"FIFRA"

Does the Nanosilver Dispute have a Silver Lining?

By: Rachel Shelton, Staff Member

The National Resources Defense Council (NRDC) is dueling with the EPA over the agency's approval of nanosilver for use in fabrics.[1] NRDC's brief, filed last year in the 9th Circuit, alleges that the EPA allowed the substance on the market without reviewing legally-required information on its potentially harmful effects.[2]

So what is nanosilver and what's the big deal? According to a report prepared for the EPA, nanosilver refers to the nano-particulate form of silver, which is used as a biocide to kill microbes in a variety of consumer products, from medical devices to food supplements to textiles.[3] The EPA report recognizes the need for a comprehensive risk assessment of the effects that nanosilver might have on the health of humans and the environment.[4] The need for an assessment is becoming increasingly important as human exposure to nanosilver becomes more and more common. Clothing treated with nanosilver, such an antimicrobial socks which are designed to decrease foot odor, is now available on the market.[5] The verdict is out on whether the additive is safe - researchers do not understand how nanosilver, toxic to bacteria and other microbes, affects humans.[6]

Despite the lack of a scientific consensus on nanosilver, in 2010 the EPA "conditionally registered" nanosilver and allowed its use for four years, subject to the requirement of additional environmental and toxicology data from manufacturers.[7] Nanosilver is classified as a "pesticide," and as such falls under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).[8] Under the FIFRA regulation scheme, a pesticide may be registered "conditionally" for such period reasonably sufficient to generate enough data to make a decision about whether or not it is harmful.[9] Registration is contingent on an EPA finding that the pesticide will not cause an "unreasonably adverse effect on the environment" during the interim period and that the use of the pesticide is in the "public interest."[10]

The NRDC claims that the EPA should be more discriminating with respect to conditional registration and accuses the agency of abusing the loophole by allowing companies to market a chemical before key data was presented on its toxicity to humans and the environment.[11] The EPA's initial analysis of the risks, NRDC argues, failed to evaluate the potential harm to infants who are exposed to nanosilver and was not supported by substantial evidence; the finding of no "unreasonably adverse effect" was therefore improper.[12]

With such a broad loophole at issue, it seems doubtful that the EPA will fail to justify the terms of their conditional approval. NRDC may have a point though - is it really in the "public interest" to put pesticides in our socks? Regardless of the outcome of the case, controversy over the use and regulation of new nanotechnology is likely here to stay.

____________________

[1]

Lawsuit Seeks to Block EPA's 'Free Pass' on Nanosilver

Natural Res. Def. Council

(Jan. 26, 2012), http://www.nrdc.org/media/2012/120126.asp.

[2]

Id.

[3]

State of the Science Literature Review: Everything Nanosilver and More

EPA 

xii (2010),

available at

http://www.epa.gov/nanoscience/files/NanoPaper1.pdf.

[4]

Id.

at xiv.

[5]

See, e.g., Magical Socks Nanosilver with Silver Nanoparticles

NanoTrade,

 http://www.nanosilver.eu/Tema/Why-Nanosilver/Magical-Socks-Nanosilver-with-Silver-Nanoparticles (last visited Apr. 7, 2013).

[6] Naomi Lubick,

Nanosilver Tracked in Rats

Chemical & Engineering News

(Aug. 17, 2012), http://cen.acs.org/articles/90/web/2012/08/Nanosilver-Tracked-Rats.html.

[7]

Pesticide News Story: EPA Proposes Conditional Registration of Nanosilver Pesticide Product

EPA

(Aug. 13, 2010), http://www.epa.gov/oppfead1/cb/csb_page/updates/2010/nanosilver.html.

[8]

State of the Science Literature Review: Everything Nanosilver and More

, supra note 3, at 12-13.

[9] 7 U.S.C. 

§ 136(c)(7)(C) (2012).

[10]

Id.

[11] Mae Wu,

Nanosilver Stinks

Switchboard: Natural Res. Def. Council Staff Blog (

Sept. 15, 2010), http://switchboard.nrdc.org/blogs/mwu/nanosilver_stinks.html.

