Monday, November 7, 2016

Co-Pack Facility Responsible for Ice Cream Recall Due to Listeria

A California company is recalling their fancy ice cream after FDA found Listeria in product and in the co-packing facility.

We see many entrepreneurs who focus on the marketing and sales and leave the manufacturing of the product to someone else.  Know the risk associated with those products and understand how the co-packer is controlling that risk.  Many would-be marketers ask if they should take a HACCP or Preventive Controls class - absolutely.  Should you institute a supply-chain control program to including audit and testing - absolutely, especially if the hazard analysis identifies potential risks.

The AC Creamery recall is also related to this co-packer. http://www.fda.gov/Safety/Recalls/ucm527875.htm

FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm528091.htm
McConnell’s Fine Ice Creams Recalls Select 16oz. Packages Due To Possible Health Risk
For Immediate Release
November 4, 2016

Vending Company Recalls Food Items Not Properly Labeled (Including Allergens)

A PA vending firm is recalling a wide range of items because they did not have ingredient labels on their product which means that they did not have any allergen listing. 

I guess they were not paying attention in the ServSafe class.

FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm528146.htm
Crescent Vending Co. Issues Allergy Alert on Undeclared (Wheat, Soy, Milk, And Egg) in ProductFor Immediate Release
November 5, 2016

Maintenance Issue Results in Foreign Material in Reformed Chicken Patties

Another complaint for plastic in reformed chicken patties that resulted in recalling  over 20,000 lbs of product.  This time it was blue plastic and the issue was brought to light by 3 customer complaints.  According to the report - "The problem was discovered when the firm received notification of three consumer complaints mentioning firm blue plastic in their product. The product was contaminated around the time a trim repair was made on belt material."

Issue - Maintenance
FSIS Recall Notice
http://www.fsis.usda.gov/wps/wcm/connect/FSIS-Content/internet/main/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2016/recall-103-2016-release
OSI Industries, LLC Recalls Chicken Products Due To Possible Foreign Matter Contamination
Class II Recall 103-2016
Health Risk: Low Nov 6, 2016

How Local is That Produce Item at the Farmers' Market?

A TV News report out of Philadelphia shows that some produce items sold at Farmers' Markets are not grown on the local farm, but rather the same commercially grown items sold at the grocery store.  Sure, it is still fresh, but not grown by the guy selling it, or probably not grown in the same region.  The problem is that people don't realize it and they are spending more for it than they would at the grocery store.

This should not come as a surprise.  If you are buying berries in Lancaster at this time of the year, it is probably not grown anywhere near Lancaster.  Farmers' markets vendors will supplement what they grow with other items to have a broader offering.  To get these items, they often go to the same produce wholesalers / distributors where your grocery store gets them.  And because they are buying in smaller quantities, they pay more and thus charge more.
There is no problem with this as long as the consumer understands what they are buying.  It the consumer wants to pay a couple extra bucks to help support their local farmers' market vendor, have at it.  If you feel you have been duped, then talk with your farmers' market vendor.  Find out which items are truly local.  Also, understand what crops are grown in your area and the season for that crop.

(Thanks Josh for this link).

ABC News Channel 6 Philadelphia
http://6abc.com/food/action-news-investigation-is-farmers-market-produce-really-from-farm/1588491/
FOOD & DRINK
Action News Investigation: Is farmers market produce really from the farm?
Friday, November 04, 2016 11:56AM
ST. DAVIDS, Pa. (WPVI) -- An Action News investigation revealed not all those fruits and vegetables, packaged alongside local grown produce, may actually be from nearby farms.

FDA Outbreak Investigation - Hepatitis A in Strawberries

An outbreak of Hepatitis A linked to frozen strawberries reported in September has now resulted in 134 cases of Hepatitis A.  The strawberries were imported from Egypt and FDA has issued an import alert.  The company has also issued a recall.

