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By Lisa M. Campbell and Lisa R. Burchi

On May 28, 2015, several United States and Canadian regulatory agencies announced the release of Regulatory Partnership Statements (RPS) and updated annual Work Plans outlining the framework for how these agencies will cooperate and coordinate specified agency actions. 

 

The RPS and Work Plans are the most recent steps since the United States and Canada established the Regulatory Cooperation Council (RCC) in 2011 to align regulatory systems and boost North American trade and competitiveness.  Information about the RCC and the released RPSs is available at: http://www.trade.gov/rcc/.

 

There are now RPSs between the following agencies focusing on four main sectors:  agriculture and food; environment; transportation; and health and personal care products:

 

  • U.S. Food and Drug Administration (FDA) -- Health Canada (HC);
  • U.S. Environmental Protection Agency (EPA) -- Pest Management Regulatory Agency (PMRA);
  • U.S. Occupational Safety & Health Administration (OSHA) -- HC;
  • U.S. Animal and Plant Health Inspection Service (APHIS) and U.S. Food Safety and Inspection Service (FSIS) -- Canadian Food Inspection Agency (CFIA);
  • FDA -- CFIA;
  • U.S. Department of Transportation (DOT) -- Transport Canada (TC);
  • U.S. Coast Guard (USCG) -- TC;
  • U.S. Environmental Protection Agency (EPA) -- TC;
  • U.S. Department of Energy (DOE) -- Natural Resources Canada (NRCan);
  • U.S. Pipeline and Hazardous Materials Safety Administration (PHMSA) -- NRCan;
  • EPA -- Environment Canada (EC); and
  • U.S. National Oceanic and Atmospheric Administration (NOAA) -- Fisheries and Oceans Canada (DFO).

 

With regard to agreements between EPA and PMRA for pesticides, the agencies have agreed to a plan and timeframes for three initiatives:

 

  • Joint Template For Project Chemistry Review:  The agencies plan, by March 2016, to commence use of a joint template for product chemistry reviews intended to present study findings in a concise, easily reviewable manner to “facilitate the evaluation of joint review products for new active ingredients, use expansions, and product chemistry only submissions, with the ultimate goal being mutual acceptance of study reviews.”  Prior to commencing use of the joint template, EPA and PMRA intend to conduct a webinar, solicit comments, and initiate a pilot project to test the use of the template. 
  • Neonicotinoid Insecticides:  EPA and PMRA are collaborating on a bilateral pesticide re-evaluation process for neonicotinoid pesticides, and implementing a risk assessment framework.  Harmonizing re-evaluation schedules and aligning risk assessment approachines are ongoing; a progress report will be published by December 2015, but the completion of risk assessments and mitigation actions are not expected until 2017-2018.
  • Joint IT Solutions:  EPA and PRMA are working together to develop information technology submissions and “move towards the establishment of a single application for crop protection products that will be accepted in both countries.”  The technology platforms include an eDossier Builder based on the Organization for Economic Co-operation and Development (OECD) Global Harmonized Submission Transport Standard and an Electronic Confidential Statement of Product Specifications Form Wizard tool (eCSPS Wizard).  The agencies are currently developing these tools and state that the eDossier may be released in 2017, but have not set timeframes for the release of the eCSPS Wizard.

 

EPA, Health Canada, and Environment Canada also have a RPS regarding two initiatives for chemical substances management:

 

  • Significant New Use Rule (SNUR) and Significant New Activity (SNAc):  The agencies are collaborating to develop common approaches for regulatory reporting requirements to improve predictability, understanding, and compliance of SNURs and SNAcs under the Toxic Substances Control Act (TSCA) and the Canadian Environmental Protection Act, 1999 (CEPA), respectively.  Working groups have been established with representatives of industries and nongovernmental organizations, and several meetings and web conferences are scheduled through June 2016 to review potential alignment collaboration opportunities.  A final summary document outlining the agencies’ findings, recommendations, and short and long term implementation plans is expected by December 2016.  A workshop to discuss the final results for both predictability and improved compliance is now planned for January 2017.
  • Risk Assessments:  The agencies are working to align chemical regulatory processes, “specifically through the development of common approaches to address emerging risk issues and jointly consider how the use of novel data can inform the assessment of chemicals.”  The agencies have already formed a Technical Working Group and the first workshop will be held in October 2015 with several web conferences scheduled through December 2016.  A draft assessment collaboration framework will thereafter be developed including:  (1) common high-level principles for chemical risk assessment; (2) identification of opportunities and impediments to joint work; (3) forward plan to build on opportunities (e.g., peer review); and (4) forward plan to explore mechanisms to address impediments.  The final summary document outlining the assessment collaboration framework is expected in December 2017


