Bergeson & Campbell, P.C. serves small, medium, and large pesticide product registrants and other stakeholders in the agricultural and biocidal sectors, in virtually every aspect of pesticide law, policy, science, and regulation.

By James V. Aidala and Carla N. Hutton

On March 3, 2021, the Farmworker Association of Florida, Environmental Working Group, and Center for Biological Diversity petitioned the U.S. Court of Appeals for the District of Columbia Circuit for review of the U.S. Environmental Protection Agency’s (EPA) order registering the use of the pesticide aldicarb on oranges and grapefruit in Florida as set forth in:

EPA published a Federal Register notice on December 7, 2020, announcing that it had received applications to register new uses for pesticide products containing aldicarb, a currently registered active ingredient.  85 Fed. Reg. 78851.  The proposed use was on oranges and grapefruit in Florida and Texas.  EPA’s January 12, 2021, Registration Decision states that during the application review, the registrant amended its request and the use was limited by amount of product that can be sold and distributed (i.e., 2,500,000 pounds product) for use during an application season (November 15 to April 30), limited to oranges and grapefruit in Florida, only, and will expire after the third application season (April 30, 2023).  The Registration Decision states that EPA “is conditionally approving the uses on oranges and grapefruit to the products MEYMIK TECHNICAL (EPA Reg. No. 87895-2), AGLOGIC 15GG (EPA Reg. No. 87895-4) and AGLOGIC 15GG OG (EPA Reg. No. 87895-7).”  According to the Registration Decision, “[t]hese conditional, time-limited registrations will allow for a narrow use of aldicarb on oranges and grapefruit in Florida to help in the control of certain insects, mites, and nematodes, including [Asian citrus psyllid (ACP)].”  EPA notes that in conditionally approving these new uses for the existing products under Section 3(c)(7)(B) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), it determined that there are insufficient data to register these uses unconditionally.

Commentary

EPA’s justification for allowing these uses centers on the need for products to control, or at least slow down the spread of, citrus-greening disease (spread by the ACP-vectored bacterial disease Huanglongbing (HLB)).  The registration rationale notes that growers have seen up to an 80 percent reduction in production value due to the disease.  This registration appears to be a time-limited registration in order to have another pest control tool while further research continues to attempt to find a more permanent solution to controlling the disease.  EPA’s rationale describes past registrations of aldicarb that have provided extensive data and reviews of the required health and ecological assessments to meet the FIFRA standards.  A time-limited registration also makes EPA’s assessment “easier” insofar as there is no presumption of long-term chronic exposure to the pesticide beyond the time-limited period.  The tolerances for aldicarb had continued to remain in place to allow for use on imported food after earlier reviews determined the tolerance levels met the relevant standards (including risks to children).  These additional uses on domestic crops was determined not to change the analytical basis of the tolerance assessment (example:  the amount of orange juice consumed does not change if a domestic or foreign supplier is the source).

At the same time, aldicarb has been a controversial pesticide for much of its history.  As a carbamate insecticide, its mode of action is cholinesterase inhibition, which has raised issues about possible long-term neurological or other developmental effects from carbamate or organophosphate pesticides.  And, as a potent insecticide, some would say there will likely be impacts on pollinators even if label directions are followed.  Lastly, arguments over possible risks to farmworkers, assessed to be acceptable in the registration decision, may prove to be an early test of the stated commitment to review more closely decisions with possible environmental justice implications under the new Biden Administration.


 

By Heather F. Collins, M.S. and Barbara A. Christianson

The January 15, 2021, deadline for payment of the U.S. Environmental Protection Agency’s (EPA) annual maintenance fee for pesticide registrations is approaching.  The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 4(i)(1)(A) requires that everyone who holds an active or suspended pesticide registration granted under FIFRA Sections 3 and 24(c) (special local needs) to pay an annual maintenance fee to keep the registration in effect.  The maintenance fee requirement does not apply to supplemental registrations of distributors, which are identified by a three-element registration number.

This year, due to the COVID-19 pandemic, EPA states that most EPA staff continue to telework and are not in the EPA offices; therefore, EPA will not send maintenance fee information by mail this year.  The instructions, maintenance fee filing form, fee tables, and product listings grouped by company numbers are available to download on EPA’s website.  When completed, the filing submission should be emailed to .(JavaScript must be enabled to view this email address).  A paper copy should not be sent to EPA.

