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

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

On October 31, 2018, the U.S. Environmental Protection Agency (EPA) announced that it is extending the registration of dicamba for two years for “over-the-top” use (application to growing plants) to control weeds in fields for cotton and soybean plants genetically engineered to resist dicamba.  EPA states that the registration for these dicamba products will expire on December 20, 2020, unless EPA decides to further extend it.  EPA states that the label changes described below were made to ensure that these products can continue to be used effectively while addressing potential concerns to surrounding crops and plants.  EPA’s dicamba registration decisions for the 2019-2020 growing season are:

  • Two-year registration (until December 20, 2020);
  • Only certified applicators may apply dicamba over-the-top (those working under the supervision of a certified applicator may no longer make applications);
  • Prohibit over-the-top application of dicamba on soybeans 45 days after planting and cotton 60 days after planting;
  • For cotton, limit the number of over-the-top applications from four to two (soybeans remain at two over-the-top applications);
  • Applications will be allowed only from one hour after sunrise to two hours before sunset;
  • The downwind buffer for all applications will remain at 110 feet, but in those counties where endangered species may exist, there will also be a new 57-foot buffer around the other sides of the field;
  • Clarify training period for 2019 and beyond, ensuring consistency across all three products;
  • Enhanced tank clean out instructions for the entire system;
  • Enhanced label to improve applicator awareness on the impact of low pH’s on the potential volatility of dicamba; and
  • Label clean up and consistency to improve compliance and enforceability.

EPA states that it has reviewed substantial amounts of new information and has determined that the continued registration of these dicamba products with the specified use restrictions meets the Federal Insecticide, Fungicide, and Rodenticide Act’s (FIFRA) registration standards.  EPA also determined that extending these registrations with the new safety measures will not affect endangered species.  More information on this extension is available on EPA’s website; more information on other dicamba issues is available on our blog.

Commentary

As expected, this decision allows the continued use of the newer dicamba formulations intended to be applied on dicamba-resistant crop varieties.  Of particular note is that EPA has not granted a permanent Section 3 registration, instead granting a time-limited, two-year registration which EPA states will expire at the end of 2020.  This will allow EPA more time to assess in more detail whether the new use restrictions will further reduce problems of misuse, label complexity, or unexpected drift which have been reported in past growing seasons. 

The most vexing issue behind plant injury reports over the past few years is whether these reports are mostly due to misuse (e.g., applicators who do not use the new formulations designed to reduce volatility, which is a label violation since the “old dicamba” product is considered more prone to cause drift injury), or, are due to characteristics of the new formulations which are not yet fully understood and which lead to unexpected volatility and other drift problems.  Some have also argued that problems are also due to the difficulty (or reluctance) in following the more prescriptive requirements for the new formulations.  The two-year renewal will continue to see EPA closely monitor injury and misuse reports, as well as continued academic and registrant research into the likely cause of any reported problems.

EPA’s decision also imposes further requirements for additional training, timing, record-keeping, and stewardship when using the new dicamba formulations that are designed to reduce or to eliminate those plant injury reports that are not clearly attributable to misuse of the older dicamba products.  EPA will rely on state officials to report and evaluate the experience of users in their respective states, especially concerning whether the additional training and stewardship requirements significantly reduce local injury reports. 


 

By Lisa M. Campbell and James V. Aidala

On May 25, 2018, the U.S. Environmental Protection Agency (EPA) issued an extension of the comment period of the proposed rule entitled “Strengthening Transparency in Regulatory Science” (Science Rule) that EPA issued on April 30, 2018.  83 Fed. Reg. 24255.  The Federal Register notice states that EPA will extend the comment period from May 30, 2018, to August 16, 2018.  EPA states that it is making these changes “in response to public requests for an extension of the comment period and for a public hearing.”  It is noteworthy that the extension was issued on the heels of EPA’s receipt of letters, one submitted by eight Attorneys General and another by 20 Senators, addressing the proposal, as described below.  Comments can be filed in Docket ID No. EPA-HQ-OA-2018-0259 on www.regulations.gov

EPA’s notice also announces that it will be holding a public hearing for the proposed rule on July 17, 2018, from 8:00 a.m. to 8:00 p.m. (EDT) in Washington, D.C. that will provide “the public with an opportunity to present oral comments regarding [the Science Rule]”; and will “provide interested parties the opportunity to present data, views, or arguments concerning the proposal.”  The notice states that EPA may ask clarifying questions during the oral presentations, but will not respond to the presentations at that time.  Registration for the public hearing will be available online; registration information is available in the Federal Register notice.

EPA’s extension and its grant of requests for a public hearing follows closely in time of its receipt, on May 7, 2018, of a letter to EPA Administrator Scott Pruitt from eight Attorneys General -- those of New York, California, Delaware, Iowa, Maine, Minnesota, Pennsylvania, and the District of Columbia -- expressing their concern regarding the Science Rule.  The letter requests EPA to withdraw the proposed rule and to consult with the National Academy of Sciences (NAS).  The letter states that if EPA is unwilling to withdraw the rule, then EPA should extend the comment period by at least 150 days to “provide for appropriate consultation with the [NAS],” as “a full six-month comment period … is necessary to provide the public and other stakeholders a meaningful opportunity to evaluate the proposal and its implications for the agency’s ability to meet its obligation to protect public health and the environment under federal environmental laws.” 

On May 14, 2018, 20 Senators submitted a letter to Pruitt requesting that the comment deadline be extended, to July 30, 2018, stating that this extra time would give “stakeholders adequate time to draft and submit thorough, well-reasoned comments,” as the rule is “expected to have a significant effect on the types and number of scientific studies EPA considers during rulemaking” and “implicates patient privacy.”

It is not clear if the extension of time for public comment indicates a desire to develop a more thorough record behind whatever may emerge as the final rule or is a reaction to some of the intense opposition to the entire scheme.  “EPA Science” has been controversial and an emerging political issue for some time, but the reaction to the proposal has been intense even in comparison to many of the changes the Trump Administration has sought to impose on other EPA policies and procedures.  To some degree, if the Trump Administration hopes to change EPA’s fundamental approach to decision-making, the sooner the better for the potential to leave a lasting change in place.  Meanwhile, even from a relatively neutral perspective, the proposal is complicated as to how such new requirements would work -- what it applies to, or how some of the critical new terms would be defined (e.g., “pivotal science”), among other complex elements.  This complexity may be its ultimate undoing, or perhaps careful consideration of voluminous (and much critical) public comment will hone the proposal into something more likely to achieve its stated goals.

More information about the Science Rule is available on our blog and in our memorandum EPA Releases Strengthening Transparency in Regulatory Science Proposed Rule.