By Heather F. Collins, M.S.

The March 1, 2020, deadline for all establishments, foreign and domestic, that produce pesticides, devices, or active ingredients to file their annual production for the 2019 reporting year is fast approaching.  Pursuant to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 7 (7 U.S.C. § 136e), “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, it saves time by making the process faster, and saves money in mailing costs and/or courier delivery and related logistics.

Link 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.

• EPA Form 3540-16:  Pesticide Report for Pesticide-Producing and Device-Producing Establishments
• Instructions for Completing EPA Form 3540-16 (available within the zip file)
• Electronic Reporting for Pesticide Establishments

Further information is available on EPA’s website.

By Timothy D. Backstrom

On January 9, 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) announced the launch of a new website created in coordination with the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) that provides information about actions the federal government is taking to oversee the development of agricultural biotechnology products.  This “one-stop-shop” website was created under the direction of Executive Order (EO) “Modernizing the Regulatory Framework for Agricultural Biotechnology Products.”

EPA regulates biotechnology-based pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and residues from such pesticides under the Federal Food, Drug and Cosmetic Act (FFDCA).  EPA also regulates under the Toxic Substances Control Act (TSCA) certain new microorganisms that are not subject to regulation under other statutes.  USDA regulates certain new biotechnology products under the Plant Protection Act (PPA), including agricultural crops that have been modified to be resistant to conventional pesticides.  FDA regulates the safety of human and animal foods produced using biotechnology, including genetically modified agricultural crops and animals, and the safety of drugs and human biologics produced with biotechnology, under the FFDCA.

The website, The Unified Website for Biotechnology Regulation, describes the federal review process for biotechnology products, outline’s each agency’s role in regulating biotechnology products, and allows users to submit questions to the three agencies.  EPA Administrator Andrew Wheeler states that the new website “will help provide regulatory certainty and clarity to our nation’s farmers and producers by bringing together information on the full suite of actions the Trump Administration is taking to safely reduce unnecessary regulations and break down barriers for these biotechnology products in the marketplace.”

Commentary

In recent years, a number of Non-Governmental Organizations (NGO) have raised concerns regarding the risks from products that have been genetically modified using biotechnology, including agricultural crops that have been genetically modified to improve pesticide or disease resistance, and agricultural animals that have been genetically modified to enhance food production.  In some instances, farmers have also expressed concern that crops with novel traits may exchange genetic information with other plant strains or species.  Implicit in all of this criticism is a presumption that the agencies with regulatory jurisdiction over these novel organisms have not adequately prevented or mitigated the risks associated with biotechnology.

In contrast, proponents of biotechnology have complained that regulatory requirements imposed by the responsible agencies have stifled useful innovation and have requested relief from regulatory requirements that they contend have impeded or slowed introduction of new products of agricultural biotechnology.  The Executive Order that underlies the new website seeks to streamline the administrative process for introducing novel agricultural products without increasing potential risks of biotechnology.

Additional information on how EPA regulates biotechnology products is available here.

By Timothy D. Backstrom and Kelly N. Garson

On December 6, 2019, the European Union (EU) announced that it will no longer permit sales of chlorpyrifos after January 31, 2020.  The Standing Committee on Plants, Animals, Food and Feed (PAFF Committee) voted in favor of two draft Implementing Regulations that denied the renewal of approvals for chlorpyrifos and chlorpyrifos-methyl.  The European Commission is expected to formally adopt the regulations in January 2020.  At that time, Member States will need to withdraw authorizations for products containing chlorpyrifos and chlorpyrifos-methyl as active substances and may implement a grace period, at a maximum of three months, for final storage, disposal, and use of the substances.

The ban in the EU follows increased concerns over the human health effects of the substances.  On August 2, 2019, the European Food Safety Authority (EFSA) published a report concluding that no safe exposure level could be determined for chlorpyrifos and that based upon available data, the approval criteria under Article 4 of Regulation (EC) No 1107/2009 for human health were not met.  EFSA also published an updated statement reiterating the same conclusion for chlorpyrifos-methyl on November 26, 2019.  EFSA’s primary health concerns were potential developmental neurotoxicity based on the available animal data and epidemiological evidence, and unresolved concerns regarding potential genotoxicity.  EFSA also concluded that toxicological reference values could not be established for either of these effects, thereby precluding a valid risk assessment for consumers, workers, or bystanders.

