Jury Verdict of 7.55 Million Awarded Against Pumpkin Farm After Child Infected with E. coli

A jury awarded 7.55 million dollar verdict to a child who contracted an E.coli O57 infection that led to HUS (hemolytic uremic syndrome) after visiting a MN farm / pumpkin stand in 2013.

From the news release:

"Dehn’s Pumpkins offers a Halloween attraction that is open to the public every year. In 2013, children were allowed to pet and feed cows that are raised on the property. Testimony at trial proved that on the day the child visited the facility, manure, contaminated bedding, and hay were in the enclosure where the cows were kept. Manure was also on the cows’ hides and hooves, and on the gate that separated the children from the animals."
"There were no handwashing stations, warning signs, or any other measures to prevent transmission of disease at the facility. The business owners claimed they had no idea that children could get sick by touching animals. They did not take preventive measures because they didn’t think the setting was a risk to children."
"The 10 year old girl went to the farm with her parents on the weekend of October 12 – 13, 2013 and got sick a few days later. At least seven people were sickened in that particular E. coli O157:H7 outbreak. The Minnesota Department of Health linked the illnesses to cows that were in the animal attraction at the farm. At least three of the case patients had bacterial isolates with the same DNA fingerprint."

While this is awful for the child, you have to think every a farm operation that has a petting area for farm animals is reading this and asking themselves if it is worth the risk.  At a minimum, it is important to have handwashing signage and an areas to wash hands.

Food Poisoning Bulletin
https://foodpoisoningbulletin.com/2016/pritzker-hageman-wins-7-55-million-verdict-for-child-with-hus-e-coli/
Pritzker Hageman Wins $7.55 Million Verdict for Child with HUS E. coli
November 23, 2016 by News Desk Leave a Comment

Man Arrested After IntentionallyContaminating Salad Bar

A California man was arrested after he intentionally contaminated a salad bar with an unknown substance.  A twelve year old reported being sick after eating at the establishment.

ABC10 , KXTV Lake Tahoe, CA
http://www.abc10.com/news/local/california/man-arrested-for-poisoning-food-in-lake-tahoe/355219270
Man arrested for poisoning food in Lake Tahoe
11:17 PM. PST November 22, 2016

Thanksgiving Charity Event Results in Foodborne Illness Including 3 Deaths

An apparent foodborne illness outbreak related to a Thanksgiving charity event has impacted 17 people and caused 3 deaths and 1 hospitalization.  Many of these people were in the "high risk' category.  While the cause and the source have not yet been identified (although this may be similar), here is what is known:

• Food was prepared at the facility as well as brought from volunteers homes.  Food prepared at the facility included mashed potatoes, stuffing, gravy, heated up creame corn and green beans.  Items made at volunteer's homes included turkeys, hams, and sweet potatoes.
• Pies purchased from local stores.
• Death ranges: Teens to 70’s
• Says patients came from at least 3 facilities
• Symptoms – nausea, diarrhea, vomiting
• People who became ill got sick within 24-hours of consuming the food
• In California, non-profits can run this type of event for members and guests without a permit. 

In Pennsylvania, a soup kitchen  operation would also be exempt from requiring a license, but the American Legion where the foods was provided would probably have one.  If the food was being sold rather than given away as a charity event, then a license would probably be required.  The additional concern would be the products that were made at home.  A licenced facility would not be allowed to serve these types of foods (TCS) made at home.

Regardless, it is an important to train volunteers on food safety, such as Cooking for Crowds.  Cases like this are reminders of that.


East Bay Times
http://www.eastbaytimes.com/2016/11/29/antioch-elder-victims-of-suspected-food-borne-illness-came-from-separate-care-homes/
News
Antioch food-related deaths: More cases of sickened patrons
By Aaron Davis | aarondavis@bayareanewsgroup.com, Matthias Gafni | mgafni@bayareanewsgroup.com and Sam Richards | srichards@bayareanewsgroup.com
PUBLISHED: November 29, 2016 at 12:42 pm | UPDATED: November 29, 2016 at 8:46 pm

Salad Leaf Juice Enhances the Growth, Attachment, and Virulence of Salmonella

A study recently published in Applied and Environmental Microbiology shows that juices from leafy greens can enhance the growth, colonization, and virulence of Salmonella.  When chopping salad leaves, juices will be released from the cut surface.  The metabolites in these juices will enhance the growth of Salmonella as well as enhance its ability to form biofilms attaching to the leaf and bag surfaces.  There was even increased virulence.

While no one should avoid eating leafy greens, this study reinforces the need for good practices when growing, harvesting, processing and storing bagged chopped leafy greens.  Contamination on leafy greens is generally low, however, if improperly processed or handled, even a few inconsequential organisms can increase to the point where it becomes a problem.  For storage, bagged chopped salad should always be stored at refrigeration temperatures.

