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.
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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.”


 
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By Lisa M. Campbell and Lisa R. Burchi

On March 31, 2021, the U.S. Environmental Protection Agency (EPA) issued a Stop Sale, Use or Removal Order (SSURO) to ViaClean Technologies (ViaClean), operating in Philadelphia, regarding the sales, distribution, and marketing of the pesticide BioProtect RTU with claims that it is effective against surfaces from public health-related pathogens such as SARS-CoV-2, the virus that causes COVID-19.

Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), products that claim to kill or repel bacteria or germs, including disinfectants, are considered pesticides and must be registered with EPA.  Public health claims can only be made regarding products that have been properly tested and are registered with EPA.

In this case, BioProtect RTU is a registered pesticide, with label claims approved by EPA, in part, to use the product to inhibit the growth of odor causing bacteria that cause staining and discoloration, and algae.  According to EPA, ViaClean provided two BioProtect RTU fact sheets containing public health claims to at least one customer, including the statement that the pesticide can be used to kill “germs.”  EPA also alleged that some online distributors, cleaning services, and end-recipients of BioProtect RTU were also making claims that this product is effective against pathogens, germs, disease-causing bacteria, viruses, and/or SARS-CoV-2 for up to 90 days.

EPA’s issuance of the SSURO is thus based on EPA’s belief that ViaClean was selling, distributing, and marketing BioProtect RTU with public health claims that have not been substantiated or approved through the pesticide registration process.  EPA states that it is concerned that customers may have used this product as protection from viruses -- SARS-CoV-2 -- in lieu of other EPA-approved disinfection methods.

This case is another example of EPA’s enforcement priorities and vigilance over the past year to identify products making claims to act against the coronavirus and taking action to prevent further sales when such products are not approved by EPA to make such claims.


 
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By Lara A. Hall, MS, RQAP-GLP and Heather F. Collins, M.S.

On March 17, 2021, the U.S. Environmental Protection Agency (EPA) announced the issuance of the final guidance document entitled "Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Technical Chemicals & Supporting Retrospective Analysis" (EPA 705-G-2020-3722; Docket ID: EPA-HQ-OPP-2016-0093) that expands the potential for data waivers for acute dermal studies to single technical active ingredients (AI) used to formulate end-use products. This new guidance builds upon the final guidance for waiving acute dermal toxicity tests for pesticide formulations published by EPA on November 9, 2016, and is an example of EPA’s continued efforts to reduce animal testing and achieve its goal of eliminating all EPA requests for studies and EPA funding of studies on mammals by 2035.  EPA states that this guidance is expected to reduce the number of test animals used annually by approximately 750, as well as save EPA, industry, and laboratory resources.

The new final guidance document also allows EPA to harmonize with the Pest Management Regulatory Agency (PMRA) of Canada, which published guidance on acute dermal toxicity waivers for both end-use product formulations and technical chemicals in 2017. 

In developing the new guidance, EPA states that the Office of Pesticide Programs (OPP) and the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) conducted a retrospective analysis of rat acute oral and acute dermal LD50 studies for 249 AIs across numerous chemical classes and toxicity categories in the EPA pesticide categorization scheme.  The overall purpose of this analysis was to address the utility of the acute dermal toxicity study for single AIs in pesticide labeling, such as the signal word and precautionary statements. Fumigants and rodenticides were excluded from this retrospective analysis based on their physical state and/or anticipated exposures to them. EPA concluded that:

  • For 67 percent of the 249 technical chemicals, the results of both oral and dermal acute toxicity studies fall within the same Toxicity Category; 
  • For 32 percent of the chemicals, the oral study falls within a lower (i.e., more protective) Toxicity Category;
  • Thus, for 99 percent of the chemicals in the analysis, if the dermal study had not been available and labeling had been based only on the Toxicity Category for the oral acute toxicity study, the labeling requirements would have been equally or more protective; 
  • For the two remaining chemicals (less than 1 percent), factors other than the dermal acute toxicity may influence labeling requirements; and
  • The acute dermal toxicity studies provide little to no added value in regulatory decision making. 

EPA states that it believes the retrospective analysis fully supports the conclusion that waivers may be granted for acute dermal toxicity studies for pesticide technical chemicals, except for fumigants and rodenticides.  Waivers may be accepted for fumigants and rodenticides on a case-by-case basis with appropriate scientific rationale. EPA maintains the ability to request acute dermal toxicity data on a case-by-case basis, but states that it anticipates granting the waiver in most cases.

