FDA Releases Investigation Report of 2020 E. coli O157:H7 Outbreak Linked to California Leafy Greens

Here are the bullet points from that report.  In a nutshell, cattle in close proximity are the issue and it will take more than the FDA to fix the issue.

• FDA has found that in this and past foodborne illness outbreak investigations "suggest that a likely contributing factor for contamination of leafy greens has been the proximity of cattle." 
• FDA "recommends that all growers be aware of and consider adjacent land use practices, especially as it relates to the presence of livestock, and the interface between farmland, rangeland and other agricultural areas, and conduct appropriate risk assessments and implement risk mitigation strategies, where appropriate."
• "The 2020 E. coli O157:H7 outbreak associated with leafy greens represents the latest in a repeated series of outbreaks associated with leafy greens that originated in the Central Coast of California (encompassing Salinas Valley and Santa Maria) growing region."
• FDA "recommends that growers of leafy greens in the California Central Coast Growing Region consider this reoccurring E. coli strain a reasonably foreseeable hazard, and specifically of concern in the South Monterey County area of the Salinas Valley."
• FDA "also recommends that the agricultural community in the California Central Coast growing region work to identify where this reoccurring strain of pathogenic E. coli is persisting and the likely routes of leafy green contamination with STEC."
• FDA "alone cannot fix this issue. Industry leadership and collaboration among growers, processors, retailers, state partners and the broader agricultural community is critical to reducing foodborne illnesses. "

Associated Documents

FDA Investigation Report: Factors Factors Potentially Contributing to the Contamination of Leafy Greens Implicated in the Fall 2020 Outbreak of E. coli  O157:H7
FDA Leafy Greens STEC Action Plan

https://www.fda.gov/news-events/press-announcements/fda-releases-investigation-report-following-fall-2020-outbreak-e-coli-o157h7-illnesses-linked-leafy
FDA Releases Investigation Report Following Fall 2020 Outbreak of E. coli O157:H7 Illnesses Linked to Leafy Greens
Agency affirms need for new collaborative actions to build on accomplishments in its Leafy Greens Shiga Toxin-Producing E. coli (STEC) Action Plan

FDA Issues First Injunction Under Produce Safety Rule Shutting Down an Illinois Food Processor

The FDA issued the first injunction against a firm or grower for violating the Produce Safety Rule enacted under FSMA.  The Illinois processor  of sprouts and soy products has stopped production until it undertakes corrective action and comes in compliance with the regulations.  This comes after FDA had conducted multiple inspections where they documented insanitary conditions showing that sprouts and soy products had been produced in insanitary conditions.

The company had been issued a Warning Letter in July in which identified violations where significant evidence of rodent activity and insanitary conditions and practices throughout the farm mixed-type facility. Based on these findings, FDA determined that the mung bean sprouts, tofu products, and soybean noodle products were adulterated.  They noted employees shoveling product back up off the floor, product getting hung up in equipment, poor water handling systems, an inadequate Listeria control program,  extensive rodent infestation, inadequate handwashing facilities,  inadequate allergen labeling, etc.


FDA News Release
https://www.fda.gov/news-events/press-announcements/fda-issues-first-injunction-under-produce-safety-rule-illinois-based-food-manufacturer-repeated-food
FDA issues first injunction under Produce Safety Rule to Illinois-based food manufacturer for repeated food safety violations

For Immediate Release:
September 15, 2020

The U.S. Food and Drug Administration announced today that Fortune Food Product, Inc., an Illinois-based processor of sprouts and soy products, has agreed to stop production until it, among other things, undertakes remedial action and complies with the Federal Food, Drug, and Cosmetic Act.

FDA Warning Letter - HACCP Issues for NY Seafood Processor

FDA issued a Warning Letter to a NY seafood processor for issues associated with HACCP compliance for their operation.   The company had four common issues noted.

1) Temperature monitoring of a cooling step did not take worse-case scenario for product characteristics as well as did not have an adequate frequency.