[12] Lynn L. Bergeson,

Recent Developments in NRDC's Case Concerning EPA's Conditional Registration of Nanosilver

Nano and Other Emerging Chem. Techs. Blog (

June 23, 2012), http://nanotech.lawbc.com/2012/06/articles/united-states/federal/recent-developments-in-nrdcs-case-concerning-epas-conditional-registration-of-nanosilver/. 

Don't Bug Me: Failure to Comply with FIFRA Can Be Costly

By: Rachel King, Staff Member

In 2012, the U.S. Environmental Protection Agency issued legal complaints against companies that the agency felt had violated the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).[1] Upon its initial conception, FIFRA established protocols regarding the registration of pesticides;[2] however, the true focus of this Act seemed to be on monitoring the effectiveness of these products.[3] Following amendments in 1972 and 1996, FIFRA's scope has been greatly enlarged: "[The] EPA is specifically authorized to: (1) strengthen the registration process by shifting the burden of proof to the chemical manufacturer, (2) enforce compliance against banned and unregistered products, and (3) promulgate the regulatory framework missing from the original law."[4] These newer duties enable the EPA to control the sale and use of pesticides.[5] It is important to note, however, that FIFRA does not fully preempt state and local law.[6]

In order to be in compliance with FIFRA, several key processes must be performed.[7] First, a company must register the product with the EPA.[8] The registration requirements vary depending on whether the pesticide is one that has been approved for registration in the past or is one that is new or imported.[9] For those that are new or imported, the registration must specify its projected use and chemical components[10] as well as provide data to the EPA for testing.[11] Desired data includes the effect of the pesticide's residues on the environment and the toxicity and irritation risk to humans and non-target animals.[12] For imported pesticides, a "Notice of Arrival" must be filed prior to the arrival of the pesticide within the United States;[13] this form allows the EPA to preemptively determine whether the product is approved for use in the country.[14] If the pesticide is barred from admission, the company has 90 days to export the product or it will be destroyed at the company's expense.[15]

In light of FIFRA, an action was initiated against Daifuku Trading Corp. for the company's sale of unregistered pesticides in late 2012.[16] Additional fines may be imposed on the company for improper labeling and importation of the products as well; "Under federal law, products used to kill pests must be registered with the EPA and contain labels written in English with instructions on their proper use."[17] Earlier in 2012, Scotts Miracle-Gro agreed to pay the EPA $6 million in penalties and spend $2 million on environmental projects in addition to criminal fines and penalties for similar violations.[18] To-date, this is the largest civil settlement under FIFRA.[19]

Companies that seek to sell pesticides within the U.S. can avoid the ever-watchful eye of the EPA by ensuring that the products stocked on their shelves fall within the purview of FIFRA or can take steps to ensure that newer products meet the EPA's strict requirements.

_____________________

[1] John Martin,

EPA Takes Action Against Companies That Sell and Import Illegal Pesticides

Environmental Protection Agency

 (Dec. 28, 2012), http://yosemite.epa/gov/opa/admpress.nsf/d0cf6618525a9efb85257359003fb69d/2be923c665ce07fd85257ae200633725!OpenDocument.

[2]

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)

Environmental Protection Agency,

available at

 http://www.epa.gov/oecaagct/lfra.html#Summary%20of%20the%20Federal%20Insecticide,%20Fungicide,%20and%20Rodenticide%20Act (last visited Jan. 16, 2013).

[3]

Id.

[4]

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), supra

 note 2;

See also

 7 U.S.C. § 136 et. seq. (2013).

[5]

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), supra

 note 2.

[6]

Id.

[7]

Id.

[8]

Id.

[9]

Id.

[10]

Id.

[11] Martin,

supra

note 1.

[12] EPA,

supra

 note 2.

[13]

Id.

[14] Martin,

supra

 note 1.

[15] EPA,

supra

 note 2.

[16] Martin,

supra

 note 1.

[17]

Id.

[18] Ernesta Jones,

Scotts Miracle-Gro Will Pay $12.5 Million in Criminal Fines and Civil Penalties for Violations of Federal Pesticide Laws

Environmental Protection Agency

 (Sept. 7, 2012), http://yosemite.epa.gov/opa/admpress.nsf/d0cf6618525a9efb85257359003fb69d/38045218faa33abe85257a72006beflc!OpenDocument.

[19]

Id.