State of USDA Organic - Growing Demand, But Beware of Fraud

USDA released summary of Investigation Reports for the USDA Certified Organic program.  While the demand for organic foods is increasing, so do the number of certified organic operations.  As with any financial opportunity, there will be those who take advantage of the situation through fraud, or those who will fail to meet the requirements needed to remain certified.

According to the Organic Trade Association, "Organic sales in the U.S. totaled around $47 billion in 2016, reflecting new sales of almost $3.7 billion from the previous year. Organic food now accounts for more than five percent of total food sales in the U.S. Organic food sales increased by 8.4 percent from last year, blowing past the stagnant 0.6 percent growth rate in the overall food market. Sales of organic non-food products were up 8.8% in 2016. "

To get a sense of the issue, we took summary data from USDA Enforcement Activity Reports  as well as the data posted for fraudulent organic certificates.  While there are those who say the issues involving organic are getting worse, this assertion may or may not be accurate.  It is difficult to tell how fraud and noncompliance are trending because it is difficult to know the reasons for the number of investigations being conducted and whether procedural changes in these investigations has changed over the past years.  But, it is clear that fraud and noncompliance issues do occur regularly.

In comes down to this.  For those purchasing organic, whether to redistribute or to use for processing, it is important to determine that the supplier is compliant and is currently listed in good standing.  This is especially important for imported products where bribes and fraudulent claims may be a bigger issue. 

For consumers, a big issue is someone calling produce organic without the official designation.  And of course there are those that say that USDA Organic is too full of loopholes allowing 'less then true organic' to meet the USDA standard.

Organic labeling fraud is booming
While organic market growth is at a double-digit pace, not all that’s labeled organic is so. Fraud and food safety issues abound.
John Vogel | May 30, 2017

Vaccinated Form of Brucella Causes Illness from Consumption of Raw Milk

While raw milk can be a risk for natural contamination from organisms such as Salmonella and Campylobacter, but there is also a concern from the vaccinated form of Brucella, RB51. RB51 is a weakened strain of Brucella that is given to cows to create immunity. In September, a woman became ill with Brucella after drinking raw milk from a vaccinated cow. "In rare cases, a cow's milk can contain traces of the vaccine. The only way to avoid this risk is by pasteurizing the milk, the CDC says. "

From, "Adverse events in humans associated with accidental exposure to the livestock brucellosis vaccine RB51" (J.Vaccine.2004.02.041)

Brucella spp. are small, non-motile gram-negative coccobacilli known to cause disease in a number of vertebrate species including humans. B. abortus is one of four Brucella species associated with systemic disease in humans. Human brucellosis was once a common public health problem in the United States, but it is now rare with approximately 100 cases reported yearly through national surveillance. Brucellosis in humans is a systemic disease that can manifest with an acute or an insidious onset. Signs and symptoms of the disease include: continued, intermittent, or irregular fever of variable duration; headache; weakness; chills; arthralgia; depression; weight loss; and generalized body aches. The disease can persist for periods ranging from days to years.

CBS News
https://www.cbsnews.com/news/udder-milk-company-raw-contamination-brucella-bacterial-cdc/
Raw milk contaminated with bacteria could make people sick, officials warn
By Sarah G. Miller Livescience.com November 21, 2017, 3:34 PM

If you consumed raw milk in the past six months, you may need antibiotics. "People who bought and drank raw milk from a company called Udder Milk may have been infected with a rare but potentially serious germ called Brucella abortus RB51" and should seek medical care, the Centers for Disease Control and Prevention (CDC) said Tuesday in a statement.

Water For Infants Recalled after Company Receives Complaints of Mold

The Kroger Company has recalled one gallon containers of Comforts FOR BABY Purified Water with Fluoride Added after receiving complaints about mold in the product.  The mold may or may not be visible.  The main issue with this mold,Talaromyces penicillium, is that some can have an allergic reaction to it.   Infants with impaired immune systems can be susceptible to infection.

