Tag Archives: traceability

Getting Ready for FSMA: How a Laboratory Information Management System Can Help

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Investing in a LIMS will give food testing labs, growers, producers and manufacturers the traceability they need to keep their products safe from contamination and to conform to the stricter regulations and reporting required by FSMA.

Do you know where your food comes from? How sure are you that it was grown, processed or produced with your safety as the priority? Increasingly this issue is headline news as we struggle with managing the outbreak of food-borne illnesses caused by the very stuff of our daily lives: salmonella contaminated peanut butter; e-coli contaminated beef and pork; contaminated spinach, lettuce and strawberries; melamine in milk.

In each instance, the grower or producer had inadequate methods in place to trace the original source of the contamination. The Mexican tomato business was devastated in 2009 when tomatoes were wrongly blamed for an outbreak of salmonella that was actually caused by tainted jalapeño peppers. Without proper systems in place to provide traceability, there was no way to know the contamination source. Several people died, many more became ill and a major business was destroyed for lack of information. The ultimate price for those food producers is that not only have they lost revenue due to product recalls, but, more importantly, they have also lost the trust of the buying public – and governments around the world have taken notice.

In the United States, the oversight of food had fallen under a fractured network of agencies responsible for different parts of the production process, from site inspections and safe processing methods, to the documentation of calorie counts and ingredient listings. Some grown and produced foods fell under the auspices of the U.S. Food and Drug Administration (FDA), while food groups that contained a combination of meat, dairy and produce fell under the oversight of the Department of Agriculture. Compound this regulatory environment with the fact that staffing for food inspections had been low compared to the volume of inspection needed to manage safe production. This lack of manpower and the separation of responsibilities exacerbated the ineffectiveness of the regulatory agencies and caused confusion among the consuming public.

The FDA Food Safety Modernization Act (FSMA), the most sweeping reform of our food safety laws in more than 70 years, aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it. The result of this legislation for consumers should be greater safety of their grown and produced foods. The impact for food producers will be mandates for upgraded business and operations plans, investments in instrumentation, software and manpower, and a safer food supply chain. This white paper discusses how to respond to FSMA, the role that traceability plays in it, and how leading food producers have implemented best practice solutions.

Employing a LIMS to meet the demanding FSMA requirements

The most important common thread throughout the FSMA is traceability. Laboratory Information Management Systems (LIMS) play a critical role in the traceability of quality in the production process from farm to fork, providing such capabilities as:

  • Automated data collection from testing and delivering the records of proof that are required for regulatory compliance;
  • A secure environment for monitoring batch relationships between raw materials, processed materials and packaged goods;
  • A centralized system that collects, stores, processes and reports all the data generated within food laboratories, allowing a complete overview of the quality of any product;
  • Automated checks for out-of-specification results and identification of suspect products to prevent release pending investigation; and
  • Assurance that all (standard, fast turnaround and condition sensitive) samples are handled and processed correctly.

Furthermore, a LIMS provides the producer with the knowledge that the quality of the product meets the standards set by the regulator, while recording that data for any subsequent inspection. Auditors can review uniform compliance reports and the certificates of inspection stored within the LIMS whenever required to confirm consumer safety.

Ultimately, a LIMS plays a key role in the integration of the laboratory environment with critical enterprise systems to facilitate faster, more informed decisions. This makes laboratory data available to process control systems, giving managers immediate accessibility to results, as well as cascading any release data through to enterprise resource planning systems.

For some food testing laboratories, commercial LIMS have been too costly for the business to absorb and support, forcing them to rely on inefficient manual and error-prone home-grown systems, spreadsheets or paper-based methods. The new legislation will put enormous strain on these labs to remain compliant. Investing in a LIMS will give food testing labs, growers, producers and manufacturers the traceability they need to keep their products safe from contamination and to conform to the stricter regulations and reporting required of the FSMA.