"FDA recommends when selecting samples to consider the variables that affect the rate of cooling and represent “worst case” conditions. This can include overlapped or closely placed units, the position of the units in the tray and on the (b)(4) where heat may be retained (e.g., the units in the center of the trays in the middle of the (b)(4)), and the distribution of cold air in the cooling room. In addition, your listed frequency, “at least every (b)(4),” is inadequate to show that your critical limit of “…no more than (b)(4) of those (b)(4) is above (b)(4)” is not exceeded."

2) The company was missing monitoring records.

"...firm did not have post cooking process cooling monitoring records documenting times and temperatures of products that were cooled after cooking between January 3 and January 14, 2019. Review of your firm's Cooking CCP monitoring records during this period revealed that your firm was manufacturing and cooking fish products during this time."

3) The company did not have corrective action records for certain process deviations. 

"a review of your Post Cooking Process Cooling monitoring records revealed that at least on one occasion products were not cooled below the listed critical limit......Your firm’s response dated December 4, 2019 stated that a corrective action was performed at the time of the deviation even though a record was not created."

4) The firm did not take appropriate corrective action in response to certain deviations.

"...firm’s “Cooking” critical control point monitoring records identified deviations from your temperature critical limit on multiple production days. However, you determined these deviations were the result of the improper use of (b)(4) temperature recording devices by employees. You firm did not perform or document any corrective actions."

FDA Warning Letter

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/shung-kee-food-co-ltd-598630-03202020
Shung Kee Food Co., Ltd.
MARCS-CMS 598630 — March 20, 2020

FDA Issues Warning Letter to AZ Candy Company

An Arizona candy company was issued a Warning Letter by FDA.
The main issues were:
1) In the hazard analysis, they did not evaluate all of the ingredients used in the product.  The hazard analysis must evaluate every ingredient in the process.
2) There was an issue with the environmental monitoring.  I have a little issue here with the FDA's statements.  Environmental monitoring is specific for the facility.  There should not be a need for testing for Listeria in a candy facility.  Not to say environmental monitoring is not needed, however, I would like to see some additional support for the comments FDA is stating in this item.
3) The firm was buying raw nuts and roasting them, but the firm claimed that Salmonella was not a hazard because there was Supplier Control.  But clearly, the firm would have a Process Preventive Control in terms of Roasting.
4) The firm did not have a good pest control program.

From the report, Item 1.
Your hazard analysis for your RTE peppermint snow mints, chocolate pretzel clusters, and cinnamon honey peanut butter did not include an evaluation of all ingredients used to manufacture these products.
Specifically,
a. The hazard analysis for "[Chocolate] Molding," which applies to its use in peppermint snow mints, did not identify or evaluate potential hazards for the ingredient crushed peppermint/candy cane, such as recontamination with environmental pathogens and unapproved colors/additives.
b. The hazard analysis for "[Chocolate] Molding," which applies to its use in chocolate pretzel clusters, did not identify or evaluate potential hazards with the ingredient pretzels, such as recontamination with environmental pathogens.
c. The hazard analysis for (b)(4), which applies to the performance of this activity to make cinnamon honey peanut butter, did not identify or evaluate potential hazards for the ingredient ground cinnamon, such as Salmonella spp. and heavy metals, and for the ingredient honey, hazards such as drug residues and pesticides.

Michigan Processor Agrees to Stop Production After Unable to Control Listeria

A Michigan food processor agreed to suspend operations after years of not being able to get compliant with regulation.   Home Style Foods of  Hamtramck, MI, a manufacturer of ready-to-eat seafood and deli salads, failed to get take sufficient corrective actions to get their Listeria monocytognes issues under control.  From the notice:

"According to the complaint filed with the consent decree, the FDA inspected the facility seven times between May 2009 and June 2018. During each inspection, the FDA investigators observed significant objectionable conditions. The FDA also found L. mono in the facility in two of the inspections, including the most recent inspection. The company was issued an FDA Form 483 after each of the seven inspections, was issued a warning letter in April 2016 and the company attended a regulatory meeting with the FDA in January 2017. The defendants repeatedly promised to take corrective actions to address the objectionable conditions. However, the FDA’s June 2018 inspection showed that the defendants have failed to take effective measures to bring Home Style Foods’ ready-to-eat food processing operations into compliance with the law."

