EPA Opens Registration Review Docket for Nanosilver

On July 6, 2012, the U.S. Environmental Protection Agency (EPA) announced the establishment of a registration review docket for nanosilver. EPA states that registration review is its “periodic review of pesticide registrations to ensure that each pesticide continues to satisfy the statutory standard for registration, that is, the pesticide can perform its intended function without unreasonable adverse effects on human health or the environment.” Registration review dockets include information intended to assist the public in understanding the types of information and issues that EPA may consider during the course of registration reviews. According to the preliminary work plan, EPA has information that there are silver-based pesticide products that were registered without the registrant disclosing to EPA the presence or characteristics of the nanosilver in their products. EPA sent a letter in August 2009 to each registrant with silver-based products requesting a statement as to whether their products contained any amount of silver in any form having a dimension that measures between 1 and approximately 100 nanometers. Four registrants responded that their products, which were registered using data for conventional silver, contain nanosilver. In the preliminary work plan, EPA states it is identifying several other products, registered using data for silver chloride, as potentially containing nanosilver. The registration review for nanosilver includes these products, as well as the two HeiQ nanosilver products conditionally registered in December 2011. According to the preliminary work plan, EPA believes that additional data are needed to determine whether the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) standard for maintaining these registrations is met “due to nanosilver’s unique physical and chemical properties, and thus nanosilver’s potentially different health and safety properties as compared to silver.”

With the exception of the HeiQ products, EPA does not have information on the composition of the nanosilver or potential nanosilver in the selected products, and is proposing that the first phase of data submission be focused on determining the characteristics of the silver present in these products. According to EPA, if nanosilver is identified during the first phase of data submission, then the next phase of proposed data submission would be determining the form and concentration of silver released from the products identified to contain nanosilver. If nanosilver is found to be released, then the final phases of data submission will concern health effects, ecological effects, and environmental fate. Comments are due August 19, 2012.

EPA notes that, on February 29, 2012, it sent data call-in notices (DCI) to registrants with products included in the silver and compounds registration review case requesting information on particle size. EPA is currently reviewing responses to the DCIs and “may determine that some of the products covered by that case and DCI should also be included in this Nanosilver Registration Review case.” If EPA determines that any of these silver and compounds products need to be included in the nanosilver registration review case, it will include a statement in the docket, and reflect that determination in the final work plan for nanosilver. EPA’s anticipated schedule is below:

Activities

Estimated Month/Year

Phase 1: Opening the docket

Open Public Comment Period for Docket

June 2012

Close Public Comment Period for Docket

August 2012

Phase 2: Case Development

Develop Final Work Plan (FWP)

August 2012

Issue DCI

August 2012

DCI 90-day responses due1

November 2012

Data Submission – All data2

August 2015

Open Public Comment Period for Preliminary Risk Assessments

January 2016

Close Public Comment Period

February 2016

Phase 3: Registration Review Decision

Open Public Comment Period for Proposed Reg. Review Decision

September 2016

Close Public Comment Period for Proposed Reg. Review Decision

November 2016

Final Decision and Begin Post-Decision Follow-up

March 2017

Total (years)

5

1 -- The 90‐day responses will be due based on the date the affected registrant receives the DCI that EPA anticipates issuing.

2 -- This date reflects the last date on which required data are due, based on the schedule expected to be included in the anticipated DCI.  Earlier deadlines for submission will be included in the DCI for various data requirements due earlier.

 

EPA OIG Concludes EPA Needs to Manage Nanomaterials More Effectively

On December 30, 2011, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) released a report entitled EPA Needs to Manage Nanomaterial Risks More Effectively. According to OIG, the purpose of its review was to determine how effectively EPA is managing the human health and environmental risks of nanomaterials. OIG states that it found “that EPA does not currently have sufficient information or processes to effectively manage the human health and environmental risks of nanomaterials.” According to OIG, although EPA has the statutory authority to regulate nanomaterials, it “currently lacks the environmental and human health exposure and toxicological data to do so effectively.” EPA proposed a policy, under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), that would identify new pesticides being registered with nanoscale materials.  After “minimal industry participation” in EPA’s Nanoscale Materials Stewardship Program (NMSP), a voluntary data collection program, EPA has chosen to propose mandatory reporting rules for nanomaterials under FIFRA, and is developing proposed rules under the Toxic Substances Control Act (TSCA).

