FDA Delays Compliance Dates for Agricultural Water as Part of FSMA Produce Safety Rule

The FDA announced that it is planning to extend the deadline for compliance to agricultural water standards used in irrigation as part of the FSMA Produce Safety Rule .  Irrigation water can be a source of pathogens, but it is not an easy to control, especially when that water comes from surface waters.  Work done here at Penn State by Luke LaBorde etal (ref below) found that it was hard to make a connection between water standards and pathogen levels.  So testing water to see if it meets standards that may not mean much in terms of the pathogens present.  It is easy to see how environmental factors will constantly change...whether that be the occasional presence of animals, the amount of rainfall, the amount of sunshine, etc.

For more information on irrigation water, visit the Penn State Extension Website -http://extension.psu.edu/food/safety/farm/gaps/safe-uses-of-agricultural-water

Food Safety Modernization Act (FSMA) Updates
FDA Intends to Extend Compliance Dates for Agricultural Water Standards

Earlier this year, the U.S. Food and Drug Administration announced that it is exploring ways to simplify the agricultural water standards established by the Food Safety Modernization Act’s (FSMA) produce safety rule (PSR) after receiving feedback from stakeholders that some of the requirements are too complex to understand and implement.

Backyard Chicken Flocks Result in Numerous Salmonella Outbreaks

CDC reports that since the beginning of this year, there have been 8 Salmonella outbreaks related to backyard chickens. Within that, there have been 372 people infected and 71 of those cases resulting in hospitalization.

Poultry is a risk for Salmonella as well as Campylobacter.  People with backyard flocks, they are apt to treat the birds more as pets than farm animals, and with that, forget the need for proper personal hygiene including proper washing of hands, changing of clothes that are poop stained, and even removing shoes after stepping in bird dropping.  And even further, people increase the risk when they allow the birds to come inside their house or they snuggle with the birds.

CDC Zoontotic Diseases - Outbreak Advisory
https://www.cdc.gov/zoonotic/gi/outbreaks/livepoultry.html
Multistate Outbreaks of Human Salmonella Infections Linked to Live Poultry in Backyard Flocks, 2017

Canadian Produced Flour Recalled for E. coli O121

Smucker Foods of Canada is recalling flour produced at Ardent Mills in Saskatoon SK, Canada for the potential to be contaminated by E. coli O121.  Impacted product is packaged in 20 lb. paper bags and was distributed nationwide to 19 distributors and two small retailers.  There have been no reported illnesses in the US.

This recall relates to a Canadian recall issued in March.  This recall was expanded in April to include product produced by Ardent Mills.


FDA Recall Notice
https://www.fda.gov/Safety/Recalls/ucm561190.htm
Smucker Foods of Canada Corp. Announces a Voluntary Recall on Select Golden Temple®, Swad®, and Maya® Flour Products in the U.S. Due to Possible E. Coli 0121 Contamination
For Immediate Release
May 31, 2017

CDC Report - Fourteen Consume Toxic Mushrooms in California

From CDC - In December of 2016, there were 14 cases of mushroom poisoning that took place in California.  "Eleven patients recovered, although three required liver transplants because of irreversible fulminant hepatic failure. One of those patients, a child, developed cerebral edema and suffered permanent neurologic sequelae."

Weather conditions provided conditions for Amanita phalloides, also known as  “death cap", to grow in the region.  The primary toxin, α-amanitin, causes damage to liver and kidney.  The toxin is heat stable and so is not destroyed by cooking.  It is interesting to note that people are initially sick with nausea, vomiting, and diarrhea, then feel better, then are sick again with potential kidney damage.

Amanita is mistaken for edible Agaricus (wood mushrooms or field mushrooms).
Source -http://www.first-nature.com/fungi/


Amanita phalloides - Death Cap (http://www.first-nature.com/fungi/amanita-phalloides.php)


Agaricus campestris L. - Field Mushroom (http://www.first-nature.com/fungi/agaricus-campestris.php)

Agaricus silvicola  - Wood Mushroom (http://www.first-nature.com/fungi/agaricus-silvicola.php)

It is important that people who pick wild mushrooms can properly identify them.  If someone gives you mushrooms.....just don't take them unless you know without a doubt that they can properly identify mushrooms, or you can properly identify wild mushrooms.

CDC - MMWR (Morbidity and Mortality Weekly Report
https://www.cdc.gov/mmwr/volumes/66/wr/mm6621a1.htm?s_cid=mm6621a1_e
Amanita phalloides Mushroom Poisonings — Northern California, December 2016
Weekly / June 2, 2017 / 66(21);549–553

Preparing for a FSMA Audit from FoodOnline

A recent article in FoodOnline (an informative online journal you should subscribe to if you haven't already) discusses how Kraft Heinz prepares for FDA FSMA inspections. A few key points brought up in this article are similar to what we have been hearing about from our industry friends about their recent audits.