FDA News Release
https://www.fda.gov/news-events/press-announcements/michigan-based-food-manufacturer-agrees-stop-production-after-repeated-food-safety-violations
Michigan-based food manufacturer agrees to stop production after repeated food safety violations
For Immediate Release:January 13, 2020

FDA Warning Letter to RTE Cheese Processor

FDA issued a Warning Letter to a cheese facility in Miami.  Issues include no Preventive Control Plan and really poor GMPs (dripping condensate, leaking pipes, and inadequate sanitation).  And they are producing RTE cheese product of some sort.

The thing that gets you is the company name....US Dairy Unlimited.   You are thinking with a name like that, that is a serious operation.  Could have called it Ury's Cheese, but who would buy that.  But US Dairy Unlimited....there are no limits to what they can do, or so one would think.

But looking at the facility (based on address from notice on Google Map Street view), it looks like nothing like Dairy Unlimited.  Not to say they can't make good products, but if this is your supplier, you may want to investigate a little closer.  For example, your purchasing person informs you that they have contracted a new co-packer....US Dairy Unlimited.  What supplier approval process granted this?

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/us-dairy-unlimited-llc-590413-11192019
WARNING LETTER
U.S. Dairy Unlimited, LLC
MARCS-CMS 590413 — November 19, 2019

FDA Warning Letter - RTE Salad Company

FDA issued a warning letter ready-to-eat RTE prepared foods manufacturing facility that produced RTE salads.  There are issues with the Preventive Control Plan as well as GMP issues.  One of the interesting items regarding their plan was that they were not following it.  Item number 3 below points out how many people write up a plan, and in that plan, they overstate what they do.

1) Listeria was found in the facility, the same strains of Listeria that were found in previous inspections - "FDA collected environmental samples from various areas of your processing facility. FDA laboratory analysis of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility, including the same strain found during FDA’s 2017 and 2018 inspections".  "Whole Genome Sequencing (WGS) of isolates detected in the FDA environmental samples identified six (6) isolates with the same strain of L. monocytogenes. Specifically, the same strain of L. monocytogenes was identified in three (3) isolates from environmental samples collected during the 2019 inspection, one (1) isolate collected from your facility in April 2018, and two (2) isolates collected from your facility in September 2017."

Because of this it can be stated that Sanitation Preventive Controls were not adequate -
The facility "identified environmental pathogens as a hazard requiring preventive controls and identified sanitation controls to address the hazard. However, as evidenced by environmental findings that indicate a resident strain of L. monocytogenes in your facility, you did not implement sanitation controls adequate to ensure that your facility is maintained in a sanitary"

2) FDA identified SSOPs that were not being followed - The company "did not implement the written sanitation control procedures identified in your SSOP entitled "

3) The company did not follow their own Supplier Preventive Controls - the Plan "states that Certificate of Analysis (CoA) “must be received prior to or on the date of ingredient delivery for all ingredients unless expressly exempted by Hans Kissle QA” and must contain “physical, chemical and microbiological test results for the specific lot number or code of the product.” It was observed that you do not receive CoA’s for RTE/refrigerated diced vegetables and RTE/refrigerated feta cheese that are used in the production of RTE Aegean Greek Pasta Salad. Although you indicated that you have an “exempt list,” these suppliers were not named on this list.  Additionally, no further kill step is applied to the diced vegetables and feta cheese in the production of RTE Aegean Greek Pasta Salad.  Note that when a hazard in a raw material or other ingredient will be controlled by the supplier and is one for which there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans, the appropriate default supplier verification activity is an onsite audit of the supplier"

4) GMP issue- Food stored directly on ground - "bags of RTE vegetables, including one (1) open bag of RTE carrots and one (1) torn bag of cucumbers, were staged on the floor of the hallway (b)(4) room.  This area was observed to be a high employee and equipment traffic area.  These bags of RTE vegetables are removed from their outer boxes in the hallway and placed onto plastic pallets or plastic totes adjacent to this area, (b)(4) was being washed and sanitized using (b)(4) that occasionally sprayed beyond the (b)(4) into the area where the vegetables were stored.

