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 James V. Aidala and Margaret R. Graham

On January 12, 2017, the U.S. Environmental Protection Agency (EPA) released its Policy to Mitigate the Acute Risk to Bees from Pesticide Products (Mitigation Policy) which describes methods for addressing acute risks to bees from pesticides.  EPA states that this Mitigation Policy is “more flexible and practical than the proposed policy” that was issued on May 29, 2015, and it has “made modifications to its approach with the goal of better targeting compounds that pose an acute risk, and with the goal of reducing potential impact of this effort on growers.”  EPA states that it will use its Tier 1 acute risk assessment to, in part, determine the products that trigger concerns about pollinator risk that the label restrictions are intended to address.  EPA will begin implementing this Policy in 2017 by sending letters to registrants describing steps that must be taken to incorporate the new labeling.  More information on the Mitigation Policy, including its supporting documents, and EPA’s response to comments submitted on the proposed policy, is available on www.regulations.gov under Docket ID EPA-HQ-OPP-2014-0818.

Also on January 12, 2017, EPA published preliminary pollinator-only risk assessments for the neonicotinoid insecticides clothianidin, thiamethoxam, and dinotefuran, and an update to its preliminary risk assessment for imidacloprid, published in January 2016.  EPA states that the preliminary assessments for clothianidin, thiamethoxam, and dinotefuran are similar to the preliminary pollinator assessment for imidacloprid, in that they showed that “most approved uses do not pose significant risks to bee colonies,” but “spray applications to a few crops, such as cucumbers, berries, and cotton, may pose risks to bees that come in direct contact with residue.”  As for the updated imidacloprid assessment, EPA states that is looked at potential risks to aquatic species, and identified some risks for aquatic insects.  Interested parties will have 60 days to comment on the preliminary risk assessments after notice is published in the Federal Register.  In terms of comments, EPA states that it is especially interested in getting input from stakeholders “on the new method for assessing potential exposure and risk through pollen and nectar.”  Links to risk assessment dockets for each individual insecticide are available on EPA’s website under Schedule for Review of Neonicotinoid Pesticides.  EPA states it is hopes to release the final neonicotinoid risk assessments by mid-2018.

Commentary

The revised Mitigation Policy has been long in coming since it was first released over eighteen months ago.  The delay in revising its approach reflects the complexity of the comments submitted, and EPA’s deliberateness in more finely crafting its policies, given the passage of time and other considerations.  This revised policy contains more flexibility and explicit discussion of the need for exceptions to blanket requirements in response to some of the comments received on the earlier proposal.  There remains significant public and regulator concern about the possible impacts on pollinators from pesticide use, however, there is currently less of a manic tone to EPA’s statements and actions.

For example, when discussing how EPA will approach changing the labels of the affected universe of pesticide products, there is a much less onerous tone and no specific deadlines for registrants to submit revised labels “or else.”  (The 2013 directives to registrants included demands for thousands of revised labels to be submitted within six weeks “or else” -- EPA would take “appropriate action” under FIFRA.)  EPA reminds us all that it retains authority to impose these new requirements broadly, a statement that will strike some as regulatory overreach, but the tone and approach is more in line with past EPA “guidance” about how it will approach a new or revised regulatory concern.   

Similar to what EPA previously concluded about imidacloprid, where that assessment concluded that the most controversial use -- corn seed treatments -- did not indicate a risk concern, EPA did include in its summary about the other three neonicotinoid pesticides that:

  • The assessments for clothianidin, thiamethoxam, and dinotefuran, similar to the preliminary pollinator assessment for imidacloprid showed:  most approved uses do not pose significant risks to bee colonies.  However, spray applications to a few crops, such as cucumbers, berries, and cotton, may pose risks to bees that come in direct contact with residue.

This might unfairly be summarized as:  after years of regulatory analysis EPA has concluded that if insecticides come into direct contact with insects, there is likely to be a risk to the exposed insect. 

