By Lisa M. Campbell and Lisa R. Burchi
On November 6, 2015, the U.S. Environmental Protection Agency (EPA) announced that it has a new webpage that compiles information about secondary containers and service containers for pesticides. Secondary and service containers are containers that are used by the pesticide industry as part of the process of applying pesticides, not for further sale or distribution. EPA states that the website combines and replaces information previously found on the Labeling Questions and Answers page and in the Label Review Manual, and addresses frequently asked questions. The announcement states “this is not new guidance, but the EPA hopes this new resource will make information on secondary and service containers easier to find and will lead to improved handling of these containers.” According to EPA, the webpage is designed to help pesticide registrants and applicators:
- Understand EPA’s definition of secondary and service containers;
- Learn about EPA’s recommendations for good management practices when labeling secondary and service containers; and
- Learn how to properly identify the contents of a secondary or service container, including when the pesticide is diluted.
Although registrants are not required to submit labels to secondary containers to EPA for review, EPA provides the following Q&A for when EPA will approve such labels if submitted to EPA for review:
Q: If a registrant wishes to submit and have EPA review the secondary container label, what does EPA require?
A: As it isn't required that a secondary container label be submitted, there are no requirements per se. EPA will review them on a case-by-case basis and would be likely to accept them if:
- The EPA-approved master label includes directions for diluting the product.
- The secondary container label is submitted as part of the master label.
- The master label bears a statement that the secondary container must be labeled as presented on the master label (e.g., “When this product is diluted in accordance with the directions on this label, the dilution container must bear the following statements:”)
- The secondary container contains a statement prohibiting further sale or distribution.
- The secondary container may have reduced precautionary language (if supported by dilution-specific acute toxicity data), but not a reduced signal word.
Requirements governing secondary containers are often a source of questions within the regulated community; many may find EPA’s new website a useful source of information on this topic.
By Lisa M. Campbell and Margaret R. Graham
The U.S. Environmental Protection Agency (EPA) has launched a new pesticides website: http://www2.epa.gov/pesticides, and a new biopesticides website: http://www2.epa.gov/pesticides/biopesticides, among others. EPA states that this gradual move to new versions of its content is part of a larger EPA effort to build a more user-friendly website.
The updated biopesticides website focuses on providing general information on biopesticides, as well as tools to assist applicants for registration, and is organized into the following areas:
- What are biopesticides?;
- Biopesticide registration information;
- Plant incorporated protectants (PIPs); and
- Where can I find more information on biopesticides?
With this transition, web page addresses will be different which may cause links and bookmarks to break. EPA states that it is working to fix any broken links. The majority of the old pesticide pages will redirect to the new web areas, but bookmarks will still need to be updated. EPA’s new “Page Not Found” notification will help website users find what they are looking for by providing suggested search terms, links to the A-Z index, and other helpful links. The search feature available on every EPA web page and in the archive (archive.epa.gov) can also be useful in finding content.
Other updated pesticide related links are:
By Lisa M. Campbell, James V. Aidala, and Lisa R. Burchi
The Canadian province of Ontario has issued its final regulations under the Ontario Pesticides Act aimed at reducing the area planted with maize and soybean seed treated with neonicotinoid insecticides. These changes have been made as part of its broader strategy to protect pollinators, and aim to reach an 80 percent reduction in the number of hectares planted with neonicotinoid-treated corn and soybean seed by 2017.
The new rules create a new class of pesticides, known as “Class 12 pesticides.” This class applies to corn seed grown for grain or silage, and soybean seeds treated with the following neonicotinoid insecticides: imidacloprid; thiamethoxam; and clothianidin. The new regulations will not apply to popping corn, sweet corn, corn used for the production of seed, or soybean seeds planted for the purpose of producing a soybean seed crop of certified status.
The new system established by these regulations will take effect on July 1, 2015, and be phased in over time. The elements include but are not limited to the following:
- Integrated Pest Management Training: The regulations will require farmers to complete training on integrated pest management methods. To encourage participation, training will be offered for free until September 1, 2016; after that time, training will be provided at a cost. After August 31, 2016, any person (e.g., farmer) who purchases neonicotinoid-treated seeds will be required to have completed the integrated pest management training course and received a certification number, which will be valid for five years.
- Pest Assessment Reports: Farmers wanting to buy and plant neonicotinoid-treated seed on more than 50 percent of the total area of their corn and soybean crop will need to complete a pest assessment report and provide it to the sales representative or seed vendor from which they purchase the seeds.
- Requirements for Vendor Licenses for the Sale of Neonicotinoid-Treated Seeds: The regulations will require companies selling neonicotinoid-treated seeds to obtain a treated seed vendor’s license, notify purchasers that the seed is a neonicotinoid-treated seed, and offer untreated seed for purchase, among other requirements. Growers will only be able to buy and use neonicotinoid-treated seeds that vendors have put on the "Class 12 Pesticides List," a list updated by August of each year.
