Bergeson & Campbell, P.C. serves small, medium, and large pesticide product registrants and other stakeholders in the agricultural and biocidal sectors, in virtually every aspect of pesticide law, policy, science, and regulation.

By Lisa M. Campbell and James V. Aidala

On February 1, 2016, the U.S. Environmental Protection Agency (EPA) announced that Yu-Ting Guilaran has been selected as the new Director of the Pesticide Re-Evaluation Division (PRD) within the Office of Pesticide Programs (OPP), effective February 7, 2016.  Yu-Ting has been the Biological and Economic Analysis Division (BEAD) Director since 2013, and with the agency for nearly 25 years.  She has worked in EPA’s Office of Water, Office of International and Tribal Affairs, and Region 10’s Superfund program prior to joining OPP.  Yu-Ting holds a BS and a MS Degree in Civil Engineering with emphasis in environmental engineering from the University of Washington in Seattle.  Wynne Miller will serve as acting Director for BEAD until that position is filled.  


 

By Lisa M. Campbell and Margaret R. Graham

On January 28, 2016, in docket EPA–HQ–OPP–2015–0302, the U.S. Environmental Protection Agency (EPA) posted its revised Antimicrobial Pesticides Use Site Index (USI).  In the USI, EPA states that it “has developed [the USI] to provide guidance about the antimicrobial pesticide use sites associated with these antimicrobial pesticide use patterns,” and it “is a guidance document to assist applicants in identifying the data that are necessary to support registration of products and to determine if labeled uses necessitate establishment of a tolerance or exemption from the requirement of a tolerance.”  EPA also posted a Response to Public Comments which stated that there have been a number of changes based on comments received, specifically from the American Chemistry Council’s Biocides Panel (ACC or Panel) and the Consumer Specialty Products Association (CSPA).  These changes include:

  • Clarifying that the USI is a guidance document and that the sites in the USI are not intended for use in labeling;
  • Simplifying the USI by organizing example use sites into broader groups;
  • Using a tabular format to provide examples of use sites organized by food use description (i.e., direct food use, indirect food use, and nonfood use) within each major use pattern category to make it easier to follow;
  • Clarifying that “food” is defined under the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. Section 321(f), and that definition applies, as appropriate, to all food use descriptions;
  • Revising the description of “nonfood use” to provide better clarity;
  • Deleting from the USI some example use sites that were ambiguous, too vague, too specific, or incorrectly categorized regarding major use pattern category or food use description; and
  • Incorporating many of ACC’s suggestions of specific use sites to include in the materials preservatives and wood preservatives general use pattern categories.

More information regarding the draft USI is available in our blog post EPA Releases Guidance Document:  Antimicrobial Pesticides Use Site Index.

 

 


 

By Lisa M. Campbell, Lisa R. Burchi, and Timothy D. Backstrom

On January 25, 2016, in a significant development in the case involving the continued registration of DowAgrosciences LLC’s (DowAgro) Enlist Duo product, the U.S. Court of Appeals for the Ninth Circuit in Case Nos. 14-73353, et al. (consolidated), denied the U.S. Environmental Protection Agency’s (EPA) motion for voluntary vacatur of the Enlist Duo registration, but granted EPA’s motion to remand its decision granting that registration.  DowAgro’s December 7, 2015, response to the EPA motions stated that DowAgro had “absolutely no problem with the requested remand to allow the agency to review that information, and hereby consents to such relief.”  DowAgro did oppose EPA’s request that the court vacate the registration, arguing that EPA was attempting to circumvent the normal cancellation process by having the court vacate the registration.  The case will now be remanded to EPA, and the Enlist Duo registration remains nominally in place.  The court’s order allows EPA to consider further action to vacate the registration, but this appears unlikely since DowAgro has previously indicated that it is willing to “stop sales of Enlist Duo, and to work out an appropriate agreement to that effect with the agency.”  After reviewing the new information concerning synergistic effects recently submitted by DowAgro, EPA will then make a new decision concerning the registration of Enlist Duo.

