FDA Issues 3 Waivers to Sanitary Transport Rule, Including Shipments by Retail Outlets

With the Sanitary Transport Rule coming, FDA announced three waivers - 1) those permitted to ship milk, 2) those shipping food directly to consumers or as part of the operations of a foodservice / retail outlets, and 3) those approved to ship shellfish.

More specifically, from the FDA on item number two, this gives a waiver to grocery stores and food-service establishments.  It covers food sold directly to the consumer as well as food within the company or affiliate (a supermarket hub operation shipping to one of their stores).

• "Businesses that are permitted or otherwise authorized by the regulatory authority to operate a food establishment that provides food directly to consumers (including restaurants, retail food establishments, and nonprofit food establishments, as defined in 21 CFR 1.227), only when engaged in transportation operations as:
  • Receivers, whether the food is received at the establishment itself or at a location where the authorized establishment receives and immediately transports the food to the food establishment;
  • Shippers and carriers in operations in which food is transported from the establishment as part of the normal business operations of a retail establishment, such as:
    • delivery of the food directly to the consumer(s) by the authorized establishment or a third-party delivery service or
    • delivery of the food to another location operated by the authorized establishment or an affiliated establishment where the food is to be sold or served directly to the consumer(s)."

FDA News Release

FDA Announces Three Waivers to Sanitary Transportation Rule

April 5, 2017

SoyNut Co-packer, Dixie Dew, Slammed in FDA Inspection, Now Suspended

FDA suspended the food facility registration of the co-manufacturing facility of the Soy Nut Butter which was recalled for E. coli contamination.

CDC now reports that there are 29 cases of E. coli infection with 9 people developing HUS.  The majority of cases (83%) affecting people under the age of 18.

FDA inspected the facility (3/3/17 to 3/15/17)  at the same time the initial recall.  FDA issued a 483 report detailing issues in facility.
Here are some of the highlight from the 8 page report.  (For ease, a copy of this document is pasted below, this was converted from the pdf file)

• The firm leaves product in the mix kettle overnight and over the weekend.
• The mixing equipment just shuts off during processing, 1 or 2 times per day, and has had this problem for 15 years.
• They do not calibrate their thermometer used for monitor the nut butter.  
• The chart recorder also does not work.
• During production of product, a clear liquid was observed dripping intermittently form a hole in the ceiling onto the floor and splashing on the equipment.  This was supposedly coming from a leaky pipe.
• Product build-up  on floors and walls, and walking platforms. Standing water on floor.
• Poor employee traffic flow as well as forklift flow, no restriction of movement from dirty areas /waste areas to processing areas.
• Cleaning supplies not properly maintained.
• Wooden pallets sitting in standing water.
• Product piping system not disassembled since 2015, smaller pipes and filling not routinely cleaned.
• Improper employee handwashing.
• Pest control issues.

While this is clearly a co-packer issue, somebody had to approve this company.  Did the IMHealthy folks visit the facility?  Did they recognize the risk, especially considering who would be eating this product - children.  To me, they are just as responsible.

As part of the movement to small, unique brands, more and  more of these small brand companies are turning to co-packers to package their product.  This includes store brands as well.  There are risks however if these co-packers are not properly vetted and managed.  One of the key elements of FSMA, supplier preventive controls, was put in place to prevent this type of travesty.  (This is why I stick to my big brands with lots of food scientists and well developed QA/QC systems protecting that product).

FDA Safety Alerts and Advisories
https://www.fda.gov/Food/RecallsOutbreaksEmergencies/SafetyAlertsAdvisories/ucm549734.htm
FDA Suspends Food Facility Registration of Dixie Dew Products, Inc.
No food may leave the facility for sale or distribution
March 30, 2017

Packaging Error Results in Allergen Recall of Nutrition Bar

A nutrition bar company is recalling their crunchy Slim Peanut Butter bars after it was discovered that a product with milk allergen was accidentally mislabeled with the Slim Peanut Butter packaging that does not list milk allergen.

In applying Preventive Controls in the operation that made this product, having a properly implemented Allergen Preventive Control at the point of labeling would help prevent this.  This would include having a step to check the labels for a match to the formulation and then having verification (another person checking, a record review of the labeling record, direct observation of the label check, etc).

This mistake occurred during one shift, but once the depth of the recall expands to store level, this recall can become fairly costly.

FDA Recall Notice

https://www.fda.gov/Safety/Recalls/ucm549680.htm
Lifestyle Evolution Voluntarily Recalls One Shift of NuGo Slim Crunchy Peanut Butter
For Immediate Release
March 30, 2017

Chili Meal Kits Recalled for Potential Salmonella Contamination in Spice Packet

Conagra is recalling its Hunt's brand Chili meal kits after their supplier informed them of potential Salmonella contamination in the spice packets.  No injuries have been reported.

The risk level would not be high in that the chili spice is added and the product is simmered for 10 minutes.  The concern would be if someone adds spice right before eating (keeping the spice out and then adding as they eat it to allow for adjustment of the amount of flavor), or if someone spills the spice on the counter and then that serves as a source of cross-contamination to another food.  For Conagra, not a risk worth taking.

