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

http://www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm518775.htm

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.

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

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.

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

 http://www.fda.gov/food/RecallsOutbreaksEmergencies/Outbreaks/ucm518775.htm

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.

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

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

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

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

http://www.fda.gov/Safety/Recalls/ucm525054.htm

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
 

Colors and Printing on Food Packaging

An article in Food Safety Magazine, Colorants in Food Packaging: FDA Safety Requirements (Oct/Nov 2016), reviews the FDA safety requirements of food packaging colors and printing.   In summary, "The rules of thumb for determining the regulatory status of a pigment or dye are as follows: A substance that colors the food, even if it is in a packaging material, is a color additive and may be used only as permitted by an applicable FDA color additive regulation. Substances that color only a packaging material, and do not impart color to the food, are regulated as food additives if components of the substance are found to migrate into food. No premarket clearance by FDA is required, however, if the substance is not reasonably expected to become a component of food, is GRAS or is included on the list of “pre-1958 colorants.”

There are always questions about printing on the primary packaging and what is the concern.  So, the primary question is whether that printing material can migrate to the food.  If it can, then that color needs to be approved for use.

Blue Bell Expands Recall After Supplier Expands Recall of Cookie Dough, Blue Bunny and Others Also Issues Recalls

Blue Bell is expanding its recall of cookie dough ice cream after its ingredient supplier of cookie dough expanded its recall for Listeria.   Just over two weeks ago, Blue Bell issued a recall for 5 lot codes of two flavors that contained the cookie dough ingredient.  That recall now includes all product made from February 2, 2016 through September 7, 2016.
Along with this, Blue Bunny is recalling its Hoppin' Hollidoodle ice cream because it also contains the suspect cookie dough.

 We have come to expect expansions of recalls when there is Listeria contamination issues.  These recalls get expanded because the facility finds that there are underlying issues which indicate that Listeria could have been around for some time in the facility.

Other recalls affected by this supplier of cookie dough.

Chocolate Shoppe Ice Cream Company Recalls Select Products Containing Chocolate Chip Cookie Dough Pieces Purchased From Outside Supplier Aspen Hills Due To Possible Health Risk

Publix Recalls Publix Premium Chocolate Chip Cookie Dough Ice Cream Due To Possible Listeria monocytogenes Contamination From Aspen Hills, Inc. Cookie Dough Pieces

Nutrisystem Retail Division Voluntarily Recalls One Product Containing Chocolate Cookie Dough Pieces Purchased From Third Party Supplier Due To A Possible Health Risk
FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm524749.htm
Outside Supplier Aspen Hills Expands Cookie Dough Recall; Blue Bell Recalls All Products Made With Aspen Hills Cookie Dough Due To Potential Health Risk
For Immediate Release
October 10, 2016

NY Taco Chain Linked to Over 150 Cases of Foodborne Illness

A NY taco chain is being linked to over 150 people becoming ill.  Cases have occurred in two counties  and it appears that a 'handful' of the Mighty Taco locations may be involved.  The symptoms are nausea and vomiting.  After removing suspect food, including refried beans, the number of cases looks to be subsiding.

An update was provided on 10/20/16.

WKBW News
http://www.wkbw.com/news/142-reported-illnesses-after-mighty-tacos-refried-beans-caused-concern-in-erie-county
142 reported illnesses after Mighty Taco's refried beans caused concern in Erie County

Cesar Brand of Pet Food Recalled for Small Plastic Pieces

Mars is recalling a limited number of Cesar Brand Filet Mignon Flavor wet dog food products due to small pieces of plastic that may be a potential choking risk.  According to the release, the small pieces of plastic entered the food during the production process.

Mars Corporate News Release
https://www.cesar.com/notice#

Micro Greens Recalled in CO for Salmonella Positive Sample

A Colorado company is recalling Organic Micro Greens sold at Whole Foods.  The recall was issued after FDA tested and found Salmonella is a sample of the product.

So what are microgreens?  They are very young plants of various vegetables, such as kale, spinach, beets, lettuce, etc, that are 7 to 14 days after germination.  Similar to bean sprouts, although sprouts are harvested 2 days after germination, so microgreens in comparison will have leaves and roots whereas sprouts will not.   However like sprouts, micro greens can be a higher risk for organisms like Salmonella.  The reason is that the conditions for growth of the micro greens will support organisms such as Salmonella.

FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm524638.htm
Osage Gardens Inc. Recalls Osage Gardens Organic 2oz Micro Greens Because of Possible Health Risk
For Immediate Release
October 7, 2016

Chicken Salad Linked to Salmonella Outbreak in WA

Costco Chicken Salad, purchased on August 26, August 31 and September 2, 2016 in one Washington state Costco store may be linked to a Salmonella outbreak.  While the product is past the expiration date, concern would be for anyone who may have frozen the product and still have it in the freezer.

The concern still has to be how the product became contaminated.  Was the chicken undercooked?  Or was it a case of cross contamination after cooking?


FSIS Recall Notice
http://www.fsis.usda.gov/wps/portal/fsis/newsroom/news-releases-statements-transcripts/news-release-archives-by-year/archive/2016/pha-100916
FSIS Issues Public Health Alert for Chicken Product Due to Possible Salmonella Contamination

Limited Amount of Lunchables Recalled Due to Allergen Mislabeling

Kraft Heinz is recalling a limited amount of Lunchables product due to a mismatched label that resulted in allergens not being declared.  According to the release  "Lunchables Ham and American Cracker Stackers” products were incorrectly labeled with the back label for a “Nacho Lunchable” product. The back label contains the product ingredient statements and as such, the “Lunchables Ham and American Cracker Stackers” products that were mislabeled do not declare wheat and soy on the label.

FSIS Recall Notice
http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2016/recall-093-2016-release
Kraft Heinz Recalls Ready-To-Eat Lunchables Ham and American Cracker Stackers Product Due to Misbranding and Undeclared Allergens
Class I Recall 093-2016
Health Risk: High Oct 9, 2016

Drumstick Sundae Cones Recalled Due to Positive LM Product Contact Surface

Nestle is recalling its ice cream treat, Drumstick cones, from Best before June 2, 2017 to June 19, 2017 after testing found the food contact surface positive for Listeria monocytogenes.  No product had tested positive.  No illnesses have been reported.

In the notice, it states "The products impacted by the voluntary recall were put into distribution inadvertently."  This may suggest that the product was on a test-and-hold and was released prior to the finalized test results.   Even though the positive was found on a surface that is classified as product contact, there is a risk that the product may have been contaminated as well, at least one has to consider it.


FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm524634.htm
Nestlé USA Initiates Voluntary Recall Of Nestlé® Drumstick® Club 16 Count Variety and 24 Count Vanilla Pack Due to Possible Health Risk
For Immediate Release
October 7, 2016

Vermont Drops Enforcement of GMO Labeling

As part of an agreement, Vermont announced that it would not enforce its law requiring the mandatory labeling of GMO foods. Put best by Pamela G. Bailey, president of GMA, the group who fought the law, “.......the Vermont law opens the door to states creating mandatory labeling requirements based on pseudo-science and web-fed hysteria......If this law is allowed to go into effect, it will disrupt food supply chains, confuse consumers and lead to higher food costs.”

Agricultural Law Weekly Review—September 8, 2016
http://www.pennstateaglaw.com/2016/09/agricultural-law-weekly-reviewseptember_8.html
GMO Labeling: GMA and Vermont Agree to Voluntarily Dismiss Litigation
Written by M. Sean High – Staff Attorney

On September 1, 2016, the United States District Court for the District of Vermont signed an order of voluntary dismissal in the state GMO labeling case Grocery Manufacturers Association v. Sorrell (Case No. 5:14-cv-117-cr, Document 161). According to the order, the parties agreed to voluntarily dismiss the action without prejudice because: (1) on July 29, 2016, President Obama signed into law S.764 which established a “National Bioengineered Food Disclosure Standard;” (2) on August 1, 2016, USDA stated that S.764 preempted states from requiring the labeling of any genetically engineered food or seed in interstate commerce; and (3) on August 2, 2016, Vermont’s Attorney General (Sorrell) announced that the state would no longer enforce Vermont Act 120 which required the labeling of food produced with genetic engineering.

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.)

