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FSMA and the Produce Industry


are-you-ready-produceHow did the FSMA started

There were three major events that drove FSMA (Food Safety News).  
  1. In 2006 the large  coli O157:H7outbreak linked to spinach, drove the produce industry to push for regulatory change.
  2. In 2007 the deliberate contamination of wheat gluten with melamine, resulted in dead and sick pets. This event got the attention of the Bush administration due to three factors: It was deliberate, it was in imported food, and it involved China.
  3. In 2008 the salmonella outbreak, traced back to peanut butter paste manufactured by Peanut Corporation of America, killed 9 people and sickened 714 others, some critically, across 46 states. It was the deadliest salmonella outbreak in recent years which resulted in one of the largest food recalls in American history. The company principals got the toughest jail sentences ever.

FSMA : fresh produce safety rules

The focus of the fresh produce regulations is on prevention of microbial contamination of fresh whole produce that may be eaten raw.

Elements of the Rule

The FDA reported that there were 6 key requirements:
  • Agricultural waterNo detectable level of generic  coli would be allowed in water used for hand washing, food contact surface application, ice that is applied directly to produce and for sprout irrigation.
  • Biological soil amendments– dealing with Raw Manure (the number of days needed between the applications of raw manure to the soil and harvesting to minimize the risk of contamination) and compost, by setting microbial limits on detectable amounts of bacteria (includingListeria monocytogenesSalmonella , fecal  coliforms, and E. coli 0157:H7).
  • Domesticated and wild animals in growing areas- Farmers are required to take all measures reasonably necessary to identify and not harvest produce that is likely to be contaminated.
  • Worker training and health and hygiene- Taking measures to prevent contamination of produce and food-contact surfaces by ill or infected persons, using hygienic practices, prevent visitors from contaminating the produce, and training farmer workers on the importance of health and hygiene.
  • Equipment, tools and buildings- establishing rules to prevent these as sources of contamination, and providing measures to prevent contamination.
  • Sprout Rules- since the product is vulnerable to contamination, there are specific rules associated with it. These rules include taking measures to prevent the introduction of dangerous bacteria, testing irrigation water for certain pathogens, testing the growing, harvesting, packing and holding environment for the presence of Listeria species orListeria monocytogenes.

Who Must Comply and When?

The rules apply to producers and packers of raw agricultural products, regardless if they are manufactured domestically or abroad.


Cost of the Farm Rule

The FDA estimates that the annualized average cost per farm of implementing the produce safety rule will be $2,885 for very small farms, $15,265 for small farms, and $28,452 for large farms, which may differ widely within farm size categories depending upon the farm’s current level of compliance. The most likely scenario is that the FDA will pass on many of the implementation costs to state and local governments, who will pass them on to the private sector. Larger enterprises may have a greater capacity to absorb costs, but these costs may be passed on down the supply chain to the final consumers in the form of higher food prices. There is an obvious benefit to these rules: Once these standards are put into action, the incidence of foodborne illness is expected to decrease, as will foodborne outbreaks, and product recalls. 

Compliance challenges

Grower needs to keep basic risk assessment in mind at all times: Training: There should be one trained supervisor who receives specialized food safety training with curriculum that is equivalent to what has been approved by FDA. All employees who handle fruit or a food contact surface need to be trained in personal hygiene. The training must occur annually, and documented. This is in industry that did not have training in the past. Knowing the quality of the water: The water needs to be tested and the question is how many times it needs to be tested. A baseline needs to be established first. Be cautious with the use of manure: The time interval until manure can be used is still under investigation.  The concern about manure is not just of the farms manure, but also of neighboring farms. Minimize wildlife presence: Limit animal intrusion and check the fields before harvestlng. Contact surfaces: Identify all surfaces that the produce touches as it moves from the field (packing containers, sorting tables, conveyor belts, etc.) until it is loaded on a truck. Cleaning and using the appropriate sanitizers and detergents is a key.

Recalls Due to Allergens on the Rise: Why?


Food Allergies on the Rise

Accorallergensding to FARE (Food Allergy Research & Education) there are an estimated 15 million Americans with food allergies.  More that 17 million Europeans have food allergies.  In a study released in by the CDC in 2013, food allergies among children increased by 50% between 1997 1nd 2011. The eight foods (the “big 8”) that cause 90% of all food allergies are milk, eggs, peanuts, tree nuts, soy, wheat, fish and shellfish. In 2004 the FDA enacted  the Food Allergen Labeling and Consumer Protection Act (FALCPA), requiring that foods are labeled to identify the 8 major allergens.

