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.
On December 19, 2014, EPA opened the public comment period for 19 registration reviews. 79 Fed. Reg. 75801. The registrations are for: 3-methyl-cyclohexen-1-one (Case 6074); alkyl trimethylenediamines (ATMD) (Case 3014); boscalid (Case 7039); dikegulac sodium (Case 3061); ethoxyquin (Case 0003); fenpyroximate (Case 7432); flonicamid (Case 7436); fluazifop butyl, isomers (Case 2285); flufenpyr-ethyl (Case 7262); HHT (Grotan) (Case 3074); metolachlor & s-metolachlor (Case 0001); napthaleneacetic acid (Case 0379); oxadiazon (Case 2485); oxyfluorfen (Case 2490); pentachlorophenol (Case 2505); sodium fluoride (Case 3132); sulfonic acid salts (Case 7619); triclopyr (Case 2710); and yellow mustard seed (Case 7618). EPA will accept comments and information until February 17, 2015.
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.
On December 15, 2014, the U.S. Environmental Protection Agency (EPA) and the U.S. Department of Agriculture (USDA), the U.S. Fish and Wildlife Service (FWS), and the National Marine Fisheries Service (NMFS) wrote a report to Congress on the status of Endangered Species Act (ESA) implementation in pesticide regulation. EPA, USDA, FWS, and NMFS seek to refine their approach to pesticide consultations in an effort to protect endangered and threatened species.
The report was required by the 2014 Farm Bill and summarizes actions carried out by the agencies since receiving the April 2013 National Academy of Sciences’ (NAS) report, entitled “Assessing Risks to Endangered and Threatened Species from Pesticides.”
Since receiving the NAS report, the agencies have:
* Built a collaborative relationship among the agencies;
* Clarified roles and responsibilities for the agencies;
* Improved stakeholder engagement and transparency during review and consultation processes;
* Held two joint agency workshops resulting in interim approaches for use in assessing risks to ESA-listed species from pesticides;
* Created a plan and schedule for applying the interim approaches to a set of pesticide compounds; and
* Hosted multiple workshops and meetings with stakeholders.
The full report is available at http://www.epa.gov/oppfead1/endanger/2014/esa-reporttocongress.pdf.
On June 20, 2014, the White House issued a “Presidential Memorandum -- Creating a Federal Strategy to Promote the Health of Honey Bees and Other Pollinators.” The strategy is directed to all federal agencies and is designed to “expand Federal efforts and take new steps to reverse pollinator losses and help restore populations to healthy levels.” The text of the memorandum lists a number of goals and comments on pollinator health, and has a focus on setting up a government-wide task force, along with directives about research into the factors affecting pollinator health and suggestions to improve pollinator habitat. The role and possible impacts of pesticides on pollinators are mentioned, but are not prominent. Specifically, the memorandum mentions that one of the strategies to consider is to include “identification of existing and new methods and best practices to reduce pollinator exposure to pesticides, and new cost-effective ways to control bee pests and diseases.” Finally, it directs the new federal task force to report back to President Obama in six months.
Six months from the date of the memorandum is drawing near (December 20) -- so now, where are we? In summary, remarks by those leading the task force (staff from the U.S. Department of Agriculture (USDA) and the U.S. Environmental Protection Agency (EPA)) report that the response to the memorandum is now planned to be sent to the White House in draft form around the due date (the Holidays probably allowing for some schedule wiggle room), and that the public will be allowed to comment on the suggestions. That might mean a public release of the draft plan sometime in early Spring 2015, a date that coincidentally could dovetail with the beginning of the use season for commercial honeybee services (the almond crop in California begins to need bees around February depending on weather, temperature, and related considerations). No public release of the strategy is expected for at least 90 days or more. Private conversations and trade press reports indicate some slowness in convening and coordinating such a large and diverse group of agencies, as some agencies appear reluctant to participate in significant ways or otherwise are not sure exactly how or what their contribution to the effort should be (that, of course, is one of the main points of the exercise).
EPA and USDA have hosted two “listening sessions” on the memo -- on November 12 and 17 -- in Washington, D.C. Little detail was presented by the hosts; mostly it was open microphone with no advanced sign-up, so participants gave remarks in person or by phone. EPA and USDA did tell the audience that they would receive written comments on the memorandum if submitted by November 24. All of this public input will apparently go into the process of formulating the strategy. Many commenters, in fact most of those who spoke, had a “for or against” opinion about pesticide use and any possible impact on pollinators. Very few spoke of habitat issues or the research issues, even though those concerns dominate the text of the President’s memorandum.