Case Studies: LIMS providing traceability for food worldwide

Chr. Hansen is one of the world’s top food ingredient companies. The company standardized on Thermo Scientific LIMS across all of its six culture production sites in the United States, Denmark, France and Germany to ensure optimum quality control in starter culture production. The LIMS implementation has delivered considerable benefits, including real-time, automated entry and processing of laboratory data, and fast extraction of results, leading to increased laboratory productivity and accelerated sample turnaround. Chr. Hansen has also integrated the LIMS with its existing ERP system, so that test results authorized in the LIMS by lab personnel can be immediately available for the processing facilities technicians and laboratory administrators.

Molkerei Alois Müller produces more than a third of all yogurt eaten in the UK from the Market Drayton factory. The Müller UK labs focus mainly on production Quality Control. Every step in the process undergoes quality checks, which are managed and stored with the LIMS. Müller UK selected Thermo Scientific LIMS to manage their QC data for raw materials, in -process, and finished dairy desserts. The LIMS reduced the amount of error-prone manual paperwork processes and expedited testing, while providing the necessary reports and documentation for a complete audit trail during regulatory inspections. By using a LIMS, Müller is able to trend all data and make quality and safety decisions, as well as any necessary improvements, much faster and more reliably.

Sino Analytica in Qingdao City, China is a world-class food analysis laboratory that provides contract analytical services to a wide range of food suppliers, trading companies, and retailers from China and all over the world. Sino Analytica historically managed data manually in the laboratory with a monthly load of over 1,200 samples. The company chose Thermo Scientific LIMS to support its food safety contract laboratory and meet the internal quality standards and accreditation requirements for food exports to countries including the United States. The LIMS has helped laboratory managers achieve faster assembly, collation, and review of information and data relating to QA/QC activities. The LIMS also demonstrates that the company meets the requirements of auditors and provides documentation for processing internal QC data.

This article has been adapted from a white paper presented by Thermo Fisher Scientific. Click here to access the white paper. For More Information about Thermo Scientific informatics solutions for the food and beverage industry, visit: www.thermoscientific.com/foodsafetyresources.

Dr. Douglass Marshall, Chief Scientific Officer – Eurofins Microbiology Laboratories

Environmental Monitoring – Another Leg on the Food Safety Management Stool

By Sangita Viswanathan
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Dr. Douglass Marshall, Chief Scientific Officer – Eurofins Microbiology Laboratories

Eurofins laboratories routinely test for the presence of the infectious bacterial generaSalmonella and Listeria monocytogenes in the food processing environment. While L. monocytogenes long has been known as an environmental contaminant, only recently Salmonella has been considered a persistent environmental contaminant.

At this year’s Food Safety Consortium (November 17-18, 2014, Schaumburg, IL), Dr. Douglas L. Marshall, Chief Scientific Officer – Microbiology, for Eurofins Scientific Inc. will present a workshop on Environmental Monitoring. This workshop will provide an overview of analytical methods used, a discussion of the zone approach to environmental monitoring, and a practical example of the use of microbial genetics in Eurofins’ Source Tracking Program to identify and eliminate a pathogen harborage.

In this Q&A with Dr. Marshall, we present a sneak-peek into what to expect in this workshop. Register today to learn more.

Food Safety Tech (FST): How are environmental monitoring requirements changing under FSMA?

Dr. Marshall: The Food Safety Modernization Act passed by Congress contains language in SEC. 418. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS stating: ‘‘(4) the preventive controls implemented under subsection (c) are effectively and significantly minimizing or preventing the occurrence of identified hazards, including through the use of environmental and product testing programs and other appropriate means” and ‘‘(C) An environmental monitoring program to verify the effectiveness of pathogen controls in processes where a food is exposed to a potential contaminant in the environment.”

The Preventive Controls for Human Food Proposed Rule has moved environmental testing to the appendix. It is clearly FDA’s intention that firms use environmental monitoring but how this will ultimately play out in the final rule is unknown. The companies we work with are finding a substantial non-regulatory push for environmental monitoring from their customers. As a result, firms without environmental monitoring programs will find it challenging to escape criticism from inspectors, auditors, and customers.

