By Margaret R. Graham
On November 29, 2016, the U.S. Environmental Protection Agency (EPA) announced the issuance of its new guidance for testing pesticides designed to reduce animal testing for acute dermal toxicity for pesticides, Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Formulations & Supporting Retrospective Analysis, in final. This guidance was issued as part of the Office of Pesticide Programs’ (OPP) Strategic Vision for implementing the 2007 National Research Council’s report on Toxicity Testing in the 21st Century.
OPP states that it “receives about 200-300 dermal formulation toxicity tests annually, each of which generally use 10 animals per test,” and “[w]e expect this waiver guidance to save 2,500 or more laboratory animals every year.” Further, as described in OPP Director Jack Housenger’s March 17, 2016, letter to stakeholders, “[t]his new policy represents significant progress toward EPA’s goal of significantly reducing the use of animals in acute effects testing.”
More information on OPP’s Strategic Direction for Adopting 21st Century Science Methodologies is available on EPA’s website and in our blog item EPA’s OPP Releases Guidance Documents Related to Strategic Vision for Adopting 21st Century Science Methodologies.
By Susan M. Kirsch
On November 1, 2016, the U.S. Environmental Protection Agency (EPA) published its Final National Pollutant Discharge Elimination System (NPDES) Pesticide General Permit for Point Source Discharges from the Application of Pesticides in the Federal Register, which regulates discharges to waters of the United States from the application of biological pesticides and chemical pesticides that leave a residue. 81 Fed. Reg. 75816. The 2016 NPDES Pesticide General Permit (PGP) replaces the 2011 PGP, which expired on October 31, 2016. The PGP applies to the following geographic areas where EPA serves as the NPDES permitting authority:
- The States of: Massachusetts, New Hampshire, New Mexico, and Idaho;
- District of Columbia;
- All U.S. territories except the U.S. Virgin Islands;
- Federal facilities in Delaware, Vermont, Colorado, and Washington;
- Discharges in Texas that are not under the authority of the Texas Commission on Environmental Quality, including activities associated with oil and gas exploration (see Appendix A of the Final 2016 PGP for further description); and
- All areas of Indian Country that are not covered by an EPA-approved permitting program (see Appendix A for Indian Country covered within each EPA Region).
Similar to the 2011 PGP, the 2016 PGP contains additional permit conditions and modifications that some states and tribes added through the Clean Water Act (CWA) Section 401 certification process and/or the Coastal Zone Management Act process. Part 9 of the 2016 PGP provides a detailed breakdown of any additional requirements. Forty-six states have delegated authority to administer state versions of the PGP. The majority of states recently revised and reissued their respective state PGPs for another five-year permit cycle.
The 2016 PGP applies to the same pesticide use patterns covered by the 2011 PGP, which are:
- Mosquito and Other Flying Insect Pest Control -- control of public health/nuisance and other flying insect pests (including mosquitoes and black flies) that develop or are present during a portion of their life cycle in or above standing or flowing water.
- Weed and Algae Pest Control -- control of weeds, algae, and pathogens that are pests in water and at water’s edge, including ditches and/or canals.
- Animal Pest Control -- control of animal pests, including fish, lampreys, insets, mollusks, and pathogens, in water and at water’s edge.
- Forest Canopy Pest Control -- application of a pesticide to a forest canopy to control the population of a pest species (e.g., insect or pathogen) where, to target the pests effectively, a portion of the pesticide unavoidably will be applied over and deposited to water.
The 2016 PGP requirements are nearly identical to those in the 2011 PGP, with the exception of the following two updates included in the 2016 PGP:
- Electronic reporting (Part 7.8) -- All reporting under the 2016 PGP (i.e., Notice of Intent (NOI), Annual Report, and Notice of Terminations (NOT) submissions) must be submitted via EPA’s eNOI system to be consistent with EPA’s Electronic Reporting Rule. EPA will make these reports publicly available through a searchable index tool -- eNOI search. More information on electronic reporting, and access to the Central Data Exchange for NOI, Annual Report, and NOT submissions is available here.
- Updated definition of the National Marine Fisheries Service (NMFS) Listed Resources of Concern -- Following consultation between EPA and NMFS, as required under Section 7 of the Endangered Species Act (ESA), EPA expanded the Listed Resources of Concern to include additional species not included in the 2011 PGP definition. Under Part 18.104.22.168, pesticide discharges that overlap with NMFS Listed Resources of Concern trigger additional NOI requirements to certify that the discharges and discharge-related activities are not likely to adversely affect federally listed “endangered” or “threatened” species, or federally-designated “critical habitat.” Permittees may consult EPA’s PGP NMFS Listed Resources of Concern -- Interactive Mapping Tool to determine whether a discharge activity will overlap with these Resources of Concern. Appendix I provides endangered species instructions for affected permittees. EPA states in the corresponding Fact Sheet for the 2016 PGP that it continues to estimate that less than two percent of the total number of Operators in the PGP coverage areas will need to meet additional permit requirements in order to meet ESA-related provisions.
The 2016 PGP permit conditions went into effect on October 31, 2016, and the PGP will expire in five years on October 31, 2021. 2016 PGP coverage is automatic through January 12, 2017, without the submission of an NOI, but pesticide Operators (i.e., pesticide applicators) must comply with all 2016 PGP conditions as of October 31, 2016. For any discharges commencing on or before January 12, 2017, that will continue after this date, a decision-maker must submit an NOI no later than January 2, 2017, to ensure PGP coverage, and for any discharges subsequent to January 12, 2017, an NOI submission is required no later than 10 days before the first discharge. Table 1-1 at Part 1.2.3 outlines which decision-makers must submit NOIs based on the particular pesticide use pattern, location (i.e., if discharging to a designated Outstanding National Resource Water), and acreage thresholds. Table 1-2 at Part 1.2.3 provides applicable NOI submission deadlines, including grace periods for NOI filing for discharges in response to a Declared Pest Emergency.
EPA’s webpage for pesticide NPDES permitting includes links to the final 2016 PGP, a related fact sheet, the permitting decision tool, and information on eNOI and ESA procedures.
Although the 2016 PGP largely mirrors the 2011 version of the permit, it will be important for decision-makers to familiarize themselves with the new electronic reporting requirements (Part 7.8). EPA’s eNOI system is publicly searchable and could subject PGP permit holders to additional scrutiny by citizens and advocacy groups concerned about potential environmental and public health implications of pesticide applications in their areas. Decision-makers should consult EPA’s PGP NMFS Listed Resources of Concern -- Interactive Mapping Tool and the Alternative PGP Sources of Information for NMFS Listed Resources of Concern to determine where discharges may overlap with these areas and trigger additional permit conditions.