RTE Bacon Recalled After Testing Finds Listeria

A Utah establishment is recalling ready-to-eat bacon "during the company’s routine internal third party testing when a product sample collected tested positive for Listeria monocytogenes (Lm). There have been no confirmed reports of illness or adverse reactions due to consumption of these products."
 
USDA News Release
http://www.fsis.usda.gov/wps/wcm/connect/FSIS-Content/internet/main/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2016/recall-092-2016-release
Daily's Premium Meats, LLC Recalls Bacon Products Due to Possible Listeria Adulteration

Researchers Find Low Income Individuals Willing to Forgo Produce

In a study published in Nutrition Today, researchers investigated opinions of  low-income individuals about organic versus conventional fruits and vegetables and found that their choices are impacted by the amount of messaging they are receiving, such as EWG's Dirty Dozen.  These people felt that organic was better, but because of the cost, were more willing to forgo fruits and vegetables because of cost even though there were lower cost conventionally grown produce.

This is a topic that has been addressed from a health standpoint,  where organic was found to be no more nutritious than conventional, and more importantly from a safety standpoint, whether biological contaminates or those that can lead to cancer.  USDA testing has continually shown that pesticide levels in produce are within established limits.

The issue is that many are missing the health benefits of having produce in their diet for the sake of avoiding some infinitesimal risk.

Nutrition Today
http://journals.lww.com/nutritiontodayonline/Fulltext/2016/09000/Low_Income_Shoppers_and_Fruit_and_Vegetables__What.6.aspx
Low-Income Shoppers and Fruit and Vegetables: What Do They Think?
Huang, Yancui MS; Edirisinghe, Indika PhD; Burton-Freeman, Britt M. PhD, MS
Abstract

Eggs from Small Producer Recalled After Link to Salmonella Infections

Good Earth Egg company is issuing a recall of shell eggs after they were linked to a Salmonella outbreak.  In this outbreak, 8 individuals have become infected with Salmonella Oranienburg 

 

 Good Earth had also issued a recall in January of this year, again for Salmonella.   A warning letter issued by FDA in February indicates that the company did not have a Salmonella control program in place and faced sanitary issues including rodent control.

 

If Salmonella is not controlled within the flocks and the facility, the eggs will have Salmonella. It would be fine if eggs were handled and cooked by the consumers, but consumer don't.  Eggs are often served undercooked such as sunny side up.  They are not handled in a way that protects against cross contamination.  As studies have shown, eggs from small producers are more likely to have Salmonella present.

 

 

CDC Outbreak

http://www.cdc.gov/salmonella/Oranienburg-10-16/index.html

Multistate Outbreak of Salmonella Oranienburg Infections Linked to Shell Eggs

Posted October 3, 2016 5:45 PM ET

  

At A Glance

Case Count: 8  (http://www.cdc.gov/salmonella/oranienburg-10-16/epi.html)

States: 3  (http://www.cdc.gov/salmonella/oranienburg-10-16/map.html)

Deaths: 0

Hospitalizations: 2

Recall: No

Highlights

Read the Advice to Consumers and Retailers >>(http://www.cdc.gov/salmonella/oranienburg-10-16/advice.html)

CDC Finalizes Investigation on E. coli (STEC O121) in Flour

CDC issued the final report on the E. coli STEC outbreak associated with flour.  The recall of the product was issued in May and then expanded in July.   While CDC expects more cases over time (as people may still have and use recalled flour), there have been 63 cases to date with 17 hospitalizations with one case of HUS (hemolytic uremic syndrome).

 

 Dough is meant for cooking, not eating raw or playing with.  Unfortunately, there are those out there who will continue to eat raw dough (you know who you are).  But please don't pass this habit onto the youth.  One, they are at higher risk.  Two, if you are willing to get sick, then fine, but let's not make a new generation of raw dough eaters.  

  

CDC Outbreak Update

https://www.cdc.gov/ecoli/2016/o121-06-16/index.html

Multistate Outbreak of Shiga toxin-producing Escherichia coli Infections Linked to Flour (Final Update)

Posted September 29, 2016 12:45PM EST

Onion Rings Recalled Due to Allergen Mislabeling - Reason for Implementing Preventive Controls

McCain Foods issued a recall notice for Onion Rings and then reissued the notice to expand the recall to additional labels.  The pre-labeled packaging did not list milk on the label although it was included in the formulation.

