Nanosized nanomaterials: how do you regulate something so tiny?

March 27, 2015

On March 24, 2015, the National Organic Program (NOP) released a policy memo clarifying the status of nanotechnology in organic production and handling under the U.S. Department of Agriculture (USDA) organic regulations at 7 C.F.R. Part 205.
Nanotechnology is science, engineering, and technology conducted at the nanoscale, which is about 1 to 100 nanometers. One nanometer equals about 3-10 atoms. To put that in perspective, the diameter of a human hair is about 20,000 nanometers wide and a smoke particle is about 1,000 nanometers wide. But, nanomaterials are more than just “tiny.” They are unpredictable. They can act in fundamentally novel ways compared to the same materials on a larger scale.

In other words, nanotechnology deals with extremely small and often capricious particles.

These tiny unpredictable particles may occur naturally, like in volcanic ash, ocean spray and even biological materials, but they can also be incidental products of human activity. Purely incidentally produced nanosized particles, like those produced through grain milling and milk homogenization are not particular areas of concern. Conversely, substances that are specifically designed and manufactured to have unique properties or behavior attributable to particle size called “engineered nanomaterials” are at the root of the NOP issue.
Nanomaterials are added to foods, fruit and vegetable coatings, food packaging materials, supplements, and cosmetics. For example, the nanomaterial titanium dioxide increases the whiteness of mints, milk, yogurt, and dairy substitutes. Other nanomaterials are used in chocolate, salad dressings, cereal, pasta, along with many other common foods.
Since these engineered nanomaterials are synthetic, they are not allowed in organic agriculture production. Herein lies the conundrum.
In 2010, the National Organic Standards Board recommended that NOP create its own definition of nanomaterials. The agency guidance clarified that the traditional definition of a nanomaterial (1-100 nanometers) is not practical and that alternatively, the NOP should use a size to mass ratio or specific reference to unique characteristics to define nanomaterials.
On March 24th 2015, NOP declined to follow this recommendation from its advisory board.
Instead, NOP determined that “to avoid conflicts about the presence of nanomaterials in substances regulated by other federal agencies, the NOP is not establishing a separate definition for engineered nanomaterials,” deferring to FDA and EPA guidance.
According to NOP, “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 NOSB; and 3) added to the National List through notice and comment rulemaking.”
Immediately following NOPs policy memo, EPA proposed new one-time reporting and recordkeeping requirements on nanoscale chemical substances in the marketplace under the Toxic Substances Control Act (TSCA). This is the first time the agency will use TSCA authority to collect health and safety information on nanoscale chemicals.
These new requirements are on the heels of a December 2014 lawsuit filed against the EPA over the agency’s failure to regulate novel nanomaterial pesticides. The complaint explains how nanomaterials have an increased potential to pose health risks. Due to their small size, nanomaterials have greater mobility than their larger versions. Their unique chemical and biological properties “increase potential for biological interaction and increase potential for toxicity, which can result in DNA mutation, structural damage within the cell, and even cell death. Once in the blood stream, they can move freely through organs and tissues, including the brain, heart, liver, kidneys, spleen, bone marrow, and nervous system.”
The complaint emphasizes the lack of regulation for one of the most common nanomaterial in consumer products, nanosilver. Nanosilver is used as an antimicrobial agent, which Plaintiffs argue should be regulated as a pesticide product by the EPA.
Nanotechnology is a fairly new and expanding field of research, especially in the realm of consumer health and safety risks. The NOP’s recent policy memo, in combination with EPA’s proposed nanomaterial reporting rule, is the first of many steps the federal government must take to regulate nanomaterials. All nanomaterials are not harmful, but without EPA and FDA oversight, the public is saddled with the potential risks.