The fee for 2021 is $4,000 for each registration up to the maximum fees that can be assessed to a single registrant.  Each registrant of a pesticide must pay the annual fee and e-mail the response to EPA by Friday, January 15, 2021.  Registrations for which the fee is not paid will be canceled, by order and without a hearing. As in years past, payment must be made electronically online at www.pay.gov.

For certain qualified small businesses, the first product registration maintenance fee may be reduced by 25 percent, if the applicant meets the following criteria:

  1. The applicant has 500 or fewer employees globally;
  2. During the three-year period prior to the most recent maintenance fee billing cycle, the applicant has average annual gross revenue from all sources that do not exceed $10,000,000; and
  3. The applicant holds a total of five or fewer registrations subject to the maintenance fee.

There also are maintenance fee waivers for products that meet the criteria in two specific categories:  minor agricultural use products and public health pesticides.  The procedure for requesting a fee waiver for individual products is described in the instructions provided by EPA.

More information on the annual maintenance fees is available on EPA’s website.


 

By Lisa M. Campbell, Lisa R. Burchi, and Barbara A. Christianson

On November 16, 2020, the U.S. Environmental Protection Agency (EPA) announced that it will now provide pesticide registrants with electronic Certificates of Registration, commonly known as “Gold Seal” letters.  A Gold Seal letter from EPA certifies that a product to be exported is registered with EPA and meets all necessary registration requirements.  EPA states that this improved process will allow for the electronic Gold Seal letters to be e-mailed to registrants rather than physically mailed.

Under the new process, a company must submit a written request to EPA, identifying the company name, the EPA Registration Number at issue, and the country to which the product will be exported.  The Pesticide Registration Improvement Extension Act (PRIA 4) category is M006 and will cover up to five Gold Seal letters for one product with a one-month decision time.  The fee for fiscal year 2020-2021 is $291.  EPA states that because the fee is low and EPA’s timeframe to respond is short, this category is not eligible for small business waivers.  EPA also clarifies that distributor products are not eligible for Gold Seal letters.

Information on how to request a Gold Seal letter, including information on how registrants should present the letters to the U.S. Department of State when authentication is needed for business purposes, is available here

This announcement is a welcome improvement to the existing process, providing a key flexibility during the COVID-19 public health emergency.  EPA expects to transition permanently to this digital process, which it notes allows for faster processing, better tracking, and greater consistency.


 

This week's All Things Chemical™ Podcast will be of interest to readers of the Pesticide Law & Policy Blog®. A brief description of the episode written by Lynn L. Bergeson is below.

This week, I sat down with Jim Aidala, Senior Government Affairs Consultant at B&C and its consulting affiliate, The Acta Group.  As a former Assistant Administrator in what is now the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention, Jim has a keen sense of how EPA prepares for and transitions to changes in Administrations.  As we prepare for the November elections, we thought it would be good to check-in with Jim and get a sense of how our colleagues at EPA are faring.  After reviewing key topics in the pesticide world, Jim walks us through how and when pesticide registrants and others in the commercial value chain can prepare for any forthcoming transition, consequential or otherwise.  Jim discusses whether regulated entities can expect policy changes occasioned by a new Administration, regardless of who wins.  Jim also addresses the implications of changes in the Supreme Court in light of Justice Ginsburg’s death. Jim’s insights in these areas is spot on and timely.

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL  AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.

©2020 Bergeson & Campbell, P.C.  All Rights Reserved


 

By Lisa M. Campbell, Lisa R. Burchi, Heather F. Collins, M.S., and Barbara A. Christianson

On August 24, 2020, the U.S. Environmental Protection Agency (EPA) announced the issuance of a Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 18 emergency exemption to the state of Texas permitting it to allow American Airlines and Total Orthopedics Sports & Spine to use a new product that is believed to inactivate coronaviruses like the SARS-CoV-2 virus on surfaces for up to seven days.  EPA states that after carefully reviewing the available data and information, it “determined that the product helps to address the current national emergency.”  According to EPA, the product is “expected to provide longer-lasting protection in public spaces, increasing consumer confidence in resuming normal air travel and other activities.”