The court also denied DowAgro’s motion to strike the Natural Resources Defense Council’s (NRDC) December 17, 2015, reply in support of EPA’s motion for vacatur and remand.  DowAgro moved to strike NRDC’s reply because NRDC’s pleading was more of a “reply brief” than a response, and a “litigant has no right to file a ‘reply’ brief in support of a motion filed by another party.”  DowAgro’s motion to strike included a request to the court to grant it leave to respond to NRDC’s filing as well as a proposed response brief.  This procedural question is now moot because the court has acted on the EPA motions and the registration has been remanded to EPA.

More information on the recent case proceedings is available in our blog entry EPA Replies in Support of its Motion for Voluntary Vacatur and Remand.


 

By Lisa M. Campbell and Timothy D. Backstrom

On January 6, 2016, a complaint was filed against the U.S. Environmental Protection Agency (EPA) in the United States District Court for the Northern District of California by a coalition of U.S. beekeepers, farmers, and affiliated non-government organizations (Petitioners).  The Petitioners allege that EPA has allowed “the ongoing sale and use of unregistered pesticide products”  because, they claim, EPA has incorrectly construed seeds coated with neonicotinoid insecticides to be “treated articles” exempt from registration under 40 C.F.R. § 152.25(a).  Petitioners argue that a 2013 guidance document prepared by EPA for enforcement personnel investigating bee incidents improperly expanded the scope of the “treated article” exemption and was in effect an unlawful rule issued without prior notice and comment.

According to Petitioners, seeds coated with neonicotinoid pesticides should not be considered eligible for the “treated article” exemption because the neonicotinoid pesticide in the coating acts systemically to protect the growing plants after the seeds germinate, rather than to protect the seeds themselves.  Based on this analysis, Petitioners argue that each coated seed product is in fact a separate unregistered pesticide that has not been properly evaluated under FIFRA.  Petitioners also argue that pesticide loss from these coated seeds has a variety of collateral environmental effects, including effects on pollinators that EPA has not appropriately considered.

The Petitioners have requested that the District Court provide declaratory relief stating that seeds coated with neonicotinoid insecticides are not eligible for the treated article exemption.  Petitioners also request that the District Court enjoin EPA from:  (1) allowing any new unregistered neonicotinoid-coated seeds of any crops; and (2) allowing any new unregistered seeds of any crops if they are coated with other systemic insecticides that cause pesticidal effects extending beyond the coated seed and plant itself.

Commentary

The potential consequences of a reviewing court finding that EPA has improperly construed or expanded the “treated article” exemption by including seeds coated with neonicotinoid insecticides are of significant concern.  Such a construction could require that EPA separately register each type of coated seed under FIFRA, regardless of whether EPA adequately evaluated the risks associated with seed treatment when each insecticide was first registered for this use.  EPA could seek dismissal of some or all of the Petitioner’s claims on jurisdictional grounds, arguing that the risks and benefits of seed treatment were considered at the time each neonicotinoid insecticide was registered for such use, and that the Petitioners should have sought prior review of those registration decisions in the Court of Appeals within the applicable 60-day window.  EPA may also object to the apparent failure of the Petitioners to exhaust their administrative remedies before challenging the policy embodied in the purported “rule,” and also to the Petitioners’ extensive reliance on extra-record evidence.


 

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

On January 6, 2016, the U.S. Environmental Protection Agency (EPA), in collaboration with California’s Department of Pesticide Regulation (DPR) announced the release of a preliminary pollinator risk assessment for the neonicotinoid insecticide, imidacloprid (Preliminary Risk Assessment or Assessment).  In its assessment, EPA states that imidacloprid potentially poses a risk to hives when the pesticide comes in contact with certain crops that attract pollinators. 