FDA Outbreak Investigation
FDA Investigates Outbreak of Hepatitis A Illnesses Linked to Frozen Strawberries
November 3, 2016
The U.S. Food and Drug Administration, the Centers for Disease Control and Prevention (CDC) and state and local officials are investigating an outbreak of hepatitis A illnesses linked to frozen strawberries.

Friday, November 4, 2016

CDC Study - Outbreaks Associated with Organic Foods

A study conducted by CDC evaluated the outbreaks associated with organic foods.  From the study: "We identified 18 outbreaks caused by organic foods from 1992 to 2014, resulting in 779 illnesses, 258 hospitalizations, and 3 deaths".  Salmonella and pathogenic E.coli were the leading causes.  There were a range of foods involved: "Eight of the outbreaks were attributed to produce items, four to unpasteurized dairy products, two to eggs, two to nut and seed products, and two to multiingredient foods."  

As stated in this study, it is hard to calculate risk of organic foods compared to conventional foods.  However, we can say that just because it is organic, it doesn't mean that you still don't need proper handling and preparation.

It is also important to point out that over the period of time covered in this study, the capabilities for identifying outbreaks and tracking to the source have improved greatly.  So looking at the number of outbreaks occurring from year to year can be misleading.

Journal of Food Protection, November 2016
http://www.ingentaconnect.com/content/iafp/jfp/2016/00000079/00000011/art00018
Foodborne Disease Outbreaks Associated with Organic Foods in the United States

Thursday, November 3, 2016

Oreo Fudge Creames Recalled Due to Milk Allergen, Even Though Listed in Precautionary Statement.

A specific type of Oreo cookie is being recalled after someone had an allergic reaction to milk, and milk was not declared on the label.  It was however, listed in the precautionary statement - "Manufactured on equipment that processes milk.."

The precautionary label is not part of any official allergen labeling rule, so it doesn't provide protection.  Basically you hope someone with a given allergy such as milk would see that and then avoid eating it.  Didn't happen.

From FARRP  - "FDA specifies that such [precautionary] labeling cannot be used as a substitute for good manufacturing practices such as allergen identification and control, cleaning of shared equipment, and segregation during processing. Some consumers believe manufacturers use precautionary labels as a way to protect themselves from legal action in case a food causes a reaction. This is not typically the case since this type of label should only be used by food manufacturers when there actually is a possibility (however small) that the food may contain an allergen which is not an ingredient but may be present as a result of the manufacturing process."
 
FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm527207.htm
Mondelēz Global LLC Conducts Nationwide Voluntary - Recall of Oreo Fudge Cremes Product Sold in the U.S. Recall Due to Milk Allergen Not Listed in Ingredient LineOctober 28, 2016

FDA Guidance - Small Company Version of Preventive Controls for Human Foods

FDA released their guidance titled: Guidance for Industry: What You Need to Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Small Entity Compliance Guide.   LINK

This guide was developed to help small companies comply with the FSMA Preventive Controls Rule.

The guide does not introduce anything new.  It is basically a simplified version of the original rule.  Being simplified, the document does make the regulation more approachable.  One particular area is On-Farm Packing and Holding of Food (pg 22).  The guidance discusses those activities not subject to the requirements for Hazard Analysis and Preventive Controls when conducted on farms.

It also reviews the Qualified facility -  a facility that does not need to comply with the Preventive Controls component of the rule (21 CFR 117).  It has been our opinion however, for companies who fit into that definition to consider taking the step and completing the Preventive Controls component.  Why?  If the company grows, looks to gain sales from a customer requiring a HACCP type plan, or just wants to improve the safety of their product, they really need to consider taking this step.

Friday, October 28, 2016

FSMA Draft Guidance for Notifying Customers of Hazards That Need to be Controlled

FDA issued a draft guidance that applies to food containing a hazard that must be controlled by a customer that is a further processor (not a consumer). This applies to the FSMA rules for Human Food, Animal Feed, Produce, and FSVP. The guidance titled "Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing the FDA Food Safety Modernization Act: Guidance for Industry " (Link) details how to make a disclosure in documents accompanying food that certain hazards have not been controlled by that entity.  

