US Marshalls Seize Dry Dairy Ingredients from a Virginia Processing Facility

US Marshalls seized dairy products worth nearly $4 million from a Virginia dairy processing facility.  Products were nonfat milk powder and buttermilk powder packaged in 40- and 50-pound bags for further manufacturing.  This comes after regulators, conducted an investigation of the facility,  "observed poor sanitary practices and reviewed the company’s records, which showed positive results for Salmonella in the plant’s internal environmental and finished product samples. FDA investigators observed residues on internal parts of the processing equipment after it had been cleaned by the company and water dripping from the ceiling onto food manufacturing equipment. In addition, environmental swabs collected during the inspection confirmed the presence of Salmonella meleagridis on surfaces food came into contact with after being pasteurized." 

Through the use of whole genome sequencing on the Salmonella samples, it was determined that the strain found was persistant in that facility over time.  "The sampling results indicate that the Salmonella strains from 2016 are nearly identical to Salmonella strains found at the company in 2010, 2011 and 2013. These findings of Salmonella meleagridis at the company dating back several years demonstrate the existence of a persistent strain of Salmonella at this facility."  

No illnesses have been linked to the product to this point, but that may be due to a number of factors such as actual amount of organisms in product, the virulence of the organism, as well as the application of the milk powder and the type of processes used where this was an ingredient.


FDA News Release
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm531188.htm
Food regulators seize adulterated milk products for food safety violations
For Immediate Release
November 30, 2016

FDA Report on Antibiotic Resistance of Bacterial Pathogens Indicates Improvement

The FDA released its 2014 National Antimicrobial Resistance Monitoring System (NARMS) report, which looks at antimicrobial resistance patterns in bacteria isolated from humans, retail meats, and animals at slaughter. Overall, the news is good, in that there have been decreases in bacterial pathogens with antibiotic resistance, or in other cases, the data has been steady, especially with regard to the medically important antibiotic types.

From the report:

• The prevalence of Salmonella in both retail chicken meat (9.1 percent) and retail ground turkey (5.5 percent) was at its lowest level since retail meat testing began in 2002. The prevalence of Campylobacter in retail chicken meat samples has gradually declined over time to 33 percent, the lowest level since testing began.
• Approximately 80 percent of human Salmonella isolates are not resistant to any of the tested antibiotics. This has remained relatively stable over the past ten years. Resistance for three critically-important drugs (ceftriaxone, azithromycin, and ciprofloxacin) in human non-typhoidal Salmonella isolates remained below 3 percent.
• Ceftriaxone, a third generation antibiotic used to treat infections where there is resistance to other antibiotics, has seen a continued decline in  resistance in non-typhoidal Salmonella with the exception of retail turkey meat isolates, where it rose slightly. In cattle, Salmonella isolates from carcasses collected at processing plants, ceftriaxone resistance reached its lowest level (7.6 percent) since 1999. In 2014, ceftriaxone resistance in human Salmonella Heidelberg isolates was 8.5 percent, down from a peak of 24 percent in 2010.   (But there have been some decreases in susceptibility in cattle and increases in resistance by strains of Campylobacter jejuni.)

FDA News Release
http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm529719.htm
FDA Releases 2014 NARMS Integrated Report; Finds Measurable Improvements in Antimicrobial Resistance Levels

November 18, 2016

FDA Guidance - Small Company Version of Preventive Controls for Human Foods

FDA released their guidance titled: Guidance for Industry: What You Need to Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Small Entity Compliance Guide.   LINK

This guide was developed to help small companies comply with the FSMA Preventive Controls Rule.

The guide does not introduce anything new.  It is basically a simplified version of the original rule.  Being simplified, the document does make the regulation more approachable.  One particular area is On-Farm Packing and Holding of Food (pg 22).  The guidance discusses those activities not subject to the requirements for Hazard Analysis and Preventive Controls when conducted on farms.