FIFRA Section 18 authorizes EPA to exempt federal or state agencies from any provision of FIFRA in the event that emergency conditions require such an exemption.  EPA regulations (40 C.F.R. Part 166) specify when state or federal government agencies will be permitted to use unregistered pesticides in response to an emergency.  EPA’s regulations provide that an emergency exists when:

  • There is an “urgent, non-routine” situation requiring the use of a pesticide to control a new pest not previously prevalent in the United States, to control significant risks to health, the environment, beneficial organisms, or endangered species, or to prevent specified types of economic loss; and
  • There is no registered pesticide or economically or environmentally feasible alternate method of control available.

40 C.F.R. § 166.3.

The exemptions granted can be very specific and time-limited; EPA has developed a database so companies can search (by chemical, site, pest, applicant, or date range) to determine if an emergency exemption has been issued and its expiration date.

In this case, EPA approved the Section 18 emergency exemption request for SurfaceWise2 -- a product manufactured by Allied BioScience -- a surface coating that Allied BioScience states inactivates viruses and bacteria within two hours of application and continues to work against them for up to seven days, between regular cleanings.  EPA’s approval will allow Texas to permit American Airlines airport facilities and planes at specific locations and two Total Orthopedics Sports & Spine Clinics to use SurfaceWise2 under certain conditions.  The approved Section 18 emergency requests are effective for one year. As new data emerge, EPA may alter the terms of the product’s emergency uses.

Over the coming months, Allied BioScience will pursue a non-emergency approval under FIFRA Section 3 by submitting additional data to meet EPA’s registration requirements as an antiviral and antibacterial surface coating.  If the full registration process is completed, the product would become available for purchase by members of the public.  SurfaceWise2 is not yet available to the general public because Allied Biosciences has not yet submitted the necessary data to qualify for registration under Section 3 of FIFRA.

Commentary

EPA states that it has not received any other Section 18 applications for products with residual efficacy against coronaviruses like SARS-CoV-2, but that is likely to change following this approval and ongoing activities by companies seeking options for products to use against SARS-CoV-2.  EPA states it will consider any such requests submitted related to the COVID-19 public health emergency, and also anticipates posting information for companies or individuals who are interested in pursuing a FIFRA Section 3 registration for antiviral surface coatings in the coming weeks.

States or federal agencies interested in pursuing a Section 18 emergency exemption request for products that claim residual efficacy against viruses should be prepared to include efficacy data demonstrating that the product is durable and effective against viruses for up to the periods of time after application.  It will be essential to ensure that these data will be deemed sufficient by EPA to determine efficacy and durability, which may require discussion with EPA.  EPA will review the results of these studies to ensure that surface coatings remain effective under the anticipated proposed conditions of use.

Additional information on Section 18 emergency exemption requests and Sars-CoV-2 is available here.


 

By Lisa M. Campbell, Heather F. Collins, M.S., and Barbara A. Christianson

On July 30, 2020, the U.S. Environmental Protection Agency (EPA) announced it approved amended labels for 13 products based on laboratory testing that shows the products are effective against SARS-CoV-2, the virus that causes COVID-19. These products, and two previously announced products (see our July 7, 2020, blog), are the only products for which EPA has reviewed laboratory testing data and approved label claims specifically against SARS-CoV-2. 

In January 2020, at the beginning of the SARS-CoV-2 public health emergency, EPA activated its Emerging Viral Pathogens guidance (Guidance).  EPA published this Guidance in August 2016, to set forth procedures for EPA to respond to the potential need for products to combat emerging viral pathogens that are not on EPA-registered disinfectant labels.  The Guidance allows product registrants to make limited off-label claims of their product’s efficacy against SARS-CoV-2, provided in part that there are efficacy data that have already been reviewed by EPA that demonstrate their products are effective against harder-to-kill viruses than SARS-CoV-2. 

Since activating its Guidance for the first time, EPA has reviewed amendments for already EPA-registered surface disinfectants on an expedited basis and developed a list -- List N -- of products that meet its criteria under the Guidance for use against SARS-CoV-2.  List N currently includes 469 products and is updated weekly.  In many cases, EPA states that it was able to approve claims in as little as 14 days.

