The U.S. Department of Agriculture (USDA) National Organic Program (NOP) issued on March 24, 2015, a policy memorandum clarifying the status of nanotechnology in organic production and handling under the USDA organic regulations. The memorandum states that NOP has received questions about the use of nanotechnology. The memorandum uses the term “engineered nanomaterials” to refer to substances specifically designed and manufactured to have unique properties or behavior attributable to particle size. The term “incidental nanomaterials” is used to refer to substances that are incidental byproducts of other manufacturing (e.g., homogenization, milling) or that occur naturally. The memorandum states that no engineered nanomaterial will be allowed for use in organic production and handling unless the substance has been: (1) petitioned for use; (2) reviewed and recommended by the National Organic Standards Board (NOSB); and (3) added to the National List of Allowed and Prohibited Substances through notice and comment rulemaking. The memorandum notes that to avoid conflicts about the presence of nanomaterials in substances regulated by other federal agencies, NOP is not establishing a separate definition for engineered nanomaterials. Instead, the descriptions in the U.S. Food and Drug Administration’s (FDA) Guidance for Industry Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology and the U.S. Environmental Protection Agency’s policies on regulating pesticides that use nanotechnology and control of nanoscale materials under the Toxic Substances Control Act “should be used as applicable.”
On November 20, 2012, Lux Research Inc. released a report entitled Bridging the Divide between Demands and Bio-Based Materials, in which the properties and commercial attractiveness of 38 applications and 21 conventional and bio-based polymers were assessed on 13 criteria, with three demand areas promising opportunity, according to Lux. Lux states that materials that fail to connect with end-user demands never reach the commercialization stage. Lux recommends that developers target large, addressable markets, among which the biggest are composites and coatings, industrial manufactured intermediates, and packaging. Lux notes that developers must offer bio-based alternatives at cost parity, offer more bio-based drop-in monomers, and continue to close performance gaps on temperature distortion and brittleness, as well as advance bio-based polymers beyond their reputation as merely “disposable.” Lux urges developers to meet or exceed expectations on cost and performance and be smart during roll-out. Kalib Kersh, a Lux analyst, stated that the U.S. Department of Agriculture (USDA) would expand the market for biobased chemicals if it fulfills its pledge to certify intermediates through its BioPreferred Program. During a recent conference held by the Society for the Commercial Development of Industrial Biotechnology, a USDA spokesperson stated that USDA intends to cover intermediates in its Program.
Tom Vilsack, Secretary of Agriculture, spoke at the 2012 GreenGov Symposium on September 25, 2012. According to Vilsack, the United States Department of Agriculture (USDA) is working to support the manufacturing industry by increasing the number of biobased products approved for federal purchase. Currently, there are approximately 9,300 BioPreferred products, and USDA intends to make 18,000 BioPreferred products available. Under Executive Order 13,514, federal agencies are required to ensure that 95 percent of new contracts use biobased products when available. Under a February 21, 2012, Presidential Memorandum, the USDA is directed to increase the number of categories of biobased products available for purchase by 50 percent by February 21, 2013. There were 64 categories of biobased products available in February 2012, and Vilsack stated that USDA has increased the number of categories to 77, including lotions and moisturizers, leather, vinyl, rubber care products, and shaving products.
On April 18, 2012, the United States Department of Defense (DoD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA) promulgated a final rule amending the Federal Acquisition Regulation (FAR) to implement changes due to the Farm Security and Rural Investment Act that require contractors to report the biobased products purchased under service and construction contracts. According to the Federal Register notice, the reporting will enable agencies to monitor compliance with the federal preference for purchasing biobased products. The information reported by prime contractors will enable federal agencies to report annually information concerning actions taken to implement the preference for biobased products, and assess compliance and measure progress in carrying out the preference for biobased products. Where information on the biobased nature of products is not already available, the notice states that contractors may need to create an inventory management system to track the product types and dollar value of United States Department of Agriculture (USDA)-designated biobased products purchased for each contract. DoD, GSA, and NASA expect that the impact will be minimal, however, because the existing clause already requires contractors to make maximum use of biobased products. The final rule will be effective May 18, 2012.
