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Certification Data Access to Enhance Food Safety throughout the Supply Chain

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By Didier Blanc, Founder & Director, ViaSyst

GLOBAL FOOD SAFETY INITIATIVE (GFSI)

Launched in 2000, GFSI  is a worldwide industry and retail driven initiative, which mission is to “provide continuous improvement in food safety management systems to ensure confidence in the delivery of safe food to consumers worldwide”.
Major international retailers (Walmart, Tesco, Carrefour, Mc Donald’s, …) and food manufacturing concerns (Nestlé, Coca Cola, Danone, …) are involved within GFSI board, technical committee and working groups for setting the common requirements and rules against which food safety management systems shall be benchmarked to get GFSI recognition. 
GFSI recognition motto is: “once certified, everywhere accepted”.
Major buyers and retailers require a GFSI recognized certification from their suppliers, more and more, since the late 90’s. Other stakeholders like authorities also are getting open to rely on third party food safety management (FSMS) certification. But certificate is not enough, more specific information is needed to build trust and confidence. This is where a database with selected and controlled access to FSMS certification audits data can contribute to food safety throughout the supply chain.

ISO 22000

ISO 22000 is a family of international standards addressing food safety management systems. The system can be applied to any organizations in the food chain. The same as GFSI benchmarking requirements, ISO 22000 certification is based on three key elements:
  1. PRPs (prerequisite programs, or GHP, GMP, GAP, etc.)
  2. HACCP
  3. Management System elements
The first ISO 22000 version has been published in 2005, after 4 years’ development work within the ISO Technical Committee 34. ISO 22000 is currently under revision. More than 120,000 certificates have been granted against ISO 22000 worldwide since publication.
ISO 22000 certification demonstrates the company’s ability to control food safety hazards and ensures the food safety at the time of consumption. Being a ISO 22000 certified allows a company to show their customers that they have in place a food safety management system that is recognized worldwide.
But ISO 22000 alone doesn’t meet the GFSI benchmarking requirements, for 2 major reasons:
  1. The choice of the applicable PRPs is open for the certified company,
  2. There is no scheme owner behind ISO 22000 certification, to control that certification bodies operate according to GFSI compliant procedure
These are the reasons why the FSSC 22000 certification scheme has been built around ISO 22000 to make it GFSI compliant.

FSSC 22000 FOOD SAFETY MANAGEMENT CERTIFICATION

FSSC 22000 is a Dutch Foundation created in 2009 with the (achieved) mission of providing a solution for GFSI recognition for ISO 22000. FSSC 22000 governance is controlled by a Board of Stakeholders involving all major stakeholders (manufacturers, retailers, certification bodies …).
In a few years, thanks non-for profit foundation status and ISO neutral and universal character, FSSC 22000 caught up against other schemes like BRC, IFS, SQF to become one of the worldwide major GFSI certification scheme, with 100+ licensed certification bodies, and soon 15000 certificates.
Major food manufacturing groups like Nestlé, Coca Cola, Cargill, Danone, PepsiCo, etc. rely on FSSC 22000 for the certification of their plants and suppliers. And major retailers accept and trust FSSC 22000 certification for their suppliers.
The directory of FSSC 22000 organizations is publicly available on the web, but this is not enough: beyond certificate, access to data of certified company is getting more and more crucial within stakeholders in a globalized supply chain.
Some examples:
  • Groups need to access data of their plants or manufacturing sites
  • Retailers and major buyers need to access data of their suppliers
  • Authorities need access to data of the food manufacturing companies in their country

TRUST THANKS DATA ACCESS

Third party certification needs trust for all users.
Trust is built on measurable facts, evidence and indicators All FSSC 22000 certification data are managed on a centralized database developed and operated by ViaSyst, FSSC IT partner. This unique data availability allowed FSSC & ViaSyst to develop specific (read only) access role and rules for external users to enable following objectives:
  • Access all audit data of agreeing assigned certified sites 
  • Extract data for data analysis purposes
  • Monitor & benchmark performance of sites, suppliers, auditors & CBs
  • Follow KPIs & indicators

