Food & Agriculture

The U.S. Food and Drug Administration in April 2012 issued two draft guidance documents relating to the use of nanotechnology in food and food packaging and cosmetics.

"[Draft] Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives," covers the use of nanotechnology in the manufacture of food ingredients, including color additives, and food contact substances, e.g., packaging.

“[Draft] Guidance for Industry: Safety of Nanomaterials in Cosmetic Products,” covers the use of nanotechnology in cosmetics.

These draft guidance documents are the subject of a summary article by attorney Lynn Tyler (Barnes & Thornburg LLP), published in Product Liability Law360, on May 29, 2012, "Tightening FDA Nanotech Regs on Food, Cosmetics."

According to Tyler: "The message of the two guidance documents is similar: Manufacturers in these industries who incorporate nanoscale ingredients into their products should be prepared to prove that the resulting products are safe and that appropriate tests were used to validate their safety."

Excerpts of the article are provided below.

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The use of engineered nanoparticles in food processing and pharmaceuticals is increasing, but the impact of chronic oral exposure to nanoparticles on human health remains unknown.

It has been estimated that the average person in a developed country consumes over a trillion man-made fine to ultrafine particles every day. Some features of nanoparticles may lead to harmful interactions with cellular material but few if any studies have yet addressed the chronic effects of nanoparticle exposure on the normal function of the intestinal lining, known as the epithelium.  

"Oral exposure to polystyrene nanoparticles affects iron absorption", published on February 12, 2012, in the journal Nature Nanotechnology, addresses that issue.

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In a new report, “The Sourcing Framework for Food and Food Packaging Products Containing Nanomaterials”, by the United States-based non-profit organization, As You Sow, sxperts in environmental health issues teamed with major companies to advise food industries to exercise caution when using nano-sized, manmade creations as nutritional additives, flavorings, colorings, or anti-bacterial coatings for packaging.

As You Sow teamed up with several major food companies, including Kraft, McDonald’s, Whole Foods, Yum! Brands, and Pepsi, to create the Framework. According to the study, as "food and food packaging companies explore the use of nanomaterials to enhance products, they need also attend to potential risks introduced."

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The legal battle has finally been joined.  The first lawsuit over the health and environmental risks of nanotechnology and nanomaterials has been filed.

On December 21, 2011, a coalition of nonprofit consumer safety and environmental groups sued the Food and Drug Administration (FDA) in the United States District Court for the Northern District of California. International Center for Technology Assessment, et al v Margaret A. Hamburg, M.D., Case No. CV 11-6592, is an Administrative Procedure Act case seeking declaratory and injunctive relief. The Plaintiffs (ICTA; Friends of the Earth; The Action Group on Erosion, Technology and Concentration; The Center for Environmental Health; Food and Water Watch; and the Institute for Agriculture and Trade Policy) demand that the FDA respond to a petition these organizations filed with the agency in 2006.

The eighty-page 2006 Petition documents the groups' claimed scientific evidence of nanomaterial risks stemming from their unpredictable toxicity and seemingly unlimited mobility. The 2006 petition requested FDA take several regulatory actions, including requiring nano-specific product labeling and health and safety testing, and undertaking an analysis of the environmental and health impacts of nanomaterials in products approved by the agency. The FDA had yet to act on the 2006 petition, prompting the suit.

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The U.S. Environmental Protection Agency announced on June 9, 2011, that it plans to obtain information on nanoscale materials in pesticide products.

Pesticidal Applications of Nanotechnology:  The use of nanoscale materials in pesticide products and treated articles may allow for more effective targeting of pests, use of smaller quantities of a pesticide, and minimizing the frequency of spray-applied surface disinfection. These could contribute to improved human and environmental safety and could lower pest control costs. For example, as a materials preservative, nanosilver should maintain its ability to reduce the number of odor causing bacteria longer and require smaller quantities than other silver preservatives due to an expected gradual and controlled release of silver ions from nanosilver as opposed to the rapid release of for example, silver ions from a zeolite structure or the immediate dissolution of a silver salt. 

Regulation of Nanotechnology in Pesticides:  FIFRA and EPA’s implementing regulations provide an effective framework for regulating pesticide products that contain a nanoscale material. Currently, the Office of Pesticide Programs (OPP) describes a nanoscale material as an active or inert ingredient of a pesticide and any component parts thereof intentionally produced to have at least one dimension that measures between approximately 1 and 100 nanometers.

The OPP recognizes that special properties that make nanoscale materials of potentially great benefit also can present new challenges for risk assessment and decision-making.  For instance, their small size may allow them to pass through cell membranes or the blood-brain barrier, possibly resulting in unintended effects.  The EPA recognizes that government, academic, and private sector scientists in multiple countries are performing research into the human health effects of diverse nanoscale materials, resulting in a substantial and rapidly growing body of scientific evidence.