It also reviews the Qualified facility -  a facility that does not need to comply with the Preventive Controls component of the rule (21 CFR 117).  It has been our opinion however, for companies who fit into that definition to consider taking the step and completing the Preventive Controls component.  Why?  If the company grows, looks to gain sales from a customer requiring a HACCP type plan, or just wants to improve the safety of their product, they really need to consider taking this step.

Warning Letter Issued to Company for Not Verifying That Corrective Measures Worked

FDA issued a Warning Letter to a California company after that company did not adequately respond to a 483 Report issued during inspection.  The inspection was performed after the company's product was involved in a Salmonella outbreak.  During the inspection, Salmonella was found during FDA environmental sampling and this was included as a finding on the FDA 483 that was issued.  From the FDA website: "An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C)".  The company is then expected to send a written response to the 483 report.  "Companies are encouraged to respond to the FDA Form 483 in writing with their corrective action plan and then implement that corrective action plan expeditiously."
When a company does not properly respond and/or take appropriate corrective action, FDA will issue a Warning Letter.  From the FDA website: "When it is consistent with the public protection responsibilities of the agency and depending on the nature of the violation, it is the Food and Drug Administration's (FDA's) practice to give individuals and firms an opportunity to take voluntary and prompt corrective action before it initiates an enforcement action. Warning Letters are issued to achieve voluntary compliance and to establish prior notice. (Prior notice is discussed in Chapter 10.) The use of Warning Letters and the prior notice policy are based on the expectation that most individuals and firms will voluntarily comply with the law."

As we have seen in a number of other recently issued Warning Letters (Examples 1, 2, 3, 4) companies are failing to properly address the elements of corrective action.  As with this case, measures are taken, but the company fails to verify that those measures have worked.  From this report: "However, you did not provide us with documentation demonstrating the effectiveness of these changes and any other changes you have made to prevent a reoccurrence of an outbreak."   The verification that corrective measures worked is especially important after the company has had an outbreak and/or was found to have pathogen contamination issues.

 FDA Warning Letter
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm524491.htm
WARNING LETTER
 October 7, 2016
 

Webinar, 'Play FDA for a Day', Drives Paranoia to a New Level

The webinar, "Play FDA for a Day: Criminalization of foodborne illness and what you can do to protect your company", is presented by a lawyer and a testing company and directs companies to do testing for outbreak-related pathogens before the FDA does.  And if FDA finds an outbreak-related pathogen in your food facility, you are as good as going to jail.  And for these outbreak-related pathogens, there is 1 million unsolved outbreaks in the FDA database just waiting to get solved.  So get a lawyer and get the test kits ASAP.  Because FDA 'investigators' are going to be busting down your door and swabbing the heck out of your facility.

A little paranoia is good, but this presentation is over the top.   There is no doubt that companies need to keep their facilities in order, including ensuring the environment is under control,  doing environmental monitoring with effective corrective action especially when there is risk (product exposed to the environment).  But to date, there have been very few cases where the Department of Justice has gotten involved in outbreak investigations.  The investigations cited were ones where pathogens were found in food and linked to outbreaks through epidemiological investigation.  Subpoenas were issued when wrongdoing was suspected.  

Testing and advice for free or just the hook?  What is an over-the-top lawyer going to tell you when you have an organism in your drain?

(Don't have the time or the will to watch the video, you can read the white paper.)

Onion Rings Recalled Due to Allergen Mislabeling - Reason for Implementing Preventive Controls

McCain Foods issued a recall notice for Onion Rings and then reissued the notice to expand the recall to additional labels.  The pre-labeled packaging did not list milk on the label although it was included in the formulation.

This is the type of recall that the Preventive Controls rule was designed to help prevent.  By having a formalized check of the labels at the receipt of those labels and then again at the time of packaging would have provided 2 opportunities to compare the label to the formulation.  Of course, it is important to have the sub-ingredients listed, in this case, they are probably purchasing the breader / batter that will be used to coat the onion rings.