This is the type of recall that the Preventive Controls rule was designed to help prevent.  By having a formalized check of the labels at the receipt of those labels and then again at the time of packaging would have provided 2 opportunities to compare the label to the formulation.  Of course, it is important to have the sub-ingredients listed, in this case, they are probably purchasing the breader / batter that will be used to coat the onion rings.

Instituting such a check is not overly difficult. It just takes a few minutes to compare the label to the formula.   However, the cost of recall resulting from non-compliance can run into the millions of dollars.

FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm522476.htm
McCain Foods USA, Inc. Announces a Product Recall Impacting Frozen Onion Rings Sold and Distributed Under Four Separate Private Label Retail Brands
For Immediate Release
September 23, 2016

Enforcement of Rule for Ground Meat Logs Starts Oct. 1

 On October 1, USDA FSIS will begin enforcement of the rule requiring establishments and retail stores that grind raw beef for sale in commerce to maintain a log of the lot information on which raw materials were used to produce that ground meat.  Specifically:

1. The establishment numbers of the establishments supplying the materials used to prepare each lot of raw ground beef product; 
2. All supplier lot numbers and production dates; 
3. The names of the supplied materials, including beef components and any materials carried over from one production lot to the next; 
4. The date and time each lot of raw ground beef product is produced, and 
5. The date and time when grinding equipment and other related food-contact surfaces are cleaned and sanitized. 

  

FSIS Notice

http://www.fsis.usda.gov/wps/wcm/connect/931c84b3-cc2e-4a10-9108-806bfab661b0/75-16.pdf?MOD=AJPERES

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE WASHINGTON, DC FSIS NOTICE 75-16 9/28/16 

NOTE: DO NOT IMPLEMENT THIS NOTICE UNTIL OCTOBER 1, 2016. 

Kids Sick from Poisonous Mushrooms - The Potential Perils of Community Gardens

Seventeen school-aged children became sick after eating poisonous mushrooms.  According to the report, "...a volunteer thought the mushroom - later identified as green-spored parasol, a common poisonous wild mushroom - was an edible part of the garden. Seventeen students ate it and suffered various symptoms. Several of the students had severe reactions."

Community gardens are great for learning, but it is important to remember that the food safety basics still apply.    And for those that put the effort into planning, growing, and harvesting, effort has to go into training.   While this incident with poisonous mushrooms is probably a worst case scenario (having a truly uninformed volunteer give kids poisonous mushrooms), there are still other areas that need attention, including all the components of GAPs - good agricultural practices to include fertilizing properly, washing hands, washing produce before consumption, using potable water for watering, and cleaning food contact surfaces.  It is too easy to see where people get stupid ideas - fertilizing food with fresh manure (manure needs to be properly composted), watering crops from a pond or a unclean rain bucket (where that water is harboring harmful bacteria), etc.   It must be remembered that many of those visiting or consuming from these gardens are children.  Pre-school aged children, considered 'high risk', are of most concern because their immune systems are still under development.

Unlike a person's home garden, these foods go to a broad group of people, often outside of those people who were involved in growing and harvesting. It is the responsibility of those involved in growing and harvesting to follow practices that will minimize risk.


The Packer
http://www.thepacker.com/news/students-ill-after-eating-mushrooms-community-garden-la
L.A. school district issues safety alert on wild mushrooms after students fall ill
By Ashley Nickle September 26, 2016 | 4:55 pm EDT

Chicken Nuggets Recalled Due to Plastic Pieces

Tyson is recalling 132, 520 pounds of cooked chicken nuggets for plastic pieces.  Product was packed in an institutional 20lb size that was shipped to Pennsylvania and the 5lb retail pack was shipped nationally.

The recall was initiated after consumer complaints were made.  According to the report "the plastic material ranged in size from 21mm in length and 6.5mm in diameter and may have come from a round, hard plastic rod used to connect a plastic transfer belt. The firm said the products pass through a metal detector, but the plastic is not detectable to this technology".
In May, Foster Farms recalled chicken nuggets due to foreign material.  And in March, Purdue recalled chicken nuggets due to plastic pieces.  In 2014, Tyson recalled chicken nuggets due to plastic pieces.  It may make sense for those making chicken nuggets to invest in X-ray technology.