For example, if Company A is selling pepper to Company B, and that pepper had not been treated to eliminate Salmonella (which Company A has identified as a potential hazard), Company A would need to disclose on paperwork / documentation that "the pepper was not processed to adequately reduce the presence of microbial pathogens". 

So what are the documents of the trade? It has to be something the manager in charge of food safety is likely to read: "documents accompanying the food, in accordance with the practice of the trade." See 21 CFR 117.136(a)(2)(i), (a)(3)(i), and (a)(4)(i). This allows for the disclosure statement to be provided using a wide variety of types of documents that accompany the food, such as labels, labeling, bill of lading, shipment-specific certificates of analysis, and other documents or papers associated with the shipment that a food safety manager for the customer is likely to read."   " It is permissible, for the purposes of the requirements of the part 117 disclosure statement, to use labeling that includes a disclosure statement such as "not processed to control microbial pathogens" and then directs the recipient to a website for additional information about those microbial pathogens."

How does it need to state the hazards?  "For biological hazards, we will consider a manufacturing/processing facility that describes the "identified hazard" using a general term (e.g., "microbial pathogens," "microorganisms of public health significance") rather than a specific biological hazard (e.g., Salmonella or Listeria" 

For a chemical or physical hazard, the statement must be more specific.  "For chemical and physical hazards, a manufacturing/processing facility that chooses to not control chemical and physical hazards and to rely on its customers to do so, would be subject to the requirements of the part 117 disclosure statement. We expect such a facility to describe the identified chemical or physical hazard using a specific term (e.g., "mycotoxins," "aflatoxin," "stones") that adequately communicates the key safety information regarding the chemical or physical hazard that needs to be controlled."

Again, this is only needed when the supplier identifies a hazard and is relying on their customer (non-consumer) to control that hazard.
 

Are Cookbooks a Food Safety Biohazard in the Kitchen?

 Okay, because someone asked....are cookbooks a biohazard in kitchen?  Some food safety guy in the UK, who works for a firm that recovers costs if you get sick on vacation, stated that cookbooks are a food safety biohazard in the kitchen.  I was not able to find any scientific support to back this claim, but I guess, if your hands are nasty as you finger through the cookbook, you can potentially transfer pathogens to your cook book.  But is it a high risk...probably not.  Just clean your hands after handling raw meats before you go rifling through your cookbook.  And don't put your cookbook in a an area where it can get raw meat droplets on it.

In general, bigger risks occur through cross contamination from contaminated food contact surfaces to prepared foods or from undercooking.  Hopefully, people follow directions in the cookbook, and those directions presented in that cookbook are based upon sound scientific principles.

 The Sun (UK)
https://www.thesun.co.uk/living/2053079/cook-books-should-be-banned-from-the-kitchen-for-carrying-food-poisoning-bacteria/
THE HIDDEN DANGER IN YOUR KITCHEN
Cook books ‘should be BANNED from the kitchen for carrying food-poisoning bacteria

Bacteria clinging to the pages of cookbooks could cause crippling bouts of sickness, leading food scientists have warned
Exclusive
By BRITTANY VONOW
26th October 2016, 1:56 pm     

Frozen Strawberries from Egypt Linked to 134 Hepatitis A Cases

In early September, an outbreak of Hepatitis A linked to frozen strawberries was identified.  As of October 20th, there are 134 cases identified all linked to frozen strawberries served in smoothie drinks (fresh blended fruit and vegetable drinks) served at Tropical Smoothie Cafes.

The frozen strawberries were sourced from Egypt.  FDA issued an import alert for detention without physical inspection of frozen strawberries from Egypt, even though the Egypt Ministry of Climate Change and Environment "claimed Frozen Egyptian strawberries are free from Hepatitis A..".
 