EPA coordinated efforts with Canada’s Pest Management Regulatory Agency (PRMA).  PMRA simultaneously released the overview and science evaluation of its imidacloprid pollinator-only assessment, which reaches the same preliminary conclusions as set forth in EPA’s Assessment.  PMRA plans to release the complete assessment with appendices as a revised version on January 18, 2016, and to accept written comments until March 18, 2016.

EPA’s Preliminary Risk Assessment will be subject to a 60-day comment period commencing on the announcement of the Assessment in the Federal Register.  EPA did not indicate how long it will be before the Federal Register notice is issued. 

This Assessment is the first of four such assessments that will be prepared in 2016 under President Obama’s National Pollinator Strategy.  The other three assessments, for neonicotinoid insecticides clothianidin, thiamethoxam, and dinotefuran, are scheduled to be released for public comment in December 2016.  EPA also states that following the receipt of public comments on this Assessment by December 2016, it plans to issue a revised Preliminary Ecological Risk Assessment that will: “(i) consider any comments or information submitted in response to this bee-only preliminary risk assessment; (ii) incorporate additional data EPA anticipates to receive that is relevant to bees; and, (iii) assess the potential risks of all registered uses of imidacloprid to all taxa.”

EPA’s Preliminary Risk Assessment describes how EPA conducted a screening level assessment (Tier I) for the various uses of imidacloprid, with a stepwise, tiered risk assessment approach evaluating risks to individual bees first and, if needed, risks to the colony.  EPA has divided its risk findings for honey bees for the registered use patterns of imidacloprid into three categories:  (1) Crop Groups/Use Patterns that Present Low On-Field Risk; (2) Crop Groups/Use Patterns with Uncertainty in Colony (Tier II) Assessment; and (3) Crop Groups/Use Patterns with Colony (Tier II) Risk Indicated, with this last category including “Citrus Fruits (Oranges)” and “Oilseed (Cotton).”  EPA further states:  “Based on a tri-agency analysis of the statistical and biological considerations of the data, a NOAEC and LOAEC of 25 and 50 μg a.i./L in nectar were determined based on reductions of the number of adult workers, numbers of pupae, pollen stores and honey stores which persisted across much of the study duration.  The level of imidacloprid in nectar at or below which no effects would be expected to the colony is determined to be 25 μg a.i./L.”

Additional information regarding EPA’s actions regarding neonicotinoid insecticides and the National Pollinator Strategy can be found on our blog.  EPA stated its intent to hold a webinar regarding the imidacloprid Preliminary Risk Assessment in early February 2016.  More information can be found on EPA’s website.

Commentary

EPA’s statements about the assessment have indicated that imidacloprid uses on citrus and cotton are of greatest concern.  Not included in this assessment is what, if any, specific regulatory actions might be needed to reduce any risks to an acceptable level.  Regardless, the registrants, along with other stakeholders, will almost certainly comment on the assessment (likely to say that the risks are both overestimated, according to the registrants, and underestimated, according to environmental groups).

What may be of less notice is what EPA appears to conclude about the other uses of the pesticide.  Not long ago, many claimed that significant honeybee decline was due to planting crops, especially corn, with neonicotinoid seed treatments such as imidacloprid.  This assessment appears to contradict that assertion (along with other improvements that have been made in reducing fugitive dust exposures during application).  And, even if EPA is correct in its assessment that the citrus and cotton uses are of concern, there are many other uses of imidacloprid currently suspended from the market in the European Union (EU) -- where cotton and citrus are not widely produced.  This EPA assessment might become part of the debate about the rationale behind the current EU policies.  

The documents released today are long (the assessment is 305 pages with an appendix of 212 pages).  That EPA plans to complete its assessment within this calendar year indicates that current EPA leaders want any decision to be issued (or at least be framed) before the arrival of any new Administration.  That alone will cause some to question the degree to which any actions are based more on “science and data” or on the “politics” of pollinator protection.  