Recalls on the Rise

  recall-3-month FDA food recall events due to the “Big 8” allergens have steadily increased between 2006 and 2012. The major allergens triggered 34% of all FDA food recalls in 2014 and were the leading reason for recalls of FDA-regulated food products during the first half of 2015. In the last 3 months undeclared allergens accounted of 26% of the FDA recalls. For USDA the leading reasons for the nearly 150 FSIS recalls in 2015 were due to undeclared allergens (40%), followed by microbial contaminants (15%), mislabeling (10%) and foreign matter (8%). FDA recalls due to undeclared allergens accounted for around 46% of all recalls. While microbial recalls accounted for approximately 45% of the recalls.


October 2016 Recalls

The latest recalls reported by FDA and USDA due to undeclared allergen are:  


FDA announces that McCormick is initiating a voluntary class I recall of 24 oz. Club Size McCormick® Original Taco Seasoning Mix. A number of dairy free Original Taco Seasoning Mix 24 oz. bottles were incorrectly filled with Original Taco Seasoning containing whey. To date the company received one notice of allergic reaction related to the product.

Kraft Heinz

The USDA announced that Kraft Heinz Company recalled around 959 pounds of ready-to-eat “Lunchables Ham and American Cracker Stackers” packaged lunch products due to misbranding and undeclared allergens . The product contains wheat and soy, known allergens, which are not declared on the product label. There have been no confirmed reports of adverse reactions due to consumption of this product

Brownwood Farms

The FDA announced that Brownwood Farms is recalling approximately 260,000 total units of Cherry butter, Cherry raspberry preserve, Michigan Cherry preserve, Pear cinnamon preserve, Strawberry perverse, etc., because they contain undeclared milk. The affected products were distributed across the United States through distributors, retailers and on-line sales from the Brownwood Farms website. No illnesses have been reported to date.  

St. Clair Foods

The USDA announced that St. Clair Foods is recalling approximately 26,800 pounds of chicken and dumplings due to misbranding and an undeclared allergen. The products contain milk, a known allergen, which was not declared on the product label. These items were shipped to food service warehouses and distributed for institutional use in Alabama, Arkansas, Kentucky, Mississippi, Tennessee, and Texas. There have been no confirmed reports of injury, illness, or adverse reactions due to consumption of these products. 

Food Allergen Labeling and Consumer Protection Act (FALCPA)

This act took effect January 1, 2006, and mandates that the food labels declare if they contain the major food allergens. Allergens must be listed on the label if they are present in any amount, even in colors, flavors, or spice blends, and specific nut (e.g., almond, walnut, and cashew) or seafood (e.g., tuna, salmon, shrimp, and lobster).  Most recalls are due to mislabeling of products, by adding the wrong label to a similar product. This is mainly due to improper or ineffective good manufacturing (GMP) practices. The recall data suggest that food allergen recalls can be reduced through improved industry awareness and simple changes in the packaging.

Why food recalls continue to happen

It might be that the increase in regulation is one of the reasons for the increase in recalls, due to increase in scrutiny and enforcement. The FDA now prepares new allergen guidelines and evaluates allergen controls mandated by the Food Safety Modernization Act (FSMA). Tightened standards enforced by the FDA and FSIS have most likely led to the significant increase of product recalls. The agencies had put an increased emphasis on food allergens by applying direct inspectors to review product formulations and a label related to Allergen Control Plans and by increasing the audit frequency in regard to allergens The requirements for gluten-free labeling might cause additional recalls. FSIS compliance guidelines from 2014 for allergens, provided recommendations to ensure product labels declare all ingredients and products do not contain undeclared allergens or other undeclared ingredients of public health concern. Food manufacturers need to better understand the current and emerging regulations and be prepared for the increased scrutiny by the regulatory agencies to avoid an increase in recalls. 