FST: What are some broad topics you are going to be covering in your FSC presentation?

Dr. Marshall: This EMP workshop will deliver tips for an effective pathogen monitoring program. Highlights include information relevant to answering many EMP questions such as what to test for, what is the value of indicators; where to test, what methods to use, what test volumes are appropriate, how to use trending, and how to remediate an environmental problem.

FST: What are some key challenges when companies do environmental monitoring? For Salmonella, and for Listeria?

Dr. Marshall: Many companies find it difficult to start an EMP program and fail to use the program in a proactive manner as an assessment tool. Environmental monitoring is an essential tool for microbial control, but it is not a control program. Robust programs target areas in a processing plant where environmental pathogen control is critical to product safety. The pathogen of concern may differ depending on food product type and processing conditions.

FST: Why is it important for food companies to pay attention to this critical area of testing?

Dr. Marshall: Numerous recent high-profile foodborne disease outbreaks and large recalls have been traced to poor environmental controls. Lack of effective environmental monitoring by producing firms contributed to these events. As a result, inspectors, auditors, and customers are demanding the placement of environmental monitoring programs as an additional leg on the food safety control stool, adding to GMPs, SSOPs, and HACCP.

FST: What kind of technologies will you be talking about in your presentation?

Dr. Marshall: The talk will present an overview of analytical tools required for routine monitoring and give an example of the use of genetic strain typing as a source-tracking tool for remediation.

Learn more, and register today for the Food Safety Consortium – Multiple Conferences, One Event, featuring 30 plus expert industry speakers, and speakers from FDA, CDC and USDA. 

Traceability Requirements and Best Practices

By Michael Biros
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What is a traceability system and how is it related to a recall plan? Will FDA require electronic record-keeping? What does FSMA require FDA and industry to do in terms of traceability? These questions and more are answered by The Acheson Group in the latest FSMA Fridays webinar.

What are the latest updates on FSMA?
In response to the substantive nature of the public comments, FDA plans on proposing new versions of the Preventative Controls Rules for Humans and Animals.

The proposed Preventative Control rule requires a recall plan. Is traceability covered through mock recalls?
A recall plan and a mock recall are not the same as a traceability system. A traceability system focuses on the ability to know what came in from where and where it was sent. A mock recall is a much more involved process that looks at production records and many other factors. However, in order to do a robust recall, you need a functional traceability system. The Preventative Control rule requires a recall plan and other parts of FSMA require traceability systems. The two are related, but they are fundamentally different.

How does FSMA address traceability and why is traceability a part of FSMA?
Traceability is distinct from a recall plan and FDA will have to address it separately from the Preventative Controls requirements. Traceability is covered in Section 204 of FSMA which describes the detection and response to food safety problems. While there’s an element of prevention in having a good traceability system, it really focuses on the response side. Traceability continues to be an Achilles’ heel for the regulators. Many of the statute components that are built into FSMA are based on prior experiences and situations. The biggest debacle with traceability was the tomato/pepper issue in 2008 where not only was the commodity wrongly identified, but it took close to eight weeks to figure out that it was wrong.

In this instance, FDA struggled with not having adequate records and being able to do the traceability components correctly and quickly. This and other similar issues has caused the food safety pendulum to swing.

Traceability is essential. FDA would love for the traceability requirements to be more robust, but they are limited by what is economically feasible and practical. Looking to the future, it’s entirely reasonable that traceability requirements could be strengthened.

What does FSMA require FDA to do in terms of traceability?
Pre-FSMA, there are record-keeping requirements in place related to traceability coming from the Bioterrorism Act. Basically, the current requirements are one-up, one-down: where did you get the product from, where did you send the product to? In developing the traceability requirements of FSMA, Congress required FDA to conduct pilot studies to determine what practices and technologies work and what doesn’t. FDA also needed to look at the cost/benefit related to technology and changes in traceability systems and what was current practice both domestically and internationally. FDA has the authority through FSMA to require additional records be kept for high risk foods. We expect FDA to issue a proposed regulation for traceability and record-keeping with high risk foods sometime in the future.