According to OIG, even if mandatory reporting rules are approved, the effectiveness of EPA’s management of nanomaterials remains in question for the following reasons:

  • 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; and
  • EPA’s management of nanomaterials is limited by lack of risk information and reliance on industry-submitted data.

OIG states that if EPA does not improve its internal processes and develop a clear and consistent stakeholder communication process, it will not be able to assure that it is effectively managing nanomaterial risks. OIG recommends 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 OIG report states that EPA “agreed with our recommendation and provided a corrective action plan with milestone dates.” By January 31, 2012, the report states, EPA will convene a workgroup “consisting of representatives from all relevant offices to begin development of process.” By July 31, 2012, EPA will “[c]omplete draft document outlining process.”

EPA Conditionally Registers Pesticide Product Containing Nanosilver As a New Active Ingredient

The U.S. Environmental Protection Agency (EPA) announced on December 1, 2011, that it is conditionally registering a pesticide product containing nanosilver as a new active ingredient. HeiQ AGS-20 is a silver-based antimicrobial pesticide product approved for use as a preservative for textiles.  The final registration is not yet in the docket.  We believe, but cannot confirm, the final registration is largely similar to the draft proposed registration issued last year. As members of the nano community know well, this is very good news and demonstrates that EPA is prepared to make regulatory decisions involving nanotechnology, even where, as here, they are likely to inspire controversy.

As a condition of Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) registration, EPA is requiring additional data to confirm its assessment that HeiQ AGS-20 will not cause unreasonable adverse effects on human health or the environment. EPA proposed on August 13, 2010, that it would conditionally register HeiQ AGS-20, which EPA stated is intended for use as a preservative in textile products, including those made from natural and synthetic fibers and which are used to manufacture indoor use articles such as sheets, blankets, towels, napkins, outerwear, sportswear, sleepwear, undergarments, socks and hosiery, and outdoor use articles such as sailcloth, tarps, tents, and awnings. EPA proposed to grant a four-year conditional registration under Section 3(c)(7)(C) of FIFRA. More information is available in our August 26, 2011, memorandum.

Comments submitted on EPA’s proposed conditional registration are available in the online docket. At this time, responses to these comments, as well as EPA’s Decision Document, have not yet been posted, but are expected shortly. EPA will also submit to the online docket a description of the additional studies and timeline when the data must be submitted.

Comment Deadline Approaches for EPA's Policy on Nanoscale Materials in Pesticide Products

Comments on the U.S. Environmental Protection Agency’s (EPA) proposed policy on nanoscale materials in pesticide products are due August 17, 2011. EPA offers two approaches for obtaining the information EPA believes it needs concerning nanoscale materials in pesticide products. Under the first approach, EPA would use Section 6(a)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to obtain information regarding what nanoscale material is present in a registered pesticide product and its potential effects on humans or the environment. EPA states that it would “prefer” to use this approach, despite industry’s concern over the use of the “adverse effects” reporting provision to obtain information. Under the second approach, EPA would use a data call-in (DCI) under FIFRA Section 3(c)(2)(B). EPA also proposes to apply an initial presumption that active and inert ingredients that are the nanoscale versions of non-nanoscale active and inert ingredients already present in registered pesticide products are potentially different from those conventionally sized counterparts. Registrants could rebut this initial presumption on a case-by-case basis.

At least one non-governmental organization, Friends of the Earth, has created an online petition that urges EPA to consider nanoscale active and inert ingredients in pesticides as new, and to use the FIFRA Section 6(a)(2) method to obtain information. With the comment deadline fast approaching, and the potential complexity, legal vulnerability, and burdens presented by the different options, it is critically important for potentially affected entities to consider carefully the issues and approaches discussed and offer strong and compelling comment of a caliber comparable to the quality and thoughtfulness of EPA’s notice.

