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

On March 31, 2020, the U.S. Environmental Protection Agency (EPA) announced it is taking further action to help ease the production and availability of EPA-registered disinfectants by temporarily allowing manufacturers of certain already-registered EPA disinfectant products to obtain certain active ingredients from any source without prior approval from EPA.  This only applies to products on EPA’s List N: Disinfectants for Use Against SARS-CoV-2 (List N).  EPA announced on March 26, 2020, similar action on certain inert ingredients

EPA typically requires disinfectant manufacturers to first apply for and receive EPA approval prior to making a change in the source of the active ingredient.  Under this temporary amendment, however, manufacturers can source certain active ingredients from alternate suppliers by informing EPA.  Once EPA has been notified, the registrant can immediately distribute or sell a product modified according to this temporary amendment, provided that the resulting formulation is chemically similar to the current formulation (i.e., the purity of resulting product from the alternate source falls within the certified limits of the currently registered formulation for which they are making the source change).  EPA states that by allowing manufacturers to obtain certain active ingredients from any source it will help alleviate reports of supply chain disruptions by pesticide registrants who manufacture disinfectant products on List N.

The eligible active ingredients are:

  • Citric Acid, Chemical Abstracts Service Registry Number (CASRN) 77-92-9;
  • Ethanol, CASRN 64-17-5;
  • Glycolic Acid, CASRN 79-14-1;
  • Hydrochloric Acid, CASRN 7647-01-0;
  • Hypochlorous Acid, CASRN 7790-92-3;
  • Hydrogen Peroxide, CASRN 7722-84-1;
  • L-Lactic Acid, CASRN 79-33-4; and
  • Sodium Hypochlorite, CASRN 7681-52-9.

EPA will assess the continued need for and scope of this temporary amendment on a regular basis and will update it if EPA determines modifications are necessary.  EPA will notify the public at least seven days prior to terminating this temporary amendment at www.epa.gov/pesticides.

After the termination date of the temporary amendment, registrants will not be able to release for shipment new registered product unless that product is produced using a source of active ingredient identified in the product’s approved Confidential Statement of Formula (CSF) or otherwise would have complied with relevant requirements in the absence of this temporary amendment.

EPA states in its temporary amendment to Pesticide Registration (PR) Notice 98-10, the following procedures to submit a notification for currently registered disinfectant products listed on EPA’s List N:

  • A cover letter with a subject line that clearly indicates that this is a “notification per TEMPORARY AMENDMENT TO PR NOTICE 98-10 (Insert date or other citation) for EPA Registration No. XXXXXX and [insert product name]”;
  • The active ingredient; and
  • The following statement:

[Name of Registrant] is notifying EPA of its intent to use one or more alternate, unregistered sources of active ingredient listed in the TEMPORARY AMENDMENT TO PESTICIDE REGISTRATION (PR) NOTICE 98-10 (Insert date or other citation) in the formulation of EPA Registration No. [xxx-xx].  Each source is chemically identical to (i.e., within the certified limits of) the active ingredients in the Confidential Statements of Formula previously accepted by EPA [insert CSF date(s)]. This self-certification is consistent with the provisions of PR Notice 98-10 and no other changes have been made to the Confidential Statement of Formula or labeling of this product.  Further, I confirm that the ingredients statement of this label remains truthful.  I understand that it is a violation of 18 U.S.C. Section 1001 to willfully make any false statement to EPA.  I further understand that if this self-certification is not consistent with the terms of PR Notice 98-10 and 40 C.F.R. 152.46, this product may be in violation of FIFRA and I may be subject to enforcement actions and penalties under section 12 and 14 of FIFRA.

Applications must be submitted via the CDX portal.  At this time, EPA is not accepting paper applications.  Once an application is submitted, EPA requests that an email is sent to .(JavaScript must be enabled to view this email address) with the CDX tracking number (CDX _ 2020 _ XXXXXXX).  A registrant may distribute or sell a product modified according to this temporary amendment to PR Notice 98-10 once EPA receives the notification.

Additional information on submission information for registrants is available at Emerging Viral Pathogen Claims for SARS-CoV-2: Submission Information for Registrants and on our blog.


 

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

On March 26, 2020, the U.S. Environmental Protection Agency (EPA) announced that it is allowing flexibility to manufacturers of disinfectants and other pesticides to increase the availability of products for use against SARS-CoV-2, the coronavirus that causes COVID-19.  EPA announced that it is allowing manufacturers to obtain certain inert ingredients from different suppliers without EPA approval after manufacturers voiced concern with EPA about challenges they face obtaining inert ingredients with the disruption of the supply chain. 

