Tuesday, November 24, 2015

FDA Developing New Micro Surveillance Sampling Approach

FDA published notice of its sampling program.  "Under the new sampling approach, the FDA is collecting a statistically determined number of samples of targeted foods over a shorter period of time—12 to18 months—to ensure a statistically valid amount of data is available for decision making."  FDA has  been sampling since 2014, but looks to increase this surveillance, especially for items considered higher risk.

Companies should have a plan in place for the event product is sampled, whether that is in the market, or during an inspection.  If FDA samples product or the environment during an facility inspection, consider:
- Holding product.
- Stopping production and conducting a complete sanitation.
- Pulling duplicate samples and having them tested.
One of the difficulties is the delay that can occur with FDA getting back to a facility with results.  The longer the period, the more exposure in terms of extent of product distribution.

A proactive approach is always best - developing and implementing a sampling program to understand and control potential risks.

FDA Website - Sampling
Sampling to Protect the Food Supply
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, you need data and other information to help identify hazards that need to be addressed and minimized.
That is why sampling is an important part of this preventive approach and why the FDA is developing 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.
Types of Sampling
Product Sampling
The FDA takes 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.
Environmental Sampling
FDA also conducts environmental sampling, which means taking samples from the environment surrounding the food, whether it’s a facility or a transport vehicle. This type of sampling is important because environmental contamination of production facilities or transport vehicles 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 to Expect When the FDA Collects Samples
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.
Next Steps
  • 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.
Recent Sampling Activity

Microbiological Surveillance Sampling
Testing to Support Prevention Under the FDA Food Safety Modernization Act
As part of the FDA’s risk-based and preventive approach to food safety, which is at the core of the FDA Food Safety Modernization Act, the agency began developing a new, more robust surveillance sampling approach in 2014. As the agency moves forward with this approach, it will continue to refine procedures based on lessons learned. The goals of the surveillance sampling are to keep contaminated products from reaching consumers and to facilitate a greater understanding of hazards.
FDA will publish information regarding test results on the web, including total number of samples collected/tested, and collection date, sample type, and pathogen detected for positive samples.
The Sampling Approach
Under the new sampling approach, the FDA is collecting a statistically determined number of samples of targeted foods over a shorter period of time—12 to18 months—to ensure a statistically valid amount of data is available for decision making. The sampling approach will help the FDA determine if there are any common factors among positive findings such as season, region, and whether the product was produced domestically or imported. The FDA’s past approach to microbiological surveillance sampling has been to collect a relatively small number of samples for many different commodities over many years.
The sampling design for each food represents what U.S. consumers are likely to find in the marketplace. Accordingly, the agency has considered the volume of the target food that is imported and produced domestically and the number of states/countries that produce the target food.
Commodities Sampled
During the first year of this new effort, the FDA focused on sprouts, whole fresh avocados, and raw milk cheese (aged 60 days). The FDA collected more than 800 samples total and tested them for Salmonella, Listeria monocytogenes and E. coli O157:H7. For fiscal year 2016, The FDA will sample and test cucumbers and hot peppers for Salmonella and E. coli O157:H7, taking 1,600 samples of each commodity. The agency also plans to test hot peppers for Shiga toxin producing E. coli. The FDA will conduct whole genomic sequence testing on any samples that test positive. In the future, the number of samples collected of a targeted commodity may vary, depending on the question(s) the FDA intends to answer. Data from the sampling assignments already conducted will be released soon.
Using the Data
The FDA will evaluate the data or results generated throughout the sample collection period and use the data to inform the agency’s short and longer term decision making. By developing these data sets, the FDA seeks to identify potential vulnerabilities and ways to enhance the food safety system.
Depending on the results, the FDA may react or take certain steps, such as:
  • Decreasing sampling, if few positive samples are obtained;
  • Implementing more targeted sampling if trends are identified; for example, if positive samples come from a specific geographic region, a specific facility, or during a particular season;
  • Follow-up inspections;
  • Working with state or international regulatory partners to take corrective actions and implement preventive controls;
  • Developing new or enhanced industry guidance; and
  • Conducting outreach and information sharing to better protect consumers.

No comments:

Post a Comment