New Policy for Nanotechnology in Pesticides:

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Nanotechnologies are being applied rapidly in food industries worldwide. A fresh review article of that growth is available in the article "Nanotech: Propensity in Foods and Bioactives," published in Critical Reviews in Food Science and Nutrition in June 2011.

Applications in food industries include molecular synthesis of new functional food compounds, innovative food packaging, food safety and security monitoring. This review article covers the use of biopolymers in the production of nanomaterials and the propensity of nanotechnology in food and bioactives.

The extensive use of nanotechnology has led to the need for paralleled safety assessment and regulations to protect public health and environmental adverse effects.  The exposure routes of nanoparticles, safety challenges and measures undertaken to ensure optimal benefits that outweigh detriments are also discussed.

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On June 9, 2011, the U.S. Food and Drug Administration announced a draft Guidance for Industry about the use of nanotechnology by industries the agency regulates, calling it the “first step” in determining whether products contain the emerging technology.

The draft guidance, "Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology," is available online and open for public comment. It represents the first step toward providing regulatory clarity on the FDA's approach to nanotechnology.

FDA is releasing its document in coordination with the "Policy Principles for the U.S. Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials" issued on June 9, 2011, jointly by the Office of Science and Technology Policy, Office of Management and Budget, and the United States Trade Representative.

The guidance is intended for manufacturers, suppliers, importers and other stakeholders. The guidance describes FDA’s current thinking on whether FDA-regulated products contain nanomaterials or otherwise involve the application of nanotechnology.

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It has long been understood that environmental conditions may influence plant ion concentrations in crop plants. Under specific growing environments, plants absorb essential and nonessential elements, which above certain concentrations may cause toxicity. In addition, toxic elements with no known function in biological systems are found to be accumulated in plant tissues, with potentially lethal effects for nontolerant species (for example, livestock or humans). Once stored within plants, beneficial or toxic elements can be transferred from producers (plants) to consumers.

A recent article in the Journal of Agricultural and Food Chemistry notes that the uptake, bioaccumulation, biotransformation, and risks of nanomaterials (NMs) for food crops are still not well understood.  "Interaction of Nanoparticles with Edible Plants and Their Possible Implications in the Food Chain," prepared by researchers at the University of Texas at El Paso, concerns a review of nearly 100 scientific articles on the effects of different types of nanoparticles on edible plants.

According to the article, the curtain is about to rise on a “much-anticipated new era of ‘nanoagriculture’ – using nanotechnology to boost the productivity of plants for food, fuel and other uses.” There remains, however, a huge gap in knowledge about the effects of nanoparticles on corn, tomatoes, rice and other food crops. Some plants can take-up and accumulate nanoparticles, but it is unclear if this process hurts the plants, or the animals that eat them. The researchers found the uptake and build-up of nanoparticles varies, with the factors depending largely on the type of plant and the size and chemical composition of the nanoparticles.

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On May 10, 2011, the European Food Safety Authority (EFSA) published a guidance document for the risk assessment of engineered nanomaterial (ENM) applications in food and feed  in response to a request from the European Commission,

 

“Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain” is the work of the EFSA’s Scientific Committee and is the first of its kind to give practical guidance for addressing potential risks arising from applications of nanoscience and nanotechnologies in the food and feed chain. The guidance covers risk assessments for food and feed applications including food additives, enzymes, flavorings, food contact materials, novel foods, feed additives and pesticides.

 

The EFSA guidance sets out the considerations for risk assessment of ENM that may arise from their specific characteristics and properties.

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A new study of popular nano-metal oxides was just published in the April 2011 issue of the Journal of Environmental Monitoring, a publication of the highly-respected Royal Society of Chemistry. The RSC is the largest organization in Europe for advancing the chemical sciences.

The article, “TiO2 and ZnO nanoparticles negatively affect wheat growth and soil enzyme activities in agricultural soil”, summarizes findings on the effects of titanium dioxide and zinc oxide nanoparticles on wheat growth and soil enzyme activities under actual field conditions. According to the authors, the increased use of nanoparticles has raised concerns about their possible harmful effects within the environment, but most studies have been in aqueous systems – not actual field conditions.

This new study found that both of the nanoparticles reduced the biomass of wheat.  The TiO2 nanoparticles stayed in the soil for long periods and primarily adhered to the cell walls of wheat.  The ZnO nanoparticles dissolved in the soil, enhancing the uptake of the nanoparticles by the wheat. Significant changes were also induced in soil enzyme activities. These enzymes are bioindicators of soil quality and health, and soil protease, catalase, and peroxidase activities were all inhibited in the presence of nanoparticles, although urease activity was unaffected.