EPA stated it is allowing applicants submitting registrations or registration amendments to obtain commodity inert ingredients, approximately 280 total as of today, from various sources without having to provide the supplier name and address on its Confidential Statement of Formula (CSF).  EPA, however, notes that only ingredients designated as commodity inert ingredients on its list will be eligible for this reduced CSF reporting.

EPA also announced it is continuing to expedite review of submissions from applicants requesting to add emerging viral pathogen claims to existing registered disinfectant labels.  Claims currently are being approved within 14 days, as resources allow, compared to the typical 90-day review.  EPA has added 70 new surface disinfectants to its List N: Disinfectants for Use Against SARS-CoV-2, which brings the total number of products listed to 351.

Additional information on EPA’s list of commodity inert ingredients is available here

Additional information on submission information for registrants is available at Emerging Viral Pathogen Claims for SARS-CoV-2: Submission Information for Registrants and on our blog.


 

By Lynn L. Bergeson and Carla N. Hutton

As reported in our February 13, 2020 blog item, the U.S. Environmental Protection Agency (EPA) announced on February 12, 2020, that it is seeking public input on a proposal to incorporate a new nanosilver pesticide product into textiles to combat odors, discoloration, and other signs of wear.  The proposed registration decision is for NSPW Nanosilver, and the proposed pesticide product, Polyguard-NSPW Master Batch (Polyguard), will be incorporated into textiles to suppress bacteria, algae, fungus, mold, and mildew, which cause odors, discoloration, stains, and deterioration.  According to EPA, based on its human health and ecological risk assessment, it has preliminarily determined that the new active ingredient in Polyguard meets the regulatory standard under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for use as a materials preservative in textiles.  According to a February 27, 2020, memorandum placed in Docket ID EPA-HQ-OPP-2020-0043, EPA received a request to extend the comment period 30 days to allow additional time to review the documentation contained in the docket.  The memorandum states that EPA “feels that 15 additional days should be sufficient to allow for adequate review of the Proposed Decision and supporting documentation.”  Comments are now due March 30, 2020.


 

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

On March 9, 2020, the U.S. Environmental Protection Agency (EPA) announced that due to the outbreak of SARS-CoV-2, the coronavirus that causes COVID-19, it is expediting review of submissions made by companies that are requesting to add Emerging Viral Pathogen claims to its labels of already-registered surface disinfectants.

EPA states that only claims that do not require review of new efficacy data are being expedited at this time.  Companies can submit these claims as non-Pesticide Registration Improvement Extension Act (PRIA 4) fast-track amendments.  Registrants are asked not to include other label changes typically covered under amendments and notifications as part of the submission to add Emerging Viral Pathogen claims.

EPA requests that registrants include the following information in a letter to ensure the efficient processing of submissions:

  • A subject line that clearly indicates “Emerging Viral Pathogen Claim for SARS-CoV-2”;
  • A request to make emerging viral pathogen claims;
  • A description of how the product meets the eligibility criteria for use against one or more categories of viral pathogens consistent with the guidance;
  • The identification of the virus(es) from the product label that the registrant is using to support the emerging viral pathogen claims and the study ID number (MRID) that supports the claim;
    • Note: EPA recommends using the minimum number of supporting viruses needed for the emerging pathogen claim in order to expedite EPA’s review
  • An up-to-date matrix (Form 8570-35); and
  • A request to add the Terms of Registration outlined in Attachment I of the Emerging Viral Pathogens Guidance.

Registrants should also submit a revised master label with a separate section for emerging viral pathogen claims that includes the generic claim statements identified in Attachment I of the Emerging Viral Pathogens guidance document.

EPA requests that applications are submitted through EPA’s CDX portal and email .(JavaScript must be enabled to view this email address) with the CDX tracking number (CDX_2020_XXXXXXX) once an application was submitted to expedite the application.

If approved, the product will be added to List N: Disinfectants for Use Against SARS-CoV-2, during the next update to the list, which is scheduled to be updated in the next two weeks.

Additional information is available at Emerging Viral Pathogen Claims for SARS-CoV-2: Submission Information for Registrants and on our blog.


 

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

On February 12, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of 11 products that have been approved for use to disinfect surfaces against the emerging multidrug-resistant fungus Candida auris (C. auris).  C. auris can cause severe infections and spreads easily among hospitalized patients and nursing home residents.  The 11 products are approved for use against C. auris to disinfect surfaces in hospitals, nursing homes, and other healthcare facilities, to help reduce patient infections.  There were no antimicrobial pesticide products registered specifically for use against C. auris prior these new use registrations.

