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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 Heather F. Collins, M.S.

The January 18, 2022, deadline for payment of the U.S. Environmental Protection Agency’s (EPA) annual maintenance fee for pesticide registrations is approaching. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 4(i)(1)(A) requires 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.

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

The fee for 2022 is $3,660 for each registration up to the maximum fees that can be assessed to a single registrant. Each registrant of a pesticide must pay the annual fee and e-mail the response to EPA by Tuesday, January 18, 2022. Registrations for which the fee is not paid will be canceled, by order and without a hearing. As in years past, payment must be made electronically online at www.pay.gov.

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

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

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

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


 

By Lisa M. Campbell and Lisa R. Burchi

On April 8, 2021, the U.S. Environmental Protection Agency (EPA) issued an Advance Notice of Proposed Rulemaking (ANPR) to solicit information on the current pesticide exemption provision process.  86 Fed. Reg. 18232.  EPA announced its intent to issue this ANPR on January 19, 2021, as discussed here.  The issuance of the ANPR was paused following the Biden Administration’s Executive Orders requiring agencies to review their rules and policies to ensure consistency with the current Administration’s environmental policies.

EPA states that it is soliciting comments and suggestions to determine whether regulatory and policy changes are needed to improve the exemption provisions for pesticides that may be considered minimum risk under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  EPA states that changes to the current process could make the implementation and evaluation of the exemption provisions more efficient.

Comments on the ANPR are due before July 7, 2021.  Discussed below are the issues raised in the ANPR for stakeholder consideration and changes made since the ANPR was first announced in January 2021.

The ANPR is generally the same as what was first announced in January 2021, in which EPA states it is seeking public input for two main categories:

  • Whether EPA should be streamlining the petition process and revisions to how EPA evaluates the potential minimum risk active and inert substances, factors used in classes of exemptions, state implementation of the minimum risk program, and the need for any future exemptions or modifications to current exemptions; and
  • Whether EPA should consider amending existing exemptions or adding any new classes of pesticidal substances for exemption.

One important difference is that the April 2021 ANPR now includes a discussion of environmental justice.  EPA states that Executive Order 12989 directed agencies, “to the greatest extent practicable and permitted by law, to identify and address, as appropriate, disproportionately high and adverse human health or environmental effects of its actions on minority and low-income populations.”  EPA states in the ANPR that it has not identified any such disproportionate effects, since this ANPR is soliciting comments and is not proposing any specific actions or regulatory changes.

Specific questions posed that relate to environmental justice include the following:

  1. Given the identified minimum risk characteristics of these products and anticipated low impacts on communities, are current approaches effective for seeking input from the public and stakeholders, including state, local, tribal, and territorial officials, scientists, labor unions, environmental advocates, and environmental justice organizations?  Are there particular approaches that are more or less effective?
  2. Are there other policies that EPA should consider in determining whether a substance should be exempt from FIFRA regulation via the Minimum Risk Pesticide Listing Program?  For example, should EPA consider additional environmental justice and pollution prevention policies?
  3. When considering products that are a “minimum risk” to public health and the environment, should the product also be considered to be of low impact to all communities, including low-income and minority populations?  Please explain why or why not.
  4. When considering whether a category or class of products are a “minimum risk” to public health and the environment, should the category or class of products also be considered as being of low impact to all communities, including low-income and minority populations?  Are there other factors that EPA should consider?

Other questions posed that have not changed substantively since the 2021 ANPR include the following:

  1. Do you have any suggestions for improving the processes for initiating a review of a substance or for implementing a decision that a substance may be used or may no longer be used in a minimum risk pesticide process?  Please explain how changes could increase efficiencies.
  2. EPA broadly requests comment on the utility, clarity, functioning, and implementation of the provisions in 40 C.F.R. Section 152.25.
  3. Are there other pesticidal substances or systems (e.g., peat) that EPA should consider adding as new classes at 40 C.F.R. Section 152.25 for exemption from registration under FIFRA?  How do these other pesticidal substances or systems meet the existing factors?
  4. What other factors should EPA consider in determining whether a category or class of products should be exempted from FIFRA regulation?  Please explain how these factors should be weighed in a determination.
  5. Have the changes to the federal program in the 2015 rule, which provided specific chemical identifiers and labeling changes, made it easier for manufacturers, the public, and federal, state, and tribal inspectors to identify specific chemicals used in minimum risk pesticide products?
  6. Are there state challenges to implementing the minimum risk program?  Can EPA address those challenges with changes to its program?  Do states have suggestions for improvements to the program?

