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Tag Archives: FIFRA

The EPA Inspector General’s Report

The task of the Inspectors General of Federal agencies is to examine "all actions of a government agency or military organization. Conducting audits and investigations, either independently or in response to reports of wrongdoing, the OIG ensures that the agency’s operations are in compliance with the law and general established policies of the government. Audits conducted by the OIG are intended to ensure the effectiveness of security procedures, or to discover the possibility of misconduct, waste, fraud, theft, or certain types of criminal activity by individuals or groups related to the agency’s operation."

At the end of 2011, the Office of the Inspector General (OIG) of the Environmental Protection Agency (EPA) posted Report No. 12-P-0162,"EPA Needs to Manage Nanomaterial Risks More Effectively" to the reports section of its website.

The OIG, in the Introduction to the report, states that the

. . .  purpose of this review was to determine how effectively the U.S. Environmental Protection Agency (EPA) is managing the human health and environmental risks of nanomaterials.

The report notes that

EPA has the statutory authority to regulate nanomaterials. . . . EPA can regulate nanomaterials during their manufacture, formulation, distribution in commerce, use, and/or disposal through the Toxic Substances Control Act (TSCA) . . . nanomaterials in pesticides through the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) . . . . EPA can regulate nanomaterials released into the environment using the Clean Air Act; the Clean Water Act; the Comprehensive Environmental Response, Compensation and Liability Act; or the Resource Conservation …

EPA Requests Public Comment on Obtaining Information Regarding Nanomaterials in Pesticides

On June 17, 2011, the Environmental Protection Agency (EPA) published a notice in the Federal Register announcing that it was seeking "comment on several possible appraoches for obtaining information about what nanoscale materials are present in registered pesticide products. . .  . and its potential effects on humans or the environment. . . ."

Under one approach to collecting this information, EPA would use the authority granted to it by the Federal Insecticide, Fungicide,and Rodenticide Act  (FIFRA) to require applicants to "provide any factual information of which [the applicant] is aware regarding unreasonable adverse effects of the pesticide on man and the environment". If EPA adopts this approach, it would require the inclusion of "such information with applications for registrations of pesticides or pesiticide products containing ‘nanoscale materials’".

Under a different section of FIFRA, EPA would gather information using Data Call-In notices.

EPA is required to collect information regarding pesticides under section 3(a) of FIFRA. Using the information collected, EPA can then determine

1) the validity of the products claims

2) that labelling complies with FIFRA requirements

3) that the pesticide or pesticide product will not cause unreasonably adverse harm to humans or the environment.

EPA "believes that certain information concerning pesticide ingredients" – in this case, nanoscale materials, defined by EPA as (1) between 1 and 100 nanometers, (2) " exhibit unique and novel properties compared to larger particlesof the same material" and (3) has been manufactured or engineered at the nanoscale level to take advantage of those unique or novel properties …

EPA nanomaterial disclosure policy submitted to OMB for review

Inside Washington’s Inside the EPA newsletter carries an article regarding the EPA’s Office of Chemical Safety and Pollution Prevention submitting for review a notice outlining EPA’s intention to use its existing regulatory authority under the Federal Insecticide, Fungicide & Rodenticide Act (FIFRA) to require that manufacturers of pesticides provide more information to EPA about their use of nanoscale materials in their products.

This proposed notice was discussed at a presentation by William Jordan of EPA’s Office of Pesticide Programs (OPP) to the Pesticide Programs Dialogue Committee and also in a recent GAO report . The notice will also include OPP’s definition of nanomaterials as ingredients containing particles between 1 and 100 nanometers in size.

During his presentation, Mr. Jordan noted that this new policy resulted from concerns expressed by the public about the potential toxic effects of nanoscale materials on the environment and humans. Industry groups and pesticide manufacturers also expressed their concern that the proposed rule could taint all nanomaterials as "adverse" and affect potential future sales of pesticides that include nanomaterials.

The text of the notice is not available from OMB’s Reginfo.gov site. When it does appear in the Federal Register following OMB’s review, it will be discussed and reviewed here.…

GAO Provides Recommendations Regarding EPA’s Effort to Regulate Nanomaterials

On Friday, the United States Government Accountability Office issued its Report to the Chairman (Barbara Boxer) of the Committee on Environment and Public Works, US Senate, GAO-10-549:

Nanotechnology: Nanomaterials Are Widely used in Commerce, but EPA Faces Challenges in Regulating Risk.

Highlights from the report follow.  The report confirms speculation that EPA intends to issue certain new rules pertaining to select nanomaterials by the end of 2010.

Background

"EPA has taken a mulitpronged approach to understanding and regulating the risks of nanomaterials, including conducting further research and implementing a voluntary data collection program. Furthermore, under its existing statutory framework, EPA has regulated some nanomaterials but not others. Although the EPA is planning to issue additional regulations later this year, these changes have not yet gone into effect and products may be entering into the market without EPA review of all available information on their potential risk. Moreover, EPA faces challenges in effectively regulating nanomaterials that may be released in air, water, and waste because it lacks the technology to monitor and characterize these materials or the statutes include volume based regulatory thresholds that may be too high for effectively regulating the production and disposal of nanomaterials."