Discussion

 

The RPS developments are a welcome development for many in industry that conduct business in the U.S. and Canada and are interested in streamlined procedures.  The SNUR and SNAc processes, for example, have many similarities that could potentially be leveraged and aligned.  The working groups that have been formed to review and discuss the TSCA/CEPA initiatives anticipate industry and nongovernmental organizations’ involvement that should assist these agency partnerships.  Continued work with stakeholders and opportunities for comment will be critical moving forward in developing effective regulatory approaches that promote efficiency, safety, trade, and competitiveness.


 

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

 

On May 22, 2015, the European Food Safety Authority (EFSA) issued a call for new scientific information relevant to the evaluation of the risk to bees in the European Union (EU) from the use of the three neonicotinoid pesticide active substances:  clothianidin, imidacloprid, and thiamethoxam (the substances).

 

The call for data complies with the decision taken by the European Commission in May 2013, Commission Implementing Regulation (EU) No. 485/2013, to put in place measures to restrict the use of the substances, which at the time included prohibiting use of the active substances clothianidin, thiamethoxam, and imidacloprid as a seed or soil treatment and for pre-flowering applications on crops attractive to bees and for cereals other than winter cereals.  In May 2013, the Commission also stated that within two years it would initiate a review of any new scientific information. 

 

EFSA is urging national authorities, research institutions, industry, and other interested parties to submit all information on the effects, exposure, and risks of the three substances regarding bees -- honeybees, bumble bees, and solitary bees -- when used as seed treatments and granules.  This can include:

 

  • Literature data, including grey literature and any other data from research activities relevant to the risk assessment for bees for the uses of the three substances applied as seed treatments and granules.  Data that have been provided and identified as relevant by EFSA in its published systematic literature review report need not be submitted, however.
  • Study reports conducted specifically to assess the risk to bees from the three substances applied as seed treatments and granules, and not yet considered under the previous EFSA assessments (EFSA Journal 2013;11(1):  3066, 3067, 3068).
  • National evaluations and/or monitoring data relevant to the risk assessment for bees for the uses of the three substances applied as seed treatments and granules that are available at the Competent Authorities of Member States and not yet considered under the previous EFSA assessments, listed in the above bullet.
  • Data that EFSA stated were not relevant in its published systematic literature review report may be submitted only if accompanied with a scientific rationale supporting their relevance.

 

The notice states that all information should be submitted by September 30, 2015.  Any information submitted can be claimed as confidential by following procedures set forth in Article 63 of Regulation (EC) No 1107/2009.  EFSA will review the material provided from this call for data and offer conclusions concerning an updated risk assessment following receipt of a follow-up mandate from the European Commission.

 

 


 

By Lisa M. Campbell and James V. Aidala

The U.S. Environmental Protection Agency’s (EPA) Proposal to Mitigate Exposure to Bees from Acutely Toxic Pesticide Products published in the Federal Register on May 29, 2015, seeks comment on a proposal to adopt mandatory pesticide label restrictions to protect managed bees under contract pollination services from foliar application of pesticides that are acutely toxic to bees on a contact exposure basis, unless the application is made in accordance with a government-declared public health response. These label restrictions would prohibit applications of pesticide products that EPA has identified as acutely toxic to bees, during bloom when bees are known to be present under contract.

As part of this mitigation proposal, the 48-hour notification exception for crops under contracted pollination services during bloom for all neonicotinoid product labels would be removed. These restrictions are intended to reduce the likelihood of acute exposure and mortality to managed bees under contract. EPA is not proposing at this time to require new language for pesticide labels for managed bees not under contract pollination services. This does not, however, alter EPA’s previous actions intended to impose more specific restrictions on neonicotinoid pesticides through label language addressing potential risks to bees not under contract for pollination services.

EPA is also seeking comment on a proposal to rely on efforts made by states and tribes to reduce pesticide exposures for application sites not under contracted services, through development of locally-based measures, specifically through managed pollinator protection plans. These plans would include local and customizable mitigation measures to address certain scenarios that can result in exposure to pollinators. EPA intends to monitor the success of these plans in deciding whether further label restrictions are warranted.

