How FDA Is Adapting Its On-Farm Sampling Practices: Questions and Answers with Ellen Morrison

March 2015

The nation’s farmers are important partners in the Food and Drug Administration’s work to ensure a safe food supply.

As part of FDA’s responsibilities, we conduct sampling for bacteria that can cause illness as one way to ensure the safety of the food supply, whether the sampling is carried out in a manufacturing facility, in the supermarket, or occasionally on the farm where our food is grown. This is not the number one way we ensure safety. We focus first on prevention as a way to keep problems from happening. But some sampling is necessary to ensure that the preventive approach is working and also to tell us about emerging problems that may be occurring in the food supply as a whole. This is what we call “surveillance sampling.”

As part of this preventive approach, in 2014, the agency started collecting a number of samples of specific commodities on farms, and some food facilities co-located on farms (such as on-farm cheesemaking facilities). Some farmers raised concerns about this new sampling. FDA listened to these concerns and that is why the agency has taken specific steps to make sure that farmers are prepared for our visits and know what to expect.

Ellen Morrison, assistant commissioner of operations in FDA’s Office of Regulatory Affairs, explains the steps that FDA has taken, and why.

Q: Why does FDA collect surveillance samples?

FDA collects samples and conducts microbiological tests on certain foods that have been linked to outbreaks of foodborne illnesses. The agency is looking for the presence of disease-causing bacteria, with the ultimate goal of keeping contaminated products from reaching consumers, reaching a greater understanding of food production risks, and evaluating the value of strategies to reduce or eliminate those risks.

Q: What surveillance sampling has FDA conducted on farms and on-farm facilities?

In the first year of this new sampling effort, the focus was on sprouts, whole fresh avocados and raw milk cheese (aged 60 days) to help identify patterns that may help predict and prevent future contamination by disease-causing bacteria.

Q: What concerns were raised about these surveillance sampling practices?

First of all, we appreciate farmers letting us know about these concerns. We heard from some farmers that they received little or no notice of the FDA sampling visits and, due to the nature of their work, farm personnel might not be readily available to assist FDA. In addition, some farmers considered the process for farmers to receive payment from FDA for the samples taken to be complicated. Further, FDA sometimes collected the entire product on hand, leaving the farm with nothing for its customers. And finally, some farmers were confused to see some of our personnel, who are members of the U.S. Public Health Service, in uniform. FDA sends both civilian and members of the U.S. Public Health Service, who are required to wear a uniform while on duty, to collect samples.

Q: What are the changes FDA has made?

In light of these concerns, FDA modified its procedures in several ways. FDA now notifies farms and on-farm facilities by telephone of our intention to collect surveillance samples at least 24 hours in advance. During that call, the farm or facility will be told what specific product will be sampled, the type of sample, and the number of samples to be collected. The agency representative will also request the purchase price so that its inspector will bring cash to pay for the samples at the time of collection.

When on site, the FDA now determines if the sample size would exhaust the farm’s or facility’s supply or prevent it from meeting customer needs. If so, consideration will be given to modifying the sample collection or returning at another time when additional stock will be available.

The farm or on-farm facility is also informed if the FDA sample collector is a member of the U.S. Public Health Service and will describe the uniform in the advance-notice call and explain the reason for wearing it.

Q: What happens after the samples are tested?

It depends on the data that is collected. Depending on the sampling results, FDA might decrease or increase sampling, work with regulatory partners to take other appropriate actions, develop guidance for industry, or reach out to consumers with information that will help protect them. FDA might also take follow-up actions, if needed, at farms or on-farm facilities (for example, to keep a contaminated food off the market).

Q: What’s ahead as FDA continues developing its preventive approach to food safety?

We will be working more closely with farms and on-farm facilities as part of FDA’s efforts to make sure that everyone involved in growing, manufacturing, distributing and preparing food takes his or her proper responsibility to prevent food safety problems.

Some of these efforts will be part of FDA’s work to implement FDA Food Safety Modernization Act (FSMA) when the rules that FDA has proposed become final starting later this year and take effect beginning in 2016, but others have been in place for some time.

FDA is committed to working closely with farms and on-farm facilities, as it does with others in the food production and supply chain, to take effective but common sense approaches to a safe food supply.