Instituting such a check is not overly difficult. It just takes a few minutes to compare the label to the formula.   However, the cost of recall resulting from non-compliance can run into the millions of dollars.

FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm522476.htm
McCain Foods USA, Inc. Announces a Product Recall Impacting Frozen Onion Rings Sold and Distributed Under Four Separate Private Label Retail Brands
For Immediate Release
September 23, 2016

First Day of Preventive Controls Compliance - What Do You Need to Know

September 19, 2016 marks the compliance day when larger facilities making human food must meet preventive controls and Current Good Manufacturing Practice requirements (CGMPs) and larger animal food facilities must meet CGMPs.

So what should one expect?  FDA issued two letters today.  To summarize from the many words in those documents:

At this point, the FDA is still learning so "the FDA’s primary focus will continue to be on education, training and technical assistance to help companies comply with the new requirements." 

Does your Food Safety Plan have to be perfect at this point - "Many businesses of that size already have a HACCP (Hazard Analysis and Critical Control Points) program; we don’t expect them to need to make many changes to come into compliance. Aspects of the CGMP and preventive controls rules are similar to HACCP, a food safety system that started with industry."

 But FDA will still evaluate the facility in order to make safe products. "The best thing that people in the food industry can do is take the measures required by the new rules – not just the letter of the law but what it represents in terms of transforming the food safety system. They should look at the big picture, at areas in which they could be vulnerable and proactively take action. Promptly responding to problems, even if they aren’t yet violations, can prevent them from getting to the point at which there is a concern about the safety of the food."
 
"In addition, facilities should set up a thorough system for documenting what they do."

FDA is still learning as well.


FDA News Release
http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm521171.htm
What to Expect Now that the First Big FSMA Compliance Dates Are Here
Questions and Answers with Joann Givens

FDA Issues Warning Letter to RTE Facility with LM Issues

FDA issued a warning letter to a Saranac Foods for an inspection completed in February.  We have seen a number of similar types of Warning letters issued.  In this one, inspectors found LM in a facility making RTE product, and  then conditions that would support the spread of that organism (issues with hose usage, condensation, and airflow).  While the company did respond, the response was lacking in terms of a 'complete' corrective action.

 

Listeria

FDA found 3 of 89 samples positive for Listeria monocytogenes. all non-contact but in the ready-to-eat pasta and deli salad production room.

1. Floor near food carts and the 2-compartment sink;
2. The floor alongside of the interior legs of stand mixer;
3. An area of the floor under the 1-compartment sink where a leak is present.

Although the company took corrective action, the FDA stated: FDA is unable to evaluate the adequacy of your response because it does not provide specific details of your corrective actions and steps taken to prevent contamination of food. 

  

GMP Issues

Internet Soups Recalled Due to Improper Process

A New York firm is recalling soup packed in jars after FDA found that the company was not using validated processes.  The product were marketed and sold via the internet.

By regulation, companies processing canned soups, which are generally low acid canned foods, must have a validated (or tested) process and that process must be filed with the FDA.  With more companies using non-traditional channels to sell products, such as the internet or farmers' markets,  it is easier for companies to get products into commerce and avoid oversight.  Then we end up with cases like this.

A process must be validated to show it can achieve a 12 log reduction of Clostridium botulinum spores.  If a process has not been validated to accomplish this, then is impossible to know whether the product will be safe.  Validation includes determining where the cold point is on the jar and then determining the processing time needed in order to achieve sufficient amount of heat at that cold spot.

Looking at the Island Soup website and the Team page, there seems to be a lot of chiefs, but no technical person listed as part of the team.  This too is occurring more often.  Entrepreneurs come up with new products, but fail to research them properly.

