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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:
With regard to agreements between EPA and PMRA for pesticides, the agencies have agreed to a plan and timeframes for three initiatives:
EPA, Health Canada, and Environment Canada also have a RPS regarding two initiatives for chemical substances management:
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.
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:
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.
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.
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:
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.
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.
Pollinator Health Task Force Issues National Strategy to Promote the Health of Honey Bees and Other Pollinators
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.
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:
The Strategy outlines “three overarching goals for action by Federal departments and agencies in collaboration with public and private partners”:
With regard to pesticides, the Strategy states the following “metrics” for Protecting Pollinators from Exposure to Pesticides:
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.
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.
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:
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:
EPA’s letter also discusses the following regarding existing and pending antimicrobial pesticide applications:
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.
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:
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.
DPR Proposal for Right-to-Know Notifications Prior to Soil Fumigant Applications Could Have Far-Reaching Implications
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.
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.
The letter states that the letter recipients are companies that have submitted an application for a new outdoor use and/or hold registrations for products containing imidacloprid, dinotefuran, clothianidin or thiamethoxam that have directions for outdoor application.
Affected neonicotinoid actions include:
* New Uses (including crop group expansion requests);
* Addition of New Use Patterns, such as aerial application;
* Experimental Use Permits; and
* New Special Local Needs Registrations.
The letter does not, however, preclude the approval of “me-too” products -- “products that are identical or substantially similar to existing uses.” In addition, EPA states that if a significant new pest issue should arise that may be uniquely addressed by one of these chemicals, EPA may consider whether an emergency use under FIFRA Section 18 might be appropriate. In the event that an emergency use is requested, EPA plans to assess such requests by relying on available information and risk mitigation strategies.
This new missive from EPA provides yet another example of a recent trend that many registrants believe is of concern, whereby EPA makes a broadly applicable set of regulatory decisions without an associated administrative process. With this approach, EPA summarily issues a letter to a class of registrants with immediate direct affect on their registrations with little or no room for consideration of individual facts, and with little explanation of important risk issues. In this letter, for example, EPA precludes the expansion of new uses, but yet allows the continued processing of “me-too” applications with no explanation from a risk profile of the risk difference that allows one type of product to be processed, but not the other. There are many possible scenarios where a new or expanded use of a product would not present any more risk to pollinators than the me-too product that EPA indicates will be considered.
This one-size-fits-all approach also appears to exclude consideration of any risk reduction potential of the pending applications (for example, when a pending neonic application represents a reduction in worker risk or endangered species when compared to an existing use pattern). Some applications may replace current exposure levels to organophosphate insecticides that EPA has generally sought to reduce. The potential processing of Section 18 exemptions may provide an avenue for such considerations, but the presumption that the pollinator issue a priori makes all other risk elements secondary is a tacit admission of where EPA currently evaluates the potential risk to honeybees in comparison to other possible impacts from pesticide use, including human health risks.
More information on EPA’s efforts to protect pollinators: http://www2.epa.gov/pollinator-protection.
Recent Studies and Reports on Pollinators: (1) New University of Maryland Report Indicates Neonicotinoids Not Primarily Responsible for CCD; and (2) Report from Congressional Research Service on Bee Health
Recently, the results of a three-year University of Maryland study assessing the potential chronic sublethal effects on whole honey bee colonies of a diet containing imidacloprid, an insecticide that belongs to the neonicotinoid class of chemicals, at 5, 20, and 100 μg/kg over multiple brood cycles have been released. The study, Assessment of Chronic Sublethal Effects of Imidacloprid on Honey Bee Colony Health, funded primarily by a Cooperative Agreement with the U.S. Department of Agriculture (USDA) Agricultural Research Service (ARS) Bee Research Laboratory, concludes that: “chronic exposure to imidacloprid at the higher range of field doses…could cause negative impacts on honey bee colony health and reduced overwintering success, but the most likely encountered high range of field doses relevant for seed-treated crops (5 μg/kg) had negligible effects on colony health and are unlikely a sole cause of colony declines.”