5) GMP issue - leaking valves through the facility - "during the most recent inspection of your facility, the following equipment conditions were observed in areas where there is significant handling of RTE product and employee movement"


https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hans-kissle-company-llc-584080-09242019
WARNING LETTER
Hans Kissle Company, LLC
MARCS-CMS 584080 — September 24, 2019

FDA Issues a Warning Letter to CA Bakery for Being Nasty

FDA issued a Warning Letter to a CA bakery for, in short, being nasty.   They missed the memo that they had to comply with FDA regulations.  A problem we have seen with many smaller companies that are now required to have registered with FDA and thus are subject to FDA inspection...especially an issue among bakeries.

"..food manufactured in your facility is 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 it was prepared, packed or held under insanitary conditions whereby it may have become contaminated with filth or rendered injurious to health.  In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by section 301(uu) of the Act (21 U.S.C. § 331(uu))." 

The inspection of the company found that they...:

• Did not have a written food safety plan.
• Did not take effective measures to exclude pests from the manufacturing, processing, packing and holding areas to protect against contamination of food on your premises by pest..had rodent excrement and insects in various places.
• Did not clean all food contact surfaces, including utensils and equipment, as frequently as necessary to protect against allergen cross-contact and against contamination
• cutting boards used to prepare products were scarred and heavily stained with a dark residue, and the plastic containers used to hold and dispense various dry ingredients were observed cracked, some being held together with blue tape,
•  ice cream scoop, used to fill lemon poppy muffins which contain almonds and wheat flour, was seen stored in a bucket of water and then used to fill gluten free muffins, which do not contain almonds or wheat flour, without being cleaned between uses
•  prepare products with raw ingredients on the same wooden table that finished products are prepared for further processing and packaging.
• The floors are not constructed in such a manner that they may be adequately cleaned and kept in good repair - specifically, during the inspection our investigators observed standing water and pitted floors with exposed aggregate, immediately adjacent to clean equipment on shelves. 
• Employees working in direct contact with food, food-contact surfaces, and food packaging materials did not conform to hygienic practices 
• Wholesale products are misbranded - the product labels fail to bear the common or usual name of the food, labels fail to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count, labels fail to include the place of business of the manufacturer, packer, or distributor, and the Lemon Poppy and Strawberry Cupcake Muffin products bear or contains a color additive which is unsafe within the meaning of section

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sweet-production-inc-578494-06172019
WARNING LETTER
Sweet Production Inc.
MARCS-CMS 578494 — Jun 17, 2019

FDA Releases Draft Industry Guidance for Voluntary Recalls

FDA issued a draft guidance on how to issue a voluntary recall.  (This draft guidance is listed FDA's webpage Industry Guidance for Recalls which has a number of valuable links including Model Press Releases. - https://www.fda.gov/safety/recalls/industryguidance/default.htm)

"The draft guidance discusses what preparations firms in a distribution chain, including manufacturers and distributors, should consider making to establish recall initiation procedures; to ensure timely identification of, and response to, product problems that might lead  to a recall; and to promptly issue recall communications and press releases or other public notices. It also discusses preparations firms in the distribution chain should consider making to ensure timely responses to a recall communication. Additionally, it discusses how FDA assists firms with carrying out their recall responsibilities to protect the public health from distributed products in violation" of federal regulations.

Firms should be recall ready.
1. General Preparations

FDA Releases Report on Strategy for Imported Food

FDA released a report on their strategy for ensuring the safety of food imported into this country.  Full report can be found here.

First, a few facts

• There is a continued 15 year trend of increasing importation of food 
• Annually, the US imports:
• 32 percent of the fresh vegetables, 
• 55 percent of the fresh fruit, and 
• 94 percent of the seafood 
• US imports food from more than 200 countries or territories and approximately 125,000 exporting food facilities plus farms
• In 2019, between 14 and 15 million shipments of imported food are expected to enter the United States
• Mexico accounts for the largest percentage of shipments followed by Asia.