By Lisa M. Campbell, Lisa R. Burchi, and Margaret R. Graham
The U.S. Environmental Protection Agency (EPA) has recently announced the availability of two proposed test methods and associated testing guidance for evaluating antimicrobial pesticides against two biofilm bacteria, Pseudomonas aeruginosa and Staphylococcus aureus, for comments. EPA states that registrants of antimicrobial products with public health claims are “required to submit efficacy data to EPA in support of the product’s registration” under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA is soliciting comments on the clarity of the standard operating procedures and the regulatory guidance. The two test methods are:
The Draft Guidance to Assess the Efficacy of Antimicrobial Pesticide Products Intended to Control Public Health Biofilms on Hard, Non-Porous Surfaces describes biofilms and their public health significance; the two test procedures for developing efficacy data supporting biofilm claims; products that may be eligible for biofilm claims; test criteria; data submission procedures for efficacy data; and labeling guidance.
The draft guidance states that the term biofilm “is reserved for claims against biofilm that contain specific bacteria that are directly or indirectly infectious or pathogenic to humans,” and “biofilm claims are considered to be public health claims for which the agency must review and approve appropriate efficacy data.” EPA states: “Examples of use sites that may be supported by the biofilm test methodologies herein, and found acceptable, include restrooms, shower stalls, sink basins or drains (excluding the drain pipe) and nearby hard, non-porous surfaces of walls, countertops, and instrument trays in patient care areas of hospitals. In contrast, claims against non-public health slimicides must also be supported by appropriate efficacy data, however, submission of the data is only required when requested by the EPA.”
The Draft Guidance also sets forth examples of acceptable label claims against public health biofilms and acceptable non-public health claims. The examples of acceptable label claims against public health biofilms are:
- Kills 99.9999% of bacteria* in biofilm on a hard, non-porous surface;
- Kills a minimum of 99.9999% of bacteria* in biofilm;
- Reduces at least 99.9999% of bacteria* growing in biofilm;
- Formulated to kill 99.9999% of bacteria* in biofilm;
- Other related claims:
- Kills biofilm bacteria*; and
- Penetrates biofilm, killing the bacteria* living there.
*[List of bacteria “tested as a biofilm”; at a minimum, Pseudomonas aeruginosa and Staphylococcus aureus].
Examples of acceptable non-public health claims supported by appropriate efficacy data include:
- Cleans away microorganism slime/grunge;
- Maintains control of slime; and
- Controls slime-forming microorganisms.
Comments will be accepted until December 5, 2016.
By Lisa M. Campbell and Lisa R. Burchi
The California Department of Pesticide Regulation (DPR) recently proposed a regulation that it states is intended to “(1) provide minimum statewide standards for all agricultural pesticide applications near public K-12 schools and child day care facilities; (2) provide an extra margin of safety in case of unintended drift or when other problems with applications occur (e.g., equipment failure causes an unintended release of pesticide, or an abrupt change in weather conditions); (3) increase communication between growers and schools/child day care facilities; and (4) provide information to assist schools and child day care facilities in preparing for and responding to pesticide emergencies.”
This proposal has been long anticipated, is far reaching, and of significant concern to many growers and registrants.
In its Initial Statement of Reasons, DPR summarizes the proposed regulations, stating that they will: “require growers to notify public K-12 schools, child day care facilities (except family day care homes), and county agricultural commissioners when certain pesticide applications made for the production of an agricultural commodity near a schoolsite are planned in the coming year and also a few days prior to the applications.” The proposed regulation also would prohibit at certain times certain pesticide applications near these schoolsites. Specifically, the regulation is proposed to do the following:
- Prohibit many pesticide applications for the production of an “agricultural commodity” within a quarter mile of schoolsites from Monday through Friday between 6:00 a.m. and 6:00 p.m. “Schoolsites” are defined by Education Code section 17609(f) as: “‘any facility used as a child day care facility, as defined in Section 1596.750 of the Health and Safety Code, or for kindergarten, elementary, or secondary school purposes. The term includes the buildings or structures, playgrounds, athletic fields, vehicles, or any other area of property visited or used by pupils.” ‘Schoolsite’ does not include any postsecondary educational facility attended by secondary pupils or private kindergarten, elementary, or secondary school facilities.” DPR also proposed to exclude from the definition of schoolsite any family day care homes “because, unlike other schoolsites, the locations of these facilities are not publically available.” DPR states it considered other distances but proposed the one-quarter mile radius based on several factors, including but not limited the fact that this restriction is similar to the restrictions on fumigant labels that prohibit closer applications around schools and other difficult to evacuate sites and based on an analysis of pesticide illnesses due to drift from agricultural applications. The proposed prohibition would apply to applications by aircraft, sprinkler chemigation equipment, air-blast sprayers, and fumigant applications. In addition, dust and/or powder pesticide applications would also be prohibited during this time unless applied as a dust or powder using field soil injection equipment.
- Require California growers and pest control contractors to notify public K-12 schools and child day-care facilities and county agricultural commissioners (CAC) when certain pesticide applications are made within a quarter mile of these schools and facilities.
Under the proposed regulation, California growers would be required to provide two types of notifications to a school or child day-care facility:
An annual notification that lists all the pesticides expected to be used during the upcoming year. This must be provided to the school or child day care facility administrator by April 30 each year. The notice must include, among other things:
The name of pesticide products (and the main active ingredient) to be used;
A map showing the location of the field to be treated;
Contact information for the grower/operator and the County Agricultural Commissioner; and
The web address for the National Pesticide Information Center where additional sources of information or facts on pesticides may be obtained.
An application-specific notification which must be provided to the school or child day-care facility 48 hours before each application is made. This begins January 1, 2018, and must include, among other things:
- Name of pesticide products (and the main active ingredient) to be used;
- Specific location of the application and the number of acres to be treated; and
- Earliest date and time of the application.
Comments on the proposed regulation are due by November 17, 2016. DPR states that a final regulation is expected to become effective in September 2017.
Many have concerns with the proposed regulation, which DPR has been discussing publicly for some time. These concerns include what many believe are significant economic impacts to growers and others that they believe may not have been adequately considered and are not necessary for appropriate use of registered pesticides. Registrants and others should review the proposal carefully.
By Lisa M. Campbell and Lisa R. Burchi
The following documents have been filed in the Anderson v. McCarthy proceedings in the U.S. District Court for the Northern District of California: (1) U.S. Environmental Protection Agency’s (EPA) Notice of Motion and Motion for Summary Judgment; (2) Defendant-Intervenors CropLife America, et al.’s Notice of Motion and Motion for Summary Judgment; and (3) Plaintiffs’ Memorandum of Points and Authorities in Support of Motion for Summary Judgment.
