The regulatory basis is the regulation 21 CFR § 500.35 Animal feeds contaminated with Salmonella microorganisms, which was published in 1975 and amended in 1985. This regulation is due to be deleted due, in part to a major shift in policy by FDA on Salmonella in feed brought on by negotiations with the American Feed Industry Association (AFIA).

Salmonella is the genus name for a class of microbes that number over 2,400 different serovars or serotypes. They are ubiquitous but only a handful is known to be pathogenic to either humans or animals. Some of the pathogenic forms are species specific. An even smaller number are pathogenic to both humans and animals. These zoonotic microbes are well known by their disease names of typhus, typhoid fever, bacterial dysentery, and others. Of greatest concern recently is Salmonella enteritidis, which is regulated by the FDA egg rule.

Two years ago, FDA dramatically changed its Salmonella in animal food policy to focus on only those common pathogenic serotypes of animals. FDA agrees that pass through from feed to humans is very rare. The policy is in its final review states, but FDA is already utilizing the policy as final. For poultry, the three serotypes are S. enteritidis, S. gallinarum and S. pullorum. There are an additional five serotypes of concern in other species. If these are found in poultry feed, the feed may be deemed to be adulterated and subject to regulatory action. In addition, FDA may return and begin sampling ingredients and the facility environment. Fortunately, these serotypes are very, very rare to non-existent in feed.

Recently, FDA notified the feed industry that it has begun sampling for Salmonella in poultry feed. No reason was given for this specific, directed sampling. A directive was sent out for the FDA district offices to take 75 samples from poultry feed. The specifics of the directive have not been discovered, but it appears all types of poultry feed is subject to this sampling.

The feed industry has urged cooperation with the sampling, as this appears to be an attempt to develop a baseline in the industry. However, FDA said it would take regulatory action if it finds the three serotypes of concern in poultry feed.

If FDA arrives at your facility to sample for salmonellae, AFIA suggests the following to consider:

• FDA will provide you with a notice of inspection. Write down the investigator(s)'s name(s) and address. S/he may issue a business card.
  
  
• You should ask why the investigator is there, and if the response is Salmonella sampling, you may ask what products and what they are looking for. They may ask to sample at a specific point in the plant. You may suggest alternatives. The best place is out of the mixer or loading chute. They may also ask to sample your ingredients - but unlikely, unless it is a follow-up sampling.
  
  
• FDA is required to take the sample aseptically, i.e. with a sterile probe and gloves. They should not contaminate the product by touching it bare-handed or walking over it without wearing sterile foot covers. They should take a sample scoop from a sterile bag and use that to sample the feed. You should remind the investigator about these procedures if s/he is not following these FDA requirements.
  
  
• It takes several days to ship the sample, analyze it, get the results back to the FDA and then to the feed mill. Usually by then the feed is consumed. If you receive a positive Salmonella report, you should ask for the serotype, which takes another 5 to 7 days. Many times no serotype can be found due to low microbes in the samples. However, FDA may find a Salmonella Group, and these three serotypes are all in Group D. Based on that result, FDA may request a recall and do follow-up inspections even if it cannot identify the serotype. The facility should push for a more definitive answer.
  
  
• As US Poultry & Egg Association is unsure what a recall request will look like in this case, as this is a new sampling routine, you should expect at minimum FDA will ask you to notify your customers (producers) to return any remaining feed and document the disposition of that feed (consumed).

Recently, FDA’s surveillance and compliance director said that a finding S. enteritidis in laying hen feed would result in CVM sending a notice to Center for Food Safety and Applied Nutrition (CFSAN) for follow-up.

The most important point here is to make sure FDA does serotyping of any finding of a Salmonella-positive feed sample.

The sampling directive can be viewed by clicking here.