Commentary

Given the change in Administrations and the “pause” that was imposed and further review that was required before this proposed rulemaking could be issued, it was unclear whether EPA would issue this proposal.

Now that EPA has issued the ANPR, it is important for stakeholders to review these issues carefully and consider submitting comments to identify challenges with the current regulatory criteria and procedures, as well as potential modifications that could improve the regulatory process.

EPA states:  “Should EPA decide to move forward with changes to the program, the next step would be to identify, develop and evaluate specific options for amending the current regulations in 40 CFR 152.25, and issue a proposed rule for public review and comment.”  EPA also notes that with regard to environmental justice, it is seeking public input on the consideration of environmental justice concerns in the context of the issues raised in the ANPR, and that “if and when the Agency proposes regulatory options regarding exemptions under FIFRA or the related procedures, EPA will seek additional input from the public, as appropriate.”


 

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

On January 19, 2021, the U.S. Environmental Protection Agency (EPA) announced it will issue an Advance Notice of Proposed Rulemaking (ANPRM) to solicit information on the current pesticide exemption provision process.

EPA announced that it is considering whether regulatory and policy changes are needed to improve the exemption provisions for pesticides that may be considered minimum risk under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  EPA states that changes to the current process could make the implementation and evaluation of the exemption provisions more efficient.

Comments on the ANPRM would be due on or before 90 days after publication of the ANPRM in the Federal Register in docket ID number EPA-HQ-OPP-2020-0537.  Although the issuance of this proposed rulemaking has been paused following the Biden Administration’s Executive Orders requiring agencies to review their rules and policies to ensure consistency with the current Administration’s environmental policies, should it proceed, it will be important for stakeholders to review carefully.  Discussed below are the issues raised in the ANPRM for stakeholder consideration.

EPA states it is seeking public input on:

  • Whether programmatic changes are necessary to ease state regulation of federally exempt products; and
  • Whether EPA should consider adding any new classes of pesticidal substances for exemption.

Specific questions posed include the following:

  1. Do you have any suggestions for improving the processes for initiating a review of a substance or for implementing a decision that a substance may be used or may no longer be used in a minimum risk pesticide process?  Please explain how changes could increase efficiencies.
  2. Are these factors appropriate for EPA to consider in determining whether a substance should be exempted from FIFRA regulation via the minimum risk exemption?
  3. Are there other factors that should be considered?  Please explain how these factors should be weighed in a minimum risk determination.
  4. EPA broadly requests comment on the utility, clarity, functioning, and implementation of the provisions in 40 C.F.R. Section 152.25.
  5. Are there other pesticidal substances or systems (e.g., peat), that EPA should consider adding as a new class at 40 C.F.R. Section 152.25 for exemption from registration under FIFRA?
  6. What other factors should EPA consider in determining whether a category or class of products should be exempted from FIFRA regulation?  Please explain how these factors should be weighed in a determination.
  7. Have the changes to the federal program in the 2015 rule, which provided specific chemical identifiers and the labeling changes, made it easier to identify specific chemicals used in minimum risk pesticide products?
  8. Are there state challenges to implementing the minimum risk program you would like to share with EPA?  Do you have suggestions for improvements to the program to address these issues?