 

By Lisa M. Campbell and Lisa R. Burchi

The final rule revising the U.S. Environmental Protection Agency (EPA) regulations governing the minimum risk pesticide exemption from pesticide registration requirements was published in the Federal Register on December 28, 2015.  The revisions include codifying the inert ingredients list and adding specific chemical identifiers, where available, for all active and inert ingredients permitted in products eligible for the minimum risk pesticide exemption.  Labeling requirements for minimum risk pesticides are also revised to require manufacturers to list ingredients on product labels with a designated label display name and to provide the producer’s contact information on the products’ labels.  EPA states that the revisions are intended to “clarify the terms of the original exemption and to provide additional clarity and transparency concerning the ingredients that are currently used in exempted products.”  Information regarding the proposed rule that was issued on December 31, 2012, is available in our memorandum entitled EPA Proposes Revisions to Minimum Risk Exemption for Pesticides.

The final rule will become effective on February 26, 2016.  The compliance date for the new label requirements is February 26, 2019

Under the revised regulations, the minimum risk exemption requirements are as follows:

  • Condition 1:  The product's active ingredients must be only those that are listed in 40 C.F.R. Section 152.25(f)(1).  Previously, the regulations included only the names of the active ingredients.  Under the newly revised reguations, the new Table 1 includes the “Label Display Name,” the “Chemical Name,” any “Specifications,” and the Chemical Abstracts Services Registry Number (CAS No.). 
    • In response to comments, EPA restored two active ingredients inadvertently omitted from the proposed rule (sodium chloride and ground sesame plant) and clarified how “mint and mint oils” are listed.  EPA also has changed the name of one active ingredient from cedar oil to cedarwood oil and clarified its chemical names and CAS Nos.
    • EPA removed United States Pharmacopeia (USP) specifications for 19 active ingredients because such specifications would have removed technical grade active ingredients that are currently eligible but do not meet USP specifications, and EPA states that it did not intend with this rule to add or remove substances from the ingredients list.  The USP specification for castor oil remains since that was part of the original active ingredient list.

 

  • Condition 2:  Prior to these revisions, EPA’s regulations stated that a product's inert ingredients may be only those that have been classified by EPA as:  (1) List 4A “Inert Ingredients of Minimal Concern”; (2) commonly consumed food commodities, animal feed items, and edible fats and oils as described in 40 C.F.R. Sections 180.950(a), (b), and (c); and (3) certain chemical substances listed under 40 C.F.R. Section 180.950(e).  The final rule codifies, at 40 C.F.R. Section 152.25(f)(2)(iv), a list of inert ingredients permitted in minimum risk pesticide products.  The codified list at Table 2 includes the “Label Display Name,” the “Chemical Name,” and the Chemical Abstract Services Registry Number (CAS No.). 
    • In response to comments, EPA removed from the “Label Display Name” certain bracketed language intended to provide clarifying language, for example, “safety limitations on certain inert ingredients such as vinegar (maximum 8% acetic acid in solutions) to chemical formulas for inert ingredients such as calcite (Ca(CO3)).”  This bracketed language remains in the Chemical Name column to assist manufacturers in correctly identifying inert ingredients eligible for the exemption.
    • As it did with respect to active ingredients, EPA states that this rule is not intended to add or remove any inert ingredients.  EPA states that it is considering developing guidance to describe the petition process and types of information EPA would need to add or delete an inert ingredient from this list.

 

  • Condition 3:  Previously, EPA required that all of the ingredients (both active and inert) be listed on the label, with active ingredient(s) listed by name and percentage by weight and each inert ingredient listed by name only.  Under the provisions of the newly promulgated rule, the label must include the following:  (1) the “Label Display Name” for each active ingredient with its percentage by weight; (2) the “Label Display Name” for each inert ingredient; (3) “prominent” display of the name of the producer or the company for whom the product was produced; and (4) “prominent” display of contact information (i.e., street address including zip code and telephone number) for the producer/company listed.

