Wineries Begin Seeing Surprise FDA Inspections as Part of FSMA

Many firms are seeing FDA inspections for the first time as the FSMA regulations are coming into effect, including wineries.  An article in Wine Business Magazine (December, 2017) indicates that a number of wineries are undergoing surprise FDA inspections.  For many, this may be a new experience.

From the article, "New registration and record keeping requirements for wineries under FSMA impose important changes. Wineries must now renew their FDA registration every two years.."  Wineries must also comply with GMP requirements, including the need to have documented employee training.  These firms are exempt from the the risk based preventive controls (Subpart C) and the supply chain program (Subpart G).

Federal Agencies Release Report on Foodborne Illness Source Attribution Estimates for 2013

FDA and CDC released their inter-agency report for determining cases of foodborne illness attributed to food sources.  Please note - this data is from 2013.

Foodborne illness source attribution estimates for 2013 for Salmonella, Escherichia coli O157, Listeria monocytogenes, and Campylobacter using multi-year outbreak surveillance data, United States - The Interagency Food Safety Analytics Collaboration (IFSAC)

December 2017

Noted from the report with comment.

• Salmonella illnesses came from a wide variety of foods.  Salmonella illnesses were broadly attributed across multiple food categories. More than 75% of Salmonella illnesses were attributed to seven food categories: Seeded Vegetables (such as tomatoes), Eggs, Chicken, Other Produce (such as nuts), Pork, Beef, and Fruits.  [Many animals carry Salmonella and then this can contaminate produce and grain items through cross contamination probably originating with contamination from fecal deposits]
• E. coli O157 illnesses were most often linked to Vegetable Row Crops (such as leafy greens) and Beef. More than 75% of illnesses were linked to these two categories.
• Listeria monocytogenes illnesses were most often linked to Fruits and Dairy products. [Note that meat products are not mentioned here and much of this is due to the work of the meat industry which has conditions and products that are a lot more of a challenge.  I suspect that we will see FDA regulated facilities taking clues from the meat industry about Listeria control.]
• More than 75% of illnesses were attributed to these two categories, but the rarity of Listeria monocytogenes outbreaks makes these estimates less reliable than those for other pathogens.
• Non-Dairy Campylobacter illnesses were most often linked to Chicken [but the main source was raw milk.  Incredible to think about when you consider how few people actually drink raw milk]
• Almost 80% of non-Dairy foodborne illnesses were attributed to Chicken, Other Seafood (such as shellfish), Seeded Vegetables, Vegetable Row Crops, and Other Meat/Poultry (such as lamb or duck). An attribution percentage for Dairy is not included because, among other reasons, most foodborne Campylobacter outbreaks were associated with unpasteurized milk, which is not widely consumed, and we think these over-represent Dairy as a source of Campylobacter illness. Removing Dairy illnesses from the calculations highlights important sources of illness from widely consumed foods, such as Chicken.

LINK

Interagency Food Safety Analytics Collaboration: Release of a New Report on Foodborne Illness Source Attribution Estimates for 2013
December 15, 2017

Warning Letter Issued to Bean Manufacturer for Inadequately Handling Can Seam Issue

Bush Beans was issued a warning letter related to how they handled a can seam issue this past summer.  Although a recall was conducted, FDA cited the plant for not notifying FDA of the issue, minimizing the issue even though a container failure issue could be danger to the public, and failing to take appropriate action regarding in-process rejects.  The issue was that the firm did not take appropriate action to a supplier related can seam issue. Can seam issues for low acid canned foods can result in serious issues such as the potential for Clostridium botulinum.

The warning letter specified two major items:
1.  Failed to promptly report to FDA any instance of spoilage or potential public health significance where any such lot of food had in whole or in part entered distribution, by distributing bean products after a side seam defect was identified by plant personnel and confirmed by the can manufacturer.  The issue was identified as a weld adhesion failure on the side seams.  The company only considered a market withdrawal for cans manufactured on one day identified as having the most can seam defects, but other dates were involved. "The explanation provided to the FDA Investigators was that your Quality Assurance Department identified this as a food quality issue and not a food safety issue."  Additionally, the firm did not conduct any microbiological tests on the questionable lots at the time of the inspection, and, was not able to give assurance that those products would pose no significant health risks to consumers due to potential post-process contamination based on the observed side seam defect.  The firm did not routinely do microbiological analysis of the cooling water, which while not expressly required, it is important to show control.

