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, 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.


 

By Lisa M. Campbell, Timothy D. Backstrom, and James V. Aidala

On June 8, 2020, the U.S. Environmental Protection Agency (EPA) announced the issuance of an existing stocks order under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 6(a)(1) governing further sale, distribution, and use of existing stocks of three reduced volatility dicamba products (XtendiMax®, EngeniaTM, and FeXapanTM) with conditional registrations that were vacated by the June 3, 2020, decision of the Ninth Circuit Court of Appeals in National Family Farm Coalition v. EPA.  EPA explained its action by stating that the existing stocks order would provide “clarity to farmers” in light of the Court decision.  Because EPA believes that vacatur made those stocks of the three dicamba products that were already in channels of trade unregistered pesticides, and the Court’s decision did not specifically address or establish any regimen to govern these unregistered existing stocks, EPA concluded that issuance of an existing stocks order was a practical necessity.  The existing stocks order includes provisions that:  (1) prohibit all sale and distribution of existing stocks of the three vacated dicamba products by the registrants, and by persons other than commercial applicators except for disposal of the products or returning the products to the registrants or their contract agents, (2) allow commercial applicators to use existing stocks of the vacated dicamba products in their possession in a manner consistent with existing labeling until July 31, 2020, and (3) prohibit end users from using existing stocks of the vacated dicamba products in their possession except in a manner consistent with existing labeling and from using such stocks in any manner after July 31, 2020.

Need for an Existing Stocks Order

To understand EPA’s position concerning the need for an existing stocks order for the three dicamba products with registrations vacated by the Ninth Circuit decision, it is important to review the legal status of those existing stocks after issuance of the decision.  In the absence of further EPA action, all stocks of the three dicamba products subject to the vacatur order that were already in channels of trade became unregistered pesticides.  Under FIFRA, as unregistered pesticides, these products could not be distributed or sold, which would prohibit stock of the unregistered products from being returned to the registrants or disposed, absent further EPA action.  Stocks of the three products that were labeled for uses other than soybeans and cotton (the uses extended by the conditional registration decision vacated by the Court) also became unregistered and thus also could not be distributed or sold absent further action by EPA.  Without further action by EPA, stocks of the three products already in the hands of end users could be lawfully used without any kind of restriction because although FIFRA Section 3(a) prohibits sale or distribution of unregistered pesticides, FIFRA does not include any provision prohibiting or limiting use of unregistered pesticides.  Thus, the Court’s vacatur action created a situation in which EPA needed to act expeditiously to establish a rational regimen governing existing stocks of the three dicamba products.  EPA was able to issue an order creating such a regimen because EPA construes the vacatur of the product registrations by Court action as a type of cancellation, which is how EPA has construed vacatur orders in the past.  FIFRA Section 6(a)(1) expressly authorizes EPA to issue orders governing sale, distribution, and use of canceled pesticides.

EPA Policy for Existing Stocks Orders

EPA adopted a policy in 1991 (56 Fed. Reg. 29362) outlining six factors it generally considers in adopting existing stocks orders for canceled pesticides under FIFRA Section 6(a)(1):  (1) the quantity of existing stocks at each level in channels of trade, (2) the risks resulting from use of existing stocks, (3) the benefits resulting from use of existing stocks, (4) financial expenditures users and others have already spent on existing stocks, (5) the risks and costs of disposal or alternative disposition of existing stocks, and (6) the practicality of implementing restrictions on the distribution, sale, or use of existing stocks.  EPA applied this policy to the current situation and determined that “[e]ach of the six factors weighs heavily in support of allowing end users to use existing stocks of these dicamba products that are in their possession.”  Since use of these unregistered pesticides is not otherwise prohibited by FIFRA as discussed above, EPA adopted prohibitions of use of the products not in accordance with the current labeling and of any use after July 31, 2020.  The only action taken by EPA to authorize further use of the three products involved stocks held by commercial applicators, which EPA allowed the commercial applicators to use according to the current labeling until July 31, 2020.

EPA Administrator Wheeler stated, “At the height of the growing season, the Court’s decision has threatened the livelihood of our nation’s farmers and the global food supply. Today’s cancellation and existing stocks order is consistent with EPA’s standard practice following registration invalidation, and is designed to advance compliance, ensure regulatory certainty and to prevent the misuse of existing stocks.”