FDA Website
http://www.fda.gov/Safety/Recalls/ucm519531.htm
Island Soups Company, Inc. Recalls Six Varieties of Island Soups Brand Products Because of Possible Contamination With Clostridium Botulinum
For Immediate Release
September 7, 2016

Warning Letter Issued to WA State Frozen Food Processor Responsible for Listeria Related Recall

FDA issued a warning letter in response to Oregon Food Company correction of inspection items as part of the Listeria recall of frozen produce.  A few things to note 1) the number of the issues the facility had in the inspection and the fact that they had a pretty big Listeria issue, and 2) their responses were rejected because while the facility addressed items they had to fix, they did not show that the fixes actually worked and that they implemented procedures for ongoing verification.  This is a good lesson in the issues that the plant faced, but also in how to, or how not to, respond to a FDA 483 report.
 
First, the letter points out that FDA found 19 Listeria positive environmental samples with 7 of those being food contact surfaces including a chiller water system (that did not have sanitizer).  These samples were linked via Whole Genome Sequencing to clinical isolates.  While the firm corrected the facility issues, FDA stated that this was not enough. "While we acknowledge these are appropriate actions to be taken, we are unable to fully evaluate the adequacy of these actions at this time without further details, documentation and results of your corrective actions."  So basically, they want to see results from extensive sampling, including when the plant is operating, that the organism is not present.

 

On GMP issues, the facility was found to be not as clean as it should have been.  While the plant indicated it trained the employees, FDA found the response lacking.  ."your response did not provide any details as to the content of this training or how you will ensure this training is effective by assessing and monitoring employee performance and adherence to the training."

 
The facility had many condensation issues, which is not good from controlling Listeria.  While the facility responded that they fixed sources of condensation, FDA responded "how you will assess whether this correction and the [fixes] are effective in minimizing the condensation above food and food contact surfaces. Your response does not address how to you will prevent future recurrence of this violation, such as through increased monitoring and assessment."

 

The facility had poorly made food contact surfaces that would provide harborage.  While the facility had repaired the surfaces, FDA responded "you provided no documentation or details on how you will ensure the repairs are adequate. Your response does not address how you will prevent future recurrence of this violation. "

 

In addition, there were steam ventilation issues and general facility issues.  Again, fixes were made, but the outcome of those fixes and measures to prevent reoccurrence were not addressed.

 

 

FDA Warning Letter

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm512776.htm

Oregon Potato Company 7/15/16

 

FDA Warning Letter Issued to Chester, PA Warehouse - Reason...for Being Nasty

We often get questions about the safety of the food supply, and our general response is - overall, our food is safe.  But then, you read something like this and start to think otherwise.   This was an FDA Warning Letter issued to a warehouse / distribution company in Chester, PA.    If you like to look at the outside of the location, you can see the location  on Google maps from 2012 but there are more recent pics on line.

 Observations directly from inspection notes:

• firm did not have running water in either the ladies or men’s restrooms used by employees. Further, the toilets and hand washing sinks were not functioning, and there are no other sinks in your facility.  used buckets, filled with water, to flush the toilets and wash their hands after using the restrooms. You informed our investigator that these buckets are prefilled with water at the hose bib where the water supply line was cut and placed in the restrooms for immediate use and others stored outside the restrooms as reserves to be used later. Further, you informed our investigator that these buckets are used interchangeably for toilet flushing and handwashing and that the buckets are not cleaned or sanitized.
• a wooden desk with dirt and green stains on it, being used as a food preparation table. You informed our investigator that the desk is not cleaned with detergent or sanitizer, and is sometimes wiped down with a paper towel and water from a bucket in the restroom.
• green leafy particles and brown dried debris on knives stored in a wooden desk. You informed our investigator that these knives are used to cut produce and were not cleaned after use, but are cleaned prior to being used again with a paper towel and water from a spray bottle. 
• an orange and white cat was moving freely throughout the warehouse. 
• rodent excreta pellets - multiple occurrences
• mold in coolers - multiple occurrences
• a stack of 5 pallets; a barrel; equipment, and tools that were rusted; and wood and debris were scattered within 3 feet of the west side of the facility where the trailer is located. Further, there were vines draped along the east and west walls, with high grass and weeds that engulfed the perimeter on the south, east and west.
• that the thermometer used in produce cooler #1, where you store vegetables, fruit, and other food articles, was not operational. Further, you informed our investigator that that this thermometer had never been calibrated and was not used for over ten years
• an apparent fetid odor of rot, in unrefrigerated produce cooler #3. You informed our investigator that this is where spoiled products and trash are stored, until taken to the dumpster located outside your facility. For example, a container of spoiled onions, cardboard boxes, and other foreign matter was observed scattered on the floor in the cooler. Further, you informed our investigator that produce cooler #3 has not been cleaned in years.
• an employee smoking a cigarette and grabbing onions with his bare hand from an unmarked box, to fulfill an order for a customer