Commentary

In the ANPRM, EPA states it is soliciting information that will help determine if any changes in the regulations should be made.  The ANPR does not contain specific possible changes to FIFRA exemptions.  EPA states:  “Should EPA decide to move forward with changes to the program, the next step would be to identify, develop and evaluate specific options for amending the current regulations in 40 CFR 152.25, and issue a proposed rule for public review and comment.”  Given the change in Administrations and the current “pause” on issuance of this proposed rulemaking, it is unclear whether EPA will issue this proposal, and if so whether EPA will take further steps regarding the exemption after reviewing the comments received.  Should EPA proceed to issue the ANPR, it will provide an opportunity for stakeholders to submit comments on these issues, and companies should consider identifying challenges with the current regulatory criteria and procedures, as well as potential modifications that could improve the regulatory process.

It is noteworthy that EPA received a petition from the Consumer Specialty Products Association in 2006 requesting that EPA address issues related to efficacy claims for Section 25(b) products and that EPA promised to address this petition by rulemaking or other avenues.  The potential for changes to the Section 25(b) requirements thus is not a new concern for EPA, and it will be important to monitor this issue.


 

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

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

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

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

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

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

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

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


 

By Lisa M. Campbell and Lisa R. Burchi

On October 15, 2020, the U.S. Environmental Protection Agency (EPA) announced a settlement with Electrolux Home Products, Inc. (Electrolux) to resolve alleged violations of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for importing air filter products that contain nanosilver.  Specifically, the settlement resolves EPA’s claims that Electrolux imported unregistered pesticides in violation of FIFRA Section 12(a)(1)(A) and failed to file the required Notices of Arrival in violation of FIFRA Section 12(a)(2)(N).  As part of the settlement, Electrolux will pay a civil penalty in the amount of $6,991,400.  The Consent Agreement and Final Order (CAFO) is available here.

According to EPA, Electrolux imported approximately 420,000 Frigidaire brand dehumidifiers and air conditioners that contained filters incorporating an unregistered nanosilver and that were labeled and marketed with pesticidal claims.  With regard to the incorporation of nanosilver, there currently are no nanosilver pesticide products registered with EPA for use in home appliances to disinfect the ambient air or protect the health of the user. The only nanosilver pesticides that are currently registered with EPA are approved solely for incorporation into textiles to protect those articles themselves from antimicrobial pests such as mold and bacteria that can cause deterioration, discoloration, or odors.  In those cases, the products (textiles) incorporated with nanosilver can be exempt from FIFRA registration under the “treated article” exemption.  With regard to the claims, EPA states that claims it considers pesticidal include “antibacterial filter,” and “helps eliminate bacteria in the air that can make breathing difficult.” 

Commentary

The penalty in this case is significant, and represents a potentially growing trend for penalty amounts substantially higher than past cases.  This trend is due at least in part to the inflation adjustments to statutory civil penalty amounts, as discussed further here

In addition to the civil penalty, the CAFO states that Electrolux has replaced the filters manufactured with nanosilver and removed the online and on-box pesticidal claims for the products it had imported, as well as some additional products already in the United States.  The CAFO states:

The SSURO also provided for the movement of subject products for the purpose of consolidating the products for a rework project whereby Respondent, among other things, would replace the filter manufactured with nanosilver contained in each unit with a filter that was not manufactured with a pesticidal substance, affix a sticker with modified language over any pesticidal claims on the product packaging, and remove all pesticidal claims made for the subject products in Respondent’s online marketing

The CAFO further states that “Respondent offered to rework all dehumidifiers and air conditioners that contained a filter manufactured with nanosilver within its possession regardless of the date those products were imported.”  To date, EPA states that Electrolux has brought over 500,000 air conditioners and dehumidifiers into compliance.


 

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 R. Burchi and Kelly N. Garson

EPA recently released the Consent Agreement and Final Order (CAFO) for the October 31, 2019, settlement discussed in our blog post “EPA Settles Two Cases Regarding Unregistered and Misbranded Pesticides.”  This October 31, 2019, settlement between U.S. Environmental Protection Agency (EPA) Region 3  and AFCO C&S, LLC (AFCO), a chemical company located in Chambersburg, Pennsylvania, to resolve alleged violations of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  Pursuant to the CAFO, AFCO agreed to pay a $1,489,000 penalty to settle the alleged violations that involved the use of 12 products to clean and sanitize food and beverage processing facilities.

