Wednesday, October 7, 2015

Acidified Food Processor Cited for Improper pH Monitoring - FDA Warning Letter

A Warning Letter was issued by FDA to a acidified food processor for not verifying equilibrium pH.  (Equilibrium pH is measuring the pH after 24 hours to ensure that low acid components within the finished product are below 4.6 in order to prevent Clostridium botulinum growth).

Along with this, there was the lack of production and processing records showing adherence to scheduled processes, lack of a recall procedure, and they were not documenting the calibration of pH meter or the accuracy checks of thermometers and were using expired buffer solutions for pH meter calibration.  
There are many small processors who focus on acidified foods.  With FSMA, more of these processors will fall under FDA jurisdiction / regulations.

For someone looking for co-packing, it is critical to review a companies capabilities beyond what is on the website.  Looking at this company's website, you would think that these folks were operating correctly.  This includes looking at audit reports, and of course, any FDA warning notices.


FDA Warning Letters
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm465325.htm
Backwoods Food Mfg Co Inc 9/15/15
September 15, 2015

2015-DAL-WL-30
Danielle (NMI) Coursey, President, Co-Owner  Michael R. Coursey, Vice-President, Co-Owner
Backwoods Manufacturing, Inc
591 Main Parkway
Tahlequah, OK 74464

Dear. Ms. Coursey,

On March 24-26, 2015, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 591 Main Parkway, Tahlequah, OK, where you manufacture a variety of acidified foods. The inspection revealed serious violations of the regulations for acidified foods (Title 21, Code of Federal Regulations, Part 108, Emergency Permit Control (21 CFR Part 108) and Part 114, Acidified Foods (21 CFR Part 114)). Accordingly, we have determined that your acidified 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 have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You can find the Act and the Acidified Food regulations through link in FDA’s home page at http://www.fda.gov.

Number of Cucumber Related Salmonellosis Cases Rises

There have been an addition 61 cucumber linked cases of salmonellosis since the September 29 CDC outbreak update. This brings the total to 732 people.  With a relatively short shelf-life of 14 days, CDC anticipates that there should not be too many more, if any, additional cases.
 
It is surprising the lack of outrage in the media.  732 cases.  4 deaths.  Let's compare that to the Salmonella outbreak associated with Foster Farms raw chicken, a product that is supposed to be cooked.  In that outbreak , CDC reported that "a total of 634 persons infected with seven outbreak strains of Salmonella Heidelberg were reported from 29 states and Puerto Rico from March 1, 2013 to July 11, 2014.  38% of ill persons were hospitalized, and no deaths were reported."   Have we become desensitized?  Or are there less deep pockets to access?
 
Certainly the scope is huge.  35 states.  This demonstrates the impact of one initial supply hub in moving product across the county. 
 
It also shows the inability to track an outbreak related to produce.  3 months is a long time for such a short shelf-life product.
 
 
 
  Epi Curve Multisate Salmonella outbreak for Imported Cucumbers - Poona
 
 
 
CDC Outbreak
Multistate Outbreak of Salmonella Poona Infections Linked to Imported Cucumbers
Posted October 6, 2015 4:00 PM ET
 
What's New?
  • Since the last update on September 29, 2015, 61 more ill people have been reported from 24 states. Given the 14-day shelf life of cucumbers and the gap between when someone gets sick and when that illness is reported to public health, it is not unexpected to continue to see illnesses reported after the recalls.
  • A death has been reported from Oklahoma, bringing the total number of deaths to four.
  • Maryland was added to the list of states with ill people, bringing the total number of states to 35.

Monday, October 5, 2015

Another Brand of Raw Dog Food Recalled - Presence of Listeria and Salmonella

If products are made from raw meat, they can contain pathogens unless treated in a way to eliminate those pathogens.  While holding that product at cold temperatures helps prevent growth, it does not eliminate it. 

When someone is into the 3rd day of uncontrollable loss of bodily fluids, my guess is they won't really be trying to determine if that food made Barky's coat more shinny.

FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm465646.htm
K-9 Kraving Dog Food Has Announced a Voluntary Recall of Their Chicken Patties Dog Food Shipped Between July 13th - July 17th, 2015 Because The Product May Be Contaminated With Salmonella and Listeria monocytogenes
Contact:   Consumer:   1-800-675-1471

FOR IMMEDIATE RELEASE – October 2, 2015 – Baltimore, MD – K-9 Kraving Dog Food has announced a voluntary recall of their Chicken Patties Dog Food shipped between July 13th - July 17th, 2015 because these products may be contaminated with Salmonella and Listeria monocytogenes. Salmonella and Listeria monocytogenes can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.