Prior to the PAFF Committee meeting, eight EU states had already banned or never approved the use of chlorpyrifos.  Canada proposed a ban of chlorpyrifos on May 31, 2019.  (More information on this proposal is available in our blog post).

Within the United States, state governments have taken steps to regulate chlorpyrifos.  On June 13, 2018, Hawaii passed an act that banned the use of pesticides containing chlorpyrifos as an active ingredient beginning January 1, 2019.

Several recent actions in California culminated in a ban on chlorpyrifos.  First, the California Department of Pesticide Regulation (DPR) decided that chlorpyrifos should be designated as a Toxic Air Contaminant.  This action was based primarily on a point of departure derived from new animal studies that report neurodevelopmental effects well below the level that inhibits cholinesterase.  On August 14, 2019, DPR issued cancellation notices for chlorpyrifos products based primarily on the same new animal data.  DPR subsequently announced on October 9, 2019, an agreement with pesticide manufacturers to end the sale of chlorpyrifos by February 6, 2020.  Growers will not be able to possess or use chlorpyrifos products in the state after December 31, 2020.

In New York State (NYS), recent efforts to ban the substance through legislation were unsuccessful.  On December 10, 2019, NYS Governor Andrew Cuomo vetoed a bill passed by the NYS Legislature (A.2477/S.5343) to phase out chlorpyrifos from use by December 1, 2021.  Governor Cuomo stated that the NYS Department of Environmental Conservation is responsible for taking regulatory action on the issue, but recommended that the agency implement its own phased-in ban of chlorpyrifos.

On the federal level, chlorpyrifos products remain registered and have been since 1965.  The U.S. Environmental Protection Agency (EPA) has taken measures to restrict the use of chlorpyrifos within households and on particular crops, but some non-governmental organizations (NGO) have long advocated that chlorpyrifos should be banned in its entirety.  On September 12, 2007, the Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) filed a petition requesting that EPA revoke all tolerances and cancel all registrations for chlorpyrifos.  EPA’s failure to respond fully to this petition was the subject of several decisions in the 9th Circuit Court of Appeals, and the Court ultimately issued a writ of mandamus requiring that EPA take final action concerning the petition.

At one point, EPA proposed to revoke all tolerances for chlorpyrifos.  This action was based in part on a controversial determination that EPA should reinstate the default safety factor for tolerance assessments under the Food Quality Protection Act (FQPA) for all organophosphate (OP) pesticides.  This determination was based on developmental neurotoxicity associated with chlorpyrifos exposure in certain epidemiology studies.  After further deliberation and a change of administrations, EPA issued an order denying the 2007 petition in its entirety on March 29, 2017, based in part on a conclusion stating that further evaluation was needed to properly assess potential neurodevelopmental effects of chlorpyrifos.  EPA later issued a final order that denied all objections to the March 2017 petition denial order.  A number of NGOs (including the original petitioners) and several states have challenged this decision, filing petitions on August 8 and August 9, 2019, respectively for judicial review of EPA’s final order retaining tolerances and registrations for chlorpyrifos.  EPA has stated that it intends to complete its evaluation of the epidemiology studies for chlorpyrifos, as well as the new animal data relied on by California, in the context of the pending registration review of chlorpyrifos under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 3(g).  A final registration review decision concerning chlorpyrifos is due by October 1, 2022, although EPA has stated that it intends to accelerate that process.  More information on the petitions and chlorpyrifos is available on our blog.

Commentary

At this juncture, the long-term impact of the gradual accumulation of adverse decisions on chlorpyrifos from EFSA and various other governmental agencies is uncertain.  Most user groups in the United States continue to describe chlorpyrifos as an essential agricultural tool.  Some commodities treated with chlorpyrifos are destined for export markets where chlorpyrifos has been banned, however, and the impacts of this change will need to be monitored closely.

EPA’s interpretation of the epidemiology studies for chlorpyrifos remains controversial in the scientific community.  Indeed, although the EFSA conclusion is predicated in part on these epidemiology studies that are the basis of the controversial EPA interpretation, the wording of the EFSA report indicates that there were some dissenters.  Moreover, the extension of EPA’s FQPA determination for chlorpyrifos to other organophosphate (OP) pesticides has never been satisfactorily explained.