  

FDA WARNING LETTER

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm509003.htm

16-PHI-07

June 23, 2016

 

Whole Foods Takes Warning Letter on the Chin for February Inspection

FDA issued a warning letter on June 8, 2016 to Whole Foods for an inspection completed back in February.  While Whole Foods responded to the inspection findings in March, the Warning was issued this week (June 8th), because FDA did not find the response acceptable.

"We do not consider your response acceptable because you failed to provide documentation for our review, which demonstrates that all your noted corrective actions have been effectively implemented. This documentation may include photographs, invoices, work orders, voluntary destruction records of any affected products, certification of actions performed by contractors, and/or any other useful information that would assist us in evaluating your corrections."

The initial inspection found a number of issues, nothing overly serious. but mostly what could be considered sloppy procedures.  This included multiple condensation issues, improper sanitation procedures with instances where too high a sanitizer concentration was used, potential cross contamination issues, inadequate handwashing water temperatures, and improperly marked sanitizing agents.  Environmental sampling of 100 samples was negative for Listeria monocytogenes, but one sample was positive for a non-pathogenic species of Listeria.

Clearly some bad vibes going on between the agency and the plant.  If issues were so bad, why did a follow-up inspection not occur, or why wasn't this letter issued in March?  A lot to take away from this.

• Tighten up procedures now rather than having an agency inspector tell you.  Inspections are rarely perfect, but the number of issues seen here show a lack of attention to detail.
• Ensure corrective actions to inspection reports are completed as soon as possible.Those corrective actions must be detailed / documented to cover each and every element addressed in the inspection and be able to demonstrate that the risk issues have been adequately  addressed .  Overkill in documentation support was needed here rather than glossing over.  

Boston Globe
https://www.bostonglobe.com/business/2016/06/14/whoole-foods-kitchen-everett-hit-with-food-safety-violations/U2oSoRitbt1FeV9s3hFf4K/story.html
FDA inspectors find evidence of Listeria at Whole Foods kitchen
By Megan Woolhouse Globe Staff June 14, 2016

FDA Recall Program Performing Poorly?

The US Office of Office of Inspector General for HHS is conducting an audit of FDA's recall program.  In their preliminary report, they found that FDA was not acting fast enough.  In this report this statement was made:

"We found that FDA did not have an efficient and effective food recall initiation process that helps ensure the safety of the Nation’s food supply. Specifically, FDA did not have policies and procedures to ensure that firms or responsible parties (collectively referred to in this document as "firms") initiated voluntary food recalls promptly. This issue is a significant matter and requires FDA’s immediate attention."

In response, FDA issued a statement, and in that, wrote:

"FDA oversaw thousands of food recalls, with an average time for recall initiation of less than a week. A small number of these recalls fell well outside of that average, with months passing before all impacted products were taken off shelves, even though the FDA notified the companies involved of a contamination as soon as it had evidence."