FSIS Recall Notice
http://www.fsis.usda.gov/wps/wcm/connect/931c84b3-cc2e-4a10-9108-806bfab661b0/75-16.pdf?MOD=AJPERES
Tyson Foods Inc. Recalls Chicken Nugget Products Due To Possible Foreign Matter Contamination
Class I Recall 089-2016
Health Risk: High Sep 27, 2016

Ham Products Recalled Due to Foreign Material

A Canadian company is recalling ham products after a complaint was received that there were rubber pieces in the ham.  These restructured hams are fully cooked / ready-to-eat.  The meat items were imported into the US and were sold at Costco and Sam's club

 

FSIS Recall Notice
http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2016/recall-085-2016-release
502 Boundary Blvd. Recalls Black Forest Ham Products Due To Possible Foreign Matter Contamination
Class II Recall 085-2016
Health Risk: Low Sep 21, 2016

Blue Bell Recalls Two Ice Cream Products due to Potential Listeria Contamination

Blue Bell Ice Cream is recalling two flavors of product for potential Listeria contamination.  There have been no illnesses reported.  According to the company's press release, product was shipped to 10 states, primarily in the Southeast US.

Last year, Blue Bell shut down its 3 plants after their ice cream product was linked to a Listeria outbreak where 10 people were infected.  The company reopened the plants with increased controls and under increased government scrutiny.  In January of 2016, the company issued a release that their controls were effective, although they were still finding Listeria in the environment.

In this particular case, it looks as though the supplier of the cookie dough, Aspen Hills, may be at fault.  Blue Bell discovered the issue through testing of incoming products and notified Aspen Hills who then issued a recall.  This recall notice is posted on the Blue Bell website.  Unfortunately, product was released before these test results came to light.  Although Blue Bell states they do test and hold (product is not released before results come back), that test and hold looks to have been focused on finished product testing (and perhaps not ingredient testing?).

Of course this cookie dough is not technically raw.  It is product that is made to resemble raw cookie dough, but is a ready-to-eat product.  Being that it is ready-to-eat, it should be free of pathogens such as Listeria.

KHOU News Release
http://www.khou.com/news/health/blue-bell-issues-recall-for-ice-cream-with-cookie-dough/323180943
Blue Bell recalls ice cream over listeria concerns
KHOU.com Staff , KHOU 11:59 PM. EST September 21, 2016

Goat Cheese Recalled Due to Listeria Positive Sample

 A small Pennsylvania goat cheese manufacturer is recalling goal cheese products after PA Dept of Ag tested and found Listeria in the product.   No illnesses have been reported.


FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm521592.htm
Apple Tree Goat Dairy Recalls Four Goat Cheeses Because of Possible Health Risk
For Immediate Release
September 20, 2016

Eggo Waffles Recalled for Potential Listeria Contamination

Kellogg's is recalling Eggo Waffles after internal testing found a potential for Listeria contamination. While the release did not say exactly where the sample was located, it may have been a positive environmental sample on or near a product contact surface.
FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm521434.htm
Kellogg Company Recalls Limited Number of Kellogg’s® Eggo® Nutri-Grain® Whole Wheat Waffles Due to Potential Health Risk
For Immediate Release
September 19, 2016

First Day of Preventive Controls Compliance - What Do You Need to Know

September 19, 2016 marks the compliance day when larger facilities making human food must meet preventive controls and Current Good Manufacturing Practice requirements (CGMPs) and larger animal food facilities must meet CGMPs.

So what should one expect?  FDA issued two letters today.  To summarize from the many words in those documents:

At this point, the FDA is still learning so "the FDA’s primary focus will continue to be on education, training and technical assistance to help companies comply with the new requirements." 

Does your Food Safety Plan have to be perfect at this point - "Many businesses of that size already have a HACCP (Hazard Analysis and Critical Control Points) program; we don’t expect them to need to make many changes to come into compliance. Aspects of the CGMP and preventive controls rules are similar to HACCP, a food safety system that started with industry."

