FDA Releases Food Defense Plan Guidance

FDA released a guidance document on developing and implementing a Food Defense Plan for mitigating against intentional contamination.  LINK.

The Food Defense Plan is required as part of FSMA.
The rule requires a written food defense plan for all covered facilities unless an exemption applies (21 CFR 121.5). The written plan must include (21 CFR 121.126):

1. 1. A vulnerability assessment to identify significant vulnerabilities and actionable process steps, and associated explanations
• Mitigation strategies and associated explanations
• Procedures for food defense monitoring
• Procedures for food defense corrective actions
• Procedures for food defense verification
2. The rule requires training for certain personnel. See “EDUCATION, TRAINING, AND QUALIFICATIONS” section (21 CFR 121.4)
3. The rule requires covered facilities to maintain the food defense plan as a record as well as records for training, food defense monitoring, food defense corrective actions, and food defense verification. (21 CFR 121.126(c), 121.140(c), 121.145(b), and 121.150(c))
4. The rule requires reanalysis of the food defense plan. (21 CFR 121.157)

For most companies, the compliance date is July of 2019. Smaller companies have more time.

FDA Conducts Pathogen survey on Sprouts

FDA conducted a sampling of sprouts for pathogens in order to determine the prevalences of Salmonella, Listeria monocytogenes and E. coli O157:H7 in sprouts. Seeds, finished product and spent irrigation water were tested.

The summary of the findings:

• Prevalence of Salmonella in the finished product sprouts to be 0.21 percent. 
• Prevalence of Salmonella in seeds (2.35%) and in spent irrigation water (0.54%)
• Prevalence of Listeria monocytogenes in the finished product to be 1.28 percent. 
• There was no significant difference in the prevalence of Listeria monocytogenes based on point in the production process. 
• None of the samples tested positive for E. coli O157:H7
• Most of the positive samples at a small number of sprouting operations

From 1996 to July 2016, there were 46 reported outbreaks of foodborne illness in the United States associated with sprouts. So while the prevalence is not high, because the fact that sprouts are especially vulnerable to pathogen contamination and growth "given the warm, moist and nutrient-rich conditions needed to grow them", sprouts are a risk for foodborne illness.......especially for high risk populations.  Salmonella and E.coli are more of an issue on incoming seeds, while Listeria would be more of a concern within the processing environment.

Going forward, FDA "intends to conduct a study at establishments that grow, harvest, condition, pack/re-pack, and/or supply seeds and beans for sprouting to gain insights on production practices, sanitation methods and manufacturing processes and to help the establishments achieve compliance in the event that insanitary conditions are observed".  "FDA also intends to inspect sprouting operations to ensure they are complying with the Produce Safety Rule and may continue to sample sprouts and the production environment"

FDA Release
https://www.fda.gov/downloads/Food/ComplianceEnforcement/Sampling/UCM566981.pdf
FY 2014 – 2016 Microbiological Sampling Assignment
Summary Report: Sprouts
Office of Compliance
Center for Food Safety and Applied Nutrition
August, 2017

Warning Letter - Oregon Canned Food Manufacturer

An Oregon canned food manufacturing company was issued a Warning Letter from FDA for inadequate responses to the FDA inspection report (483) that they were issued regarding low acid canning procedures.  With low acid canned food, there are specific regulatory requirements that must be met including having approved processes, filing those processors, controlling the process, and collecting the appropriate documentation.  (LACF Regulations).

• Non-validated venting process for the retort.
• Failure to record critical data including potato dimensions, cooling overpressure time and temperature, and headspace.
• Failure to identify deviations from the filed schedule
• Failure to record the results of visual examination of the container closures at intervals of sufficient frequency to ensure proper closure

The primary issue of not following strict procedures is the risk of Clostridium botulinum growth and toxin production.

FDA Warning Letter
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm571602.htm

Oregon Wild Berries, Inc. 8/9/17

FDA Releases Food Safety Plan Builder

FDA has provided a Food Safety Plan Builder which is an input driven tool that helps one to document and organize their company's Food Safety Plan.

While some may like having such a tool, I find it more difficult in some ways.  For one, you have to have all of your information ready as you input the data.  It is almost better to have your plan written before inputting for ease.  Second, it is hard to keep an overview of what you have written since with this, you are going step by step.  Lastly, it put the document into a format that is not as easy to change as if you used Word or Excel.

So this is not going to be something I recommend. I find it much easier to use open forms that are easy to add information, modify that information, or visual your plan when working on it.  I also prefer having my documentation in a format that will always be available, and for me, I prefer working in Excel for tables and Word for policies and procedures.