Question - Are Transportation Companies Preparing for Food Safety Requirement per FSMA

Are your transportation companies preparing for upcoming FSMA regulations?  The FSMA Rule on Sanitary Transportation of Human and Animal Food was enacted to help maintain the safety of both human and animal food during transportation by establishing criteria, e.g., conditions and practices, training and record keeping, for the sanitary transportation of food.

According to the article in Bulk Transporter - probably not.  But they should begin.....getting an organization in the habit of executing food safety controls will take time.

A few highlights from the article:
  • Carriers must develop and implement procedures that describe how they will comply with provisions for temperature control and how they will provide this information to shippers and receivers.
  • Drivers will need to be trained on temperature management and reporting requirements, and temperature records for each shipment must be retained for one full year.
  • Food shippers must specify in writing to carriers the sanitary requirements for transport vehicles and temperature control systems for all shipments of “Time/Temperature Control for Safety Food” (TCS food).
  • Food receivers must carry out loading and unloading operations under conditions that will prevent TCS food from reaching unsafe temperatures.
  • Condensation inside a refrigerated or tank trailer may get more attention.
  • Carrier personnel must be trained.
So it would behoove you to ask the question of your logistical provider.

Bulk Transporter
http://bulktransporter.com/fleet-management/bulk-food-haulers-need-prepare-advance-fda-s-comprehensive-food-transport-requireme
Bulk food haulers need to prepare in advance for the FDA’s comprehensive food transport requirements
Oct 5, 2015 Charles Wilson | Bulk Transporter
 
NEW RULES covering food transportation and distribution will begin to take effect starting in June. However, there is growing concern that many food transporters still are not ready to deal with these new rules.
 
The lack of preparedness was a key point addressed during a panel discussion that took place during the 2015 Mid-America Trucking Show in Louisville, Kentucky.

Company Issues Another Recall for Green Beans After Listeria Positive Sample is Detected

Cascadian Farms, an organic division of General Mills, is recalling frozen green beans after a product sample was found to be positive for Listeria.   This comes after Cascadian Farms issued a recall back in August for product produced in 2014 when that product was found to be positive for Listeria.

Proper cooking of the green beans by the consumer will eliminate the Listeria, but there is a concern that people will not follow cooking instructions.  There have been no illnesses associated with this product.

The most likely source of Listeria contamination is in the processing environment.  Generally, green beans are blanched by the processor before freezing.  This blanching would eliminate the organism.  however, Listeria is problematic in that it can establish itself within moist, cool processing environments such as those used to make green beans.  Facilities work to prevent Listeria contamination through following practices such as good sanitation, controlling movement in and out of more critical areas (post blanch - freezing - packaging), and then monitoring those areas.

Freezing the product does not allow the organism to grow, but freezing will not eliminate it.


Wall Street Journal Business
http://www.wsj.com/articles/general-mills-recalls-another-batch-of-green-beans-due-to-listeria-1443815248
General Mills Recalls Another Batch of Green Beans Due to Listeria
Company says it found a pack of Cascadian Farm Cut green beans with listeria; it had seen another in August
By Josh Beckerman Oct. 2, 2015 3:47 p.m. ET

General Mills Inc. GIS 0.39 % is voluntarily recalling a small amount of frozen Cascadian Farm Cut Green Beans after a package tested positive for listeria, the second listeria-related recall for this brand of green bean this year.

The recall involves green beans produced on one day in June and is limited to 16-ounce bags with a “Better If Used By” date of 29JUNE2017.

General Mills said no related illnesses have been reported.

Breaded Chicken Product Recall Expanded Due to Salmonella Presence in Facility

Aspen Foods is expanding an recall for stuffed and breaded chicken products due to potential Salmonella contamination.  The initial recall issue in July was for close to 2 million pounds of product.  This recall is for product produced after the company had the first recall and was issued because USDA sampling found that the responsible strain of Salmonella was still in the facility.

Facilities with a Salmonella issue can find that once it becomes endemic within the facility, it can be very difficult to eliminate. 

This is not a ready-to-eat product, but one that appears to be one.  Thus the concern for Salmonella being present.



USDA Recall Notice
http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2015/recall-101-2015-release-expansion
Aspen Foods Recalls Frozen, Raw, Stuffed & Breaded Chicken Products Due to Possible Salmonella Enteritidis Contamination
Class I Recall 101-2015 expansion
Health Risk: High Oct 2, 2015

Congressional and Public Affairs   Gabrielle N. Johnston (202) 720-9113

EDITOR’S NOTE: This release is being reissued to expand the July 15, 2015 recall to include additional products. After further analysis, Aspen Foods chose to recall products in an effort to prevent additional illness. Details of this release were also updated to reflect a change in poundage and distribution area.