EXCLUSIVE DASHBOARD

Data users & decision makers need real-time concise, visual & comprehensive, data display for proceeding to their risk & assurance analysis.
The ViaSyst platform opens on a executive synthetic performance dashboard, tailored according needs of relevant users (e.g. scheme owners, groups, retailers …)
This unique dashboard allows performance monitoring and benchmarking, down to the last relevant detail: one click – all data available, fully exploitable.
This is how database can contribute to enhance food safety and confidence throughout the food supply chain.
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Listeria contamination at Deutsch Käse Haus forced nationwide cheese recall

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The recall of cheeses due to the presence of Listeria monocytogenes in Deutsch Käse Haus caused a snowball effect since Deutsch Käse Haus is a business–to-business provider of cheeses.
Once a food recall is issued, each company that receives the contaminated products has to look at how contamination may have spread through its own plant. The situation becomes more complicated as supply chains grow longer and longer. The globalization of food supply chains makes widespread outbreaks more likely, and in some ways more difficult to track.
It is hoped that the new FDA regulation as shown in the draft “Control of Listeria monocytogenes in Ready-To-Eat Foods” will eliminate the repeat of the ripple effect of recalls.

How Deutsch Käse Haus Started the Snowball

On January 30 the Tennessee Department of Agriculture took a sample of the Amish Classic Colby from a store in Trenton, TN, and found it to be contaminated with Listeria monocytogenes (LM). By February 9, they posted an alert announcing a recall of Amish Classic cheeses and Meijer branded cheeses, all made by Deutsch Käse Haus, a company owned by Michigan Milk Producers association since fall 2016. 
 
Since Deutsch Käse Haus is a business–to-business provider, a number of their customers were required to recall their products. The customers of these customers had again to notify their customers, resulting in a snowball effect.
The voluntary recall covered products made at Deutsch Käse Haus factory between September 1, 2016 and January 27, 2017. All the recalled products were produced by Deutsch Käse Haus. Meanwhile, all production has been suspended at the LaGrange County plant while the Food and Drug Administration (FDA) officials investigate the cause of the contamination.

The Snowball Effect

Sargento Foods Inc 

Sargento recalled seven of its branded sliced and shredded cheese products made by Deutsch Käse Haus. Products included Ultra Thin Slicked Longhorn Colby and Chef Blends Shredded Nacho & Taco Cheese. These products were made on the same line as five other products that Sargento recalled.

Taylor Farms

Secondary recalls related to Listeria discovered in cheese produced by Deutsch Käse Hausis have begun, with Taylor Farms recalling 6,630 pounds of chicken salad and pork products since they contain recalled Sargento cheese. The products packaged under the Signature Cafe and H-E-B brands were recalled. The problem was discovered on Feb. 10, 2017, when the establishments were notified of the recall by Sargento Foods, their supplier of Bevel Shred Pepperjack cheese products.

Country Fresh

Sargento’s products were also used by Country Fresh LLC in a number of cooking and snacking products. The firm recalled 2,552 cases of various kinds of stuffed mushrooms and other snacks that contained Sargento cheeses that were produced and packaged from February 6–9, 2017.

Choice Farm

It’s unclear if the cheese recalled by Choice Farm came from Sargento or Deutsch Käse Haus. The recall pertains to just seven trays of individually-wrapped mushrooms in the following flavors: Traditional Gourmet Portabella Mushrooms, Pizza Style Portabella Mushroomsand/or Stuffed Mushrooms. The products were sold on Feb. 10 at selected stores in Texas and Kansas.

MDS Foods Inc.

MDS Foods cut and packaged cheese from Deutsch Käse Haus, before distributing it under the Amish Classics brand. The firm recalled six cheese products that were found to have Listeria, and another 20 due to potential contamination. The cheese was labeled under various brands such as Amish Classics, Meijer, Deli Made EZ, Old Tyme, and Deli Readi.

Meijer

Meijer recalled its branded Colby cheeses after receiving notice from their supplier MDS that uses Deutsch Käse Haus Colby cheese. All Meijer branded “Colby Cheese” and “Colby Jack Cheese” sold in Meijer’s in-store deli counters (between from Nov. 10, 2016, through Feb. 9) were included in the recall.