Reuters
http://www.reuters.com/article/us-health-salmonella-bagged-salads-idUSKBN13O2VM
Health News | Wed Nov 30, 2016 | 7:24am EST
Bagged salads may encourage Salmonella growth
By Carolyn Crist

FDA Report on Antibiotic Resistance of Bacterial Pathogens Indicates Improvement

The FDA released its 2014 National Antimicrobial Resistance Monitoring System (NARMS) report, which looks at antimicrobial resistance patterns in bacteria isolated from humans, retail meats, and animals at slaughter. Overall, the news is good, in that there have been decreases in bacterial pathogens with antibiotic resistance, or in other cases, the data has been steady, especially with regard to the medically important antibiotic types.

From the report:

• The prevalence of Salmonella in both retail chicken meat (9.1 percent) and retail ground turkey (5.5 percent) was at its lowest level since retail meat testing began in 2002. The prevalence of Campylobacter in retail chicken meat samples has gradually declined over time to 33 percent, the lowest level since testing began.
• Approximately 80 percent of human Salmonella isolates are not resistant to any of the tested antibiotics. This has remained relatively stable over the past ten years. Resistance for three critically-important drugs (ceftriaxone, azithromycin, and ciprofloxacin) in human non-typhoidal Salmonella isolates remained below 3 percent.
• Ceftriaxone, a third generation antibiotic used to treat infections where there is resistance to other antibiotics, has seen a continued decline in  resistance in non-typhoidal Salmonella with the exception of retail turkey meat isolates, where it rose slightly. In cattle, Salmonella isolates from carcasses collected at processing plants, ceftriaxone resistance reached its lowest level (7.6 percent) since 1999. In 2014, ceftriaxone resistance in human Salmonella Heidelberg isolates was 8.5 percent, down from a peak of 24 percent in 2010.   (But there have been some decreases in susceptibility in cattle and increases in resistance by strains of Campylobacter jejuni.)

FDA News Release
http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm529719.htm
FDA Releases 2014 NARMS Integrated Report; Finds Measurable Improvements in Antimicrobial Resistance Levels

November 18, 2016

GAO Finds FDA Technical Assistance Network (TAN) Response Times Slow

The US Government Accountability Office (GAO) found that FDA's Technical Assistance Network (TAN), a system for answering questions regarding FSMA regulations including the produce rule, has been slow in responding to questions.

From the report:

"We asked representatives from industry associations and other organizations we interviewed about their experiences submitting questions to the TAN. These representatives generally told us that wait times for answers from the TAN can be long, and some had not yet received answers to their questions. For example, representatives from one industry association told us it took 4 months to get an answer through the TAN."

While FDA is working on reducing the response times, there are questions that are not as easy to answer.  In some cases, the rule is still under development or the questions are more complex.

".....according to FDA officials, response times to TAN questions may be longer in some cases because agency guidance on the produce rule and other FSMA rules is still under development, and the agency does not want to provide information through the TAN that might conflict with the subsequent guidance. In addition, officials said that while simpler questions can often be addressed immediately by FDA staff that monitor the TAN, about 95 percent of the questions are more complex. These questions are forwarded to subject matter experts within the agency and, consequently, require more time for a response. According to FDA, median response time for questions forwarded to subject matter experts is 22 business days. FDA officials told us that if a question is still unaddressed after 30 days, FDA will send an automated message saying the agency is working on a response; a second automated message is sent after 60 days if the question is still unresolved."

These rules are new for many including the FDA, and many components of the rule have not yet been worked out for every permutation  So while delays in response times are completely understandable, I think that FDA officials and their surrogates need to acknowledge this when suggesting people go to the TAN for answers.  And considering that FDA technical support staff have a hard time answering these questions, this needs to be taken into account when inspectors are doing facility inspections.

GAO Release
http://www.gao.gov/products/GAO-17-98R
Food Safety:
FDA's Efforts to Evaluate and Respond to Business Concerns Regarding the Produce Rule
GAO-17-98R: Published: Nov 28, 2016. Publicly Released: Nov 28, 2016.

Three Recalls of Cooked Meat Products After Customers Complained of Undercooked Appearance

In the past few weeks, there have been three recalls of cooked meat products after customers/consumers complained that the product appeared to be undercooked.  The recalls were for firms located in OK, GA, and MO.  It is interesting in that these companies must have not been able to demonstrate that the suspect products had been properly cooked, and thus, they felt the need to do a recall.

