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FDA issued a draft guidance on how to issue a voluntary recall.  (This draft guidance is listed FDA's webpage Industry Guidance for Recalls which has a number of valuable links including Model Press Releases.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"The draft guidance discusses what preparations firms in a distribution chain, including manufacturers and distributors, should consider making to establish recall initiation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

Real Risk of Arsenic in Bottled Water

The article from Consumer Reports, "Arsenic in Some Bottled Water Brands at Unsafe Levels, Consumer Reports Says" grabbed a lot of press this month.  Oh no, something else I can't consume?  Only if you buy into the spin that looks more to grab readership than to provide sound science.

A rebuttal to that article was posted in Forbes and goes into detail dissecting the wording used.
A few keys, .

• Only one out of 130 bottles tested was in excess of FDA's limit of 10 ppb,..some obscure brand Peñafiel that had 17 ppb. 
• Five were higher than 3 but less than 10, which the article claimed that 3 should be the limit according to the report (but no reason why 3 instead of 10 is a better number).

So the summary from Forbes, "The primary spin-free numbers in the Consumer Reports article are that, of the 130 brands of bottled water examined for arsenic, 1 exceeded F.D.A. standards. And our refrigerators aren’t exactly teeming with that 1 – if you mixed all the bottled water in the world in a massive vat, Peñafiel would probably make up less than 3 parts per billion itself."

The article could have been titled "No real risk of arsenic in your bottled water", but that would not have garnered much of any mass media attention.  Not that we shouldn't be looking and controlling arsenic when levels are high.  A 2013 NY Times article points out that there are many place in the world, including the US where levels can range from 10 to 1000 ppb.

Forbes
https://www.forbes.com/sites/alanschwarz/2019/04/22/arsenic-in-water-scare-raises-risk-for-eye-rolling/#62c92239772d
Arsenic-In-Water Scare Raises Risk For Eye-Rolling
Alan Schwarz 
Apr 22, 2019, 09:40am

Topics in Supply and Demand - Sweet Potatoes, Chicken Strips, Bananas and Bug Flour

Trend in vegetable farming - there is a decrease in acreage planted for  sweet corn, green beans, peas and potatoes, with an increase in sweet potatoes and leafy greens such as spinach, kale and romaine lettuce.  

Chicken strips gaining on chicken nuggets - While more chicken nuggets are sold compared to chicken strips, chicken strips sales have increased against a decline in chicken nuggets.

Bananas are on the ropes, can CRISPR save them - In case you missed it, a virus is likely to make America's favorite fruit, the banana, extinct.  The hope is that scientist can modify the genetic makeup of the virus to make it resistant...otherwise, there will be no bananas, no bananas someday too soon.

Bugs as ingredients, "There is an increasing range of insect-based products, such as whole/flour, snacks, health bars, pasta, pasta sauce and burgers. Edible insects are promoted as a sustainable food alternative. It is also claimed there are numerous health benefits from eating bugs and insects."  But what strategy do purveyors take in identifying their product to attract customers?

Washington Post

Business

https://www.washingtonpost.com/business/2019/04/20/sweet-corn-out-sweet-potatoes-data-shows-fundamental-shifts-american-farming/?utm_term=.70dfc8fca246

Sweet corn out, sweet potatoes in: Data shows fundamental shifts in American farming

By Laura Reiley and Andrew Van Dam

April 20

Hepatitis A Case in Philly Grocery Worker Highlights Need for Controls

A Hepatitis A-infected food handler working in a Philadelphia grocery store triggered an alert for those who may have purchased pre-cut RTE fruits and vegetables.  This case is one of an increasing number of Hepatitis A cases seen.   Philadelphia Health Department noted that they are seeing 5 times the number of cases over the 2016 baseline.  While many of these cases are associated with people who are homeless or are drug users, it still increases the risk for food operations in that workers may face increased exposure within the community.

Therefore, it is important for food operations to maintain control including educating workers of the importance of reporting illness or potential exposure. Proper handwashing and glove use are important mitigations against the spread of the disease.

Hepatitis A is a highly infectious virus that is easily spread from an infected person to others through person-to-person contact or person-to-food-to-person.  Once exposed, it takes approximately 6 weeks to see the symptoms, jaundice and fever, but a person can be administered a vaccine within the first two weeks immediately after the exposure event.

Philly.com
https://www.philly.com/health/hepatitis-a-foodborne-illness-acme-philadelphia-health-inspection-reports-20190411.html
After hepatitis A warning at Philly Acme, should you eat precut fruits and veggies?
by Mari A. Schaefer, Updated: April 11, 2019

LGMA Updates Requirements to Improve Safety of Leafy Greens

California Leafy Greens Marketing Agreement Board has adopted additional requirements to reduce risk when it comes to water used in growing lettuce and leafy greens,  These new standards are "in direct response to investigations conducted by the U.S. Food and Drug Administration into last year’s e. Coli outbreak involving romaine lettuce."

The main action is to no longer allow the use of untreated surface water for overhead irrigation of leafy greens prior to harvest.    While the "LGMA program has always required growers to test their water because it can be a carrier of pathogens", the new requirements will now include additional safeguards including:  'categorizing the source of the water; considering how and when water is applied to the crop; conducting testing to assure the water is safe for the intended use; sanitizing water if necessary; and verifying that all of the above precautions have been taken.'

"The LGMA’s food safety practices meet, and often exceed, what is required under federal Produce Safety Rule regulations for other produce crops."

Perishable News
https://www.perishablenews.com/produce/leafy-greens-marketing-agreement-adopts-new-more-stringent-food-safety-practices-to-prevent-outbreaks/
Leafy Greens Marketing Agreement Adopts New, More Stringent Food Safety Practices to Prevent Outbreaks
April 22, 2019