EPA’s documents are of particular interest to those who have been following this case and are concerned about the assertions in the case regarding the treated article exemption. In its motion, EPA argues that the Ninth Circuit lacks jurisdiction to hear Plaintiffs’ claims, as the “EPA guidance document they challenge is not a judicially reviewable agency action -- much less a final action -- regarding the regulatory status of treated seed,” and Plaintiffs “have not identified any discrete, mandatory duty or action that EPA has failed to perform under [the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)].”
EPA’s main arguments in support of its motion include:
- Plaintiffs have not identified any final agency actions. The Inspection Guidance is not an agency action, and even if the Inspection Guidance were an agency action, it is not final.
- Count II (Plaintiffs’ allegation of EPA’s failure to regulate and enforce FIFRA with respect to pesticide-treated seeds) must be dismissed because there is no nondiscretionary duty identified by Plaintiffs that is unreasonably delayed or unlawfully withheld.
- Enforcement of FIFRA is a discretionary action not subject to review.
In its motion, Defendant-Intervenors argue: “Each of Plaintiffs’ claims constitutes an impermissible programmatic attack on EPA’s existing pesticide regulatory program --specifically, the interplay between EPA’s regulation of pesticides registered to be applied as seed treatments and what Plaintiffs characterize as its categorical application of the treated article exemption to the treated seed. As a result, each of these claims is non-justiciable as a matter of law, entitling Defendants to summary judgment in their favor.” Defendant-Intervenors note that pesticides used for seed treatments are subject to “rigorous, scientifically robust review and approval under FIFRA,” making Plaintiffs’ attempt to impose a regulatory process “entirely duplicative of EPA’s existing exercise of its authority under FIFRA, while having no impact on human health or environmental safety.”
Plaintiffs’ memorandum sets forth its arguments for why the court should “find in favor of Plaintiffs on their four claims for relief: that EPA failed to enforce FIFRA against an entire class of pesticides; that EPA improperly amended the treated article exemption without following proper [Administrative Procedure Act (APA)] rulemaking procedures; that EPA’s exemption of neonicotinoid-coated seeds was ultra vires and/or arbitrary and capricious under the APA; and that EPA’s labeling requirements for unregistered pesticide-coated seed bags was arbitrary and capricious under the APA and FIFRA.” Specifically, Plaintiffs address why they believe EPA has failed to enforce FIFRA against neonicotinoid-coated seeds, why this asserted failure amounts to what they believe is “an unlawful abdication of [EPA’s] statutory responsibilities” and why they believe “EPA’s failure to enforce FIFRA against neonicotinoid-coated seeds and pesticidal dust-off is a ‘consciously and expressly adopted general policy,’ which ‘amounts to an abdication of its statutory responsibilities’ that this Court has the power to remedy.”
A hearing on EPA’s motion was set for October 27, 2016, but due to scheduling conflicts has been rescheduled for November 3, 2016. It will be important to monitor the court’s consideration of these important issues closely. More information on these proceedings can be found in our pesticide blog items District Court Declines to Rule on Jurisdictional Issues in Neonicotinoid Case until Summary Judgment and EPA Requests Dismissal of Complaint For Lack of Subject Matter Jurisdiction.
By Lisa R. Burchi and Zameer Qureshi
On August 23, 2016, the European Chemicals Agency’s (ECHA) Board of Appeal (BoA) adopted its first decision on a data sharing dispute under the Biocidal Products Regulation (BPR).
Thor GmbH (Thor) lodged the appeal in 2015 after ECHA granted permission to a company to cite studies owned by Thor for the substance reaction mass of 5-chloro-2-methyl-2H-isohtiazol-3-one and 2-methyl-2H-isothiazol-3-one (CIT/MIT). According to ECHA, Thor had insisted on a technical equivalence assessment of its substance with the other company’s active substance to check if the companies’ substances had similar chemical composition and hazard profiles. ECHA stated this was not required under BPR and data owners “do not have the right to demand any form of similarity check as a prerequisite for getting a letter of access.”
The BoA ruled in favor of Thor, which raised five pleas in law, as the companies had mutually agreed to perform a technical equivalence assessment before sharing data. The BoA concluded that while ECHA “might be correct” in concluding that the technical equivalence assessment is not a legal requirement for data sharing under BPR, “this legal observation cannot constitute an assessment of the parties’ efforts to reach an agreement within the meaning of Article 63.” The BoA stated “it is part of the Appellant’s and the prospective applicant’s contractual freedom to insert a clause relating to a technical equivalence assessment in the data sharing agreement.”
The BoA also reviewed the negotiations between the parties to determine whether those parties make every effort to reach an agreement, and found that ECHA “did not consider all the relevant facts in a balanced manner when assessing whether every effort had been made by Appellant and the prospective applicant under Article 63.” The BOA found that ECHA disregarded some of Thor’s efforts based on its legal conclusion that there was no need to perform a technical equivalence assessment. Consequently, the BoA concluded that Thor had made every effort to reach an agreement with the other company and ECHA had failed to consider all the facts of the case.
Although ECHA’s decision was annulled, there remains a question whether a new decision is required. Since the BoA’s decision, the prospective applicant submitted a successful application under Article 95, which may negate the need for the prospective applicant to cite to Thor’s data. The case was remanded to ECHA to determine whether a new decision is required.
By Zameer Qureshi
The fourth Biocides Stakeholders’ Day took place on September 1, 2016, at the European Chemicals Agency’s (ECHA) headquarters in Helsinki, Finland. The event provided biocides stakeholders with information on the Biocidal Products Regulation (BPR) and the tools and support available. The focus was on experiences from companies, ECHA, and the European Commission (EC). ECHA stated “[t]he objective was to equip companies with information about their roles and obligations to meet the legal requirements for biocides.”
The program for the event included three plenary sessions. Plenary Session 1, “Challenges and Opportunities,” was commenced by ECHA’s Executive Director, Geert Dancet. Topics discussed in Plenary Session 1 included a “[r]egulatory update from the [EC],” “[a]ctivities in 2016,” and “Union [Authorization] in Practice.” Plenary Session 2 focused on “IT Tools and Dossier Preparation,” and included discussions on IUCLID 6 and R4BP 3. IUCLID 6 is used to collect, organize, and store data on active substances and biocidal products. Dossiers generated through IUCLID 6 are submitted to ECHA and national authorities through R4BP 3, “the central hub through which all biocides applications are made.” Plenary Session 3 on the “Enforcement of Biocidal Products” consisted of discussions on enforcement by the EC and Member States, and closed with a case study on “Enforcement from an Industry Perspective.”
