News

American Chemical Society (ACS) National Meeting: Fall Agrochemicals (AGRO) Division – August 13-17, 2023

American Chemical Society (ACS) National Meeting: Fall Agrochemicals (AGRO) Division - August 13-17, 2023

Come join Compliance Services International (CSI) staff technical and regulatory consultants at the American Chemical Society (ACS) Fall National Meeting, August 13-17, 2023 in San Francisco, CA. #ACSFall2023 #ACSAgro

Under the theme of Harnessing the Power of Data, our staff of Bernalyn McGaughey, Larry Brewer, Ashlea Frank, and Leah Duzy will be presenting and available throughout the meeting to meet with you to answer any questions you have regarding our regulatory and technical consultancy services pertaining to Federal and State pesticide registration support, Endangered Species Act Compliance & Strategy, including sustainable agriculture and protecting public health and the environment through chemistry. To contact our staff prior to the meeting, please click the contact us button below to send an email, otherwise contact them directly while attending the meeting.

Presenting Staff

Bernalyn McGaughey's Picture

Bernalyn McGaughey

President / CEO

Washington State

SYMPOSIUM TITLE: Advancing Public Engagement in Effective Pesticide ESA Education and Regulation

DIVISION: AGRO Division of Agrochemicals

SESSION FORMAT: Oral – In-person & Hybrid

ROOM & LOCATION: Room 3018, West Bldg. (Moscone Center)

SESSION DATE: Wednesday, August 16, 2023

SESSION TIME: 8:00 am – 12:00 pm (USA / Canada – Pacific)

SYMPOSIUM CO-ORGANIZERS: Gary Bahr, Bernalyn McGaughey, Greg Watson

PRESENTING: (3931547) Geographically unique projects to inform pesticide registrations 

DIVISION: AGRO Division of Agrochemicals

PRESENTATION FORMAT: Oral – In-person

ROOM & LOCATION: Room 3018, West Bldg. (Moscone Center)

PRESENTATION DATE: Wednesday, August 16, 2023

PRESENTATION TIME: 10:40 am – 11:05 am (USA / Canada – Pacific)

Ashlea Frank, M.S. (Presentor), Leah Duzy, Tony Burd, Stephanie Darnell

The US Environmental Protection Agency’s (EPA) process for complying with the Endangered Species Act (ESA) in pesticide registration decisions has evolved rapidly in the past few years. As a result, the FIFRA Endangered Species Task Force (FESTF) has seen the need to collaborate on efforts to bring local and regional expertise and knowledge of diverse agronomic practices into national-level decisions. Local and regional approaches provide opportunities to leverage expertise in cropping systems that are often unique to a regional or ecological subsection of the country. At present, the FIFRA/ESA process, as being applied by EPA under the ESA Workplan Update, does not look closely at what may be limiting factors to the feasibility or effectiveness of certain pesticide mitigations. This is clearly illustrated in the dynamics of specialty and export crops or unique niche areas. These cropping systems produce 75% of the world’s vegetable seed supply but use virtually no owned land to do so and thus may have limited 

Ashlea Frank's Picture

Ashlea Frank

Principal Consultant

Texas

ability to implement certain production activities on the landscape. In other regions and cropping systems, farmers have expended  monumental efforts for conservation and water quality protections in erosion or flood-prone areas. Across these diverse systems, FESTF sees the need for outreach to ensure that decisions made at the national level are understood at the local level by end-users and can be effectively implemented with sufficient flexibility for the specific local needs of the system. This presentation will discuss FESTF’s efforts on geographically unique and regionally specific projects that demonstrate ways of building bridges between assumptions made in national assessments and realities of actual crop settings and to facilitate communication between the regulators and the regulated community. Projects currently underway and under development will be discussed to provide examples of how data collected at the regional scale can inform decisions made by EPA, including through the consultation process with the US Fish and Wildlife Service and the National Marine Fisheries Service.