FDA applies the same U.S. food safety requirements to all food consumed in the United States, regardless of whether the facility or farm that produces the food is located within the United States or half way across the globe.  But the strategy for overseeing this is different than for domestic product.  Much of this is based upon a risk based approach with focus on highest risk items with a continued optimization of the process.  It also utilizes partnerships as well as pre-approvals.

GOAL 1: Food Offered for Import Meets U.S. Food Safety Requirements

Objectives

1. Optimize use of foreign inspections
2. Ensure importer use of verified foreign suppliers through effective implementation of the Foreign Supplier Verification Programs final rule
3. Take into account the public health assurances of reliable audits such as those issued under FDA’s Accredited Third-Party Certification Program or pursuant to other assurance programs aligned with FDA food safety requirements
4. Incentivize importers to use verified suppliers of safe food through the Voluntary Qualified Importer Program
5. Leverage the oversight efforts of regulatory counterparts with strong food safety systems
6. Increase awareness of and training on food safety requirements and strengthen the capacity of foreign suppliers to produce safe food

GOAL 2: FDA Border Surveillance Prevents Entry of Unsafe Foods

Objectives

1. Continue to enhance and refine FDA’s import screening and entry review processes
2. Optimize use of physical examination and sampling of imported food
3. Strategically utilize import alerts and import certifications
4. Improve testing methodologies and tools used to determine admissibility of food offered for import
5. Maximize the benefit to border surveillance from state and other partnerships

GOAL 3: Rapid and Effective Response to Unsafe Imported Food

1. Maximize effectiveness of FDA response to an event involving an imported food
2. Enhance the efficiency and effectiveness of imported food safety recalls
3. Use information-sharing opportunities to prepare for and respond to the entry of unsafe imported food

GOAL 4: Effective and Efficient Food Import Program

1. Optimize resource allocation by developing a comprehensive global inventory of food facilities and farms and assessing the cumulative oversight applied to the global inventory
2. Ensure effectiveness of import activities through performance assessment and continuous improvement

FDA Issues Final Guidance on Conducting Recalls

FDA issued a final guidance document on conducting recalls - Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C Guidance for Industry and FDA Staff.  The document can be found here:  LINK

Your own recall procedures should reflect what is in the guidance.

A few key items to note:

FDA Updates E.coli Outbreak Linked to Romaine Lettuce, At Least One Farm Identified

Updating the ongoing investigation into the E.coli O157:H7 contamination in romaine lettuce, FDA announced that one farm so far has been linked so far as a source of product.  FDA "identified a positive sample result for the outbreak strain in the sediment of a local irrigation reservoir used by a single farm owned and operated by Adam Bros. Farms in Santa Barbara County."    With that, they are leaving the romaine warning in place for "Monterey, San Benito, and Santa Barbara Counties".  While the E.coli organism found in the sediement matched the outbreak strain via Whole Genome Sequencing (WGS), the traceback analysis indicates that more than this one farm are probably involved.

They went on to state, "It’s important to note that although this is an important piece of information, the finding on this farm doesn’t explain all illnesses and our traceback investigation will continue as we narrow down what commonalities this farm may have with other farms that are part of our investigation. While the analysis of the strain found in the people who got ill and the sediment in one of this farm’s water sources is a genetic match, our traceback work suggests that additional romaine lettuce shipped from other farms could also likely be implicated in the outbreak. Therefore, the water from the reservoir on this single farm doesn’t fully explain what the common source of the contamination."

"As of Dec. 13, our investigation yielded records from five restaurants in four different states that have identified 11 different distributors, nine different growers, and eight different farms as potential sources of contaminated romaine lettuce. Currently, no single establishment is in common across the investigated supply chains. This indicates that although we have identified a positive sample from one farm to date, the outbreak may not be explained by a single farm, grower, harvester, or distributor."

Also as of the December 13th report, there have been 59 people infected in 15 states, with the last reported illness onset date being Nov. 16.

