EPA Grants Conditional Registration to Nanosilver Product Before Reviewing Pertinent Data

Washington, DC–(ENEWSPF)–December 14, 2011.  The U.S. Environmental Protection Agency (EPA) is conditionally registering a pesticide product containing nanosilver as a new active ingredient. The antimicrobial pesticide product, HeiQ AGS-20, a silver-based product for use as a preservative for textiles to help control odors, is being granted registration despite a long list of outstanding studies that have yet to be submitted and reviewed by EPA. As a testament to EPA’s flawed registration process, the agency will now require additional data on the product after it has entered the marketplace to confirm its assumption that the product will not cause ‘unreasonable adverse effects on human health or the environment,’ the general standard for registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

HeiQ AGS-20 is a nanosilver-silica composite with nanosilver particles that are incorporated into textiles and release of silver ions to suppress the growth of bacteria, which cause textile odors, stains, and degradation. Despite an emerging database that shows that nanosilver is much more toxic than conventional-sized silver and can cause damage in new ways, the agency pressed forward with registration of a product for which it has not fully evaluated human and environmental health data. For conditional registration, which is allowed under Section 3(c)(7) of FIFRA, pesticide registration can be granted even though all data requirements have not been satisfied or reviewed, by assuming that no unreasonable adverse effects on the environment will occur. Conditional registration allows pesticides to be introduced to the market with unknown and unevaluated risks to human and environmental health, which oftentimes leads to serious consequences. EPA is giving the registrant, HeiQ, four years to submit its data.

While all data must eventually be submitted, it often takes years before EPA acquires relevant data. It is rare that the regulatory decision will be altered once data has been submitted. Recent cases have illustrated just how flawed and dangerous granting conditional registration can be. Thousands of spruce trees were killed or severely damaged this past spring after being exposed to the herbicide Imprelis, which was granted conditional registration before an adequate review of environmental effects. Similarly, it was revealed that the pesticide clothianidin, also granted conditional registration, did not have required bee field studies adequately reviewed even though it is known that this chemical is highly toxic to important pollinators like honey bees.

In its decision document, EPA states that for the period of conditional registration for HeiQ AGS-20 there is a low probability of adverse risk to children and the environment from treated textiles, and concludes that use of HeiQ AGS-20 will not cause unreasonable adverse effects on the environment during the period when newly required data are being developed. Several studies are required and include route-specific toxicity studies for occupational exposure scenarios, as well as tests to determine if nanosilver detaches from treated articles. Additionally, EPA continues to place industry needs ahead of public health. The agency states that allowing HeiQ’s product on the market pending generation of data allows HeiQ to participate in the textile economy along with the other registrants with like-situated products. In 2008, HeiQ AGS-20 was submitted for registration on the grounds that it was identical or substantially similar to currently registered products and thus would not need to submit data to support its registration. However, EPA determined that HeiQ AGS-20, since it contained a nanoscale ingredient, may have properties that are different from those of conventionally-scaled ingredients. This decision is part of EPA’s recognition that nanomaterials should be considered new active ingredients under FIFRA, which triggered a new rulemaking process that has yet to be completed.

In the few independent studies that EPA looked at for this registration, adverse effects were identified for inhalation, oral and dermal exposures to nanosilver. Other studies have found that nanomaterials pass easily into cells and affect cellular function, depending on their shape and size. Preliminary research with laboratory rats has found that silver nanoparticles can traverse into the brain, and can induce neuronal degeneration and necrosis (death of cells or tissue) by accumulating in the brain over a long period of time. A study conducted in 2008 and confirmed by another study in 2009 shows that washing nano-silver textiles releases substantial amounts of the nanosilver into the laundry discharge water, which will ultimately reach natural waterways and potentially poison fish and other aquatic organisms. One study found nanosilver to cause malformations and to be lethal to small fish at various stages of development since they are able to cross the egg membranes and move into the fish embryos. Wastewater treatment officials, who first raised an alarm over nanomaterials in water back in 2006, are concerned that the influx of nanomaterials into wastewater will adversely impact the efficacy of wastewater treatment processes and reduce beneficial bacteria used in vital nutrient removal processes. Needless to say, EPA has not evaluated these environmental fate risks and threats to public health and drinking water quality when granting registration.

Nanotechnology, the science involving manipulation of materials on an atomic or molecular scale, is an emerging technology with a broad range of potential applications, such as increasing bioavailability of a drug, improving food packaging and in cosmetics. There are hundreds of products currently on the market that contain nanomaterials of various types and functions, the most popular application being the use of nanosilver as an antibacterial substance in many consumer products. Given this, the federal government at this point is playing a game of ‘catch-up.’ The International Center for Technology Assessment (CTA) and a coalition of consumer, health, and environmental groups, including Beyond Pesticides, filed a legal petition on May 1, 2008 with the Environmental Protection Agency (EPA), demanding the agency use its pesticide regulation authority to stop the sale of 250+ consumer products now using nanosized versions of silver. As a result of this petition, EPA announced plans to obtain information on nanoscale materials in pesticide products. At the same time, the Food and Drug Administration (FDA) released draft guidelines to industries about when the use of nanomaterials might trigger regulatory interest. The National Organic Standards Board (NOSB) also passed a recommendation directing the USDA National Organic Program (NOP) to prohibit engineered nanomaterials from certified organic products as expeditiously as possible.

In the meantime, consumer products that contain nanosilver and other nanomaterials continue to grow with little to no regulatory oversight. So far, there are hundreds of products with nanosilver from toys to band-aids. For more information on nanosilver, visit the program page.

Sources: EPA NEWS, beyondpesticides.org

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