EPA states that if it receives evidence during the public comment period, and/or through outreach at stakeholder meetings, that the contract provisions that are the subject of the proposed rule commonly considered effective and mutually agreed upon stakeholder practices (i.e., beekeeper-to-grower) indicating that the application of acutely toxic pesticides is not of risk concern for bees under contract, then EPA will consider this information in determining whether this scenario needs the mitigation indicated in the proposed language.

EPA states that the proposed actions are consistent with the Presidential Memorandum issued in June 2014 to reduce the effect of factors that have been associated with pollinator declines in general, as well as the mandate to engage state and tribal partners in the development of pollinator protection plans. Comments on the proposal are due by June 29, 2015.

Commentary

The main elements of EPA’s pesticide regulatory strategies and policies were only a small part of the response to the President last week on a National Strategy for pollinators, but now that EPA has issued this proposal, attention will turn to what EPA is more precisely planning to do with regard to proposing and implementing new restrictions on pesticides generally and/or neonicotinoid products in particular.

As expected, the focus of the proposal is on new restrictions for acutely toxic pesticide applications (defined in the notice as “pesticides with an acutely lethal dose to 50% of the bees tested of less than 11 micrograms per bee”), where the pesticide application site is also where there are contracted pollination services. Essentially, foliar application of pesticides acutely toxic to bees are prohibited where there are bee colonies present pursuant to a contract to provide pollination services. EPA’s proposal (at Appendix A) includes a long list of pesticides (over 75) that meet the acute toxicity criteria that will be subject to the new restrictions. This list includes many more pesticides than just the neonicotinoid products.

In addition, for managed bees not under contracted services, or for other “unmanaged” bees, EPA’s reliance on state “Managed Pollinator Protection Plans” (MP3s) is consistent with public statements that EPA officials and line staff have made in recent months, so there appears to be few surprises in the proposal at first glance. Some states already have plans; many are under development. EPA has worked closely with state pesticide regulatory officials on development of state plans, and signaled that it expects state plans to incorporate three core ideas: public participation in developing the plan; some kind of notification scheme to alert beekeepers of insecticide applications; and a way to evaluate whether the state plan is effective in reducing insecticide exposure to bees.

Even so, what may generate the most public comment about EPA’s proposal is what it does NOT do; for example: 

  • The proposal does not impose a ban on neonicotinoid pesticides as some advocacy groups have sought; 
  • The proposal does not require EPA approval of state management plans (MP3s); 
  • The proposal does suggest options for registrants to seek product-specific exemptions to what is mandated; in other words, it again seeks to impose EPA regulatory actions “by letter” using a “one size fits all” approach; and 
  • The proposal does not offer significantly new restrictions regarding pollinators generally, but maintains a focus on contracted honeybees and commercial pollination services.

As the proposal has just been issued, stakeholders will now review the content to look for “the devil in the details” -- and develop comments to submit during the 30-day comment period EPA offers. (It would not be surprising if the comment period on such a high profile proposal is extended.)

More information concerning the Presidential Memorandum and the national strategy are available in Bergeson & Campbell, P.C.’s (B&C®) blog post on Pollinator Health Task Force Issues National Strategy to Promote the Health of Honey Bees and Other Pollinators.


 

By Lynn L. Bergeson and Carla N. Hutton

 

On May 19, 2015, the U.S. Environmental Protection Agency (EPA) announced that it issued a conditional registration for a nanosilver-containing antimicrobial pesticide product named “NSPW-L30SS,” or “Nanosilva.”  This is the second nanosilver registration issued by EPA and reflects the Agency’s growing expertise in addressing, processing, and approving nanopesticide registration applications.  According to EPA, the product will be used as a non-food-contact preservative to protect plastics and textiles from odor- and stain-causing bacteria, fungi, mold, and mildew.  Items to be treated include household items, electronics, sports gear, hospital equipment, bathroom fixtures, and accessories. EPA based its decision “on its evaluation of the hazard of nanosilver after reviewing exposure data and other information on nanosilver from the applicant, as well as data from the scientific literature.”  EPA states that these data show that treated plastics and textiles release “exceedingly small amounts of silver.”  Based on this evaluation, EPA “determined that NSPW-L30SS will not cause unreasonable adverse effects on people, including children, or the environment and that it would be beneficial because it will introduce less silver into the environment than competing products.”  EPA notes that it is requiring the company “to generate additional data to refine the Agency’s exposure estimates.”  According to EPA, it will post a response to comments received on its 2013 proposed registration decision document, as well as the current decision document, in the rulemaking docket.