Leah Duzy's Picture

Leah Duzy

Principal Consultant

Alabama

PRESENTING: (3931534) Developing practical, effective, and implementable mitigations in pesticide registration using a sequential and repeatable approach

DIVISION: AGRO Division of Agrochemicals

PRESENTATION FORMAT: Oral –  Hybrid

ROOM & LOCATION: Room 3018, West Bldg. (Moscone Center)

PRESENTATION DATE: Wednesday, August 16, 2023

PRESENTATION TIME: 9:20 am – 9:45 am (USA / Canada – Pacific)

Leah Duzy (Presentor), Andrew Clawson, David Campana, Annie Krueger

Under FIFRA, pesticide registration requires compliance with the ESA and includes evaluating potential risk of pesticide on ESA-listed species and designated critical habitats. For the agencies responsible for this, it is an extensive exercise involving many complex datasets and processes, as demonstrated in recent draft assessments from the US Environmental Protection Agency (EPA), the US Fish and Wildlife Service, and the National Marine Fisheries Service (collectively, the Services) and the release of EPA’s workplan in April 2022 and subsequent update in November 2022. As clearly stated by EPA, ongoing litigation and the threat of future litigation related to ESA is driving the decisions being made by EPA and they are quickly moving forward with implementing the workplan by making “likely jeopardy” and “likely adverse modification” determinations as part of the Biological Evaluation (BE).

This approach by EPA essentially sequences species so that species potentially requiring additional mitigations receive a “Likely to Adversely Affect/Likely Jeopardy” determination. While EPA’s recent release of their plans has increased conversations around pesticides and ESA, the conversation around the process of sequencing species as part of pesticide registration and registration review is not new. In 2018, CSI and Syngenta began initial conversations around the process of species sequencing as part of a collaborative project. Over the next four years, discussions with the Services, EPA, and USDA reviewed the process including overall concept, data, and outcomes. The sequencing process has evolved, reflecting evolving policy from EPA related to ESA and registration and consultation decisions from EPA and the Services. The resulting sequencing process is flexible, adaptable, and responsive; implemented through a multi-functional tool to identify species for which reasonable and prudent mitigations may need to be explored at species individual and population levels. The process of sequencing species by degree of potential risk and vulnerability can be used to inform suitable mitigation measures, following the mitigation strategy of avoidance, minimization, and compensatory mitigation. The objective of this presentation is to demonstrate how a sequential and repeatable process that aggregates multiple data sources to sequence species provides valuable output for consideration in mitigation discussions as part of pesticide registration and registration review.

Other Staff in Attendance

Larry Brewer's Picture

Larry Brewer

Senior Science Fellow

Oregon

Larry has expertise in terrestrial ecotoxicology and specializes in wildlife, pollinator, and endangered species risk assessment; pesticide registration/re-registration support; and regulatory study placement and oversight.

Larry has over 35 years of experience spanning terrestrial ecotoxicology, laboratory ecotoxicology testing, ecological risk assessment and endangered species assessment. He is well known for designing and implementing full scale (Tier III) ecotoxicology field studies throughout North America with particular focus on avian, small mammal, and pollinator studies.

Compliance Services International (CSI) is an award-winning consultancy providing innovative solutions to meet regulatory and environmental challenges. Regulatory requirements, environmental challenges, and global markets are ever-changing. Our diverse staff of regulatory professionals and scientists in North America and Europe, along with associates around the world, continually adapt to develop strategic approaches to meet our clients’ needs.

CSI’s strength is in staying current on industry trends, and anticipating and applying new regulatory and scientific strategies. Our clients include multinational firms and small and medium-sized enterprises striving to introduce new and keep existing products in the global marketplace. While we keep pace with our ever-evolving regulatory and scientific environment, we strive to deliver outstanding service for each client and project.

CSI has an established reputation in providing registration support to the global marketplace and have successfully assisted firms with registrations in Canada, Latin America, Asia (China/Taiwan), Australasia, and other geographical markets.