The NGOs and states that have challenged EPA’s final order refusing to revoke the tolerances and cancel the registrations for chlorpyrifos will argue that the final order cannot be reconciled with EPA’s prior scientific determinations.  Even if EPA can successfully rebut those arguments, there is also a possibility that EPA’s own review of the new animal chlorpyrifos studies may obviate that controversy.  On balance, the remaining manufacturers and registrations for chlorpyrifos are likely to confront a variety of challenges in the coming months.

By Timothy D. Backstrom and James V. Aidala

On December 18, 2019, the Office of Pesticide Programs (OPP) of the U.S. Environmental Protection Agency (EPA) issued for comment a Proposed Interim Decision (PID) in the ongoing registration review process for each of the three registered triazine herbicides: atrazine, propazine, and simazine.  EPA will allow 60 days for comment on each of these triazine PIDs, but the specific comment deadline will only be established after EPA has published notice concerning the proposed interim decisions in the Federal Register.  EPA can utilize an “interim registration review decision” under 40 C.F.R. Section 155.56 whenever it is not yet ready to complete the registration review process, but EPA has nonetheless completed sufficient review to determine that new or interim risk mitigation measures are needed or that additional data or information should be submitted to complete the review.  For each of the three triazine herbicides, EPA is proposing to impose specific risk mitigation measures for particular registered uses to mitigate potential health and environmental risks.  For each triazine herbicide, EPA is not yet ready to make a final registration review decision because EPA has not made findings in the Endocrine Disruptor Screening Program (EDSP) or an effects determination under the Endangered Species Act (ESA).  Several key factors that will affect the final registration review decision for each of the triazine herbicides are discussed below.

Common Factors for Triazine Risk Assessment

There are several common factors to consider with regard to the triazines risk assessment.  These include:

1. Atrazine, propazine, and simazine are all included in the chlorotriazine chemical class.  EPA has determined that these three herbicides, along with three specific chlorinated metabolites, share a common mechanism of toxicity, so human health risks from all of these substances are being assessed by EPA together through one cumulative triazine risk assessment. The contribution of each product to aggregate human risk differs because of somewhat dissimilar use patterns. The combining of risks resulting from use of each triazine means, however, that it may be necessary for EPA to coordinate the ultimate registration review decisions for the three active ingredients.
2. As part of the ecological risk assessment for each triazine herbicide, EPA plans to make an effects determination for potentially vulnerable species under the ESA, which in turn will determine whether it is necessary for EPA to consult with the Fish and Wildlife Service or the National Marine Fisheries Service (the Services) concerning potential impacts of each active ingredient and relevant metabolites on endangered or threatened species.  Atrazine, propazine, and simazine are all included in a stipulated settlement between the parties in Center for Biological Diversity et al. v. EPA et al. No. 3:11 cv 0293 (N.D. Cal.), and EPA agreed in that stipulated settlement to set August 14, 2021, as the deadline for EPA to make a nationwide effects determination for each active ingredient, and to request any required consultation with the Services, under ESA Section 7(a)(2).
3. EPA states that the predominant human health effect of concern for all three of the triazine herbicides and their chlorinated metabolites is potential suppression of the luteinizing hormone (LH) surge, which is considered to be both a neuroendocrine and a developmental effect.  Atrazine and simazine were both included on List 1 for screening testing under the EDSP required by the Food Quality Protection Act (FQPA) amendments.   All of the required Tier 1 screening assays for each of these substances are complete and have been evaluated by EPA, but EPA has not yet made human health or environmental findings under the EDSP.  The EDSP screening testing has not been completed yet for propazine.

Risk Mitigation Measures

Each PID proposes specific risk mitigation measures intended to address potential human and environmental risks identified by the EPA risk assessments.

For atrazine, the PID includes the following measures to mitigate aggregate human risk:

• Reduce the permissible application rates for use of granular and liquid formulations on residential turf.
• Require additional personal protective equipment (PPE) and engineering controls for certain uses.
• Restrict aerial applications to liquid formulations only.
• Limit backpack sprayer applications to landscape turf to spot treatment only.
• Prohibit pressurized handgun application to certain commodities.

To mitigate ecological risks, the atrazine PID proposes to require various spray drift reduction measures, to add a non-target advisory statement to labeling, and to adopt a nationwide stewardship program.

For propazine, the PID proposes to cancel the greenhouse use to mitigate aggregate human risk.  Ecological risks would be mitigated by proposing to require various spray drift reduction measures and by adding a non-target advisory statement to labeling.

