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, Lisa R. Burchi, and Barbara A. Christianson

On January 11, 2022, the U.S. Environmental Protection Agency (EPA) announced it is implementing a new policy regarding the evaluation and registration of new conventional pesticide active ingredients (AI) to comply further with the Endangered Species Act (ESA) (ESA Policy). EPA also issued a Question and Answer document regarding its ESA Policy. Effective immediately, EPA will evaluate the potential effects of new conventional AIs on federally threatened or listed endangered species (Listed Species) and their designated critical habitats, and initiate ESA consultation with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service (the Services) if necessary before EPA registers any new conventional AIs. The new ESA Policy will apply to all new conventional AI applications, including applications already submitted to EPA but not yet completed.

Under the ESA, EPA must ensure that its actions are not likely to result in jeopardy or adverse modification of designated critical habitat or Listed Species. To determine whether the action may affect Listed Species and their designated critical habitats, EPA makes one of three types of species-specific effects determinations: No Effect (NE), Not Likely to Adversely Affect (NLAA), or Likely to Adversely Affect (LAA). EPA states that historically it did not “consistently assess the potential effects of conventional pesticides on listed species when registering new AIs.” This, EPA states, “resulted in insufficient protections from new AIs for listed species, as well as resource-intensive litigation against EPA for registering new AIs prior to assessing potential effects on listed species.” EPA believes its new ESA Policy should assist in reducing these types of cases against EPA and improve the legal defensibility of new AIs.

EPA states that under the new ESA Policy, if EPA makes an LAA determination through its analyses of a new conventional pesticide AI, EPA will initiate formal consultation with the Services before granting a new AI registration. As part of its analysis and under its existing authorities, EPA will consider the likelihood that the registration action may jeopardize the continued existence of Listed Species or adversely modify their designated critical habitat and provide its findings to the Services. To determine or predict the potential effects of a pesticide on these species and habitats, EPA will use appropriate ecological assessment principles and apply what it has learned from past effects determinations and the Services’ biological opinions. EPA states it is determining whether any new information would be useful for assessing the potential impacts on Listed Species from a new AI, and it will specifically contact registrants that have a new Al application currently under consideration to discuss whether additional information is necessary for EPA’s ESA assessment for the new conventional AI.

If EPA determines that jeopardy or adverse modification is likely for a designated critical habitat or Listed Species, it will only make a registration decision on the new conventional AI after requiring registrants to implement mitigation measures that EPA determines would likely prevent such jeopardy or adverse modification. If EPA finds that a new AI is likely to affect adversely a Listed Species or its critical habitat, but that a jeopardy or adverse modification is not likely, it may nonetheless require registrants to include mitigation measures as part of their registration and product labeling to minimize the potential effects of incidental take to Listed Species that could result from use of a pesticide. In both situations, formal consultation with the Services would still be necessary, as EPA states final jeopardy or adverse modification determinations must be made by the Services. Regarding timeframes, EPA states in the Q&A that it “strives to complete new AI applications within PRIA timelines,” but will work with affected registrations to “renegotiate” PRIA deadlines if EPA believes additional time will be needed under the ESA Policy.

EPA states that it has prioritized conventional pesticide AIs but that it is continuing to explore applying these new ESA approaches to new biopesticide AIs and new antimicrobial AIs. EPA also is developing a comprehensive strategy to address ESA for pesticides at all stages of the registration process. EPA is currently developing a detailed work plan to outline additional improvements to further its compliance with the ESA, including steps to implement protections for high-risk species more efficiently, provide growers with more flexible mitigation measures, and increase stakeholder engagement.

Commentary

This announcement represents the next attempt by the Office of Pesticide Programs (OPP) to comply with ESA requirements in a way that, as the ESA Policy points out, will be more legally defensible while continuing its work to review and approve new pesticide AIs. In recent years, EPA has tried various arguments, mostly futile, to convince courts that past attempts to comply with ESA were sufficient.

This ESA Policy hints at important changes both in EPA’s past rhetoric regarding compliance and possible changes to the ways ESA assessments have been conducted in the past. On the record, EPA has maintained it complied with ESA when registering a new product. The courts have found this claim unsupported and almost always agreed with groups that challenged that claim. There have been a few exceptions where EPA, while not entirely resolving ESA concerns, had more “up front” consideration of ESA issues. Such earlier attention to resolving any ESA concerns, however, can add significantly to the time spent and data requirements to evaluate and address ESA issues.