2.  Failed to perform and record defects of containers, and perform a corrective action when cans were identified as losing their hermetic seal.  Basically, the firm had an inline dud detector to determine which cans had lost vacuum, but the record keeping was poor and there was no follow-up to cans that were rejected.

The Low Acid Canned Food regulations (LACF) are in place for all those who package low acid canned foods where Clostridium botulinum can be an issue. 


https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm578558.htm
September 29, 2017
Warning letter 535494

FDA Warning Letter - Bakery with 'Love' Listed in Ingredient Statement - Nasty Food Operations Exposed

A MA bakery received a Warning Letter from FDA.  While the bakery violated most all basic GMPs, the one item that has caught the eye of the press is the fact the the company listed 'love' as an ingredient.  "Ingredients required to be declared on the label or labeling of food must be listed by their common or usual name [21 CFR 101.4(a)(1). "Love" is not a common or usual name of an ingredient, and is considered to be intervening material because it is not part of the common or usual name of the ingredient."  But this was just a minor issue compared to the vast array of GMP violations.  That is, unless they refer to nastiness as 'love',..,..then there was plenty.

Now, if I am overseeing a bread operation, and seeing this as well as this Warning Letter in August for a NM bakery, I am getting a sense that FDA will probably be looking at bakeries a little more critically than they have in the past, and thus, it may be time to tighten up the ship a bit more.

There were a ton of issues, but as a sampling:

• Food residue on equipment that was stated as being clean and sanitized including "empty color-coded barrels designated for use with different allergens including tree nuts and cheese with apparent dough residue inside and out, and stacked inside one another."  It was stated that the "firm does not have a procedure or production schedule to ensure cleaning and sanitation is done before production or in between changes to prevent cross-contamination of different allergen products."
• Failed to maintain equipment and utensils and finished product containers in an acceptable condition through appropriate cleaning and sanitizing  - bread residues on screens, totes, etc.
• failed to maintain buildings, fixtures, and other physical facilities in a sanitary condition - ceilings, air intakes etc coated with stuff.
• Failed to ensure equipment, containers, and utensils used to convey, hold, or store raw materials, work-in-process, rework, or food shall be constructed, handled, and maintained during manufacturing or storage in a manner that protects against contamination
• failed to provide, where necessary, adequate screening or other protection against pests - flies and crawing bug in processing area.
• Personnel not following basic GMPs. - wearing jewelry, eating in operational areas.

FDA Warning Letter
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm577393.htm
Office of Human and Animal Food Operations East
Division 1

WARNING LETTER
CMS# 532236

Nashoba Brook Bakery, LLC 9/22/17
September 22, 2017

Auditor General - FDA Follow-up to Inspections Found to Be Slow and Lacking

In a report by the Auditor General to the FDA, there was criticism that FDA was not taking enough action fast enough.  "Auditors examined data from 2011 to 2015 and determined the agency was on pace to conduct the required inspections, but hadn’t made sure that all problems were corrected."  In defense, many of the inspections that were longer in response were for dietary supplements - the wild west of FDA's regulatory world.  And with new regulations just coming upon implementation date, there is a huge gap in knowledge for both the firms and the inspectors.

• In the time frame analyzed, inspectors found significant dificiences in 1245 establishments.
• While some type of actions was taken in 78% of the inspctions, in 22% nothing was done.
• "Almost half of the warning letters were sent after the agency’s goal of four months [which is still a long time]. Twenty percent were sent after more than six months, and 2 percent were sent more than a year after the inspection."
• "The agency took an average of 6.7 months to initiate judicial action, the audit said. In one case, a seizure didn’t occur for more than a year, and an injunction didn’t occur for nearly two years."
• "Of 766 facilities that received “advisory” actions, about 1 in 5 were found to have significant violations on follow-up inspections. In about three-quarters of them, the violations were identical to those previously discovered."

The Morning Call (Allentown, PA)

http://www.mcall.com/news/watchdog/mc-nws-food-safety-inspection-problems-watchdog-20171003-story.html
Food safety oversight not well done
by Paul Muschick•Contact Reporter
The Watchdog
October 4, 2017, 8:55 PM

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

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

A NM Bakery Issued a Warning Letter - Issues with Sanitation and Lack of Management Training

A New Mexico bakery was issued a warning letter from the FDA.  Most of the issues cited involved basic sanitation, and they were issues that were also noted in a 2014 inspection...thus the issuance of the Warning Letter.  To look at the facility from Google Street view (below), it looks like a legit operation (compared to this)

Many bakeries may be new to FDA inspections, although it was noted that this firm had a previous FDA inspection in 2014 (and unfortunately, didn't make much progress from that time...or so it seems).  But one of the items that is most interesting involves training, or the lack of training, specifically of management (see further down).

