Tag Archives: Focus Article

Traceability: Leveraging Automation to Satisfy FSMA Requirements

By Dr. Christine Paszko
No Comments

In America’s food supply chain, food is sourced globally. Since ingredients often come from multiple countries, inspection and quality control is challenging, as regulations, policies and processes differ in each country. Product management begins with the suppliers, from the fields where the foods are grown, to the pesticides and fertilizers used, to harvesting, washing, shipping, storing, and processing (manufacturers), and finally, to packaging and delivery to consumers.

Figure 1. LIMS will facilitate FSMA by providing complete traceability from farm to table, in addition to accelerating collaboration, communication and providing operational insight.
Figure 1. LIMS will facilitate FSMA by providing complete traceability from farm to table, in addition to accelerating collaboration, communication and providing operational insight. (Click to enlarge)

Figure 1 shows each step of the product management process can introduce contamination due to unsafe practices or other risks. As such, test data and traceability must begin in the field and end when the final product is delivered to the consumer. The Laboratory Information Management System (LIMS) captures all information to ensure that quality data is effectively managed, communicated, and easily and quickly accessible in the event of a contamination issue. The LIMS allows producers to provide authorities with the required sampling and testing documentation to prove compliance.

U.S. consumers expect their food products to be affordable, consistent, safe and unadulterated. Consumers have seen numerous food recalls in the news, and it has shaken their confidence. The CDC estimates that about one in six Americans (or 48 million people) get sick, 128,000 are hospitalized, and approximately 3,000 die of foodborne diseases each year. Global food directives for international food initiatives include CODEX, ISO (International Standards Organization), and the Global Food Safety Initiative (GFSI).

The U.S. Government has implemented various food safety programs, from Hazard Analysis & Critical Control Points (HACCP) to FSMA in order to identify and correct potential contamination in the food supply. In fact, one of the primary focuses of FSMA is preventive action based on risk assessment.

The food landscape has changed significantly, especially over the past decade, as consumers demand year-round fresh fruits, vegetables and juices, along with more exotic foods. The fact that U.S. food is globally sourced has resulted in numerous challenges in quality assurance, shipping, traceability, labeling, storage, blending, testing, and reporting.

Use LIMS to track and manage information in a relational SQL Server LIMS database
Use LIMS to track and manage information in a relational SQL Server LIMS database. (Click to enlarge)

For example, upon reading the labeling on an apple juice can, it is not uncommon to learn the juice has been possibly sourced from numerous countries including the United States, China, Brazil, Argentina, Chile and many other countries from the European Union. Oftentimes, labels state that ingredients may come from some of the countries listed, but it does not specify what percentage comes from each country or exactly from which country the product was sourced. Figure 2 shows how LIMS can track and manage this information in a relational SQL Server LIMS database.

A similar scenario is true for tracking hamburger meat: The meat that was used to make burgers can come from multiple ranches and hundreds of cows. Many consumers don’t understand why their food/beverage is blended in large ton batches, and producers want to reach the required final product specifications, while offering a consistent product and experience to the consumer. Blending has become commonplace in the food industry, and it makes traceability much more challenging. The same is true in blending different meats, for example regulators have found pork in products marked 100% beef, this has led to the use of molecular tests to determine if meat has been adulterated.

FSMA and Traceability

FSMA focuses on a preventive approach rather than reaction and response to foodborne outbreaks. A central focus is on traceability, involving a complete understanding of the complex food chain and conducting testing at the key control points that can introduce contamination. It is important to understand the source of all the raw ingredients that make up a final product as well as the details of where they are sourced, the CoA (Certificate of Analysis) report, other test results, and all associated documentation. These elements are especially important, because each region of the world has different approved testing methods and is challenged with different potential contaminants and processes. As a result, food manufacturers must manage a significant amount of information on all raw materials that they receive, along with the associated paperwork, which includes the CoA, confirmatory test data, and all plant, production and final product test data.