 

By Lisa M. Campbell and James V. Aidala

On May 19 2015, President Obama’s interagency Pollinator Health Task Force -- co-chaired by the Secretary of Agriculture and the Administrator of the U.S. Environmental Protection Agency (EPA) -- issued its long awaited and anticipated “National Strategy to Promote the Health of Honey Bees and Other Pollinators,” as well as its “Pollinator Research Action Plan.”  This work was done in response to President Obama’s June 20, 2014, memorandum entitled “Creating a Federal Strategy to Promote the Health of Honey Bees and Other Pollinators,” pursuant to which the Pollinator Health Task Force was formed and direction was given to develop a Pollinator Research Action Plan, Public Education Plan, and Public-Private Partnerships, and to identify steps the agency Task Force members will take to increase and improve pollinator habitat.  All of these are addressed in the May 19, 2015, documents.

Notable issues are raised by the documents, and some of these are outlined below in the Commentary section of this blog, following the overview.  A more detailed discussion will be forthcoming.

Overview

The Strategy states that it “expands and adds to actions already being undertaken by Federal departments and agencies to reverse pollinator losses and restore populations to healthy levels.”  It further states that it “focuses on both immediate and long-term changes that can be made to improve the well-being of pollinator populations.”

The Strategy includes the following components:

  • Pollinator Research Action Plan;
  • Plans for expanding education and outreach;
  • Opportunities for public-private partnerships; and
  • Improving pollinator habitat.

The Strategy outlines “three overarching goals for action by Federal departments and agencies in collaboration with public and private partners”:

  1. Reduce honey bee colony losses during winter (overwintering mortality) to no more than 15% within 10 years. This goal is informed by the previously released Bee Informed Partnership surveys and the newly established quarterly and annual surveys by the USDA National Agricultural Statistics Service.  Based on the robust data anticipated from the national, statistically-based NASS surveys of beekeepers, the Task Force will develop baseline data and additional goal metrics for winter, summer, and total annual colony loss.
  2. Increase the Eastern population of the monarch butterfly to 225 million butterflies occupying an area of approximately 15 acres (6 hectares) in the overwintering grounds in Mexico, through domestic/international actions and public-private partnerships, by 2020.
  3. Restore or enhance 7 million acres of land for pollinators over the next 5 years through Federal actions and public-private partnerships.

 

With regard to pesticides, the Strategy states the following “metrics” for Protecting Pollinators from Exposure to Pesticides:

  • Tiered guidance for assessing the risk posed by pesticides to bees was completed in 2014 (in collaboration with Canada Pest Management Regulatory Agency (PMRA) and California Department of Pesticide Regulation (DPR)).
  • Document the number and percentage of registration and registration review chemicals required to submit testing data at each Tier of the above guidance.
  • Complete all honey bee exposure and effect protocols and implement the harmonized pollinator risk assessment process by the end of 2016.
  • Achieve conformance with the 2015-2017 re-evaluation schedule of the nitroguanidine-substituted neonicotinoid subclass to satisfy the standard for registration under FIFRA.
  • Finalize benefits assessments for imidacloprid and thiamethoxam soybean seed treatments by fall 2015.
  • Provide annual updates on the number of pesticides for which the new framework for assessing risks to bees has been incorporated. Document the number of labels that contain pollinator-specific mitigation measures.
  • Issue for public comment a proposed prohibition on foliar application during contracted pollinator services by December 2015.
  • Issue for public comment a draft framework outlining an approach to protect monarch butterflies that balances monarch protection and weed management by summer 2015.
  • Document the number of state/tribal pollinator protection plans addressing the need for improved communication between growers/applicators and beekeepers with respect to pesticide applications under development and the number of plans implemented.
  • Bee mortality incident guidance was issued May 9, 2013; EPA will report annually on the number of reported mortality incidents, cumulative hive mortality, and results of inspections.
  • Document the time required to evaluate proposed new Varroa control products.
  • Document the number of Varroacide products available for use.