 But FDA will still evaluate the facility in order to make safe products. "The best thing that people in the food industry can do is take the measures required by the new rules – not just the letter of the law but what it represents in terms of transforming the food safety system. They should look at the big picture, at areas in which they could be vulnerable and proactively take action. Promptly responding to problems, even if they aren’t yet violations, can prevent them from getting to the point at which there is a concern about the safety of the food."
 
"In addition, facilities should set up a thorough system for documenting what they do."

FDA is still learning as well.


FDA News Release
http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm521171.htm
What to Expect Now that the First Big FSMA Compliance Dates Are Here
Questions and Answers with Joann Givens

Backyard Chickens and Eggs - Beware of the Salmonella Risk

In two news stories this week - one on raising chickens at home and the other on eggs from small chicken flocks - there is discussion on the higher risk for Salmonella.

In the Post article, people raising chickens at home threat the chickens more like pets.  Many people will cuddle or kiss baby chicks and nearly half of the patients who contracted Salmonella from the chickens allowed the chickens into the house (and some into the bedroom).

Penn State conducted a large survey looking at the prevalence in Salmonella in eggs which were purchased from farm stands across the state.  These eggs were from small chicken flocks and fall outside of regulations for controlling Salmonella.  The survey found that 2% of the eggs tested were positive for Salmonella.  The contamination was primarily found inside the egg.  For commercial egg producers, this number is less than 0.5%.

Salmonella is a natural contaminate of chickens, and unless carefully controlled, it can be passed to humans through handling of the chickens or through mishandling or undercooking of the eggs.   Commercially, Salmonella is controlled through diet (including probiotics), house maintenance procedures, and Salmonella testing.  With backyard flocks, these controls are normally not in place.  Another risk, not discussed in these articles, is Campylobacter.  This has been shown to have a higher prevalence in small flocks as well.

This is not saying that people should not raise chickens or consume their eggs, but people have to be aware of the risk.  Keep chicken in the coup.  Wash your hands after handling the chicken.  Cook the eggs and the chicken to the proper temperature.  No Rocky breakfast drink with these eggs, not unless you plan your next bout at the American Standard Bowl.

Penn State News
http://news.psu.edu/story/425880/2016/09/14/research/eggs-small-flocks-just-likely-contain-salmonella-enteritidis
Eggs from small flocks more likely to contain Salmonella enteritidis
By Jeff Mulhollem
September 14, 2016

Coliform Positive Sample in Well Water Results in Product Recall

A PA meat establishment is recalling pork products after inspectors found the facility's water test results had been positive for coliform bacteria.  These test results would classify the water as non-potable.

While the risk is probably low to non-existent (the fresh pork itself would have coliforms), the water used to make that product is deemed as non-potable.  While the presence of coliforms in themselves are not a hazard, their presence could indicate that other pathogenic bacteria could be present.  More importantly, their presence could indicate that  a contamination pathway could exist linking the water supply to a contamination source - surface water, septic system, animal waste, etc.

Corrective action needs to be taken immediately upon these types of results. This is normally done by dosing or shocking the well with chlorine. or even better for protecting a business is continuous disinfection.
 
FSIS News Release
http://www.fsis.usda.gov/wps/wcm/connect/FSIS-Content/internet/main/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2016/recall-082-2016-release
Bunge's Meats Recalls Pork Products Formulated With Water That Did Not EPA Meet Drinking Water Standards
Class I Recall 082-2016
Health Risk: High Sep 16, 2016 

FDA Issues Warning Letter to RTE Facility with LM Issues

FDA issued a warning letter to a Saranac Foods for an inspection completed in February.  We have seen a number of similar types of Warning letters issued.  In this one, inspectors found LM in a facility making RTE product, and  then conditions that would support the spread of that organism (issues with hose usage, condensation, and airflow).  While the company did respond, the response was lacking in terms of a 'complete' corrective action.

 

Listeria

FDA found 3 of 89 samples positive for Listeria monocytogenes. all non-contact but in the ready-to-eat pasta and deli salad production room.

1. Floor near food carts and the 2-compartment sink;
2. The floor alongside of the interior legs of stand mixer;
3. An area of the floor under the 1-compartment sink where a leak is present.

Although the company took corrective action, the FDA stated: FDA is unable to evaluate the adequacy of your response because it does not provide specific details of your corrective actions and steps taken to prevent contamination of food. 

  

GMP Issues