WASHINGTON, October 2, 2015 – Aspen Foods, a Chicago, Ill. establishment, is recalling approximately 561,000 pounds of frozen, raw, stuffed and breaded chicken products that appear to be ready-to-eat (RTE) and may be contaminated withSalmonella Enteritidis, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

Friday, October 2, 2015

Study - Removing Pathogens from Produce by Brushing or by Peeling

In this month's Journal of Food Protection, a research article looks at removing pathogens from the surface of produce by brushing and peeling.  Celery, carrots, honeydew and cantaloupes were inoculated with high does of pathogens, brushed and or peeled, and then analyzed.

In the end, it comes down to this  - if, as in this study, produce is heavily contaminated with pathogens, those pathogen can be difficult to remove with either brushing or peeling, especially once the brushes or peelers become contaminated.  But in reality, with very few exceptions where GAPs are not follow, pathogens are absent from produce.

A few of the findings:
  • "Pathogen removal (either E. coli O157:H7 or Salmonella) was significantly lower from contaminated cantaloupes than from other contaminated produce items".  Yeah, it's the rougher surface, so it is going to stick there.
  • "Both pathogens could still be detected on all produce items brushed with any of the three brush types suggest that contamination of the peeler is a likely route for transfer of pathogens from the surface to the internal tissues."  Once your cleaning tools encounter contamination, they can spread it. 
  • "The incidence of contamination for the nylon brush was significantly lower than that for the Sparta brush, which in turn was significantly lower than that for the scouring pad."  The harder to clean the brush or pad, the more that it can contaminate.
  • "To reduce risk further, consumers should be advised that brushing or peeling under running water may be beneficial for limiting contamination of the utensil and thus the risk of cross contamination to noncontaminated produce items subsequently processed with the same utensil."  Keep your brushes and peelers clean.
Carlisle 4054102 8 inch White Sparta Spectrum General Clean Up / Pot Scrub Brush
A Sparta Brush
 
Journal of Food Protection®, Number 9, September 2015, pp. 1624-1769, pp. 1624-1631(8)
Role of Brushes and Peelers in Removal of Escherichia coli O157:H7 and Salmonella from Produce in Domestic Kitchens
Authors: Erickson, Marilyn C.1; Liao, Jean2; Cannon, Jennifer L.2; Ortega, Ynes R.2

Thursday, October 1, 2015

Using the Smartphone for Stealth Auditing

Is that person checking the score of the Steeler game....or I am getting audited? 


Penn State News
http://news.psu.edu/story/372963/2015/10/01/research/phone-app-allows-researchers-conduct-concealed-food-safety
Phone app allows researchers to conduct concealed food safety observations
By Jeff Mulhollem
October 1, 2015
food safety app

UNIVERSITY PARK, Pa. -- Smartphones are so ubiquitous, and text messaging and social media activities so common in public places, that no one questions what anyone does with their phone. That pervasiveness allows a phone application to be used in direct, concealed observations without alerting the people being observed.

That is the conclusion of food science researchers in Penn State's College of Agricultural Sciences, who studied whether phones could be used in place of the traditional clipboards to improve the quality of data collection related to food safety observations.

Two PCA Operational Managers Sentenced to Time in the Big House

Sentences were handed down for the two operational managers involved in the PCA Salmonella outbreak case.  Operations Manager Samuel Lightsey, 50, will serve three years in prison while Daniel Kilgore, 46, another ex-manager at the plant, will serve six.  Because they agreed to testify against the owner, Steward Parnell (who received a 28 years), their sentences were shorter as part of the plea bargain agreement.

Like the Quality Manager, these two operations managers who were probably just following orders, may have never considered the implications associated with positive Salmonella test results for the product.  Or the fact much of their product was destined for high risk individuals as part of thief foodservice sales.  Easy to justify since the owner didn't seem to worry...it was just another day of making and shipping product that may or may not have a little Salmonella.  In the end, it was a big deal.  And unfortunately for these pawns, they will be spending time in the big house. 

Think about it.....one of them picking up the phone and dialing the FDA about the positive results would have saved them, all the consumers who had gotten sick, and provided it was early on, would have limited impact to the owner and his company.  Or hell, if they had only put forth the effort to clean the damn plant to rid the source of contamination. 

USA Today
http://www.usatoday.com/story/money/2015/10/01/lenient-sentences-ex-officials-salmonella-outbreak/73149204/
Lenient sentences for ex-officials in salmonella outbreak
Kevin McCoy, USA TODAY 2:50 p.m. EDT October 1, 2015

Two ex-officials of Peanut Corporation of America drew lenient sentences Thursday for their self-admitted roles in a salmonella outbreak blamed for killing nine and sickening hundreds.

Georgia U.S. District Court Judge W. Louis Sands sentenced Samuel Lightsey, 50, a former operations manager at the peanut firm's Blakely, Ga. plant, to serve three years in prison. Daniel Kilgore, 46, another ex-manager at the plant, drew a six-year sentence from the judge.