The water in this case was steam distilled water and then minerals and fluoride were added back.  Minerals include potassium bicarbonate, calcium chloride, and magnesium chloride.  These are not items that we would expect to support mold growth.

https://www.fda.gov/Safety/Recalls/ucm587618.htm
FDA Alerts Consumers to Recall of Certain Comforts FOR BABY Water with Fluoride
For Immediate Release
December 4, 2017

In Minnesota, Two Burger King Restaurants Closed After Numerous Cases of Salmonella Infection Linked

In Minnesota, two Burger King restaurants were shut down after at least 27 cases of Salmonella infection have been linked.

Very unusual to have a national brand, fast-food burger operation involved in an outbreak.  The article indicates cases since September, with 4 more cases now.  This would tend to indicate more of an environmental point source contamination in the restaurant rather than a particular food (unless the food supplier has a point source environmental contamination issue).

CBS Minnesota Ch 4
http://minnesota.cbslocal.com/2017/12/03/salmonella-burger-king-bemidji/
Salmonella Outbreak Closes 2 Burger Kings In Bemidji [Minnesota]
December 3, 2017 1:13 PM

In OR, Salmonella Outbreak Linked to Sliced Melons

Eighteen people have been reported as becoming infected with Salmonella after eating store-bought, pre-but watermelon, canteloupe, and mixes containing those fruits.

Companies producing cut melon products normally have tight controls over this type of RTE operation, including a fruit washing/sanitizing step and then tight sanitary controls to prevent contamination after washing/sanitizing, through slicing and then packaging - good line sanitation and hygienic zoning.  So to have Salmonella contamination, one would guess either the washing/sanitizing was inadequate or there were some lapses in sanitation/hygienic zoning.

Oregon Live
http://www.oregonlive.com/pacific-northwest-news/index.ssf/2017/12/salmonella_outbreak_in_oregon.html
Salmonella outbreak in Oregon, Washington linked to pre-cut fruit
Updated Dec 1; Posted Dec 1
By Brad Schmidt, bschmidt@oregonian.com
The Oregonian/OregonLive

Article Summary - Five Techniques to Manage Supply Chain Risk

Supplier control can be difficult, and the results of not having the proper checks in place can have huge financial costs on the company, as well as impact the safety of product they sell to consumers.  Saw this article link on United Fresh Weekly News (they provide great information) and thought it would be good to repost for those involved in supplier oversight.

In summary, the author provides five important considerations for managing supply chain risk.  While stated, to move forward in this world, avoiding risk is impossible, so we have to take intelligent risk.  These are:

• innovation and efficiency in contracting management;
• strategic requirements for supplier insurance, indemnification and limitations of liability;
• provider optimization and redundancy;
• supplier financial stability visibility; and
• proper diligence in operational supplier assessment reviews.

Here are those components from a food safety perspective.

Innovation and efficiency in contracting management - it is important to review contracts regularly, updating to current systems of management, and incorporating information such as updated specifications, required controls.  Goal is to avoid outdated information on contracts.

Strategic requirements for supplier insurance, indemnification and limitations of liability - Are they
required to support, and can they financially support an issue that they cause to the product you sell.

Provider optimization and redundancy - Does the supplier have a back-up plan to get you product or do you have a back-up plan (secondary supplier).

Supplier financial stability visibility - Do you know that your entire supply chain can remain financially viable.  This is especially important when we work internationally.

Proper diligence in operational supplier assessment reviews - this is one where the technical people are most actively involved.  Sure we can review audits, but are we following up on those audits to obtain verifiable proof that our suppliers are responding to the audits.

SupplyChain Management Review
http://www.scmr.com/article/five_techniques_to_manage_supply_chain_risk
Five Techniques to Manage Supply Chain Risk

This Week in Mislabeled Product - Ending December ,. 2017

Temporary Breakdown Leads to Undeclared Milk - Colorado Nut Company of Denver, CO is recalling Cashew Cranberry Cherry Jubilee, Oat Bran Nutty Crunch, Honey Nutty Granola, Peanut Delight, and Frontier Trail Mix, because they may contain undeclared Milk. The recall was initiated after it was discovered that product containing “Milk” was distributed in packaging that did not reveal the presence of (Milk). Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's production and packaging processes."