This conclusion would be too simplistic since EPA and other regulatory bodies have expressed concern about what unintended exposures to insecticides might cause, and more generally the possibility of colony level impacts on honeybee and other pollinator populations from pesticide use.  Some critics will continue to insist that EPA broaden its regulatory approach to more than just pesticides used for crops under contracted pollinator services.  The broader issue of pesticide drift and possible impacts on non-target species will continue to be a concern for all pesticides.

Perhaps the more deliberate consideration of needed data generation and assessment that seems to be the current approach will allow both more refined regulatory controls if needed, and a reduction in the sometimes hot rhetoric which has accompanied the pollinator issues.

Lastly, although this revised Mitigation Policy and the three new preliminary assessments are not unexpected next steps as part of the ongoing registration review program for pesticides, given their very late release -- less than ten days before the arrival of a new Administration -- some might question whether this is part of the “midnight regulations” pushing the political agenda of the outgoing Administration.  The new leadership may revise what has been released, and may come to different conclusions about any needed restrictions.  That said, the issue of whether certain pesticides are having a dangerous impact on honeybee populations will continue to be a concern for regulators both in the U.S. and globally.


 

By Lisa M. Campbell and Timothy D. Backstrom

On July 20, 2016, the U.S. Environmental Protection Agency (EPA) issued a memorandum attaching minutes from the April 19-21, 2016, FIFRA Scientific Advisory Panel (SAP) meeting, Transmittal of Meeting Minutes of the April 19-21, 2016 Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP or Panel) Meeting Held to Consider and Review Scientific Issues Associated with “Chlorpyrifos: Analysis of Biomonitoring Data.”  This SAP was convened to advise EPA regarding the evaluation of biomonitoring chlorpyrifos data from epidemiology studies conducted by the Columbia Center for Children’s Environmental Health (CCCEH).

The minutes indicate that the SAP has significant concerns with EPA’s proposal to use the biomonitoring chlorpyrifos data from the CCCEH epidemiology studies to establish a point of departure (PoD) for chlorpyrifos risk assessment.  The minutes state:  “Because many uncertainties cannot be clarified, the majority of the Panel does not have confidence that the Columbia Center for Children’s Environmental Health (CCCEH) cord blood data on chlorpyrifos concentrations can accurately be used in quantitative risk assessment to determine a Point of Departure (PoD).”  A major source of uncertainty cited by the FIFRA SAP is “the lack of verification and replication of the analytical chemistry results that reported very low levels of chlorpyrifos (pg/g),” because EPA had to impute a finite quantitative value to “a large fraction of cord blood samples included in the analyses presented with levels below [level of detection (LOD)].”  Moreover, some SAP members “thought the quality of the CCCEH data is hard to assess when raw analytical data have not been made available, and the study has not been reproduced.”

The SAP also, however, stated that “both epidemiology and toxicology studies suggest there is evidence for adverse health outcomes associated with chlorpyrifos exposures below levels that result in 10% red blood cell (RBC) acetylcholinesterase (AChE) inhibition (i.e., toxicity at lower doses).”  Nevertheless, it agreed with EPA that “applying additional safety factors to the AChE PoDs to account for a possible noncholinergic mode of action (MOA) would be problematic because of challenges in justifying any particular value for such an adjustment.”

Of note, the SAP concluded that it would be appropriate to use a “10X intra-species extrapolation factor” in any analysis based on the cord blood data.  It also identified other sources of uncertainty that should be considered in such an analysis, including “the inability of single measures of chlorpyrifos concentration in blood to provide information regarding source, frequency, duration and magnitude of exposure, and how these exposures are linked to specific outcomes measured in the CCCEH study participants.”  Although EPA suggested in a Status Report filed in the chlorpyrifos litigation pending in the Ninth Circuit Court of Appeals on June 29, 2016, that the FIFRA SAP might recommend a “hybrid approach” that EPA could use in lieu of a PoD based on AChE inhibition, thereby altering the prior EPA analysis for chlorpyrifos, the SAP minutes do not include a recommendation for such a hybrid methodology.