EPA worked in collaboration with the Centers for Disease Control and Prevention (CDC) and other federal partners to ensure that the products would be effective against C. auris.  Previously, on October 16, 2019, EPA had granted public health exemptions under the provisions of section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) as amended, to the CDC, for uses of antimicrobial products, on hard, nonporous surfaces in healthcare settings for disinfection from C. auris.

The 11 products that are now registered for use against C. auris are:

  •  Avert Sporicidal Disinfectant Cleaner (EPA Reg. No. 70627-72);
  •  Blondie (EPA Reg. No. 67619-24);
  •  Dagwood (EPA Reg. No. 67619-25);
  •  Micro-Kill Bleach Germicidal Bleach Wipes (EPA Reg. No. 37549-1);
  •  Oxivir 1 (EPA Reg. No. 70627-74);
  •  Oxivir 1 Wipes (EPA Reg. No. 70627-77);
  •  Oxivir Wipes (EPA Reg. No. 70627-60);
  •  Oxycide™ Daily Disinfectant Cleaner (EPA Reg. No. 1677-237);
  •  Virasept (EPA Reg. No. 1677-226);
  • Wonder Woman Formula B Germicidal Wipes (EPA Reg. No. 9480-12); and
  •  Wonder Woman Formula B Spray (EPA Reg. No. 9480-10).

Because there are few products with C. auris claims at this time, CDC and EPA have identified additional products that are effective against C. auris. Although these products do not yet have formal EPA-registered claims for C. auris, testing at CDC has confirmed they are effective against C. auris.  The label on the product will not include instructions for C. auris.  CDC guidance states to “follow the instructions provided for C. albicans, if included, or else follow those for fungicidal activity.” These products include:

  •  Oxivir TB Spray (EPA Reg. No. 70627-56); and
  •  PDI Super Sani-Cloth (EPA Reg. No. 9480-4).

The CDC Guidance further states that, if none of the above-listed products are available, or any of the EPA-registered products that are newly approved for the specific claims against C. auris, CDC recommends use of an EPA-registered hospital-grade disinfectant effective against Clostridioides difficile spores, because CDC believes these products have been used effectively against C. auris (List K).

 Additional information on C. auris is available on EPA’s website and CDC’s website.


 

By Kelly N. Garson and Carla N. Hutton

On January 27, 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) issued a notification for Project Number OA&E-FY20-0095, announcing that it will begin fieldwork to audit EPA’s adherence to pesticide registration risk assessment regulations, policies, and procedures.  In a memorandum addressed to EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP), OIG stated that its objective is to evaluate EPA’s ability to address human health and environmental risks prior to pesticide product registration.  OIG will conduct the audit from EPA headquarters.  According to the memorandum, the anticipated benefits of this audit include determining whether EPA has adequate controls to address human health and environmental risks prior to pesticide product registration.

OIG is an independent office created by the Inspector General Act of 1978, as amended.  Though located within EPA, Congress funds OIG separately to ensure independence as it conducts activities such as audits and investigations to determine the efficiency and effectiveness of EPA’s operations and programs.  Following the audit, OIG will prepare a report that may include recommendations for corrective actions OCSPP should take based upon OIG’s findings.  More information on OIG’s previous reports and audit system is available on OIG’s website.  Recent OIG reports regarding the implementation of FIFRA include:


 

By Heather F. Collins, M.S.

The January 15, 2020, deadline for payment of the U.S. Environmental Protection Agency’s (EPA) annual maintenance fee for pesticide registrations is fast approaching.  The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Section 4(i)(5) 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.

The fee for 2020 is $4,000 for each registration up to the maximum fees which can be assessed to a single registrant.  Each registrant of a pesticide must pay the annual fee and mail the response to EPA by Wednesday, January 15, 2020.  Registrations for which the fee is not paid will be canceled, by order and without a hearing.

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 3-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 5 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 Heather F. Collins, M.S. and Barbara A. Christianson

On October 1, 2019, the U.S. Environmental Protection Agency (EPA) issued a Federal Register notice announcing the that fees under the Pesticide Registration Improvement Extension Act of 2018 (PRIA 4) were increased by five percent for pesticide applications received on or after October 1, 2019.  The five percent increase is on fee amounts established by Public Law 116-8, which became effective on March 8, 2019.  The revised fees will remain in effect until September 30, 2021.