Additional information on EPA’s efforts to reduce animal testing is available here.


 
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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.


 
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By Carla N. Hutton

The European Food Safety Authority (EFSA) announced on March 15, 2021, that it has begun a public consultation on a draft updated Guidance on the assessment of exposure of operators, workers, residents, and bystanders in risk assessment for plant protection products (PPP).  According to EFSA, the Guidance is designed to assist risk assessors and applicants when quantifying potential non-dietary, systemic exposures as part of the regulatory risk assessment for PPPs.  The Guidance is based on the Scientific Opinion on “Preparation of a Guidance Document on Pesticide Exposure Assessment for Workers, Operators, Residents and Bystanders” developed by the EFSA Panel on Plant Protection Products and their Residues (PPR) in 2010.  EFSA states that highlighting some inconsistencies between the approaches adopted by regulatory authorities, the PPR Panel proposed a number of changes to the practices in use (i.e., use of deterministic methods for individual PPPs; need to perform an acute risk assessment for PPPs that are acutely toxic; use of appropriate percentile for acute or longer term risk assessments).  In the first version of the Guidance, issued in 2014, EFSA included several scenarios for outdoor uses, with an annexed calculator, as well as recommendations for further research.  EFSA has updated the Guidance in 2021 to include additional scenarios and revise default values on the basis of the evaluation of additional evidence.  To support users in performing the assessment of exposure and risk, EFSA further developed an online calculator that reflects the Guidance content.  Comments on the draft updated Guidance are due May 9, 2021.  EFSA will assess all comments submitted in line with the specified criteria.  The relevant EFSA Panel will further consider the comments and take them into consideration if found to be relevant.


 
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By Lynn L. Bergeson and Carla N. Hutton

On March 5, 2021, the U.S. Environmental Protection Agency (EPA) announced that “in support of the Biden-Harris Administration’s commitment to making evidence-based decisions to protect human health, U.S. Environmental Protection Agency (EPA) is taking an important step by proposing the cancellation of the registration of pentachlorophenol.” Pentachlorophenol, a well-recognized wood preservative in use for decades, is registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). According to EPA, it is used primarily on utility poles.

EPA states that after completing a risk assessment, it determined that pentachlorophenol poses significant human health risks to workers. To address this issue, EPA proposes to cancel all uses of pentachlorophenol through the FIFRA registration review process. EPA will accept public comments on the proposed interim decision (PID) for 60 days in docket EPA-HQ-OPP-2014-0653. Comments are due May 4, 2021. 86 Fed. Reg. 12940. At this time, the PID has not yet been posted in the docket. After considering any comments concerning the PID, EPA will issue an interim decision, which would make final the cancellation of pentachlorophenol.

EPA notes that this proposed action would align the United States with the United Nation’s (UN) Stockholm Convention on Persistent Organic Pollutants, which has banned the use of pentachlorophenol. According to EPA, it worked with industry stakeholders “to identify a number of viable, safer alternatives such as copper naphthenate and DCOIT, along with well-established wood preservatives such as chromated arsenicals and creosote.” EPA’s March 5, 2021, Federal Register notice also announces the availability of PIDs for creosote and chromated arsenicals and dichromic acid, disodium salt, dehydrate.

Commentary

That EPA is seeking to eliminate pentachlorophenol is by no means surprising and its demise has been in the works for a while. Its commercial use is already banned in many countries. The Biden Administration was expected to propose cancellation, and wasted little time in doing so. The real debate will be in the terms that EPA eventually settles upon with regard to phase-out and continued use of stockpiled material. The elimination of this product paves the way for a more robust commercial future for the existing pentachlorophenol replacements, and likely soon to be emerging replacements that are efficacious and more sustainable.