Sara Lee 

Sara Lee recalled 734 cases of two types of cheese that were distributed to food retailers in Alabama, California, Louisiana, Michigan, Pennsylvania, and Texas. Three brands of cheese produced by Deutsch Käse Haus LLC and two brands of salads produced by Taylor Farms and included cheese recalled cheeses from Deutsch Käse Haus.

Guggisberg Cheese 

Guggisberg Cheese, which owns Deutsch Käse Haus, recalled a dozen products, mostly cheese available at deli counters. The affected products were manufactured both by Guggisberg Cheese, Inc. and by Deutsch Käse Haus, under the Guggisberg label. These products were packaged in clear plastic and sold primarily in retail stores at deli counters and deli cases.

Dutch Valley Food Distributors, Schlabach branch  

On 2/15/2017 the firm recalled products after they were notified by Deutsch Käse Haus that various cheese product they received may have been contaminated with LM. 

Biery Cheese

On 02-15-17 the firm was notified by Deutsch Kase Haus, that they supplied Biery Cheese with various type cheeses that may be contaminated with LM. These products were packaged at Biery in Louisville, OH and distributed to distribution centers.

Saputo Inc 

Saputo recalled certain Gouda cheese products after having been notified by Deutsch Kase Haus, that these products may have been contaminated with LM. The recalled products were sold to retailers nationwide. The Great Midwest Applewood® Smoked Gouda cheeses were sold primarily in retail stores at deli counters and deli cases.

How does Listeria Enter the Products?

Listeria Monocytogenes is present all around us, mainly on dust on the ground. Once Listeria enters into a manufacturing facility it is difficult to get rid of it. The primary reason for it is that LM tolerates salty environments and cold temperatures and can even continue to grow at temperatures as low as -5˚C. It is difficult to eliminate it; therefore the focus must be on prevention.
Contaminated boots can allow Listeria to enter the plans. Drains can harbor Listeria and must be properly maintained.  It is important to keep the factory floors dry at all times, since Listeria like most other bacteria needs water to grow.
In the FDA  Draft Guidance for Industry: “Control of Listeria monocytogenes in Ready-To-Eat Foods” there are detailed recommendations on how to control Listeria. The FDA encourages a “seek and destroy” approach.

FDA new rules RTE products- Listeria

For the first time, FDA has a legislative mandate that will require comprehensive prevention-based controls across the food supply to prevent or significantly minimize the likelihood of problems related to LM.
 
Facilities have “one free pass” of detecting Listeria in the environment and continue production, without a need to stop production. The finding still requires the performance of root cause analysis, extensive cleaning, sanitation, retesting, and investigation.
In the draft, there is a differentiation between low risk (do not support more than 1 log of growth) and high risk products. This differentiation affects the monitoring regiment as well as corrective action that need to be taken.  The guidance discusses product formulating as a mean to control of Listeria. The formulation must limit the growth of Listeria to less than one log. To be considered Listeria reduction a process must reduce it by 5 logs.
 
There are instructions on how to develop a robust environmental, sanitation and supplier verification programs. The goal is to find Listeria and eliminating the source of contamination. There is an emphasis on record keeping. There is a lengthy discussion on corrective actions should an environmental sample be found positive.
 
If LM is detected on Food Contact Surfaces (FCS), the food should be reprocessed, diverted or destroyed. The firm should consider a recall.
The guidance includes recommendations for controls involving personnel, cleaning and maintenance of equipment, and sanitation, as well as for treatments that kill Listeria monocytogenes and formulations to prevent it from growing during storage of the food between production and consumption.
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Food Fraud- Prevalence, Current Status, and Mitigation

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What is Food Fraud

Food FraudMany cases of food fraud are reported both in the US and around the globe. For example, a year ago there were many reports about Parmesan cheese that contained fillers like wood pulp, cellulose, and cheddar. In Europe horse meat was labeled as beef.
There is no universal definition of food fraud. The U.S. Pharmacopeial Convention maintains a Food Fraud Database and describes food fraud as a “deliberate substitution, addition, tampering or misrepresentation of food, food ingredients or food packaging, or false or misleading statements made about a product for economic gain.”
Michigan State University in its Food Fraud Initiative defines it as “a collective term used to encompass the deliberate and intentional substitution, addition (or dilution), tampering, or misrepresentation of food, food ingredients, or food packaging; or false or misleading statements made about a product, for economic gain.”
In most cases, when discussing food fraud we refer to EMA (Economically Motivated Adulteration). It involves misrepresentation of the true nature of a food product or ingredient. The goal of the seller is economic gain.