Ripple effect of Recalls due to Listeria Contamination

listeria-recallThe potentially contaminated cookie dough with Listeria monocytogenes from Aspen Hills (Garner, IA) has resulted in a number of recalls including Chocolate Shoppe, Blue Bunny, Blue Bell, Nutrisystem , cookie dough bars, and Publix ice cream. It might cause additional because the cookie dough could be in dozens of secondary products on yet unnamed companies. The recall of Aspen Hills cookie dough went to 27 food manufacturing companies that had received the dough produced from July 15 through Sept. 30.   Aspen Hills spokesman Jon Austin reported that the recall was voluntarily because “the company found lapses in its food safety system such as inadequate documentation and failure to wear proper uniforms- that could allow the product to become contaminated”. As a result 22,000 cases of cookie dough produced during that time frame and now under recall were sold to food manufacturers. “… our lab results for all of our products are negative for (Listeria monocytogenes) and we have no reports of any illness attributable to this product — but we are acting out of an abundance of caution because a thorough review of our manufacturing environment has revealed instances where we may not have met our food safety standards,” Aspen Hills owners said in a prepared statement.  No illnesses have been reported in connection to the recalled ice cream.   As asked in our previous report: Is the increase in Listeria recalls a sign of more problems or a sign of the industry getting better in catching the problems earlier?

Chocolate Shoppe Ice Cream Company

FDA announced announced the recall of Chocolate Shoppe Ice Cream Company Recalls Select Products Containing Chocolate Chip Cookie Dough Pieces due to Listeria. The ice cream products were distributed to the following states AL, AZ, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MI, MN, MO, ND, NE, OH, OK, PA, SC, TX, WA, WI & WV. The ice cream products were distributed to various ice cream shops around the country, online outlets and limited grocery stores. No illnesses have been reported to date that we are aware of.   Chocolate Shoppe Ice Cream Company, Inc. of Madison, WI is recalling select ice cream products, because they were made with a chocolate chip cookie dough ingredient supplied by Aspen Hills, Inc., which has the potential to be contaminated with Listeria monocytogenes.  

Blue Bunny ice cream snickerdoodle cookie dough

FDA reports that Wells Enterprises, Inc. is voluntarily recalling two lots of 46-ounce containers of Blue Bunny Hoppin’ Holidoodle ice cream sold at retail outlets, because they contain snickerdoodle cookie dough pieces recalled by the supplier, Aspen Hills, due to potential contamination with Listeria monocytogenes. The product was distributed in six states: Nebraska, Oklahoma, Kansas, Missouri, Arizona and Texas. Wells has received no reports of illness attributable to this product. No other Blue Bunny product is included in this recall.  

Blue Bell Ice Cream

Blue Bell Creameries is expanding its recent recall to all of its ice cream products containing cookie dough. The company said while its new test-and-hold program hasn’t detected any contamination concerns, it initiated the expanded recall after Aspen Hills provided additional information on the impacted products.   Blue Bell’s latest action expands a Sept. 21 voluntary recall of two flavors, Chocolate Chip Cookie Dough and Cookie Two Step ice creams, in 10 states, to one that now encompasses five flavors in 16 states. Blue Bell said it is working in conjunction with the U.S. Food and Drug Administration on the recall.   The products were produced from Feb. 2, 2016, through Sept. 7, 2016, and distributed in Alabama, Arkansas, Florida, Georgia, Kansas, Kentucky, Louisiana, Mississippi, Missouri, New Mexico, North Carolina, Oklahoma, South Carolina, Tennessee, Texas and Virginia.  

Nutrisystem , Cookie Dough Bars

according to FDA Nutrisystem, Inc., is voluntarily recalling the Nutricrush Chocolate Chip Cookie Dough bar, manufactured by Noble Foods, Inc. This bar contains a chocolate chip cookie dough ingredient supplied by Aspen Hills, which advised that its ingredient might potentially contain Listeria monocytogenes.   The product had very limited distribution of 1 lot/455 cases to ShopRite and Hannaford stores in Connecticut, Delaware, Massachusetts, Maryland, Maine, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Virginia, Vermont, and online through and  No illnesses have been reported.  

Publix Premium Chocolate Chip Cookie Dough Ice Cream

After being notified by Aspen Hills, the supplier cookie dough pieces used as an ingredient in the Publix Chocolate Cookie Dough Ice Cream, of the potential of Listeria monocytogenes contamination, Publix recalled the products.   The ice cream was sold at Publix stores in Florida, Georgia, Alabama, South Carolina, Tennessee and North Carolina with a UPC of 000-41415-03843, and a sell by date of May 27 2017, which is printed on the bottom of the half gallon container.   “As part of our commitment to food safety, potentially impacted product has been removed from all store shelves,” said Maria Brous, Publix media and community relations director. “To date, there have been no reported cases of illness.  