More Issues with Milk in Dark Chocolate - Farrell Farms, Inc. of Goldsboro, NC is recalling 7 oz Dark Chocolate Almonds, 7 oz Dark Chocolate Cashews, and 7 oz Dark Chocolate Pecans, because these products may contain undeclared milk. The recall was initiated after the supplier, Dutch Valley Food Distributors, Inc. of Myerstown, PA notified Farrell farms on November 18th, 2017 that the product was being recalled due to undeclared milk in the chocolate raw material used to coat the various nut products.

In Allergen Labeling, Cashews are Different than Peanuts - Virginia Diner, Inc. is voluntarily issuing a recall of 10 oz. cans of Plow & Hearth Chocolate Covered Cashews at Plow & Hearth’s locations and nationwide (Mail Order) as a precaution because they may contain peanuts and peanut allergens.  A label mix up was discovered by a consumer who received and opened a Cashew Tower Set (3 individual cashew cans) of which one can, the 10 oz. Chocolate Covered Cashews, were found to have Salted Peanuts.

Customer Finds Egg Missing on Label - A N.J. establishment, is recalling approximately 46,810 pounds of beef meatball products due to misbranding and undeclared allergens - egg, The problem was discovered when the establishment’s customer noticed that the label did not include eggs in the ingredient statement.

https://www.fda.gov/Safety/Recalls/ucm586430.htm
Food Co. Issues Allergy Alert on Undeclared Allergen (E.G. Milk) in Product
For Immediate Release
November 22, 2017

Study Links Pathogenic E. coli (STEC) to Flour in 2016 Outbreak

A study published in the New England Journal of Medicine shows that flour was the source of a 2016 pathogenic E. coli (STEC) outbreak. In this outbreak 56 cases were identified in 24 states, with more than a quarter of those cases developing hemolytic–uremic syndrome - very severe kidney damage.   Although there were many challenges related to flour as an ingredient, this study was able to conclude that the flour was the source of the contamination. In concluding, the study highlights the risky behaviors that led to infection - "These behaviors included the consumption of raw or undercooked homemade dough or batter, which has long been discouraged because of the known risk of salmonellosis from consuming raw eggs, as well as allowing children to play with raw dough in restaurants and using flour to make play-dough for children at home. Our data show that although it is a low-moisture food, raw flour can be a vehicle for foodborne pathogens."

Still, people continue to eat raw dough
New England Journal of Medicine
http://www.nejm.org/doi/full/10.1056/NEJMoa1615910#t=article
Shiga Toxin–Producing E. coli Infections Associated with Flour

FDA Warning Issued to a Processor of RTE Salads

A NC refrigerated ready-to-eat (RTE) salad manufacturing facility was issued a warning letter.

FDA found two positive Listeria monocytogenes samples in the processing area - one from a wheel of (?) that was supported by a stack of lids located in the back kitchen. The lids contained accumulated water and debris and were continuously leaking product at connection junctions.  And another positive sample from under the packer [equipment?] in the back kitchen.  Potato salad was being manufactured in the back kitchen during the inspection.

The WGS analysis found two different strains of LM, and both of these strains had been found in the company's other processing facility during a previous year's sampling.  Because of this, FDA deemed that the plant did not have adequate control of Listeria.

• One of the strains of LM found was genetically identical to isolate found in thier other processing facility.  "that it is identical to (b)(4) FDA environmental swabs collected from your Chester, SC facility in May 2012, August 2013, and April 2015. This strain was also found in (b)(4) isolates that were obtained from USDA samples of chicken salad and ham salad from your Charlotte, NC facility, and (b)(4) of USDA’s environmental swabs collected from your Charlotte, NC facility in 2015."
• The other strain of L. monocytogenes  "shows that it is identical to L. monocytogenes isolated from FDA’s February 2017 sample of your Chester, SC facility’s pimento spread, the state of North Carolina’s 2017 sample of your pimento cheese and old fashioned spread, and FDA environmental swabs collected from your Chester, SC facility in May 2012, August 2013 and April 2015. This evidence demonstrates that L. monocytogenes had maintained a presence in your Chester, South Carolina facility from 2012-2017 and an identical strain of L. monocytogenes has been isolated in your Charlotte, NC processing environment."