What did the traceability pilots recommend and are those recommendations now in effect?
Ten recommendations were made to FDA based on the results of the pilot studies and stakeholder input. The first recommendation was that all foods should be designated as traceable, not just those that are designated as high risk. Another recommendation was that FDA should accept electronic records rather than going in person and getting photocopies and that FDA should develop a system for processing traceability data. It was also recommended that FDA work collaboratively with industry. Over the past few years, there have been several industry led efforts with varying levels of adoption that are generally moving towards standardized and electronic records-keeping systems. Finally, it was recommended that FDA identify subject matter experts to help the agency understand specific industries for when there is an issue with the supply chain.

None of these recommendations are currently in effect because FDA hasn’t released a proposed rule yet and is still reviewing the report and public comments. The full report is available for the public to view, but ultimately it is up to FDA whether they accept the recommendations and if/how they put them into regulation.

Will FDA require electronic record-keeping?
The agency does not have the statutory authority to require companies to use electronic record-keeping. FDA recognizes that electronic record-keeping is the way of the future and prefers it, but they cannot require it. They will let companies keep their records how they want as long as they can be produced within 24 hours if requested.

What should companies do today to prepare and what do you think FDA will do next?
Companies should read the IFT report, read the recommendations, and consider how they would have fared if they participated in the pilot studies. They should give some critical thought to how they would perform if there was an outbreak and they were the focus of a traceability study. Traceability is a byproduct of good record-keeping. If a company has an opportunity to make improvements, consider how traceability can factor in to those changes. Companies should talk to supply partners and understand the whole supply chain. Ultimately, the company is connected to all the other links in the supply chain and any one of those links can impact you.

FSMA: What’s the Latest, and What Do You Need to Know

By Michael Biros
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Is your company ready for ‘TACCP?’ Do you know how long you will be required to retain your records? Is your carrier up-to-date on the sanitary transportation section of FSMA? Dr. Bob Strong, Senior Food Safety Consultant at SAI Global, gives an overview of the newest updates on FSMA.

Questions were raised recently by brewers and distillers about spent grains being sold as animal feed. FDA recognizes that hazards will be minimal, but charges facilities with protecting spent grains during storage awaiting collection and during transportation as required under FSMA Section 103. This will require protection against physical and chemical contamination and references the inadvertent addition of industrial waste oil to used fryer oil that exposed 100,000 chickens to PCBs. The comment period for this is closed and the final rule is expected to be published this summer. The final rule is scheduled to take effect by August 30, 2015.

Record retention and availability applies to anybody who processes, packs, transports, distributes, receives, holds, and imports human or animal food. However, farms, restaurants, USDA plants, personal consumption, non-food packaging, and food contact packaging manufacturers (but not users of this packaging material) are exempt from this requirement.

The length of record retention depends on the perishability of the food product. If the shelf life is less than 60 days, both the handler and transporter must retain records for 6 months. If the shelf life is between 60 days and 6 months or if the food is animal/pet food, both the handler and transporter must retain records for 12 months. If the shelf life is greater than 6 months, the handler must retain records for 2 years, but the transporter must retain records for only 12 months. Records must be available within 24 hours of a request by FDA and civil action may be taken if records are not kept or made available. This final rule was published on April 4, 2014.

FSMA section updates

These updates are confined to Section 106 — Intentional Adulteration of Foods; Section 111 — Sanitary Transportation of Human and Animal Food; and Section 204 — Designation of High Risk Foods Relative to Record-keeping for Traceability.

To recap, FSMA does not apply to facilities regulated by USDA (meat, poultry, and eggs). Also exempted are juice manufacturers, seafood processors, alcohol-related facilities, low-acid canning (except to expand their hazard analysis), and small businesses.