The Plenary Sessions were followed by Questions and Answers, closing remarks from Jack De Bruun, ECHA’s Director of Risk Management, and an opportunity for attendees to meet the ECHA staff.
By Lisa M. Campbell, Lisa R. Burchi, and Timothy D. Backstrom
On September 19, 2016, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) issued a report, EPA Needs a Risk-Based Strategy to Assure Continued Effectiveness of Hospital-Level Disinfectants, the result of OIG’s review of EPA’s Antimicrobial Testing Program (ATP) to “determine whether the program ensures the efficacy of EPA-registered hospital sterilants, disinfectants, and tuberculocides (“hospital-level disinfectants”); and to evaluate options for improving the ATP.” OIG found that the ATP “does not assure that hospital-level disinfectant products continue to be effective after they are registered,” specifically that:
- Once the EPA tests a product and it passes, it is listed as Agency Confirmed Efficacy on the agency’s website and is typically not tested again; the long-term efficacy of the product cannot be assured.
- EPA relies on manufacturers to voluntarily submit product samples for testing. In the last three years, out of the approximately 300 registered hospital disinfectant products that have not been tested, manufacturers submitted only 12 samples to EPA for ATP efficacy testing.
Importantly, however, OIG concludes: “Although the program as currently designed and conducted does not assure that most hospital disinfectant products continue to be effective, at this point it is redundant and unnecessary to make adjustments, since the EPA is concurrently having the products re-registered.”
OIG makes two major recommendations:
- EPA should suspend administering the current Antimicrobial Testing Program until completion of the one-time re-registration process.
- EPA should develop a risk-based antimicrobial testing strategy to assure the effectiveness of public health pesticides used in hospital settings once products are in the marketplace. At a minimum, OIG states, the strategy should:
- Include a framework for periodic testing to assure products continue to be effective after registration.
- Define a program scope that is flexible and responsive to current and relevant public health risks.
- Identify risk factors for selecting products to test.
- Identify the method to be used for obtaining samples for testing.
- Designate a date to commence risk-based post-registration testing.
In its response, EPA agreed with OIG’s recommendations, and stated it will develop a plan to coordinate and implement the discontinuation of the present-day program, with the closure of the ATP program to take place by November 2017. EPA also stated that by December 2018 it plans to develop a risk-based strategy to assure the effectiveness of public health pesticides used in hospital settings once products are in the marketplace.
Registrants of the affected products should monitor closely the development of EPA’s plans both to discontinue the program and to establish this new risk-based strategy for assuring product efficacy.
By Lisa M. Campbell, Lisa R. Burchi, and Margaret R. Graham
On September 16, 2016, the U.S. Environmental Protection Agency (EPA) announced it settled an enforcement matter with Syngenta Crop Protection, LLC (Syngenta or Respondent) via a Consent Agreement and Final Order (CAFO) concerning EPA’s allegations that Syngenta violated the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and EPA’s Pesticide Container and Containment Rule (PCCR). The investigation took place over three years, starting in August 2012 and concluding in January 2015. The multi-regional investigation which took place over three years, from August 2012 to January 2015, was conducted by EPA Regions 4, 5, 7, and 8, and found violations in six states: Ohio, Colorado, Iowa, Kansas, Michigan and Missouri.
The CAFO listed the alleged violations in three parts:
- Failure to have repackaging agreements and failure to maintain records concerning the repackaging agreements: In the CAFO, EPA states that it identified numerous and separate occasions when Respondent distributed or sold approximately 19 registered pesticides to approximately 222 refillers “prior to having written repackaging agreements in place with such refillers,” “and/or failed to maintain records of the repackaging agreements with the refillers.” The requirements for such agreements and record keeping are set forth at 40 C.F.R. §§ 165.67(b)(3), 165.67(d), and 165.67(h).
- Distribution and sale of misbranded pesticides: In the CAFO, EPA states that at least seven inspections conducted at different facilities that were refillers of Respondent’s pesticides found pesticides affixed with outdated labels, as well as sales of such products with outdated labels. EPA states that Syngenta was the registrant of all the products at issue and had provided the refillers with the outdated labels for repackaging the pesticide products in refillable containers or bulk tanks on at least 19 separate occasions.
- Failure to maintain data submitted for pesticide registration: In the CAFO, EPA states it conducted an inspection at two laboratories to review compliance with Good Laboratory Practice requirements, and to audit the data for studies submitted by Respondent to EPA to support one of its pesticide registrations. In both cases, Respondent informed EPA that it did not maintain records or raw data associated with the studies and the laboratories confirmed they did not maintain the records at their facilities.
Syngenta neither admits nor denies these allegations, but has agreed to pay a civil penalty of $766,508, as well as to complete an environmental compliance promotion Supplemental Environmental Project (SEP) within four years at a cost of not less than $436,990. Specifically, the SEP will involve a four-year educational awareness training and campaign to educate the regulated community on FIFRA regulatory compliance requirements pertaining to the PCCR. The training will focus on the requirements relevant to bulk pesticide containers, containment, labels, storage, transportation, delivery, clean-out, repackaging agreements, and recordkeeping. The training is intended to increase awareness across a broad array of businesses that handle pesticides, including registrants, refillers, retailers, commercial applicators, and custom blenders of pesticides.
EPA states that the settlement sends “a strong message to pesticide companies to maintain compliance with all federal environmental laws.” Indeed, the breadth of EPA’s investigation and the ultimate size of the penalty signify EPA’s focus on pesticide violations and, particularly, misbranded pesticides. EPA in recent years has focused on labeling violations between registrant and supplemental distributor labels and the issues in this case have some similarities, particularly the need for written contacts between registrants and refillers or supplemental distributors, and also the need to ensure that current pesticide labels are provided before repackaging and relabeling take place.
More information concerning supplemental distributors and repackaging is available in our blog item Registrants Penalized for Actions of Third-Party Pesticide Distributor, our memorandum EPA’s Enforcement Efforts Regarding FIFRA Supplemental Distribution and How to Avoid Noncompliance and in the materials from our webinar EPA's Supplemental Distribution: Enforcement Actions Are Buzzing: How to Avoid Getting Stung.