Any relatively successful cases over past years complement the renewed and explicit commitment by the Biden Administration with the ESA Policy to attempt to resolve the long-standing problem of establishing a registration process that better addresses ESA issues with, among other things, improved coordination between EPA procedures and the review process (and conclusions) of the Services. Past Administrations have expressed similar rhetoric, but so far, many have tried, and all have failed.

In various forums, EPA has dryly described the efforts generally as -- “EPA is currently developing a detailed work plan to outline additional improvements to further the Agency’s compliance with the ESA.” More importantly, perhaps, and new to the mix is that EPA now has a senior political appointee (Jake Li as Deputy Assistant Administrator of OCSPP) especially tasked to lead efforts regarding the ESA-FIFRA integration process.

For applicants and registrants of new conventional AIs, these revised efforts may lead to some delays in the current expected timeframes to “work out” ESA concerns earlier in the process. And importantly, EPA’s ESA Policy describes how new approvals will include more “up front” mitigation measures designed to protect threatened and endangered species to a sufficient, or at least better, degree -- which appears to be a key change designed to reduce the litigation risks that have dogged new registration decisions in recent years.


 

By Lisa R. Burchi and Barbara A. Christianson

On December 2, 2021, the U.S. Environmental Protection Agency (EPA) announced it released the registration review schedule for the next four years through fiscal year (FY) 2025. While historically this schedule has been updated once each year, EPA states that going forward it will be updated on a quarterly basis.

The 2007 amendment of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires that EPA review each registered pesticide at least every 15 years. For the 726 pesticide cases that were registered before October 1, 2007, the amendment to FIFRA requires EPA to complete its review by October 1, 2022. This is significant, as it is intended to mark the end of the first 15-year registration review cycle.

Working toward that goal, EPA states that it has completed the following over the past 15 years:

  • Issued more than 550 interim or final decisions;
  • Completed more than 600 proposed interim decisions;
  • Conducted more than 680 human health and ecological draft risk assessments (excluding endangered species assessments);
  • Imposed new risk mitigation requirements for 51 percent of antimicrobial pesticides and 70 percent of conventional pesticides for which EPA issued an interim or final decision; and
  • Canceled some or all uses in 120 cases.

EPA states its updated registration review schedule provides a “roadmap” for the next four years of EPA’s registration review program. EPA’s schedule includes 297 entries describing the registration review “action” (e.g., Draft Risk Assessment, Proposed Interim Decision, Interim Decision, Preliminary Work Plan, Final Work Plan) to be addressed by EPA’s different divisions (e.g., Pesticide Reevaluation Division; Antimicrobials Division, Biopesticides and Pollution Prevention Division). Throughout its review, EPA makes the information, assessments, and supporting material for each case available to the public at regulations.gov.

Significantly, but not surprisingly, EPA acknowledges that for some pesticides registered before October 1, 2007, it “anticipates that its review will extend beyond” the October 1, 2022, deadline “due to a number of challenges including delays in receiving data from registrants; the demands of responding to COVID-19; and a significant increase in recent years of resources devoted to litigation.” EPA also warns that the schedule is “subject to change based on shifting priorities and is intended to be an estimated timeline.” EPA notes further that data that are not submitted on time may affect EPA’s registration review timeline and that “several cases are not found on the schedule due to uncertainty of when necessary data will be received.”

Complying with the Endangered Species Act (ESA) is also part of the registration review process. Since 2007, EPA states that it has completed ESA assessments for certain high-priority pesticides and, in the coming years, plans to assess the effects of many more pesticides on endangered species in registration review. According to EPA, it will release its first ESA pesticides work plan in the coming months, which will outline steps EPA will take to come into compliance with the ESA in ways that are fair and transparent to the agriculture sector.

Information on EPA’s registration review process is available here.


 

By Barbara A. Christianson

On November 19, 2021, the U.S. Environmental Protection Agency (EPA) announced that it is extending COVID-19 activation of the emerging viral pathogens (EVP) guidance for antimicrobial pesticides indefinitely. EPA states that its EVP guidance for antimicrobial pesticides is a part of the federal government’s pandemic preparedness, allowing manufacturers to provide EPA with data, even in advance of an outbreak, demonstrating that their products are effective against hard-to-kill viruses.

EPA activated its EVP guidance for antimicrobial pesticides for the first time in January 2020 in response to the emergence of SARS-CoV-2. EPA has allowed for expedited review and approval of surface disinfectant products for use against SARS-CoV-2 for more than 12 months, including accelerated review for products seeking to add EVP claims to product labels. To date, EPA has added 591 products with emerging viral pathogens claims to its list of Disinfectants for Coronavirus (List N).