EPA Proposes Policy on Nanoscale Materials in Pesticide Products

The U.S. Enviromental Protection Agency (EPA) published in the June 17, 2011, Federal Register a notice describing several possible approaches for obtaining certain additional information on the composition of pesticide products. EPA focuses particularly on information about what nanoscale materials are present in registered pesticide products, and defines “nanoscale material” as “an active or inert ingredient and any component parts thereof intentionally produced to have at least one dimension that measures between approximately 1 and 100 nanometers (nm).” Under one approach, EPA would use Section 6(a)(2) of the Federal Insecticide, Fungicide, and rodenticide Act (FIFRA) to obtain information regarding what nanoscale material is present in a registered pesticide product and its potential effects on humans or the environment. Under an alternative approach, EPA would obtain such information using a data call-in (DCI) under FIFRA Section 3(c)(2)(B). According to the notice, EPA believes FIFRA Section 6(a)(2) “is the most efficient and expedient administrative approach to obtaining information about nanoscale materials in pesticides and EPA would prefer to use this approach.” The notice also proposes a “new approach” that EPA will use to determine on a case-by-case basis whether a nanoscale active or inert ingredient is a “new” active or inert ingredient for purposes of FIFRA and the Pesticide Registration Improvement Act, even when an identical, non-nanoscale form of the nanoscale ingredient is already registered. Comments are due July 18, 2011.

EPA Proposes Policy on Nanoscale Materials in Pesticide Products

The U.S. Environmental Protection Agency (EPA) released on June 9, 2011, a pre-publication copy of a forthcoming Federal Register notice describing several possible approaches for obtaining certain additional information on the composition of pesticide products. EPA focuses particularly on information about what nanoscale materials are present in registered pesticide products, and defines “nanoscale material” as “an active or inert ingredient and any component parts thereof intentionally produced to have at least one dimension that measures between approximately 1 and 100 nanometers (nm).” Under one approach, EPA would use Section 6(a)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to obtain information regarding what nanoscale material is present in a registered pesticide product and its potential effects on humans or the environment. Under an alternative approach, EPA would obtain such information using a data call-in (DCI) under FIFRA Section 3(c)(2)(B). According to the notice, EPA believes FIFRA Section 6(a)(2) “is the most efficient and expedient administrative approach to obtaining information about nanoscale materials in pesticides and EPA would prefer to use this approach.” The notice also proposes a “new approach” that EPA will use to determine on a case-by-case basis whether a nanoscale active or inert ingredient is a “new” active or inert ingredient for purposes of FIFRA and the Pesticide Registration Improvement Act (PRIA), even when an identical, non-nanoscale form of the nanoscale ingredient is already registered. Comments will be due 30 days after the notice is published in the Federal Register.

EPA Claims Company Made Illegal Public Health Claims For Nano Silver Product

On December 15, 2010, the U.S. Environmental Protection Agency (EPA) announced that it fined Kinetic Solutions Inc., doing business as Rabbit Air, $82,400 for allegedly selling unregistered and misbranded pesticides and making unproven claims about their effectiveness. According to EPA, Kinetic Solutions Inc. made illegal public health claims for its air purifier branded “Nano Silver Pre Filter” and the filter’s ability to control over 650 types of bacteria, a violation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). In addition, its air purifiers did not list a valid EPA Establishment Number on the packaging, a federal requirement that helps regulators keep track of where pesticides and devices are produced. EPA states that the violations were discovered through an online search and subsequent inspection by the California Department of Pesticide Regulation (CDPR). According to Kinetic Solutions Inc., the Nano Silver Pre Filter incorporates a substance called “nano silver” or “silver nano ions,” a substance or mixture of substances intended to prevent, destroy, repel, or mitigate bacteria and mold. Products that kill or repel bacteria or germs are considered pesticides, and must be registered with the EPA prior to distribution or sale. According to EPA, the Nano Silver Pre Filter is a pesticide and was not registered as such as required by federal law.

NanoBusiness Alliance Interviews Lynn L. Bergeson

NanoBusiness Alliance included Lynn L. Bergeson in its recent interview series. The interview covers a wide range of issues related to nanotech environmental, health and safety, including such “hot” topics as establishing a nano nomenclature that is uniform, thoughtful, and useful for regulatory purposes; the U.S. Environmental Protection Agency’s (EPA) three Toxic Substances Control Act (TSCA) proposals that will have an immediate and significant impact on the commercialization of nanoscale materials; and the EPA’s Office of Pesticide Programs development of a policy under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) that will apply to nanopesticides. The NanoBusiness Alliance is an industry association founded to advance the emerging business of nanotechnology and microsystems for corporations, start-ups, researchers, universities, investors, and a host of other key stakeholders.  The Alliance’s mission is to create a collective voice for the emerging small-tech industry and develop a range of initiatives to support and strengthen the nanotechnology business community, through public policy efforts, events, research, and the creation of partnerships.