Experienced Support For:

  • Global Regulatory Strategy
  • Registration Dossier Preparation & Submission
  • Ecotoxicology & Risk Assessment
  • Environmental Fate & Exposure Modeling
  • Study Design, Placement & Monitoring
  • Spatial Analysis & Data Systems
Scroll to Top

Bernalyn McGaughey
President & Lead Consultant

With a career that began in regulatory and field support of agricultural chemicals, Bernalyn has a wealth of experience in US Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) registration and strategic analysis and support of pesticide registrations. She moved from information technology to field technical sales and then to regulatory study development and management. Much of her work now involves the complicated intersection of the FIFRA and the Endangered Species Act (ESA) with respect to product defense and species protection. Bernalyn serves as an expert witness in pesticide regulatory and data compensation matters.

EDUCATION
B.S., Biology (specializing in Entomology), California State University.

Ashlea Frank
Principal Consultant

Expertise: Endangered Species

Ashlea offers technical and regulatory planning and strategic support for risk and conservation decision-making related to agriculture, pesticides, and endangered species issues.

Ashlea enjoys finding workable solutions that support end users and promote environmental stewardship by integrating sound science with management decisions.  Over the past 20 years she has acted as Visiting Scientist at the Queensland Institute of Medical Research conducting research on the efficacy of vector control products and Research Assistant at the Texas A&M Extension Agency helping growers find solutions to plant disease transmission in vineyards. She serves as Technical Consultant to the FIFRA Endangered Species Task Force (FESTF) providing endangered species and pesticide data analysis and agency interaction support for regulatory decisions under the US FIFRA and the Endangered Species Act (ESA).

EDUCATION
M.S., Entomology, University of Queensland.
B.A., Physical Anthropology, Southwestern University.

Leah Duzy
Principal Consultant

Expertise: Agricultural Economics

With a background in production agriculture and working lands conservation, Leah applies economic principles to risk and conservation decision-making to support agrochemical product development, assessment, and defense. She also provides applied economics research support through collaboration on federal grants and other projects. Her skills support pesticide benefit assessments and endangered species assessments.

Leah previously worked for the USDA Natural Resource Conservation Service and the USDA Agricultural Research Service as an agricultural economist for 15 years. She has worked in both the Federal conservation program and agricultural research arenas conducting applied economic research on conservation production systems, cover crops, and herbicide-resistant weed management, and preparing cost-benefit analyses for Federal conservation programs as part of the rulemaking process. 

EDUCATION
Ph.D., Agricultural Economics, Auburn University.
M.S., Agricultural Economics, Purdue University.
B.A., Economics, The University of the South.

Larry Brewer
Senior Science Fellow

Expertise: Terrestrial Ecotoxicology

Larry specializes in wildlife, pollinator, and endangered species risk assessment; pesticide registration/re-registration support; and regulatory study placement and oversight.

Larry has over 35 years of experience spanning terrestrial ecotoxicology, laboratory ecotoxicology testing, ecological risk assessment and endangered species assessment. He is well known for designing and implementing full scale (Tier III) ecotoxicology field studies throughout North America with particular focus on avian, small mammal, pollinator, and terrestrial invertebrate studies. Larry served as Director of Wildlife Toxicology for Smithers (17 years), and as President and Senior Scientist at Ecotoxicology and Biosystems Associates, Inc. directing domestic and international ecotoxicology field research, and ecological risk assessment (8 years). He was an Assistant Professor at the College of Human Health and Environmental Toxicology, Clemson University and the Wildlife Toxicology Section Lead in The Institute of Wildlife and Environmental Toxicology. He taught graduate courses in Wildlife Ecotoxicology and Field Research Techniques. He served as Field Research Leader for the Institute of Wildlife Toxicology, Western Washington University, and spent 17 years as a Wildlife Research Biologist with the Washington State Dept. of Wildlife. Larry has authored numerous publications and book chapters on topics of wildlife and pollinator ecotoxicology field research, and ecological risk assessment.

EDUCATION
M.S., Wildlife Science, University of Washington.
B.S., Fish and Wildlife Biology, Iowa State University.