By Lisa R. Burchi and Margaret R. Graham
On September 2, 2016, the U.S. Environmental Protection Agency (EPA) issued guidance to registrants on the process for making claims against emerging viral pathogens not on EPA-registered disinfectant labels (Guidance). A draft of this guidance was issued in April 2016 and comments were sought at that time. More information concerning the draft guidance is available in our blog item EPA Combats Emerging Pathogens Through Updating Guidance for Antimicrobial Pesticide Products.
The current Guidance document, which EPA states “provides general guidance to registrants that can be used to identify effective disinfectant products for use against emerging viral pathogens and to permit registrants to make limited claims of their product’s efficacy against such pathogens,” includes changes incorporated following EPA’s review of the three public comments received in response to that draft.
The Guidance retains the voluntary two-stage process, but amends the first stage as indicated:
- In the first stage, which may be performed prior to any outbreak, registrants with an eligible disinfectant product may submit a request, via label amendment or during the registration of a new product, to control a specific emerging viral pathogen to add a designated statement to the master label and additional terms to the product registration. If the product meets the eligibility criteria suggested in this Guidance, [EPA] generally will approve the amendment. Approval of the amendment would include additional terms and conditions of registration regarding how the designated statement may be published and communicated.
In its response to comments document, EPA responded to several comments, including:
- Changes were made to EPA’s mandated non-label statements to remove certain language that could be considered redundant.
- EPA is developing a coordinated process with the Centers for Disease Control and Prevention for the purpose of providing a more standardized and consistent approach to emerging viral pathogen outbreaks. Once this process is established, the agency expects to consult with the U.S. Department of Agriculture to develop a similar approach.
- The Guidance document allows for the addition of emerging pathogen claim language to the master label during the new product registration process if the product is eligible. Additional language has been added to multiple locations in the Guidance document to clarify that the process is appropriate for new product registrations.
- EPA “may consider allowing use of additional modes of claim communication under future versions of this Guidance document, however, hangtags and other promotional materials are not authorized at this time. Because the statements authorized under this Guidance are pesticidal claims that do not meet the FIFRA registration criteria, it is essential that these off-label claims are not made outside of an emerging pathogen outbreak as described in the Guidance. Accordingly, the Guidance limits these off-label claims primarily to communications outlets that are wholly within the registrant’s control (800 numbers, social media and websites) from which the off-label claims can be immediately removed. Hangtags and other promotional materials directed towards general consumers are largely out of the registrant’s control once the products enter the chain of commerce, and may persist long after the period during which the off-label claims are authorized.”
EPA also notes that this Guidance document “provides general guidance to EPA, pesticide registrants, applicants for pesticide registrations, and the public. This guidance is not binding on EPA or any outside parties, and EPA may depart from the guidance where circumstances warrant and without prior notice.”
by James V. Aidala
The threat of the Zika Virus grows every day, and the need for clear information is especially pressing if you are pregnant. How do you prevent getting infected with the Zika Virus, and what insect repellents are best? The first question is easy to answer: public health experts agree that women who are pregnant or who might be pregnant should use insect repellents. The answer to the second question is not so simple.
I am a former senior official at the U.S. Environmental Protection Agency (EPA), and familiar with how the U.S. evaluates and approves pesticides, which include insect repellents. It is not easy for the average consumer to know what works and what does not work. Unfortunately, EPA policies have made this question much more complicated, having made important distinctions between some “natural”-type repellents and other products available in the marketplace.
Years ago, EPA de-regulated a number of natural, non-toxic materials from being subject to the registration requirements of the federal pesticide law (the Federal Insecticide, Fungicide, and Rodenticide Act). This made sense at the time since garlic, pepper, rotten eggs, vinegar, and other common chemicals are sometimes used as pesticides. Before de-regulation, these products were also subject to the same requirements as synthetic chemical pesticides with long unpronounceable names (e.g., diethyltoluamide, better known as DEET) which EPA requires to have volumes of efficacy and safety test data. Being natural does not mean a substance is non-toxic; some natural ingredients are fully evaluated and widely used. But in the interest of efficient use of resources EPA issued a list of products that could be sold as pesticides, but would not be subject to EPA data requirements and review (EPA calls them “minimum risk pesticides”).
This list of pesticides which are not subject to EPA evaluation, and which are not required to have data which proves they are effective, includes a number of botanical ingredients, such as oil of citronella, geranium, rosemary, peppermint, and many others. Many of these products can be used as pesticides -- some may work better than others -- and many work for the intended use (example: rotten eggs, or as EPA refers to them -- “putrescent whole egg solids” -- are used as a deer repellent).
Many of these ingredients have been marketed as “natural” insect repellents, and labeled as “safe” or “non-toxic” using words that will not appear on products where EPA reviews and approves the instructions on the product label.
Here is the bureaucratic distinction which matters greatly to EPA, but will not be understood by consumers:
- If the repellant label includes “public health claims” -- that it repels mosquitoes that may cause a disease (like Zika Virus or West Nile Virus) -- then the product has to have data showing that it works;
- If the product just says “repels mosquitoes,” it is not required to have data that shows it is effective, and may very well be ineffective.
Few, if any, humans outside of EPA label experts realize this important distinction: if there is no health claim on the label, then it is, in effect, a situation of “buyer beware.”
What remains: EPA’s deregulation of these products means it is legal to sell products which do not work, as long as the ingredients appear on the EPA minimum risk pesticides list.
Consumer Reports (CR) recently reported in May of this year on studies conducted on repellents. Their results:
- Using a “natural” mosquito repellent, with active ingredients such as citronella or clove, lemongrass, or rosemary oils, might seem like a good idea, especially if you’re pregnant or planning to be.
- But five of the six plant-based repellents we tested…lasted one hour or less against Aedes mosquitoes, the kind that can spread Zika.
Not all repellents with the same ingredient are equally effective, and they found that some formulations of the chemical repellents also do not work for very long in their tests. Some botanical pesticides are effective and have the public health claims on the label (example: lemon eucalyptus, a botanical ingredient not on the exempt product list, and CR testing did find it to be effective).
To reduce confusion about what works, EPA for years has struggled to correct the situation by trying to impose changes to the requirements for insect repellents.
Unfortunately, to end the confusion about the difference between “repels mosquitoes” and “repels mosquitoes that can cause the Zika Virus,” EPA has to conduct a rulemaking which requires a long and bureaucratic process to complete. The good news is that EPA is working on such a solution. The bad news is that they have been working on it for almost ten years and they still have more work to do. There are details and petitions and proposals and reasons why it has taken so long, but it is the kind of story that gives bureaucracy a bad name.
With the onset and fears about the Zika Virus, however, EPA should make the needed changes immediately to ensure that consumers are not misled into using products which are not proven effective in repelling mosquitoes.