 
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By Lynn L. Bergeson and Carla N. Hutton

On February 1, 2021, the U.S. District Court for the District of Montana granted the U.S. Environmental Protection Agency’s (EPA) January 31, 2021, unopposed motion to vacate and remand its January 6, 2021, final rule on “Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information” (86 Fed. Reg. 469).  EDF v. EPA, No. 4:21-cv-03-BMM.  On January 11, 2021, the Environmental Defense Fund (EDF), Montana Environmental Information Center (MEIC), and Citizens for Clean Energy (CCE) filed suit against EPA, claiming that the January 6, 2021, final rule was unlawful and that EPA’s decision to make the final rule effective on publication was unlawful.  On January 27, 2021, the court granted summary judgment to the plaintiffs, finding that EPA did not provide good cause to exempt the final rule from the Administrative Procedure Act’s (APA) 30-day notice requirement.  The court stated that “EPA’s decision to make the Final Rule immediately effective on publication was ‘arbitrary, capricious’ and ‘otherwise not in accordance with law.’”  In its January 31, 2021, motion, EPA states based on the court’s conclusion that the final rule constitutes a substantive rule and that EPA “lacked authorization to promulgate the rule pursuant to its housekeeping authority.”  According to EPA, where EPA lacked the authority to promulgate the final rule, “remand without vacatur would serve no useful purpose because EPA would not be able to cure that defect on remand.”  EPA notes that because the final rule was in effect for less than a month, and it had not applied the rule in any circumstance while the rule was in effect, “there would be no disruptive consequences in remanding and vacating the rule.”

Prior to EPA’s motion to vacate and remand the final rule, on January 20, 2021, President Joe Biden signed an Executive Order (EO) on Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis.  According to the EO, it is the policy of the Biden Administration “to listen to the science; to improve public health and protect our environment; to ensure access to clean air and water; to limit exposure to dangerous chemicals and pesticides; to hold polluters accountable, including those who disproportionately harm communities of color and low-income communities; to reduce greenhouse gas emissions; to bolster resilience to the impacts of climate change; to restore and expand our national treasures and monuments; and to prioritize both environmental justice and the creation of the well-paying union jobs necessary to deliver on these goals.”  The EO directs all executive departments and agencies to review immediately and, as appropriate and consistent with applicable law, take action to address the promulgation of federal regulations and other actions during the Trump Administration that conflict with the Biden Administration’s national objectives, and to commence work immediately to confront the climate crisis.  The EO calls for the heads of all agencies to review immediately “all existing regulations, orders, guidance documents, policies, and any other similar agency actions (agency actions) promulgated, issued, or adopted between January 20, 2017, and January 20, 2021, that are or may be inconsistent with, or present obstacles to,” the Biden Administration’s policy.  For any identified actions, the EO directs the heads of agencies to “consider suspending, revising, or rescinding the agency actions.”  In addition, for certain specified agency actions, the EO states that the head of the relevant agency “shall consider publishing for notice and comment a proposed rule suspending, revising, or rescinding the agency action within the time frame specified.”  The specified agency actions include EPA’s January 6, 2021, final rule on “Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information.”

As reported in our January 11, 2021, memorandum, the origin of EPA’s January 6, 2021, final rule is rooted in legislative proposals more clearly intended to challenge important regulatory requirements, particularly related to EPA’s air program.  We predicted that the final rule would likely be among the first items subject to reversal or “clarifying” guidance making it consistent with previously established science policies (see Bergeson & Campbell, P.C.’s (B&C®) Forecast 2021 memo).  With Democratic control of both houses of Congress, there might also be attempts to repeal the rule via action under the Congressional Review Act (CRA) of recently promulgated regulations.


 
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By Lisa M. Campbell and Heather F. Collins, M.S.

On January 19, 2021, the U.S. Environmental Protection Agency (EPA) announced the issuance of a Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 18 emergency exemption to the states of Oklahoma and Arkansas, permitting American Airlines to use SurfaceWise2, believed to inactivate coronaviruses like the SARS-CoV-2 virus on surfaces, in specific airport facilities and planes.  EPA also has revised the terms of use for SurfaceWise2 for all current emergency exemptions. 

EPA’s initial emergency exemption for the state of Texas issued on August 24, 2020, specified that the product remained effective for seven days.  According to its updated labels for all three states, EPA has now approved claims that SurfaceWise2 provides residual surface control of the coronavirus SARS-CoV-2 on surfaces that are undisturbed for up to 30 days.  The updated labels state “When used in accordance with the directions for use, SurfaceWise®2 provides residual surface control of coronaviruses, including SARS-CoV-2, for up to 30-days on undisturbed (e.g., are not routinely disinfected with List N products) non-porous treated surfaces.” 

