FDA Wants to Move to a New Era of Smarter Food Safety

FDA released a statement on 'A New Era of Smarter Food Safety'.  What does this mean?  There will be a push to move tracking and measurement systems to electronic format that can be easily monitored and tracked.  While the word 'blockchain' was not stated, one could assume this will be part of that picture.

From the release - "it’s time to look to the future of food safety once again, with a view that builds on the progress we’re making with our regulatory framework, but also leverages the use of new and emerging technologies to create a more digital, traceable and safer system. That’s why, today, we’re announcing a “New Era of Smarter Food Safety” to augment our efforts implementing important FSMA requirements while also leveraging, among other things, the use of new and emerging technologies."

In a blockchain type of environment, not only will lot codes be tracked, but also the parameters associated with that given lot.  This will make tracking data transparent to producers, processors, retailers, and ultimately consumers.

This train is coming...not sure when or how fast it will be going, but it is coming.  Now whether the industry will have the inclination to undertake..we'll see.

Statement from Acting FDA Commissioner Ned Sharpless, M.D., and Deputy Commissioner Frank Yiannas on steps to usher the U.S. into a new era of smarter food safety
For Immediate Release:April 30, 2019

FDA Issues Warning Letter to Rendering Facility Regarding Tallow with Pentobarbital

The U.S.FDA issued a warning letter to JBS USA urging the company to take corrective actions at their Souderton PA rendering facility regarding the continued production and sale of beef tallow that may contain pentobarbital, a drug used for anesthetizing and euthanizing animals.  "FDA alleges that JBS Souderton, doing business as MOPAC, continued to sell adulterated products after receiving formal notification of pentobarbital contamination from a customer on Feb. 13, 2018, and after formal notification of positive pentobarbital samples from the Pennsylvania Department of Agriculture on or about April 5, 2018."

The Meatingplace article, also states "According to FDA, MOPAC said that as of May 2018 it had made several changes to try to correct the problems, everything from requiring suppliers to sign guarantees that they do not pick up euthanized animals to extensive tank cleaning to random testing of tallow. But the agency collected a sample on August 2018 from a tank that was positive with trace levels of pentobarbital, indicating the company’s efforts were not sufficient. Samples taken at customers’ facilities also indicated levels of pentobarbital, the agency noted

Meatingplace
http://www.meatingplace.com/Industry/News/Details/85383
FDA tells JBS to stop selling beef tallow contaminated with euthanasia drug 
By Tom Johnston on 5/3/2019

FDA Issues Alert on French Soft-Ripened Cheese for Potential Listeria Contamination

FDA issued a public health alert for l’Explorateur soft ripened cheese due to the potential for Listeria contamination. This is a pasteurized, cow’s milk cheese that was made in St. Simeon, France and distributed throughout the U.S."The FDA advises consumers and retailers to not eat, sell, or serve cheese labeled as l’Explorateur."

The same brand of cheese was recalled a year ago, also due to Listeria. 

FDA Public Health Alert
LINK
Public Health Alert Concerning a Possible Listeria Contamination of French Soft Ripened Cheese
May 3, 2019

CDC Report on Food Pathogen Surveillance via FoodNet 2018

CDC released a report Preliminary Incidence and Trends of Infections with Pathogens Transmitted Commonly Through Food — Foodborne Diseases Active Surveillance Network, 10 U.S. Sites, 2015–2018 (MMWR Weekly / April 26, 2019 / 68(16);369–373) that shows the incidence of most infections increased during 2018 compared with 2015–2017, 'although it is probably do to automated (non-cultrure or culture independent) methods' [so the incidence is probably not rising, but rather the ability to detect allows investigators to determine cause] (The number of bacterial infections diagnosed by CIDT (with or without reflex culture )increased 65% in 2018 compared with the average annual number diagnosed during 2015–2017).

Basically, "The incidence of Cyclospora infections increased markedly, in part related to large outbreaks associated with produce. The number of human infections caused by Campylobacter and Salmonella, especially serotype Enteritidis, remains high."

• Poultry is a major source of Campylobacter
• The incidence of infections with Enteritidis, the most common Salmonella serotype, has not declined in over 10 years. Enteritidis is adapted to live in poultry, and eggs are an important source of infection.
• Produce is a major source of foodborne illnesses (2). During 2018, romaine lettuce was linked to two multistate outbreaks of STEC O157 infections (8). The marked increase in reported Cyclospora infections was likely attributable to several factors including produce outbreaks and continued adoption of DNA-based syndrome panel tests

FDA Releases Draft Industry Guidance for Voluntary Recalls

FDA issued a draft guidance on how to issue a voluntary recall.  (This draft guidance is listed FDA's webpage Industry Guidance for Recalls which has a number of valuable links including Model Press Releases. - https://www.fda.gov/safety/recalls/industryguidance/default.htm)

"The draft guidance discusses what preparations firms in a distribution chain, including manufacturers and distributors, should consider making to establish recall initiation procedures; to ensure timely identification of, and response to, product problems that might lead  to a recall; and to promptly issue recall communications and press releases or other public notices. It also discusses preparations firms in the distribution chain should consider making to ensure timely responses to a recall communication. Additionally, it discusses how FDA assists firms with carrying out their recall responsibilities to protect the public health from distributed products in violation" of federal regulations.