Additional Listeria Recalls

Listeria in Nestle Drum Stick Ice Cream

drumstick_recallNestlé USA, Inc. initiated a voluntary recall of its Nestlé Drumstick Club 16 count Variety Pack and 24 count Vanilla Pack (with cones marked for easy individual sale) due to a possible Listeria monocytogenes contamination. The two pack sizes contain 4.6 fl.oz. cones and were manufactured in Bakersfield, Calif. and distributed nationally. No other production codes, sizes or varieties of Nestlé Drumstick products are affected by this recall.   The company received positive test results for Listeria monocytogenes (LM) from equipment contact surfaces from a location on the production line where these products are made. There have been no positive test results for LM present in the Drumstick cones themselves. The products impacted by the voluntary recall were put into distribution inadvertently.   No illnesses have been reported to date; the company is initiating this recall as a precautionary action to avoid any potential for consumer illness.  

Kuster’s Cheese

Kuster’s, Inc. is voluntarily recalling 14,238 pounds of its shredded, sliced and cubed cheese out of an abundance of caution.  Kuster’s, Inc., was notified by its supplier, Farm Country Cheese, Lakeview, MI, that the cheese has the potential to be contaminated with Listeria monocytogenes.   “The recall was the result of confirmation from the cheese manufacturer of a possible contamination of the product received,” according to the recall notice. Kuster’s, Inc. is complying with this recall and recalling any product that may have been processed on its manufacturing equipment after the cheese in question was processed. The shredded cheese was distributed in Michigan, Indiana, Illinois, Ohio and Pennsylvania.   Products included in this voluntary recall are: sharp white cheddar, mozzarella/muenster/provolone, Monterey Jack, pepper jack,four blend, three blend; pepper jack cubes; and co/jack slices. Product dates can be found in the bottom center of the label. No illnesses had been reported in connection with the recalled cheese as of the posting of the recall notice.  

Daily’s Premium Meats Bacon Products

USDA announced that Daily’s Premium Meats, is recalling approximately 170 pounds of ready-to-eat bacon products that may be adulterated with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced.   The “Regular Ends Precooked Bacon” items were produced on September 22, 2016is the subject of this recall. 17 CASES of 2-5 lbs.  Containing “48108 REGULAR ENDS PRECOOKED BACON NET WT. 10 lbs. 2/5 lbs.” with a packaging date of “9/22/16” and use by date of “6/19/17.   The problem was discovered 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.

The role of gut bacteria on health and diseases

The human ggutmicrobiota2astrointestinal tract contains over 1,000 different types of bacteria. The role of the gut bacteria (microbiota) on health and disease is a subject of extensive research in recent years. As a result, our knowledge and understanding of their impact is rapidly growing.
The articles “Role of the gut microbiota in health and chronic gastrointestinal disease: understanding a hidden metabolic organ” and “Rapidly expanding knowledge on the role of the gut microbiome in health and disease” discuss the impact of gut microbiota on Irritable bowel syndrome, inflammatory bowel disease, colorectal cancer, obesity and type 2 diabetes.  
Prebiotics (nutritional compounds used to promote the growth of beneficial bacteria and thus have the potential to improve GI health, such as non-digestible carbohydrates such as inulin and fructo-oligosaccharides which can selectively promote the growth and activity of beneficial bacteria in the gut) and probiotics (beneficiary cultures to restore the gut microbiota, found in a variety of foods and dietary supplements, and include the strains lactobacilli and bifidobacteria) are becoming increasingly popular. Both are extensively used as food additives.
A study by Researchers from the University of Louisville confirms gut bacteria play a role in the development of neurodegenerative diseases. Neurodegenerative diseases such as Parkinson’s disease, amyotropic lateral sclerosis, and Alzheimer’s disease are characterized by misfolded proteins and inflammation of the brain.   
An article in Nature communication describes an in vitro model to study the gastrointestinal human–microbe interface. The model includes co-culture of human and microbial cells under conditions representative of the gastrointestinal human–microbe interface. The ability to co-culture human and microbial cells in a controlled manner and perform systematic investigations of such co-cultures opens up numerous avenues for basic and applied research in the context of the human microbiome in the future.
More accurately explanation of the relationships between the gut microbiota and several intestinal pathologies is needed. Understanding the part that microbial populations play in GI disease is fundamental to the ultimate development of appropriate therapeutic approaches. The concept of altering our gut community by microbial intervention in an effort to improve GI health is currently a topic that is receiving considerable interest. The targeting of specific components of the gut microbiome will potentially allow the removal of the harmful organisms and enrich the beneficial microbes that contribute to our health. Increased knowledge in this area can be used to improve human health.