FSMA PC Rule Readiness | Environmental Monitoring: What is it?

This message is posted on behalf of the Office of Food Safety, Center for Food Safety and Applied Nutrition, Food and Drug Administration. Please direct any questions to Kelly Morin at 

PC Readiness Training

June 25, 2015

Event Title
Environmental Monitoring: What is it?


As a part of the hazard analysis and the preventive control management components for the PCHF and PCAF Rules, there is a proposed requirement to ensure the effectiveness of the preventive controls as implemented in a facility’s food safety system.  This involves:

• Performing an evaluation of environmental pathogens whenever a Ready-to-Eat (RTE) food is exposed to the processing environment prior to packaging and the food does not receive a subsequent lethality treatment as a component of the hazard analysis.
• Implementing verification activities to assess the effectiveness of the preventive controls (e.g. sanitation controls) applied to address environmental pathogens identified as hazards requiring a preventive control.

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Speaker Information

Deann Akins-Lewenthal, Ph.D. is the Director of Food Safety and Microbiology, ConAgra Foods 

Deann Akins-Lewenthal

Deann Akins-Lewenthal, Ph.D. is the Director of Food Safety and Microbiology for ConAgra Foods.  In this role, she leads and directs the corporate microbiology and food safety function for all aspects of the company including consumer and commercial business units, product development, manufacturing and supplier quality.  In addition she establishes the strategic direction for the corporate food safety program, proactively identifying and addressing microbiological and allergen risks in products and manufacturing facilities and evaluating and integrating new technology into ConAgra Foods’.  Deann has been with ConAgra Foods for 6 years.  She received her B.S.A in Biological Sciences and M.S. and Ph.D. in Food Science from the University of Georgia.


Richard Driggs, Director of Operational Quality, Nestle

Richard Driggs

As the current Director of Operational Quality, Richard leads a team of quality professionals committed to ensuring pet food safety, nutrition and compliance. Through adherence to Nestle Quality Management Systems, HACCP, FSSC22000 and regulatory requirements such AAFCO and FSMA, the team is dedicated to the continued delivery of high performing brands and products for their customers and consumers.  Richard has over 25 years of experience in the food industry. Prior to Nestle, he worked in water quality assurance and infant formula manufacturing. Since joining Nestle in 1993, Richard has had several different roles including Pathogen Laboratory Supervisor, Senior Microbiologist, Quality Assurance Manager, Production Manager, Plant Superintendent, Director of Food Safety, and Director of Quality Compliance. These roles were held across a variety of product categories including ice cream, chocolate, beverage, baking, sugar confections and pet food.

Richard is a graduate of The Ohio State University with a B.S. in Microbiology.  He has been involved with various industry collaborative efforts such as the technical working group for PAS222 – ‘Prerequisite Programmes for Food Safety in the Manufacture of Food and Feed for Animals’, Product Safety Sub-committee for the Pet Food Institute (PFI), as well as the FSMA Technical/QA commenting teams for PFI.


Theodora Morille-Hinds, Vice President of Global Quality Food Safety and Regulatory, The Kellogg Company

Theodora Morille

Theo joined The Kellogg Company as a Sr. Director of Global Food Safety and Sanitation in July of 2011 and was promoted to Vice President of Global Quality Food Safety and Regulatory in November of 2013.  In this role, Theo provides leadership for multiple global functions including; Food Safety, Quality Compliance to Design, Quality Innovation, Supplier Management for Ingredients, Packaging and Premiums, Auditing, and Quality Management Systems, Regulatory Affairs, Nutritional Labeling and Consumer Affairs. Prior to joining Kellogg, Theo was employed by Kraft in Tarrytown, New York.

Theo is on the Food Safety Advisory Board of University of Georgia and Tuskegee University. She is also on the Board of SSAFE and affiliated with a number of Industry associations.

Theo holds a B.S from York College City University of New York and an M.S in Food Microbiology from Long Island University, City University of New York


Edith Wilkin,  Lead for Food Safety and Regulatory Compliance, Leprino Foods Company

Edith Wilkin

Edith Wilkin leads food safety and regulatory compliance for Leprino Foods Company.  Her 34 years of industry experience began in plant operations as Laboratory Supervisor and Quality Assurance Manager.  She advanced quickly and now leverages scientific knowledge, business acumen and plant experience in her advisory role with the organization.  Her areas of expertise include pathogen control, process validations, laboratory operations, sanitation and food regulations.

She has helped develop and publish Enhanced Traceability Guidance for Dairy Operations, IFT’s Best Practices for Food Traceability, and is currently finalizing a Listeria Control Guidance for Dairy Operations with the Innovation Center for US Dairy.  She also led work teams that contributed heavily to FDA’s Food Safety Preventive Controls Alliance Training.

Edith is a passionate food safety advocate who serves on the Food Safety Operating Committee of the Innovation Center for US Dairy, the Scientific Advisory Committee for NCIMS and Vice-Chair for the Low Water Activity PDG for the International Association for Food Protection.  She still finds time to teach and speak at industry food safety forums.

She earned both her Bachelor’s and Master’s degrees in Microbiology and Food Science at the University of Missouri-Columbia where she was inducted into Gamma Sigma Delta—Agriculture’s Honor Society.


Donald L. Zink, Ph.D., Senior Science Advisor for CFSAN in the Office of the Center Director, FDA

Donald L. Zink, Ph.D

Dr. Donald L. Zink received a Bachelor of Science degree from Abilene Christian University. He earned an M.S. degree in Microbiology and a Ph.D. in Biochemistry and Biophysics from Texas A&M University. Between 1978 and 1983, he held faculty positions at Texas A&M University’s College of Veterinary Medicine and at the University of Arizona in the Department of Microbiology and the Department of Food Science. He joined Campbell Soup Company in 1983 as Manager of Process Microbiology where he worked in the area of refrigerated food safety and aseptic processing. In 1990, he joined Nestlé, where he held various positions in Quality Assurance for the Carnation Company and later served as Director of Food Safety for Nestlé USA. In 2000, he joined a new beef processing venture company, Future Beef Operations, as Vice President of Research and Development and Product Safety. In 2002, he joined the U.S. Food & Drug Administration’s Center for Food Safety and Applied Nutrition where he now serves as Senior Science Advisor for CFSAN in the Office of the Center Director.

 Dr. Zink has served as a member of several advisory committees including the Committee on Program and Technical Review of the U.S. Army Natick RDEC for the National Research Council and the National Advisory Committee on Microbiological Criteria for Foods. Dr. Zink has been a member of various industry committees during his years with the food industry, including the ILSI North America Food Microbiology Committee and the Grocery Manufacturers of America Science and Regulatory Affairs Committee and Microbiological Safety Committee. Dr. Zink is the current President of the International Association for Food Protection.


Upcoming PC Rule Readiness events:

  • Supplier Management Programs – August 27
  • Minimizing Allergens Risk – October 22
  • Food Safety Culture 301 – November 12



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