The fee schedule provided in PRIA 4 identifies the registration service fees and decision times organized according to the organizational units of the Office of Pesticide Programs (OPP) within EPA.  EPA presents the schedules as 19 tables, organized by OPP Division and by type of application or pesticide subject to the fee, and lists the registration service fee for actions received in fiscal years 2020 and 2021.  Applicants must submit fee payments at the time of application.  EPA will reject any application that does not contain evidence that the PRIA 4 fee has been paid.

The revised fee schedule for PRIA 4 fiscal years 2020 and 2021 is available on EPA’s website.  More information on the PRIA 4 legislation is available on our blog under key word PRIA.


 

By Lisa M. Campbell and Timothy D. Backstrom

On September 9, 2019, the U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP) published a notice in the Federal Register announcing the availability of, and an opportunity for comment on, a document describing an “interim process” that OPP’s Environmental Fate and Ecological Effects Division is currently using to evaluate potential synergistic effects of mixtures of pesticide active ingredients on non-target organisms. As part of a lawsuit challenging the 2012 decision by EPA to register Enlist Duo Herbicide (a combination of 2,4-D and glyphosate), OPP scientists learned that patent applications for some registered pesticide products included claims that particular combinations of active ingredients provide “synergistic” control of target species.  Although EPA was not at that time considering potential synergies in assessing the risk for ecological effects on non-target organisms, based on the patent application claims regarding synergy for Enlist Duo, EPA decided to request that the reviewing court vacate its registration decision and remand the application for Enlist Duo for further study of these effects and any measures that might be needed to mitigate the risk to non-target organisms.  This decision sparked much controversy, and many in industry were concerned that patent application claims were not being correctly interpreted by EPA for the category of pesticide products at issue.

The new document released by EPA for review and comments is entitled: “Process for Receiving and Evaluating Data Supporting Assertions of Greater Than Additive (GTA) Effects in Mixtures of Pesticide Active Ingredients and Associated Guidance for Registrants.”  EPA states that it “has generally been applying this interim process since 2016.” The process described in the document has five steps: (1) registration applicants must search for any granted patents that include synergy (GTA) claims for combinations of pesticides; (2) applicants must review the patent claims and supporting data for relevance to ecological risk assessment; (3) applicants must report to EPA all effects testing data from the relevant patents; (4) applicants must do a statistical analysis (using a method prescribed by EPA) to determine whether any observations of GTA effects are statistically significant; and (5) EPA will review all submitted information to decide whether it should be utilized in ecological risk assessment.

In the Federal Register notice, OPP lists five specific areas pertaining to the interim risk assessment process described in the document on which it is requesting comment:

  • Are there technical aspects of the interim process that warrant change? If so, what changes are recommended?
  • What aspects of the process could be applied to the evaluation of open literature sources of GTA effects pesticide interactions?
  • Should EPA consider standardizing a more detailed search and reporting approach, and how should EPA do that?
  • Should EPA continue the evaluation process as described in this document? If so, what performance metrics (e.g., number of evaluations) should EPA consider before deciding the utility of this approach?
  • What applicant burden is associated with the activities described in this memorandum, including compiling, analyzing, and submitting the information? Specifically, does an estimate of 80-240 hours of burden per applicant cover the respondent burden associated with the interim process?

When the National Research Council (NRC) evaluated the importance of toxicological interactions between pesticide active ingredients in 2013, the NRC concluded that such interactions are rare, but that EPA should nonetheless consider such interactions when the best available scientific evidence supports such an evaluation.  In the current Federal Register notice, EPA makes it clear that it is uncertain concerning the utility for risk assessment of the information used by manufacturers to support synergistic effects claims in pesticide patents.  According to EPA, 24 applicants for new registrations have submitted patent data to date, but only three of these submissions contained information that indicated a need for further testing and no submission ultimately led to any adjustment of the ecological risk assessment.  At this juncture, EPA will continue collecting patent data that may be pertinent to GTA effects, but when it has sufficient experience upon to base a general policy it may either continue or improve this process or discontinue it after explaining why.

Commentary

When EPA requested that the reviewing court vacate and remand the registration EPA had granted for Enlist Duo, the parties seeking judicial review located data in the patent applications that EPA had not previously seen or reviewed and that EPA believed could possibly be pertinent to potential adverse effects on non-target plants.  EPA concluded that it should revisit the decision based on the additional data.  Although EPA decided to request vacatur and remand, the applicant Dow AgroSciences had arguably followed all of the procedures then in place, because FIFRA Section 3(c)(5) allows EPA to waive data requirements pertaining to efficacy, and EPA typically registers pesticide product that are not intended to protect public health without any independent evaluation of efficacy data.  Nevertheless, in general EPA may choose to evaluate pesticidal efficacy data; such circumstances in the past often involved cases where EPA was required to consider whether pesticide benefits are sufficient to outweigh identified risks.  In the Enlist case, EPA determined that it should do so where potential synergy in pesticidal efficacy is pertinent to evaluating ecological effects on non-target species.