• Unsanitary condition noted on 1) walls, overhead door, and cooling fan in areas used to cool baked bread., 2) condenser fans and support pole in walk-in refrigerator used to store uncovered apple pies, and 3)  3-Compartment sink used to clean in process equipment.
• Peeling paint in the incoming supply room above ingredient containers which had broken lids, no lids, lids not fully covering materials. Additionally, peeling paint was observed on the ceiling of the walk-in refrigerator used to store uncovered apple pies.  
• Fresh and dried dough on the ceiling above an uncovered mixer and along the rim of the (b)(4) bucket. (b)(4) is used as a processing aid in the production. 
• Condensation issues  with buildup inside the proofing  along the ceiling, sides of walls, and along the door frame. As the uncovered dough enters the  proofing (b)(4), condensation drips directly onto uncovered dough.  Dark brown condensation buildup was observed in the production area on the ceiling above the proofing  and the final bread rolling area.  Condensation buildup was observed in the walk-in freezer fans located above finished product.
• Inadequate screening or other protection against pests - the outer door and warehouse garage doors were open during food production activities without adequate protection to prevent entry of pests into the production facility.
• The procedure used for cleaning and sanitizing of equipment and utensils has not been shown to provide adequate cleaning and sanitizing treatment - the 3-compartrnent sink was set up in the following incorrect order: wash, sanitize, and rinse. Utensils were then immediately used without allowing them to air dry. At the final dough, recently used trays covered with residue were slammed on the floor to remove particles and then placed onto the cart, without washing, to be reused. Our investigator observed fresh dough immediately placed on these trays and sent to proofing .   In the proof , there is no evidence that the conveyor trays used to transport the dough from the extruder to the are sanitized.  The firm’s water filters have not been changed since 2013. There was dark brown and slimy residue in the filter. The filtered water is used in the production of dough, to clean large pieces of equipment, and used in the 3-compartment sink.

But this is the item to note - "Personnel responsible for identifying sanitation failures and food contamination lack a background of education and experience to provide a needed level of competency as required by 21 CFR 110.10(c). Specifically:

•  The production manager did not know the correct order of operation to properly clean and sanitize utensils at the 3-compartment sink. The 3-compartrnent sink was set up in the following incorrect order: wash, sanitize, and rinse. During the inspection, the rinse water was observed to be cloudy and dirty, providing a possible source of cross-contamination.
• The production manager did not know what the adequate sanitizer concentration should be; there were no test strips available to verify the concentration, and he relied solely on placing one capful of bleach into water
• The president of the company lacks basic sanitation knowledge. For example, when asked about the sanitation procedures, he commented on cleaning the floors and was not aware of equipment cleaning and maintenance schedules. He also did not know the required sanitizer concentration and did not provide test strips to employees for verification."

As we know, as part of 21CFR117, it is required that management be adequately trained in food safety.

Finally - the firm failed to provide appropriate training in food handling techniques and food protection principles have not been provided to food handlers 1) an employee touching ready to eat bread rolls with bare hands to determine if they were cool enough for packaging. 2) an employee in the packaging area wearing only one glove, on the right hand. The employee was manually sorting bread into final packaging with both the gloved and bare hands.

FDA Recall Notice
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm570807.htm
July 5, 2017
WARNING LETTER
Brent A. Bischoff
President
K & B Company Inc.
109 Arnold St.
Gallup, NM 87301

Virginia Peanut Company Issued Warning Letter - A Cat for Pest Control? The Risks of Ordering Food Online

FDA issued a warning letter to a Virginia peanut products company.    A summary of the key findings:

• A cat as pest control.  And cat feces in the facility.
• Sliding doors not sealed providing an opening to the outside
• Employees not properly washing hands
• Employees using tobacco in food contact areas
• Food residues left on equipment
• Old, unused equipment stored throughout facility
• Air flow blowing peanut dust around.
• Employees not wearing hair restraints.
• Labeling issues involving nutrient claims, ingredient statements, and company listing.

It seems that they sell products online, and looking at their website (http://www.epeanuts.com/), it seems like a legitimate company.   However, entering the address into google street view, this is the picture that comes up..

While I am not sure if this is the processing facility or facilities, it does seem to match the description painted by the warning letter.