The facility was sited with numerous GMP violations.

• The production sprayers and the water bath hose were observed pooling water throughout the entire production room floor and splashing water onto food contact surfaces
• Soiled garments of employees including hair nets, arm guards, and aprons coming into direct contact with raw ingredients and in-process finished product.
• An employee was observed using a probe thermometer to check the temperature of each batch of pimento spread without cleaning or sanitizing it between uses.
• Employees storing and resting food contact equipment such as product scoops and spatulas on non-food contact surfaces such as brown paper towels and tables then using them to manipulate raw materials and/or in process finished product without first washing or sanitizing them.
• After sanitation operations, had been completed in the back kitchen a mixer had chicken salad residue and dried mayo debris on the paddle, the interior and the mixer stand attachment. The equipment was used for the next production run without any additional sanitation being performed
• A bucket labeled as sweet pickle relish to contain bleach, a bucket labeled as diced celery to contain quaternary ammonia, and an unidentified container, which reportedly contained bleach, was found to contain a 50ppm chlorine solution.
• Chemicals were observed to be stored directly adjacent to the potato washer and the potato conveyor where food items were actively undergoing processing. In addition, the investigators observed sanitizer overspray to be inside an open box containing finished product containers as well as wetting boxes containing finished product container.
• Finished product troughs, raw ingredient transport bowls, and mixers were observed to be pitted and cracked, cutting boards contained numerous gauges and cuts and salad tubs were heavily gouged.
• Two pallets of canned pimentos and one pallet of canned jalapenos were observed to be stored in the maintenance shop. The pallet of jalapenos had opened motor oil containers and lubricants stored on top. The front pallet of pimento had a viscous black liquid spilled onto the middle cans on the pallet. Chemical drums stored adjacent to the rear kitchen were observed to be leaking onto open boxes of finished product containers
• Condensate was observed dripping onto packaged product, exposed raw materials such as relish and cabbage, and food contact surfaces. Condensate was also observed pooling where sanitized production equipment was being stored. 
• Accumulated condensation from a shop fan in the front and was blowing onto sanitized cooked potato containers.
• An employee in the front kitchen was observed using gloved hands to assemble sanitized production equipment. This employee stopped assembly to manipulate the hose that had been on the floor and then resumed assembling the sanitized equipment without first washing and sanitizing or changing the gloves.
• Multiple employees were observed returning from breaks without washing their hands or washed their hands and then put on hairnets and earphones, without first re-washing their hands, before resuming production activities in the front and back kitchens and the spice room.
• The equipment washing sink in the front kitchen was observed to be directly plumbed into the sewer system without an air break or a backflow prevention device.

FDA Warning Letter
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm586088.htm

November 14, 2017

 WARNING LETTER

18-ATL-01

Stanley C. Bracey, President
Bill R. Rudisill, General Manager
B&H Foods
2122 Thrift Road
Charlotte, NC 28208

Dear Mr. Bracey:

The United States Food & Drug Administration (FDA) inspected your refrigerated ready-to-eat (RTE) salad manufacturing facility located at 2122 Thrift Road, Charlotte, NC 28208 from May 9 through 31, 2017. During our inspection, FDA collected environmental samples (i.e., swabs) from various areas in your processing facility, including areas that are near food and food contact surfaces.  FDA laboratory analyses of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen in your facility. Additionally, FDA investigators observed serious violations of the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packing, or Holding Human Food regulation, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110) [1]. Based on FDA’s analytical results for the environmental sample and inspectional findings documented during the inspection, we have determined that your RTE food products are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)], in that they were prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act and FDA's regulations through links in FDA's home page at http://www.fda.gov.