 

  • Condition 4:  The label cannot include any false or misleading statements.  The final rule does not propose any explicit changes to this condition, but some new changes may affect the requirements necessary to meet this condition.  For example, under the newly promulgated revisions, while all active and inert ingredients may be used in non-food use products, “food and animal feed in commerce can bear pesticide residues only for those ingredients that have tolerances or tolerance exemptions in part 180 of this chapter.”  Regarding requirement, EPA states:
    • EPA is not attempting to enforce adherence to the labels of minimum risk pesticides, which as noted cannot be done for pesticides subject to 40 CFR 152.25(f).  Rather, the Agency is assisting minimum risk pesticide producers in ensuring that the use directions on the product do not cause the label to be false or misleading.  An exemption from FIFRA requirements under section 25(b) of the statute, including the minimum risk exemption at 40 CFR 152.25(f), cannot exempt pesticides from the requirements of a tolerance or tolerance exemption under FFDCA.  Under FFDCA, any pesticide chemical residue to be used in or on foods in commerce in the United States must have either an established tolerance or tolerance exemption.  When a minimum risk product explicitly states on its label that it can be used in or on food or food-use sites in commerce, but one or more of the ingredients does not have an established tolerance or tolerance exemption, the label is indicating that the product may be used in a way that would violate Federal law.  Such a label is therefore false or misleading.

 

  • Condition 5:  The product must not bear claims either to control or mitigate organisms that pose a threat to human health, or to control insects or rodents carrying specific diseases.  The final rule does not change this condition.

EPA states that it intends the newly promulgated revisions to assist manufacturers, the public, and federal, state, and tribal inspectors in determining whether a chemical substance can be used in a minimum risk product (i.e., is eligible for the exemption) as well as to provide improved clarity and transparency for consumers who want more information about the ingredients used in a product.  EPA also hopes that requiring company contact information on labels will provide further transparency and accountability should an adverse event occur during the use of a minimum risk pesticide product.

EPA has determined that the total cost for industry to comply with the labeling requirements of this rulemaking is approximately $800,000, under a three-year implementation period.  The three-year implementation period was extended from the two-year proposed implementation plan in response to comments that “[s]ince most companies update their labels every three years…a rule implementation period of three years will allow most companies to meet the labeling requirements of the rule as part of their normal labeling practices and will therefore keep industry costs to a minimum.” 

EPA’s recently updated minimum risk pesticides webpage includes guidance on pesticide tolerances for minimum risk ingredients and provides alternative formats of the active and inert ingredient lists that may be more suitable for some users.  EPA states that it intends to include additional guidance, as needed, such as labeling guidance for minimum risk pesticides and how to request additional ingredients to be added or removed from the minimum risk exemption shortly after the final rule becomes effective.  


 

By Lisa M. Campbell and Lisa R. Burchi

The U.S. Environmental Protection Agency (EPA) recently launched a new Pesticide Worker Protection Dashboard (Dashboard).  EPA states this Dashboard is “focused on the universe of agricultural operations regulated and farm workers and pesticide handlers covered by the Worker Protection Standard.”  EPA states that the Dashboard provides charts and graphs presenting certain key enforcement and compliance information related to the Worker Protection Standard (WPS) program under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  Specifically, the Dashboard has screens which show the number of WPS inspections conducted, the number of violations found during inspections, the types of violations found, and the types and numbers of enforcement actions taken.  Since the Dashboard is interactive, users can find answers to questions such as:

  • How many facilities in the United States employ workers or handlers covered by the WPS;
  • How many inspections are reported; and
  • How many violations have been found, and what enforcement actions have been taken by states, tribes and/or EPA.

EPA states that Dashboard information from states and tribes is compiled from data on state and tribal inspections and regulatory actions submitted annually (Form: 5700-33H) to EPA.  This form provides information regarding the number of WPS inspections conducted, the types and numbers of violations found, and the number and types of regulatory actions taken during the year.  EPA inspection data is obtained from EPA’s Integrated Compliance Information System (ICIS) database.  Other information is compiled from data from the U.S. Department of Agriculture’s National Agricultural Statistics Service’s Agricultural Statistics, 2007 and 2012 Census of Agriculture database. 

