IEH Academy Webinar

Addressing Botulism in FDA and USDA Regulated Foods

This webinar will cover the characteristics of C. botulinum and botulism, as well as practical steps the food industry can take to reduce the risk of contamination in their products.

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Webinar Recording

Description

Botulism is one of the most severe foodborne illnesses, with symptoms that may include muscular paralysis, suffocation, and, if left untreated, death. Although antitoxins are available, the most effective approach remains prevention, specifically by limiting the growth of Clostridium botulinum through proper formulation and preventive controls. Given the significant public health risk it presents, regulatory measures have been established to reduce the likelihood of botulism in processed foods. Requirements for FDA-regulated products are outlined in 21 CFR Parts 108 and 109, and for those regulated by USDA, in 9 CFR Part 431. This webinar will cover the characteristics of C. botulinum and botulism, as well as practical steps the food industry can take to reduce the risk of contamination in their products.

Benefits and Learning Objectives:

Characterize Clostridium botulinum and its relevance in foodborne illness
Analyze the impact and public health consequences of botulism
Examine regulatory requirements for botulism prevention under 21 CFR Parts 108 and 109 and 9 CFR Part 431
Understand the role of formulation and processing in limiting C. botulinum growth

Agenda

Overview of Clostridium botulinum and botulism
Health risks and symptoms of botulism
Prevention strategies through formulation and processing
Overview of 21 CFR 108/109 and 9 CFR 431 regulatory requirements
Strategies for limiting C. botulinum growth in processed products

Who Should Attend

Food safety and quality assurance professionals
Regulatory and compliance personnel
Product development and formulation teams
Process and manufacturing staff
PCQI and HACCP certified individuals
Professionals involved in FDA or USDA regulated food production

Webinar Length

1 hour with Q&A to follow.

The webinar will include a 10-minute Q&A session where attendees can ask questions related to Botulism in FDA and USDA Regulated Foods. This interactive portion is designed to offer personalized guidance and facilitate the sharing of practical insights among participants.

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Meet the Instructor

Dr. Robert Brackett

Dr. Robert Brackett leads the industry training team under the IEH Academy. He received his Ph.D. in Food Microbiology, his M.S. in Food Microbiology, and his B.S. in Bacteriology from the University of Wisconsin.

Prior to joining IEH, Dr. Brackett served as IIT Vice President and Executive Director of the Institute of Food Safety and Health at Illinois Institute of Technology, and Senior Vice President and Chief Scientific and Regulatory Officer for the Washington, DC based Grocery Manufacturers Association (GMA) now under the name, Consumer Brands Association. Prior to serving at GMA, Dr. Brackett worked for the U.S. FDA as the Director of the Center for Food Safety and Applied Nutrition, as well as several other executive positions within FDA. Earlier in his career, Dr. Brackett spent 19 years in academia at North Carolina State University where he served as Food Safety Specialist and as Professor at the University of Georgia, where he conducted research on foodborne pathogens.

At IEH, he is focused on developing and executing training programs that will enable the food industry to produce safer and higher quality products. Dr. Brackett is an expert on the microbiological and chemical safety of processed foods and fresh produce. He has over 40 years of experience on factors that affect the growth and survival of foodborne pathogens in both fresh and processed foods and ingredients. In addition, he has extensive experience in developing and providing training for both regulatory and private sector personnel, both internationally and in the U.S.

Carol Cave

Ms. Carol Cave joined IEH as the Executive Vice President in 2024, bringing with her extensive expertise in regulatory affairs and consumer protection. She holds a B.S. in Consumer Economics from the University of Maryland.

Before joining IEH, Ms. Cave served as the Acting Associate Commissioner (ACRA) for the Office of Regulatory Affairs (ORA) at the Food and Drug Administration. In this role, she oversaw approximately 5000 ORA employees stationed across the U.S. and around the world.

Prior to her role as Acting ACRA, Ms. Cave served as Deputy Associate Commissioner, where she managed inspections, compliance, enforcement, field laboratory operations, import operations, and strategic planning.

Earlier in her career at the FDA, she served as the Assistant Commissioner of Import Operations, where she led the Office of Enforcement and Import Operations, ensuring FDA-regulated imported products comply with U.S. laws. Ms. Cave also led coordination efforts between the FDA and U.S. Customs and Border Protection, developing joint regulations, policies, procedures, and operations.

Before her tenure at the FDA, Ms. Cave was the Deputy Director of the Office of Compliance and Field Operations at the U.S. Consumer Product Safety Commission (CPSC). In this role, she collaborated with federal government agencies to identify potentially defective consumer products. With nearly 26 years at the CPSC, Ms. Cave held various leadership positions, including Director of State and Local Programs and Assistant Executive Director for the Office of Import Surveillance, ensuring the safety of consumer products nationwide.

Let's get in touch

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