Webinar, 'Play FDA for a Day', Drives Paranoia to a New Level

The webinar, "Play FDA for a Day: Criminalization of foodborne illness and what you can do to protect your company", is presented by a lawyer and a testing company and directs companies to do testing for outbreak-related pathogens before the FDA does.  And if FDA finds an outbreak-related pathogen in your food facility, you are as good as going to jail.  And for these outbreak-related pathogens, there is 1 million unsolved outbreaks in the FDA database just waiting to get solved.  So get a lawyer and get the test kits ASAP.  Because FDA 'investigators' are going to be busting down your door and swabbing the heck out of your facility.

A little paranoia is good, but this presentation is over the top.   There is no doubt that companies need to keep their facilities in order, including ensuring the environment is under control,  doing environmental monitoring with effective corrective action especially when there is risk (product exposed to the environment).  But to date, there have been very few cases where the Department of Justice has gotten involved in outbreak investigations.  The investigations cited were ones where pathogens were found in food and linked to outbreaks through epidemiological investigation.  Subpoenas were issued when wrongdoing was suspected.  

Testing and advice for free or just the hook?  What is an over-the-top lawyer going to tell you when you have an organism in your drain?

(Don't have the time or the will to watch the video, you can read the white paper.)

Lab Error Blamed for 2012 Case of Chocolate Recalled for Salmonella

In 2012, chocolate bars from Belgium were rejected for import into the US after a Belgium laboratory reported the product as Salmonella positive.  The product was destroyed.   After an investigation, the Salmonella strain identified was the same strain found by the laboratory in fish meal.  Cross contamination in the laboratory?  That is what is believed.  Unfortunately, a few years back, there were not the whole genomic sequencing tools readily available as we do today.

This puts a light on laboratories and the impact of poor practices can have on a company's product.  Tight controls need to be in place to prevent cross contamination.  Companies need to question results that seem unlikely.  Today, further investigation can be completed using whole genome sequencing to rule out laboratory error, including excluding the laboratory's positive control sample.

BioMed Centralhttp://bmcresnotes.biomedcentral.com/articles/10.1186/s13104-016-1969-7
Case report of Salmonella cross-contamination in a food laboratory

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

http://www.fda.gov/Food/ComplianceEnforcement/Sampling/ucm20041972.htm

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.

Impact of Rapid Clinical Testing of Foodborne Pathogens on Outbreak Investigations

It is easy to make the assumption that rapid diagnostics, CIDT or Culture Independent Diagnostic Tests, would help in determining the cause of an outbreak, but this may not be the case.   While rapid testing may help with the treatment of a patient by determining the type of organism that caused the illness, without isolating the organism through good old fashion culture methods, the investigation essentially stops there.  To go beyond diagnosis of the illness to a point where the exact strain of the organism can be determined for matching purposes, isolation and cultural confirmation is needed.

An increasing number of tests completed by clinical laboratories are using CIDTs.  In some cases where a positive is found, no further isolation was attempted, and in other cases, the lab was not able to isolate the organism.  In the past, the isolated organisms would then be forwarded to the public health laboratories for further identification and characterization, including if an organism was antibiotic resistant.  The organism could be subtyped and this information is used in determining if this illness/organism is part of a wider outbreak.

The inability to culture a CIDT positive sample may also indicate a false positive, especially where the type of CIDT used was an antigen based technology.


CDC MMWR
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6409a4.htm?s_cid=mm6409a4_e
Bacterial Enteric Infections Detected by Culture-Independent Diagnostic Tests — FoodNet, United States, 2012–2014
Weekly

 March 13, 2015 / 64(09);252-257

Martha Iwamoto, MD1, Jennifer Y. Huang, MPH1, Alicia B. Cronquist, MPH2, Carlota Medus, PhD3, Sharon Hurd, MPH4, Shelley Zansky, PhD5, John Dunn, DVM6, Amy M. Woron, PhD6, Nadine Oosmanally, MSPH7, Patricia M. Griffin, MD1, John Besser, PhD1, Olga L. Henao, PhD1 (Author affiliations at end of text)

The increased availability and rapid adoption of culture-independent diagnostic tests (CIDTs) is moving clinical detection of bacterial enteric infections away from culture-based methods. These new tests do not yield isolates that are currently needed for further tests to distinguish among strains or subtypes of Salmonella, Campylobacter, Shiga toxin–producing Escherichia coli, and other organisms. Public health surveillance relies on this detailed characterization of isolates to monitor trends and rapidly detect outbreaks; consequently, the increased use of CIDTs makes prevention and control of these infections more difficult (1–3). During 2012–2013, the Foodborne Diseases Active Surveillance Network (FoodNet*) identified a total of 38,666 culture-confirmed cases and positive CIDT reports of Campylobacter, Salmonella, Shigella, Shiga toxin–producing E. coli, Vibrio, and Yersinia. Among the 5,614 positive CIDT reports, 2,595 (46%) were not confirmed by culture. In addition, a 2014 survey of clinical laboratories serving the FoodNet surveillance area indicated that use of CIDTs by the laboratories varied by pathogen; only CIDT methods were used most often for detection of Campylobacter (10%) and STEC (19%). Maintaining surveillance of bacterial enteric infections in this period of transition will require enhanced surveillance methods and strategies for obtaining bacterial isolates.

