The U.S. Government Accountability Office (GAO) recently released a report criticizing the Food and Drug Administration’s (FDA’s) oversight of food ingredients determined to be generally recognized as safe (GRAS). Noting that companies are not required to submit their GRAS determinations to regulators, GAO examined whether FDA can vouch for these substances, which increasingly include nanomaterials. The report apparently concludes that not only does FDA’s oversight process fail to ensure the safety of both new and preexisting GRAS determinations, but it allows engineered nanomaterials to enter the food supply without the agency’s knowledge. According to the report, FDA “has not systematically reconsidered GRAS substances since the 1980s,” nor has it responded to “concerns about GRAS substances, such as salt and the trans fat in partially hydrogenated vegetable oils, that individuals and consumer groups have raised through 11 citizen petitions submitted to the agency between 2004 and 2008.” The findings also fault…
Tag Archives nanotechnology
The European Commission has released a report, “Understanding Public Debate on Nanotechnologies: Options for Framing Public Policy,” that discusses several commission projects designed to assess “the nature of public debate on nanosciences and nanotechnologies, and the ways in which deliberative approaches could lead to better governance of these technologies.” The overview includes summaries of the FramingNano, Nanocap, Deepen, and Nanoplat projects. The authors, who were involved as coordinators or participants in these projects, acknowledge that nanotechnology policy is still in its initial phases of development and could be overwhelmed by the sheer volume of products expected to enter the market in the near future. They note that international authorities have not yet agreed to definitions relating to the technology and that the European Union is regulating nanoparticles as “chemical substances” under REACH. Among other matters, they observe that nanotechnology in food is expected to be defined as a “novel food,”…
The Environmental Protection Agency (EPA) has issued a proposed rule that “would require persons who intend to manufacture, import, or process [multi-walled carbon nanotubes] for an activity that is designated as a significant new use by this proposed rule to notify EPA at least 90 days before commencing that activity.” The activities identified in the proposed rule as “a significant new use” are (i) “protection in the workplace” (“full-face respirators with N100 cartridges”), and (ii) “industrial, commercial, and consumer activities” (“additive/filler for polymer composites and support media for industrial catalysts”). According to the notice, EPA has issued the proposal under the authority of the Toxic Substances Control Act (TSCA) and would adopt the 90-day notice requirement to give the agency the opportunity to evaluate the intended use and “prohibit or limit that activity before it occurs,” if necessary. Comments must be submitted by March 5, 2010. See Federal Register, February 3,…
California’s Department of Toxic Substances Control (DTSC) has been gathering information from companies that produce or import carbon nanotubes in the state and has posted the information received by its January 22, 2010, deadline on the agency’s website. The agency has also indicated which companies did not submit the information requested; a news source reports that DTSC may take action through the attorney general’s office against them. DTSC launched the information call-in program in 2009, hoping to identify information gaps and build data about carbon nanotubes. Manufacturers and importers were requested to supply information about “analytical test methods, fate and transport in the environment, and other relevant information.” The agency’s initial request involved reactive nanometal oxides, including aluminum oxide, silicon dioxide, titanium dioxide, and zinc dioxide. It has since identified as nanomaterials of interest nano silver, nano zerovalent iron and cerium oxide. According to a press report, agency sources have…
Legislation recently introduced in the House and Senate would take different approaches to the continuing development and use of nanotechnology. Senators Mark Pryor (D-Ariz.) and Benjamin Cardin (D-Md.) have co-sponsored a bill (S. 2942), the “Nanotechnology Safety Act of 2010,” that would establish a program within the Food and Drug Administration (FDA) to investigate nanoscale materials used in FDA-regulated products to assess their “potential toxicity” and interactions with biological systems. The measure would appropriate $25 million for each year from 2011 through 2015 to carry out the program. Among other matters, the proposal calls on FDA to assess scientific literature and data, develop models to formulate general principles for “the behavior of classes of nanoscale materials with biological systems,” undertake collaborative efforts to understand the “science of novel properties at the nanoscale that might contribute to toxicity,” build agency expertise on these issues, ensure ongoing training, and “participate in international…