FDA News Release
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm505926.htm
Statement on HHS OIG Early Alert on FDA food recall initiation process
For Immediate Release
June 9, 2016

Adult Multivitamin Gummies Recalled After Company Fails to Complete Testing for Salmonella and Staph

Nature Made is recalling their Gummies Adult Multivitamins after they found that Salmonella and Staphylococcus testing was not properly completed on the batches those batches recalled.

It is hard to know the risk of these products without knowing the test results the company had found on a historical basis.  One would guess minimal.

FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm505706.htm
FDA Recall Notice
Nature Made® Recalls Various Products Because of Possible Health Risk
For Immediate Release
June 8, 2016

FDA Report on 5th Annual Review of Reportable Food Registry

FDA released their 5th annual report from entries into Reportable Food Registry.

The Reportable Food Registry (RFR or the Registry) is an electronic portal to which reports about instances of reportable food must be submitted to FDA. "A reportable food is an article of food/feed for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals."

The findings in this report provide a summary of the issues experienced within the food supply chain. These issues are seen in the many recalls reported.

Highlights from Report:

SALMONELLA

• Overall, the 50 primary reports for Salmonella in Year 5 remained similar to the 58 primary reports observed in Year 4.
• Data from the fifth year of operation of the RFR indicates that spices and seasonings account for the majority of Salmonella-related reports.
• The largest decrease in Salmonella was observed in the animal food/feed (including pet food) commodity, with a total of 6 primary entries in Year 5 compared to 18 entries in Year 4, representing 31% of Salmonella entries in Year 4 and decreasing to 11.8% of total Salmonella entries in Year 5.

FDA Releases Final Rule on Food Defense - Preventing Intentional Contamination of Food - Summary

The rule, titled Mitigation Strategies To Protect Food Against Intentional Adulteration, applies to domestic and foreign food companies that are registered with the FDA to address hazards that may be introduced with the intention to cause wide scale public health harm. . Basically, if you are producing food for sale and have registered your facility with FDA, then you have to have a food defense plan. There are a few exemptions to who has to apply.

Commentary - this is very broad/open and care must taken when preparing this program  A concern would be claiming too many vulnerabilities and then having to correct too much (and the expense of that).

Below is a summary of the major sections of the document.

Requirements - "Each covered facility is required to prepare and implement a food defense plan. This written plan must identify vulnerabilities and actionable process steps, mitigation strategies, and procedures for food defense monitoring, corrective actions and verification. A reanalysis is required every three years or when certain criteria are met, including mitigation strategies that are determined to be improperly implemented. " .

1.  You must prepare, or have prepared, and implement a written food defense plan.

This includes:

FDA Updates Nutrition Facts Labels for Food Products

It is time to begin updating the nutrition facts labels on food packages.  FDA is updating their requirements for the nutrition facts label in order to "consumers have updated nutritional information for most packaged foods sold in the United States, that will help people make informed decisions about the foods they eat and feed their families."

While about half or more of the people say they look at labels, research has show that very few actually look at the label.  But some are very excited:

“I am thrilled that the FDA has finalized a new and improved Nutrition Facts label that will be on food products nationwide,” said First Lady Michelle Obama. “This is going to make a real difference in providing families across the country the information they need to make healthy choices.”

Well, it will be good business for the labeling companies and those who do the nutritional determinations.

The compliance date is July 26, 2018 for most companies, and for smaller companies with less than $10 million in sales, the date is extended to July of 2019.

FDA News Release
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm502182.htm
FDA modernizes Nutrition Facts label for packaged foods
Refreshed design and relevant information will help consumers make healthy food choices
For Immediate Release
May 20, 2016

FDA Issues Draft Guidance on Qualified Facilities within the Preventive Controls Rule

As part of the Preventive Controls Rule, FDA establishes 'Qualified Facilities' as those facilities exempt from having to establish HACCP based systems (Preventive Controls), but only having to comply with GMPs. But in order to become 'Qualified', they must submit a form to FDA attesting to their status as 'Qualified". This guidance provides detail on how to submit the required form, Form FDA 3942.