Major Types of Food Fraud

The National Center for Food Protection and Defense at the University of Minnesota has identified the following eight types of EMA:
Substitution involves complete replacement of a food product or an ingredient with an alternate product or ingredient. Examples include extra virgin oil substituted with oil of a lower cost such as regular olive oil or diluted with soybean oil and substituting higher value fish with lower cost, more abundant fish.
Dilution involves partial replacement of a food product or ingredient with an alternate ingredient. Examples include dilution of honey with sugar syrups, olive oil with other oil, and the addition of horse meat to ground beef.
Artificial enhancement is the addition of unapproved chemical additives to enhance the perceived quality of a product. Examples include the addition of Sudan dyes to chili powder and the addition of melamine to milk.
Counterfeit is fraudulent labeling of a product by an unauthorized party as a brand-name product. Examples include counterfeit infant formula and counterfeit Heinz ketchup bottles.
Transshipment or origin masking refers to misrepresentation of the geographic origin of a product to avoid import duties, regulatory oversight, or to benefit from consumer demand. Examples include routing Chinese honey shipments through Vietnam to avoid U.S. import duties and mislabeling imported shrimp as U.S. Gulf coast shrimp.
Mislabeling refers to misrepresentation with respect to harvesting or processing information. Examples include misrepresentation of label information for organic produce, cage-free eggs, kosher foods, halal foods, and date-markings.
Intentional distribution of a contaminated product is the intentional sale of a product despite knowledge of foodborne contamination. Examples include the intentional sale of Salmonella contaminated peanut products and the intentional export of dioxin-contaminated fish.
Theft and resale refers to situations where a food product has been stolen and re-enters into commerce through unapproved channels. Examples include retail theft of infant formula and cargo thefts.
From the Food Protection and Defense Institute (FPDI) the following graph was generated to show the prevalence of each categories of adulteration. EMA by type

Impacted FOODS

The most common foods involved in fraud, in order of prevalence are:
Fish and seafood: The most common type of products being adulterated are seafood products.  According to a study by Oceana the highest mislabeling rates are for fish sold as snapper (87%) or tuna (59%), with the majority of the samples identified by DNA analysis as something other than what was found on the label. Only seven of the 120 samples of red snapper purchased nationwide were actually red snapper. The other 113 samples were other fish.
Dairy Products: Cow milk can have milk from other types of animals such as sheep, buffalo, and goats-antelopes, added to it.  It can be adulterated with reconstituted milk powder, urea, and rennet, among other products (oil, detergent, caustic soda, sugar, salt, and skim milk powder). Adulterated milk may also be watered down and then supplemented with melamine to artificially raise the apparent protein content and hide dilution.
Oils and Fats: Almost 70 percent of extra virgin olive oil is said to be adulterated, the oil is often substituted or mixed with lower cost alternatives oils such as soybean, corn, peanut, sunflower, etc.
Meat Products: Meat product fraud comprise of the majority of EU fraud. It includes the replacement of high values species with lower value species and dilution of product with water. In 2013, consumers in England, France, Greece and several other countries were defrauded and unknowingly purchased meatballs, burgers and other food products that contained horse meat.
Honey: Honey might have added sugar syrup, corn syrup, fructose, glucose, high-fructose corn syrup, and beet sugar, without being disclosed on the label. Honey from a “non-authentic geographic origin” is also common, e.g., where honey from China is transshipped through another Asian country and falsely sold as honey from the second country—usually to avoid higher customs duties and tariffs that would be imposed on honey from China.
A number of other products such as Fruit Juice might be watered down, or a more expensive juice (such as from pomegranates) might be diluted with a cheaper juice (such as apple or grape juice). Coffee and tea e.g. ground coffee may contain roasted corn, ground roasted barley, and roasted ground parchment.
From FPDI the following graph was generated to show the prevalence of fraud in each food type. EMA by group