OPP Considering Labeling of Nanopesticides

The State Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Research and Evaluation Group (SFIREG) Pesticide Operations and Management (POM) Committee held a meeting on September 20, 2010. During the meeting, Jennifer McLain, Associate Director of the Antimicrobials Division, U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP), provided an update on EPA’s regulation of pesticides containing nanoscale materials. McLain’s presentation includes two previously unreported OPP regulatory activities. First, according to McLain, OPP intends to require that nanoproducts be labeled in the same way as other pesticide products. Ingredients would be listed as “nano-X,” and OPP would evaluate the claims on a case-by-case basis. Second, OPP apparently is considering issuing data call-ins to obtain information EPA may need to evaluate the registerability under FIFRA of nanoscale materials. Using its FIFRA data call-in authority is, of course, an option several industry groups have been urging in lieu of repurposing FIFRA Section 6(a)(2).

Plainly, OPP’s cryptic reference to FIFRA “nano labeling” requires far more explanation and some observers may find it disturbing. The presentation’s statement that “Nano-Products will be labeled the [sic] in the same way as other pesticide products” is, of course, ambiguous at best. Such an approach would lead to a number of important questions: What exactly is subject to labeling? Will the presence of any nanoscale material in a formulation trigger a nano label? How will confidentiality issues be addressed? The presentation raises other thorny issues, many of which appear to not have been publicly discussed.

OMB Receives EPA Notice Concerning Pesticide Products Containing Nanoscale Materials

According to the Office of Management and Budget (OMB) website, on July 30, 2010, OMB received from the U.S. Environmental Protection Agency (EPA) a notice concerning “Pesticide Products Containing Nanoscale Materials.” No additional information regarding the notice is available on OMB’s website. During the April 29, 2010, meeting of EPA’s Pesticide Program Dialogue Committee (PPDC), William Jordan, Senior Policy Advisor, Office of Pesticide Programs (OPP), stated that EPA was in the process of preparing a Federal Register notice on nanomaterials and pesticide products. The notice will announce a new interpretation of Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 6(a)(2) regulations, that the presence of a nanoscale material is reportable under FIFRA Section 6(a)(2). This controversial interpretation would apply to already registered products, as well as products pending registration. In the same notice, EPA is expected also to memorialize OPP’s view that an active or inert ingredient would be considered “new” if it is a nanoscale material. The new policy would apply even when a non-nanoscale form of that same active or inert is already in a FIFRA-registered product. On June 25, 2010, the U.S. Government Accountability Office (GAO) issued a report entitled Nanotechnology: Nanomaterials Are Widely Used in Commerce, but EPA Faces Challenges in Regulating Risk, which recommends, among other actions, that EPA should complete its plan to clarify that nanoscale ingredients in already registered pesticides, as well as in those products for which registration is being sought, are to be reported to EPA and that EPA will consider nanoscale ingredients to be new. EPA responded that it agreed with GAO’s recommendation and is working on clarification of registrant’s responsibilities under FIFRA with respect to nanomaterials.

GAO Report States That EPA Faces Challenges in Regulating Risk of Nanomaterials

According to a report released on June 25, 2010, by the U.S. Government Accountability Office (GAO), the U.S. Environmental Protection Agency (EPA) faces challenges in effectively regulating nanomaterials that may be released in air, water, and waste because EPA 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. In preparing its report, GAO identified examples of current and potential uses of nanomaterials; determined what is known about the potential human health and environmental risks from nanomaterials; assessed actions EPA has taken to better understand and regulate the risks posed by nanomaterials as well as its authorities to do so; and identified approaches that other selected national authorities and actions U.S. states have taken to address the potential risks associated with nanomaterials. GAO analyzed selected laws and regulations, reviewed information on EPA’s Nanoscale Materials Stewardship Program, and consulted with EPA officials and legal experts to obtain their perspectives on EPA’s authorities to regulate nanomaterials.

GAO’s report includes the following recommendations, all of which are “in process.” EPA’s responses are from its May 4, 2010, letter responding to GAO’s recommendations. The letter is included in GAO’s report.

  • The Administrator of EPA should complete its plan to issue a significant new use rule (SNUR) for nanomaterials.