Of course if the meat had not been fully cooked, there is the potential for pathogens such as Salmonella.


http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2016/recall-115-2016-release
National Steak and Poultry Recalls Food Service Ready-To-Eat Chicken That May Be Undercooked
Class I Recall115-2016
Health Risk: HighNov 23, 2016

Pumpkin Ice Cream Pies Recalled Because Peanut Ingredient Not Listed on Label

A Buffalo NY establishment, Anderson's Frozen Custard, is recalling Pumpkin Ice Cream pies because the product which contains peanuts did not list peanuts on the label.  So it was an undeclared allergen issue.

http://www.fda.gov/Safety/Recalls/ucm530645.htm
Anderson’s Frozen Custard issues Allergy Alert on Undeclared Peanuts in Pumpkin Ice Cream Pies
For Immediate Release
November 22, 2016

A 2015 Thanksgiving Luncheon Becomes Scene for C. perfringens Outbreak - A CDC Report

With Thanksgiving leftovers still in the fridge, it is a good time to review a 2015 outbreak that occurred during a Thanksgiving luncheon.  About 40 people who attended a catered company Thanksgiving lunch became ill with diarrhea and abdominal pain the following day (roughly 13 hours later).  C. perfrignes entrotoxin was found in the patient stool samples and C. perfrigens was isolated from the turkey as well as the patients.

According to the CDC report "The caterer had previously maintained a permitted facility, but reported having prepared the lunch food served at this event in an uninspected, residential kitchen. Turkeys were cooked approximately 10 hours before lunch, placed in warming pans, and plated in individual servings. Food was then delivered by automobile, which required multiple trips. After cooking and during transport, food sat either in warming pans or at ambient temperature for up to 8 hours. No temperature monitoring was conducted after cooking."

C. perfringens toxicoinfection is a foodborne illness caused by ingestion of toxin-producing bacteria where then the organism produces the toxin in the gut.  This type of foodborne illness is often associated with consumption of meat that has been improperly prepared and handled.

So store your leftover turkey at the proper temperatures (either below 40F or hot, above 140F).


Notes from the Field: Clostridium perfringens Gastroenteritis Outbreak Associated with a Catered Lunch — North Carolina, November 2015
Weekly / November 25, 2016 / 65(46);1300–1301

Sabra Hummus Recall Leads to Secondary Recalls

Greencore and Sky Chefs are recalling prepared sandwiches that were made with the recalled Sabra hummus.  Sandwiches were delivered to 7-Eleven stores in various markets including Pittsburgh, PA.

Taylor Farms is recalling various veggie trays and boxes that contain the Sabra humus.

FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm530607.htm
National Recall by Sabra Dipping Company Leads to Secondary Recall of Deli Sandwich in Pittsburg (PA), Cleveland (OH) and Buffalo (NY) Markets
For Immediate Release
November 23, 2016

Sabra Hummus Recalled Due to Listeria Discovery in Processing Facility

Sabra of Colonial Heights, VA is recalling hummus products, about 50 SKUs in all, after finding Listeria monocytogenes in their facility.  The product being recalled is all product manufactured before November 8, 2016 (Coded “Best Before” date up through January 23, 2017).   The statement says that product had not tested positive, but there is probably a concern of where they found it in the facility.

With what appears to be a shelf-life of 75 days, there is probably over 2 months of production potentially in the marketplace or in consumer's refrigerators.  As a ready-to-eat product, there can be significant risk if the organism is present, so it is important to dispose of product.

According to the FDA investigation...."27 swabs of the processing environment that contained Listeria monocytogenes. Analysis by pulse-field gel electrophoresis (PFGE) revealed that one of the strains of Listeria monocytogenes found during the recent inspection matches a strain found in a retail product sample collected in 2015, indicating this strain of Listeria monocytogenes may be persistent in the production environment."

Sabra had another recall in 2015 when a positive product sample was found. Another company recalled hummus product in 2014.  Finding the same Listeria strain in the environment is a concern, and especially the large number of samples.
 
FDA Recall Noticehttp://www.fda.gov/Safety/Recalls/ucm529967.htm
Sabra Dipping Company Issues Voluntary Recall Of Certain Hummus Products Because Of Possible Health Risks
For Immediate Release
November 19, 2016

Worcestershire Sauce With Soy - Lots of BBQ Pork Recalled Due to Missing Allergen on Label

A North Carolina company is recalling over 200,000 lbs of pork BBQ after discovering an allergen mislabeling issue - soy was not declared on the label although it was used in the recipe in the form of
Worcestershire Sauce.  The issue was discovered by FSIS inspection personnel.

Worcestershire sauce contains many different ingredients and those ingredients can differ depending upon the manufacturer.  Normally, it contains anchovies, which is a fish allergen, but not always soy.  In this case, the soy was listed in as part of the flavorings. The Lea & Perrins brand from Heinz, which is considered the authentic Worcestershire Sauce, does not list soy as a component.