The 13 products approved include 12 unique products from the manufacturer Lonza and one additional Lysol product from Reckitt Benckiser.  The 13 products approved are:

  • Lonza Formulation S-21 (EPA Reg. No. 6836-75);
  • Lonza Formulation S-18 (EPA Reg. No. 6836-77);
  • Lonza Formulation R-82 (EPA Reg. No. 6836-78);
  • Lonza Formulation S-18F (EPA Reg. No. 6836-136);
  • Lonza Formulation R-82F (EPA Reg. No. 6836-139);
  • Lonza Formulation S-21F (EPA Reg. No. 6836-140);
  • Lonza Formulation DC-103 (EPA Reg. No. 6836-152);
  • Lonzaguard RCS-256 (EPA Reg. No. 6836-346);
  • Lonzaguard RCS-128 (EPA Reg. No. 6836-347);
  • Lonzaguard RCS-128 PLUS (EPA Reg. No. 6836-348);
  • Lonzaguard RCS-256 PLUS (EPA Reg. No. 6836-349);
  • Lonzaguard R-82G (EPA Reg. No. 6836-381); and
  • Lysol® Disinfecting Wipes (All Scents) (EPA Reg. No. 777-114).

Additional information is available here.


 

By Lisa M. Campbell, Heather F. Collins, M.S., and Barbara A. Christianson

On July 7, 2020, the U.S. Environmental Protection Agency (EPA) announced the release of new guidance (Guidance) for registrants of products on or eligible for inclusion on List N, EPA’s list of disinfectant products that EPA has concluded meet EPA’s criteria for use against SARS-CoV-2, the virus that causes COVID-19.  This new guidance provides expedited procedures for those registrants that wish to add electrostatic application methods to their disinfectant product labels.  The Guidance outlines information that EPA asks registrants to submit to obtain expedited review of their proposed addition of this application method to their labels.

EPA notes that electrostatic spraying has drawn increased interest through the current public health emergency posed by COVID-19 because of the need to disinfect large indoor spaces, such as schools, offices, businesses, and other large areas, or areas with many surfaces.  Unlike conventional spraying methods, electrostatic sprayers apply a positive charge to liquid disinfectants as they pass through the nozzle.  The positively charged disinfectant is attracted to negatively charged surfaces, which allows for efficient coating of hard, nonporous surfaces.

EPA’s Guidance addresses adding electrostatic spray application methods to both new and currently registered disinfectant products that are on EPA’s List N: Disinfectants for Use Against SARS-CoV-2, or that would qualify for List N, and require review under the Pesticide Registration Improvement Extension Act (PRIA 4). 

EPA states that it will expedite the following registration applications:

