FDA sued for not responding to rulemaking petition on nanoparticles

published in McAfee & Taft RegLINC | April 1, 2012

By Robert Joyce

The Food and Drug Administration has been sued by a group of consumer safety and environmental advocates concerned over possible health and environmental effects of engineered nanomaterials. In this first-of-a-kind lawsuit, the group alleges that the FDA failed to adequately respond to the group’s May 16, 2006, petition under the Administrative Procedures Act (APA) seeking amendment of FDA regulations regarding such materials. According to a statement issued by one of the plaintiffs, Friends of the Earth, “The agency’s unlawful delay unnecessarily places consumers and the environment at risk.”

In 2006, the group petitioned the FDA to enact new regulations which would better define the materials at issue, treat them as new substances distinct from their bulk forms, require them to have detailed labeling, and subject them to “nano-specific paradigms of health and safety testing.” The petition also requested the FDA to prepare an Environmental Impact Statement under the National Environmental Policy Act to assess the impacts of nanotechnology in products regulated by the FDA. According to the complaint filed on December 21, 2011, with the U.S. District Court for the Northern District of California (International Center for Technology Assessment v. Hamburg, Case No. CV-11-6592-MEJ), “The FDA has not meaningfully responded to or taken action on the 2006 petition in violation of the Administrative Procedure Act” and, “in the interim, nanomaterial consumer products have proliferated.” Plaintiffs have requested the court to declare the FDA to be in violation of the APA and to order the FDA “to respond to the 2006 petition as soon as possible.”

Of particular concern to plaintiffs is that, because of their small size, nanomaterials have unique properties, functions and effects. Nanoparticles are typically between 1 and 100 nanometers in size (a nanometer is one-billionth of a meter), while “a red blood cell is approximately 7,000 nanometers wide.” As such, nanoparticles have novel “electrical, optical, magnetic, toxicity, chemical, photoreactive, persistence, bioaccumulative and explosiveness” properties that are alleged to pose hazards to humans and the environment. The small size of the particles purportedly results in “unprecedented mobility in the body and environment” and allows them to “enter the body and pass through biological membranes – like cell walls, cell tissues, and organs – more easily than larger particles.” Consequently, when inhaled, ingested or absorbed, the particles are said to be able to accumulate in cells, organs and tissues and even make their way into cell mitochondria and nuclei “where they can interfere with cell signaling and induce structural damage, including DNA damage.”

The fundamental concern is that the FDA’s existing information on bulk forms of the materials from which the particles are made is inadequate to characterize them. According to the complaint, the FDA’s belief that “particle size is not an issue… is a loggerheads with the consensus view of the scientific community, which is that the adverse effects of nanoparticles cannot be reliably predicted or derived from the known toxicity of the bulk material.” Consequently, the groups want the FDA to treat nanoparticles and nanotubes as new chemicals with properties distinct from their bulk forms.

According to plaintiffs, there are well over 1,300 products containing nanoparticles that are intended for human consumption or application. Of immediate concern to plaintiffs are sunscreens containing nanoparticles of zinc oxide and titanium oxide. Plaintiffs point out that there are “several hundred sunscreen products containing manufactured nanoparticles… currently on the market in Australia.” They maintain that FDA’s “first and only words” on such sunscreens was that it “considered manufactured nanoparticle ingredients in these sunscreens a mere reduction in size and not a new drug ingredient, permitting manufacturers to sell [them] based on the agency’s safety assessment of bulk material sunscreens.” However, plaintiffs fear that zinc oxide and titanium oxide nanoparticle ingredients in sunscreens pose new and distinct risks not associated with their bulk forms. In particular, they cite early studies that link these ingredients with damage to colon cells and brain stem cells, and that purport to affect gene expression in the brains of mice fetuses in ways that have been associated with autism, epilepsy and Alzheimer’s disease. Plaintiffs also cite studies which indicate that nanoparticles smaller than 240nm can pass through the human placenta to the fetus, “meaning that the toxicity of manufactured nanomaterials could extend across generations.”

Not limiting themselves to potential effects of human exposure, the plaintiffs’ complaint also raises various environmental issues. They characterize nanomaterials as “a new class of non-biodegradable pollutants” which can enter the environment by being sprayed on, washed off, or disposed of. They claim the potential environmental issues include: “mobility, reaching places that larger particles cannot, moving through aquifers and soils; transport, the ability to absorb or bond to harmful chemicals and carry them places they would not otherwise reach; reactivity, interacting with natural substances to develop toxic compounds; fate and persistence; and bioaccumulation.” Plaintiffs even cite the EPA for the proposition that “there is a significant gap in our knowledge of the environmental, health, and ecological implications associated with nanotechnology.”

The complaint chastises the FDA for the fact that its only response to the 2006 petition has been a November 9, 2006, letter stating that the EPA could not address the petition “because it raises complex issues requiring extensive review and analysis by agency officials, and in relation to which the agency is seeking public input.” Further, despite having had the petition before it for more than five years, the EPA issued several guidance documents and proposed rules regarding sunscreens in 2011, which purportedly “ignored the 2006 petition and issues it tabled.”

By stipulation, the FDA has been granted an extension of time until April 23, 2012, to respond to the complaint.