‘Qualified Facility’’ as defined by FSMA:
• Business with average annual sales of <$500,000 and at least half the sales to consumers or local retailers or restaurants (within the same state or within 275 miles); or.
• Very small business, which the rule defines as a business (including any subsidiaries and affiliates) averaging less than $1,000,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale (e.g., held for a fee).

You can access that document here.

Important Points in FSMA Final Rule on Sanitary Transportation of Human and Animal Food

Earlier this month, FDA issued the FSMA Final Rule on Sanitary Transportation of Human and Animal Food.  What are some interesting points you should know?

This rule defines transportation as “any movement of food in commerce by motor vehicle or rail vehicle” and establishes requirements for sanitary transportation practices applicable to shippers, loaders, carriers by motor vehicle and rail vehicle, and receivers engaged in food transportation operations.  The rule address vehicles and transportation equipment; transportation operations; training; records; and waivers.

The goal is to ensure that practices are in place that prevents food from becoming adulterated during transport from such issues as failure to control temperatures or cross contamination or cross contact (allergens) from inadequate cleaning.  

The rule makes the shipper responsible for compliance to the rule.  The shipper is defined as the one who arranges for the transportation of food by the carrier. The shipper could be the manufacturer or a freight broker. By rule, the shipper  must develop and implement procedures for required parameters such as temperature control and cleanliness of the vehicle. The shipper can transfer some of this responsibility to the ‘loader’ or the ‘carrier’ based upon contractual agreement. They must have documentation to demonstrate this.

The rule is not prescriptive in that FDA does not establish mandatory procedures; rather it allows industry to use best practices to do this. So there are no regulatory requirements for continuous temperature monitoring, or the sharing of documentation for each load, or how a truck should be cleaned. Rather, it requires the shipper determine what is best in order for that food to be transported without becoming adulterated.

While there are some exemptions from the rule for food that is transported, such as farm activities, most other transport is covered including intra-company transport and food destined for food banks.

What about food that arrives and is out of temperature?  According to the rule "An inconsequential failure by a carrier to meet the shipper's temperature control specifications will not necessarily create a per se presumption that the affected food has become adulterated. However, if a person subject to this rule becomes aware of an indication of a possible material failure of temperature control or other conditions that may render the food unsafe during transportation, the person must take appropriate action to ensure that the food is not sold or otherwise distributed, unless a determination is made by a qualified individual that the temperature deviation or other condition did not render the food unsafe. Failure to take such action may render the food adulterated."

For Loaders, those who put product onto the trucks, they must check the vehicle for sanitary condition and ensure proper temperature control prior to loading.

For receivers, those who unload the product, they must ensure that the product was not temperature abused and intact. 

Carriers, those transporting product, must meet conditions established by the shipper – to include having the right equipment to meet sanitary and temperature requirements. The must also provide cleaning as required.

When carriers have responsibilities put on them by the shippers, their employees must be trained about potential food safety problems and basic sanitary practices. This must be documented.

Here is a link to the final rule.

FDA Inspection Report from Salad Facility Responsible for Listieria Outbreak

Earlier this year, bagged salads produced by Dole in their Ohio facility, were involved in a Listeria outbreak.  According to the CDC Final Report, issued March 31 2016, 19 people became infected and there was 1 death.  In Canada, the CFIA reported 14 cases  and 3 deaths, although stated that the deaths may or may not be related to Listeria monocytogenes (LM).

FDA conducted an investigation of the facility and during that investigation, completed environmental sampling.   A 483 report was issued, and thanks to the Marler Blog, that report was posted (a 2014 report was also included there, but was not included here).  In reviewing this 483 report, there were some important findings.   A summary of those below as well as reports.
(An FDA 483 Report 'lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations, and do not represent a final Agency determination regarding your compliance')

OBSERVATION 1
Failure to perform microbial testing where necessary to identify sanitation failures and possible food contamination.