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.
On December 16, 2014, the U.S. Environmental Protection Agency (EPA) will host a half-day workshop on the application process for the use of inert ingredients in pesticide products. The workshop will take place in Arlington, Virginia. The goal of the workshop is to clarify the necessary elements of an application for approval to use an inert ingredient in a pesticide product. Complete application packages save applicants time and money, and reduce the number of application rejections. The workshop will cover: selection of a Pesticide Registration Improvement Act (PRIA) category, elements of an application, EPA’s evaluation process, and a retrospective review of inerts under PRIA. EPA will answer stakeholder questions throughout the workshop.
On October 22, 2014, the U.S. Environmental Protection Agency (EPA) requested public comment on a proposal to remove 72 chemicals from its list of substances approved for use as inert ingredients in pesticide products. EPA reportedly is responding to petitions submitted by the Center for Environmental Health, Beyond Pesticides, Physicians for Social Responsibility, and others that have asked EPA to issue a rule requiring disclosure of 371 inert ingredients found in pesticide products. EPA developed an alternative strategy designed to reduce the risks posed by hazardous inert ingredients in pesticide products more effectively than by disclosure rulemaking. EPA outlined its strategy in a May 22, 2014, letter to the petitioners, which is available online. Many of the 72 inert ingredients targeted for removal are on the list of 371 inert ingredients identified by the petitioners as hazardous. The 72 chemicals are not currently being used as inert ingredients in any pesticide product. The list of chemicals is available online.
Ingredients that are directly responsible for controlling pests such as insects or weeds are called active ingredients. An inert ingredient is any substance that is intentionally included in a pesticide that is not an active ingredient. Comments are due November 21, 2014. General information on inert ingredients can be found online.
On October 15, 2014, the Office of Pesticide Programs (OPP) announced a voluntary program to document the effectiveness of agricultural pesticide spray application technologies on reducing pesticide spray drift. Under the Drift Reduction Technology (DRT) Program, agricultural equipment manufacturers would conduct (or make arrangements for a testing facility to conduct) studies to determine the percent drift reduction according to a verification protocol. Once completed, the manufacturer would submit the study to the U.S. Environmental Protection Agency (EPA) for review and evaluation. As verified, these reductions could then be quantitatively credited in the environmental risk assessments used to develop the drift reduction measures appearing on the label of the pesticide product. EPA will then review the manufacturers’ studies and, based on these data, it will assign spraying devices a rating on a four-star scale:
* Four stars: Device can reduce spray drift by 90 percent or more.
* Three stars: Device can reduce spray drift by between 75 percent to 89 percent.
* Two stars: Device can reduce spray drift by between 50 percent to 74 percent.
* One star: Device can reduce spray drift by between 25 percent to 49 percent.
* No stars: Device can reduce spray drift by less than 25 percent.
EPA allows pesticide manufacturers to include labeling on their products that contain dual-use instructions, one for farmers using devices that have received stars through the DRT program and another for those using devices that do not have a DRT rating.
On September 30, 2014, the U.S. Environmental Protection Agency (EPA) redesigned the Pesticide Registration Improvement Extension Act of 2012 (PRIA 3) website. The new website is available at www2.epa.gov/pria-fees. The purpose of the redesign is to make PRIA 3 information more easily accessible to stakeholders and the public, regardless of the type of device being used. EPA made no technical or regulatory changes to PRIA 3.
Spray Drift and Volatilization: Issues to Navigate Carefully as EPA Develops Registration Review Decisions
Spray drift and volatilization issues increasingly are significant issues in pesticide product risk assessments. Earlier this year, the U.S. Environmental Protection Agency (EPA) issued drafts of key guidance documents, which focused on issues that were key in the chlorpyrifos petition response, and more recently, at least one registration review decision that reflects current and still evolving EPA policy on spray drift and volatilization issues.
How potential for spray drift and for volatilization are identified and then managed are likely to be key elements of ongoing and future risk assessments underlying forthcoming EPA registration and reregistration, with significant potential impact on these decisions. Registrants should monitor closely the policies, EPA decisions implementing them, and their potential impact on their products, particularly given the public interest in these issues.
The EPA documents issued in the past eight or so months are significant, particularly given the years of controversy and difficulty in past attempts to propose a clear and “simple” definition of “drift.” The perception by some advocacy groups is that EPA is not adequately addressing alleged harms posed by drift, and resulting appeals for court intervention will undoubtedly complicate the matrix of considerations influencing EPA’s policy. These reasons alone make monitoring the development of these policies critical for registrants.