FDA Enforcement Report - Week of August 30, 2017 - Summary

FDA's Weekly Enforcement Reports - Whereas not all recalls are announced in the media or on FDA's Recalls press release page, all recalls go into FDA's Enforcement Report once they are classified according to the level of hazard involved.

As a way to see more fully issues occurring, we thought we might summarize the food related items (allergen issues are posted on This Week in Mislabeled Product).

• Go-Fresh of MN and Fresh Venture of CA Mary's Harvest Fresh Foods, Inc. of OR were impacted when firm test results found potential E-coli O26 contamination in Broccoli Florets. This has impacted a number of brands. - Class 2
• Lakeside Foods of WI is recalling french style green beans for potential Listeria contamination.  This company has has Listeria contamination issues in the past.  Class 2
• Koogee-Queen Anne, of KY is recalling ice bream products due to E. coli and high coliform counts. - Class 2

It is interesting to note how these recalls were classified.  The recalls for broccoli due to E. coli O26 and for green beans due to Listeria were classified as Class 2 recalls even though these are serious pathogen.  This is because the packages had validated cooking instructions, with the thought that proper cooking would minimize the risk of these pathogens.   Now if these pathogens had genetic matches to a serious outbreak as determined by WGS, then this would be a different story.

This Week in Mislabeled Product - August 25 to September 1, 2017

A list of recalls related to mislabeling / allergens.

• A Calif. establishment, is recalling approximately 15,092 pounds of beef, chicken and pork products due to misbranding and undeclared allergens The problem was discovered on Aug. 22, 2017 when FSIS Inspection Program Personnel observed that the establishment utilizes a soy protein concentrate in the production of several products, but the finished product labels do not declare soy. In addition, some of the same products contain wheat flour and wheat is also not declared on the finished product labels.
• A Mass. established reissued a recall notice to include the states in which the product was distributed. The establishment is recalling approximately 3,448 pounds of chicken breakfast sausage products due to misbranding and undeclared allergens. The product contains soy lecithin, a known allergen, which is not declared on the product label. The problem was discovered during routine FSIS label verification activities
• A Mass. establishment, is recalling approximately 32,228 pounds of fully cooked chicken sausage product due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains milk, a known allergen, which is not declared on the product label. The problem was discovered by FSIS Inspection Program Personnel during routine label verification activities. There have been no confirmed reports of adverse reactions due to consumption of this product
• A firm in MI, is recalling several brands of butter flavored popcorn because they may contain undeclared milk.  The recall was initiated after a non-illness consumer complaint in relation to flavor.
• A distributors in GA is recalling 1467 packets of Jalebi because it may contain undeclared Almond pcs "This problem was highlighted by FDA inspectors while inspecting our food distribution facility. The problem was caused due to recent change in the packing of the product to enhance the appearance of the product."  (So what, now we could see the almonds that should not have been there?).

And from the FDA Weekly Enforcement Reports

• Shatto Milk Co of Osborn, MO, labels on butter products failed to mention the milk allergen.
• D&D Foods missed soy lecithin on the label for co-packed pizza products.
• Penobscot McCrum missed milk on labels for Jo-Jo wedges (potato wedges)
• The Best Bar Ever initiated a voluntary recall of the Peanut Butter Crunch flavor (40g size) because the individual wrapper mistakenly has a gluten-free logo on the label. The wrapper for Peanut Butter Crunch flavor (40g size), had a gluten-free logo on the individual wrapper label. The ingredient listing and allergen statements are correct. The only issue is the gluten-free icon was not supposed to be on that flavor

UDSA FSIS Recall
https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2017/recall-098-2017-release
Blossom Foods, LLC Recalls Frozen Meat Products Due to Misbranding and Undeclared Allergens

FDA Updates Preventive Controls Guidance With Chapter on Heat Processing PC

FDA updated their Preventive Controls Guidance document with a chapter on addressing the use of heat treatments as process controls.  To this point, the guidance provided somewhat similar information to that in the FSPCA manual, although the information is split differently among the chapters. However, the information covered in Chapter 6 goes into more detail, providing more information on heating, including examples for baking cookies, heating soup, and processing salsa.  This information covers how one would validate that information, and then implement and manage the process - monitoring, corrective actions, verification, and records.

Currently, the Guidance has 5 previous chapters, while Chapters 7 to 14 are yet to be released.

• Chapter 1 is an introduction
• Chapter 2 discusses how to conduct a hazard analysis.
• Chapter 3 provides additional information on hazards in foods. For example, it discusses pesticides, animal drugs, and mycotoxins as chemical hazards and when you may want to consider those hazards.  While it does not provide complete information on each of the hazards, it does provide some additional information.
• Chapter 4 overviews the preventive controls - Process, Sanitation, Allergen, and Supply Chain controls - highlighting primary types for each.  Under Process Controls, the chapter covers leathality treatments (heat, HPP, irradiation, fumigation), cold holding, formulation control, etc.  Again, not a complete listing of types, but give information on the major types.
• Chapter 5 is the application and management of preventive controls...provides some additional information to the preventive controls discussed in chapter 4.

Each of the coming chapters will expand upon the preventive controls as was done in Chapter 6 for heat processing.

This will become more of a companion reference document as examples of the process controls are expanded upon.  This guidance will give information on the types of things an FDA inspector will be looking for as they conduct inspections.  Certainly a document worth printing or bookmarking.  Be sure to watch for updated sections as they are released.

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