Case example. As operations scale, so does the testing. In order to manage all the testing, most laboratories turn to LIMS and laboratory automation to manage high throughput screening. A client that was performing nearly 1,000 Listeria tests per day was using an automated microbiological screening platform to complete this testing. They were struggling to hire more resources to manage and run the instrument, as the time was short and the increased sample volume was imminent. The goal was to automate testing from the nine plants that were submitting samples to the main laboratory, such that the entire process could be automated from the laboratory knowing how many samples were coming from each plant and from deploying pre-configured worklists to upload to the instruments. The instruments would then run the samples and send the result back into the LIMS. This integration alone saved more than six hours per day. In addition, the electronic data transfer was fast and error-free, and since the data was imported into the LIMS, any positives were automatically flagged in real time. This approach allows immediate action.

In addition, all data from shelf life studies and additional testing on the food product (i.e., pesticide testing, environmental testing for Listeria sp., mold, yeast, etc., formulations, and blending) can be managed in the LIMS, one centralized database.

How LIMS Supports FSMA

Over the years some manufacturers have relied on less-robust tools to manage and maintain testing data, from multiple Excel spreadsheets to paper log books. Challenges with using these tools include data corruptions, data loss, typographical errors, and accidental or malicious data changes. These systems are often costly, especially from a resource standpoint (i.e., data errors, hours spent interacting with the data for calculations, tracking samples, and manual report creation alone). In addition, creating reports for regulating authorities can be time-consuming and because there is no control over changes to the Excel sheets or logbooks, there is typically no audit trail, and because the data is not in the database, querying the data can be very difficult.

A quality LIMS will ensure that the organization is bullet-proof when it comes time for regulatory audits. It also provides a complete and secure solution to manage, track and monitor batches of product from farm to table. LIMS not only helps clients manage their regulatory compliance goals, but it also facilitates communication across the organization and provides laboratory intelligence that gives buyers insight into the best suppliers to purchase from, based on final product specification, consistency and pricing. Managers can also better understand when it is time to outsource testing based on workload data, allowing them to maximize their resources and profitably through more efficient operations. The system also accelerates communication: As soon as testing is completed, reports can be automatically emailed and alerts sent to cell phones, if any issues arise.

When dealing with perishable products, time is of the essence, LIMS save time. Table 1 lists just a few of major benefits of the LIMS in FSMA regulatory compliance.

Process/Requirement Advantage
Sample tracking and management Integrated barcode support (both 1D and 2D), manage all batch data, tests, from raw materials, in process testing to final packaged product testing
21 CFR Part 11 Compliance with electronic signature requirements
CoA Easily, automatically generate the CoA report once testing is completed, validated and approved
Specification Management Manage final product, supplier and customer specifications and pricing
Document Management Link all paperwork to Work Order for ready access and retrieval
Full Chain of Custody Automatically generated and linked to the order
Records data and all paperwork associated with product All paperwork that arrived with the raw ingredients, CoA, and shipping documentation or additional test data
Records all test results Automatic data import from instruments as well as hand entered data
Shelf-life Studies Setup, manage and track all aspects of shelf life studies
Formulations and Blending Manage and track as components and specifications for final product blends, and leverage predictive tools for optimal purchase options from suppliers
Audit Trail Track actions in the system and generate a report of all audits made to any result data
CAPAs (Corrective and Preventative Actions) Track and manage open CAPAs in the LIMS, and tie to testing results for easy management to increase customer satisfaction
Traceability back to the source (farm, country) and  forward to the store that it was shipped to, with key data (lot number, ship date, etc.) Users can view all components and associated test results, along with any notes on the final product, back to the supplier and forward to locations that offer the product to the consumer
Employee Training Manage employee training records and view Standard Operating Procedures online to ensure access to work instruction and provide evidence for audits
Instrument Management Manage all quality control data on the instruments used in the testing, as well as documented calibration data, maintenance, any repairs, or any issues. Users can link the PDF manual in the LIMS
Enterprise integration (ERP, SAP, SCADA, MES, SAS JMP) Data sharing allows users with permissions access to data when they need it, so that they can quickly view and monitor information they need to perform their job. Users can also view data with integrated statistical tools to view trends that may not be readily evident
Table I