From a consumer’s point of view, it really is that simple. Legally, it is more complicated. In the meantime, EPA should be loud and clear in its communication about the distinction, even if they cannot take immediate action to reduce the confusion.
By Lisa M. Campbell, Timothy D. Backstrom, and Lisa R. Burchi
On August 12, 2016, a three-judge panel of the Ninth Circuit Court of Appeals issued an order denying the U.S. Environmental Protection Agency’s (EPA) request for an additional six months to decide whether to ban agricultural uses of chlorpyrifos. The court opted instead to afford EPA a three month extension, stating that “this is the final extension, and the court will not grant any further extensions."
EPA sought the six month extension on June 29, 2016, to allow time for EPA to complete two scientific analyses that may bear on EPA’s conclusions in the final rule, and to request further public comment before taking final action on a prior proposal to revoke all chlorpyrifos tolerances. The two analyses that EPA wanted to complete are: (1) a refined drinking water assessment that may allow EPA “to develop more tailored risk mitigation for some regions of the country,” and (2) an evaluation of the epidemiological data for chlorpyrifos to determine whether EPA should retain the point of departure based on acetylcholinesterase (AChE) inhibition in the proposed rule.
The court concluded that EPA’s request for a six month extension “is not justified in light of EPA’s history in this matter as well as the court’s previous extensions.” The court stated that EPA’s request was "another variation on a theme 'of partial reports, missed deadlines, and vague promises of future action' that has been repeated for the past nine years,” and that “nothing has changed that would justify EPA’s continued failure to respond to the pressing health concerns presented by chlorpyrifos."
The court ordered EPA to take final action on its proposal to revoke tolerances for chlorpyrifos by March 31, 2017. A further status report by EPA will be due in November 2016.
EPA’s updated analysis of the epidemiological data for chlorpyrifos will be a matter of considerable interest. After EPA issued a proposed rule utilizing a point of departure for chlorpyrifos based on AChE inhibition, EPA issued a blanket determination based on the epidemiological data for chlorpyrifos in which EPA decided to retain the Food Quality Protection Act (FQPA) safety factor for all organophosphate (OP) pesticides. This FQPA determination could cause EPA to conclude that the tolerances for chlorpyrifos must be revoked regardless of the outcome of the refined drinking water assessment.
EPA later proposed to use an alternative point of departure for chlorpyrifos based on biomonitoring data from one of the chlorpyrifos epidemiology studies, but the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) met on April 19-21, 2016, and recommended against this new approach. In its request for an extension, EPA stated that the FIFRA SAP might recommend a “hybrid approach” to adjusting the point of departure for AChE inhibition. The FIFRA SAP meeting minutes do not appear to include such a hybrid recommendation.
In a related development, EPA has reached an agreement with the Columbia Center for Children’s Environmental Health (CCCEH) regarding the release of raw data from one of the chlorpyrifos epidemiology studies. During the FIFRA SAP meeting, concerns were raised regarding use of the CCCEH study without access to the underlying raw data. In an April 19, 2016, letter to Dr. Linda P. Fried, Dean of the Mailman School of Public Health at Columbia University, EPA requested that CCCEH provide access to the underlying data. In her response dated May 18, 2016, Dr. Fried offered to work with EPA “to determine if we can develop one or more data sets that can be properly de-identified, consistent with our obligation to protect the privacy of our research subjects, and that will also enable EPA to conduct its own analyses in order to address its transparency goals” or, in the alternative, offered to allow EPA staff to review the original data “in a secure data enclave onsite at Columbia.” In its June 27, 2016, response, EPA stated that the offer to allow EPA staff to review the underlying data at a secure site did not resolve issues concerning the transparency of EPA’s analysis. This correspondence is available in EPA Docket ID EPA-HQ-OPP-2008-0850. While EPA maintained it is “unnecessary” for CCCEH and EPA to develop redacted data sets, EPA accepted CCCEH’s offer to develop such data sets.
EPA’s request for a six month extension was filed on June 29, 2016, two days after it accepted the offer by CCCEH to develop redacted data sets for the CCCEH epidemiology study. Moreover, the FIFRA SAP meeting minutes issued on July 20, 2016, do not appear to provide the guidance that EPA had expected concerning a potential “hybrid” approach to adjusting EPA’s proposed point of departure for AChE inhibition.
Given the lesser extension granted by the court, it is questionable whether EPA will have sufficient time to review adequately the redacted underlying data sets offered by CCCEH, or even to determine whether those redacted data sets are adequate for this review, and to make any determination based on such data before EPA issues a supplementary proposal based on the refined drinking water assessment and the updated epidemiology assessment. The court has stated that it will entertain no further extension requests, so EPA must complete its work expeditiously to allow time for comment before final action is due on March 31, 2017.
By Lisa M. Campbell and Lisa R. Burchi
The U.S. Environmental Protection Agency (EPA) today released a pre-publication version of a Federal Register notice to be issued on August 16, 2016, extending the deadline to submit comments on draft Pesticide Registration Notice (PRN) 2016-X from August 15, 2016, to September 14, 2016. A discussion of draft PRN 2016-X, which proposes to update Section 5 of PRN 97-2, and to clarify and update criteria by which EPA classifies crops as “minor use,” is discussed in our blog item EPA Solicits Comments on Updated Method for Establishing Economic Minor Use.
In the notice extending the comment period, EPA noted that the current comment period is “one of the busiest times of year for pest control experts” and provides an extension that “will allow them extra time to complete their review and comment on the PR Notice.”
There is one comment that already has been submitted by the U.S. Department of Agriculture (USDA), which EPA stated it consulted prior to releasing the draft PRN 2016-X. In its comments, USDA states:
- Regarding acreage cutoffs, USDA supports EPA’s use of acreage estimates from the USDA Agricultural Census, as it is the “most reliable and comprehensive public source for such information in the country.”
- Regarding EPA’s proposal to apply a seven percent discount rate, USDA recommends that EPA be “open to using supplemental information in determining whether or not an alternative discount rate should be considered.”
- Regarding EPA’s proposal that all cases be evaluated using values for costs that range from 60 to 85 percent of gross revenue, USDA requests that EPA provide its rationale as to why this range was chosen. USDA states: “Although USDA understands that EPA is attempting to reveal the ratio of gross revenue to cost associated with the minor use rather than across an entire company, one could assume that a rational company would not pursue registering a minor use if the ratio of costs to gross revenue was exceedingly higher than the average standard ratio for the company. Qualitative information, as suggested by EPA, could then be used to further refine the estimate for this ratio.”