Of note, EPA also states in its announcement that SurfaceWise2 should be reapplied every time surfaces are disinfected to ensure continuous product performance as exposure to prolonged wetness may adversely impact the efficacy of the product.  The updated labels state in the Directions for Use that the user must “Reapply SurfaceWise®2 after surfaces are disinfected to ensure continuous product performance” and “Do not expose SurfaceWise®2 to prolonged wetness as this may adversely impact the efficacy of the product.”

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

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

40 C.F.R. § 166.3.

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

In this case, EPA approved the Section 18 emergency exemption request for SurfaceWise2 -- a product manufactured by Allied BioScience.  SurfaceWise2 is a surface coating that Allied BioScience states inactivates viruses and bacteria within two hours of application and continues to work against them for up to 30 days, on undisturbed non-porous treated surfaces.  EPA’s approvals will allow Texas, Oklahoma, and Arkansas to permit American Airlines airport facilities and planes at specific locations identified on the label and two Total Orthopedics Sports & Spine Clinics in Texas to use SurfaceWise2 under certain conditions.  The approved Section 18 emergency requests are effective for one year. This public health exemption will expire August 24, 2021.  As new data emerge, EPA may alter the terms of the product’s emergency uses, as it did with the modifications discussed here. 

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


 
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By Lisa M. Campbell and Lisa R. Burchi

In January 2021, the U.S. Environmental Protection Agency’s (EPA) Office of Enforcement and Compliance Assurance (OECA) announced that it issued a revised compliance advisory (Advisory) on products claiming to kill SARS-CoV-2, the novel coronavirus that causes COVID-19.  EPA first issued this guidance on June 1, 2020, and it is discussed in our blog here.

The Advisory has been revised significantly, reflecting new developments and experience since the Advisory was first issued.  

The first section of the Advisory addresses “Products claiming to be effective against the coronavirus causing COVID-19.”  That title has changed, as well as the language throughout the Advisory, to refer now to products that are “effective against” the coronavirus, instead of products that “kill” the coronavirus.

EPA has added a new section entitled “What is the difference between an EPA registration number and an EPA establishment number?”  Presumably, this is intended to address confusion among some with regard to this important difference.  The Advisory now states: 

An EPA establishment number is not the same as an EPA registration number. An EPA registration number signifies that the pesticide and its claims have been reviewed and approved by EPA. An establishment number identifies the EPA-registered location where the product was produced.  EPA provides a National List of Active EPA-Registered Foreign and Domestic Pesticide and/or Device-Producing Establishments at: https://www.epa.gov/compliance/national-list-active-epa-registered-foreign-and-domestic-pesticide-andor-device-producing.

The section entitled “Devices that claim to kill the coronavirus” has been significantly modified.  In particular, EPA has now deleted from the Advisory language that “ozone generators, UV lights and other pesticide devices may not be able to make claims against coronavirus where devices have not been tested for efficacy or safety for use against the virus causing COVID-19 or harder-to-kill viruses.”  Instead, the Advisory states legal requirements applicable to devices, namely that the labels “include adequate warning and caution statements and directions for use” and have an EPA establishment number.  EPA further adds the following: “Additionally, making false or misleading labeling claims about the safety or efficacy of a pesticidal device is prohibited and could result in the issuance of a Stop Sale, Use, or Removal Order and penalties under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).”

In its “Compliance Concerns” section, EPA states it continues to pursue enforcement against products making false and misleading claims regarding their efficacy against the coronavirus, adding that it is “particularly concerned with pesticide and pesticide device products sold online on e-commerce platforms that are fraudulent, counterfeit, and/or otherwise ineffective.” 

EPA has added new language to address a particular issue with regard to “residual” claims:

In the United States, it is unlawful to distribute or sell a pesticide which includes claims that it will kill a particular pathogen, unless that pesticide is registered by EPA and that particular claim has been deemed acceptable by the agency. In some instances, companies have unlawfully added additional claims to the labels of their registered pesticide products that have not been approved by EPA. For example, a claim for persisting or long-lasting effect against viruses, referred to as “residual claims” (i.e., claims that a product provides an ongoing antimicrobial effect beyond the initial time of application, ranging from days to weeks to months), may be accepted by EPA only when supported by acceptable studies demonstrating satisfactory residual efficacy. Until EPA approves a residual claim, it cannot lawfully be included on a registered product as part of distribution or sale. For more information on residual claims, see: https://www.epa.gov/coronavirus/there-anything-i-can-do-make-surfaces-resistant-sars-cov-2.  For more information on registering products with residual claims, see EPA’s Interim Guidance: https://www.epa.gov/pesticide-registration/interim-guidance-expedited-review-products-adding-residual-efficacy-claims.