The farm with the positive E.coli sample in the sediment, Adams Brothers, has been cooperating.   They are a fifth generation farm.

FDA Statement
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm628400.htm
Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner Frank Yiannas on new findings and updated consumer recommendations related to the romaine lettuce E. coli O157:H7 outbreak investigation
For Immediate Release
December 13, 2018

Summary of FDA's Report on Risk Factors in Food Service Establishments

FDA compiled analysis of inspection reports of different foodservice establishments over 2013/2014 as part of a 10 year study.    The whole report can be found here, but we have summarized the most important findings:

• Most establishments had 3 or more food safety issues.
• It helps to have a Certified Food Safety Manager onsite.  Many jurisdictions do not require it.
• It is beneficial to have an established food safety management system.  Most have no system to a rudimentary system.
• While people generally cook food correctly and handle raw meats properly, handwashing and keeping TCS foods out of the temperature danger zone are the biggest issues.

FDA Issues Warning Letter to NY Processor for Nastiness

The U.S. FDA issued a Warning letter to a NY firm that manufacturers Ready-to-Eat (RTE) single serve condiment manufacturing and has a warehouse facility.  Based on FDA’s findings during the inspection, the FDA determined that the food products were adulterated within the meaning of regulation in that they were prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health.

The issues were too numerous to detail, so in summary:

• Were packing product that had a pH above 4.6 without proper controls for this low acid product.
• Lots of dead rodents and lots of rodent poop (REP -rodent excreta pellets)
• Roaches
• Unclean surfaces and equipment
• Condensation issues
• Improper processing and cleaning procedures

Elwood International has a website. From the website about the company:

30 years ago, Elwood began making dietetic portion controlled products exclusively for hospital service. Today, Elwood is a recognized leader in the dietetic food industry; with a complete line of Salad Dressings, Jellies and Condiments specifically formulated for diabetics and others who must follow modified and restricted diet meal plans.
Elwood manufactures a complete line of great tasting sucrose-free foods that diabetics can trust, such as:
Salad Dressings, Jellies, Sauces, Condiments and Pancake Syrup. Some of our exciting flavors are Russian, Oil & Vinegar, Thousand Island and Blue Cheese Salad Dressings, Cranberry, Tartar, Barbecue and Seafood Cocktail Sauces, Strawberry, Grape, Apricot, Raspberry and Apple Jelly, Pancake Syrup and Condiments like Mayonnaise and Mustard.  

So great, this product is going to people likely to be considered high risk.

FDA Warning Letter

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm623049.htm
Elwood International, Inc. 9/27/18

FDA Statement on Efforts to Prevent Cyclospora

FDA released a statement concerning Cyclospora in produce in light of the two large outbreaks - Fresh Express and McDonald's Salads where 511 cases where people were infected, and the Del Monte Veggie Tray with 250 cases.

In short, they were not able to find a source in either of the outbreaks, but with the new test they developed, they detected Cyclospora in domestically grown cilantro and romaine lettuce.  From the statement,  "During our investigation, two samples of domestically grown romaine lettuce were also found to be positive for Cyclospora even though they were not sourced from locations associated with the lettuce that was linked to this outbreak. None of the romaine lettuce associated with these positive test results for Cyclospora went into the marketplace and all of the produce suspected of being contaminated was destroyed, preventing additional Cyclospora illnesses from occurring. "

Though increased surveillance of domestic and imported produce along with the implementation of the Produce Safety Rule by farms, FDA hopes to get a handle on this parasite.

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm620867.htm
Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s ongoing efforts to prevent foodborne outbreaks of Cyclospora
For Immediate Release
September 18, 2018

FDA Releases Information for Companies Wishing to Claim 'Qualified Facility' Status

FDA released information for those facilities wishing to file as a Qualified Facility - very small business who only have to meet modified requirements (do not need to develop a formal Food Safety Plan) as defined within the Preventive Controls for Human (or Animal) Rule. 