Economical Impact

According to a 2014 report by the Congressional Research Serviceit is estimated that up to 10% of the food supply could be affected by food fraud.  Thus, the costs of fraud food are borne by industry, regulators and, ultimately, consumers. It is estimated that economically motivated adulteration (EMA) of food, or food fraud, costs the food industry $30–40 billion per year.
According to Grocery Manufacturers Association (GMA) the estimated food fraud costs the world economy $49 billion annually.
“The impact on any particular company can range from minor economic damage to the potential loss of economic viability of the organization”, said Shannon Cooksey, vice president of science policy & regulatory affairs for GMA.  “GMA joined with Battelle, the world’s largest non-profit R&D organization, to develop a better way of prioritizing the actual risks to specific commodity supply chains at any time, so that decision makers can best apply their resources to the vulnerabilities of greatest importance.”

How to Prevent it- the FSMA Effect

The preventative control rule of FSMA published in September 2016, addresses EMA (Economically motivated adulteration) when there is a reasonable possibility that adulteration could result in a public health hazard. This rule requires mitigation (risk-reducing) strategies for processes in certain registered food facilities.
The FDA guidelines require that each covered food manufacturing facility prepare and implement a food defense plan. The plan must identify:
  • Vulnerability assessment: This is the step of identification of vulnerabilities and determining actionable processing steps. It includes the identification of the severity and scale of the potential impact on public health. Reviewing and assessing various factors, which create vulnerabilities in a supply chain (i.e. weak points where fraud has greater chances to occur).
  • Mitigation strategies: Measure taken to decrease vulnerability to a certain type of adulteration in the supply chain. The steps are implemented at each actionable processing step to provide assurances that vulnerabilities will be minimized or prevented.
  • Mitigation strategy management components: Steps must be taken to ensure the proper implementation of each mitigation strategy. Establishing and implementing procedures for monitoring the mitigation strategies. Corrective actions implementation. Verification activities that ensure that monitoring is being conducted and appropriate decisions about corrective actions are being made.
  • Training and recordkeeping: Facilities must ensure that personnel assigned to the vulnerable areas receive appropriate training; facilities must maintain records for food defense monitoring, corrective actions, and verification activities.
It is important to validate and verify that mitigation measures are working, and continually review food fraud management system. A guideline for step by step assessment is available at U.S. Pharmacopeia . Assessing the risk of fraud for a food ingredient requires the understanding of the inherent raw material vulnerabilities, the business vulnerabilities, and establishing the appropriate controls. This will allow to define which preventive actions are needed (and where) to mitigate the risk of food fraud. The vulnerability assessment is not a onetime activity but a dynamic continuous process.
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Listeria monocytogenes is back in the News

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Blue Bell Recall is due to Aspen Hill

Aspen-Hills-logoIn October 2016, BioExpert reported that cookie dough contaminated with Listeria Listeria monocytogenes is back in the News  from Aspen Hills (Garner, IA) has resulted in a number of recalls including Blue Bell ice cream. Recently, the FDA inspectors have confirmed that Listeria found in Blue Bell ice cream, prompting the recall of its products in October 2016, came from Aspen Hills.
Federal inspections of the cookie dough maker Aspen Hill confirmed, using Whole Genome Sequencing (WGS) analysis, that the Listeria isolated from Aspen Hill was found in the Blue Bell product. This settled the dispute between the two companies regarding the origin of the contamination.
The FDA issued a form 483 warning letter to Aspen Hill. In the letter the FDA claims that it has found Listeria monocytogenes in four areas of the Aspen Hills plant, and the company itself identified the pathogen in 10 areas as well as one finished batch of cookie dough that was not distributed to customers.
In the letter the FDA states “… The frequency of these environmental findings in conjunction with your finished product finding indicates that your firm is not taking aggressive action to identify harborage sites for L. monocytogenes,”  “… The presence of L. monocytogenes in your facility is significant because it demonstrates your cleaning and sanitation practices are inadequate to effectively control pathogens in your facility to prevent contamination of food”.
The Huston Chronicle reports that due to the FDA’s findings the owners of Aspen Hill, Thomas and Nancy Lundeen now plan to leave Aspen Hills. The company’s production ceased at the end of December.
Aspen Hills spokesman Jon Austin wrote in an email: “We are committed to addressing any questions raised by the FDA so that the agency can be assured that our commitment to the safety and wholesomeness of our products will not waver even as we exit the market”.