FDA Recall Notice

https://www.fda.gov/Safety/Recalls/ucm550184.htm
Conagra Brands Recalls Hunt’s Chili Kits Due To Potential Presence Of Salmonella In Spice Packet
For Immediate Release
March 2, 2017

Shipping Food Products on Truck or Rail - Get Ready for Sanitary Transport Rule

FDA's Sanitary Transport Rule takes effect in April for the larger firms.  A nice article published in American Trucker outlines how various players (drivers, dispatchers, and planners) will be involved in implementing the rule.   A few things to know - this applies to product shipped from USDA facilities as well as FDA facilities, the shipper or the person arranging shipment has responsibility for that shipment, and smaller shippers have until next year to comply.

American Trucker
http://trucker.com/regulations/new-food-safety-rules-are-you-ready
New food safety rules: Are you ready?
FMSA begins to take effect in April
Mar 30, 2017 Cristina Commendatore

Norovirus Outbreak Associated with Oysters in WA and BC (Canada)

Washington State authorities are reporting that there have been approximately 39 cases of Norovirus infections associated with eating raw oysters.   While testing is normally not done in these cases, the characteristic symptoms of acute-onset vomiting, along with nausea and diarrhea are pretty telltale.

Oysters are filter feeders and can filter up and then hold the viruses.

There have been even more cases of oyster related Norovirus infections in Canada.  In BC, hundreds have become infected with Norovirus after eating oysters.

Interesting, while there appears to be no link between outbreaks in the US and Canada because the cases in Washington are said to be linked to oyster from Washington, not Canada.  But in the article, it states that the Canadians are said to export much of their product to the US,....so, could it be that these Canadian oysters really the oysters that caused illness in the US, but these oysters were labeled as such to make them appear local and these are linked to the cases further north?  Or did someone eat the Canadian oysters neat the US waters, have a bout of illness, thus contaminating the US oysters?  Or...it is just a weird occurrence that two oyster-related Norovirus outbreaks are happening at the same time?

In any event, eating raw oysters has a Norovirus risk, no matter how tasty they are.

Q13 Fox News
http://q13fox.com/2017/03/28/raw-oyster-norovirus-warning-issued-after-multiple-people-in-area-become-ill/
Raw oysters, norovirus warning issued after multiple people in area become ill
Posted 5:04 PM, March 28, 2017, by Q13 FOX News Staff, Updated at 11:12PM, March 28, 2017

Canada - E.coli Outbreak Linked to Flour

In Canada, there have been 25 cases of E.coli infection linked to Robin Hood flour, with 6 of those cases requiring hospitalizations.  The CFIA found that the flour was contaminated with E. coli O121.

Don't eat raw dough.  Treat raw flour as though it can be potentially contaminated by cleaning it up from the counter or other surfaces.

For the hazard analysis, include E. coli and Salmonella as a hazard in flour (unless it is treated in some way.)

CBC News
http://www.cbc.ca/news/canada/calgary/flour-ecoli-sick-recall-robin-hood-brand-cfia-public-health-agency-1.4046011
25 illnesses in 4 provinces linked to E. coli-tainted Robin Hood flour
10-kilogram bags with best-before date of April 17, 2018, should be thrown out or returned

Brazilian Meat Industry Rocked by Investigation into Unsanitary Practices

Brazilian meat is returning to a number of countries that banned import of the product after Brazilian authorities found that some of the Brazilian meat companies were bribing inspectors to look the other way as they packed less-than-desirable product.  The US did not ban imports as it appears that none of the plants shipping to the US were under investigation (maybe our supply control systems are better?).

Brazil is one of the largest exporter of meat products in the world.  This scandal has had a huge impact on exports.

Tri-State Livestock News
http://www.tsln.com/news/brazil-resumes-exporting-meat-to-major-markets/
Brazil resumes exporting meat to major markets

Judge Issues a Consent Decree Against Milk Powder Producer

In December of 2016, FDA seized milk products from Valley Milk Products , a Virginia diary processor.  This past week, a Judge issued a consent decree of condemnation and permanent injunction against the company and three individuals - the General Manager, the Plant Manager, and the Quality Compliance officer.  Basically the product is bad and the company can not produce dry dairy products until they fixed specific issues.

It may be worth reading the Consent Decree here.  In fact, I suggest reading the Injunction Provisions starting on page 8, including the requirements for development and implementation of a Salmonella Monitoring Plan (F.1.) on page 10.   While there have been no reported illnesses, FDA found Salmonella is the facility and the facility did not appear to take sufficient action.   This can be seen as what is to come for FDA facilities with FSMA and the new tool of whole genome sequencing.

FDA Press Release
https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm531188.htm
Food regulators seize adulterated milk products for food safety violations

UPDATE: On March 14, 2017, Judge Elizabeth K. Dillon of the United States District Court for the Western District of Virginia entered a consent decree of condemnation and permanent injunction against Valley Milk Products LLC (Strasburg, VA), and three individuals, General Manager Michael W. Curtis, Plant Manager Robert D. Schroeder, and Quality Control Compliance Officer Jennifer J. Funkhouser. The seized milk powder products have been condemned and forfeited to the United States. The company may attempt to bring the condemned products into compliance but only under the supervision of the FDA, and it may not resume manufacturing powdered milk products without first implementing corrective action. The action does not affect liquid milk products made by the company. More information can be found on www.pacer.gov (case number 5:16cv76). No illnesses have been reported to date associated with these products. Consumers can report problems with FDA-regulated products to their district office consumer complaint coordinator.