EPA states that registrants must remove EVP claims from consumer messaging no later than 24 months after the original notification of the outbreak, unless directed otherwise by EPA. With this extension, EPA will now provide a notification at least six months before inactivating the EVP guidance for SARS-CoV-2 to allow registrants time to adjust product marketing materials as required.

Additional information on the EVP guidance is available here.


 

By Carla N. Hutton

On November 3, 2021, the U.S. Environmental Protection Agency (EPA), the White House Council on Environmental Quality (CEQ), the U.S. Department of Agriculture (USDA), the U.S. Department of Commerce, and the U.S. Department of the Interior “reaffirm[ed] their commitment to working together and with stakeholders to protect endangered species, provide effective pest control tools, and regulate pesticide use in a fair, transparent, and predictable manner.” According to EPA’s November 3, 2021, press release, on October 15, 2021, all five agencies met as part of the Interagency Working Group (IWG) created under the 2018 Farm Bill to discuss improvements to the consultation process for pesticide registration and registration review under Section 7 of the Endangered Species Act (ESA). EPA states that the group’s first meeting resulted in specific commitments to improve the pesticide consultation process for endangered species and engaging stakeholders, including by capitalizing on the strong interest among stakeholders for a workable process.

According to the press release, the IWG is optimistic about its ability to collaborate on improvements that the Biden Administration can implement. The IWG’s actions focused on improving processes that will contribute to tangible benefits for species conservation and for stakeholders. EPA states that the IWG “is intent to adopt improvements expeditiously and that endure across administrations.” To guide its future work, the IWG has identified the following initial priorities and approaches:

  • Focus on improvements that deliver real world benefits for species conservation, public health, and food production. Examples include:
    • Use pilot projects to begin implementing mitigation measures as part of upcoming pesticide consultations and to demonstrate process improvements;
    • Adopt measures early in the pesticide consultation process to avoid, minimize, and offset the effects of pesticide use on ESA-listed species; and
    • Ensure that mitigation measures are effective and practical to implement;
  • Consider opportunities to engage with stakeholders as an interagency body to complement the stakeholder activities of each agency; and
  • Communicate the IWG’s work to stakeholders in a transparent manner.

EPA states that “[e]ffective endangered species protection cannot be accomplished solely by federal agencies,” but also requires “open and continuous engagement with stakeholders on practical solutions to harmonizing species conservation with pesticide use.” To that end, the IWG plans to hold its first stakeholder listening session in early 2022 and will provide details on the proposed session before the end of 2021.


 

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

On September 15, 2021, the U.S. Environmental Protection Agency (EPA) announced that it is terminating the Temporary Amendment to Pesticide Registration (PR) Notice 98-10, effective September 15, 2022. EPA states that it is providing 12 months’ notice to registrants before the termination takes effect to give registrants time to adjust their contractual commitments. Registrants must ensure that by September 15, 2022, their product is produced using a source of active ingredient identified in the product’s EPA-approved Confidential Statement of Formula (CSF) or otherwise complies with the requirements of PR Notice 98-10. All notifications submitted to EPA under the temporary process are valid only for the time period of the temporary amendment. After September 15, 2022, registrants “will not be able to release for shipment formulations produced under the conditions of the temporary amendment without first complying with the registration requirements that were in place prior to the issuance of the temporary amendments.”

EPA states that this notice applies to products on EPA’s List N: Disinfectants for Use Against SARS-CoV-2 (the virus that causes COVID-19) or products that serve as the source of active ingredient for disinfectants on EPA’s List N. This notice also applies to food contact surface sanitizer products containing the active ingredient isopropyl alcohol that are used in the essential role of food manufacturer and preparation.

In 2020, EPA issued temporary amendments to PR Notice 98-10 to ensure that antimicrobial products remained available in response to the COVID-19 public health emergency. According to EPA, supply chains have stabilized and disinfectant products expected to kill SARS-CoV-2 have become consistently available to consumers, so it has determined that this flexibility is no longer needed. When the temporary amendment was issued, EPA stated it would assess the continued need for and scope of the temporary amendment to PR Notice 98-10 on a regular basis and would update it if EPA determined modifications were necessary. EPA stated it would post a notification at www.epa.gov/pesticides at least seven days prior to terminating the temporary amendment. EPA acknowledges in the termination memorandum that registrants require time to make the temporary changes permanent through CSF amendment or notification and therefore is providing 12 months, rather than the seven days guaranteed in the temporary amendment.