EPA response: EPA agrees. EPA will continue to issue SNURs for nanoscale materials that are new chemical substances on a case-by-case basis, as appropriate, and intends to propose a SNUR for nanoscale materials that are existing chemical substances by December 2010.

  • The Administrator of EPA should modify Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) pesticide registration guidelines to require applicants to identify nanomaterial ingredients in pesticides.

EPA response: EPA agrees and intends to clarify that, as part of the application for registration, applicants for pesticide registrations which contain nanomaterial ingredients need to specifically identify those ingredients.

  • The Administrator of EPA should complete its plan to clarify that nanoscale ingredients in already registered pesticides, as well as in those products for which registration is being sought, are to be reported to EPA and that EPA will consider nanoscale ingredients to be new.

EPA response: EPA agrees and is working on clarification of registrant’s responsibilities under FIFRA with respect to nanomaterials.

  • The Administrator of EPA should make greater use of the Agency’s authorities to gather information under existing environmental statutes. Specifically, EPA should complete its plan to use data gathering and testing authorities under the Toxic Substances Control Act (TSCA) to gather information on nanomaterials, including production volumes, methods of manufacture and processing, exposure and release, as well as available health and safety studies.

EPA response: EPA agrees and intends to propose a Section 8(a) information-gathering rule as described in the recommendation and also intends to propose a Section 4 test rule.

  • The Administrator of EPA should make greater use of the Agency’s authorities to gather information under existing environmental statutes. Specifically, EPA should use information-gathering provisions of the Clean Water Act (CWA) to collect information about potential discharges containing nanomaterials.

EPA response: EPA agrees that collecting information about discharges is a critical component of understanding potential environmental risks. EPA’s Office of Research and Development, and others, is conducting research to determine whether nanomaterials may enter the water in forms and levels of concern, as well as how to detect and monitor nanomaterials in effluents and aquatic systems. Once we have these capabilities, EPA will consider whether new reporting requirements should be applied to companies who may be discharging nanomaterials into the environment, including under the CWA.

  • The Administrator of EPA should consider revising the Inventory Update Rule (IUR) under TSCA so that it will capture information on the production and use of nanomaterials and so that the Agency will receive periodic updates on this material.

EPA response: EPA agrees and will consider proposing periodic reporting under the IUR for nanoscale materials.

 

PPDC Discusses Nanotechnology and Pesticides

On April 29, 2010, during the U.S. Environmental Protection Agency’s (EPA) Pesticide Program Dialogue Committee (PPDC) meeting, William Jordan, Senior Policy Advisor, Office of Pesticide Programs (OPP), presented slides regarding nanotechnology and pesticides. Jordan briefly described how OPP is defining nanoscale materials and how the technology is being applied to the field of pesticides. His presentation described OPP’s recent consultation with EPA’s Scientific Advisory Panel (SAP) concerning nanosilver and other nanometal pesticide products, as well as other ongoing regulatory activity and future actions OPP intends to take.

OPP’s working definition of nanomaterial is:

An ingredient that contains particles that have been intentionally produced to have at least one dimension that measures between approximately 1 and 100 nanometers.

Although nanomaterials occur naturally and can be produced unintentionally, Jordan noted that OPP’s working definition includes the phrase “intentionally produced,” and that those are the ones OPP intends to address.

To obtain more data on hazard and exposure from nanosilver and other nanometal pesticide products, OPP is in the process of preparing a Federal Register notice on nanomaterials and pesticide products. The notice will announce a new interpretation of regulations under Section 6(a)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and propose a new policy in June 2010. The new interpretation will be that the presence of a nanoscale material is reportable under FIFRA Section 6(a)(2). In the same notice, EPA is expected also to memorialize OPP’s view that an active or inert ingredient would be considered “new” if it is a nanoscale material.

Jordan also announced that OPP intends to respond in June 2010 to the International Center for Technology Assessment’s (ICTA) May 2008 petition. In its petition, ICTA urged EPA to regulate nanosilver products as pesticides, and asked EPA to take action on an estimated 600 unregistered nanosilver products marketed in the U.S.

Jordan noted the following activities in other EPA offices:

  • Office of Research and Development (ORD) developing a Draft Case Study on nanosilver (expected in 2010); and
  • Office of Pollution Prevention and Toxics (OPPT) developing the following rules under the Toxic Substances Control Act (TSCA):
  • Significant New Use Rule (SNUR) -- Intended to address nanoforms of existing chemicals;
  • Section 8(a) Rule -- Would obtain existing data on current nanomaterials; and
  • Section 4 Test Rule -- Likely at the end of 2010.