TSCA

"In the fall of 2009, EPA announced it would reconsider the policy described in its January 2008 document, TSCA Inventory Status of Nanoscale Substances — General Approach, and subsequently announced it planned to develop a SNUR to regulate nanoscale versions of conventional scaled chemicals that are already on the TSCA inventory as a significant new …

Silver Research Consortium LLC Objects to the Environmental Protection Agency’s Proposed Interpretation of Nanomaterials Under the Federal Insecticide, Fungicide, and Rodenticide Act

 

The Silver Technology Working Group (“SNWG”) of the Silver Research Consortium LLC recently sent a letter to the Environmental Protection Agency (“EPA”) expressing concern about a proposed interpretation issued by the EPA’s Office of Pesticide Programs (“OPP”) of a nanoscale pesticide products regulation under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”), 7 U.S.C. § 136 et seq. (1996). SNWG contended that the pending Federal Register policy applicable to nanotechnology constituted a damaging change which could threaten all nano-related industries. Specifically, SNWG argued that the OPP’s new interpretation would: (1) establish a definition of “nanomaterial” that arbitrarily provides a size limit of 100 nm, “focus[ing] too heavily on size rather than the underlying properties of the…material;  (2) consider the presence of any nanoscale material in any registered pesticide to be reportable as having an unreasonable adverse effect, a proposition which contradicts the articulated purpose of FIFRA §6(a)(2); and (3) erroneously declares nanosilver and all other products containing nanomaterials to be “new” materials, even though, as SNWG contends, nanosilver materials allegedly have “decades of historical records of safe use.” SNWG further noted that these policy changes could stifle innovation and progress in the nanotechnology field, as well as create an unjustifiable and negative public perception of the technology. …

EPA Set to Rule on FIFRA Nanosilver Petition in June

Inside EPA reports today that a "senior policy adviser for EPA’s Office of Pesticide Programs, said EPA would issue in June a long-awaited response to a 2008 activist petition asking the agency to regulate nanoscale silver under FIFRA."  The article also mentions that EPA intends to define nanoscale ingredients for FIFRA purposes as "an ingredient that contains particles that have been intentionally produced to have at least one dimension that measures between approximately 1 and 100 nanometers."…

Nanosilver and the FIFRA Scientific Advisory Panel Public Meeting

Earlier today, the Federal Register carried a notice regarding the 4 day consultation meeting of the FIFRA Scientific Advisory Panel concerning the assessment of hazard and exposure associated with nanosilver and other nanometals in pesticides, previously announced in the FR for September 16, 2009 and discussed previously here. Today’s announcement notes a change in the time for the meetings. The consultation meeting will take place from 1:30-5PM on Nov. 3, 2009. Wednesday Nov. 5 – Friday, Nov. 6, 2009, will still take place from 8:30AM – 5PM. For further information on submitting filings, please see the notice.

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EPA Takes Aim at Anitmicrobial Products Under FIFRA

In this article, we note a couple of recent EPA enforcement actions against manufacturers allegedly making unsubstantiated antimicrobial claims for their products – much like occurred in the IOGEAR computer keyboard/mice episode in 2008.  Although these products do not purport to use nanoscale materials, the alleged claims for these products are similar to those made by manufacturers for certain nano-based antimicrobial products. Thus, our readers may be interested in EPA’s actions.

The EPA issued a press release today stating that the parent company of North Face camping and outdoor gear faces up to $1,000,000 in fines for allegedly making unsubstantiated health-related claims for almost 70 of its shoe products using Agion silver ion technology. The EPA press release states:

“At issue were more than 70 styles of footwear that incorporated an AgION silver treated footbed. The company sold the products making unsubstantiated claims that the footwear would prevent disease-causing bacteria. Specifically, The North Face made the following public health claims about the footwear on-line and on product packaging:  • ‘AgION antimicrobial silver agent inhibits the growth of disease-causing bacteria’ • ‘Prevents bacterial and fungal growth’ • Continuous release of antimicrobial agents”

The fines are being sought by EPA under the Federal Insecticide Fungicide and Rodenticide Act which prohibits unsubstantiated public health claims regarding unregistered products.

From Agion’s website: “Agion technology operates at the surface of a product through the controlled release of silver ions which attack microbes and inhibit their growth in three different ways. We offer a variety of …

EPA Scientific Advisory Panel to Discuss Nanoscale Silver at Public Meeting

A much valued contributor from CyberRegs provided us with the following information from the Federal Register that may be of interest to readers:

There will be a 4-day consultation meeting of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to consider and review a set of scientific issues related to the assessment of hazard and exposure associated with nanosilver and other nanometal pesticide products.

DATES: The consultation meeting will be held on November 3 – 6, 2009, from approximately 8:30 a.m. to 5:00 p.m. The consultation meeting will be held at the Environmental Protection Agency, Conference Center, Lobby Level, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA 22202.

Comments. The Agency encourages that written comments be submitted by October 20, 2009 and requests for oral comments be submitted by October 27, 2009. Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

FOR FURTHER INFORMATION CONTACT: Joseph E. Bailey, DFO, Office of Science Coordination and Policy (7201M), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (202) 564-2045; fax number: (202) 564-8382; e-mail address: bailey.joseph@epa.gov.

 

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Interesting Nano-Regulatory Developments

Inside U.S. Trade reports three interesting nano-regulatory developments: (i) the "EPA has signaled that it may soon decide to regulate nano-silver as a pesticide under " FIFRA; (ii) the "EPA may rule favorably on some points" raised in the 2008 citizen’s petition filed by 14 advocacy groups seeking more restrictive regulation of nanoscale silver; and (iii) Congresswoman Kathy DahlKemper (D-Pa) on the House Science and Technology Committee "is pursuing a Cosmetics Safety Bill that would require registration of cosmetics containing nanomaterials."…

Nanosilver–In Case You Forgot

An article by Barnaby Feder in this morning’s New York Times reminds us of a question that, even a year later, has not been completely resolved.  Astute readers (and by "astute" I mean everyone who wasn’t under a rock) will remember the large discussion over the use of nanosilver as an anti-bacterial device, including the Samsung Silvercare washing machines.  Well, its back, or rather, never really left.…

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