Really makes you think twice about ordering food online, doesn't it?


FDA Warning Letters
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm569815.htm
Coleman Peanut Company 8/2/17
August 2, 2017

FDA Delays Compliance Dates for Agricultural Water as Part of FSMA Produce Safety Rule

The FDA announced that it is planning to extend the deadline for compliance to agricultural water standards used in irrigation as part of the FSMA Produce Safety Rule .  Irrigation water can be a source of pathogens, but it is not an easy to control, especially when that water comes from surface waters.  Work done here at Penn State by Luke LaBorde etal (ref below) found that it was hard to make a connection between water standards and pathogen levels.  So testing water to see if it meets standards that may not mean much in terms of the pathogens present.  It is easy to see how environmental factors will constantly change...whether that be the occasional presence of animals, the amount of rainfall, the amount of sunshine, etc.

For more information on irrigation water, visit the Penn State Extension Website -http://extension.psu.edu/food/safety/farm/gaps/safe-uses-of-agricultural-water

Food Safety Modernization Act (FSMA) Updates
FDA Intends to Extend Compliance Dates for Agricultural Water Standards

Earlier this year, the U.S. Food and Drug Administration announced that it is exploring ways to simplify the agricultural water standards established by the Food Safety Modernization Act’s (FSMA) produce safety rule (PSR) after receiving feedback from stakeholders that some of the requirements are too complex to understand and implement.

Preparing for a FSMA Audit from FoodOnline

A recent article in FoodOnline (an informative online journal you should subscribe to if you haven't already) discusses how Kraft Heinz prepares for FDA FSMA inspections. A few key points brought up in this article are similar to what we have been hearing about from our industry friends about their recent audits.

A summary of what this company's regulatory affairs manager discussed about their company's experiences:

• 'Inspectors are calling these ‘routine FSMA inspections' and are not distinguishing between Preventive Controls and modernized GMP inspections' 
• These audits are generally more focused on high-risk products.
• Auditors had visited 7 of these audits - one full Preventive Controls inspection and six modernized GMP audits.
• Generally there are three inspectors.
• Audits have lasted 1 to 5 days, mostly 4 to 5 days.
• Four of the seven audits included swabathons (100 to 150 swabs), which included Zone 1 (30%), Zone 2 (20%) and Zone 3 (50%).  No zone 4.
• There is a focus on the company's environmental monitoring program including the records and corrective actions on positvie results.
• With regard to verification activities, they are focusing on records including corrective action logs, production schedules, sanitation records, and calibrating inspection equipment records.
• With regard to the Preventive Control plan, inspectors are reviewing the hazard analysis with questions on the justification behind each of the identified hazards.
• There is also a review of the written recall plan.
• Recently there is attention on the supply chain program.
• Review of handling of byproducts used for animal feed, consumer complaint handling, and FSPCA training looking for certificates of completion.

An interesting item in the article is that FDA will want to take photos in the facility, so a company needs to have a policy to address this.  The same goes with photocopying records.

Source: Food Online 
Inside Kraft Heinz's FSMA Inspection Readiness 
Link
By Sam Lewis, associate editor
Follow Me On Twitter @SamIAmOnFood

FDA Issues Warning Letter To Company Because Proof of Corrective Action to Inspection Items Not Provided

FDA issued a Warning Letter to a Kansas City Company after the company failed to provide evidence or proof of corrective action following an FDA inspection.  So while the company stated in their response letter that corrective action was taken, they failed to provide proof of that corrective action.

While it is hard to know the circumstances involved in this case, it demonstrates what some FDA offices are looking for in terms of response to FDA inspirational observations.

KC Innovations, Inc 3/24/17
March 24, 2017
WARNING LETTER
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm549341.htm

FDA Issues Warning Letter to Bakery

FDA issued a warning letter to a California bakery for...a lot of stuff.

- No allergen control

- Poor cleaning - residual raw dough present after cleaning (and we all know this creates a Salmonella / E. coli growth opportunity).

- Leaky roofs - source of Salmonella and moisture

- Poor pest control - presence of insects, poor protection against entry

- Poor personal hygiene practices - people not wearing hair protection
- Improper labeling

With FSMA, bakeries may be getting more attention than in the past.  Because products are generally considered low risk, they have not received the scrutiny of higher risk products.  However, with issues from allergens to Salmonella in flour/dough, they are not risk free.