 

Commentary

The May 19 documents are lengthy and only a few highlights are mentioned.  A more detailed review of the documents will be forthcoming, but some initial comments are worthy of note.  These include the fact that the Strategy is a catalog of agency activities across the federal government.  Like the President’s 2014 memorandum, the emphasis is on enhancing and expanding habitat and forage opportunities for pollinators, especially honey bees.  The three strategic goals are repeated often:  reduce honey bee colony losses, protect monarch butterflies, and increase pollinator habitat acreage.  What is more pronounced in the Strategy when compared to the 2014 directive from the President is an emphasis on the monarch butterfly.  Though mentioned in the President’s memorandum, protecting the monarch butterfly is now among the three central, overarching goals of the Strategy.

The catalog of agencies involved varies widely from the obvious (EPA, U.S. Department of Agriculture (USDA), and Department of Interior) to the less obvious (Department of State (DOS) and the Federal Emergency Management Agency).  The Strategy thus discusses everything from adding millions of dollars for more research by USDA to planting a pollinator-friendly garden on the roof of DOS.  Much of the agenda is an extension of current programs (incentives in the Conservation Reserve Program, accelerated pesticide reviews), along with what may be some new initiatives (Department of Transportation initiatives along Interstate 35, as it is along the migration path of the monarch butterfly).

Regarding pesticides, many items addressed in the response have been anticipated or otherwise discussed by EPA staff in various settings over the last few months.  EPA announced that it will impose a number of new restrictions and conditions on the application of neonic insecticides where the grower who will apply the pesticides has contracted for pollination services.  This will especially apply to the almond pollination situation, but is not limited to that case.  It also means that even if the person applying the pesticide is contracting for pollination services and has permission from the beekeeper to apply the pesticide outside of the new limitations, doing so may be a violation of the pertinent product label.

For products applied by growers who are not using commercial pollination, the essence of the pollinator protection requirements will be in compliance with a state management plan (known as a Pollinator Protection Plan (P3)).  Some states already have plans, many are under development.  EPA has signaled that it expects state plans to incorporate three core ideas: public participation in developing the plan, some kind of notification scheme to alert beekeepers of insecticide applications, and a way to evaluate whether the state plan is effective in reducing insecticide exposure to bees.

EPA states that this scheme may be applied to more insecticides than simply neonicotinoid products, and that evaluation would be part of the registration review process for other insecticides.  EPA cites its recent correspondence to registrants of the neonicotinoids that no new formulations of products will be processed until more data on possible effects have been submitted and evaluated.

EPA also states that it will continue the benefits assessment of the neonicotinoid products, but has a milder tone when referring to the exercise than when it released its soybean seed treatment benefits memorandum last October.  EPA now describes its rationale for doing the soybean assessment as being essentially “because some scientific publications" stated they have “little value” -- in contrast to some of the rhetoric EPA used in October effectively concluding that there is no benefit from their use.

The most novel element of the EPA response may be the description of actions to “mitigate pesticide impacts on monarch butterflies.”  The document hints at field restrictions and what may be refugia-like requirements, even though these are not genetically modified organism products.  To some degree, this concept presents some novel policy and regulatory issues, since it would represent attempts to regulate use of a pesticide outside the site of application of the pesticide -- and insist on maintenance of some weed species otherwise intended to be controlled.  It could also portend some scheme for protection of endangered species from a pesticide’s use, although the monarch is not (yet) listed as threatened or endangered.

EPA states it will issue a draft strategy for protecting the monarch butterfly for comment in summer 2015.


 

By Lisa M. Campbell and James V. Aidala

On May 8, 2015, in El Comite Para El Bienestar De Earlimart v. EPA, a Panel of the U.S. Court of Appeals for the Ninth Circuit denied a petition for review filed by several groups that the court describes as “community organizations” who challenged the U.S. Environmental Protection Agency’s (EPA) 2012 approval of California State Implementation Plan (SIP) elements under the Clean Air Act (CAA), including its related approval of certain fumigant regulations.  This challenge was previously discussed in our blog post "Ninth Circuit to Consider Civil Rights Issue in Review of California SIP".

Of particular interest in the case is the contention before the court that “EPA failed to secure necessary assurances from California that its proposed rules would not violate Title VI of the Civil Rights Act by exposing Latino schoolchildren to a disparate impact from pesticide use.”  The court rejected this and other contentions by the community groups.  