Facilities must determine if they meet conditions for a Qualified facility and then must submit as attestation.   Starting October 1, 2018, facilities will be able to submit the qualified facility attestation forms electronically via the Qualified Facility Attestation Module.  Facilities must submit their first attestation to FDA by December 17, 2018, for facilities under Human Food and  December 16, 2019 for Animal Food.

1. Determine if you are a Qualified Facility - see this Guidance Document.
2. Follow instruction for submitting attestation form - See this FDA procedure
• Fill out this form for Human Food - Link to Human Food Attestation Form
• Fill out this form for Animal Food - Link to Animal Food Attestation Form

Or you can take a class and develop a Food Safety Plan like regular food companies.


FDA Releases Information for Qualified Facilities under Preventive Controls Rules
September 14, 2018
Today, the U.S. Food and Drug Administration issued documents designed to help food facilities subject to the preventive controls for human and animal food rules determine if they meet the definition of a “qualified facility” under those rules, and if so, what modified requirements are applicable to such facilities.

Cereal Facility Issued Warning Letter for Inadequate Salmonella Control

FDA issued Kerry Inc a warning letter for their Illinois cereal facility after FDA testing found Salmonella and an FDA audit found that the facility had found numerous Salmonella positive environmental samples.  The FDA ruled that the product was "was prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health".  This is a very interesting case study for product that was most likely used as an ingredient in further processing.

One of major issues was the Salmonella positive samples. From the report:  " Between September 29, 2016 and May 16, 2018, you repeatedly found Salmonella throughout your facility, including in cereal production rooms. During this time period, you had 81 positive Salmonella environmental samples and 32 positive Salmonella vector samples (samples taken in response to finding a positive on routine testing), including four Salmonella (b)(4) samples in the cereal coating room and one Salmonella (b)(4) sample in the cereal (b)(4) room (Line (b)(4)). Further, you had repeated findings of other Salmonella species in some production lines and rooms used for the manufacture of cereal. These repeated findings of Salmonella in your environment should have resulted in a reanalysis of your food safety plan as required by 21 CFR § 117.170(b)(4) and the identification of contamination of RTE cereal with environmental pathogens as a hazard requiring a preventive control (i.e., sanitation preventive control).

 A summary of the points made in the warning letter:

1. The hazard analysis of RTE cereal process did not list environmental pathogens when the finished product was exposed to the environment prior to packaging. This was especially concerning since the facility did find Salmonella in the environment
2. Environmental controls to prevent Salmonella were not implemented sufficiently to control Salmonella. FDA found Salmonella in the processing environment as well as the facility found Salmonella.
3. Corrective actions were not properly implemented to get rid of Salmonella. There were no steps taken to remove the root cause of the Salmonella from the enviromet. Basically, a root cause analysis was not completed even though Salmonella was constantly being found.
4. Sanitation controls were not verified. The company did not follow its own SOP for environmental monitoring

There was no further information regarding the facility, but as an ingredient manufacturer, it is likely that this cereal product is made for use as an ingredient  in foods that will be further processed.   Perhaps this is why a less-than-sufficient effort.  Regardless, 1) FDA viewed this as an RTE product and that may have been difficult to convince otherwise - including providing notice to customers 2) the company should have included it in the hazard analysis, and 3) a better effort should have been made in controlling it.

FDA Warning Letter
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm615073.htm
Kerry Inc 7/26/18

Should We Care About Food Product Standards of Identity?

A news release from FDA discussed the need to review and modernize the 'standards of identity' for food products, specifically in this case, dairy products.  With all of the FSMA regulations in addition to responsibility for drugs, food product 'standards of identity' just don't seem to be that much of a priority.  But should they be?

The standard of identity are used "in an effort to promote honesty and fair dealing for the benefit of consumers, the FDA is authorized to establish by regulation, a common or usual name, a reasonable definition and standard of identity, a reasonable standard of quality, and reasonable standards of fill of the container for any food"  (NDSU Law).  So it says what a product is so that when you buy it, you know what it is.  If you buy grape jelly, you are getting what is considered grape jelly.