The authors conclusion: “The nanoparticles themselves or their dissolved ions were clearly toxic for the soil ecosystem.”

Source: RSC Publishing

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Single-walled carbon nanotubes (SWCNTs) have many unique structural and mechanical properties. As a result, their potential applications -- especially in materials science and mechanical engineering, biomedical engineering and medical chemistry -- have been increasing. Results of studies in animals have raised concerns about the potential toxicity of some shapes and sizes of carbon nanotubes but the toxicological impact of nanoparticles has rarely been studied in plants.

Recent research by a team of scientists from China, led by Dr. Nan Yao, explored the effects of nanoparticles on plant cells. Their assessment of SWCNT cytotoxicity is published in the October 2010 issue of the American Journal of Botany.

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One of the most exciting new developments in pesticides is the prospect of nanopesticides. Nanotechnology is being used to develop pesticides with new or enhanced activity, or more targeted application (such as through microencapsulation or affinity for specific target pests).

Pesticides are regulated under several laws, primarily the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) which authorizes EPA to oversee the registration, distribution, sale, and use of pesticides. The Act applies to all types of pesticides, including insecticides, herbicides, fungicides, rodenticides, and antimicrobials. The EPA’s Office of Pesticide Programs has already formed a Nanotechnology Work Group to develop a regulatory framework for nanopesticides. Two recent OPP presentations are instructive.

“Nanotechnology and Pesticides” presentation was made in April 2010, at the EPA Pesticide Program Dialogue Committee (PPDC) meeting.  The April 2010 OPP presentation included the following:

“Why is OPP Concerned?

Potential Human Health Concerns:
- Dermal absorption (so small they may pass through cell membranes)
- Inhalation (go to the deep lung and may translocateto the brain i.e, could cross the blood brain barrier)

Potential Environmental Concerns:
- High durability or reactivity of some nanomaterials raises issues on the fate in environment
- Lack of information to assess environmental exposure to engineered nanomaterials.”

For a good summary of the nanotechnology pesticide issues discussed at the PPDC meeting, see http://nanotech.lawbc.com/2010/05/articles/united-states/federal/ppdc-discusses-nanotechnology-and-pesticides/

“EPA Regulation of Pesticides Containing Nanoscale Materials” presentation was made in September 2010, at the meeting of the State Federal Insecticide, Fungicide, and Rodenticide Act Research and Evaluation Group (SFIREG) Pesticide Operations and Management (POM) Committee.  The September 2010 OPP presentation included an indication that EPA intends to require that nanoproducts be labeled in some fashion under FIFRA.

The EPA is of course not the only organization working on this issue. In a study published on October 4, 2010, in the International Journal of Occupational and Environmental Health, scientists from Oregon State University and the European Union outline six regulatory and educational issues that should be considered whenever nanoparticles are going to be used in pesticides.

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In late September 2010, The Centre for Food Safety (CFS), an arm of the Government of the Hong Kong Special Administrative Region of the People’s Republic of China, published a risk assessment study “Nanotechnology and Food Safety.”

The aims of the study were:

- to identify applications of nanotechnology in the food sector
- to identify the potential health and safety implications of nanotechnology in the food sector; and
- to review existing strategies for the risk assessment of engineered nanomaterials in food.

Some key excerpts from the CFS Study are included below.

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The European Food Safety Authority (EFSA) and Belgian Federal Agency for the Safety of the Food Chain are hosting an International Symposium on Nanotechnology in the Food Chain, to be held in Brussels, Belgium on November 24, 2010.

Nanotechnology has many promising applications emerging for the areas of agriculture and food (smart packaging, agrochemicals, etc.). It has the potential to bring significant benefits to the agriculture and food industries and to consumers, but may also introduce potential risks for human health and the environment.

The Symposium will present the current knowledge regarding the applications, opportunities and risks of nanotechnology in the food chain.  It will also consider the gaps in knowledge, legislation and control methods, in order to inform an international audience of policy makers, consumers, researchers, industrial representatives, etc.

Complete information on the Symposium and the program may be found on this site:
http://www.favv-afsca.fgov.be/nanotechnology/information/

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Nanotechnology can enhance the flavor and other sensory characteristics of foods, introduce antibacterial nanostructures into food packaging, and encapsulate and deliver nutrients directly into targeted tissues, among other applications. However, as with any new technology, along with the benefits, there is the potential for unanticipated adverse effects.

There is still a great deal to learn about any health outcomes related to introducing nanosized materials into foods and food packaging materials. Developing nanotechnology into a safe, effective tool for use in food science and technology will require addressing these and other questions.