Commentary

Given the concerns expressed by the SAP regarding EPA’s proposal to derive a PoD from cord blood biomonitoring data collected in the CCCEH epidemiology studies, it may be unlikely that EPA will further pursue this specific approach.  It is less clear whether EPA will be inclined to propose any further adjustments to its existing risk assessment for chlorpyrifos, which utilizes a PoD based on animal AChE data, along with intra-species and inter-species uncertainty factors and an additional Food Quality Protection Act (FQPA) 10X factor.  EPA’s decision to retain the special FQPA factor in its risk assessment for chlorpyrifos will remain controversial, because it is based on an assessment of the value and significance of several epidemiology studies for chlorpyrifos that many in the pesticide industry strongly dispute.  The discussion in the minutes of the uncertainties resulting from the refusal of the CCCEH investigators to provide underlying raw data may provide further support for arguments by industry that EPA should not predicate risk assessments on the epidemiology studies for chlorpyrifos before obtaining and reviewing these data.

More information on the FIFRA SAP and its surrounding legal issues is available in our blog item EPA Requests Six Month Extension of Deadline for Decision on Chlorpyrifos Tolerance Revocation, and more generally on our blog with keyword chlorpyrifos.


 

By Lisa M. Campbell and Lisa R. Burchi

On March 16, 2016, the European Commission (EC) issued its final report on the sustainable use of biocides.  Article 18 of the European Union’s (EU) biocidal products regulation (BPR) directs the EC to issue a report on how the BPR contributes to the sustainable use of biocidal products, and on whether there is a need to introduce additional measures, in particular for professional users, to reduce the risks posed to human health, animal health, and the environment by biocidal products.  Sustainable use for biocidal products is defined in the report as “the objective of reducing the risks and impacts of the use of biocidal products on human health, animal health and the environment and of promoting the use of integrated pest management and of alternative approaches or techniques such as non-chemical alternatives to biocidal products.”

Significantly, the EC’s report does not recommend the creation of further regulations, stating that the  “risks posed to human health, animal health and the environment by biocidal products … are already appropriately addressed by measures imposed through the conditions of approval of active substances or the authorisation of biocidal products.”  The EC also declined to extend the scope of the Framework Directive on the Sustainable Use of Pesticides (Directive 2009/128/EC) to biocidal products, stating: “due to the very diverse nature of biocidal products and the variety of applications, it does not seem appropriate to simply extend the scope of the Framework Directive on the Sustainable Use of Pesticides to biocidal products.”

Instead, the EC states that the “first and main priority” of EU Member States and industry must be “the completion of the on-going assessment of all the active substances that were already on the market when the BPD entered into force and the authorisation of biocidal products containing these active substances … with a view to promoting the sustainable use of biocidal products.”  Further, Member States also should focus on the “need to invest additional resources on enforcement activities to ensure that no product is illegally placed on their market and that biocidal products are properly labelled.” 

The EC’s report concludes by listing the following actions that it intends to pursue, and invites Member States to collaborate with the EC to do the same:

  • Focus and strengthen efforts on the review programme of existing active substances to ensure it is completed at the latest by 2024;
  • Ensure that once active substances are approved, product authorisations are granted, amended, or cancelled within 3 years;
  • Invest additional resources on enforcement activities;
  • Benefit from the legislative tools available, in particular by closely following the developments of best available techniques reference documents (BREF) that can be relevant for biocidal products used in industrial processes;
  • Encourage communication and awareness raising campaigns to inform end users, through websites, in-store leaflets or videos, quick response codes on biocidal products, etc.;
  • Encourage the development and implementation of standards (e.g., under the European Committee for Standardization), that could contribute to the sustainable use of biocidal products; and
  • Welcome research initiatives on the sustainable use of biocides and alternatives to biocidal products.