The court’s findings with regard to the alleged Civil Rights violation state a standard that appears to defer greatly to EPA and its review of the record.  More specifically, the court found with regard to the claimed Civil Rights Act violation that “EPA explained that this evidence failed to draw any connection between the proposed rules and a potential disparate impact,” and that EPA “fulfilled its duty to provide a reasoned judgment because its determination was cogently explained and supported by the record.”

By way of background with regard to the Civil Rights Act claim, the petitioners argued that EPA’s determination that California provided assurances that no federal or state law prohibits the SIP approval was arbitrary and capricious because EPA failed to consider evidence claimed to support a violation of Title VI of the Civil Rights Act.  This claim rested on an EPA finding of a Title VI violation in connection with an earlier administrative complaint, referred to as the Angelita C. complaint, which was filed with the EPA Office of Civil Rights in 1999.  There, Latino parents and schoolchildren alleged that schools with high percentages of Latino children were disparately affected by the California Department of Pesticide Regulation’s (DPR) renewal of the registration for methyl bromide, a fumigant pesticide.  EPA concluded in that action that there was support for “a preliminary finding of a prima facie Title VI violation,” and EPA and DPR entered a settlement agreement in 2011.

Petitioner argued that EPA’s findings in Angelita C., and evidence that it claimed to demonstrate that pesticide use had not gone down since EPA completed its original review, supported the claimed Title VI violations that are the subject of the Ninth Circuit petition, and further that EPA did not do enough to determine that California had satisfied its burden to provide assurances of compliance with federal law.  The Ninth Circuit decision states in this regard that the petitioner “effectively contends the EPA should have evaluated California’s assurances the same way the EPA would have to deal with a pending Title VI complaint setting forth allegations of a current violation.”

The court states:  “El Comite’s argument fails because it misconstrues the EPA’s burden regarding the ‘necessary assurances’ requirement.  The EPA has a duty to provide a reasoned judgment as to whether the state has provided ‘necessary assurances,’ but what assurances are ‘necessary’ is left to the EPA’s discretion.”  The court further found:  “El Comite provided no proof of a current or ongoing violation.  It merely provided evidence of the earlier violation, and pointed to continued pesticide use since that time.  The EPA explained that this evidence failed to draw any connection between the proposed rules and a potential disparate impact.  The EPA fulfilled its duty to provide a reasoned judgment because its determination was cogently explained and supported by the record.” 

The decision in this case is of significant interest to many who have been observing the emerging trends regarding environmental justice issues arising in connection with pesticide applications.  This concern may grow larger as EPA continues and expands its evaluations of the potential bystander risks from pesticide use, potentially leading to additional restrictions for certain pesticides in the future.


 

By Lisa M. Campbell and Lisa R. Burchi

On Thursday, April 30, 2015, the U.S. Environmental Protection Agency (EPA) issued interim guidance that it intends to clarify its toxicology data requirements for antimicrobial pesticides used on food contact surfaces.  In addition, EPA issued a letter to antimicrobial registrants that EPA states is intended “to summarize how the Agency has been implementing 158W with respect to existing registered antimicrobial pesticides, as well as new and pending antimicrobial pesticide applications.” 

The interim guidance is intended to satisfy a condition of the March 2, 2015, settlement agreement between EPA and the American Chemistry Council (ACC), which followed ACC’s July 2013 initiation of a legal challenge to the antimicrobial data requirements (subpart 158W of Title 40 of the Code of Federal Regulations) in the U.S. Court of Appeals in the District of Columbia.  The settlement agreement is discussed here. 

In the settlement, EPA agreed to issue, within 60 days of the Agreement becoming final, an interim guidance document explaining EPA’s interpretation of the 200 parts per billion (ppb) residue level above which additional toxicology testing would be required for indirect food uses. 

The interim guidance states with regard to the 200 ppb standard: 

No later than September 2, 2017, the Agency will propose a correction to 40 CFR Part 158W to make the rule’s language as it pertains to the 200 ppb level established in 40 C.F.R. § 158.2230(d) consistent with the U.S. Food and Drug Administration’s use of that same level. The proposal will be to clarify that the 200 ppb level established in the rule is based on total estimated daily dietary intake, and is not based on the amount of residue present on only a single commodity. The Agency is providing this interim guidance to registrants that the referenced 200 ppb level is based on total estimated daily dietary intake rather than on the amount of residue present on only a single commodity.