Recent Recalls due to Listeria

Ruth’s Salads Company of Charlotte, NCRuth's Pimento

The FDA reported that Ruth’s Salads recalled refrigerated pimento spread from stores in five states, because random product testing by the NC Department of Agriculture returned positive results for Listeria monocytogenes.
The products were distributed to multiple retailers in North Carolina, South Carolina, Georgia, Virginia and Tennessee. No illnesses had been reported as of the posting date.

Fromi USA. of New York, NY

The FDA Reported that Fromi USA recalled 7 cases of Soureliette cheese and 2 cases of Tomme Brebis Fedou. The products might have been  contaminated with Listeria monocytogenes. The potential for contamination was detected in a routine testing by the foreign supplier that revealed the presence of Listeria monocytogenes.
The recalled Tomme Brebis Fedou cheese and Soureliette were distributed to CA, NY and MA through retail stores. No illnesses have been reported to date in connection with this recall.

Barberi  International Inc. of Miami, FLSunmba

The FDA Reported that the company recalled its Sunmba Frozen Ajiaco (vegetable mix) product across Florida due to possible contamination with Listeria monocytogenes.
Florida’s Department of Agriculture and Consumer Services received the positive lab results from a routine product testing. No illnesses have been reported in connection with this product.

Dion’s restaurants in Colorado, New Mexico and Texas

The U.S. The Department of Agriculture’s Food Safety and Inspection Service (FSIS) issued a public health alert due to concerns about assorted sliced deli meat (sliced roast beef, ham, pastrami, and turkey) served to customers at Dion’s restaurants that may have been contaminated with Listeria monocytogenes. The sliced deli meats were produced by Peter DeFries Corporation, an Albuquerque, N.M. establishment. The problem was discovered through routine testing conducted as part of the Peter DeFries Listeria testing program. 

Blue Ridge of Eatonton, GABlue Ridge gogfood

The FDA reported that the company is recalling frozen beef sold in 2 lb chubs for dog consumption due to potential contamination with Listeria monocytogenes.
 
Listeria can affect animals consuming the product. There is a risk to humans from handling contaminated pet products, especially if they do not thoroughly wash their hands after having contact with the products or any surface exposed to these products. The affected products were distributed to retail stores in NC, SC,   GA,   and FL.

New Listeria monocytogenes Prevention in Ready-To-Eat Foods- Draft

listeriamonocytogenesThe FDA has published a new guidance for the prevention of Listeria monocytogenes  in ready-to-eat foods. The updated draft guidance has an emphasis on prevention, consistent with the FDA Food Safety Modernization Act (FSMA). The draft focuses on prevention and reflects the FDA’s current good manufacturing practice (CGMP) requirements. It also includes new requirements for hazard analysis and risk-based preventive controls, including verification of preventive controls.
The draft contained many detailed recommendations such as sanitizers to be used, clothing, equipment maintenances and design. There is a lengthy discussion on corrective actions if an environmental sample is found to be positive. The FDA points out that the corrective action is dependent upon the particulars of the facility and the product.
The document discusses that product formulation must limit the growth of Listeria to less than one log. It also discusses reduction processes, and that processes that are considered Listeria reduction if they reduce it by 5 logs.
As for environmental monitoring, The FDA recommends that Listeria ssp be monitored and that the swabs cover both food contact surfaces and non-food contact surfaces. It is important to emphasize that the FDA points 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.”
The draft discusses control, environmental monitoring, and corrective action. It imposes more responsibility on the processor for determining risk, which might be more forceful in terms of expected controls and monitoring.
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Rapid Methods for Food Pathogens- an Update