EPA makes several caveats to the data presented, including:  (1) EPA does not require regional offices to enter all regulatory actions into ICIS, so many “informal” actions are not recorded; (2) the data included in the Dashboard do not reflect all compliance monitoring/inspections or enforcement activities, nor the full extent of enforcement activity within a state or tribe; and (3) tribal inspections and enforcement actions conducted under sovereign tribal authority and regulations are not EPA reviewed or reported, and are not included in the Dashboard.

The Dashboard shows data from 2010 to 2014 to provide context at the national level, or within a state or tribe.  EPA plans to update the information annually when new data are available (e.g., after annual state and tribal reporting forms are submitted to EPA).

The Dashboard provides interesting information and should be monitored, as many groups will likely use it in support of their unique interests.  

More information on the WPS is available in our blog item EPA Publishes Worker Protection Standard Final Rule.


 

By Lisa M. Campbell and Timothy D. Backstrom

On December 17, 2015, in the U.S. Court of Appeals for the Ninth Circuit Case Nos. 14-73353, et al. (consolidated), the U.S. Environmental Protection Agency (EPA) filed a reply in support of its motion for voluntary vacatur and remand of its decision granting a registration to intervenor DowAgroSciences LLC (DowAgro) for Enlist Duo herbicide under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  DowAgro responded to the motion by agreeing that remand is appropriate but opposing vacatur as an effort to circumvent the normal cancellation process, while the petitioners Center for Food Safety, et al. (CFS) filed a response supporting the motion for vacatur.  More information on the DowAgro and CFS responses is available in our blog entry DowAgro and Center for Food Safety File Responses to EPA’s Motion for Voluntary Vacatur and Remand.

In its reply, EPA rejects the argument by DowAgro that it is trying to “short-circuit” the normal cancellation procedures under FIFRA.  Citing recent Ninth Circuit precedent on vacatur, EPA argues that “vacatur would be more protective of the environment during the time in which EPA evaluates the new information, and Dow has failed to demonstrate any disruptive consequences of vacatur.” 

EPA also takes issue with certain statements by CFS that it characterizes as “erroneous or irrelevant.”  EPA contradicts assertions by CFS that EPA overlooked important evidence concerning the synergistic effects of Enlist Duo’s principal ingredients, that EPA determined that Enlist Duo will not protect endangered non-target plants, that EPA has violated the ESA, and that EPA is approaching synergistic effects as a new issue.  EPA also objects to the efforts of CFS to introduce an extra-record newspaper article.

This case will continue to be watched closely, as there is widespread industry concern about EPA’s effort to use a judicial process in lieu of normal adjudicatory procedures and about EPA’s substantive approach to evaluating synergistic efficacy data.  In this regard, it is noteworthy that the issue of potential synergistic effects is relatively narrow and does not appear to be among the purported deficiencies in the EPA decision originally cited by the petitioners. 


 

By Sheryl L. Dolan and Margaret R. Graham

The U.S. Environmental Protection Agency (EPA) recently updated the electronic reporting option for pesticide establishments using the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section Seven Tracking System (SSTS), now referred to as the Enhanced Section Seven Tracking System (eSSTS).  On December 17, 21, 22 and 28, EPA will hold four public webinars to explain the Central Data Exchange (CDX) registration process for the eSSTS and demonstrate report submission using eSSTS.  EPA state that any establishments/authorized agents that used electronic reporting last year should automatically be registered to use the new eSSTS system.  CDX registration for eSSTS will be open after December 18, 2015; submitters will need to register to use the new system.  Pesticide establishments can use the CDX to submit EPA Form 3540-16 “Pesticide Report for Pesticide-Producing and Device-Producing Establishments,” the annual pesticide establishment report required under FIFRA Sections 7 and 17 to be submitted by all active domestic and foreign pesticide producing establishments, regardless of whether or not the establishment produced or distributed a pesticide, active ingredient, or device, by March 1 of each calendar year.