Commentary

Of interest among the changes to the Advisory is the removal of the language stating that pesticide devices could not make claims against the coronavirus unless they had been specifically “tested for efficacy or safety for use against the virus causing COVID-19 or harder-to-kill viruses.”  While any such testing may be necessary to demonstrate efficacy or appropriate directions for use, EPA had not previously stated what particular testing was required for devices or against what testing standard it would determine whether a device claim is “false or misleading.”  It remains important for pesticide device producers to review carefully the data supporting the claims made for their devices to ensure that they comply with the regulatory requirements under FIFRA.


 
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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.


 
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By Lisa M. Campbell and Heather F. Collins, M.S.

On January 15, 2021, the U.S. Environmental Protection Agency (EPA) announced the issuance of a Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 18 emergency exemption to the states of Georgia and Tennessee permitting the use of an air treatment product, Grignard Pure, in health care facilities, intrastate transportation, food processing facilities, and indoor spaces within buildings -- including government facilities -- where people are conducting activity deemed essential by the state.  According to the EPA Authorizations for Georgia and Tennessee (EPA Authorizations), Grignard Pure forms a mist with activity against airborne SARS-CoV-2, the virus that causes COVID-19.  It contains the active ingredient triethylene glycol (TEG), an ingredient commonly used in fog machines for concerts and theater productions. 

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

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

40 C.F.R. § 166.3.

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

EPA’s approval will allow the Grignard Pure product to be applied in Georgia and Tennessee in certain indoor spaces where adherence to current public health guidelines is impractical or difficult to maintain.  The areas where it can be used under the exemption include breakrooms, locker rooms, bathrooms, lobbies, elevators, eating areas, and food preparation areas within health care facilities, intrastate transportation, food processing facilities, and indoor spaces within buildings.  According to the EPA Authorizations, Grignard Pure may only be applied by trained professionals through a building’s HVAC system or using portable devices positioned strategically in an indoor space.  Additionally, the label states that use of Grignard Pure does not eliminate the need for critical precautions like mask wearing and social distancing.  Signs must be posted to indicate that a space is being treated and to advise that the product may cause temporary irritation to sensitive individuals.

Based on a review of laboratory testing data, EPA states that it expects that when used as directed, Grignard Pure will inactivate continuously 98 percent of airborne SARS-CoV-2 particles. Grignard Pure was tested against a surrogate virus that is harder to kill than SARS-CoV-2.

The approved Section 18 emergency requests are effective for one year.  Any unexpected adverse effects related to the use of this product must be reported immediately to EPA as required under the terms of the FIFRA Section 18 emergency exemption approval.


 
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By Heather F. Collins, M.S.

The March 1, 2021, deadline for all establishments, foreign and domestic, that produce pesticides, devices, or active ingredients to file their annual production for the 2020 reporting year is fast approaching.  Pursuant to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 7(c)(1) (7 U.S.C. § 136e(c)(1)), “Any producer operating an establishment registered [under Section 7] shall inform the Administrator within 30 days after it is registered of the types and amounts of pesticides and, if applicable, active ingredients used in producing pesticides” and this information “shall be kept current and submitted to the Administrator annually as required.”

Reports must be submitted on or before March 1 annually for the prior year’s production.  The report, filed through the submittal of EPA Form 3540-16:  Pesticide Report for Pesticide-Producing and Device-Producing Establishments, must include the name and address of the producing establishment; and pesticide production information, such as product registration number, product name, and amounts produced and distributed.  The annual report is always required, even when no products are produced or distributed.

EPA has created the electronic reporting system to submit pesticide-producing establishment reports using the Section Seven Tracking System (SSTS).  Users will be able to use SSTS within EPA’s Central Data Exchange (CDX) to submit annual pesticide production reports.  Electronic reporting is efficient, saves time by making the process faster, and saves money in mailing costs and/or courier delivery and related logistics.  EPA is encouraging all reporters to submit electronically to ensure proper submission and a timely review of the report, as the majority of EPA staff are still working remotely and may not be on site to receive mailed reports.