 

EPA SAP Releases Report on Nanosilver and Other Nanometal Pesticide Products

The U.S. Environmental Protection Agency (EPA) Scientific Advisory Panel (SAP) has released the minutes of its November 3-5, 2009, meeting regarding evaluation of the hazard and exposure associated with nanosilver and other nanometal pesticide products.  In addition to the general observations noted here, more information is available in our February 8, 2010, memorandum. First, the SAP final recommendations address nanosilver almost entirely, and little or no mention is made of “nanometal pesticide products.” Second, the Panel stated that existing models “are not appropriate” for use with silver nanomaterials and “will not accurately predict nanosilver exposure scenarios.” The Panel stated that it “strongly believe[s] that in addition to current data requirements under [the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)], additional assays which compared nanoscale and bulk materials would be most beneficial in addressing” differences in toxicokinetics and toxicodynamics for nanoscale materials. This conclusion alone poses formidable challenges for nanosilver pesticide applicants wishing to obtain registration status under FIFRA. Third, the Panel agreed that pesticide products should be tested on a “case-by-case basis,” EPA should use a meta-analysis on the products to understand better trends in life cycle analyses, and “close attention” should be given to products that claim a non-ionic mode of action as an antimicrobial agent. Fourth, the Panel outlined detailed research needs that EPA should consider. The outline will discourage even the most optimistic potential FIFRA registrant for a nanopesticide as the research needs are extensive and likely costly. The Panel also identified the “most useful short-term information needs,” of which stakeholders should be aware. Finally, the Panel stated that a “critical issue” that “must be clarified is the use of [the] terminology ‘nano’” and that for standardization, “the unique property for nanosilver should be established.”

SNWG Presents Data on Silver and Nanotechnology to the SAP

The Silver Nanotechnology Working Group (SNWG) issued a press release regarding its presentation to the U.S. Environmental Protection Agency’s (EPA) Scientific Advisory Panel (SAP) at its November 3-6, 2009, meeting. EPA asked the 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.” According to EPA, companies with an interest in marketing products that contain nanosilver and/or other nanometals or nanometal oxides as pesticides regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) have approached the Office of Pesticide Programs (OPP) seeking product registration. SNWG’s analysis included the key conclusions that nanosilver is not a new material and that EPA has “safely and successfully” regulated nanosilver products for decades.

EPA Will Webcast SAP Meeting

The U.S. Environmental Protection Agency (EPA) has announced that it will stream its November 3-6, 2009, Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) meeting on the Internet. EPA has asked the 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.” According to EPA, companies with an interest in marketing products that contain nanosilver and/or other nanometals or nanometal oxides as pesticides regulated under FIFRA have approached the Office of Pesticide Programs (OPP) seeking product registration. OPP believes, based on its understanding of the scientific literature, that pesticides containing nanoscale materials may pose different risks to humans and the environment than those of pesticides that do not contain nanomaterials.

EPA Announces SAP Meeting Concerning Nanosilver

The U.S. Environmental Protection Agency (EPA) announced in a September 16, 2009, Federal Register notice that the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) will meet November 3-6, 2009, “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.” Nominations of candidates to serve as ad hoc SAP members for this meeting are due September 30, 2009. The meeting will be open to the public. EPA asks that written comments be submitted by October 20, 2009, to allow for distribution to the SAP, and that requests for oral comments be made by October 27, 2009.  EPA also states that written comments and requests to make oral comments may be submitted until the date of the meeting, however.

NGOs Call for Obama Administration to Establish Moratorium on Pesticidal Nanotechnology

According to a draft January 7, 2009, document, non-governmental organizations (NGO) such as Beyond Pesticides and the Pesticide Action Network for North America recommend that the Obama Administration take a number of immediate actions within its first 100 days, including establishing a moratorium on pesticidal nanotechnology. The NGOs call for the suspension of the registration of nanoproducts with pesticidal properties, and the removal of untested products from the market.  The NGOs urge the Obama Administration to direct the U.S. Environmental Protection Agency (EPA) to develop a clear testing protocol that identifies the full range of potential adverse health and environmental effects of nanoproducts with pesticidal properties. The NGOs cite the 60-day comment period on the International Center for Technology Assessment (ICTA) petition as an acknowledgment by EPA of “the critical need for in-depth review of products utilizing nanotechnology pesticides.” ICTA petitioned EPA in May 2008 to regulate nanoscale silver products as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

