The FDA Food Safety Modernization Act is based on preventing problems before they happen, rather than solely responding to outbreaks of foodborne illness. But in order to develop prevention-based systems, data and other information are needed to help identify and address hazards.
That is why sampling is an important part of this preventive approach and why the FDA is refining a new microbiological surveillance sampling model designed to identify patterns that may help predict and prevent future contamination by disease-causing bacteria.
This new proactive and preventive approach was developed in 2014 and is part of FDA’s efforts to further protect the food supply by keeping contaminated food from reaching consumers. The FDA will publicly share the data it receives through this approach and will engage stakeholders throughout the process.
Surveillance sampling is just one type of sampling that is important for food safety. There are different kinds of sampling, and the methods that the FDA uses fall into three broad categories: environmental, product, and emergency response/emerging issues sampling.
The FDA collects samples of food products ready to go to market, as well as in-process and raw ingredient samples, to ensure they don’t reach consumers with harmful contaminants, or to verify that they contain ingredients at levels as declared on product labeling.
- Microbiological Surveillance Sampling
- Gluten-Free Food Product Surveillance Sampling
- Milk Allergen Sampling
The FDA also conducts environmental sampling, which means collecting samples from the environment surrounding the food, typically in a production facility. This type of sampling is important because environmental contamination of production facilities may contribute to contamination of finished product.
Emergency Response/Emerging Issues Sampling
This type of sampling can take the form of either environmental sampling or product sampling, and often involves both. Emergency response sampling is routinely conducted in response to outbreaks of foodborne illness to help identify the source of the disease-causing pathogen. Emerging issues sampling helps the agency to gather information about potential food safety issues based on trends or intelligence the FDA might have.
What the Investigator Does
- The FDA investigator who arrives to collect samples will first present his or her agency credentials.
- If there’s going to be an inspection, the investigator will give you a "Notice of Inspection" (FDA Form 482). After samples are collected or the inspection is completed, the investigator will provide a receipt (FDA Form 484) for all samples collected.
- Some FDA investigators may be in uniform when they arrive to conduct sampling. They are members of the Commissioned Corps of the U.S. Public Health Service (USPHS) – professionals dedicated to protecting and promoting public health and safety. They are required to be in uniform when on duty. Though their uniform is similar to military dress, these health professionals are not members of the armed forces and work only in the interest of health promotion and disease prevention. (USPHS is a component of the Department of Health and Human Services and is directed by the U.S. Surgeon General.)
What You Do
- We suggest that you have a person knowledgeable about your company, such as the plant or production manager, accompany the investigator at all times so that person has the opportunity to ask questions and to ensure your company is clear on the actions being taken. It is often best to designate this representative ahead of time so that he or she is prepared for the visit.
- If samples are collected, you should tell the FDA investigator if you intend to hold product until sampling results are available.
- You will be paid for all product or ingredient samples, except those collected under authority of a court order or decree. The FDA has issued a guidance document for determining sample cost. The costs may be billed to the district or cash may be used to pay for the samples.
- The facility’s owner, operator, or agent in charge will be promptly notified if a sample tests positive for contaminants.
- The FDA district staff will share all sample results, both positive and negative, when a firm agrees to hold products pending further analysis by the agency and notifies the FDA that it is planning to do so.
- The district will call the firm management or its designee to discuss test results and may follow up with an e-mail or fax.
- If potentially harmful contaminants are found in a product that has been distributed or is actually on the market, the FDA will consider regulatory and enforcement options. These include
- encouraging a voluntary recall,
- ordering a mandatory recall,
- ordering administrative detention to prevent the product from being distributed,
- and/or issuing public warnings to alert consumers to the potential danger.
- If potentially harmful contaminants are found in samples taken from imported food, the shipment(s) may be detained and refused entry, and future shipments may be subject to an Import Alert (detention without physical examination) as warranted.