This study examines a number of recent controversial issues behind the bee health discussion, including: whether pesticides have an impact when one examines exposure levels approximating actual field condition exposure levels and whether the pesticide use has a substantial impact on hive and hive survival (and not just an impact on individual bees). The study results will likely be used by others to help evaluate the meaning of many of the studies various researchers have conducted over the past three to five years that are often cited in the media. Critics of these other studies have noted the “excessive” amounts of the pesticides used in the research protocol. They have also noted that, as insecticides, the neonicotinoid products are designed to kill insects, and since bees are insects, some bee mortality can be expected if exposed to the material. The University of Maryland study sought to emulate more realistic field conditions in the study protocol. Its conclusion, that there were “negligible effects on colony health” over a three-year period, is significant.
Also fairly recently, the Congressional Research Service (CRS) issued a report on bee health and pesticides, Bee Health: the Role of Pesticides. The report states that although the report focuses on bee exposure to pesticides, this does not imply that pesticides have a higher influence on the health and wellness of bees than other identified factors. The report states: “Although pesticides have been shown to damage bee health, it is unclear whether the level of harm is sufficient to attribute pesticides as the single or as the major cause of honey bee population declines.” The report further states that there is “the possibility that bees are being negatively affected by cumulative, multiple exposures and/or the interactive effects of several of these factors.” The CRS report refers to conclusions outlined in the USDA and the U.S. Environmental Protection Agency’s (EPA) joint Report on the National Stakeholders Conference on Honey Bee Health, including that “no research conclusively points to one single cause for the large number of honey bee deaths.”
The report details several actions the federal government is taking to promote the health of honey bees and other pollinators:
* The establishment of a Pollinator Health Task Force co-chaired by USDA and EPA that will “focus federal efforts on understanding, preventing, and recovering from pollinator losses.”
* EPA’s pesticide registration review of all neonicotinoid insecticides, and EPA’s development of new pesticide labels that prohibit use of some neonicotinoid pesticide products where bees are present, including products containing imidacloprid, dinotefuran, clothianidin, thiamethoxam, tolfenpyrad, and cyantraniliprole.
* The U.S. Fish and Wildlife Service (FWS) will be phasing out the use of neonicotinoid pesticides in all of its wildlife refuges as well as the feeding of genetically engineered crops to wildlife by January 2016.
By Lynn L. Bergeson and Carla N. Hutton
Almost seven years ago, the International Center for Technology Assessment (ICTA) filed a petition for rulemaking requesting that the U.S. Environmental Protection Agency (EPA) regulate products containing nanosilver as pesticides and for related other forms of relief. On March 19, 2015, EPA responded to the petition. In general, the response does not alter EPA’s legal position with regard to nanosilver and its regulation under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), or otherwise contribute any new interpretations of existing EPA pesticide registration or enforcement policy.
Briefly, the key decisions articulated in EPA’s response to the petition are:
* EPA will treat products containing nanosilver as pesticides under FIFRA if intended for pesticidal purposes, even in the absence of explicit pesticidal claims.
* EPA rejected ICTA’s claim that all products containing nanosilver are categorically pesticides and should be regulated as such.
* EPA will continue to apply its statutory and regulatory criteria as to what is a pesticide on a case-by-case basis. The determination “would be fact specific, typically based upon information on the use patterns intended, the claims or other advertising used to distribute or sell the ingredient or product, and any other information or knowledge made known to or known by the distributor or seller.”
* Importantly, EPA disagrees with ICTA’s claim that the treated article exemption should not apply to any nanosilver pesticide product because nanosilver specifically is not the registered pesticide active ingredient. According to EPA, application of the treated article exemption is available if a registered pesticide product is used, consistent with any terms and conditions of use of the registered product.
* EPA granted ICTA’s request to review the health and safety impacts from use of a nanosilver ingredient in a pesticide product based on nanosilver data for the portion released as nanosilver and based on macro-scaled silver for the portion released as silver ions, and agrees that FIFRA Section 3(c)(7)(C) is the appropriate authority for review of applications for registration of products containing nanosilver ingredients.