For simazine, the PID includes the following measures to mitigate aggregate human risk:

• Cancel simazine use on residential turf.
• Require additional PPE and engineering controls for certain uses.
• Limit pressurized handgun applications to certain commodities to spot treatment only.

Ecological risks would be mitigated by proposing to require various spray drift reduction measures and by adding a non-target advisory statement to labeling.

Commentary

In each of the PIDs for the triazine herbicides, EPA has focused its efforts on adopting mitigation measures which should be efficacious in reducing human and ecological risks without materially impairing the availability of the products in question for key agricultural uses.  In some instances, the PID documents explicitly state that the product registrants have agreed to proposed changes.  An EPA Pesticide Program Update dated December 19, 2019, that discusses the interim decision for atrazine includes statements of support from several grower groups.

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

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

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

1. The applicant has 500 or fewer employees globally;
2. During the 3-year period prior to the most recent maintenance fee billing cycle the applicant has average annual gross revenue from all sources that do not exceed $10,000,000; and
3. The applicant holds a total of 5 or fewer registrations subject to the maintenance fee.

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

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

By Lara A. Hall, MS, RQAP-GLP and Barbara A. Christianson

On December 17, 2019, the U.S. Environmental Protection Agency (EPA) will host its first annual conference in Washington, D.C., to discuss alternative test methods and strategies to reduce animal testing.  EPA states that its conference “will bring together some of the leading voices in environmental and health research to discuss efforts to reduce testing on mammals.”  The conference will focus on the New Approach Methods (NAM), which include “any technologies, methodologies, approaches or combinations thereof that can be used to provide information on chemical hazard and potential human exposure that can avoid or significantly reduce the use of testing on animals,” and will have U.S. and international scientific experts present information on advancements in the field.  On-site participants attending the conference will have an opportunity to exchange information about scientific advancements in the NAMs field to develop a better understanding of the state of the science, discuss approaches for developing scientific confidence in using alternatives, and summarize existing studies characterizing the uncertainties in results from animal testing.

This conference is part of Administrator Wheeler’s “Directive to Prioritize Efforts to Reduce Animal Testing,” issued on September 10, 2019, which outlines EPA’s pursuit to aggressively reduce animal testing.  In his directive, Administrator Wheeler calls for EPA to reduce its requests for, and funding of, mammalian studies by 30 percent by 2025 and eliminate all mammalian study requests and funding by 2035.  Any mammalian studies requested or funded by EPA after 2035 will require Administrator approval on a case-by-case basis.  The directive also supports scientific advancements that allow scientists to predict potential hazards for risk assessments without using traditional animal testing methods.

Information on how to register to participate in the conference by webinar is available here.

By Timothy D. Backstrom

On December 5, 2019, the U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP) announced the availability of a revised interim registration review decision for use of sodium cyanide in the M-44 predator control device.  The M-44 device is a restricted use pesticide (RUP) and may be used only by certified applicators in compliance with specific mandatory restrictions set forth on the label.  Although the registration review process for sodium cyanide remains pending, EPA has decided to issue an interim decision for the M-44 device now to adopt new label restrictions intended to mitigate potential risks.  The revised interim decision adopts two new restrictions and also modifies certain existing restrictions, which EPA states "will reduce the potential for unintended impacts on humans, pets, and other non-target animals.”

The M-44 predator control device uses a spring-loaded ejector to fire a capsule containing a single lethal capsule of sodium cyanide.  The M-44 is used by livestock producers to control predators (primarily coyotes) that kill sheep, goats, and cattle.  Registrations for the M-44 device are currently held by the U.S. Department of Agriculture, and by five individual States (South Dakota, Texas, Montana, Wyoming, and New Mexico) where livestock predation has been a particular problem.

New or revised restrictions that will be incorporated in the approved labeling for the M-44 device include:

• Requiring a 600-foot buffer zone around residences where an M-44 cannot be used (except for a cooperating landowner who has given written permission).
• Requiring that the applicator notify occupants of all residences within a 0.5 mile radius (by face-to-face communication, person-to-person telephone communication, door hanger, or certified mail) prior to an M-44 placement.
• Increasing from 50 feet to 300 feet the distance from designated public paths and roads where M-44 use is prohibited.
• Requiring two elevated warning signs placed 15 feet from the M-44 device and facing the most likely directions of approach, instead of one elevated sign placed 25 feet from the device.