Three days after EPA issued the dicamba existing stocks order, on June 11, 2020, the Petitioners in the National Family Farm Coalition case submitted a motion requesting that the Court provide emergency relief “to enforce its vacatur” decision and that the Court hold EPA and Administrator Wheeler in contempt.  According to the Petitioners, EPA’s entire rationale for issuing an existing stocks order is based on false premises.  In the Petitioners’ view, existing stocks of the three dicamba products are not “unregistered” because the vacatur order only invalidated certain newly authorized uses, and the existing stocks should not be deemed to be “cancelled” either, although the conditional registration decision for the products has been vacated.  In their motion, the Petitioners also assert that EPA is wrong because, “When read in context, FIFRA clearly prohibits the use of unregistered pesticides.”  In addition to their request that the Court take emergency action to enforce its decision and hold EPA in contempt, the Petitioners also requested that the Court adjudicate their Endangered Species Act (ESA) claims, an action that would require that the Court recall the mandate and issue another decision on the ESA claims it previously declined to reach.

On June 12, 2020, the Court issued an order requiring EPA to file its response to the motion by 5:00 p.m. PDT on June 16, 2020, and the Petitioners to file any reply by 5:00 p.m. PDT on June 18, 2020.

In another development, BASF Corporation and E.I. DuPont de Nemours each filed separate “emergency motions” to intervene in the case on June 12, 2020.  Each company asserts that it was not afforded notice that the Court might take adverse action concerning the registration for its dicamba product until after the decision vacating that registration was issued by the Court.  At this juncture, the Court has not yet indicated whether it will consider these emergency intervention motions or whether it would be willing to allow any further briefing on the merits of the case.

Additional information on the Ninth Circuit Court of Appeals decision is available on our blog.

Commentary

The Court’s June 3, 2020, decision stated, “We are aware of the practical effects of our decision,” but it is not clear from the discussion that follows whether the Court fully considered the chaotic effects of issuing a vacatur decision that did not specifically address the fate of existing stocks of the dicamba products with vacated registrations.  On May 21, 2020, EPA asked for leave to file information on its plans to issue a cancellation order governing existing stocks of products with vacated registrations, but the Court declined to allow that filing.  In any case, it should not have been surprising that EPA would construe its vacatur order as a form of cancellation, because that is what EPA did when the Ninth Circuit previously issued a vacatur order for sulfoxaflor products in 2015.

The Petitioners’ motion rejecting the basic legal premises underlying the EPA existing stocks order reflects a novel view of pesticide registration that is difficult to reconcile with the plain language and established constructions of FIFRA.  Under FIFRA, EPA issues registrations for specific pesticide products, which may be labeled only for those uses that EPA has previously determined meet applicable requirements.  Under FIFRA Section 6(b), EPA can decide that particular uses no longer meet the standard for registration and must be removed from an existing product label, but the only means by which EPA can effectuate that determination is by taking action to cancel any product for which the registrant does not agree to make the necessary changes.  The Court vacated EPA’s conditional registration decision that authorized three registered dicamba products to be labeled for use on dicamba-tolerant soybeans and cotton but did not direct or establish any process for EPA to consider amending the product labeling or restoring the prior registrations.  Under these facts, EPA has concluded that under FIFRA, existing stocks that are labeled for those uses became unregistered pesticide products because the labeling no longer conforms to the product registrations as they have been altered by the Court.  In the absence of an existing stocks order, stocks of the affected products labeled for the disallowed uses could not be lawfully distributed for any purpose, including voluntary recall by the registrant, disposal, or relabeling to remove the disallowed uses.

Despite the assertions by the Petitioners that FIFRA prohibits use of unregistered pesticides, FIFRA has not been construed in this manner.  While it a violation of FIFRA to distribute or sell any pesticide product with labeling that does not conform to a valid registration, FIFRA does not include any similar prohibition on use of an unregistered pesticide.   Thus, in the absence of an existing stocks order, stocks of the three dicamba products with vacated registrations that are already in the hands of end users could be lawfully used without restriction.  This notion is reflected in the provisions addressing end users in the order.  No provision in the order authorizes end users who have the three dicamba products in their possession to do anything.  Rather, the order prohibits end users from using the three products except in compliance with the existing labeling and from using the products at all after July 31, 2020.

Of course, it is not surprising that EPA applied its established criteria for existing stocks orders in the manner that it did.  Representatives of affected growers argued that prohibiting all use of the products in the middle of the 2020 growing season would lead to billions of dollars in damages, at a time when the entire agricultural economy has already been severely impacted by the Covid-19 pandemic.

In addition to arguing that an existing stocks order was necessary to establish a practical regimen governing distribution and use of those stocks of the three dicamba products in channels of trade when the Court’s decision was issued, EPA will likely argue that the Circuit Court lacks jurisdiction to review the existing stocks order.


 

From new product or new use approvals, to impact on chemical supply chains, Bergeson & Campbell, P.C. (B&C®) monitors key federal and international chemical legislative and regulatory initiatives to keep firm clients and friends informed. We have compiled a comprehensive and frequently updated listing of our content related to the coronavirus crisis that we hope will serve as a useful, one-click source of information: www.lawbc.com/uploads/docs/COVID-19.pdf.