FDA Release
FDA Investigates Outbreak of Hepatitis A Illnesses Linked to Frozen Strawberries
October 20, 2016

Rancidity of Tortilla Chips Leads to Outbreak of Gastrointestinal Distress

Approximately 77 people became ill in a correctional facility in Wyoming after eating rancid tortilla chips.  Rancidity is the breakdown of oils and fats that occurs when fats and oils were extensively heated.  Debris and moisture in the oil facilitates that breakdown.  This oil breakdown impacts flavor and quality, and as seen here, can lead to gastrointestinal distress.   In this case, the tortilla chips were probably fried in oil that had been used too long.

Generally indicators of rancidity are measured to detect the level of rancidity, in this case, hexanal and peroxide.  By measuring these indicators, firms know when oil is beginning to go bad and then replace the oil.  For smaller firms without the capability of conducting measurements, they replace oil after a certain time or amount of usage.  Others replace oil when the oil in the fryer begins to darken, smoke or smell 'off'.  Continuing to use oil after it goes rancid leads to off-flavors in the food, and more importantly, illness.

As noted in the MMRW article, this is one of the first documented cases of illnesses related to rancid oil.  But a good guess would be that this happens more frequently than reported.  How many times have you gone to a fair or a greasy spoon burger joint and ate fried food that had an off-flavor?  Then a hour or two later your stomach starts to roll.  Too often, purveyors try to use oil longer than it should be used.  In some cases, the consumer notices the flavor and throws the food out, but in other cases, when really hungry, they choke it back.

Morbidity and Mortality Weekly Report (MMWR)
https://www.cdc.gov/mmwr/volumes/65/wr/mm6542a4.htm?s_cid=mm6542a4_w
Gastrointestinal Illness Associated with Rancid Tortilla Chips at a Correctional Facility — Wyoming, 2015
Weekly / October 28, 2016 / 65(42);1170–1173
Tiffany Lupcho, MPH1; Alexia Harrist, MD, PhD1,2; Clay Van Houten, MS1

 Summary

What is already known about this topic?
Although consumption of rancid food can cause gastrointestinal illness, few outbreaks have been documented.

Monday, October 24, 2016

Free Range Chickens and Bald Eagles - High Cost of Organic Farming

An interesting read in Audubon Magazine about the impact of bald eagles on a free range chicken farm in Georgia.  Each year, this farm has an increasing number of bald eagles overwintering around the farm and feasting on high priced organic chicken.  There are now approximately 75 eagles, eating 3 or 4 chickens per day and costing the farm about $1000/day.  (Don't worry too much for the farm, the taxpayers pick up a good portion of that bill...and many of them don't even eat organic / free range chicken).

In addition to the loss by the eagles, free range farming has higher mortality rates...usually about 18% compared to 4% for conventional chicken farming.  "Even discounting the three or four chickens each eagle takes every day throughout the winter, Coady thinks the farm’s chicken-mortality rate is too high. It’s roughly 15 percent throughout the year, though some weeks it’s higher and some weeks it’s lower. He’d like it to be somewhere around 10 percent—far below the estimated 18 percent mortality rate the USDA expects for free-range chickens (for comparison, it’s 4 percent for confined chickens)." 

 The farmer's solution - "Harris has his own ideal solution, and it has nothing to do with noise-makers or reimbursement programs or tourism. If everyone farmed in the nature-first way he does, he says, eagles wouldn’t concentrate on his farm. Flocks of chickens scattered across the Georgia countryside would naturally cause eagles to disperse into smaller, healthier populations."  I guess I am missing something here...so yes the eagle population would spread out..for now, but what would limit eagle population growth if farms all over became raptor dinner tables?  And with an unchecked eagle population explosion, what else will be on that dinner table....little Sparky and Mr. Tibbs?