Commentary

Livestock producers and State departments of agriculture contend that the M-44 device is essential to limit economic losses resulting from predation, which reportedly amount to hundreds of millions of dollars annually.  In contrast, wildlife advocates have strongly opposed any continued use of the M-44 device.  In 2017, WildEarth Guardians and the Center for Biological Diversity petitioned EPA to suspend and cancel all registrations for M-44 capsules, but EPA concluded that the petition did not contain substantial new information and denied the petition in 2018.  Although the new and modified label restrictions adopted by EPA in the interim decision for the M-44 device are not likely to satisfy opponents, these changes should nonetheless reduce the likelihood that humans, pets, or other non-target species will be exposed to the M-44 capsules or the toxin they contain.

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

On November 21, 2019, the U.S. Department of Justice announced a settlement with Monsanto Company (Monsanto) in which Monsanto agreed to plead guilty to a misdemeanor count of illegally using the pesticide Penncap-M, a methyl parathion product that was cancelled by the U.S. Environmental Protection Agency (EPA) on July 27, 2010.  This settlement of several criminal counts by Monsanto followed an investigation by the EPA Criminal Investigation Division.  Under the existing stocks provision in the EPA cancellation order, continued use of Penncap-M became unlawful after December 31, 2013.  In the settlement documents, Monsanto admits that its employees knowingly violated this order by using Penncap-M on July 15, 2014, to treat corn seed research crops at Monsanto’s Valley Farm research facility in Maui, Hawaii. Monsanto also admits that Monsanto employees directed other employees to re-enter the treated site seven days after the July 15, 2014, application, although the re-entry period established for this pesticide prior to its cancellation was 31 days.  Monsanto further admits that it stored stocks of Penncap-M after December 31, 2013, when unused stocks of this product became an acute hazardous waste under the Resource Conservation and Recovery Act (RCRA), at several locations in Hawaii without obtaining the required permits.

As part of the settlement, Monsanto agreed to pay a total of $10.2 million in fines and penalties, which includes a maximum fine of $200,000 for illegal use of a cancelled pesticide, $6 million in fines for the hazardous waste violations, and $4 million in community service payments to Hawaii governmental entities for various environmental remediation programs.  Monsanto also agreed to be sentenced to two years of probation.  If Monsanto adheres to all of its obligations under this settlement, at the end of the two-year period of probation, the criminal felony counts for the RCRA hazardous waste violations will be dismissed with prejudice.

Commentary

Although the agreement reached with Monsanto will allow Monsanto to escape any felony convictions, it is clear from the stiff penalties imposed (which include the maximum fine permissible for the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) violation) that EPA considers the violations at issue to be very serious.  Pesticide research facilities often handle dangerous pesticides, and EPA typically affords such research facilities wide latitude to use unregistered active ingredients in small-scale research projects, but Monsanto has admitted that its personnel deliberately violated a FIFRA cancellation order, and did not comply with the restrictions on re-entry that were in place before the product in question was cancelled.  Monsanto also has admitted that it stored stocks of a cancelled pesticide at several sites after they became acute hazardous waste without obtaining the required permits.  The substantial penalties imposed may not seem surprising to some given those admissions.

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.

By Jason E. Johnston

On October 15, 2019, EPA posted a total of 11 documents to the registration review docket for paraquat dichloride (EPA-HQ-OPP-2011-0855).  Of primary interest in the registration review process under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) are the draft human health and ecological risk assessments.  Additional supporting documents posted to the docket include dietary, residential, and occupational exposure assessments; a review of analytical chemistry and residue data; a label use summary; a screening level usage analysis, results of a drinking water jar test; open literature and epidemiology literature reviews; and an incident report summary.

Paraquat is currently registered in the United States for use as an herbicide on over 100 crops in agricultural and commercial settings.  All paraquat products are restricted use products and may be applied only by certified pesticide applicators.  EPA has previously imposed additional restrictions and conditions to ensure the safe use of paraquat consistent with label directions.  These actions include a safety awareness campaign, changes to labels and product packaging, and specialized training for certified applicators using paraquat.  Evaluation of the effectiveness of these steps will be conducted in the registration review process.

