Building a Team to Meet FSMA Requirements: Three Questions to Ask

By Jennifer McEntire, Ph.D.

The Food Safety Modernization Act (FSMA) is an act of Congress that directs the US Food and Drug Agency (FDA) to enhance the rules and policies around food safety. FSMA touches on so many aspects of the business that a company’s “FSMA team” should include representatives that extend well beyond food safety and regulatory roles. Here are some of the questions you and your team should be asking:

• Which rules apply to your business?
Different rules cover different parts of the supply chain and may intersect and overlap. Additionally, the compliance dates depend on business size, which is uniquely defined for each rule. In some cases, you’ll need to consider sales of total food or sales of a food category (e.g., produce sales); you might also need to consider the number of full time employee equivalents.

You’ll want to assemble a team that understands the nature of your business to evaluate the various rules and determine which apply. This team should include representatives from legal, regulatory, food safety, operations, supply chain, and perhaps others.

• Do you have separate sub-teams for each rule?
The very different requirements for each rule require different expertise. Here are some examples:

Produce Safety Rule. Your team here should include food safety representative(s) knowledgeable about Good Agricultural Practices and, if applicable, Good Manufacturing Practices; because there are requirements for water testing, people with expertise in water sources as well as labs should be involved, and human resources for worker training.

Preventive Controls (human or animal food). Your team here should include food safety representatives knowledgeable about relevant hazards (biological, chemical including allergens, physical etc.), operations, sanitation, and potentially those involved in supply chain logistics.

Foreign Supplier Verification Program. Include people who are knowledgeable about procurement, food safety, and supply chain.
Sanitary Transportation. Include team members knowledgeable about supply chain logistics, transportation, food safety, and legal, because many responsibilities can be assigned via contracts.

Intentional Adulteration (food defense). Include people from human resources, physical security, and food safety experts, but there are fewer responsibilities in this rule than others.

• What records are required to be kept to demonstrate compliance with each rule? Who is responsible for making sure this happens?
More specifically, are IT improvements needed to facilitate the capture and retention of required information? Do employees understand how to make a record (accurate, legible, etc.) Are records accessible? Who has access to policies, procedures, and records showing implementation?

Successfully implementing the FSMA-related rules will take time and effort, and the engagement of different parts of your company. While food safety and/or regulatory staff may have the lead on many of the rules, it’s important that a number of different areas of the business are informed and involved so that implementation is as smooth and efficient as possible.

About the Author

Jennifer McEntire, PhD, is VP Food Safety and Technology at United Fresh Produce Association. She was previously Vice President of Science Operations at the Grocery Manufacturers Association, and has also had roles as VP and Chief Science Officer at The Acheson Group, and as the Senior Staff Scientist and Director of Science & Technology Projects at the Institute of Food Technologists. McEntire earned a PhD from Rutgers University and received a Bachelor of Science with Distinction, magna cum laude, from the University of Delaware.