  • Requests to amend currently registered products, including products on List N, that require review of data under PRIA 4:
    • Current EPA-registered products approved for spray use application methods, already on List N, and the application is supported by the following data and revised label language: 
      • Confirmatory efficacy data conducted with an electrostatic sprayer to bridge from the existing approved claims to application by electrostatic sprayers;
      • A wetness test consistent with MLB SOP MB-31 and a video to demonstrate that the surface remains wet for the duration of the contact time; and
      • The following amendments made to the product label for electrostatic spray use directions:
        • Spray droplet particle size (regardless of the ability to change nozzles that impact particle size) should be limited to a volume median diameter (VMD) ≥40 µm1.
        • Include the contact time and minimum and maximum spray distance from the application equipment to the treated surface that is supported by the efficacy data, and instructions to reapply if the surface dries before the contact time is achieved.
        • Place the electrostatic spray function in the ON position for electrostatic spray models that have the functionality to toggle ON/OFF.
        • Specify that bystanders and pets must not be in the room during application.
      • The following personal protective equipment (PPE) should be specified on the product label as part of the electrostatic spray use directions:
        • For chemicals that have low vapor pressures (less than 1. x 10-4 mm Hg), use N95 filtering face piece respirators or half face respirators with N95 filters.
        • For high vapor pressure chemicals (greater than 1. x 10-4 mm Hg), such as hydrogen peroxide, use half face respirators with chemical specific cartridges and N95 filters.
        • Other PPE, including gloves, clothing, and eye protection is applicable as specified on the approved product label consistent with the acute toxicity profile of the product.
    • Current EPA-registered products approved for spray use application methods for inclusion on List N:
      • For a request to amend currently registered products for inclusion on List N and to specify electrostatic spray as an approved method of application, follow the directions in EPA’s previously announced expedited review of certain PRIA 4 submissions for products intended for use against SARS-CoV-2. Specifically, follow the directions in the “Request to add a virucidal claim to a product that requires EPA to review efficacy data (including both newly submitted data and citations to existing data)” section and include the additional information specified above for electrostatic sprayers as part of the submission. Submission of new efficacy data to add claims to an already EPA-registered product along with the information specified for electrostatic sprayers can be submitted together as a PRIA 4 A570 action for expected expedited review.
      • The submission should include a PRIA 4 fee payment in the amount of $4,023, or small business fee waiver request with the appropriate fee for a PRIA 4 A570 action. EPA states that it will make every effort to complete the review and make a regulatory decision one to two months faster than the standard four-month time frame under PRIA 4.
    • Current EPA-registered products not approved for spray use application methods or for which modified PPE label language is desired for inclusion on List N:
      • If the currently registered product labeling for the active ingredient is not approved for spray use application methods and/or the registrant wants to conduct and submit data to modify the default PPE label language specified above, these data should be submitted as a PRIA 4 code A572 and include the efficacy data, directions for use for electrostatic sprayers, and other documents specified above. EPA states it will make every effort to complete the review and make a regulatory decision one to two months faster than the standard nine-month time frame under PRIA 4.
      • In addition, include the receipt of a PRIA 4 fee payment in the amount of $13,888 for an A572 action, or small business fee waiver request with the appropriate fee for a PRIA 4 A540 action or PRIA 4 A572 action.
  • Requests to add electrostatic spray use directions to a new product that requires the review of data under PRIA 4:

EPA’s Guidance builds on EPA’s previously announced expedited review of certain submissions for products intended for use against SARS-CoV-2.

This guidance is important for many disinfectant products.  Affected registrants or potential registrants should review it carefully. 


 

This week's All Things Chemical™ Podcast will be of interest to readers of the Pesticide Law & Policy Blog®. A brief description of the episode written by Lynn L. Bergeson is below.

This week I sat down with James Aidala, B&C’s Senior Government Affairs Consultant, to catch up on what the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) is up to and to get a sense of what we might expect to develop over the remainder of the year.  As a former Assistant Administrator of what is now the Office of Chemical Safety and Pollution Prevention, Jim’s thoughts and analyses are always spot on.

We discuss leadership within OPP, which is transitioning.  Not surprisingly, who holds the position of Office Director is always of great interest to the agricultural and biocidal chemical communities.

We also touch upon a number of high-profile pesticide science policy debates about substances, some of which have been raging literally for years.  These substances include dicamba, glyphosate, and chlorpyrifos.  The legal and scientific administrative and judicial reviews under way in the United States and internationally are fascinating, precedent setting, and closely watched.

Our conversation also includes a bit about the commercial agricultural chemical community.  Industry consolidation and international trade issues continue to challenge the commercial landscape, and they make keeping up with these issues all the more important.

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL  AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.


 

By Lisa M. Campbell, Lisa R. Burchi and Barbara A. Christianson

On July 6, 2020, the U.S. Environmental Protection Agency (EPA) announced that it approved amended labels for two products, Lysol Disinfectant Spray (EPA Reg. No. 777-99) and Lysol Disinfectant Max Cover Mist (EPA Reg. No. 777-127), based on laboratory testing that shows the products are effective against SARS-CoV-2.  These are the first products for which EPA has reviewed laboratory testing data and approved label claims against SARS-CoV-2. 

In January 2020, at the beginning of the SARS-CoV-2 public health emergency, EPA activated its Emerging Viral Pathogens guidance (Guidance),  This Guidance was developed in April 2016 to set forth procedures for EPA to respond to the potential need for products to combat emerging viral pathogens that are not on EPA-registered disinfectant labels.  The Guidance allows product registrants to make limited claims of their product’s efficacy against SARS-CoV-2, provided in part that there are efficacy data that have already been reviewed by EPA and demonstrate their products are effective against harder-to-kill viruses than SARS-CoV-2. 