USDA 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-108-2016-release
Morty Pride Meats, Inc. Recalls Pork Barbeque Products Due To Misbranding and Undeclared Allergens

Class II Recall 108-2016

Health Risk: Low Nov 17, 2016

FDA Phone Survey Finds that Food Safety Knowledge Among Consumers Still Lacks

 FDA conducted a phone survey of consumers to gain an understanding of food safety knowledge and attitudes.  Phone surveys can be sketchy, so it is always important to review results with some skepticism.  Here are a few of the results that are interesting:

1. While the majority people owned a thermometer, not many people actually used them, especially on products where thermometer use would be most helpful - when cooking hamburgers (only 10%) and cooking chicken (19%).
2. Not everyone washes their hands - 15% surveyed don't when handling raw meats and 25% don't wash their hands before preparing food.
3. But it is interesting that about half the people think that they are more likely to get foodborne illness when eating out rather than in the home. 

Food Safety Survey Shows Consumer Knowledge Up, Still Room to Grow

November 17, 2016

Cheese Company Owner Sentenced 15 Months in Prison for Shipping Listeria Contaminated Cheese

The owner of a cheese company was sentenced to 15months in prison for knowingly shipping Listeria contaminated cheese.  The issue started in 2014 when Virginia regulatory officials found Listeria in the company's cheese products.   This triggered an FDA investigation which found numerous unsanitary conditions and additional products with Listeria.  While the owner agreed to clean his operation and recall product, he still went ahead and shipped product.

WFTV.com
http://www.wftv.com/news/local/florida-man-gets-15-months-for-selling-south-american-cheese-products-tainted-with-listeria/467770021
Florida man gets 15 months for selling South American cheese products tainted with listeria
Updated: Nov 16, 2016 - 11:36 AM

Additional Companies Recall Ice Cream Due to Cookie Dough Pieces with Potential Listeria Contamination

A number of companies are recalling ice cream products after the supplier of cookie dough pieces, Aspen Hills, has had a Listeria contamination issue.  The Listeria issue in the cookie dough pieces supplied by Aspen Hills was first discovered by Blue Bell Ice Cream as part of their intensified Listeria control program back in September.  In this round of recalls, recalled brands include Weight Watchers, Ashby's Sterling, Cedar Crest Specialties and Chocolate Shoppe Ice Cream Company
 
It is hard to determine why there is such a time lapse from the intial Blue Bell Ice Cream recall related to the Aspen Hill cookie dough pieces that occurred in September and these recalls.

FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm529155.htm
Voluntary Recall of Weight Watchers Smart Ones Chocolate Chip Cookie Dough Sundae Due to Possible Health Risks from Cookie Dough Pieces Purchased from a Third Party Supplier
For Immediate Release
November 14, 2016

Grated Cheese Recalled After Sample Tests Positive for Salmonella

 A Brooklyn company, 4C Foods, is recalling grated cheese after FDA product testing found a sample to be positive for Salmonella.  There have not been any reported illnesses.

FoxNews.com

http://www.foxnews.com/health/2016/11/17/4c-foods-corp-recalls-grated-cheeses-over-salmonella-risk.html

4C Foods Corp. recalls grated cheeses over salmonella risk

Published November 17, 2016

Ice Cream Co-Packer Ceases Operations After Listeria Recalls

A California ice cream company, Dr. Bob's, closed it operations after FDA recall notices were issued by companies for which Dr. Bob's copacked.  The initial recall was issued November 4th after FDA found Listeria in the product and in the production facility.

The company, owned by a former dean for the Hospitality Management Program at Cal Poly, is located at a fairground in California.

Inland Valley Daily Bulletin
http://www.dailybulletin.com/business/20161117/dr-bobs-ice-cream-company-closes-after-fda-recalls
Dr. Bob’s ice cream company closes after FDA recalls

Study - TV Cooking Shows Don't Demonstrate Good Food Safety Practices

A newly released study shows that television cooking shows show improper food safety techniques.   “The majority of practices rated were out of compliance or conformance with recommendations in at least 70% of episodes and food safety practices were mentioned in only three episodes,” said lead author Nancy L. Cohen, PhD, RD, LDN, FAND.

This study shows what many food safety experts have been saying for some time....that cooking shows are awful when it comes to food safety.   To be honest, most cooking shows are not really focused on how to cook, but rather on eating food (eating weird foods, finding restaurants, food facts, etc).


Newswise
http://www.newswise.com/articles/view/664417/?sc=dwhn
Television Cooking Shows Overlook Safe Food Handling Practices Many programs miss the opportunity to model proper safety measures, according to a new study published in the Journal of Nutrition Education and Behavior

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.