Nobel Bakery, Inc. 3/16/17

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm549608.htm
WARNING LETTER
March 16, 2017
WL# 19-17
Norik Nikogosyan, President/Co-Owner
Nobel Bakery, Inc.
5638 Cahuenga Blvd.
North Hollywood, CA 91601-2103

FDA Releases Draft Guidance to Assist Sprout Operations Comply with FSMA

FDA released a draft guidance to help sprout operations comply with FSMA regulations. 

The issue with sprouts is that the same conditions that allow the sprouts to grow from seeds also allows bacteria present on the seed to grow, and if these are pathogenic bacteria and the sprouts are eaten raw, then illnesses can occur.  One of the keys is sanitizing the beans before beginning the sprouting process to eliminate any pathogenic bacteria.

FDA Constituent Update
http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm536958.htm
FDA Announces Draft Guidance to Help Sprout Operations Comply with Produce Safety Rule
Constituent Update
January 19, 2017

Warning Letter Issued to Manufacturer of RTE Cookie Dough Contaminated with Listeria

FDA issued a warning letter to Aspen Hills, the manufacturer of ready-to-eat (RTE) cookie dough that was used in ice cream. Aspen Hills conducted a recall of the product after the FDA audit, and along with that, a number of manufacturers who used their product as an ingredient, also issued recalls, including Blue Bell.

FDA found 4 positive Listeria monocytogenes (LM) samples. They appear to be zone 2 and 3 samples. Interesting is that we see that the zone 3 samples - wheels and ladders - are typical types of samples that scream Listeria is on the move in the facility. From the report ((b)(4) redacted text):

• On the second stair/rung of the ladder well leading to the elevated control room. This ladder is adjacent to the (b)(4) used on the cookie dough (b)(4).
• On the wheels of the pallet jack used to move food products within the production room. The pallet jack was located in the (b)(4) of the production room adjacent to the (b)(4) at the time of sampling.
• On the basket located in the (b)(4), which is adjacent to the (b)(4) where the exposed cookie dough receives (b)(4).
• In the (b)(4), which is adjacent to the (b)(4) where the exposed cookie dough receives (b)(4).

FDA saw that the firm was seeing Listeria put was not aggressive in cleaning it up. The firm found 10 positive environmental LM samples and one positive product samples

"indicates that your firm is not taking aggressive action to identify harborage sites for L. monocytogenes, to deep clean your facility effectively, and to prevent finished product contamination."

The isolates from the facility were stated as all being genetically the same. This indicates an organism that has become well adapted to that facility.

• As far as GMP issues which would contribute to cross contamination:
• Spraying of the floor with hoses while product was not covered (1a)
• Residue on the floor with pallet jacks and forklifts running through it. (1b)
• Poor employee practices with regard to protecting clothing and boots from cross contamination. (1c)
• Sparying floor and drain with overspray hitting equipment (1d)
• Inadequate cleaning of a scale used to weigh pasteurized egg (2a)
• Rust and missing bolts on processing equipment (3)

Preventing these issues is the goal of FDA's new draft guidance for Listeria control in facilities that manufacture RTE products. It comes down to putting good practices in place, monitoring the environment and thus how well those practices are working, and then having a seek-and-destroy mentality with regard to Listeria.

FDA Warning Letter

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm536757.htm

Aspen Hills, Inc. 1/10/17

FDA Releases Draft Guidance: Control of Listeria monocytogenes in Ready-To-Eat Foods

FDA released its Draft Guidance for the control of Listeria monocytogenes in RTE foods. This document applies to facilities that are subject to the Preventive Controls as well as smaller firms only subject to cGMPs. This document is open for comments before becoming finalized.

This is a necessary read for any FDA regulated company producing RTE product where there is exposure of the product to the environment before packaging. This document discusses control, environmental monitoring, and corrective action. While less prescriptive than the earlier version (it puts more responsibility on the processor for determining risk), it is more aggressive in terms of expected controls and monitoring.

The guidance does differentiate high risk from low risk product (low risk will not support more than one log of growth), and this impacts the monitoring regiment as well as corrective action, although both low risk and high risk product require both monitoring and corrective action.

The guidance discusses product formulating for control of Listeria where that formulation must limit the growth of Listeria to less than one log. It also discusses reduction processes, and processes that are considered Listeria reduction must reduce by 5 logs.

Environmental monitoring should cover both food contact surfaces (FCS) and non-food contact surfaces (non-FCS) and they recommend Listeria ssp. FDA suggests 5 FCS and 5 non-FCS taken several hours into production. This is more aggressive than doing pre-operational swabs. They suggest a sampling frequency of monthly for low risk products and weekly for high risk products.