The memorandum addressing the termination is available here. Information on the temporary amendments to PR Notice 98-10 are available on our blog.


 

By Lisa M. Campbell and Lisa R. Burchi

On June 7, 2021, Health Canada’s Pest Management Regulatory Agency (PMRA) announced the issuance of its Interim Order Respecting Ultraviolet Radiation-emitting Devices and Ozone-generating Devices under the Pest Control Products Act (Interim Order), setting forth new requirements for certain devices claiming to control, destroy, make inactive, or reduce the level of bacteria, viruses, and other micro-organisms that are human pathogens. PMRA also issued an “Explanatory Note” and a Questions and Answers document regarding the Interim Order.

PMRA states that it issued the Interim Order following the increased sale of ultraviolet (UV) radiation-emitting and ozone-generating devices such as lights and wands in Canada since the COVID-19 pandemic. These devices are marketed to kill bacteria and viruses, including SARS-CoV-2, the virus that causes COVID-19. According to PMRA, it has not received enough evidence to confirm that UV radiation-emitting and ozone-generating devices are safe for users and the public, or that they are effective.

Thus, PMRA is now requiring that companies register certain UV radiation-emitting devices and ozone-generating devices before they may be sold or used in Canada. In its Explanatory Note, PMRA states:

By bringing certain UV and ozone-generating devices under the [Pest Control Products Act (PCPA)], they need to be registered or otherwise authorized in order to be on the Canadian market. An application to register a pest control product must be submitted to Health Canada in the form and manner directed by the Minister and must include any information and other material that is required by the Pest Control Products Regulations to accompany the application. Applications to register devices consist of a number of information and data requirements, including a cover letter stating the purpose of the application, an application and fee estimate forms, the proposed English and French product labels, as well as data to support the safety and efficacy of the device. A registration will be granted under the PCPA if the Minister considers that the health and environmental risks and the value of the device are acceptable after any required assessments.

The Interim Order clarifies that certain UV radiation-emitting devices and ozone-generating devices claiming to kill bacteria and viruses are not subject to the regulatory requirements of the PCPA and its Regulations. These include:

  • Devices that are manufactured, represented, distributed, or used to control, destroy, or inactivate viruses, bacteria, or other micro-organisms that are human pathogens for use in swimming pools, spas, or wastewater treatment systems;
  • Devices that meet the definition of “device” in Section 2 of the Food and Drugs Act and are classified as a Class II, III, or IV medical device under the Medical Devices Regulations; and
  • UV radiation-emitting devices that satisfy the following conditions:
    • The device is certified by a standards development organization accredited by the Standards Council of Canada as meeting the applicable Canadian electrical safety requirements;
    • The certification mark of the standards development organization appears on the label of the device;
    • Any efficacy claim that is made in respect of the device is only a claim of supplemental sanitization;
    • No express or implied reference to prevention, treatment, or mitigation of disease is made in respect of the device;
    • The device has at least one of the following mechanisms:
      • A mechanism that locks the device during operation, or
      • A mechanism that automatically shuts off the device if it is opened during operation; and
    • The UV lamp is fully shielded or enclosed in the device in a manner that prevents access to it by users of the device and prevents exposure to UV radiation.

For UV radiation-emitting devices that satisfy these conditions, there are additional labeling requirements for the display panels and operating manual.

Discussion

This Interim Order changes significantly the requirements applicable to these types of devices that did not previously require registration. PMRA is providing a 30-day transition period after the Interim Order is issued before companies must comply with these requirements. PMRA also is advising Canadians to “stop using UV lights and wands that claim to disinfect against the virus that causes COVID-19 especially if the product is for use on the skin.”

Companies that produce devices that may be subject to this Interim Order should review the new requirements and exemptions carefully. PMRA states that unregistered or unauthorized devices are prohibited and may be subject to compliance and enforcement action.


 

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 Lisa M. Campbell, Lisa R. Burchi, and James V. Aidala

On December 7, 2020, the U.S. Environmental Protection Agency (EPA) issued for comment the Proposed Interim Decision (PID) for chlorpyrifos.  85 Fed. Reg. 78849.  EPA announced it is proposing new risk mitigation measures to address potential human and environmental risks identified in EPA’s September 2020 draft risk assessments.  The PID proposes the following measures:

  • Label amendments limiting application to address potential drinking water risks of concern.
  • Additional personal protection equipment and application restrictions to address potential occupational handler risks of concern.
  • Spray drift mitigation, in combination with the use limitations and application restrictions identified to address drinking water and occupational risks, to reduce exposure to non-target organisms.