But take a look and let us know what you think.
Download the Food Safety Plan Builder Tool

Food Safety Plan Builder
https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm539791.htm

Canadian Firm Recalls Fully Cooked Chicken Skewers for Listeria Contamination

A Canadian firm is recalling fully cooked chicken skewers for Listeria.  The Listeria was discovered during FSIS import inspection.  Product had been shipped to retail locations in Arizona, Connecticut, Florida, Illinois, Maryland, Michigan and Texas.


USDA FSIS Recall Notice
https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2017/recall-095-2017-release
Expresco Foods Inc. Recalls Chicken Skewer Products Due to Possible Listeria Contamination
Class I Recall 095-2017
Health Risk: High Aug 23, 2017
En Español
Congressional and Public Affairs Mitch Adams (202) 720-9113 

Press@fsis.usda.gov

Packaged Frozen Cherries from Turkey Recalled for Listeria

Sunrise Growers Inc. a subsidiary of SunOpta Inc’s subsidiary, is recalling frozen organic dark sweet pitted cherry products due to the potential to be contaminated with Listeria monocytogenes.  The issue was discovered during routine testing by Sunrise Growers.

Not directly stated in the announcement is that the product is imported from Turkey (printed on package) and distributed within the US.  So this is a supplier control issue, and knowing how well the packer of this product controls Listeria in the processing environment.  The distributor did testing, but it appears that product had already been distributed.  So was a sample and hold procedure in place?

While Listeria will not grow on the frozen cherries, the concerns would be related to the level of Listeria on the cherries and how the application for using cherries. The risk increases with a higher level of Listeria present and if the cherries will be used in 1) RTE applications such as a fruit smoothie and 2) in a matrix that will allow for growth, (if the blended smooth has a sufficient PH and 3) that product will be held for a sufficient time to allow for growth...someone leaves that smoothie on their desk all day.

FDA Recall Notice
https://www.fda.gov/Safety/Recalls/ucm572971.htm
Recall of Certain Frozen Organic Dark Sweet Pitted Cherry Products Due to Possible Contamination by Listeria Monocytogenes
For Immediate Release
August 23, 2017

Salmonella Cases Linked to Backyard Chickens Continues to Increase

Chickens can carry Salmonella, and if you raise chickens, you need to be aware of that you have an increased risk of Salmonella infection.  But as the backyard chicken craze continues, more people are becoming infected with Salmonella.

CDC has a nice publication regarding backyard flocks - https://www.cdc.gov/Features/SalmonellaPoultry/index.html

Follow these guidelines - including washing your hands after handling birds -  and you will reduce your risk.

CDC Outbreak Notice
https://www.cdc.gov/salmonella/live-poultry-06-17/index.html
Multistate Outbreaks of Human Salmonella Infections Linked to Live Poultry in Backyard Flocks, 2017
Posted August 21, 2017 11:00 AM ET

Outbreak Advisory
961  Cases
48 States
215 Hospitalizations
1 Death

Firm Recalls RTE Sausage After Accidentally Shipping Product on Hold for Listeria

A Wisconsin firm is recalling fully cooked sausage patties after product being held for potential listeria contamination was accidentally shipped.  "The problem was discovered when firm’s routine testing indicated positive results for Listeria monocytogenes. The products were on hold at a distribution center, however, the products were inadvertently shipped. There have been no confirmed reports of adverse reactions due to consumption of these products."


USDA Recall Notice
https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2017/recall-094-2017-release
News Release
Fair Oaks Farms, LLC Recalls Pork Sausage Patties Due to Possible Listeria Contamination 
Class I Recall  094-2017
Health Risk: High
Aug 22, 2017
En Español
Congressional and Public Affairs  Mitch Adams  (202) 720-9113
Press@fsis.usda.gov

FDA Warning Letter - King of Pops - Nasty Food Operations Exposed

FDA issued a warning letter to a GA firm after that firm inadequately responded to the findings of an FDA inspection.

The findings - pretty nasty especially considering this company is producing ready-to-eat foods, and if we had to guess because they are ice pops, will be eaten by children.

• Rodent droppings throughout the facility.
• Food residues on equipment
• Untreated and unsanitary floors
• Improper glove usage - not changing gloves after touching unsanitary surfaces.
• Inadequate floor drainage leading to standing water
• Table top surfaces not of sanitary construction - not cleanable.
• Not removing debris from production area in a timely manner.
• Large gaps in facility capable of allowing pests in.
• Exposed glass light bulbs in production areas.

Looking at the facility, it appears to be just a bad looking retail location.

But looking at the website, you can see it is a much larger operation.  Started by some young corporate-dropout types, it looks as though they never took the time to learn about safe food processing, or the need to implement food safety systems.

FDA Warning Letter
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm572052.htm
August  3, 2017