Pesticides in Animal Health

This workshop is beneficial to both new and experienced professionals in animal health and agriculture industries involved in regulatory, research and development, marketing, legal and operational roles at pesticide sponsor and contract research-based companies.

Attendees will be provided with an understanding on the registration process on the following topics:

• Pesticide definitions
• Introduction to pesticides registration
• Laws, regulations, and guidance of pesticides registration
• Preparing an application for registration of a pesticide
• Post registration activities including record keeping and inspections
• Case study applications on a variety of products to assess potential challenges

Haley Larson, Ph.D.
Teaching Assistant Professor of Animal Health

Haley Larson, Ph.D., is a teaching assistant professor of animal health at Kansas State University's Olathe campus. She joined as a faculty member since August 2020. Prior to this, she was a senior scientist for Cargill Animal Nutrition and Health for four years, where oversaw the rumen fermentation lab and lead projects focused on new product development for multiple species.

Dr. Larson is the instructor for several animal health graduate-level courses within the department of applied and interdisciplinary studies as well as the College of Veterinary Medicine’s diagnostic medicine and pathobiology department. She leads regulatory affairs courses on preclinical and clinical research strategies, post-approval product stewardship, EPA and FDA regulations for new animal health products. She has served as the major professor or as a supervisory committee member to graduate students within the veterinary biomedical science program, the professional science masters program, and the masters of public health program.

In her role at K-State, Dr. Larson also designs academic courses and professional development programming tailored to Greater Kansas City's growing animal health industry.

Dr. Larson earned her B.S. in Animal Science and Ph.D. in ruminant nutrition from University of Minnesota.

Nader Elkassabany, Ph.D.
EPA Regulatory Expert

Dr. Nader Elkassabany is a regulatory affairs professional with more than 20 years of experience across public and private sectors. He has spent the last nine years in Regulatory Affairs director roles at S.C. Johnson, Merial, Boehringer-Ingelheim Animal Health, and Elanco Animal Health, where he supervised teams dedicated to securing and maintaining federal and state registrations for consumer and animal health pesticide products.

Prior to his entry into private industry, Dr. Elkassabany served in the Office of Pesticides Program in the USEPA for 15 years. During his tenure at EPA OPP, Dr. Elkassabany advanced through several managerial roles, including three years as the Branch Chief of the Risk Assessment and Science Support branch of the Antimicrobial Division. He was awarded several bronze medals for his achievements on a variety of projects.

In his early career, Dr. Elkassabany was a research assistant in the Department of Entomology at the University of Arkansas, Fayetteville, for five years. He also taught as an adjunct professor of microbiology for Montgomery County Community College in Rockville, Md., for 12 years. Dr. Elkassabany continues to enjoy teaching and is currently teaching two courses in the Animal Health Regulatory Affairs Graduate Certificate program at Kansas State University.

Dr. Elkassabany received a Bachelor of Science in Agriculture from the University of Alexandria in Egypt and a Master of Science in Entomology from the University of Tennessee, Knoxville. He earned his Ph.D. in Entomology from the University of Arkansas, Fayetteville.

All times below are in central time (CT).

8:30 a.m. | Welcome

8:50 a.m. | Background on EPA
Haley Larson and Nader Elkassabany

• Introduction to history of agricultural culture in EPA
• Structure of EPA
• Discussion/Activity: Determining what is a registered EPA product
• Introduction to pesticides registration
• Outline of regulatory framework: Laws, regulations and guidance of pesticides registration

10:20 a.m. | Break

10:30 a.m. | Approval Process
Haley Larson and Nader Elkassabany

• Timelines for registration
  • Compare and contrast industry registrant vs. agency reviewer perspective
  • Discuss building strategies as a regulatory affairs team for EPA registration

Noon | Lunch

12:45 p.m. | Approval Process continued
Haley Larson and Nader Elkassabany

• Additional information to consider when preparing an application for registration

2:15 p.m. | Break

2:30 p.m. | Approval Process continued
Haley Larson and Nader Elkassabany

• Discussion: Understanding when a product needs to be registered with EPA
• Importance of product label development as part of the registration process
  • Activity: Comparing master labels and container labels

4:30 p.m. | Dismiss
Lauren Racki

All times below are in central time (CT).

8:30 a.m. | Approval Process continued
Haley Larson and Nader Elkassabany

• Data requirements for registration of pesticides

9:45 a.m. | Break

10 a.m. | Approval Process continued
Haley Larson and Nader Elkassabany

• Data compensation
  • Case Study – Understanding strategy of data compensation timelines: Seresto example

12:30 p.m. | Lunch

9 a.m. | USDA's Role in Regulating Biologics
Norm Brown

• Virus Serum Toxins Act
• USDA CVB
• Federal laws, regulations and guidance documents

1 p.m. | Post-Approval Activities
Haley Larson and Nader Elkassabany

• Discuss actions after registration
  • Case Study - Active ingredient cancellation: Pentachlorophenol example
  • Explain Re-registration cycle
    • Risk Assessment (Eco vs Human)
    • Case Study – challenges that exist in marketplace when legislation conflicts: FIFRA vs. ESA in Brodifacoum example

2:45 p.m. | Break

3 p.m. | Post- Approval Activities
Haley Larson Nader Elkassabany

• Market Compliance
  • Discussion: Gray space for label claims
  • Case Study -- Maintaining compliance with marketing and advertising materials: Liphatech examples
• Discussion: challenges of public influence with approved products
  • Case Study - How public perception can influence approved animal health products: fruit industry example
• Contrasting EPA with other agencies post-approval activities

4:20 p.m. | Wrap-Up and Dismiss
Lauren Racki