Potential risks of concern to workers applying paraquat or entering treated fields are identified in the draft human health risk assessment, as are potential risks to bystanders from spray drift.  Prior submissions to EPA suggest a link between proper use of paraquat and Parkinson’s Disease, but EPA’s review of relevant data does not support a causal relationship.  This conclusion is not without controversy, as evidenced by an October 15, 2019, press release from the Center for Biological Diversity that calls out EPA’s failure to recognize a link between paraquat exposures and Parkinson’s Disease.  The ecological risk assessment identifies potential risks to mammals, birds, adult honey bees, terrestrial plants, and algae.  EPA is seeking comments on these and other issues raised in the draft risk assessments for paraquat.  Comments will be accepted on these documents until December 16, 2019.

By James V. Aidala and Susan M. Kirsch

On October 31, 2019, as required by the 2018 Farm Bill, the U.S. Department of Agriculture’s (USDA) Agricultural Marketing Service published its interim rule, “Establishment of a Domestic Hemp Production Program” (Interim Rule).  The Interim Rule proposal specifies rules and regulations governing hemp production in the U.S., including:

• Requirements for state/tribal plans for states pursuing regulatory authority over hemp production;
• Recordkeeping requirements;
• Licensing requirements;
• Delta-9 tetrahydrocannabinol (THC) testing;
• Procedures for disposing of non-compliant plants; and
• Compliance provisions and procedures for handling violations.

The Interim Rule does not alter the federal definition distinguishing hemp from marijuana, a distinction hinging on the levels of THC in the plant. Plants containing 0.3 percent or less THC on a dry weight basis are considered hemp, while plants exceeding this level of THC are marijuana. The Interim Rule introduces the term “acceptable hemp THC level” to account for a degree of uncertainty in testing results and explains how to interpret lab results with a measurement of uncertainty.  This is a critical clarification given that THC levels dictate whether a grower is engaged in the legal production of hemp or is growing marijuana -- prohibited federally and in the majority of states.

The USDA is not proposing a single uniform testing method and will accept numerous testing methods and protocols employed by states. The Interim Rule does not include a federal seed certification program. The Interim Rule makes clear that interstate transport of hemp is permissible regardless of whether the states the shipment passes through allow hemp production.

The publication of the Interim Rule initiates USDA’s implementation of the hemp program, which includes reviewing state/tribal plans and issuing licenses. USDA will accept public comments on the Interim Rule for 60 days through December 30, 2019.  Within two years of publication, USDA will publish a final rule.  Also relevant for hemp producers are forthcoming proposals from the U.S. Food and Drug Administration and the U.S. Environmental Protection Agency (EPA) addressing the sale of cannabidiol (CBD) and pesticide approvals for application to hemp plants, respectively.

Commentary

For some, federal policies facilitating hemp production not only is a long-awaited policy goal, but a kind of “gateway drug” (pun intended) for renewing the debate about approval for pesticide products to be used on the legal production of marijuana crops.

To date, the federal government position is that since marijuana production is not allowed under federal law, attempts by states to permit pesticides for state use are forbidden.  Some states have argued that since their state law allows the production of marijuana crops, pesticide products should be subject to registration under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 18 emergency use or FIFRA Section 24(c) special local needs.

Separate from any debate about marijuana production, residues of pesticides on hemp products intended for human consumption, such as CBD products, will force EPA to consider how such products should be reviewed.  Those policies, in time, will be relevant to any eventual evaluation of similar exposure and risk assessment questions regarding approval of pesticide products to be used in marijuana production.

By Susan M. Kirsch and Barbara A. Christianson

On October 24, 2019, the U.S. Environmental Protection Agency (EPA) announced that it is proposing narrow updates to the Worker Protection Standard’s (WPS) provision on the Application Exclusion Zone (AEZ) requirements.  By narrowing updates to the WPS, EPA states that it will “improve the long-term success of the agency’s Application Exclusion Zone requirements” and “would improve enforceability for state regulators and reduce regulatory burdens for farmers.”  EPA believes narrowing updates to the WPS will also continue to protect the health of farm workers and other individuals near agricultural establishments who could be exposed to agricultural pesticide applications.  The proposed updates are consistent with the 2019 Pesticide Registration Improvement Act (PRIA).

EPA Administrator Andrew Wheeler states that EPA’s proposal “would enhance the agency’s Application Exclusion Zone provisions by making them more effective and easier to implement.”  Wheeler states that “our proposal will make targeted updates, maintaining safety requirements to protect the health of those in farm country, while providing greater flexibility for farmers.”