Audubon Magazine
http://www.audubon.org/magazine/fall-2016/an-organic-chicken-farm-georgia-has-become-endless
An Organic Chicken Farm in Georgia Has Become an Endless Buffet for Bald Eagles
By Susan MatthewsFall 2016

Thursday, October 20, 2016

Bacillus cereus in Refried Beans Responsible for Mighty Taco Outbreak

A NY taco chain has been connected to over 160 people becoming ill with Bacillus cereus toxin.  Cases have occurred in two counties  and it appears that a 'handful' of the Mighty Taco locations have been involved.  The symptoms are nausea and vomiting.

The source of the illness was refried beans.  Bacillus cereus is a sporeforming organism and these spores can survive the cooking process.  If that food is then temperature abused, the organism will sporulate and grow in the food if that food is at elevated temperatures.  As the organism grows to high numbers, it produces a toxin.  So we would expect that the beans would have been temperature abused somewhere along the supply chain, including distribution down through store level.  (This is where the FSMA Sanitary Transport rule becomes important).

Cooked rice is another product often associated with Bacillus cereus related illness.  In a similar fashion, the cooked rice is left at room temperature for an extended period, allowing growth of the organism which produces toxin.

WGRZ Channel 2 News
http://www.wgrz.com/news/toxic-bacteria-identified-as-likely-source-of-mighty-taco-outbreak/337094922
Toxic Bacteria Identified As Likely Source Of Mighty Taco Outbreak
Steve Brown, WGRZ 8:33 AM. EDT October 19, 2016

Monday, October 17, 2016

Pulsenet - Tracking of Foodborne Disease

The US surveillance system for tracking foodborne illnesses, or PulseNet, is 20 years old.  Through time, the technology has improved and its reach is now global. 

In the US, the system is comprised by a network of 83 laboratories linked to the CDC in Atlanta.  Using genetic identification technology, including Whole Genome Sequencing or WGS, it can identify outbreak clusters through matching bacterial isolates involved in cases.  This information is then used to help identify the source of the outbreak.

This article in EMBO is a nice summary of Pulsenet and how it has impacted food safety.

EMBO Reports
http://onlinelibrary.wiley.com/doi/10.15252/embr.201643128/full
Future challenges for tracking foodborne diseases

PulseNet, a 20-year-old US surveillance system for foodborne diseases, is expanding both globally and technologically

Authors - Efrain M Ribot and Kelly B Hise
Centers for Disease Control and Prevention, Atlanta, GA, USA
First published: 19 September 2016Full publication history

Turkey Products Recalled for Unidentified Black Substance

A Michigan establishment is recalling 54000 pounds of turkey products after a customer complaint was received for a black substance.  This is a foodservice item so likely this was discovered by a retailer or foodservice operator.  The black substance has not yet been identified.



USDA / FSIS Recall Notice
http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2016/recall-097-2016-release
Michigan Turkey Producers Recalls Turkey Products Due To Possible Foreign Matter Contamination
Class I Recall 097-2016
Health Risk: High Oct 15, 2016

Popcorn Chicken Recalled Because of Foreign Material

Tyson Foods New Holland, PA facility is recalling popcorn chicken nuggets packed due plastic pieces.  According to the report - "The problem was discovered when the establishment received a consumer complaint from a school regarding foreign material, specifically hard plastic, found inside a bag of Tyson brand whole grain popcorn chicken product."

USDA News Release
http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2016/recall-096-2016-release
Tyson Foods Recalls Frozen Popcorn Chicken Products Due To Possible Foreign Matter Contamination
Class I Recall 096-2016
Health Risk: High Oct 15, 2016

Friday, October 14, 2016

Venture Capitalist Start-Up, Soylent, Recalls Meal Replacement Due to Illnesses

A venture capitalist start-up nutrition company, Soylent, is recalling their nutrition snack bar after complaints of vomiting, diarrhea, and nausea.