In an April 4, 2012, final rule, the U.S. Department of Agriculture (USDA) amended the Guidelines for Designating Biobased Products for Federal Procurement to add 13 sections to designate product categories within which biobased products will be afforded federal procurement preference. USDA also established minimum biobased contents for each of these product categories. The 13 categories are: air fresheners and deodorizers; asphalt and tar removers; asphalt restorers; blast media; candles and wax melts; electronic components cleaners; floor coverings (non-carpet); foot care products; furniture cleaners and protectors; inks; packing and insulating materials; pneumatic equipment lubricants; and wood and concrete stains. USDA has determined that each of these product categories meets the necessary statutory requirements; that they are being produced with biobased products; and that their procurement will carry out the following objectives of Section 9002 of the Farm Security and Rural Investment Act of 2002, as amended by the Food, Conservation, and Energy Act of 2008: to improve demand for biobased products; to spur development of the industrial base through value-added agricultural processing and manufacturing in rural communities; and to enhance the nation’s energy security by substituting biobased products for products derived from imported oil and natural gas. With the designation of these specific product categories, USDA invites the manufacturers and vendors of qualifying products to provide information on the product, contacts, and performance testing for posting on its BioPreferred website. The final rule will be effective May 4, 2012.
President Obama signed a February 21, 2012, memorandum entitled “Driving Innovation and Creating Jobs in Rural America through Biobased and Sustainable Product Procurement.” The BioPreferred Program, which was established by the Farm Security and Rural Investment Act of 2002 (2002 Farm Bill) and amended by the Food, Conservation and Energy Act of 2008 (2008 Farm Bill), is intended to increase federal procurement of biobased products, which will promote rural economic development, create new jobs, and provide new markets for farm commodities. According to the memorandum, the federal government, with leadership from the United States Department of Agriculture (USDA), has made significant strides in implementing the BioPreferred Program. The goal of the Presidential memorandum is to ensure that agencies effectively execute federal procurement requirements for biobased products.
On November 16, 2010, the United States Department of Agriculture (USDA) Office of Risk-Assessment and Cost-Benefit Analysis (ORACBA) convened a Risk Forum on “Moving Beyond Nanogeneralities -- Providing Focus to Nanopolicy Progress.” Presenters included Richard Canady, Ph.D., DABT, Director, Center for Human Health Risk Assessment Research Foundation of the International Life Sciences Institute; Steve Froggett, Expert Consultant, ICF International, Inc; and Guillaume Gruere, International Food Policy Research Institute. The speakers propose that the issues concerning nanotechnology and nanomaterials are so varied, broad, and controversial that they impeded the development of beneficial uses, even where the risks are negligible. The speakers suggest that, early in any discussion or in any risk assessment of nanomaterial uses, the problem selection and problem formulation are critical. If the selection and formulation are done well, regulators and stakeholders can make progress in risk assessment policy and risk management of specific uses of nanomaterials.
At the U.S. Department of Agriculture’s (USDA) National Organic Standards Board’s (NOSB) October 25-28, 2010, meeting, NOSB unanimously recommended that the USDA National Organic Program (NOP) prohibit engineered nanomaterials from certified organic products. NOSB considered a September 2, 2010, guidance document prepared by its Materials Committee concerning engineered nanomaterials in organic production, processing, and packaging. According to the Materials Committee, public comment “overwhelmingly agrees that nanotechnology in organic production and processing be prohibited at this time.” The Materials Committee notes, however, that “there is considerable debate and disagreement on what exactly nanotechnology is and what products of nanotechnology should be prohibited.”. The Materials Committee requested that the NOP allow NOSB to call for a symposium “to discuss the issues related to the human-engineered portion of this science,” which “would help to clarify these confusing issues, and serve to educate both the Board and the NOP on this topic.”
The Materials Committee proposed, and the NOSB approved, the following definition of engineered nanomaterials:
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 (e.g. 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.