Does Your Food Safety Plan Meet The Demands Of FSMA's Preventive Controls Rule?

By Sam Lewis

FSMA’s Preventive Controls For Human Food rule was published on September 17 and became effective November 17. Large food manufacturers must be compliant with it beginning next fall. A major part of complying with this rule is creating and implementing a Hazard Analysis and Risk-based Preventive Controls (HARPC) food safety plan. Here, Jennifer McEntire, Vice President of Science Operations at the Grocery Manufacturers Association (GMA), took some time to answer my questions about creating a HARPC-based food safety plan to comply with FSMA’s Preventive Controls For Human Food rule.

Food Online: How does HARPC differ from HACCP?

McEntire: HARPC is more than HACCP. HACCP can be considered a core, but in order to expand from HACCP to HARPC, more elements need to be included. The most notable differences are in the breadth of preventive controls. HACCP is centered on critical control points (CCPs) which are the specific processes that significantly minimize the likelihood of a hazard. Sometimes the controls that are also effective at impacting a hazard don’t fall into the conventional CCP bucket. This is where HARPC moves beyond HACCP and requires that supply chain controls, allergen controls, and sanitation controls, when appropriate, be utilized as appropriate to control the hazard. 

Food Online: What are the components of a Preventive Controls-Based Food Safety Plan?

McEntire: Many of the elements of a Food Safety Plan look very similar to a HACCP plan, except for the expanded menu of control options. This is a brief list of the main components, but it’s important to realize that each aspect requires careful consideration:

• Hazard analysis (including hazard identification and evaluation)
• Determination of hazards requiring a preventive control
• Assignment of appropriate preventive control
  • Process controls
  • Allergen controls
  • Sanitation controls
  • Other preventive controls
• Validation of process controls, as appropriate
• Monitoring and verification for preventive controls
• Corrective actions for preventive controls
• Supply chain controls
• Recall plan
• Reanalysis

Food Online: What hazards should food manufacturers look for in their hazard analyses? What are some best practices when conducting a hazard analysis?

McEntire: Manufacturers should think broadly about the hazards that have previously been associated with the product (either as reported in the literature or that they otherwise have knowledge of). Importantly, they should consider hazards that could be introduced through ingredients, including allergens. Producers of ready-to-eat foods will also need to think about the potential for post-process contamination with environmental pathogens. The final rule includes a list of the factors that should be considered when conducting the hazard analysis.

Food Online: Once a food manufacturer has implemented a Preventive Controls-Based Food Safety Plan, how can the company maintain the program and ensure it will hold up to the scrutiny of auditors?

McEntire: The food safety plan must be a practical, workable plan that is implemented by people in the facility every day. Substantial training at all levels will be needed so that an auditor or inspector can readily ascertain adherence to the plan. At GMA, we will review members’ food safety plans and components of those plans (such as environmental monitoring programs) to identify areas where clarity can be improved before the plan is scrutinized by an auditor or inspector.

Food Online: Where can food manufacturers get more information and education on creating, implementing, and upholding their HARPC-based Food Safety Plan?

McEntire: The food safety plan needs to be developed, or have the development overseen, by a “Preventive Controls Qualified Individual”. The PC QI status can be attained either through experience or training. The FDA established the Food Safety Preventive Controls Alliance to develop a 2.5 day curriculum that can help people prepare to be PC QIs, and GMA will be offering this course throughout 2016, kicking off the first course December 15-17. We will follow up this course with individual workshops that go into details about implementing some of the “new” kinds of preventive controls.

It’s important to realize that although the FDA won’t inspect for compliance until at least September 2016, it could take some time for facilities to adapt their current approach to food safety and build their food safety plan. Because of this, having a PC QI sooner rather than later is recommended.  Additionally, the FDA recently launched a Technical Assistance Network which accepts inquiries about FSMA, including implementation strategies.

About Jennifer McEntire, Ph.D.
Dr. Jennifer Cleveland McEntire is Vice President of Science Operations at the Grocery Manufacturers Association where she oversees the microbiology, chemistry and packaging laboratories, process authority team, and consumer complaint product forensic analyses.

A food microbiologist by training, Jennifer’s areas of expertise include recall and crisis management, traceability, food defense, and food regulations. Jennifer was previously Vice President and Chief Science Officer at The Acheson Group, where she supported food industry clients through recall and crisis situations.

Prior to joining TAG, Jennifer served as the Senior Staff Scientist and Director at the Institute of Food Technologists (IFT). She also held a two-year appointment with the USDA’s National Institute for Food and Agriculture, and served as a visiting scientist at FDA CFSAN.

Jennifer earned a Doctor of Philosophy from Rutgers University as a USDA National Needs Fellow in food safety and received a Bachelor of Science with Distinction, magna cum laude, in food science from the University of Delaware. She was the 2010 recipient of the Rutgers University Food Science Alumni Association Communication Award and in 2012 was honored with the University of Delaware College of Agriculture and Natural Resources Distinguished Young Alumni award. She has also received two awards from the FDA CFSAN Center Director related to her work on food defense as well as food safety collaboration training materials.

She has authored more than 20 peer reviewed publications, six book chapters, and numerous white papers. She is on the Board of Phi Tau Sigma (the food science honorary society) and is a member of the Advisory Council of the Global Food Traceability Center.