EPA to Seek Public Comment on ICTA Petition on Nanoscale Silver Products

Recent press reports have indicated, and an attorney with the International Center for Technology Assessment (ICTA) has confirmed, that the U.S. Environmental Protection Agency (EPA) contacted ICTA last week and informed the organization that it (EPA) intends to seek public comment on the nanoscale silver petition filed by ICTA and 13 other consumer, health, and environmental groups on May 1, 2008. The petition demanded, inter alia, that EPA regulate as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act consumer products containing nanoscale silver. The petitioners requested that EPA respond to the petition “within a reasonable time.”

According to the ICTA attorney, EPA is preparing a Federal Register notice that will invite public comments on the ICTA Petition. It is not yet known how long the comment period will be or when the notice will be published in the Federal Register. The EPA Office of Pesticide Programs’ recently posted webpage on nanotechnology does not make any mention of the impending notice.

OPP Posts Page on Nanotechology and Pesticides

On July 22, 2008, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) posted a web page entitled “Pesticide Issues in the Works:  Nanotechnology, the Science of Small.” The web page states: “[The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)] and EPA’s implementing regulations provide an effective framework for regulating pesticide products that are a product of nanotechnology or that contain nanoscale materials.” According to the page, “EPA is currently examining potential hazard, exposure, policy, regulatory, and international issues that may be associated with pesticides that are a product of nanotechnology or that contain nanoscale materials.” While EPA has met with several companies “to discuss requirements for some specific nanoscale materials being considered for use as pesticides,” EPA has not yet received a formal registration application. EPA “strongly recommends” that companies contact the pesticide registration Ombudsmen “to arrange a pre-application conference as early as possible in the development of any pesticide that would be a product of nanotechnology or that would contain nanoscale material.”

ICTA-Led Coalition Petitions for FIFRA Regulation of Nanoscale Silver Products

On May 1, 2008, the International Center for Technology Assessment (ICTA), together with 13 other consumer, health, and environmental groups, filed a petition with the U.S. Environmental Protection Agency (EPA) demanding that EPA regulate as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and that it take additional actions under FIFRA and other environmental statutes concerning, consumer products containing nanoscale silver. ICTA also released an inventory of the nano silver-containing consumer products referenced in the petition.

The petition contends that nano silver is “the most commonly used nanomaterial in consumer products and the fastest growing sector of nanomaterial commercialization,” and that most companies “market their nano-silver products [by] putting emphasis on the nano-silver ingredient, touting its antimicrobial and antibacterial qualities . . . .” The petition states that “research has mounted to indicate that nano-silver materials pose serious risks to human health and the environment.” In support of the petition, the ICTA-led coalition pointed to, inter alia, EPA Region 9’s recent FIFRA enforcement settlement with a California company, IOGEAR, that had been making antimicrobial claims for the nano silver coating on computer accessories it was marketing.

The petition requests that EPA take the following actions:

  • Clarify that nano silver and products containing it are pesticides requiring registration under FIFRA;
  • Classify nanomaterial pesticides such as nano silver as new pesticides [i.e., new active ingredients] that require new registrations, with nano-specific toxicity testing and risk assessment;
  • Assess the potential human health and environmental risks of nano silver under FIFRA, the Food Quality Protection Act, the Endangered Species Act, and the National Environmental Policy Act;
  • Take immediate action, including the issuance of Stop Sale, Use, or Removal Orders, to halt the sale of nano silver products with unapproved antimicrobial claims;
  • Fully apply all FIFRA regulations in the event EPA registers any nano silver products; and
  • Utilize its FIFRA authority to further review the potential human health and environmental impacts of nano silver, including undertaking either a classification review or a Special Review, amending the FIFRA regulations to require as part of a registration application the submission of nanomaterial and/or nano silver-specific data, undertaking a registration review of existing bulk silver registrations, regulating nano silver pesticide devices, and establishing a tolerance for nano silver under the Federal Food, Drug, and Cosmetic Act.

The coalition requests that EPA respond to the petition “within a reasonable time.”