There is a lengthy discussion on corrective actions should an environmental sample be found positive, but much of this, as they point out, is dependent upon the particulars of the facility and the product. This passage is important to point out:

"As discussed in section II.C, L. monocytogenes is widespread in the environment, has been isolated from food packing and processing environments, and has been shown to persist in equipment and the processing environment in harborage sites. As a result, you should expect to detect the presence of Listeria spp. or L. monocytogenes on an occasional basis in environmental samples collected from your plant. As discussed in section XIII.A, the goals of an environmental monitoring program include finding L. monocytogenes and harborage sites if present in your plant and ensuring that corrective actions have eliminated L. monocytogenes and harborage sites when found in your plant. If you consistently see negative test results in environmental samples collected from your plant, we recommend that you revise your environmental monitoring procedures to add, substitute, or both add and substitute other surfaces in your plant for sample collection and testing to ensure you are not missing a source of contamination."

There is also a section on finished product testing.


Please contact us if you have any questions on this document.

Court Upholds FDA Not Negligent in Issuing Warning in 2008 Salmonella Outbreak

The US Court of Appeals upheld the ruling that FDA did not negligently issue a warning about tomatoes contaminated with Salmonella as part of the 2008 Salmonella outbreak. In this case where 1442 people reported illness after eating salsa. FDA initially issued a warning that tomatoes were the likely source, but later it was discovered it was the peppers. Of course, this warning resulted in many tomatoes going unsold as people avoided them. "The court determined that the warning properly fell within the discretionary function exception of the Federal Tort Claims Act and that the district court "ruling was essential to protect FDA's vital role in safeguarding the public food supply."

This case points to the pressure on reporting potential sources of contamination versus the economic impact of a misdiagnosis of the real source. In this case, the tomato industry last millions of dollars. The impact of newer technologies, specifically whole genome sequencing, will benefit these types of investigations.

Penn State Law - The Agricultural Law Brief
https://pennstatelaw.psu.edu/academics/research-centers/center-agricultural-and-shale-law/agricultural-law-brief
JANUARY 2017
Food Safety: Court Rules FDA did not Negligently Issue Salmonella Warning

FDA Makes Complaint Database Available, Updates Process for Filing Complaints by Consumers

FDA is making its adverse-event database available.  This list voluntary reports of adverse effects from food as well as reports of drugs.

"The new data can be particularly helpful in the area of food-safety issues, Jacobson said, because the FDA has “a very limited budget, and traditionally has been behind the curve in identifying problems and trying to correct them.”
The database “gives some hint about hot spots in the food supply,” Jacobson said. “If you see large numbers, it’s probably not some random consumer making a spurious association between a headache and something they ate.” 

In the past, this information was available though the Freedom of Information Act, now, it will be available for researchers, companies, and of course lawyers.

Interestingly, FDA receives only about 7500 complaints per year.  Not a lot when you think about the number of products sold each day to 320 million people.

The FDA updated procedures for filing complaints for consumers.  FDA directs consumers on how to report non-emergency complaints.   They can call the FDA Consumer Complaint Coordinator assigned for each state or to go online and report to MedWatch website.

Bloomburg BNA
https://www.bna.com/fda-food-cosmetics-n73014448792/
FDA Food, Cosmetics Data Boon for Attorneys, Companies
December 19, 2016

Milk Product Producer Issues Recall After FDA Seized Product

(Updated Dec 13, 2016.   Valley Milk Products issued recall announcement on FDA website).

Valley Milk Products issued a recall of milk and buttermilk powder after FDA seized product due to the potential for Salmonella contamination.   As reported a few days earlier, FDA seized product after an investigation found Salmonella in the environment, the same strains that had been hanging around for years.  While FDA had urged the company to recall, they initially refused because they stated that testing had never found Salmonella in product.  Well, FDA felt the environmental evidence was strong enough to warrant seizing product.

It is hard to guess the circumstances that were present to have this standoff, however, it does indicate that FDA will take action based upon conditions that might support adulteration, but not necessarily product contamination.  In this case, the facility had some ongoing issues that should have been resolved, but the degree of risk is hard to guess.

FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm532828.htm
Valley Milk Products, Strasburg, Virginia Recalls Limited Amount of Milk and Buttermilk Powder Because of Possible Health Risks
For Immediate Release December 9, 2016