EPA states that this interpretation is consistent with the U.S. Food and Drug Administration’s (FDA) policy.  In general, if pesticide residues in food resulting from use on food contact surfaces are 200 ppb or less, EPA requires certain toxicology data.  If residues are greater than 200 ppb, additional data may be required, depending on other conditions such as test results.

Also in the settlement, EPA agreed to propose, within four months of the Agreement becoming final, a guidance document entitled Antimicrobial Pesticide Use Site Index (USI), and provide a 30-day comment period.  The USI guidance will provide descriptions of direct food uses, indirect foods uses, and nonfood uses.  The letter states the following regarding its development of the USI guidance:

The Agency is developing a guidance document called the Antimicrobial Pesticide Use Site Index (USI) that will serve as a compilation of existing use sites and will identify how each use site fits within the twelve use patterns established in 158W.  The guidance document will serve to assist prospective registrants with the application requirements by making it easier for them to identify which data are necessary to register their product(s). 

EPA’s letter also discusses the following regarding existing and pending antimicrobial pesticide applications:

  • EPA may find it necessary, “in the context of, but not limited to, the requirements in 158W,” to call in data as each active ingredient is evaluated under the Registration Review program.  EPA does not intend to conduct this generic evaluation for new products or applications to amend existing products that are covered in Pesticide Registration Improvement Extension Act (PRIA3) fee category Table 9 -- Antimicrobial Division -- New Products and Amendments.
  • During early implementation of the 158W requirements, EPA recognizes that not all new applications will have all the newly-required data.  EPA may thus find it appropriate to issue Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 3(c)(7) conditional registrations and set a deadline for the submission of the required data.
  • Any application submitted after July 8, 2013 (the effective date of the 158W requirements) must contain the required data or an adequate justification for any data requirements not submitted.  On the issue of timing, applicants should explain why any data are not yet submitted and when the data can be submitted.  Failure to submit required data or provide an adequate justification will result in EPA rejecting the application as incomplete under the 45/90 day preliminary technical screen under the Pesticide Registration Improvement Act (PRIA).

The settlement agreement and additional documents are available at http://www2.epa.gov/pesticide-registration/epa-data-requirements-registration-antimicrobial-pesticides-part-158w#interim and www.regulations.gov in docket EPA-HQ-OPP-2008-0110.  More information on antimicrobial policies and guidance is available here.


 

By Lisa M. Campbell and Lisa R. Burchi

On April 20, 2015, the U.S. Environmental Protection Agency (EPA) announced it had reached settlements with three major pesticide registrants, for the actions of a third-party pesticide distributor, Harrell’s LLC (Harrell’s), a Florida-based lawn and turf care business that was distributing the registrants’ respective products.  EPA alleged that Harrell’s sold improperly labeled products that contained the pesticides dithiopyr, chlorantra-niliprole, and imidacloprid.

Without admitting liability, each registrant agreed to pay a penalty with one agreeing, in addition to completing a supplemental environmental project (SEP), to create a $231,000 educational website for the pesticide industry that will feature information on complying with federal pesticide laws.

A 2012 EPA investigation found more than 350 instances of Harrell’s products having been sold without proper pesticide labels -- in some cases, labels were either illegible or were not on the products at all.  The products at issue were registered and were sold and distributed by Harrell’s under supplemental distributor relationships.  In late 2013, Harrell’s agreed to pay a $1,736,560 civil penalty to EPA, one of the largest ever for a pesticide case.  

Under EPA regulations, supplemental distributors like Harrell’s are agents of the registrants, and those registrants are thus responsible and liable for the actions of their supplemental distributors.  In its recent National Enforcement Program Managers Guidance (NPMG), EPA’s Office of Enforcement and Compliance Assurance identifies Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) supplemental distribution as a mandatory “focus area.”  Specifically, EPA states:

Although required to be consistent with the labels of the basic registered products, distributor product labels frequently deviate substantially from the EPA accepted labels.  Such unapproved product labeling can lead to misuse and misapplication as well as pose significant risks to the users who rely on product labels to inform them about proper and safe pesticide use.  Due to the potential risk associated with the use of improperly labeled pesticides, it is important that the EPA aggressively pursue compliance for supplemental registrations. 