In a development that could have a significant impact on the global food industry, the U.K.’s House of Lords has completed an inquiry into the use of nanotechnology in foods, food packaging and food contact materials. In a January 8, 2010, press release and comprehensive report accompanied by a separate volume of evidence, the Lords’ Science and Technology Committee criticizes the food industry for “not publishing or discussing details of its research in this area.” The committee calls for the government “to adequately fund research into potential health and safety risks arising from the use of nanomaterials in the food sector” and recommends that the Food Standards Agency “contribute to consumer confidence in the use of nanomaterials in food by maintaining a publicly available register of food and food packaging containing nanomaterials.” Noting the unavailability to border and port authorities of “tests to check whether imported food contains nanomaterials,” the committee…
Purdue University scientists have reportedly altered a nanoparticle found in sweet corn to prevent oxidation and spoilage, thus offering a way to extend the shelf life of foods, cosmetics and other products containing emulsified lipids. Siqi L Scheffler, et al., “Phytoglycogen Octenyl Succinate, an Amphiphilic Carbohydrate Nanoparticle, and ε-Polylysine To Improve Lipid Oxidative Stability of Emulsions,” Journal of Agriculture and Food Chemistry, December 2009. According to a December 8, 2009, press release, researchers with Purdue’s Whistler Center for Carbohydrate Research “successfully modified the phytoglycogen nanoparticle, a starch-like substance that makes up nearly 30 percent of the dry mass of some sweet corn. The modification allows the nanoparticle to attach to oils and emulsify them while also acting as a barrier to oxidation, which causes food to become rancid.” Known as phytoglycogen octenyl succinate (PG-OS), the nanoparticle when combined with food-grade e-polylysine “significantly increased the amount of time it took for oxidation to…
The Investor Environmental Health Network (IEHN) has requested that the Securities & Exchange Commission (SEC) include in its 2010 2015 strategic plan the development of guidance for public companies requiring narrative disclosures in their annual financial reports about emerging risks such as nanotechnology. Attached to the IEHN November 15, 2009, letter is a report titled Bridging the Credibility Gap: Eight Corporate Liability Accounting Loopholes that Regulators Must Close that focuses on asbestos and nanomaterials “to assess the effectiveness of the existing financial disclosure regulations, and to develop recommendations for improvements.” According to IEHN, the report “found some companies heavily investing in nanomaterials today that appear to be engaging in inadequate or misleading disclosures related to potential hazards and the resultant financial implications. In particular, some of the materials being developed by nanomaterials companies have already been found to bear significant hazard similarities to asbestos, but this information is not contained in any…
Noting the absence of significant regulatory oversight, this article discusses the use of nanotechnology in foods, food packaging and food supplements. While the Food and Drug Administration has decided not to regulate products according to the technology used, it will apparently issue a guidance document on nanotechnology in 2010. The article cautions that “companies need to realize the EU, Canada and the State of California have all requested information from manufacturers of nanoscale products.” According to the market data on nanotechnology, while little food with nanotech ingredients are on grocery store shelves today, food packaging is an active application that accounts for billions in sales. Manufacturers are apparently using the technology to develop “improved tastes, color, flavor, texture and consistency of foodstuffs, increased absorption and bioavailability of nutrients and health supplements, new food packaging materials with improved mechanical, barrier and antimicrobial properties, and nano-sensors for traceability and monitoring the condition…
The National Industrial Chemicals Notification and Assessment Scheme of Australia’s Department of Health and Ageing has released for public comment a plan to (i) eliminate a regulatory review exemption for the production of small quantities of new nanoscale materials; and (ii) establish a voluntary reporting system for manufacturers producing nanoscale chemicals. Comments must be provided no later than December 23, 2009. U.S. observers have reportedly indicated that the Australian proposal is presented in a manner that may make it a model for other countries also grappling with safety issues involving nanomaterials. See BNA Daily Environment Report, November 17, 2009. Meanwhile, new reports on purported health and environmental effects of nanoscale materials continue to be released. The November 16 issue of Cancer Research contains a study suggesting that titanium dioxide nanoparticles, found in toothpaste, food colorants, cosmetics, sunscreens, paints, and vitamins, caused genetic damage in mice. According to senior author Robert Schiestl,…