There is a robust debate about the appropriate use of nanotechnologies in the food/agriculture industry when open questions remain about consumer safety, as I observed in Part I of this series of posts on June 3, 2010.

I suggest two additional sources of information for folks interested in the nanotechnology food safety issue:

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. . . then you simply must start becoming knowledgeable, if not expert, on the uses of nanotechnology in agriculture and food production, food products, food processing, and food packaging. It is going to be a significant growth area and an expected litigation field within the food safety/toxic exposure arena.

I'd suggest you might do a couple things to get started:

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Responding to a recent series of AOL News articles questioning the oversight of nanotechnology product safety, nanoTox™, Inc. COO Greg King said that nano-product companies will need to confront possible negative perceptions directly to avoid the kinds of public outcry experienced by bioengineered food companies in the past.

“It’s in people’s nature to fear the unknown,” said King. “And while companies may not be able to educate everyone in the complexities of nanotechnology, they can turn safety concerns to their advantage by being transparent about its use in their products, documenting their careful research and emphasizing concern over human and environment health.”

King was responding to the recent AOL News Special Report series entitled “The Nanotech Gamble” which explored possible risks that may accompany nanotechnology research and product development.   The series was greeted with concern by most in the U.S. nanoproduct industry.  See my May 12, 2010 post for more about the series. 
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“A mounting body of research shows nanoparticles can cause disease and death. But regulators are doing little to respond.”

Strong words.  They are the opening sentence in Part 1 of a recent Special Report series of articles by Andrew Schneider, an investigative reporter, two-time Pulitzer winner, and Senior Public Health Correspondent for AOL News.  In his series, "The Nanotech Gamble: Bold Science, Big Money, Growing Risks,” which ran in AOL News beginning March 24, 2010, Schneider is harshly critical of federal government’s nanotech safety research efforts so far, asserting that federal funding actually “skimps on safety.”

The AOL Special Report series is a "must read" for anyone keeping abreast of the ongoing debate and discussion of nanotechnology safety. 

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Regulation and Standards Development is Active . . .

- Government
- Quasi-Government
- Industry/Private Sector

. . . but still in early stages. No current health or environmental regulatory program squarely addresses nanotechnology or its applications.   EPA, FDA, OSHA, CPSC and USDA all claim statutes and regulations that could pertain to nanomaterials, as do federal research agencies such as CDC-NIOSH, NIH, and NIEHS (all agencies of the Dept. of HHS).  Each is currently evaluating to address novel risks of nanotechnologies and nanoparticlesgermane to their respective regulatory missions, and several now have stand-alone nanotechnology-focused working groups and have published initial reports of interest.  For example:

Environmental Protection Agency (EPA)

-   EPA, Nanotechnology White Paper (2007) http://epa.gov/ncer/nano/publications/whitepaper12022005.pdf 

For current information see the EPA's nanotechnology web page.

Food and Drug Administration (FDA)

 -  FDA, Nanotechnology Task Force Report (2007)http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/NanotechnologyTaskForceReport2007/default.htm

For current information see the FDA's nanotechnology web page.

Centers for Disease Control and Prevention / National Institute for Occupation al Safety and Health (CDC-NIOSH)

-  CDC-NIOSH, Progress Toward Safe Nanotechnology in the Workplace (2007) http://www.cdc.gov/niosh/docs/2007-123/pdfs/2007-123.pdf

For current information see the CDC-NIOSH nanotechnology web page.

Consumer Product Safety Commission (CPSC)

    Although the CPSC has no similar agency-level nanotechnology report, a good discussion of relevant consumer product nanotechnology issues was published by the Project on Emerging Nanotechnologies:

-  The CPSC and Nanotechnology (2008)
http://www.nanotechproject.org/process/assets/files/7033/pen14.pdf

 The CPSC recognizes that nanotechnology will be a continuously increasing concern, and nanotechnology was a focal point of the CPSC's August 25, 2009, hearing on its 2010-2011 agenda, priorities, and strategic plan.  Panelists at the hearing urged the CPSC to increase oversight of products manufactured with nanomaterials and to establish relevant safety guidelines for their use.    To read the panelists full testimony, see the CPSC web page.

 

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The Age of Nanotechnology is here. Welcome to the Nanotort Law Blog.  

The Nanotort Law Blog aims to be a useful resource for lawyers and risk managers. It will help you stay abreast of the current state of hazard assessment knowledge, pertinent governmental regulation, industry and NGO standards and guidelines, and other important information germane to environmental, health, and safety risks and potential liabilities. The Nanotort Law Blog will also offer ideas and links to other helpful resources to help you monitor, understand and manage the potential - and as yet unkown - liability risks of Nanotechnologies.

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