FDA sued over lack of Nanotech oversight, labels

The first ever lawsuit concerning risks of nanotechnology was filed in federal court last month when several groups jointly sued the US Food and Drug Administration for its lack of response to a 2006 petition demanding that products with nanomaterials be labeled and their affects tested for safety.

Led by the International Center for Technology Assessment (ICTA), plaintiffs also include Friends of the Earth, Food and Water Watch, the Center for Environmental Health, the ETC Group, and the Institute for Agricultural and Trade Policy (IATP).

‘It is unacceptable that the FDA continues to allow unregulated and unlabeled nanomaterials to be used in products consumers use every day,’ said Wenonah Hauter, executive director of Food & Water Watch. ‘It is past time for this agency to live up to its mission and protect public health by assessing the health and environmental risks of nanomaterials, and to require labeling so that consumers know where these new materials are being used.’

Based on the scientific literature so far, several hundred products should be recalled due to their toxicity to lab animals and bacteria.

Much of the 2011 complaint argues that because nanomaterials are patented, and exhibit novel characteristics unique to their size, they clearly represent new substances requiring regulation and safety tests. Plaintiffs demand a recall on all such products until their safety is proven.

Consumer groups including some of the same plaintiffs in the current lawsuit also filed petitions urging nanotech regulation with the Environmental Protection Agency back in 2006 and 2008, reports the Chemical Regulation Reporter.

Nanotechnology is the science of manipulating materials on an atomic or molecular scale, measured in billionths of a meter. Nanotech-engineered materials (NEMs) are used in food, cosmetics (including toothpaste and sunscreen), drugs, fertilizers, and home cleaning products with little regulation in the United States. They are found in ice cream and the coating sprayed on fruits and vegetables, and even line bottles and cans, reported Andrew Schneider in his 2010 exposé on the subject.

NEMs are also used in industry processes and military applications including drones, combat gear and miniature surveillance devices. The Dept. of Defense has spent billions on nanotech R&D. Per its 2007 report, nanotech is used in “chemical and biological warfare defense; high performance materials for platforms and weapons; unprecedented information technology [like smart clothes]; revolutionary energy and energetic materials; and uninhabited vehicles and miniature satellites.” (Also see the 2011 National Nanotechnology Initiative Strategic Plan.)

In June 2011, both the FDA and the EPA issued draft guidelines on NEMs. Though nano-pesticides are already on the market, the EPA made its first approval last month. The Swiss firm, HeiQ, now sells its composite nanosilver and nano-silica for use in clothing (to reduce microbial odor) with EPA approval.

Upon publication of the FDA’s voluntary guidlines, the Alliance for Natural Health immediately demanded that nanomaterials be banned from organic certification, as they are in Canada.

The FDA has done nothing on NEM regulation since last June. Prior to that, the FDA absurdly denied that any nanofoods were being sold in the U.S.

“Not true, say some of the agency’s own safety experts, pointing to scientific studies published in food science journals, reports from foreign safety agencies and discussions in gatherings like the Institute of Food Technologists conference,” reports Schneider.

Several of the plaintiffs have issued public reports on nanotech, including IATP. In Racing Ahead: U.S. Agri-Nanotechnology in the Absence of Regulation, IATP notes that as of March 2011, there were over 1,300 products known to contain NEMs. That’s up from 200 in 2006, but the number is conservatively expected to rise to 3,400 by 2020. The ETC Group estimates well over 1,600 products in its 2010 report, The Big Downturn? Nanogeopolitics.

The Project on Emerging Nanotechnologies (PEN), a partnership of the Pew Charitable Trusts and the Woodrow Wilson International Center for Scholars, a U.S. government research center, notes that there is no registry of nano-scale ingredients and materials used in products or industrial processes.

“Establishing such a registry, as well as consumer products registry,” advises IATP, “would be necessary components of the eventual regulation of nanotechnology.”

Meanwhile, some products containing nanomaterials can be found with PEN’s iPhone application for using the Nanotechnology Products Inventory.

Size Matters

“There is a dependent relationship between size and surface area and nanoparticle toxicity; as particles are engineered smaller on the nano-level, they are more likely to be toxic,” plaintiffs wrote in their 2006 petition. “Many relatively inert and stable chemicals, such as carbon, pose toxic risk in their nano-scale form.”

That small of a size makes nanoparticles capable of crossing the blood-brain barrier noted food research scientist Ellin Doyle. In 2006, she published a literature review on nanotechnology advising, “Nanoparticles are readily taken up by many types of cells in vitro and are expected to cross the blood-brain barrier that excludes many substances that might harm the brain.”

Despite this, in 2006, the FDA ruled that “particle size is not an issue” for regulation. Basic chemistry teaches the opposite. At that small of a scale, a particle’s electrochemical features more heavily influence its interactions with nearby substances, including viruses, bacteria and DNA. The small nanosize means there are more atoms on its surface than inside the particle.

Both the US Patent Office and the National Nanotechnology Initiative, an agency of the US National Science Foundation, refuted the FDA’s stance, explaining that the small size of nanoparticles enable “unique and novel characteristics” that impact not only electrochemical interactions, but also their optical, photoreactive, magnetic, persistence, bio-accumulation, toxicity and explosiveness features.

Nanosized aluminum, a suspected ingredient in chemtrails, has been shown to spontaneously combust, reports ETC. Texas-based Quantum Logic Devices holds Patent No. 7,338,711, which is an “enhanced nanocomposite combustion accelerant” used in fuels, propellants and explosives.

In its 2007 Nanotechnology Task Force Report, the FDA finally reversed itself admitting that, “at this scale, properties of a material relevant to the safety and (as applicable) effectiveness of FDA-regulated products might change repeatedly as size enters into or varies within the nanoscale range.”

Nanohazards

In addition to several studies showing nanosize-induced harm cited in the 2006 petition, ETC listed ten studies from 1997 through early 2004 that showed DNA and brain damage, lung dysfunction, and bioaccumulation (whereby earthworms and other creatures absorb, inhale or ingest the nanoparticles and pass them up the food chain).

This is especially significant as nanopollution grows with the release of thousands of pounds of nanomaterials into the environment, notes Friends of the Earth in its 2006 report, Nanomaterials, sunscreens and cosmetics. (More studies can be found at this companion FOE report.)
ETC also pointed to studies showing that nanoparticles can break down in the body causing metal poisoning, and can cross the placenta from mother to unborn fetus.

A 2010 British study confirmed that anything smaller than 100 nm poses even greater health risks because it can “access all areas of the body” and can even penetrate the nucleus of cells where DNA is located.

Stronger than steel, carbon nanotubes look and act like asbestos, which causes lung cancer. This FOE report also cites reduced kidney growth in lab animals exposed to nanomaterials.

Under its 2011 guidelines, the FDA will consider particles that are from 1 to 100 nanometers in size, but up to one micron if the end products “exhibit properties or phenomena, including physical or chemical properties or biological effects, that are attributable to its dimension(s).”

By dragging its feet on nanotech regulation for the past several years, the FDA and EPA have allowed the proliferation of nanomaterials into consumer products without disclosure. Similar to the federal government’s refusal to label genetically modified foods, US consumers are once again lab animals for the biotech industry. Hopefully, this lawsuit will spur appropriate safety testing and the removal of unsafe products from the market.

Rady Ananda is an investigative reporter and researcher in the areas of health, environment, politics, and civil liberties. Her two websites, Food Freedom and COTO Report are essential reading.