.”
Similar statements were also release by the White House in coordination with announcements by EPA and FDA, entitled “Policy Principles for the U.S. Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials” issued jointly by the Office of Science and Technology Policy, Office of Management and Budget, and the United States Trade Representative.
Nanotechnology, the science involving manipulation of materials on an atomic or molecular scale, is an emerging technology with a broad range of potential applications, such as increasing bioavailability of a drug, improving food packaging and in cosmetics. There are hundreds of products currently on the market that contain nanomaterials of various types and functions, the most popular application being the use of nanosilver as an antibacterial substance in many consumer products. Given this, the federal government at this point is playing a game of ”˜catch-up.’ Studies have shown that nanosized materials are able to cross the blood-brain barrier and can accumulate in the brain, under and skin and other compartments of the body. Others have found that clothing treated with nanomaterials leach from these materials during laundering and enters the wastewater treatment system and the environment. Much is unknown on the fate of these materials in the human body and the environment,t and scientists and researchers are becoming increasingly concerned with the potential impacts of these particles. A recent study by scientists from Oregon State University (OSU) and the European Union (EU) highlight the major regulatory and educational issues that they believe should be considered before nanoparticles are used.
Last year, the National Organic Standards Board (NOSB) passed a recommendation directing the USDA National Organic Program (NOP) to prohibit engineered nanomaterials from certified organic products as expeditiously as possible. While there is overwhelming agreement to prohibit nanotechnology in organics generally, there is still confusion over the definition of what exactly should be prohibited and how to prohibit nanotech products in the organic industry. The recommendation deals specifically with engineered nanomaterials and purposefully omits those that are naturally occurring. Further it would block petitions seeking an exemption and keep nanomaterials out of food packaging and contact surfaces. The board adopted the following definition:
“Engineered nanomaterials: substances deliberately designed, engineered and produced by human activity to be in the nanoscale range (approx 1-300 nm) because of very specific properties or compositions (eg. shape, surface properties, or chemistry) that result only in that nanoscale. Incidental particles in the nanoscale range created during traditional food processing such as homogenization, milling, churning, and freezing, and naturally occurring particles in the nanoscale range are not intended to be included in this definition. All nanomaterials (without exception) containing capping reagents or other synthetic components are intended to be included in this definition.”
The International Center for Technology Assessment (CTA) and a coalition of consumer, health, and environmental groups, including Beyond Pesticides, filed a legal petition on May 1, 2008 with the Environmental Protection Agency (EPA), demanding the agency use its pesticide regulation authority to stop the sale of 250+ consumer products now using nanosized versions of silver. The legal action is the first challenge to EPA’s failure to regulate nanomaterials. In November 2008, EPA determined that ICTA’s petition “raises serious issues that potentially affect private and public sector stakeholders” and opened a 60-day period for public comment. At that time, EPA said it would review the petition and any comments received “before deciding how best to respond to the petition.”