Since activating its Guidance for the first time, EPA has reviewed amendments for already EPA-registered surface disinfectants on an expedited basis and developed a list -- List N -- of products that meet its criteria under the Guidance for use against SARS-CoV-2.  List N currently includes 431 products and is updated weekly.  In many cases, EPA states that it was able to approve claims in as little as 14 days.

This week, EPA updated the entries for the two Lysol products on List N to indicate they have now been tested directly against SARS-CoV-2.  This is significant since they are the first List N products for which EPA has reviewed laboratory testing data specifically against SARS-CoV-2, and not listed based on EPA’s determination that a product can be used against SARS-CoV-2 because of the product’s effectiveness against a harder-to-kill virus. 

EPA states that it expects to approve such claims for additional List N products in the coming weeks.


 

By Lisa M. Campbell, Timothy D. Backstrom, and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on July 2, 2020, that it has registered NSPW Nanosilver (a new nanosilver formulation) to suppress odor-causing bacteria and algae, fungus, mold, and mildew that can cause deterioration or staining in textiles.  Textiles that may be treated with NSPW Nanosilver include fabrics, sportswear, footwear, linens, and awnings.  NSPW Nanosilver is the active ingredient in the pesticide product POLYGUARD-NSPW MASTER BATCH (Polyguard).  The NSPW Nanosilver in Polyguard will be embedded within beads or pellets of a polymeric material in a “master batch,” and these beads of pellets will then be incorporated into treated textiles through a closed-loop manufacturing process.  EPA states that once the beads or pellets containing NSPW Nanosilver are introduced into this manufacturing process, no beads or pellets can escape into the environment.  EPA also states that the available data indicate that the leach rate of nanosilver from NSPW Nanosilver-treated textiles is below the limit of detection.

The same type of nanosilver was the active ingredient in another product that EPA previously conditionally registered under FIFRA Section 3(c)(7)(C) in 2015.  The U.S. Court of Appeals for the Ninth Circuit issued a decision vacating that conditional registration because the court concluded that the mandatory public interest finding by EPA was not adequately supported by the administrative record.  According to EPA, the new registration for NSPW Nanosilver involves a modified use pattern that will limit exposures compared to the product that received the previously vacated conditional registration.  Based on additional data that the applicant has submitted to support the use pattern as modified, EPA has prepared an updated risk assessment for NSPW Nanosilver and has determined based on that risk assessment that the product as modified meets the standard for an unconditional registration under FIFRA Section 3(c)(5).  Materials supporting this action will be posted in Docket ID EPA-HQ-OPP-2020-0043.

Commentary

Registering any new metallic silver product that satisfies the EPA criteria for classification as nanosilver for use as an antimicrobial pesticide presents special challenges, because EPA has adopted a policy that it will construe each new nanosilver product as a new pesticidal active ingredient.  The predecessor to NSPW Nanosilver (Nanosilva) was granted a conditional registration, a procedure that EPA uses when there are data gaps that must be filled before EPA is ready to make the determinations that would support issuance of an unconditional registration.  EPA may only issue a conditional registration for a product containing a new pesticidal active ingredient when EPA makes a determination that “use of the pesticide is in the public interest,” and the Ninth Circuit Court determined that EPA did not compile an administrative record adequate to support that finding.

Colloidal metallic silver products that meet the definition of nanosilver were first synthesized in the late 19th century.  Some industry stakeholders question whether the differences between different pesticide products that satisfy the EPA definition of nanosilver are sufficiently great to treat each new product as a new active ingredient, but it is also clear that the size and shape of the particles in these products do vary.  In this instance, EPA has determined that the supporting data for the application allow EPA to issue an unconditional registration.  Accordingly, the legal issue on which the Ninth Circuit based its prior decision to vacate the conditional registration for Nanosilva is not pertinent to the current registration decision.  Given the challenge to the prior registration decision, it will be important to monitor any opposition to the newly issued registration.


 
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