 

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

On April 29, 2020, the U.S. Environmental Protection Agency (EPA) and the Centers for Disease Control and Prevention (CDC) released updated guidance to give assistance to facility operators and families on how to clean and disinfect spaces properly. Developed in cooperation with the White House, the updated guidance provides step-by-step instructions for public spaces, workplaces, businesses, schools, and homes, and falls in line with the Opening up America Again guidelines, the three-phased approach, based on the advice of public health experts, to help state and local officials when reopening its economies, getting people back to work, and continuing to protect American lives.

The comprehensive plan was developed in consultation with EPA’s expertise on the safe and effective use of disinfectants against the SARS-CoV-2, the virus that causes COVID-19.  The guidance offers a three-step process for preparing spaces for reopening:

  1. Develop a plan
    • Determine what needs to be cleaned;
    • Determine how areas will be disinfected; and
    • Consider the resources and equipment needed.
  2. Implement the plan
    • Clean visibly dirty surfaces with soap and water;
    • Use the appropriate cleaning or disinfectant product; and
    • Always follow the directions on the label.
  3. Maintain and revise the plan
    • Continue routine cleaning and disinfection;
    • Maintain safe practices; and
    • Continue practices that reduce the potential for exposure.

EPA states that cleaning and disinfecting surfaces is an important, two-step process essential to any effort to reduce the risk of exposure to SARS-CoV-2, the virus that causes COVID-19.

  • Clean:  Use soap and water to remove germs, dirt, and impurities from surfaces. It lowers the risk of spreading infection.
  • Disinfect:  Use disinfectant products to kill germs on surfaces. By killing germs on a surface after cleaning, it can further lower the risk of spreading infection.

EPA has compiled a list of disinfectants for use against SARS-CoV-2, List N: Disinfectants for Use Against SARS-CoV-2, which include ready-to-use sprays, concentrates, and wipes.  EPA emphasizes to follow the product label instructions and safety information, including leaving the product on the surface long enough to kill germs, rinsing off the product to avoid ingesting it, and putting the product out of reach of children right away.

EPA also states that it is important to avoid over-using or stockpiling disinfectants or personal protective equipment, which can result in shortages of critical products needed for emergencies.  In the event that disinfectant products on the EPA list are not available, the guidance provides other techniques for disinfecting surfaces that are as effective in reducing the risk of exposure to SARS-CoV-2, the virus that causes COVID-19.

EPA’s guidance documents are available here.


 

Bergeson & Campbell, P.C. (B&C®) is pleased to release a timely episode of the All Things Chemical™ podcast, “Chemical Distribution in the Time of COVID-19 — A Conversation with Eric R. Byer, NACD.” In this episode, Lynn L. Bergeson, Managing Partner, B&C, and Eric Byer, President and CEO of the National Association of Chemical Distributors (NACD), sat down to discuss current challenges facing small and large chemical distributors, and how NACD member companies are able to continue to distribute much needed chemical products, including sanitizers and other cleaning products, in response to the pandemic.

Lynn and Eric’s conversation focuses on unique “in the moment” issues and a broad range of federal, state, and international issues on which NACD is focused, including extending the Chemical Facility Anti-Terrorism Standards (CFATS) program, Toxic Substances Control Act (TSCA) implementation initiatives, and the impact of tariffs on imports from China on NACD member companies.  Eric is an amazing leader of an essential trade association, and this conversation provides insights into his success as President and CEO of NACD.

The full podcast episode is available to stream online, where listeners can also find the recent podcast “COVID-19, FIFRA, and EPA — A Conversation with Lisa Campbell”  Additional updates on chemical regulatory activity related to COVID-19 can be found on B&C’s Pesticide Law and Policy Blog® and on the Regulatory Developments page of B&C's website, including these recent updates:

All Things Chemical™ engages listeners in intelligent, insightful conversation about everything related to industrial, pesticidal, and specialty chemicals and the law and business issues surrounding chemicals. B&C’s talented team of lawyers, scientists, and consultants will keep listeners abreast of the changing world of both domestic and international chemical regulation and provide analysis of the many intriguing and complicated issues surrounding this space.  All Things Chemical™ is available now on iTunes, Spotify, Stitcher, and Google Play Music.  Subscribe so you never miss an episode. 


