Last week we won a lawsuit we’d filed this past January to block a potent antimicrobial nano-pesticide, from market access. The Environmental Protection Agency (EPA) has conditionally registered nanosilver under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for use as an antimicrobial in textiles including such things as clothing, baby blankets, and pillow cases. The "conditional" part of the registration means that EPA does not have all the legally required toxicity data, but is letting the pesticide on the market anyway, on the "condition" that the manufacturer, HeiQ, provide it sometime over the next four years.
(More on the broken conditional registration process is in our report here)
Silver, a well-recognized antimicrobial, is highly toxic and kills both harmful and beneficial bacteria. Nanosilver is engineered from silver and marketed as an even stronger antimicrobial than silver. Because of its smaller size, nanosilver penetrates organs and tissues in the body that larger forms of silver cannot reach, like the brain, lung, and testes.
In early November, 2013 the Ninth Circuit court ruled in our favor, that the EPA had improperly approved the use of nanosilver by one U.S. textile manufacturer. The court vacated the approval and sent it back to the agency for reevaluation. The key part of the ruling addressed EPA’s determination that there is no risk concern for toddlers exposed to nanosilver-treated textiles. The agency’s rules state that if there’s an aggregate exposure to the skin or through ingestion at or below a specific level, there is a risk of health concerns. But the Ninth Circuit found that the EPA had data showing that nanosilver was right at the level that should have triggered a finding of potential risk, but approved the pesticide anyway. That led to the Ninth Circuit vacating EPA’s approval and sending it back down to the agency for reevaluation. (The court decision was reported by a corporate law firm here)
Unfortunately, even before the court finalized its decision, EPA had already proposed to conditionally approved another nanosilver pesticide product, this one called Nanosilva, for textiles and plastics in late August, 2013. The Nanosilva proposed registration expands the age range in its risk assessment by considering exposures specifically to infants, which the earlier HeiQ hadn't, but was in our lawsuit. Among other things, Nanosilva is proposed to be incorporated into textiles, plastic films, sheets, slabs, and molded parts, meaning it can end up in consumer products such as footwear, sportswear, uniforms, and auto parts, floor coverings, outdoor furniture, decking, and house siding.
And, it’s not just pesticides that have gotten “smaller”. Under the Toxic Substances Control Act (TSCA) many new nanomaterials have been reviewed and approved for market, all with far less risk assessment data than EPA had for nanosilver. In June 2013 EPA issued significant new use rules (SNURs) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for chemical substances which were the subject of pre-manufacture notices (PMNs), including carbon nanotubes (CNT), multi-walled carbon nanotubes (MWCNT), double-walled carbon nanotubes (DWCNT), and single-walled carbon nanotubes (SWCNT). NRDC joined with labor unions including AFL-CIO and the United Steelworkers to file comments opposing the proposed rule (Document ID EPA-HQ-OPPT-2010-0279-0130).
In its FR Notice of the proposed rule, EPA identified the following health concerns for the carbon nanotubes: pulmonary toxicity, fibrosis, carcinogenicity, mutagenicity, and immunotoxicity of the PMN substances. There are also data suggesting that pulmonary deposition of some nanoscale materials, including carbon nanotubes in the agglomerated form, may induce cardiovascular toxicity when these nanoscale materials are inhaled. The major health concerns are for potential pulmonary toxicity, fibrosis, and cancer to workers exposed via inhalation. Sublethal effects have been noted for some carbon nanoscale substances in fish at levels as low as 100 parts per billion (ppb). (76 FR 81447). For fullerenes EPA identified that, “based on test data on poorly soluble particulates, including some carbon-based nano-sized chemicals, and test data correlating lung irritation to particle size, EPA has concerns for lung effects from inhalation exposure.” Nonetheless, EPA gave its approval despite lacking: in vitro and in vivo mutagenicity testing including genotoxicity and chromosomal aberration tests; acute toxicity including oral, inhalation, and dermal routes of exposure; dermal sensitization and irritation tests; subchronic neurotoxicity tests; chronic tests including oncogenicity, teratogenicity, reproduction toxicity, and developmental toxicity.
Despite the potential risks, the research and development of nanotechnology has skyrocketed in recent years. The independent advisory firm, Research, predicts that in 2015 nanotechnology value chain sales could reach $2.5 trillion. The U.S. government and U.S. corporations spend more money on nanotechnology than any other country, and nanomaterials are found in thousands of everyday products. Russia, the EU and many Asian countries also spend billions each year on new nano chemicals.
The White House is telling the public not to worry, that existing regulatory frameworks are handling these novel nanomaterials adequately.
In contrast, many non-government organizations (NGOs) including NRDC are calling for proper regulatory oversight, and the use of established best practices followed in other chemical handling facilities to protect workers. Without mandatory oversight for the development, use, and disposal of nanomaterials, companies will remain reluctant to invest resources into new products or technologies without knowing their future regulatory fate or liability risks.
Nanomaterials are pitched as “new and improved” chemicals, engineered at the teeny-tiny “nano” scale (one-thousandth of a micrometer) to be stronger, lighter, faster, brighter, or just plain better than their normal-scale chemical counterparts. And, they are rapidly replacing hazardous chemicals that are being phased out or forced out of consumer products, either through market demands or regulatory restrictions.
But, are we really risk-trading downwards? Or are we just replacing the risks we know about with ones we don’t? A January 2013 report of the National Academies found that, "Despite extensive investment in nanotechnology and increasing commercialization over the last decade, insufficient understanding remains about the environmental, health, and safety aspects of nanomaterials."
The problem is that there are currently no standardized testing protocols, no labeling requirements, and weak regulation of most nanomaterials. And, what we don’t know about the environmental and occupational impacts of nanomaterials may be hurting us. We do not know enough about these materials to make informed decisions about how they should – or should not be used.