The CAFO provides more information on the violations Region 3 alleged.  The CAFO allegations state that AFCO sold and distributed 10unregistered pesticide products on at least 1,031 separate occasions in violation of FIFRA Section 12(a)(1)(A).  The CAFO also alleges that AFCO sold and distributed a product that made claims beyond those permitted by its FIFRA registration on at least five separate occasions.  It additionally alleges that AFCO sold or distributed a misbranded pesticide on 41 separate occasions.

EPA initially collected the information during an inspection of AFCO’s establishment in Chambersburg, Pennsylvania on June 20, 2016.  The settlement also addresses violations of a Stop Sale, Use or Removal Order (SSURO) that EPA issued to AFCO on July 13, 2018, requiring AFCO to immediately cease all sales and distributions of the 12 products.  The CAFO alleges that AFCO engaged in sales and distributions that violated this order, having sold or distributed the products from at least January 1, 2015, through either August 8 or August 9, 2019.  AFCO has since discontinued sales of all of the involved products, except for one registered product, for which EPA issued an Order Modification letter on March 4, 2019, allowing AFCO to recommence sales.

AFCO will pay the civil penalty within one year in 12 equal monthly installments, plus interest payment of $7,954.96, totaling $1,496,954.96.


 

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)(1)(A) requires that everyone who holds an active or suspended pesticide registration granted under FIFRA Sections 3 and 24(c) (special local needs) to pay an annual maintenance fee to keep the registration in effect.  The maintenance fee requirement does not apply to supplemental registrations of distributors which are identified by a three-element registration number.

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 Lisa R. Burchi and Kelly N. Garson

The U.S. Environmental Protection Agency (EPA) recently settled two cases involving allegations of non-compliance with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  Although the Consent Agreement and Final Orders (CAFO) and Stop Sale, Use or Removal Orders (SSURO) issued in these cases are not yet available online, the penalty amounts at issue -- $200,000 and $1,489,000 -- reflect increased enforcement in targeted areas and EPA’s willingness to seek and obtain heroic penalties.

On November 18, 2019, EPA Region 9 announced that Decon7 Systems LLC (Decon7) would pay a $200,000 civil penalty in a settlement related to FIFRA violations.  Specifically, EPA found that Decon 7:

  • Sold and distributed two products that were not registered with EPA.  These products, “D7 Part 1” and “D7 Part 2,” combined to disinfect hard nonporous surfaces.  EPA regulations (40 C.F.R. § 152.15) set forth the conditions under which EPA will consider a product to be a pesticide product required to be registered, including but not limited to products containing certain “active” ingredients and/or making claims to kill, repel, or “disinfect” certain pests (e.g., germs, bacteria, viruses).
  • Sold and distributed pesticides that were labeled with false and misleading claims regarding safety and efficacy.  In addition to misleading efficacy claims to kill all bacteria, viruses, and fungi, EPA states:

The products also had false and misleading safety claims, which created the incorrect impression that the products were noncorrosive and nontoxic. The products’ formulations in fact could have caused skin burns and irreversible eye damage. The products’ labeling also claimed the products were used by various federal government agencies to clean up buildings following anthrax attacks, implying that the federal government recommends or endorses their use.

  • Exported unregistered pesticides that did not include necessary notifications and failed to comply with reporting obligations following a SSURO issued to the company in 2018.

On October 31, 2019, EPA Region 3 announced that it reached an agreement with AFCO C&S, LLC (AFCO), a chemical company located in Chambersburg, Pennsylvania, to resolve alleged FIFRA violations.  AFCO agreed to pay a $1,489,000 penalty to settle the alleged violations that involved the use of 12 products to clean and sanitize food and beverage processing facilities.  EPA alleges that AFCO sold and distributed ten unregistered pesticide products, a misbranded product, and a product that made claims beyond those permitted by its FIFRA registration.

The settlement also addresses violations of a SSURO that EPA issued to AFCO on July 13, 2018.  AFCO engaged in sales and distributions that violated this order.  AFCO has since discontinued sales of all of the involved products, except for one registered product.


 
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