 

By Lisa M. Campbell and Margaret R. Graham

On March 17, 2016, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP), announced in an open letter to stakeholders, that it has developed new tools to “enhance the quality of its risk assessments and risk management decisions and better ensure protection of human health and the environment from pesticide use.”  These tools have been developed as part of EPA’s efforts to implement OPP’s Strategic Vision for Adopting 21st Century Science Methodologies (Strategic Vision) initiative.  As part of this initiative, OPP released two guidance documents:

  1. Final Guidance:  Process for Establishing & Implementing Alternative Approaches to Traditional In Vivo Acute Toxicity Studies.  OPP states that this guidance will “expand the use of alternative methods for acute toxicity testing” and “describes a transparent, stepwise process for evaluating and implementing alternative testing methods (not using live animals) for acute oral, dermal and inhalation toxicity, along with skin and eye irritation and skin sensitization.”  
  2. Draft Guidance:  Retrospective Analysis & Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Formulations. OPP states that this draft guidance “to waive all acute lethality dermal studies for formulated pesticide products” was developed through an analysis “across numerous classes representing conventional pesticides, antimicrobials, and biopesticides [that] examined the utility of the acute dermal toxicity study for formulations in pesticide labelling for end-use products.”  

Comments on the draft guidance for waiving acute dermal toxicity tests are due May 16, 2016.  The National Research Council’s 2007 report, Toxicity Testing in the 21st Century:  A Vision and a Strategy, instigated OPP’s Strategic Vision initiative.  EPA states that these guidance documents are significant steps in the report’s implementation and intended to reduced animal testing. 


 

By Lisa M. Campbell and Timothy D. Backstrom

Significant issues concerning the scope of the U.S. Environmental Protection Agency’s (EPA) authority to cancel conditional registrations are raised by recent events concerning flubendiamide products sold in the U.S. by BayerCrop Science LP (Bayer) under the trade name Belt.  Bayer announced on February 5, 2016, that it will not comply with EPA’s request that Bayer “voluntarily” cancel its registered flubendiamide products.  In a January 29, 2016, letter, EPA stated that flubendiamide and a  degradate compound are “mobile, stable/persistent, accumulate in soils, water columns and sediments and are toxic to aquatic invertebrates.”  Based primarily on EPA’s ecological risk assessment, EPA has determined “that the continued use of the currently registered flubendiamide products will result in unreasonable adverse effects on the environment.”  Bayer disagrees strongly with the EPA risk assessment, because Bayer believes it is based on overly conservative modeling estimates that cannot be reconciled with actual monitoring and environmental fate data for this pesticide.

Conditional registrations for pesticides containing flubendiamide were first granted by EPA under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 3(c)(7) in 2008.  As one condition of registration, EPA required Bayer to conduct specific environmental fate studies, which have now been submitted and reviewed.  EPA also adopted an initial expiration date for all registrations of flubendiamide products of July 31, 2013, which EPA later agreed to extend several times to allow time for further review and discussion of the submitted data.  The current dispute with Bayer involves a specific condition that EPA included in its preliminary acceptance letter for this active ingredient, which EPA contends obligates Bayer to request voluntary cancellation of the registrations now that EPA has made a finding of unreasonable adverse effects.  Bayer characterizes the condition in question as “unlawful,” and argues that EPA must afford Bayer a full adjudicatory hearing under FIFRA Section 6(b) before the registrations can be cancelled.

Commentary

Because Bayer has not submitted the “voluntary” cancellation requests demanded by EPA, EPA has stated that it will initiate the cancellation process for conditional registrations established by FIFRA Section 6(e).  Although this process affords Bayer an opportunity for an administrative hearing, the issues in a conditional registration hearing under FIFRA Section 6(e) are limited to “whether the registrant has initiated and pursued appropriate action to comply with the condition,” and the EPA determination concerning disposition of existing stocks.  Bayer argues that the condition as it was originally imposed by EPA was improper and denies statutory due process rights, and that EPA must afford Bayer a full adjudicatory hearing under FIFRA Section 6(b) rather than the limited hearing provided under FIFRA Section 6(e).

This dispute presents a variety of important legal questions, including what authority EPA has under FIFRA to impose time limitations or expiration dates for pesticide registrations, the rights a registrant has when it applies to amend or to renew a time-limited registration, and the nature of the conditions that EPA may lawfully impose for a conditional registration under FIFRA Section 3(c)(7).  The entire pesticide industry will be watching this matter with great interest.