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USDA-FSISThe USDA / FSIS recently updated the list of Foodborne Pathogen Test Kits Validated by Independent Organizations.  
The rapid detection of pathogens in food is important to ensure the safety of consumers. Traditional methods to detect foodborne pathogens rely on time-consuming growth in culture media, followed by isolation, biochemical identification, and sometimes serology.
Recent advances in technology result in faster detection and identification of pathogens, more convenient, more sensitive, and more specific than conventional methods. These new methods are often referred to as “rapid methods”.
It is important to remember that in most foods, rapid methods still lack sufficient sensitivity and specificity for direct testing of the food; therefore, the foods still need to be enriched in a culture media before analysis.
In the USDA / FSIS document there are 3 separate lists of methods: for Salmonella, Campylobacter, and Listeria.
The list for Salmonella includes more than 25 companies, many of which offering multiple assay options, resulting in more than 40 methods listed.

Methods

The methods include antibody-based assays, genetic amplification methods and newer sensor development methods. 
 
Growth based methods: Including unique enrichment methods, chromogenic plates, and film based methods.
 
Immunological-Based Methods: Include enzyme-linked immunosorbent assay (ELISA) and lateral flow immunoassay. Also included are immune separation methods such as immunomagnetic separation (IMS).
 
Molecular Detection Methods: (nucleic acid-based methods): include simple polymerase chain reaction (PCR), multiplex PCR, real-time PCR (qPCR), nucleic acid sequence-based amplification (NASBA), loop-mediated isothermal amplification (LAMP) and oligonucleotide DNA microarray.
Biosensor devices: A Biosensor is an analytical device that consists of two main elements: a bioreceptor and a transducer. The bioreceptor is responsible for recognizing the target analyte and can either be a biological material (enzymes, antibodies, nucleic acids and cell receptors), or biologically derived material, or Biomimic: imprinted polymers and synthetic catalysts. The transducer that converts the biological interactions into a measurable electrical signal can be optical, electrochemical, mass-based, thermometric, micromechanical or magnetic.

ValidationMethod validation

The methods were validated by recognized independent organizations (e.g., AOAC, AOAC-RI, AFNOR, MicroVal, NordVal). None of the test kits listed is implicitly approved by USDA FSIS. A validated test kit must also be fit for purpose (i.e. validated for the appropriate matrix and sample size) and appropriate for the specific application in a food safety program.
In 2011 FDA issued guidelines for validation (FDA Methods Validation Guidelines for Microbial Pathogens) . It states that for commercially-available microbiological diagnostic kits:
  1. Performance parameters must be fully validated in a collaborative study by an independent accrediting body e.g. AOAC-OMA, AFNOR, etc. 
  2. Each lab must perform an in-house verification for the “first use” and for subsequent use of the method;
  3. Lab controls shall be used per lot to re-verify the method.

List of methods

The USDA / FSIS list is organized by organism and includes the manufacturer, assay commercial name, the method of external validation, the sample size, and the matrices. From the USDA / FSIS list the following table was created: TTTB
 

Status of Rapid Methods

Rapid methods have not been adopted as rapidly as projected when they were first introduced. While the new methods offer advantages in technology, speed and accuracy, they represent an incremental progress, rather than a revolution.
With the large number of competitors in the pathogen system arena, it is hard to differentiate among the technologies and find the clear winners. Every small progress of one technology is soon followed by a competitor that makes it slightly better.
With 40 different assays on the market it is increasingly more difficult for companies to choose a new rapid method. It is becoming increasingly more difficult to decide to invest in a new rapid method. This might be one of the reasons that more companies are moving to third party testing laboratories (http://www.strategic-consult.com/2014/11/growth-food-safety-testing-gone/). Small and mid-sized food plant labs are closing, and looking to third-party contract testing labs for their pathogen testing.
The extensive validation requirement as part of FSMA, and the increased training and documentation requirement also drive smaller manufacturers toward contract laboratories.