FDA is considering modified requirements for warehouses and having Preventative Controls only if they are storing refrigerated products.

Section 106 — Intentional Adulteration of Foods

The intent of the proposed rule is for companies to begin using a “qualified individual” to develop a written food defense plan. This plan will protect against intentional adulteration of food for the purpose of causing harm to consumers. The plan should focus on actionable process steps, mitigation strategies, monitoring, corrective actions, and verification.

The regulation exempts very small businesses, companies with a majority of sales to very small businesses, storage facilities (except for bulk liquid storage), alcoholic beverage manufacturers, and animal feed manufacturers and distributors.

Actionable areas and mitigation strategies:

Key actionable areas identified by FDA include: bulk liquid receiving and loading, bulk liquid storage and handling, secondary ingredient handling, and mixing and similar activities. Deliberate acts of contamination may come from acts of terrorism; disgruntled employees, consumers, or competitors; or economically motivated adulteration such as the melamine tainted milk incident.

Companies must identify and implement mitigation strategies, establish procedures to monitor these strategies, implement corrective actions, verify that monitoring is being conducted, train supervisors assigned to actionable process steps, and maintain records.

Examples of mitigation strategies include restricting access to potential adulteration points such as loading and receiving areas, bulk liquids, secondary ingredient handling rooms, and open processing points. Facilities must require tankers to be sealed after loading and the seals must be checked at receiving.

TACCP

FDA is asking for comments on using HACCP principles to develop food defense plans. They are considering calling a control point a TACCP (Threat Assessment Critical Control Point). They are also trying to identify the risk of adulteration to specific processes. Some examples of low risk foods that are hard to adulterate are: shell eggs, whole produce, game meats (not ground), peanuts/tree nuts, and sugar cane/beets. FDA has extended the comment period through June 30, 2014. 

Section 111 — Sanitary Transportation of Human and Animal Food 

This section builds upon the previously issued Sanitary Food Transportation Act of 2005. It has five major sections: vehicle and transportation equipment, transportation operations, information exchange, training, and records.

The regulation exempts shippers, receivers, and carriers that have less than $500k in total annual sales; the transportation of raw agricultural commodities by farm vehicles; food being shipped through the US to another country; food imported to be exported, but not consumed in the US; shelf stable foods that are completely enclosed in a container; the transportation of compressed gases; and the transportation of live animals.

Vehicles and transportation equipment

The proposed rule will establish requirements for the design and maintenance of vehicles and equipment to ensure that they do not cause contamination of the food being transported. This includes bulk and non-bulk containers, bins, totes, pallets, pumps, fittings, hoses, gaskets, and loading/unloading systems.

The regulation identifies the potential for cross-contamination from: incorrect use of packing materials (reusing wood containers for produce that once held raw meat); using the same hoses or pumps with different allergens or raw and ready-to-eat products; and pallets in poor condition (splintering or projecting nails).

The proposed rule will establish requirements for cleaning, inspection, maintenance, loading/unloading, and operation of transportation equipment to ensure no contamination or temperature abuse of the products during transport. This includes the growth of spoilage bacteria as well as pathogenic bacteria. This will be achieved by ensuring adequate temperature controls, separation of foods with different temperature requirements, and the cleanliness and physical condition of trailers, tankers, pallets, etc.

Communication

Carriers, shippers, and receivers will be required to exchange information regarding prior cargos, the cleaning of bulk transportation equipment, and temperature controls. A log of prior loads must be kept. FDA will not restrict what can be hauled. Rather, they will regulate the cleaning between loads. Wash tickets must be kept and shared with customers. Washing may include sanitizing where necessary.

The carrier must communicate with the shipper and receiver that temperature sensitive foods were transported under the required temperature conditions. This requirement can be waived for short hauls or if the shipper loads a temperature recording device with the shipped products. The shipper and receiver are required to specify in writing the temperature requirements to the carrier. The receiver must confirm compliance.