EPA states that the PID presents proposed mitigation with the 10-fold (10x) Food Quality Protection Act (FQPA) safety factor, reflecting the uncertainties around doses that may cause pre- and post-natal neurodevelopmental effects.  Under FQPA, EPA evaluates new and existing pesticides to ensure they can be used with a reasonable certainty of no harm to infants, children, and adults.  EPA is required to consider the special susceptibility of children to pesticides by using an additional 10x safety factor unless adequate data are available to support a different factor.  EPA additionally included a FQPA factor of 1x to reflect the range of potential risk estimates of chlorpyrifos, as illustrated in the September 2020 draft risk assessments.

Comments on both the September 2020 draft risk assessments and the PID are due on or before February 5, 2021.  EPA states that by holding the comment period for both actions at the same time, the public has access to more information and can provide more informed, robust comments.  Comments can be submitted at EPA-HQ-OPP-2008-0850.

EPA announced that it will also consider the input and recommendations from the September 2020 Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) meeting once it releases its report in December 2020.  Depending on the SAP’s conclusions, EPA may further revise the human health risk assessment. 

Commentary

The inclusion of both 1x and 10x calculations for the appropriate FQPA safety factor is unusual.  EPA states the final decision on the appropriate FQPA safety factor is partly dependent on any recommendations expected from the SAP meeting, which reviewed the “use of new approach methodologies (NAMs) to derive extrapolation factors and evaluate developmental neurotoxicity for human health risk assessment.”  This is part of a larger and longer evaluation of whether test methods that avoid using test animals can reliably substitute for current test guideline requirements, that is, whether it is appropriate to rely on in vitro test protocols to substitute for current in vivo testing protocols.

EPA’s articulation at this point in time of mitigation needed if the FQPA 10x safety factor is retained may indicate a prediction about the SAP’s likely recommendations.  It will be important to monitor developments on this issue closely.


 

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

On October 28, 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 (FY) 2018 (2018 Report).  85 Fed. Reg. 68327.  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 2018 Report discusses the completion of tolerance reassessment and describes the status of various regulatory activities associated with reregistration.  The 2018 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 December 28, 2020.

EPA’s completed product reregistration actions totaled 177, short of EPA’s goal of 400 actions.  The table below details the actions completed in FY 2018.

Table 1.  Product Reregistration Actions Completed in FY 2018 (as of September 30, 2018)

Actions FY 2018
Product reregistration actions 19
Product amendment actions 33
Product cancellation actions 125
Product suspension actions 0
Total actions 177

 

 

 

 

 

 

EPA also states that 4,193 products had product reregistration decisions pending at the end of FY 2018, compared to 4,370 products with product reregistration decisions pending at the end of FY 2017, and 4,621 products with product reregistration decisions pending at the end of FY 2016.  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 2,422, 2,574, and 2,303 in 2016, 2017, and 2018, respectively.


 

By Barbara A. Christianson

On October 26, 2020, the U.S. Environmental Protection Agency (EPA) announced that it is soliciting public comment on the interim guidance on registering products that claim to have “residual” or “long-lasting” effectiveness against viruses.  This announcement follows up on EPA’s October 14, 2020, announcement that it would begin expediting its review of products with residual efficacy intended for use against SARS-CoV-2, the coronavirus that causes COVID-19.  While traditional disinfectants only kill viruses and bacteria that are on the surface at the time they are used, surfaces treated with residual antimicrobial products kill pathogens that come into contact with the surface days, weeks, or years after the product is applied.

EPA announced in an October 26, 2020, memorandum that it is seeking feedback from the public on the expedited process, design elements for evaluating residual product claims, and the test methods associated with this initiative. 

All comments on the interim guidance must be submitted to Docket Number EPA-HQ-OPP-2020-0529 on or before January 4, 2021. 

The interim guidance documents -- Interim Method for Evaluating the Efficacy of Antimicrobial Surface Coatings, Interim Guidance - Expedited Review for Products Adding Residual Efficacy Claims, and Interim Method for the Evaluation of Bacterial Activity of Hard, Non-Porous Copper-Containing Surface Products -- are available in Docket Number EPA-HQ-OPP-2020-0529.  More information on the interim guidance is available on our blog.


 
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