- Tracking of the Sale of Neonicotinoid-Treated Seeds: The regulations will require the annual submission of the sales of treated seeds “to ensure an open and transparent system to track progress.” The Ministry of the Environment will publicly report amalgamated sales and seed treatment data for neonicotinoid-treated corn and soybean seed.
The regulations do not include requirements for the transport and storage of Class 12 pesticides.
Further information is available at the below links:
It is important to consider these new requirements in conjunction with those being developed in the U.S. EPA’s approach to date in considering additional restrictions to neonicotinoid pesticides to protect pollinators appears to focus not as much on reducing the use of products, but instead on controlling and preventing unwanted exposure of pollinators to these products.
In recent weeks, the U.S. government issued a “National Strategy to Promote the Health of Honey Bees and Other Pollinators” on May 19, and on May 28, EPA released for comment: “EPA’s Proposal to Mitigate Exposure to Bees from Acutely Toxic Pesticide Products.”
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.
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 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.
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”:
- 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.
- 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.
- 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.
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 Susan Hunter Youngren, Ph.D.
The U.S. Environmental Protection Agency (EPA) issued an updated schedule for the Pesticide Registration Review program that sets forth a timetable for opening dockets for the next three years, through end of fiscal year 2017 (September 2017).
Through the Pesticide Registration Review program, EPA reviews all registered pesticides at least every 15 years, as mandated by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Following the newly issued schedule, all pesticides registered as of October 1, 2007, will have entered the registration review process with the exception of certain biopesticides. All pesticides registered by October 1, 2007, are scheduled to be assessed by October 1, 2022.
The rodenticide and triazole groups of chemicals have had their schedules adjusted so that all chemicals in the groups will be assessed during the same time frame. The rodenticides have dockets opening in first and second quarter 2016, while the triazoles have dockets opening from fourth quarter 2015 through third quarter 2016. In addition, EPA states that it has moved some chemicals that it believes may have significant data needs earlier in the schedule, but does not specify which were moved. Those with significant moves forward in the schedule (all moved from fourth quarter 2015 to first quarter 2015) include yellow mustard seed, sulfonic acids, fluazifop butyl, isomers, and flonicamid.
More information about the Pesticide Registration Review schedule is available here.
By Lynn L. Bergeson and Timothy D. Backstrom
On December 16, 2014, the Center for Food Safety (CFS) and its affiliate the International Center for Technology Assessment (ICTA), along with a coalition of other non-governmental organizations, brought suit in the U.S. District Court for the District of Columbia. The suit concerns a May 1, 2008, petition by these organizations requesting that the U.S. Environmental Protection Agency (EPA) take regulatory action concerning nanoscale silver (nanosilver) products, including classifying nanosilver as a pesticide under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Since receiving the CFS/ICTA petition, EPA has taken a number of incremental steps to regulate nanosilver. After inviting comment concerning the petition, EPA referred scientific issues concerning risks from and exposure to nanosilver to the FIFRA Scientific Advisory Panel (SAP), announced that it would treat nanoscale pesticides (including nanosilver) as a separate pesticidal active ingredient, established new registration requirements for several specific nanosilver products, and initiated the registration review process for registered nanosilver products.
Notwithstanding these actions, EPA has not formally responded to the 2008 CFS/ICTA petition, and the petitioners have characterized the steps taken by EPA to date as “toothless.” Rather than contesting the suit, EPA may seek an agreement requiring EPA to respond formally to the petition by a specified date. Perhaps EPA will characterize the regulatory actions taken to date as a partial grant of the petition. On the other hand, many of the nearly 400 nanosilver products that CFS/ICTA claim EPA should regulate under FIFRA have no pesticidal claims or purpose or are being sold and distributed outside of the U.S. With respect to these products, EPA will likely respond that it has no authority to provide the relief sought by the petitioners.
By Sheryl Lindros Dolan
The U.S. Environmental Protection Agency (EPA) announced that it has “decided to postpone the [Pesticide Program Dialogue Committee (PPDC)] meeting scheduled for December 11-12, 2014.” EPA notes that “this is a particularly busy time of year in [the Office of Pesticide Programs (OPP)] as we are working to complete several major decisions and projects by the end of the year/early next year. We want to keep the momentum going so that we can share our progress with you early in 2015.” At this time, EPA intends to hold a half-day update via the web in February 2015 to bring stakeholders “up-to-date on these activities.” According to EPA’s November 21, 2014, Federal Register notice announcing the December PPDC meeting, the PPDC Work Group on Integrated Pest Management and Work Group on Pollinator Protection were scheduled to meet on December 10, 2014. EPA has scheduled the next two PPDC “in-person” meetings for May 14-15, 2015, and October 22-23, 2015.