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.

Justice Department Investigates Salad Plant After Listeria Outbreak

 The US Justice Department is investigating the Dole with regard to the Salad / Listeria outbreak.  The question being raised is 'what did they know'?  This comes after an FDA inspection of the facility found Listeria monocytogenes.

The outcome of this investigation is important for processors who manufacturer products that can be affected by Listeria, especially those that had been regarded as lower risk (do not support appreciable growth).  Why?  Many manufacturers have Listeria Control Programs that have verification monitoring that focuses on Listeria species testing before production, or pre-operational, on non-food-contact environmental surfaces.  If found, then corrective action focuses on cleaning that area.

The concern is that this may not be aggressive enough.  We have now seen that Listeria can be an issue in product that supports minimal to no growth.  For one, we do not know how the consumer is going to handle products - perhaps using them as an ingredient in foods that better support growth, and in light of the Blue Bell outbreak, what minimal levels can cause illness in those at highest risk.  A more aggressive sampling would look at sampling during production and looking more at food contact surfaces.

Can you fault the plant?  Not based upon the current FDA Listeria Control Guidance.  What will it look like going further?

Wall Street Journal
http://www.wsj.com/articles/dole-food-under-investigation-over-listeria-outbreak-linked-to-salads-1461966955#:tqCQf4DgV4N9hA
Business
U.S. Probes Dole Food Over Listeria Outbreak Linked to Salads
Samples suggest Dole had evidence of bacteria at Ohio plant a year earlier

Massive Recall of Frozen Vegetables Follows Linkage to Listeria Outbreak

A Washington state frozen food manufacturer is recalling frozen vegetable products affecting approximately 2 years of production, 358 consumer products sold under 42 separate brands

This was an expansion of a recall that was issued on April 23rd after the Ohio state health officials reported the finding.  Since that time, it had been linked to 8 cases.  (2 deaths are listed on the CDC website, but they state it was not due to Listeria.  Complications from Listeria?).  CRF had suspended operations after the first recall in April and had not resumed production.  FDA did isolate Listeria monocytogenes from the facility and "...... were found to be closely related genetically to seven of the isolates of ill people associated with this outbreak."

In the CDC report [below], a linkage was made after the Ohio state isolated the organism from frozen product.  It does not appear this product was sampled because of linkage to the outbreak in that the report states there were no reported illnesses.   It is also important to not that while 2 cases were from 2016, the other cases were said to have been done in a 'retrospective analysis' where the DNA from the isolated organism was matched against past outbreak cases.


According to the CDC Report, "Whole genome sequencing showed that the Listeria isolate from the frozen corn was closely related genetically to seven bacterial isolates from ill people, and the Listeria isolate from the frozen peas was closely related genetically to one isolate from an ill person.  The way his case has unfolded looks very similar to the Blue Bell outbreak/recall.

The products include organic and non-organic broccoli, butternut squash, carrots, cauliflower, corn, edamame, green beans, Italian beans, kale, leeks, lima beans, onions, peas, pepper strips, potatoes, potato medley, root medley, spinach, sweet potatoes, various vegetable medleys, blends, and stir fry packages, blueberries, cherries, cranberries, peaches, raspberries, and strawberries.  Brands include Trader Joes, Kirkland, and Great Value as well as others.

There are some things that would be good to know.
1)  The products in question required cooking....were they cooked by the consumers who became ill?
2)  The report states that he Listeria isolated from product and in the outbreak cases were closely related.  How close is close?
3) What type of Listeria Control Program did the facility have?



FDA News Release
http://www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm499157.htm
FDA Investigates Listeria Outbreak Linked to Frozen Vegetables

May 4, 2016

What is the Problem and What is Being Done About It?

The FDA, CDC and state and local officials are investigating a multi-state outbreak of listeriosis identified in March 2016.

Thriving in a Post-Chipotle World

In light of their food safety gaffs, the restaurant chain Chipotle is still struggle to recover.  In their first quarter report, sales are down 30% in same-store sales and their share price is down about 40%.

But where there is decline for one, others have thrived.  Panera sales have increased, with same-stores increase of 4.7%

Business Insider
http://www.businessinsider.com/panera-benefits-from-chipotles-downfall-2016-4
PANERA PRESIDENT: 'We live in a post-Chipotle world'
Kate Taylor
 
Apr. 27, 2016, 10:57 AM

As Chipotle struggles, Panera is thriving.

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.

Cooked Poultry Products Recalled Because of Foreign Material

Pilgrim's Pride is recalling 4.5 million pounds of cooked chicken products, institutional or foodservice packs, due to the potential for foreign matter.  The issue was initially identified by customer complaints received by the company, and after notifying FSIS, FSIS then identified additional consumer complaint issues.  No injuries have been reported.

The recalled product has the EST. 20728 posted, indicating the product came out of their Waco TX processing facility.  The period of time is 18months from August of 2014 to March of 2015.

This is a surprising amount of product in a very large time frame to be included in a Class 1 recall, especially considering there were no injuries reported.  This is the expansion of the April 7th recall that focused on institutional packs of chicken nuggets.



USDA Recall Notice
http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2016/recall-027-2016-expanded
Pilgrim’s Pride Corp. Recalls Poultry Products Due To Possible Foreign Matter Contamination
Class I Recall 027-2016 EXP
Health Risk: High Apr 26, 2016

Tea Bags Recalled for Salmonella After Ingredient Tests Positive for Salmonella

 CVS Pharmacy is recalling tea bags after an ingredient produced by the manufacturer’s raw material supplier tested positive for Salmonella in another company’s product.

The tea, if prepared with boiling water, would eliminate the pathogen.   However, it is one of the reasons why drinking sun tea is not a good idea.

FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm497299.htm
CVS Pharmacy Announces Voluntary Recall of Gold Emblem Abound Organic Spiced Herbal Tea Due to Possible Health Risk