A summary of what this company's regulatory affairs manager discussed about their company's experiences:

• 'Inspectors are calling these ‘routine FSMA inspections' and are not distinguishing between Preventive Controls and modernized GMP inspections' 
• These audits are generally more focused on high-risk products.
• Auditors had visited 7 of these audits - one full Preventive Controls inspection and six modernized GMP audits.
• Generally there are three inspectors.
• Audits have lasted 1 to 5 days, mostly 4 to 5 days.
• Four of the seven audits included swabathons (100 to 150 swabs), which included Zone 1 (30%), Zone 2 (20%) and Zone 3 (50%).  No zone 4.
• There is a focus on the company's environmental monitoring program including the records and corrective actions on positvie results.
• With regard to verification activities, they are focusing on records including corrective action logs, production schedules, sanitation records, and calibrating inspection equipment records.
• With regard to the Preventive Control plan, inspectors are reviewing the hazard analysis with questions on the justification behind each of the identified hazards.
• There is also a review of the written recall plan.
• Recently there is attention on the supply chain program.
• Review of handling of byproducts used for animal feed, consumer complaint handling, and FSPCA training looking for certificates of completion.

An interesting item in the article is that FDA will want to take photos in the facility, so a company needs to have a policy to address this.  The same goes with photocopying records.

Source: Food Online 
Inside Kraft Heinz's FSMA Inspection Readiness 
Link
By Sam Lewis, associate editor
Follow Me On Twitter @SamIAmOnFood

Breakfast Sausage Recalled Due to the Potential for Metal Foreign Material

A Kansas establishment is recalling 90,000 lbs of RTE breakfast sausage for metal pieces after "another FSIS-regulated establishment that pieces of metal were embedded in a fully cooked sausage product".

Over the past year, there has been an increasing amount of recalls due to foreign objects.  While these foreign objects may not result in any major injuries, the cost of conducting a recall warrants companies putting in more effort in foreign object control.  This goes beyond just having a metal detector installed into the process.

First, many metal detectors do not get the attention they need.  A really nice guide for metal detectors is "The Guide to Reducing Metal Contamination in the Food Processing Industry" published by Safeline.  

X-ray equipment is much more affordable than it once was, and it can pick-up items metal detectors can't, such as glass, hard plastic, stones, etc.  They are even suitable for metal and foil containers.

But detection is just one part of a foreign object control program.  Other important elements include raw material inspection, preventive maintenance, employee training to prevent accidental drops, and controls at ingredient addition steps to prevent foreign material from packaging and inline preventive devices such as magnets and sifters.

All of these systems need to be properly maintained and verified for performance.  Additionally, consumer complaints must be reviewed with an investigation and appropriate corrective action for any foreign material issues.

USDA / FSIS Recall Notice

https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2017/recall-054-2017-release
Armour Eckrich Meats, LLC Recalls Ready-To-Eat Sausage Products Due to Possible Foreign Matter Contamination
Class II Recall 054-2017
Health Risk: Low 

May 24, 2017

Packaged Salad Items Recalled Due to Metal Pieces from Construction

A NY based produce company is recalling salad products due to the potential for metal pieces.  The metal was said to be generated from construction activities. 

Many facilities carryout construction activities while they are producing products.  However, it is critical to protect product from contamination.  Metal pieces can easily be shot over wide areas during construction activities such as grinding and wielding.

BrightFarms is an interesting company.   Based in NY, the company is building huge hydroponic greenhouses in various market areas in order to grow produce locally to supply those markets.  [Story below].

FDA Recall Notice
https://www.fda.gov/Safety/Recalls/ucm559445.htm
Brightfarms Announces Voluntary Regional Recall of Produce Due to Potential Presence of Metal Pieces From Construction
For Immediate Release
May 18, 2017

One Man Dead, A Mom Still Hospitalized after Three Weeks, Both Consumed Contaminated Nacho Cheese Sauce

One woman's story, associated with the botulism in gas station nacho sauce case, highlights the issues for someone with botulism poisoning.  A few hours after eating Doritos drizzled with nacho cheese sauce, she felt fatigue and by the next day, she had blurred vision followed by vomiting and difficulty in breathing.  These symptoms are caused by the  neurotoxin produced by Clostridium botulinum as it grew in the nacho cheese sauce. Once the toxin contaminated food is consumed, "Botulinum toxin causes flaccid paralysis by blocking motor nerve terminals at the neuromuscular junction. The flaccid paralysis progresses symmetrically downward, usually starting with the eyes and face, to the throat, chest, and extremities. When the diaphragm and chest muscles become fully involved, respiration is inhibited and, without intervention, death from asphyxia results". (FDA Bad Bug Book)

There has also been one death being associated with the tainted nacho cheese.  A man had been on life support.  This has not yet been confirmed by State officials.

There are now 10 people that have been affected from eating at this establishment.


Sacramento Bee
http://www.sacbee.com/news/local/health-and-medicine/article150908817.html
Mom put nacho cheese on her Doritos. Three weeks later, she’s still in the hospital.
By Sammy Caiola  scaiola@sacbee.com
May 16, 2017

Meat Processor Recalls Hot Dogs After Receiving Three Complaints for Metal

An Ohio meat processor is recalling 210,000 lbs of  hot dogs after 'the establishment received three complaints of metal objects in the beef frank product package'.


USDA / FSIS Recall Notice
https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2017/recall-052-2017-release
John Morrell and Co. Recalls Beef Frank Products Due to Possible Foreign Matter Contamination
Class II Recall 052-2017
Health Risk: Low May 19, 2017