Links to EPA Form 3540-16, as well as instructions on how to report and how to add and use EPA’s SSTS electronic filing system, are available below.

Further information is available on EPA’s website.


 
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By Lynn L. Bergeson and Carla N. Hutton

Last week, press reported that the U.S. Food and Drug Administration (FDA) would assess distilleries making hand sanitizer $14,060 in fees as Monograph Drug Facilities (MDF) under the Over-the-Counter (OTC) Monograph Drug user fee program for fiscal year (FY) 2021.  Several days later, on December 31, 2020, the Department of Health and Human Services (HHS) Office of Public Affairs tweeted a statement from Brian Harrison, HHS Chief of Staff.  According to the statement, HHS has “directed FDA to cease enforcement of these arbitrary, surprise user fees.”  FDA announced the fee rates on December 29, 2020.  85 Fed. Reg. 85646.  According to the notice, MDFs are exempt from FY 2021 facility fees if they had ceased OTC monograph drug activities and updated their registration with FDA to that effect, prior to December 31, 2019 -- an impossibility for distilleries that began making hand sanitizer in 2020 in response to the COVID-19 pandemic.

According to the complete HHS statement, posted by the Distilled Spirits Council, FDA’s March 2020 guidance document, Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19), “contains no discussion regarding user fees or any indication such fees would be due by these entities, many of which would be entering the drug manufacturing business for the first time.”  HHS states that FDA’s action “was not cleared by HHS leadership, who only learned of it through media reports.”  The HHS Office of the General Counsel (OGC) reviewed the matter and “determined that the manner in which the fees were announced and issued has the force and effect of a legislative rule.  Only the HHS Secretary has the authority to issue legislative rules, and he would never have authorized such an action during a time in which the Department is maximizing its regulatory flexibility to empower Americans to confront and defeat COVID-19.”  Because HHS OGC has determined the FDA’s notice is a legislative rule and that no one at FDA has been delegated authority to issue such a rule, HHS states that the notice is void.  HHS leadership, based on the legal opinion, has ordered FDA’s Federal Register notice to be withdrawn, “meaning these surprise user fees will not need to be paid.”

Commentary

The decision comes as a huge relief to businesses far beyond the distillery industry.  FDA is to be commended for ensuring well-intended businesses that redeployed their infrastructure for all the right reasons were not inadvertently penalized for stepping up.


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

On December 10, 2020, the U.S. Environmental Protection Agency (EPA) announced a new policy that will allow registrants of antimicrobial pesticide products voluntarily to disclose all inert ingredients more efficiently in response to the request of retailers, states, and industry.

Registrants who wish to disclose all inert ingredient can choose to do so in three ways under the new policy:

  • On the product label as part of the full ingredient statement or on the product’s back or side panel with a referral to the full ingredient statement;
  • On a website referenced on the product label; or
  • On a website that is not directly linked to the product label.

EPA states that it will allow registrants to use alternate nomenclature to disclose inert ingredients.  This policy is effective as of January 16, 2021

EPA states that there is no statutory or regulatory requirement to identify inert ingredients in the ingredient statement, except when EPA determines that such inert ingredients may pose a hazard to humans or the environment.  EPA states that if EPA determines an inert ingredient may pose a hazard, EPA may determine that the name of the inert ingredient must be listed in the ingredient statement on a case-by-case basis for either risk-based or hazard-based reasons.  Examples include the following ingredients:

  • Petroleum distillates, xylene, or xylene range aromatic solvents > 10%;
  • Sodium nitrate > 0.1%; or
  • Inert ingredients of toxicological concern (formerly known as “List 1 Inerts”).

EPA’s long-standing policy, as stated in its Label Review Manual, has been that “if a registrant wants to list a particular inert ingredient in the ingredient statement, the registrant should list all inert ingredients directly below the ingredient statement in descending order by weight. A partial listing on the label could be misleading.”  EPA’s new policy applies to voluntary identification of inert ingredients using alternate nomenclature and not to cases where EPA directs registrants to list particular inert ingredients because of risk-based or hazard-based reasons.