Firms should be recall ready.
1. General Preparations

Another Company Issue Ground Meat Recall Due to E. coli O103

As part of the E. coli outbreak investigation, another establishment is recalling ground beef due to the presence of E. coli O103.  It has not been declared if this product is related to the outbreak that has affected 156 people in 10 states.  This recall comes a day after another company, K2D Foods issued a recall for ground beef due to the presence of E. coli O103.

https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2019/recall-048-2019-release
Grant Park Packing Recalls Raw Ground Beef Products Due to Possible E. coli O103 Contamination
Class I Recall
048-2019
Health Risk:High
Apr 24, 2019

FDA Reports on Sampling Results from Ice Cream Processing Facilities

FDA released a report today on the the results of environmental testing in ice cream plants for Listeria and Salmonella.  They sampled 89 ice cream production facilities in 32 states from September 12, 2016, to August 30, 2017

Listeria

• Listeria monocytogenes was detected in 19 of the 89 establishments (an establishment-based prevalence of 21.3%), and in 65 of the 5,295 subsamples (a subsample-based prevalence of 1.25%). 
• The organism was found on non-food contact surfaces in 18 of the 19 establishments, and only one establishment also had it on food contact surfaces.  

Salmonella

• Only one positive sample out of all samples and that was a non-contact surface,

Inspections

• 39 inspections (43.8%) as “Voluntary Action Indicated (VAI),” meaning objectionable conditions or practices were observed and documented, but the operation should be able to address them without official action by the FDA; and 
• 6 inspections (6.7%) as “Official Action Indicated (OAI),” meaning objectionable conditions or practices warranting official action by the FDA were observed and documented.

While it is not surprising to find the occasional Listeria positive sample on non-contact surfaces in a food facility, 13 of the 19 facilities had positives in zone 2 samples, and one of those thirteen had it on a contact surface. These faculties also tended to have higher percentage of samples positive.  From the FDA sampling report, the facility with the product contact surface had a whopping 16% positive rate, while one facility had 30% and another 10%.  These facilities are clearnly not doing enough to control Listeria within the enviroment.  As the prevalence of Listeria gets higher in zone 3 areas, the increased risk it causes for the product.

Ice cream is relatively protected from the environment in that the product travels in enclosed pipes and tanks.  Primary exposure is at the filler and tank and mixing port openings.  Plus the fact that it is frozen to prevent the growth of Listeria.   Still, as the pressure of high Listeria prevalence in the environment can overcome these obstacles.

If this is the status of ice cream plants, perhaps FDA will be looking at other facility types to investigate?  Perhaps it is time to step up the facility's Listeria control program.

https://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm636084.htm
FDA Releases Report on Inspection and Environmental Sampling of Ice Cream Production Facilities for Harmful Bacteria
Constituent Update
April 24, 2019

Company Recalls Ground Beef Due to E. coli, Is that Product Linked to the Latest Outbreak?

K2D Foods, doing business as (DBA) Colorado Premium Foods, a Carrolton, Ga. establishment, is recalling approximately 113,424 pounds of raw ground beef products that may be contaminated with E. coli O103.  The raw ground beef items were produced on March 26, March 29, April 2, April 5, April 10, and April 12, 2019.

This comes as CDC and FSIS have been investing an outbreak of E. coli O103 where a total of 156 people infected with the outbreak strain of E. coli O103 have been reported from 10 states.

Twenty people have been hospitalized. No cases of hemolytic uremic syndrome, a type of kidney failure, have been reported. No deaths have been reported.

Preliminary epidemiologic information suggests that ground beef is the source of this outbreak.
CDC has "been investigating an outbreak of E. coli O103. Unopened, intact ground beef collected as part of the ongoing investigation from a restaurant location, where multiple case-patients reported dining, tested positive for E. coli O103. At this time, there is no definitive link between this positive product and the ongoing E. coli O103 outbreak. Further traceback and product analysis continues to determine if the recalled products are related to the E. coli O103 outbreak."

https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2019/recall-047-2019-release
K2D Foods Recalls Raw Ground Beef Products Due to Possible E. coli O103 Contamination
Class I Recall
047-2019
Health Risk: High
Apr 23, 2019

FDA to Start Inspections for Food Defense Plan Compliance in March of 2020

As part of the Food Safety Modernization Act, or FSMA, FDA's Rule Mitigation Strategies to Protect Food Against Intentional Adulteration, or IA Rule, requires facilities to write and implement a Food Defense Plan.  For facilities not considered small or very small,  the compliance date begins on July 2019.  Small facility compliance date will be the next year.  The list of exempted companies is listed below.

FDA announced this past week that it will begin to conduct compliance inspections in March of 2020.  The rule requires the facility "to develop and implement a food defense plan that identifies vulnerabilities and mitigation strategies for those vulnerabilities. These facilities will then be required to ensure that the mitigation strategies are working".

In March of this year, FDA released an updated draft guidance titled Mitigation Strategies to Protect Food Against Intentional Adulteration: Guidance for Industry.  A summary of that document is provided here.  Penn State will be conducting basic workshops on developing a Food Defense Plan.

FDA Food Safety Modernization Act (FSMA)
https://www.fda.gov/fsma
FDA Announces Intentional Adulteration Inspections to Begin March 2020
April 17, 2019