- Regarding EPA’s proposal to use study cost estimates provided by independent laboratories, USDA notes there are instances where data can be significantly more expensive than what would be expected generally and, thus, recommends that EPA “be open to additional, verifiable data a registrant wishes to submit that may indicate that its cost of data generation differs from EPA's standard estimates.” USDA also suggests that EPA “consider making the cost estimates it is using for individual tests available publically to aid registrants in determining whether or not they need to submit alternative incurred costs for studies they have conducted.”
By Lisa M. Campbell and Lisa R. Burchi
The comment deadline of August 15, 2016, is approaching on the June 14, 2016, notice of availability of the draft Pesticide Registration Notice (PRN) 2016-X issued by the U.S. Environmental Protection Agency (EPA), in consultation with the U.S. Department of Agriculture (USDA). Draft PRN 2016-X proposes to update Section 5 of PRN 97-2, and to clarify and update criteria by which EPA classifies crops as “minor use.”
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 2(ll) defines “minor use.” One of those definitions at Section 2(ll)(2) defines a minor use, in part, as one that does not provide “sufficient economic incentive.” Current guidance in PRN 97-2 defines a use as minor under FIFRA Section 2(ll)(2) if gross revenues at full market potential do not cover the costs of registration. EPA’s concern with this policy is, in part, that:
- [T]he method in PRN 97-2 does not accurately measure economic incentive to register pesticides. Gross revenue will overstate the registrant’s true return on the cost of registration while reliance on a single year of sales will understate the total stream of revenues. The direction of bias is unknown. Most importantly, it does not account for the difference in timing between costs of registration and future returns.
EPA states that the draft PRN is intended to clarify and update “its interpretation of how economic minor use status under FIFRA section 2(ll)(2) can be determined.” Under the proposed PRN, EPA would interpret a minor use as one that “does not provide sufficient economic incentive to support the … registration” when “the registrant would not obtain sufficient revenues from sales of the pesticide to justify the cost of registration.” Specifically, EPA states:
- This PRN describes the revised approach to interpreting economic minor use based on the concept of the registration of a pesticide as an investment. The registrant incurs costs associated with applying for a registration while the registration once granted allows the pesticide product to be sold, generating a stream of revenue in the future. This approach provides several measures by which EPA can assess whether there are sufficient incentives for the registration of a pesticide use. These measures include the net present value of returns, the benefit-cost ratio, and the internal rate of return, each of which provides insight into the magnitude of the incentive to register or maintain the registration of a pesticide.
With regard to calculating the net present value (NPV) of the investment (in registration), EPA provides the following formula:
In the draft PRN, EPA provides guidance on the four primary components to conduct a quantitative analysis to estimate NPV, the benefit-cost ration (B/C), and the internal rate of return (IRR). These components are: (1) costs of registration (e.g., cost to generate data necessary to show the product can be used safely for the proposed use, PRIA fees, cost to prepare and submit an application); (2) net revenues from sales of the pesticides; (3) the discount rate; and (4) the time of investment. EPA states that, in general, “if a use of a pesticide has a negative NPV, a B/C ratio < 1, and IRR that is lower than average for a particular sector, it will be considered to have insufficient economic incentives to pursue registration.” EPA is not setting a firm threshold, however, and will review minor use determinations on a case-by-case basis.
For a use that the applicant requests a designation of economic minor use under FIFRA Section 2(ll)(2), the applicant should include the following types of information in writing with the application:
- The type of registration action for the specific site/use;
- A list of the registration data requirements for the specific site/use;
- Information to inform future sales, which might include the target pest(s), the application rate, the extent of the pest problem;
- Information to inform the sales price of the pesticide, which might include the price of relevant competitors; and
- A narrative addressing at least one of the criteria described in FIFRA section, 2(ll)(2)(A-D). This summary should contain, at least, a brief description of how the pesticide will be used including the target pest(s) and alternatives.
Applicants may also wish to include the following to improve EPA’s understanding of the incentives they face in producing and/or registering a pesticide for the specific use:
- A narrative describing any relevant factors that influence the cost of manufacturing and, therefore, the net revenue from product sales;
- A narrative describing any relevant factors that influence the fixed costs of registering and marketing the pesticide;
- A narrative describing any aspects of the market that might limit or enhance sales; and
- A narrative describing any other factors which affect the economic incentive to register this use.
EPA states its intent in revising the method and criteria for determining when a potential minor use does not present a sufficient economic incentive is because the current “outdated approach could prevent applicants from obtaining the incentives for registration that should be available to them.” EPA further states that it is interested in developing an approach that is “simple and transparent” because a burdensome process would be “an added deterrent to registration.” The draft PRN would indeed seem to expand the ability of registrants to seek minor use status; since EPA will be making determinations under this revised approach on a case by case basis, how broadly EPA will apply these criteria and what minor use approvals it makes will only be seen over time, however.
It is important to note that EPA’s proposed policy has potential implications beyond minor use determinations. For example, EPA’s discussion of the elements of the costs of registration as well as how those costs for applying for a registration are a part of the registrant’s investment could have implications in FIFRA data compensation contexts:
- The cost of applying for registration can be viewed as an investment toward the eventual marketing of a registered product. Applying for registration is the final step in the process of developing and marketing a pesticide. The costs of applying for registration include the costs of generating data that EPA requires for registration, the registration fees, and the cost of paperwork burden from the registration process. In terms of “economic incentive,” the main question to answer is whether the investment in registration of a particular use is worthwhile to the registrant, that is, whether future returns from sales are sufficiently high to justify the cost of obtaining/maintaining a registration.
The proposal also is significant because it can be applied to conventional pesticides, biopesticides, and antimicrobial pesticides to determine whether they meet the definition of minor use.
Comments are due August 15, 2016.
By Lisa M. Campbell and Lisa R. Burchi
On July 29, 2016, the Environmental Appeals Board (EAB or Board) issued its Final Decision and Order (Order) upholding the Administrative Law Judge (ALJ) Initial Decision and an earlier order denying Bayer CropScience LP and Nichino America, Inc.’s (BCS/NAI) Motion for Accelerated Decision that held that the U.S. Environmental Protection Agency (EPA) was authorized to cancel the conditional flubendiamide registrations under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 6(e) and did not need to provide BCS/NAI the full Section 6(b) cancellation process. The Board also upheld EPA’s determination prohibiting BCS/NAI from the continued sale, distribution, and use of existing stocks of flubendiamide products, but found that EPA’s determination to prohibit the continued sale and distribution of existing stocks of flubendiamide end-use products by distributors and retailers other than BCS/NAI was not supported by the record.