EPA states that beginning December 15, 2020, the Office of Pesticide Programs (OPP) will review antimicrobial pesticide applications for voluntary inert ingredient disclosure.  Under this new process, EPA states that if a registrant chooses to utilize alternate chemical nomenclature on its product labeling, the registrant must resubmit the Confidential Statement of Formula (CSF) containing the inert ingredient as approved on the existing formulation as well as the alternate chemical nomenclature.  EPA requires that a “crosswalk” between the approved nomenclature of the CSF and the alternate nomenclature be provided with the registrants’ non-Pesticide Registration Improvement Extension Act (PRIA 4) application, which will fall under a 90-day review.

If registrants choose to use alternate nomenclature, EPA encourages using the following sources:

If a registrant chooses to disclose voluntarily inert ingredients on the label, the registrant should list all of the inert ingredients directly below the ingredient statement in descending order by weight, so that the list does not interfere with the required labeling information.  If space is limited, however, to avoid crowding of required labeling information, a referral statement may be used directing the reader to the back or side panel for the full list of inert ingredients in descending order by weight.  The referral statement should be placed directly below the ingredient statement with an asterisk or some other equivalent symbol connecting the “Inert Ingredients” or “Other Ingredients” heading in the ingredient statement with the full list of inert ingredients placed on the back or side panel of the label.  For example, an acceptable referral statement is “*See back panel for complete inert ingredient statement,” and acceptable corresponding text on the back panel is “*Inert Ingredients:  Inert A, Inert B., etc.”

When registrants choose to add a website address or quick response (QR) code to their labeling that leads to inert ingredient information, EPA asks that registrants, in a cover letter transmitting the labeling amendment application, self-certify that the inert ingredient information provided on the registrant’s website(s) and in other marketing materials is consistent with the information provided on the latest approved CSF.

EPA states that registrants do not need to amend its their master label or notify EPA before adding an inert ingredient statement to a website, provided that the site is not referenced on the product label.  In such cases, the application process outlined below does not apply.

EPA states that no other actions should be included with inert ingredient disclosure applications.  The following information is required to be included in the application:

  • Applications to add alternate nomenclature to the label must:
    • Crosswalk link the current CSF nomenclature to any alternate nomenclature as confirmation that the current CSF nomenclature and alternate nomenclature are synonyms of each other (the exact same inert ingredient).  EPA provides a template spreadsheet for the alternate nomenclature crosswalk to link the current CSF nomenclature to any alternate inert ingredient nomenclature.
    • Identify in the cover letter the proposed changes to the alternate nomenclature on product labels and CSFs, the revised CSF (which includes the current and alternate nomenclature) and master label with changes highlighted.
    • For applications to add currently approved nomenclature to the label registrants should include with the application a cover letter identifying the proposed change(s) on product labels and master label with changes highlighted, including the following self-certification statement: “The inert ingredients voluntarily disclosed in the labeling for EPA Registration No. [add registration number], are accurate for the EPA-registered product listed above. No changes to the product formulation have been made. I certify that no other changes have been made to the labeling of this product. I understand that it is a violation of 18 U.S.C. 1001 to willfully make any false statement to EPA. I further understand that if the information I have provided is misbranded as defined in section 2(q) of FIFRA, 7 U.S.C. 136(q), this product may be in violation of FIFRA and EPA may pursue enforcement actions under sections 12 and 14 of FIFRA, 7 U.S.C. 136(j) and 136(l).”
  • For applications to add or change a website or QR code to include inert information, applicants must include a cover letter that identifies the proposed change(s) on product labels and master label with changes highlighted, including the following self-certification statement: “The inert ingredients voluntarily disclosed in the labeling for EPA Registration No. [add registration number], are accurate for the EPA-registered product listed above. No changes to the product formulation have been made. I certify that no other changes have been made to the labeling of this product. I understand that it is a violation of 18 U.S.C. 1001 to willfully make any false statement to EPA. I further understand that if the information I have provided is misbranded as defined in section 2(q) of FIFRA, 7 U.S.C. 136(q), this product may be in violation of FIFRA and EPA may pursue enforcement actions under sections 12 and 14 of FIFRA, 7 U.S.C. 136(j) and 136(l).”

According to EPA, the scope of this policy is currently limited to antimicrobial pesticide products.  EPA states that it may consider expanding to conventional pesticide and biopesticide products in the future.

Additional information is available here.


 
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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.


 
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