Implementing FSMA: What Do I Need To Know And Do?
By Sam Lewis
Several of FSMA’s major rules are now in effect, but that doesn’t mean all food makers are clear on what is expected of them. There are thousands of pages of regulations for the law, which can be confusing and daunting, not to mention the rules present food companies with a plethora of new challenges. Here, Hilary Thesmar, Ph.D., RD, CFS, VP of food safety programs at the Food Marketing Institute (FMI), answers my questions on what food makers need to know to comply with FSMA’s requirements and offers guidance on how they can achieve it.
Food Online: Which parts of FSMA’s implementation are you seeing food manufacturers struggle with most? What can they do to overcome those challenges?
Dr. Thesmar: FSMA regulations are a major shift for everyone in the food industry, as well as for the FDA, in how they perform inspections/investigations. The changes required by the regulations are making it necessary for multiple departments within food companies to work together to implement the requirements. For example, food safety, procurement, IT, and HR departments all have major roles in implementing FSMA regulations because of the complex components.
Companies have to approach FSMA with a project plan, with resources, and with a collaborative approach. Food safety or QA cannot manage this alone. Communication is key and leadership from the top down is needed to make sure companies understand what the requirements are and how important it is to comply with the regulations.
Food Online: Can you offer an overview of the Preventive Controls Rules’ requirements and what food manufacturers need to do to get their food safety plan in compliance?
Dr. Thesmar: The regulation, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food, is focused on having a food safety plan to prevent known or reasonably foreseeable hazards from occurring. The keyword is, “prevent,” and everything is based on the hazard analysis which is based upon risks. The Preventive Controls for Human Food regulation is one of the seven major regulations of FSMA and is foundational to several other regulations.
The first thing companies should do is make sure they have a trained Preventive Controls Qualified Individual (PCQI) who is responsible for their food safety plan. This person must be trained, or have the job experience, to develop and implement the food safety plan. They, along with the senior management of the company, are responsible for compliance.
Food Online: The Foreign Supplier Verification Program (FSVP) is a very intricate piece of legislation. Can you break it down — requirements, standards, deadlines, exemptions, etc. — into its simplest terms?
Dr. Thesmar: The most basic requirements of the FSVP regulations are that a U.S.-based FSVP importer is responsible for verifying that the product was produced to the same level of public health protection as U.S. food safety laws. The rule applies to FDA-regulated products covered by FSMA regulations at the time of import. The rule then focuses on the requirements for verification and who, how, and what needs to be done and documented.
In general, the FSVP regulations go into effect six months after the respective supply chain regulation goes into effect. FDA-regulated products are covered by the rule and exemptions apply to products under USDA jurisdiction or other FDA regulations, such as juice HACCP or seafood HACCP.
Food Online: What impact are FSMA’s seven pillars having on the day-to-day operations of food manufacturers?
Dr. Thesmar: These seven rules, and the other FSMA requirements, are reshaping the food safety management systems (FSMS) of food manufacturers. FSMA’s requirements are vast and widespread across the industry and across all FDA-regulated products. Just about every company in the U.S. who manufacturers, processes, packs, or holds food is impacted and almost every international company that sells food in the U.S. is impacted by FSMA regulations. There are small business exemptions for small companies, but for the most part, FSMA is impacting the day-to-day operations and planning of all food companies.
Food Online: Where can food companies find FSMA guidance documents and education?
Dr. Thesmar: For information about FSMA, the first place to start is the FDA FSMA website. It can be overwhelming, so you need to just dig in. For training resources, the best place to look is the Food Safety Preventive Controls Alliance (FSPCA). For industry specific information, both FMI and GMA have FSMA sites with curated material for members.
One of the best ways we have found to talk about FSMA is by type of facility. Do you have manufacturing/processing plants, do you have a warehouse or distribution center, do you have trucks, do you import? Those are the key questions and really help identify when and how FSMA applies to you. Many companies just want to know what they have to do and how to comply. We try to make it easy and provide those answers.
About Hilary Thesmar
In her role as the Chief Food & Product Safety Officer & vice president of food safety programs for the Food Marketing Institute (FMI), Dr. Thesmar provides leadership for all safety programs for FMI’s retail and wholesale members and provides support for members on food safety training programs, FSMA training, recall plans and management, crisis management, research, and overall safety and sanitation programs. She also works with the FMI Foundation on food safety education and research projects.
Dr. Thesmar has a Ph.D. in Food Technology from Clemson University, a Master of Science degree in Human Nutrition from Winthrop University, a bachelor’s degree in Food Science from Clemson, and she is a Registered Dietitian. She has over a decade of experience in scientific and regulatory affairs with food trade associations.
Dr. Thesmar is an active member of the Institute of Food Technologists (IFT), the International Association for Food Protection and the Academy of Nutrition and Dietetics. She is an active volunteer with the Food and Culinary Dietetic Practice Group of the Academy of Nutrition and Dietetics holding several leadership positions in recent years. Dr. Thesmar currently serves as the Chair of the Board of Directors of the Partnership for Food Safety Education.