What EPA must decide now is how often efficacy data that has been deemed adequate by the Patent and Trademark Office to support a patent for a new pesticide mixture will have any material significance in the context of ecological risk assessment.  Before EPA makes a determination whether or not patent data has sufficient pertinence to continue requiring routine collection and evaluation of such data, EPA has decided it is prudent to afford all stakeholders an opportunity to comment on whether EPA has been asking the right questions.

All comments on the draft document must be submitted no later than October 24, 2019.


 

By Lisa M. Campbell and Timothy D. Backstrom

On August 23, 2019, the U.S. Environmental Protection Agency (EPA) issued a Federal Register notice announcing the receipt of 10 applications to amend currently registered pesticide products to add hemp as a new use site.  The 10 application amendments are the result of the 2018 Farm Bill, signed in to law on December 20, 2018, that removed hemp from the Controlled Substances Act and legalized commercial use and production of hemp that contains less than 0.3% tetrahydrocannabinol (THC).

EPA states in the notice that Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 3(c)(4) does not require EPA to provide notice and opportunity to comment concerning these 10 applications because hemp falls within the terrestrial outdoor and residential outdoor use pattern previously approved for the pesticidal active ingredients in question, and approval of the applications would therefore not involve "a changed use pattern."  Instead, EPA states that it has decided to provide an opportunity to comment in this instance "because of the potential significant  interest from the public" and to be "completely transparent about these applications." EPA also states that it does not intend to provide notice or opportunity to comment for similar applications to add hemp that are likely to be submitted in the future.

EPA also states that the products with requested label amendments contain active ingredients for which EPA "has previously determined the residues will be safe under any reasonably foreseeable circumstances." Each active ingredient has an established tolerance exemption for residues on all raw agricultural or food commodities.

The 10 products for which EPA has received an application to add hemp are:

  1. Debug Turbo, EPA Registration No. 70310-5, active ingredients: azadirachtin and neem oil;
  2. Debug Optimo, EPA Registration No. 70310-7, active ingredients: azadirachtin and neem oil;
  3. Debug Trés, EPA Registration No. 70310-8, active ingredients: azadirachtin and neem oil;
  4. Debug-ON, EPA Registration No. 70310-11, active ingredient: neem oil;
  5. REGALIA Bioprotectant Concentrate, EPA Registration No. 84059-3, active ingredient: extract of Reynoutria sachalinensis;
  6. MBI-110 EP, EPA Registration No. 84059-28, active ingredient: Bacillus amyloliquefaciens strain F727;
  7. GH CMT, EPA Registration No. 91865-1, active ingredients: soybean oil, garlic, oil, and capsicum oleoresin extract;
  8. GH MPMT, EPA Registration No. 91865-2, active ingredient: potassium salts of fatty acids;
  9. GH DNMT, EPA Registration No. 91865-3, active ingredient: Bacillus amyloliquefaciens strain D747; and
  10. GH NAMT, EPA Registration No. 91865-4, active ingredient: azadirachtin.

Once public comments are received, EPA anticipates making its decision on adding hemp as a new use site on the specific products before the end of 2019, so that these products may be available for the 2020 growing season.

Commentary

Although the Federal government has legalized commercial production and use of hemp (as opposed to marijuana that contains higher levels of THC), not every State has changed its laws to conform to the new classification.  EPA took the unusual step of announcing receipt of the new amendment applications at Hemp Production Field Day at the University of Kentucky.  Senator Rand Paul of Kentucky has long been a proponent of commercial hemp production, and about 1,000 growers in Kentucky now have licenses to grow hemp for commercial use.

As hemp production increases, there will also be increased demand for pesticides to combat weeds, insects, and plant diseases that pose a potential threat to this crop.  Although hemp fiber and oil have many potential industrial uses, hemp also has potential medicinal uses because extracts containing cannabidiol (CBD) are now being widely marketed for their purported health benefits.  This use of hemp means that EPA will have to consider whether new tolerances may be required for some active ingredients before they can applied to hemp.  As EPA has noted, the active ingredients in the 10 products for which EPA announced that applications are pending to add labeling for hemp already have tolerance exemptions, and therefore do not present this issue.

Comments are due on or before September 23, 2019.  The public can submit comments at www.regulations.gov in Docket Number EPA-HQ-OPP-2019-0369.


 
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