Bergeson & Campbell, P.C. (B&C®) recently issued a memorandum discussing the enforcement actions, the regulatory requirements for supplemental distribution, and what issues companies should address to help avoid such an enforcement action. That memorandum, “EPA’s Enforcement Efforts Regarding FIFRA Supplemental Distribution and How to Avoid Noncompliance,” is available online.

B&C also presented a webinar, “EPA's Supplemental Distribution Enforcement Actions Are Buzzing: How to Avoid Getting Stung,” on July 23, 2014, highlighting the most important steps that both registrants and supplemental distributors can take to ensure compliance and avoid being stung in the current heightened enforcement environment.  A recap of the webinar is available online.


 

By Lisa M. Campbell and James V. Aidala

 

On April 9, 2015, the California Department of Pesticide Regulation (DPR) held the first of a planned series of workshops intended to help DPR develop “regulation concepts” for possible notifications prior to field fumigations.  The presentations and video from that workshop are now available on DPR’s website.

 

DPR’s presentation at the workshop focused on the background that it believes supports the consideration of a notification requirement, and on current methyl bromide notification regulations and fumigant labeling requirements that it believes potentially could be used as a foundation to assist in the development of a rulemaking concept for soil-applied field fumigants. 

 

In addition, DPR considered whether the concept can be reconciled with the current label requirements as emergency preparedness and response requirements, or maintained as a separate “right-to-know” requirement.  DPR recommended expanding notification to all field fumigations, including applications of chloropicrin, 1,3-dichloropropene, methyl bromide, or pesticides that generate methyl isothiocyanate.

 

This potential regulatory development is of significant interest to pesticide registrants in general.  The application of a right-to-know model to pesticide applications, pursuant to which growers and applicators would have to notify those in a defined proximity to the planned pesticide application, would have far-reaching ramifications.  DPR’s further development of this potential regulation should be monitored closely.

 

Of note are similar notification schemes reportedly under consideration by the U.S. Environmental Protection Agency (EPA) as part of its pollinator protection proposals.  EPA staff has spoken of how one essential component of any pollinator protection program will be some kind of notification scheme for beekeepers, or at least commercial beekeepers, who have hives in the vicinity of the use area for certain pesticides.  As that issue evolves, it will invite comparison with EPA’s position on other requirements for mandatory notification, where generally EPA has not supported blanket federal requirements for notification of nearby pesticide applications.  This development in the pollinator area could lead to reconsideration at the federal level regarding broader advance notification requirements for specified pesticide applications. 


 

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


On April 15, 2015, the U.S. Environmental Protection Agency (EPA), the U.S. Fish and Wildlife Service (FWS), the National Oceanic and Atmospheric Administration National Marine Fisheries Service (NMFS), and the U.S. Department of Agriculture (USDA) held a one-day workshop regarding assessing risks to endangered and threatened species from pesticides. This workshop was intended to provide a forum for stakeholders to offer scientific and technical feedback on the ongoing agency efforts to develop draft Biological Evaluations (BE) for three pilot chemicals (chlorpyrifos, diazinon, and malathion) in response to the National Academy of Sciences’ (NAS) report “Assessing Risks to Endangered and Threatened Species from Pesticides.” The workshop was the fourth interagency workshop on this issue, and follows previously-held public meetings in November and December 2013, April 2014, and October 2014, and was held as part of the enhancement of the stakeholder engagement process finalized in March 2013. A copy of the Fourth ESA Stakeholder Workshop agenda is available online. The Interagency presentations are also available online.

This workshop presentations and discussion appeared to demonstrate progress among the agencies in coordinating their work to address the issues that have been the subject of this and prior workshops. The presentation content exhibited a better understanding of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) evaluation process by the Services, and the presentations themselves allowed for more interaction between the presenters and participants; some of the question and answer sessions (conducted after each segment) included detailed exchanges of information among the participants.

To the dismay of some registrants and observers, however, as the various evaluation models were described, and an avian case study presented, the direction of the joint analyses seemed to be moving towards the marriage of very conservative EPA assessment models and assumptions with the Services’ desire to avoid any potential impacts on individual members of a protected species and any habitat. Should this direction not change, the Endangered Species Act pilot assessments could be very conservative and indicate what many may believe is an unwarranted need for significant changes in some current pesticide labels. Simply put, from a registrant perspective, the good news is that the agencies are cooperating and working better together; the bad news is that both EPA and the Services appear to be planning to use very conservative models and assumptions, which could result in proposals for severe restrictions on some current use patterns.

 


 
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