A LIMS is a critical tool to the success of food companies. It organizes and securely manages all aspects of food testing, facilitates regulatory compliance, enhances communication within the organization, and maximizes productivity. Many food producers are concerned about protecting their brand and providing a high quality, consistent, and safe product to consumers while operating efficiently and at a profit. An LIMS allows them to meet these goals.

FST Soapbox

HACCP, HARPC, and How Using Software Helps

By Steven Burton
No Comments

With nearly one in every six Americans falling prey to foodborne illnesses each year, food safety is a major public health issue. For several decades, current Good Manufacturing Practices (cGMPs) provided the basic food safety framework for manufacturers. However, these guidelines were not sufficient to cover all potential food safety hazards. In the 1960s, NASA asked Pillsbury to manufacture the first foods for space flights, and so the Hazard Analysis & Critical Control Point (HACCP) system was born. HACCP was later endorsed by the Codex Alimentarius Commission, which was formed by the Food and Agriculture Organization of the United Nations and the World Health Organization in 1963.

HACCP is a global standard and its principles are the defining elements of ISO 22000, BRC and SQF, all premiere global food safety standards. In 1996, an E. coli outbreak in Scotland claimed 10 lives. The Pennington report in the aftermath of this tragedy recommended use of HACCP by all food manufacturers to ensure food safety. While HACCP is mandatorily used for seafood, juice and USDA-regulated meat processing, it could not win universal acceptance across the food industry; most of the food industry sectors rely on cGMP for providing a food safety framework.

The number of people affected by foodborne illnesses can be attributed to a flawed food safety system. Thinking caps were put on and President Obama’s administration rigorously pursued what it hoped would be an effective food safety paradigm. On July 4, 2012 Hazard Analysis and Risk Based Prevention Control (HARPC) was introduced under FSMA section 103. Although the system is still a work in progress and FDA has yet not disclosed the regulations that will determine the functionality of HARPC, the agency is bound to issue the regulations by August 30, 2015. HARPC will become effective 60 days following this date, and companies will be required to enforce HARPC within a period of 12 to 36 months, depending on the size of a facility.

HARPC is designed along the lines of HACCP but is meant to be more comprehensive. For a “Simple Simon” it would be tough to differentiate between the two, but HARPC provides an all-encompassing food safety structure by focusing on preventive controls to make food safety more iron clad. With the exception of exempted facilities, HARPC will apply to all facilities subjected to FDA’s Bioterrorism Facility Establishment registration. All such facilities will be expected to enforce a functioning and adequate HARPC plan. Failure to do so and FDA would be authorized to take legal actions such as issuing a public warning letter or an import alert (in case of a foreign supplier), initiating criminal proceedings against a non-compliant facility, or suspending food facility registration of a facility until requirements are met. By doing so, FDA has put the onus squarely on the shoulders of respective facilities. Companies will be required to do a lot more and should expect deeper FDA involvement. Expert help to enforce a rather complex HARPC protocol seems unavoidable; there is a fair chance that users could find themselves lost in the translation and may end up facing FDA’s wrath if their plan is inadequate. Let me break it down a bit more and distinguish the main differences between HARPC and HACCP.

Qualified Food Safety Experience. HARPC requires one member of a company to be the qualified individual to complete an entire food safety plan. This means that said individual has undertaken education from a credible institution and gained experience by completing it. HACCP requires at least one person to be HACCP certified, but the plan must be constructed by a team of people.

Process Flow Diagram. Under the HACCP standard, food safety plans must include a clear flow diagram outlining the process, from start to finish, that the ingredients will take throughout your facility. HARPC has no regulations regarding this.

