Updated ASTA Guidance on Science-Based Groupings to Optimize Validation of Spice Process Controls

Under the Preventive Controls for Human Food regulation, manufacturers of ready-to-eat spices must have validated process controls to ensure that Salmonella and other known pathogens are effectively controlled. Since it is typically resource prohibitive and redundant to run a validation study on every single product produced by a spice company, ASTA has assisted its members in developing a science-based approach to validation that involves conducting a study on a representative product of a group of spices, rather than every different commodity.

The updated ASTA Guidance on Science-Based Groupings and Report on Microbial Inhibition of E. Faecium, along with the accompanying webinar will provide an update on the ASTA guidance and scientific evidence regarding validation for spices. The presenters will explore the latest scientific evidence on key factors for selecting a representative “worse case” scenario for groupings and the impact of microbial inhabitation on validations. The webinar will also include a review of the regulatory requirements related to validation and an overview of the ASTA resources that have been developed on this topic.

ASTA previously offered the ASTA Webinar Series on Validation of Microbial Reduction Processes, and has published a White Paper on Process Validation. During ASTA Online in 2020, FDA presented Validation Information for Spice Companies. Then, during ASTA Online 2021, there was a Panel Discussion on Science-Based Groupings for Spice Validations. Registrants of this webinar will get access to all of these resources in advance of the session.

A recording of this presentation is available.


No cost for ASTA members
$495 non-members

Please make sure you login as an ASTA member to receive the member rate. Non-members, contact ASTA at [email protected] for a login user name to register online.

Meet Our Speakers

Jim S. Dickson (Jim) | Professor, Iowa State University, Department of Animal Science, Inter-Departmental Program in Microbiology

Dr. Dickson is currently a Professor in the Department of Animal Science and the Inter-Departmental Program in Microbiology at Iowa State University. Dr. Dickson’s research focuses on the control of bacteria of public health significance in foods of animal origin. Prior to his appointment at Iowa State University in 1993, he was employed by USDA-ARS as a Research Food Technologist and lead scientist of the Meat Safety Assurance Program, located at the Roman L. Hruska U.S. Meat Animal Research Center, Clay Center, NE. Dr. Dickson was employed in the food industry for three years before joining USDA-ARS.

He is a Fellow in the American Academy of Microbiology, and is a Past President of the International Association for Food Protection. He is also active in the American Society for Microbiology and the Institute of Food Technologists. On behalf of ASTA, Dr. Dickson conducted a scientific review of the FDA’s Draft Risk Profile on Pathogens and Filth in Spices and presented his perspective at the 2014 ASTA Annual Meeting.

Maile Gradison | Partner, Hogan Lovells

Maile Gradison is a Partner at Hogan Lovells and also serves as ASTA’s General Counsel. She has considerable experience with the Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA), having worked with numerous companies and trade associations on all aspects of the law since the day it was signed. She translates her in-depth knowledge of FSMA into practical solutions for companies working on implementation strategies. She also frequently presents trainings related to FSMA compliance and preparedness. Reflecting her deep involvement with all things FSMA, Maile is a Food Safety Preventive Controls Alliance (FSPCA) Lead Instructor for the Preventive Controls for Human Food training and an FSPCA Trainer of Trainers and Lead Instructor for the Foreign Supplier Verification Programs (FSVP) training.

Maile is known for helping companies become and remain compliant with regulations overseen by federal agencies such as the FDA and U.S. Department of Agriculture (USDA). She helps companies navigate tough situations involving product recalls, government inspections, and other enforcement actions such as Warning Letters and import detentions.

Maile also provides clients with advice on public policy issues and strategies for affecting regulatory change. She has vast experience advocating to FDA, including preparing comments on agency rulemakings. Additionally, Maile helps clients with food labeling requirements and development of label and advertising claims.

Maile is a frequent speaker and contributor to industry publications. Prior to joining us, she served as a judicial clerk to the Honorable Charles F. Lettow of the U.S. Court of Federal Claims. Maile graduated with high honors from The George Washington University Law School, where she served as executive editor of The George Washington Law Review.

Laure Pujol  |Food Safety and Quality Expert, PhD, Novolyze

Laure Pujol is an Associate Research Fellow: Food Safety, Quality and Customer Success at Novolyze. She has a PhD in Predictive Microbiology and Risk Assessment from INRA, France. As a Preventive Control Qualified Individual (PCQI) and a Process Authority recognized by the Technical Expert Review Panel (TERP) and Almond Board of California (ABC), she is very experienced working with low water activity foods and has performed in-plant validation trials around the world. Now she is supporting all aspects of the Food Safety and Quality needs of customers including Process Control, Environmental Monitoring, Validations, Food Safety Plans, and managing Customer Success for clients who have adopted the digitalization of Food Safety and Quality. She holds the position of vice-chair of the low water activity foods product development group at IAFP starting next Summer and is part of the ASTA Validation Task Force. She organized symposiums at the IAFP, webinars on the best practice to conduct validation study and participate in several scientific conferences helping food processor managing their food safety and quality issues.