First, who is buying this stuff?  One look at the website and it looks like something a bunch of computer hipsters came up with.  With all these real food companies with flat or decling sales, I am not sure why people feel that a bunch of techno-geeks can make a better product.

Second, the name....didn't they see the movie?  Yeah, Soylent Green...that was a meal replacement too.  But we all know what that was.  And in case you don't, we'll let Charlton Heston tell you: https://www.youtube.com/watch?v=9IKVj4l5GU4


LA Times
http://www.latimes.com/business/technology/
Soylent stops selling nutrition bars after customers report diarrhea, other illnesses
by Paresh Dave
October 12, 2016

Meal replacement start-up Soylent halted sales of its new nutrition snack bar Wednesday and advised customers to discard any in their possession.

Michigan Cheese Company Recalls Cheese Due to Supplier Listeria Issues

 A Michigan company, Kuster's is recalling its institutional sized shredded, sliced and cubed cheese after the company was notified by their supplier, Farm Country Cheese, that there is the potential for Listeria contamination.
 
Farm County Cheese is no large industrial processor, quite the opposite.  From the Farm County Cheese website:
Tradition ~ Heritage ~ Community

For over 25 years, Farm Country Cheese House has worked in partnership with our local Amish community to create fresh, antibiotic-free, artisanal cheeses. Located in Lakeview, Michigan (northeast of Grand Rapids), we are proud of the “family” of Amish farmers and workers who make up the majority of our staff. Our culture is supportive and kind, and we work together to bring the highest-quality and freshest cheese to you, our consumer.

Our cheeses are pure, simple, and clean. We use milk made by cows on our local Amish dairy farms, and follow Amish traditions and practices. Because the health and comfort of the cows is a top priority, the small dairy farms that we work with raise herds of only 4 to 20 cows, where each cow is hand-milked twice daily. In the operation of our equipment and business, we use minimal amounts of electricity, which is supplied to us by an electric cooperative.
Sounds great, but if this is your supplier, are they controlling for Listeria?  How about a FSMA required Supplier Preventive Control.
 
FDA Recall Notice
Kuster's, Inc. Voluntarily Recalls Product Because Of Possible Health Risk
For Immediate Release
October 12, 2016

Warning Letter Issued to Company for Not Verifying That Corrective Measures Worked

FDA issued a Warning Letter to a California company after that company did not adequately respond to a 483 Report issued during inspection.  The inspection was performed after the company's product was involved in a Salmonella outbreak.  During the inspection, Salmonella was found during FDA environmental sampling and this was included as a finding on the FDA 483 that was issued.  From the FDA website: "An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C)".  The company is then expected to send a written response to the 483 report.  "Companies are encouraged to respond to the FDA Form 483 in writing with their corrective action plan and then implement that corrective action plan expeditiously."
When a company does not properly respond and/or take appropriate corrective action, FDA will issue a Warning Letter.  From the FDA website: "When it is consistent with the public protection responsibilities of the agency and depending on the nature of the violation, it is the Food and Drug Administration's (FDA's) practice to give individuals and firms an opportunity to take voluntary and prompt corrective action before it initiates an enforcement action. Warning Letters are issued to achieve voluntary compliance and to establish prior notice. (Prior notice is discussed in Chapter 10.) The use of Warning Letters and the prior notice policy are based on the expectation that most individuals and firms will voluntarily comply with the law."

As we have seen in a number of other recently issued Warning Letters (Examples 1, 2, 3, 4) companies are failing to properly address the elements of corrective action.  As with this case, measures are taken, but the company fails to verify that those measures have worked.  From this report: "However, you did not provide us with documentation demonstrating the effectiveness of these changes and any other changes you have made to prevent a reoccurrence of an outbreak."   The verification that corrective measures worked is especially important after the company has had an outbreak and/or was found to have pathogen contamination issues.

 FDA Warning Letter
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm524491.htm
WARNING LETTER
 October 7, 2016