AERF NEWS – AUGUST 2016, No. 14
Bernalyn McGaughey, President/CEO of Compliance Services International (CSI) has been highlighted within the latest Aquatic Ecosystem Restoration Foundation (AERF) August 2016 Newsletter. Article abstract and excerpts from the newsletter are below. If you would like a copy of the August 2016 Newsletter, please click the AERF logo to the right or the text below.
- At the Front of a Storm: What Emerging Federal Processes for Endangered Species Risk Assessment will mean to the Registration of Aquatic Herbicides. Bernalyn McGaughey, Compliance Services International (CSI)
ABSTRACT: Under the Endangered Species Act (ESA), every federal agency must determine the impact of its potential actions on species listed by that act. If a potential effect on a single individual within a listed species is deemed possible, either through direct or indirect effects, then the agency taking that action must consult with the Services to determine whether or not its action will have an adverse impact on, or present jeopardy to, the affected listed species at the population level. Under FIFRA, the EPA Office of Pesticide Programs (OPP) is taking the action to register or reregister a pesticide, and they therefore must consult with either the USDI Fish and Wildlife Services (FWS) or the USDC National Marine Fisheries Services (NMFS, or Services collectively) if their proposed action “may affect” an ESA-listed species. However, a fully operational consultation process under FIFRA/ESA has never been achieved, partly because the laws describe endpoints differently and because FIFRA, as a law, preceded ESA and is much more descriptive and somewhat more regimental about effects testing and consequential environmental risk assessment techniques than are methods used under ESA. And of course, there is also the complication of dealing with three different federal agencies and their internal processes and cultures. FIFRA was developed to address a national level registration; ESA was developed to address a site-specific event within an area where a listed species may occur. Thus, under FIFRA, the headquarters office is considered to hold the expertise to make registration decisions, but under ESA, the local office is considered the authority to recommend protective actions for species.
The intersection of FIFRA and ESA has long been the subject of procedural litigation based on EPA’s failure to consult the Services, and OPP has gone through several iterations of attempted FIFRA/ESA compliance. This does not mean that programmatically species have gone unprotected; it means that the failures to procedurally meet the required process are subject to litigation, which in the early 2000’s brought OPP’s existing methods of species assessment and protection into question. Currently, OPP and the Services are operating under an “Interim Process” for dealing with FIFRA/ESA endangered species assessment, which grew out of recommendations put forth by the National Academy of Sciences in 2013. In the three years since that report’s publication, OPP and the Services have worked together on three pilot Registration Review chemicals (chlorpyrifos, diazinon and malathion, all organophosphate insecticides) to apply a trial-and-error, develop-as-you-go “Interim Process” for endangered species assessment – a process that is intended to meet both FIFRA and ESA needs.
In April of this year, the first three draft biological evaluations of the pilot chemicals were docketed for public review, accompanied by over 12,000 pages of background records. This is an overwhelming amount of material to review within a 60-day comment period. However, upon general examination, it is clear that the logistics of dealing with about 1500 listed species and thousands of potential use sites have driven the agencies to attempt shortcuts in managing the process, largely by automation and modeling. In these shortcuts, broad assumptions, frequent absence of method validation, and some virtually impossible “worst case” settings drove the assessment outcome to the point that, in some cases, we see a 0.0000002% probability of a possible effect as a “may affect” for a given species.
While the Interim Process used for the three pilot chemicals is by the agencies admittedly flawed and subject to change, when aquatic herbicides come into view, we are likely to see a greatly impacted risk conclusion from OPP in the ESA biological evaluation process because:
– It is likely that an aquatic herbicide treatment will be considered a “wide ranging” use with no spatial definition in exposure modeling
– Exposure will be calculated from maximum label rates and minimum dilution and degradation estimates
– Toxicity endpoints will be from most sensitive species and lowest published values with little consideration of data relevance and reliability
– Best management and state or local permitting practices and the protection they bring will not be considered in the species assessment process
– Assumed use rates and frequencies, and area of a waterbody treated, will be assumed to be unrealistically high
With this awareness of potential methods and adverse outcome, it will be important to be proactive in dealing with the FIFRA/ESA conundrum. A proactive strategy will curtail lost uses and delayed new registrations and will be important to the regulatory success and sustainability of aquatic herbicide weed and algae management tools.
- The Endangered Species Act as it pertains to aquatic pesticide use remains a challenge to pesticide use in general including aquatic plant management activities. We have already initiated research efforts to change the restrictive perspective on this from pesticides being a “threat” to endangered species (ES) to thinking in terms of our management efforts improving ES habitat by controlling invasive species. As a first step, the AERF has funded Dr. Lauren Pintor, OH State Univ. and a graduate student to conduct a literature search and analysis of existing papers relating to this subject. Furthermore, we have engaged the guidance of Dr. Bernalyn McGaughey, a toxicologist with Compliance Services International (CSI) and Chair of the FIFRA Endangered Species Task Force (FESTF) to further assist in these efforts. Both will be attending our AERF Board meeting following the July APMS annual conference in Grand Rapids.
- Invited by AERF, Dr. Bernalyn McGaughey from Compliance Services International (CSI) and Dr. John Rodgers from Clemson University presented an afternoon seminar to a packed room of very interested attendees. Hosted by Carlton Layne, Executive Director of AERF, the session was divided into a discussion of the science supporting copper algaecide and herbicide labeling related to human health and the environment followed by a presentation on copper fate and effects post-treatment.Dr. McGaughey presented information regarding human health and margins of safety afforded by copper-based algaecides and herbicides. She engaged the audience in responding to frequently asked questions regarding these materials.