A key area of FSMA compliance for which questions continually arise from food and beverage processing plants is that of environmental monitoring. The topic was a key focus of the panel session, “Shifting Foods to R2E and Testing Implications,” at the Grocery Manufacturers Association (GMA) Science Forum in April. On the panel were Food Industry Counsel Global Food Safety Attorney Shawn Stevens, Hormel Foods Corporate Manager of Regulatory, Compliance & HACCP Brent Brehmer, General Mills QRO Global Food Safety and Regulatory Affairs Scott Hood, Hogan Lovells Counsel Elizabeth Falwell, and FDA CFSAN Office of Food Safety Senior Advisor Jenny Scott.
Environmental monitoring is a critical aspect of FSMA’s Preventive Controls rule, focused primarily toward ready-to-eat foods. However, whether you are producing these or foods that require additional preparation for food safety, “environmental monitoring is a tool for food safety, and it’s a very powerful tool that we have,” Scott said. This is particularly important because it can be difficult to determine whether some foods are considered ready to eat or not.
DEFINING READY TO EAT. “We made it clear in the preventive controls rule that we are expecting environmental monitoring in ready to eat,” Scott said. While explaining that she was limited in what she could say about how FDA views ready-to-eat food because the Agency is in the process of writing the guidance document, Scott did say that it is defined in the rule as any food that is normally eaten in its raw state or without further processing. “If you would put it in your mouth as is, we would consider it ready-to-eat.”
As this also brings up the question of who is responsible for determining if a food is ready to eat or not, it brought thoughts and input from other panel members. “We all have a responsibility to follow trends and know how consumers are eating your product,” Falwell said.
“In the end, it has to be upon us to do it,” Brehmer agreed. “We need to know what products are being used as ready to eat.”
The lines are blurred, and there are grey areas, but Stevens recommended that companies follow a risk-based assessment: “Is it reasonably likely or foreseeable that the food could lead to illness?” If so, it is best to implement ready-to-eat food safety practices, even if it isn’t generally a ready-to-eat food.
There is also the temptation for manufacturers to determine a food to not be ready to eat in order to avoid environmental monitoring, Stevens said. “That is making a huge mistake.” Even if you don’t, technically, have to comply with that provision of the rule, the consequences can be very high. FDA will be coming into the plant, taking environmental samples, and comparing them with PulseNet, he said. “If you don’t know what’s happening in your facility, when FDA shows up, they’ll tell you.” Nothing says environmental monitoring is limited to ready-to-eat foods.
INDUSTRY EDUCATION. There also is an education process that will be important as we continue to move forward with environmental monitoring, focused primarily on the testing program and the importance of seek and destroy, Falwell said. Finding a positive doesn’t mean your operation is “bad,” it means you need to take corrective action. In fact, she said, “If you’re not finding [a positive], you’re not looking.” Or it may be that you’re getting a negative because you are swabbing the same spots over and over.
Stevens agreed, stating that it is important that any positive be treated as a reason for improvement, that the facility ask key questions and consider the big picture: How did it get there? If it is there, it will also be someplace else; if it is someplace else, it will eventually get into the food – and you could even end up with criminal sanctions for failing to do enough about it.
“You need to do whatever you can to eliminate contamination from the environment,” Stevens said.
It also is for this reason that manufacturers need to ensure their suppliers also are of the test-and-hold mindset and follow those practices. Ask suppliers if they have environmental monitoring programs in place and conduct finished product testing with a reputable lab, Brehmer said.
Stevens agreed, “When it comes to your suppliers, their issues will become yours.”
NOT READY-TO-EAT LABELING. In response to an audience question as to whether labeling a product with a disclaimer or caution statement would help in defining it for consumers as not ready to eat – and defending that in court, Stevens said, “Yes, but …” FSIS requires that meat carry labels, but if a case went to litigation, the prosecution could argue about the size, clarity, etc. of the warning, he said. However, the presence of the statement does carry some weight, so it’s likely that the Agency would have similar thinking. “Err on the side of caution,” he said. “Consider: What would 12 jurors think?”
Scott’s response indicated that the FDA would be of similar thinking. Labeling does help reduce risk, she said, but you still need to consider any known or foreseeable risk.
What is also likely to be considered is: How easy is it to reduce the risk? Stevens said. For example, you can’t reduce the risk of raw animal meat, so a warning is enough. But if the risk is relatively easy to manage at your facility or control in the supply chain, a warning label will be less effective or defensible.
Hood agreed, saying, “Conducting a risk assessment and understanding what’s reasonable is all part of the equation.” It is a statement that is applicable to determining your plant’s environmental monitoring requirements and recommendations – whether your food is ready to eat or not.
The author is Editor of QA magazine. She can be reached at llupo@gie.net.