The first webinar on December 17, 2015, from 1:00 p.m. to 2:00 p.m. (EST) will explain the CDX registration process for the eSSTS.  Webinars 2, 3, and 4 will cover eSSTS training, but will all have the same information -- participants only need to attend one of these sessions.  Additional announcements and reporting instructions are posted on EPA’s Pesticide Establishment webpage.  More information on the specific trainings is listed below.  The links will not be active until the time of the webinar:

  1. CDX Registration Training for EPA's eSSTS, Thursday, December 17, 2015, 1:00 p.m. - 2:00 p.m. (EST) (Recorded):  An Overview of how to set up an EPA CDX account and set up a user role under EPA's eSSTS, will be available at http://epawebconferencing.acms.com/eSSTSCDX.
  2. EPA's eSSTS Industry User Training 1, Monday, December 21, 2015, 11:00 a.m. - 12:00 p.m. (EST) (Recorded):  Industry overview of EPA's eSSTS, will be available at http://epawebconferencing.acms.com/eSSTS_Industry_Testing.
  3. EPA's eSSTS Industry User Training 2, Tuesday, December 22, 2015, 2:30 p.m. - 3:30 p.m. (EST):  Industry overview of EPA's (eSSTS), will be available at http://epawebconferencing.acms.com/eSSTS_Industry_Testing2.
  4. EPA's eSSTS Industry User Training 3, Monday, December 28, 2015, 11:00 a.m. - 12:00 p.m. (EST):  Industry overview of EPA's eSSTS, will be available at http://epawebconferencing.acms.com/eSSTS_Industry_Testing3.

 

By James V. Aidala and Margaret R. Graham

On December 11, 2015, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) made publicly available several documents associated with the Biological Evaluations (BE) for the first three “pilot” chemicals that are being evaluated:  chlorpyrifos, diazinon, and malathion.  For each chemical, the following supporting documents are now available:  problem formulation; fate and effects characterizations; and related appendices.  The provisional models are available here

EPA states on its website that these documents contain the analysis plan and underlying data that will be used to make effects determinations as part of the pesticide consultation process.  The entire draft biological evaluations for the three chemicals, including the effects determinations, will be released for public comment in the spring of 2016

These BEs are a product of the collaboration among the National Marine Fisheries Service (NMFS), the U.S. Fish & Wildlife Service (FWS) (together, the Services), EPA, and the U.S. Department of Agriculture (USDA) in response to the National Academy of Sciences’ April 2013 report, Assessing Risks to Endangered and Threatened Species from Pesticides, which examined topics pertaining to tools and approaches for assessing the effects of proposed Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) actions on endangered and threatened species and their critical habitats, and provided recommendations.

USDA provided expertise on crop production and pesticide uses and assistance with the use of the National Agricultural Statistics Service Cropland Data Layer to help define the footprint of agricultural use patterns.  The FWS and the NMFS will use the analyses and data from the biological evaluations and integrate it into their final Biological Opinions for the three chemicals due in December 2017.

Commentary

This is the opening blow for developing the next round of the EPA-Services’ Endangered Species Act (ESA) assessment process.  This bolus of information, in the range of 30,000 pages, is the EPA part of the assessment process -- now to be examined by the Services to become the complete ESA assessment of the pesticide products and their possible impact.

It is less clear what these extensive efforts will achieve; in essence, it is likely to indicate little more than “everything affects everything.”  On the other hand, it will provide information useful to indicate where the greatest risks to certain species in specific habitats may lie.  Separately, the mere volume of the information and the amount of effort needed to produce it presents a daunting prospect for the ability of the government agencies (EPA and the Services) to further refine the process into anything resembling a timely and efficient process (not to mention the implications for any public review of the information or associated regulatory conclusions).


 
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