 

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:  “ased 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 J. Brian Xu, M.D., Ph.D., DABT®  and Margaret R. Graham

Like so many other regulatory programs in China, pesticide regulations are changing.  At the 8th China High-Level Forum on Pesticides, Ying Ji, Chief Agronomist of the Institute for the Control of Agrochemicals, Ministry of Agriculture (ICAMA), stated that the future of pesticide regulation in China will see more emphasis placed on industrial development, registration security, the application of more risk assessment techniques, and will focus more on reducing the burden of procuring registrations for minor use crops.  In China, the vast majority of registrations are for major crops and only a few registrations have been issued for minor crops.  The Ministry of Agriculture also intends to prepare a "List of Pests and Pesticide Shortage for Minor Crops.”

Jun Yang, Director of the Efficacy Division, ICAMA, summarized recent trials and registrations of pesticides.  By the end of August 2015, China had a total of 33,029 registered pesticide products, an increase of 4,300 products when compared with 2013.  The total includes insecticides (12,812), fungicides (8,378), herbicides (7,807), and others including acaricides and plant growth regulators (4,032).  Insecticides were down 3 percent and fungicides and herbicides up 2 percent as a proportion of the total when compared with the total at the end of 2013.  The majority of registered products were issued for off-patent products.  The top ten active ingredients for which products were registered as of 2014 were reported to include:  the antifeedant, pymetrozine; the fungicides, azoxystrobin, tebuconazole and difenoconazole; the insecticides, thiamethoxam, emamectin-benzoate, avermectin and imidacloprid; and the herbicide, cyhalofop and glufosinate.  For more information on the report (which is available only in Mandarin), please e-mail Dr. Brian Xu at .(JavaScript must be enabled to view this email address).


 

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

In an opinion issued on September 10, 2015, the U.S. Court of Appeals for the Ninth Circuit vacated the U.S. Environmental Protection Agency’s (EPA) unconditional registration for the pesticide sulfoxaflor and remanded the matter to EPA to obtain further studies and data regarding the effects of sulfoxaflor on bees and bee colonies.  Sulfoxaflor is a new insecticide in the class of insecticides referred to as neonicotinoids, but its mechanism of action is distinct from other neonicotinoids.  The Petitioners in this case were various trade organizations representing commercial beekeepers, as well as some individual beekeepers.  The registrant Dow AgroSciences LLC (Dow) intervened in the action.

EPA granted an unconditional registration for sulfoxaflor on May 6, 2013, subject to a variety of risk mitigation measures, including a lower application rate, longer intervals between applications, and certain crop-specific label restrictions.  EPA had previously proposed to issue a conditional registration for sulfoxaflor in January 2013, citing pollinator data gaps that could be addressed by requiring Dow to conduct and submit further studies.  Under that proposal, use of sulfoxaflor would have been allowed at a reduced application rate during the time needed to complete data development.  The court found that the subsequent decision by EPA to register unconditionally sulfoxaflor was not supported by substantial evidence, as required by Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 16(b), both because EPA failed to adhere to its own scientific methodology and because the rationale that EPA provided for granting an unconditional registration could not be reconciled with the analysis upon which EPA based its prior proposal to register conditionally sulfoxaflor.

EPA evaluated the potential risk to bees and bee colonies from sulfoxaflor use utilizing the Pollinator Risk Assessment Framework, a scientific risk assessment methodology developed after consultations between EPA, Canada’s Pest Management Regulatory Agency, and the State of California, and presented by EPA to the FIFRA Scientific Advisory Panel in 2012.  The court found that the rationale provided for EPA’s unconditional registration decision could not be reconciled with findings that EPA itself made using this methodology or with the rationale EPA provided for its prior proposal to issue a conditional registration.  EPA had decided it was necessary to proceed to Tier 2 of the pollinator risk assessment after reviewing risk quotients and residue data in Tier 1 of the assessment.  EPA found the available data for Tier 2 to be insufficient to allow indefinite use of sulfoxaflor, even at a reduced application rate.  The court could not reconcile this finding with the subsequent decision to grant an unconditional registration, even with the specified mitigation measures.  The court found that “given the precariousness of bee populations, leaving the EPA’s registration of sulfoxaflor in place risks more potential environmental harm than vacating it.”  The court stated that “EPA has no real idea whether sulfoxaflor will cause unreasonable adverse effects on bees, as prohibited by FIFRA.”