* EPA rejected ICTA’s claim that EPA must comply with the National Environmental Policy Act (NEPA) to assess the environmental impacts of EPA’s decision regarding nanopesticides, citing EPA’s well-settled view that it is exempt from NEPA requirements under FIFRA under Merrell v. Thomas, 807 F.2d 776 (9th Cir. 1986).
* EPA denied ICTA’s request to use a particular enforcement strategy to address unregistered pesticides sold or distributed in the U.S., believing that EPA lacks a factual basis to conclude that all nanosilver products are pesticides and thus does not have the legal basis upon which to conclude that all products are illegally sold or distributed.
By Lynn L. Bergeson, James V. Aidala, and Lisa R. Burchi
On March 20, 2015, the United Nations World Health Organization’s International Agency for Research on Cancer (IARC) announced it had completed evaluations assessing the carcinogenicity of five organophosphate pesticides. Specifically, IARC classified the herbicide glyphosate and the insecticides malathion and diazinon as probably carcinogenic to humans (Group 2A), and classified the insecticides tetrachlorvinphos and parathion as possibly carcinogenic to humans (Group 2B). IARC also found there is “limited evidence” that glyphosate can cause non-Hodgkin’s lymphoma and lung cancer in humans.
A summary of the final evaluations, together with a brief rationale, is published online in The Lancet Oncology; the detailed assessments will be published as Volume 112 of the IARC Monographs. IARC’s press release announcing its evaluation is available at http://www.iarc.fr/en/media-centre/iarcnews/pdf/MonographVolume112.pdf.
Monsanto, on behalf of glyphosate task forces in the U.S. and the European Union (EU), immediately voiced its vigorous disagreement with IARC’s conclusions, noting various scientific issues with IARC’s evaluation that resulted in a conclusion that has not been reached following review by the U.S. Environmental Protection Agency (EPA) and in the EU. Monsanto’s statement is available at http://news.monsanto.com/news/monsanto-disagrees-iarc-classification-glyphosate.
The IARC announcement with regard to glyphosate will further energize both sides of the debate about genetically modified organism (GMO) crops, since there are several crops that have been genetically engineered to be resistant to glyphosate. If some occupational risks are identified as needing possible further mitigation, the distinction between food safety issues and occupational risks may be lost in the rhetoric. Opponents of GMO crops and those who support GMO food product labels can be expected to cite the IARC designation regardless of any further clarification or nuance that the scientific debate over the data might provide. Defenders of the technology will insist that not only is the IARC designation wrong and misleading, but it is clearly at odds with numerous other conclusions reached by multiple competent governmental authorities concerning the safety of using glyphosate and especially consuming GMO crops.
Regardless of Monsanto’s rapid and detailed response, “dueling science” views are not helpful towards enhancing public confidence in the safety of the food supply, which is ultimately where this headline will be most influential. That will only add pressure on the review process and conclusions contained in the expected EPA registration review of glyphosate data scheduled for completion in 2015.
The U.S. Environmental Protection Agency (EPA) and the U.S. Food and Drug Administration (FDA) have executed a Memorandum of Understanding (MOU) on Information Sharing regarding the sharing of data and other confidential information related to substances that may be present in human food, animal food and feed, animal drugs, and cosmetics. EPA and FDA state in the MOU that the sharing of such information will “open channels of communication between the agencies” and will “serve to facilitate [EPA and FDA’s] accomplishment[s] of their respective missions.” The MOU sets forth the safeguards to be implemented with regard to the sharing of confidential information to “protect against unauthorized use or disclosure of any non-public information shared or exchanged pursuant to this MOU.”
EPA and FDA’s decision to share information will have a direct impact on companies with substances that have pesticidal and non-pesticidal applications. As noted in an example in the MOU, an antimicrobial food wash that can also be a labeled pesticide for other uses could have data submitted to FDA demonstrating that the product’s use is safe and does not adulterate food and data submitted to EPA demonstrating that the pesticide will not cause unreasonable adverse effects on the environment. Companies that have submitted information to EPA and FDA should be mindful of the potential that such information could be shared between the agencies, and consider whether additional safeguards or data compensation protection may be needed.