One of the big issues has been related to milk.  From the FDA release, one of the primary issues is "plant-based foods that are being positioned in the marketplace as substitutes for standardized dairy products. Many of these plant-based foods use traditional dairy terms (e.g., milk, yogurt, cheese) in the name of the product. For instance, we’ve seen a proliferation of products made from soy, almond or rice calling themselves milk. However, these alternative products are not the food that has been standardized under the name “milk” and which has been known to the American public as “milk” long before the 1938 Federal Food, Drug, and Cosmetic Act (FD&C Act) was established. In addition, some of these products can vary widely in their nutritional content – for instance in relation to inherent protein or in added vitamin content – when compared to traditional milk."

Basically, soy milk or rice milk is not really milk.  Milk is collected lactation from animals.  Soy beans don't have mammary glands. It's not milk, it is expressed bean juice.  So is this an issue?  Well, it can be because some people don't understand that milk and bean juice don't have the same nutritional parameters.  Just being white doesn't make it milk.    FDA used a few cases to demonstrate this issue, in one "case reports show that feeding rice-based beverages to young children resulted in a disease called kwashiorkor, a form of severe protein malnutrition. There has also been a case report of a toddler being diagnosed with rickets, a disease caused by vitamin D deficiency, after parents used a soy-based alternative to cow’s milk".

I like standards of identity. I like the structure that it creates within the marketplace.   Marketing people don't because they can blur the lines and make something seem to be what it's not.  If people took time to understand, that would be one thing.  But some out there do not.

For the most part, many of the standards in place have been there for decades.  This is not to say they should remain constant, but certainly there should be on ongoing review process to say what a given food is, and what it is not.

Take bacon as an example.  Bacon should be from an animal.  I am fine with turkey bacon, but eggplant bacon....no. 

FDA News Release
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm614851.htm
Statement from FDA Commissioner Scott Gottlieb, M.D., on the process FDA is undertaking for reviewing and modernizing the agency’s standards of identity for dairy products
For Immediate Release
July 26, 2018

FDA Uses Ability to Mandate Recall for First Time, This for Contaminated Kratom

FDA issued its first mandatory recall of contaminated 'food' product (although this product is a dietary supplement which are considered food) when the agency issued one for powdered kratom product contaminated with Salmonella.  The ability to mandate a recall was granted to FDA under the FSMA regulation.  Kratom has been involved in a wide spread Salmonella outbreak.

According to the news report, "The agency asked Triangle on Friday to voluntarily recall the kratom items. When the company did not comply with the request, the FDA the next day ordered the firm to cease distribution. The company could have requested a hearing, the agency said, but it did not respond within the required time frame. The agency then issued the mandatory recall order."

Once the weapon is pulled out of the holster for the first time, it become a lot easier the second time around.

Washington Post
https://www.washingtonpost.com/news/to-your-health/wp/2018/04/03/in-a-first-fda-orders-recall-of-a-contaminated-food-kratom-with-salmonella/?utm_term=.214cd8fb6fe4
In a first, FDA orders recall of a ‘contaminated food’ — kratom with salmonella
by Laurie McGinley by Laurie McGinley Email the author
To Your HealthApril 3, 2018

FDA Issues Summary of Inspection Items Listed on 483 Reports Issued in FY2017

FDA posted the summary of inspectional observation items listed on 483 reports from FY 2017 (10/2016 to 9/2017). During an inspection, ORA investigators may observe conditions they deem to be objectionable. These observations, are listed on an FDA Form 483 when, in an investigator’s judgment, the observed conditions or practices indicate that an FDA-regulated product may be in violation of FDA’s requirements. "These spreadsheets are not a comprehensive listing of all inspectional observations but represent the area of regulation and the number of times it was cited as an observation on an FDA Form 483 during inspections conducted by FDA and its representatives."

According to the posting, there were 2662 483's issued during FY 2017, compared to 2196 in 2016.    While the top 5 are similar to those listed in 2016, and most issues involve pest control, sanitation, processing concerns, and building  structure issues, there is a new item which is the Failure to Develop a FSVP (Foreign Supplier Verification Program).  The FSVP is for controlling foreign suppliers when a company not operating under Preventive Controls is importing the food.