EPA argued that with a reduced application rate, the risk quotients and residue analysis in Tier 1  was “close enough” to sufficient to avoid the specified quantitative trigger for a Tier 2 analysis, thereby rendering any deficiencies in the available Tier 2 data irrelevant.  The court effectively stated in response that close enough is not good enough, citing another recent Ninth Circuit decision in which a risk concern that is triggered by a margin of exposure less than or equal to 1000 was held to be triggered when the margin was exactly 1000.  Thus, this court once again placed EPA on notice that it must follow its own methodology with precision, and that EPA cannot justify deviations from its own methodology by simply stating that it is exercising expert judgment.

Commentary

This is an unusual case because the registration of a new pesticidal active ingredient has been vacated on substantive as opposed to procedural grounds.  The court’s rationale reflects a lack of judicial deference to what EPA typically refers to as the scientific “weight of the evidence.”  While the term itself does not appear in the opinion, the court is insisting that EPA must follow its standard methodology without allowing for any deviations based on professional judgment.  Although in this instance the court has supported the position of opponents of pesticide use, judicial reluctance to accept scientific “weight of the evidence” conclusions could also make it harder for EPA to impose additional restrictions when new but inconclusive evidence appears.

This case could cause EPA to be more explicit in adding procedures to its standard analytic methodologies that allow deviations from the methodology based on professional judgment.  The case could also cause EPA to reconsider its recent reluctance to avoid issuing conditional registrations and its preference for unconditional registrations for new active ingredients.  In any case, decisions that afford EPA less discretion to use “weight of the evidence” reasoning when basing scientific conclusions on less than conclusive data or studies could have an impact on a number of EPA practices and policies involving interpretation of scientific data.


 

By Susan Hunter Youngren, Ph.D., James V. Aidala and Lisa M. Campbell

The Environment Protection Agency (EPA) extended the comment date on its draft guidance, Pesticide Cumulative Risk Assessment: Framework for Screening Analysis, in a Federal Register notice published on August 28, 2015.  EPA’s draft framework provides guidance on how the EPA will screen groups of pesticides for cumulative evaluation.  EPA proposes using a two-step approach, beginning with the evaluation of available toxicological information and, if necessary, followed by a risk-based screening approach.  This framework supplements the existing guidance documents for establishing common mechanism groups (CMG) and conducting cumulative risk assessments (CRA).  Additionally, EPA is also seeking comments on a draft copy of the human health risk assessment where the cumulative assessment was conducted in conjunction with pending actions for abamectin.

EPA has described a process that is data intensive and that requires sophisticated knowledge and modeling.  EPA acknowledges that “the level of refinement provided by this approach is not necessary or even feasible for all existing pesticide classes.”  The policy documents for conducting the first step in the process, “developing CMGs,” are still being refined.

This document provides the guidance for screening information to identify candidate CMGs and does not outline how actually to conduct CRAs.  Rather, this document relies on policies and principles provided in other documents found on the EPA cumulative risk assessment website.  These additional policies and principles were developed during the conduct of five CRAs for chemical groups such as the organophosphates and carbamates.

One of the major questions raised by the issuance of this document is the extent of the information that EPA will require for each chemical to determine if there are CMGs.  The five CMGs currently assessed have relatively well defined mechanisms of action.  It is not clear, however, what EPA will consider to be adequate justification that there are no other chemicals with the same mechanism of action for other chemicals of concern.

Requirements for EPA to determine and assess the risks of possible common mechanism of action among groups of similar pesticides was one of the most far-reaching new requirements imposed by the Food Quality Protection Act.  Some observers expected a larger impact on pesticide use than what has occurred to date; whether EPA’s new approach results in more groupings or otherwise leads to restrictions on more groups of pesticides remains to be seen.

Comments on the draft guidance are due September 28, 2015.  More information regarding EPA’s assessment of pesticide cumulative risk is available online.


 
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