Black Pepper in 3.53 oz Jars Recalled after FDA Testing Finds Positive Salmonella Sample

A NJ based company, Gel Spice, is recalling black pepper, packaged in 3.53 oz containers, after FDA routine testing found a sample positive for Salmonella.  The product was sold through Big Lots.  There have been no reported illnesses.

FDA appears to be evaluating spice products heavily since they issued their spice risk assessment in November of 2013.  We have also seen a number of recalls in produce for Listeria and Salmonella which would indicate a focus on those products in light of the Listeria outbreak in cantaloupes.  This is where we come back to fact that companies need to consider a pathogen testing program if their product is viewed as having risk for a given pathogen.  A program does not mean end product testing exclusively, but rather compressive program that takes into account raw material, environmental, in-process and finished product testing with an eye on risk reduction.
 

Gel Spice is a value provider of spices for industrial, foodservice, and consumer ( Brands - Spice Supreme, Spice Time, Spice Select, Chef's Select, Gel, Spice Pride, and various private label products in the grocery, drug, and discount chains).



Market Watch / PRNewswire
http://www.marketwatch.com/story/gel-spice-company-inc-issues-a-voluntary-recall-of-fresh-finds-brand-ground-black-pepper-353-oz-100-g-due-to-possible-salmonella-risk-2014-09-15

Gel Spice Company, Inc. Issues a Voluntary Recall of Fresh Finds brand Ground Black Pepper, 3.53 oz (100 g), due to Possible Salmonella Risk Published: Sept 15, 2014 9:30 p.m. ET

BAYONNE, N.J., Sept. 15, 2014 /PRNewswire-USNewswire/ -- Gel Spice Company, Inc., of Bayonne, NJ, is issuing a voluntary recall notice for 16,443 cases of Fresh Finds-Ground Black Pepper, 3.53 oz, plastic jars, because it has the possibility to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

USDA to Begin Testing Ground Beef for Salmonella

USDA will begin testing for Salmonella in addition to E. Coli (STEC) in ground beef this summer.  Samples found to be Salmonella positive will be analyzed for antibiotic resistance.

It will be interesting to see if any recalls are issued due to antibiotic resistant Salmonella strains.


 USDA Website - Blog
http://blogs.usda.gov/2014/05/16/food-safety-scientists-double-up-on-ground-beef-testing-this-summer/
Food Safety Scientists Double Up on Ground Beef Testing This Summer
Posted by Brian Ronholm, Acting Under Secretary for Food Safety, on May 16, 2014 at 1:00 PM


As grilling season heats up, the USDA’s Food Safety and Inspection Service is enhancing our food safety testing program for ground beef. While FSIS has a range of safeguards to reduce E. coli in ground beef, this summer we will begin new testing to improve the safeguards against Salmonella as well. Salmonella is commonly found in ground beef and, in fact, caused an illness outbreak in January 2013 in six states. Salmonella is an especially difficult bacteria for food safety experts to address because it is so prevalent in almost all food sources.

Raw Milk Testing Requirements - Outbeak of Campylobacter in Family Cow Raw Milk

In a recent report (below), there are now 77 cases of campylobacterosis from the consumption of raw milk associated with Family Cow.  What standards are in place for a dairy to sell raw milk?  Attached is the section on testing schedule from Pennsylvania's guidenance for those selling raw milk.  Note that there is no requirement for continuous testing.  In general, APC, coliform, and somatic cell counts are required twice per month and these parameters serve as indicators of sanitary quality,  However, actual pathogen testing is only required once every six months.  Now, dairies selling raw milk may be testing  more frequently.  Probably a good question for the producer of your raw milk.

Raw Milk Testing Standards
Guideance -
PERMITS ALLOWING THE SALE OF
RAW MILK FOR HUMAN CONSUMPTION
http://www.portal.state.pa.us/portal/server.pt/gateway/PTARGS_0_2_24476_10297_0_43/AgWebsite/Files/Publications/Draft_-_Revision_of_Raw_Milk_Guidance_Doc_Final.pdf
9. Regular Testing of Raw Milk.
a.  Responsibility. A raw milk permit holder is responsible to arrange for the regular sampling and testing required with respect to the raw milk permit, and to pay for this testing.

9b. 
Pennsylvania Approved Dairy Laboratories. All raw milk samples submitted for testing must be analyzed at an official laboratory (a laboratory which is under the direct supervision of the Department) or a  Pennsylvania approved dairy laboratory (a laboratory authorized or designated
by the Department as allowed to perform specific milk testing).
c.  Testing Schedule. A raw milk permit holder must coordinate raw milk testing on the following
schedule, and the raw milk samples must meet the following standards: 

Another illness case linked to The Family Cow's raw milk

http://www.publicopiniononline.com/localnews/ci_19984720

CHAMBERSBURG - The number of cases of sickness linked to The Family Cow raw milk stands at 77 in four states.