Training, records and waivers

Carrier personnel must complete training in sanitary transportation practices and must have documentation of this training. This will include personal hygiene for drivers and loading/ unloading workers, training in security, accessibility to hand washing, and avoiding cross contamination in handling mixed loads. Procedures, training, cleaning, prior cargos, and temperature control must be recorded and properly maintained.

Shippers, carriers, and receivers who hold valid permits and are inspected under the National Conference on Interstate Milk Shipments (NCIMS) Grade “A” Milk Safety Program may be waived from these requirements only when they are involved in shipping Grade A milk and milk products. Transportation of food relinquished to consumers may also be waived (such as the pizza delivery guy).

Section 204 — Designating High Risk Foods for the purpose of record keeping related to Traceability

This proposed rule designates high-risk foods based on known food safety risks. The criteria for modeling and scoring risk are:

  1. Frequency of Outbreaks and Occurrence of Illnesses: This must include chemical and microbiological food safety hazards. Chemical hazards include allergens, mycotoxins, pesticides, and heavy metals.
  2. Severity of Illness: This will take into account illness duration, hospitalization, and mortality.
  3. Likelihood of Contamination: This is based on number of recalls and contamination that has been known to occur.
  4. Pathogenic Growth Potential/Shelf Life: Strong growth potential is likely at temperature at which the food is intended to be held and stored, including refrigeration and room temperature. This will be coupled with shelf life where longer shelf life can increase risk.
  5. Manufacturing Process Contamination Probability/Intervention: High probability has recurring or frequent detection of contamination. Low probability has infrequent detection of contamination or where contamination is introduced post manufacturing. This will be coupled with the availability and implementation of control measures.
  6. Consumption: This is the percent of the population that consumes the food.
  7. Economic impact: Lower is defined as $100-500k impact per year and higher is greater than $10m per year.
FST Soapbox

The Private Food Label Dilemma

By Barbara Levin
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Prevention-based food safety and quality assurance technologies have a good return on investment, and may be critical to the ongoing financial health of the food private label industry.

Tuesday morning I had my typical breakfast while running out the door – Trader Joe’s almond butter on a toasted whole grain waffle. Good, and good for you, as my mom likes to say. Then of course I got to my desk, looked through my daily FSQA news feeds, and saw that the peanut butter recall was expanded to almond butter – and to other brands besides Trader Joe’s from the supplier, Sunland!

Well so far so good – I’m healthy and not in a high risk group, but it did make me think once again about the problem for food retailers that – in the need to remain competitive for shelf space in their own stores – have turned to private labeling for more and more products store-wide.

I’m a big fan of Trader Joe’s.  I buy a lot of their private label brands – everything from almond butter, to tomato sauce to olive oil. And they did a good job of aggressively getting the tainted nut butters off of their shelves.

But it does make one think of the added challenge for those manufacturing and selling private label goods – where a manufacturer problem can create a huge negative impact on your private label brand. Obviously in cases such as the Sunland nut butters, the ability to trace where the product had gone was key for recalling it. And while that ability is critical – the initial damage to the private label brands is done. Now, it’s just a matter of how extensive the damage is and how much it will cost to repair: loss of inventory, loss of sales, loss of consumer confidence and of course the cost of illness and related lawsuits which have already begun to follow.

And this doesn’t count the non-direct costs – such as advertising to eventually get those customers back – those who may now be “private label shy” and go back to the brand names under the perception that they may be safer.

We challenge the industry to look not just at reactive measures – but proactive, preventative measures as well. How are you leveraging food safety and quality technology? Are you using technology only to trace back once a problem has already occurred? Or are you also using technology to help prevent contaminated ingredients from going into production – and non-compliant finished goods from being labeled and shipped – in the first place. Are you as retailers putting this extra pressure on your manufacturers to take not just the reactive steps but the proactive ones as well?  

Prevention-based food safety and quality assurance technologies have a good return on investment, and may be critical to the ongoing financial health of the food private label industry. Have a thought on this topic? Join the conversation by posting a comment below.