Dec 29: U.S. EPA's Office of Inspector General (OIG) issued a report entitled, EPA Needs to Manage Nanomaterial Risks More Effectively (No. 12-P0162, December 29, 2011). OIG said the purpose of the review was to determine how effectively EPA is managing the human health and environmental risks of nanomaterials. OIG indicates that nanomaterials are currently used in a wide variety of applications, including consumer products, health care, transportation, energy, and agriculture. The Agency considers nanomaterials as chemical substances that are controlled at the scale of approximately one-billionth of a meter. EPA has the authority, through several environmental statutes, to regulate nanomaterials. Although the development of nanomaterials and nanomaterial-enhanced products is expanding rapidly, the health implications of nanomaterials have not yet been determined.
OIG found that "EPA does not currently have sufficient information or processes to effectively manage the human health and environmental risks of nanomaterials. EPA has the statutory authority to regulate nanomaterials but currently lacks the environmental and human health exposure and toxicological data to do so effectively." The Agency proposed a policy under the Federal Insecticide, Fungicide, and Rodenticide Act to identify new pesticides being registered with nanoscale materials. After minimal industry participation in a voluntary data collection program, the Agency has proposed mandatory reporting rules for nanomaterials under the Federal Insecticide, Fungicide, and Rodenticide Act, and is also developing proposed rules under the Toxic Substances Control Act.
However, OIG said "even if mandatory reporting rules are approved, the effectiveness of EPA's management of nanomaterials remains in question for a number of reasons" including:
- Program offices do not have a formal process to coordinate the dissemination and utilization of the potentially mandated information.
- EPA is not communicating an overall message to external stakeholders regarding policy changes and the risks of nanomaterials.
- EPA proposes to regulate nanomaterials as chemicals and its success in managing nanomaterials will be linked to the existing limitations of those applicable statutes.
- EPA's management of nanomaterials is limited by lack of risk information and reliance on industry-submitted data.
OIG said, "These issues present significant barriers to effective nanomaterial management when combined with existing resource challenges. If EPA does not improve its internal processes and develop a clear and consistent stakeholder communication process, the Agency will not be able to assure that it is effectively managing nanomaterial risks. OIG concludes by recommending that, "the Assistant Administrator for Chemical Safety and Pollution Prevention develop a process to assure effective dissemination and coordination of nanomaterial information across relevant program offices. The Agency agreed with our recommendation and provided a corrective action plan with milestone dates."
On January 4, 2012, the Nanotechnology Panel of the American Chemistry Council (ACC) released a statement about the OIG report. Jay West, senior director of Chemical Products & Technology at ACC said, "The Nanotechnology Panel feels that the Office of Chemical Safety and Pollution Prevention (OCSPP) has demonstrated leadership in nanotechnology management and that the agency overall has made an enormous investment of time and talent in this area. We were surprised by OIG's assertion that EPA is not communicating an overall message to external stakeholders regarding policy changes and information about nanomaterials.
"We agree with OIG that the agency should have an internally consistent and coordinated approach across all offices, and are supportive of the recommendation that EPA develop an inter-office process for sharing information about nanomaterials. Creating a single public website about nanotechnology management, as OIG recommends, is one possible outcome of this information sharing and could help refute the notion that there is a lack of data about the potential health and environmental effects of nanomaterials and insufficient action being taken by EPA."
In a related matter, on December 21, a coalition of nonprofit consumer safety and environmental groups sued the Food and Drug Administration (FDA) in the first lawsuit over the health and environmental risks of nanotechnology and nanomaterials. The lawsuit demands FDA respond to a petition the public interest organizations filed with the Agency in 2006, nearly six years ago. The coalition is led by the International Center for Technology Assessment (CTA), on behalf of fellow plaintiffs Friends of the
Earth, Food and Water Watch, the Center for Environmental Health, the ETC Group, and the Institute for Agricultural and Trade Policy.
The eighty-page petition documents the 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. Nanomaterials in sunscreens, one of the largest sectors of the nano-consumer product market, were also a focus of the action. The petitioners called on the agency to regulate nano-sunscreens to account for their novel ingredients rather than assume their safety, and to pull such sunscreens from the market until and unless the agency approves them as new drug products.
The groups said that since 2006, numerous studies and reports, including agency publications by EPA, OIG, and the U.S. Government Accountability Office, acknowledge significant data gaps concerning nanomaterials' potential effects on human health and the environment. Most troubling are studies using mice that show that nano-titanium dioxide when inhaled and when eaten can cause changes in DNA that affect the brain function and may cause tumors and developmental problems in offspring. One study found titanium dioxide nanoparticles were found in the placenta, fetal liver and fetal brain.
Wenonah Hauter, executive director of Food & Water Watch said, "It is unacceptable that the FDA continues to allow unregulated and unlabeled nanomaterials to be used in products consumers use every day. 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."
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