 

Register now for the American Bar Association (ABA) webinar “Navigating the Jurisdictional Tightrope Between Biopesticides, Biostimulants, and Related Emerging Technologies” with Bergeson & Campbell P.C. (B&C®) professionals deconstructing the jurisdictional boundaries distinguishing pesticides, biopesticides, plant regulators, biostimulants, and related technologies. The webinar will focus on draft EPA guidance intended to clarify the lines between and among those products that are subject to FIFRA registration as plant regulators and those biostimulant products not subject to FIFRA registration. The webinar also will focus on new and evolving chemistry and technology issues that may blur some jurisdictional lines or potentially move products from one category to another.  Lynn L. Bergeson, Managing Partner, B&C; Lisa R. Burchi, Of Counsel, B&C; and Sheryl Dolan, Senior Regulatory Consultant, B&C, will present.


 

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

On April 14, 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 registrants to notify EPA of certain formulation and manufacturing facility changes and immediately release the product for sale without waiting for EPA approval.  This only applies to products on EPA’s List N: Disinfectants for Use Against SARS-CoV-2 (List N). 

EPA’s announcement builds on EPA’s temporary amendment to Pesticide Registration (PR) Notice 98-10 announced on March 31, 2020.  Among other changes, the temporary amendment to PR Notice 98-10 streamlines the process for adding additional registered sources of active ingredients to a formulation and setting up an approved pesticide manufacturing establishment.  This enhanced flexibility allows List N with registered sources of active ingredients to be manufactured in those establishments without prior EPA approval. 

EPA’s temporary amendment to PR Notice 98-10 states that registrants may submit a notification to substitute registered sources of active ingredients that are not similar.  If registrants are unable to substitute a similar registered source (similar defined as the active or inert ingredient obtained from the source has the same Chemical Abstracts Service Registry Number (CASRN) and same purity) of the active ingredient, they may use an alternate source but must adjust the inert ingredient to ensure the nominal concentration of the active ingredient in the product does not change.  As long as the nominal concentration of the active ingredient in the product remains the same and adjustments in inert ingredients is limited to water only, this change will be allowed by notification and confirmatory efficacy data will not be required.

Additionally, EPA’s temporary amendment to PR Notice 98-10 will allow registrants to submit a notification to add EPA-registered establishments for formulations having a registered source of the active ingredient and where there are no other changes to the formulation.

EPA states that the changes allowed through notification by this action will not result in any substantive changes to the final pesticide formulations already approved by EPA, and the products’ effectiveness will not be affected and the products’ current precautionary labeling will remain protective.  EPA adds this action will not cause any unreasonable adverse effects to human health and the environment.

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 (April 14, 2020) for EPA Registration No. XXXXXX and [insert product name]”;
  • The active ingredient; and
  • The following certification statement:

[Name of Registrant] is submitting this notification consistent with the provisions of PR Notice 98-10 and [insert section(s) of the Temporary Amendment to PR Notice 98-10 dated April 10, 2020, and no other changes have been made to the Confidential Statement of Formula or labeling of this product.  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, the Temporary Amendment 98-10 dated April 10, 2020, 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 the Product Manager for the product 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.  Receipt to EPA occurs when the requestor receives a CDX number when submitting the application via the CDX portal.

Additional information on submission information for registrants is available at Temporary Amendment to PR Notice 98-10 and on our blog.


 

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

On April 6, 2020, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the availability of its progress report in meeting its performance measures and goals for pesticide reregistration during fiscal year 2017 (2017 Report).  Section 4(l) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires EPA to publish information about EPA’s annual achievements in this area.  The 2017 Report discusses the completion of tolerance reassessment and describe the status of various regulatory activities associated with reregistration.  The 2017 Report also provides the total number of products reregistered and products registered under the “fast-track” provisions of FIFRA.  The report is available at EPA-HQ-OPP-2014-0125.  Comments can be submitted on or before June 5, 2020.

EPA’s completed product registration actions totaled 255, short of EPA’s goal of 600 actions.  The table below details the actions completed in FY 2017.

Table 1.—Product Reregistration Actions Completed in FY 2017 (as of September 30, 2017)

Actions FY 2017
Product reregistration actions 14
Product amendment actions 113
Product cancellation actions 128
Product suspension actions 0
Total actions 255

EPA also states that there were 4,370 products had product reregistration decisions pending at the end of FY 2017, compared to 4,621 products with product reregistration decisions pending at the end of FY 2016, and 5,133 products with product reregistration decisions pending at the end of FY 2015.  Regarding changes in the universe of products in product reregistration, EPA states: “an increase or decrease can be due to fluctuations in numbers of products associated with product-specific Data Call-Ins (PDCIs).”

The number of applications for registration requiring expedited processing (i.e., “fast track” applications) that EPA considered and approved has been more consistent in recent years, with 2,223, 2,422, and 2,574 in 2015, 2016, and 2017 respectively.


 

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.


 
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