EPA will hold a 90-day public comment period and seeks input on select updates that were publicly suggested to EPA by both state pesticide agencies responsible for enforcing the provision and agricultural stakeholders since the AEZ requirement was adopted in 2015.  The proposed updates are also consistent with the U.S. Department of Agriculture’s comments during a May 2017 meeting of EPA’s Pesticide Program Dialogue Committee.

Specifically, EPA is proposing to:

• Modify the AEZ so it is applicable and enforceable only on a farm owner’s property, where a farm owner can lawfully exercise control over employees and bystanders who could fall within the AEZ.  As currently written, the off-farm aspect of this provision has proven very difficult for state regulators to enforce.  These proposed changes would enhance both enforcement and implementation of the AEZ for state regulators and farm owners, respectively.  Off-farm bystanders would still be protected from pesticide applications with the existing “do not contact” requirement that prohibits use in a manner that would contact unprotected individuals.
• Exempt immediate family members of farm owners from all aspects of the AEZ requirement.  This will allow farm owners and their immediate family members to decide whether to stay in their homes or other enclosed structures on their property during certain pesticide applications, rather than compelling them to leave even when they feel safe remaining.
• Add clarifying language that pesticide applications that are suspended due to individuals entering an AEZ may be resumed after those individuals have left the AEZ.
• Simplify the criteria for deciding whether pesticide applications are subject to the 25- or 100-foot AEZ.

Publication of the proposed rule in the Federal Register will begin a 90-day comment period.  Comments are due on or before January 30, 2020.

When EPA included the AEZ concept in its 2015 WPS updates, of chief concern for pesticide applicators, farmers, and state departments of agriculture were the compliance and enforcement practicalities of aspects of the AEZ requirements.  For example, in scenarios where the AEZ extends to nearby roads and highways, it is difficult for pesticide applicators to be aware of every vehicle that may pass by that could enter the AEZ during applications.  It is unclear if the revised AEZ requirements adequately address these practical realities.  Agricultural stakeholders and pesticide applicators may wish to submit comments on the proposed revisions.

Additional information on the WPS is available on EPA's website.

By Heather F. Collins, M.S.

On October 17, 2019, the U.S. Environmental Protection Agency (EPA) released the Spanish Translation Guide for Pesticide Labeling resource for use by all, including pesticide registrants that choose to display parts of their pesticide product label in Spanish.  The purpose of the guide is to be a resource for the translation of the health and safety sections on pesticide labeling from English to Spanish.  EPA states that the “guide is written in a universal form of Spanish to reach as many Spanish speakers as possible.”

While translating pesticide labels is not a requirement, EPA generally allows pesticide registrants to translate their product labels into any language so long as there is an EPA-accepted English version of the label and the translation is true and accurate.  The guide is not intended to substitute for or eliminate the pesticide labels in English. An English version of all required labeling text is needed for all pesticide products in accordance with 40 C.F.R. Section 156.10(a)(3).

The guide provides translations for standard language typically used in the health and safety sections of pesticide product labels such as the:

• First aid and precautionary statement label language;
• Signal words;
• Misuse statements;
• Storage and pesticide container disposal instructions;
• Personal protection equipment label statements; and
• Worker Protection Standard agricultural use requirements.

EPA states that it “developed the Spanish translation guide in response to feedback from stakeholders who believe that having bilingual pesticide labeling is critical to the well-being of pesticide handlers, applicators, and farmworkers, many of whom do not speak English as a first language.”

The English statement appears in the left-hand column and the corresponding Spanish translation is available in the right-hand column of the guide.  EPA states that the “guide will help registrants maintain accurate, consistent translations on product labels and ease their burden when adding Spanish translations.”

By Susan M. Kirsch

On September 30, 2019, the U.S. Environmental Protection Agency (EPA) released an updated Aquatic Life Benchmarks Table for registered pesticides.  The update includes four newly registered pesticides and their degradants as well as new values for more than 30 previously registered pesticides. The benchmarks inform state and local regulators in their interpretation of water quality monitoring data. Waterbodies where benchmarks are exceeded may be prioritized for further investigation.  EPA derived the latest updates from toxicity values from the most recent ecological risk assessments for the registered pesticides as part of the regular registration review. EPA aims to update the table on an annual basis.  The full table and links to source documents for each of the benchmarks are accessible on EPA’s website here.