Additional information regarding this case is available in our blog items EPA ALJ Issues Initial Decision in Bayer Flubendiamide Cancellation Proceeding, EPA ALJ Denies Bayer’s Motion for Accelerated Decision and Flubendiamide Registrants and EPA File Post-Oral Argument Briefs.
The EAB summarized BCS/NAI’s arguments concerning the overall proceeding with two questions: (1) whether EPA has properly initiated this cancellation action under Section 6(e) rather than Section 6(b); and (2) if the proceeding is properly initiated under Section 6(e), whether BCS/NAI can nonetheless challenge the lawfulness of a condition in their registrations in a Section 6(e) proceeding.
With regard to the first issue, the Board found that EPA appropriately commenced the proceeding under the expedited cancellation procedures set forth in FIFRA Section 6(e) because two criteria were satisfied: (1) the registration must have been issued as a conditional registration under FIFRA Section 3(c)(7); and (2) EPA must have determined that BCS/NAI failed to satisfy a condition of that registration. The Board found that “neither the plain language of the statute, its structure, nor legislative history” supported BCS/NAI’s argument that if EPA “has made an unreasonable adverse effects finding, FIFRA’s general cancellation provision in section 6(b) trumps section 6(e) and bars the Program from initiating a 6(e) cancellation proceeding, even where the elements for a section 6(e) cancellation are met.” The Board further stated: “Bayer and Nichino’s argument that section 6(b) takes priority over section 6(e) is inconsistent with the structure and environmental protection goals of FIFRA.” Instead, EAB states:
- Given Congress’ decision to add an expedited cancellation provision to FIFRA -- separate and independent from section 6(b) -- it is difficult to square FIFRA’s environmental protection goals with Bayer and Nichino’s argument that the Pesticide Program must use the more time-consuming and resource-intensive section 6(b) procedures to cancel a pesticide in circumstances where section 6(e)’s expedited procedures are applicable. That is particularly the case when one considers that, unless the Program issues an “emergency order,” a registrant is allowed to sell and distribute the pesticide during the course of section 6 cancellation proceedings. See FIFRA § 6(b)-(c), 7 U.S.C. § 136d(b)-(c). If the Program were required to initiate cancellation proceedings under section 6(b) instead of under section 6(e), registrants would, in effect, be rewarded with additional time to sell and distribute their pesticides. Had Congress intended such a result, it could have subordinated section 6(e) to section 6(b) when it added the new conditional registration authority (including section 6(e)) to the existing statutory structure in 1978. See S. Rep. No. 95-1188, at 11 (1978) (Conf. Rep.). But Congress did not take such a step. Rather, in creating the possibility of allowing pesticides to be introduced to the market conditionally when they could not meet all the requirements for a general registration, Congress took steps to assure that such pesticide registrations could be promptly canceled when the terms of the conditional registrations were not met.
The Board also found that BCS/NAI could not demand a Section 6(b) cancellation proceeding because they “willingly accepted the termination condition in 2008 and 2009, knowing that it required them to submit a request for voluntary cancellation if the Program were to issue a determination that flubendiamide causes unreasonable adverse effects.” EAB stated: “Given the language of the conditional registrations, Bayer and Nichino’s affirmative concurrence on that language, and the record of negotiations, we find that Bayer and Nichino willingly agreed to the termination condition, knowing that they were agreeing to an approach that could remove the flubendiamide products from the market rapidly. Having knowingly agreed to this procedure, they cannot contest it now.”
With regard to the second issue as to whether BCS/NAI can nonetheless challenge the lawfulness of a condition in their registrations in a Section 6(e) proceeding, EAB found that the scope of a Section 6(e) cancellation is “narrowly limited to the following issues: (1) whether the condition was satisfied, and (2) whether the Pesticide Program’s determination on the appropriate disposition of the existing stocks of the canceled pesticide is consistent with FIFRA.” The Board found that the facts in this particular case demonstrated that BCS/NAI “had ample opportunity to challenge the lawfulness of the termination condition in a timely and permissible way but failed to do so.” EAB noted, for example, that BCS/NAI could have declined to accept the registration terms and challenged EPA’s refusal to grant a conditional registration with terms acceptable to BCS/NAI. The Board further found that BCS/NAI understood the consequences of agreeing to the condition at issue and thus “knew, or should have known given the clarity of section 6(e), that any objection they had to the condition giving the Pesticide Program the option to effectively require cancellation without instituting a section 6(b) proceeding could not be raised in a section 6(e) cancellation for failure to comply with the termination condition.”
As for the specific issues that the Board stated were properly before it in this appeal, it found BCS/NAI did not comply with their obligation to submit voluntary cancellation requests. The Board rejected arguments that BCS/NAI’s failure to request cancellation is excused because EPA did not meet an important pre-condition to the termination condition by “engaging in dialogue” with BCS/NAI regarding the data and EPA’s conclusions related to that data. Specifically, the Board found that this objection was not timely raised and thus was precluded, but that even if it had not been precluded, BCS/NAI had failed to establish by a preponderance of the evidence that EPA did not engage in such dialogue.
One aspect of the EPA’s determination that was overturned relates to whether existing stocks can continue to be sold or distributed. Although the Board upheld as reasonable EPA’s denial of the sale and distribution of existing stocks by BCS/NAI because they violated the termination condition, EAB amended EPA’s existing stocks determination described in the Notice of Intent to Cancel “to allow distributors and retailers other than Bayer and Nichino to sell and distribute end-use flubendiamide products that have been formulated, packaged, and labeled for use and [that] have been shipped or released into commerce to distributors on or before the date of this Final Decision and Order, until those stocks are exhausted.” EAB instead stated that EPA’s “rationale for denying the sale and distribution of existing stocks by Bayer and Nichino -- because they violated the terms of their conditional registrations -- has limited, if any, applicability to non-registrants.” Distributors and retailers other than BCS/NAI can continue to sell and distribute end-use flubendiamide products that were formulated, packaged, and labeled for use and shipped or released into commerce to distributors on or before the date of this Final Decision and Order, until those stocks are exhausted.
Although the resolution of this case has potential implications for current and future registrations, EPA has acknowledged the unique circumstances of this case, and indicated that it is unlikely that a conditional registration like that issued for flubendiamide will be issued again. If a registrant ever finds itself in a similar position to BCS/NAI, or facing a situation, as EPA has indicated, that seeks a condition of registration that would allow a registration to simply expire, such companies should carefully consider how to proceed, including considering options to challenge the lawfulness of the condition proposed by EPA or to demonstrate that the applicant/registrant is entitled to a general, not conditional, registration.