Hazard Variables. Traditionally, hazards were limited to biological, chemical and physical hazards under the HACCP paradigm. Yet, under HARPC, you must also outline Radiological and Terrorism hazards.

Controlling Hazards. Here is largely where the main difference lies: How to control a hazard. HACCP requires companies to mention their critical control points as well as outline a prerequisite program (PRP), although this has no set requirements. HARPC requires you to apply a sanitation preventive control to the hazards, which looks at monitoring, confirmation, corrective action, reviewing records and re-analyzing.

Reviewing the Plan. HACCP requires the individual in charge to review all HACCP documentation every year. This is in comparison to HARPC, which requires a facility to reanalyze its plan every three years.

Recall Plans. Recalls, as required under HARPC, are a special type of incident, with all of the attributes necessary to create and manage a recall plan. HACCP does not have such a requirement.

Use Software to Implement HARPC Plan

Using software can make life easier when it becomes time to implement a HARPC plan. Documentation is an important part of the HARPC system, and software can help generate most of the documents used to establish the plan. Such a system can link regulatory requirements with procedures and customize several aspects of the system during run time.

A risk analysis component of software helps a user identify the likelihood and severity of a particular hazard (a HARPC requirement). HARPC also requires sanitation control procedures at food surface contact points; software features can support cross contamination points to which hazards are assigned and controlled. Software also allows users to define equipment, with a facility to schedule and record calibration, maintenance, and verification activities, including management task assignment to satisfy HARPCs provisions regarding sanitation of utensils and equipment. In addition, it has the provision to document procedures as required by HARPC and can also flag employees for refresher training if they are involved in a violation.

Software also enables users to electronically record inspections, which satisfies the obligation under HARPC to carry out an environmental monitoring program (for pathogen controls). Interestingly, sensors could also be integrated with logging facilities to automatically collect sensor data, which could then be used to send out alerts if there is an abnormality. Software systems can also accommodate coverage of allergen hazards and run a food allergen control plan, including documentation of the process.

An incident management plan can assign and track corrective actions, root causes, employee retraining tasks, and preventive measures to individuals, and recall plans can be created and managed using the system. As many inspectors prefer remote review of documentation, software can provide such remote access, allowing inspectors to conduct off-site document reviews. This process can reduce on-site inspection times from five to three days. A list of approved suppliers can be maintained as well, and these suppliers can be linked to receiving functions, enabling users to receive and maintain a detailed and comprehensive record of ingredients.

HARPC is a reality that will have to be embraced very soon. Using software is a simple solution for the tough times that lay ahead for the food industry. It can serve as an all-encompassing and one-stop-shop for businesses that need help enforcing HARPC plans.

Complacency Kills. What To Do Before a Recall

By Maria Fontanazza
2 Comments

A control point breakdown can lead to a food safety recall. Here’s what to expect, what to do, and how to move forward. But most importantly, this discussion with Alan Baumfalk, lead auditor and technical manager for Eurofins food safety systems, will focus on prevention and re-evaluating whether your company’s current plans will be effective in the wake of a recall.

Food Safety Tech: What is the role of the crisis management plan as it relates to a company’s food safety program?

Alan Baumfalk: The crisis management plan is an interwoven topic. Some people use crisis management or business continuity interchangeably, but they tend to have a bit of a different focus.

First of all, a crisis management plan usually goes together with a food safety plan, and in some cases, it is part of a food safety plan. We are all familiar with the food safety plan, which includes a HACCP plan (Hazard Analysis and Critical Control Points). HACCP consists of seven principles. We’re all involved in HACCP everyday; it’s related to everything we do. We identify the hazards that might be involved in the food we’re producing; we identify the hazards that might be involved in our daily lives (for example, we choose no to drive in rush hour traffic because of the potential hazards that might be involved).

This all fits into our food safety program where we try to eliminate risk through risk assessment. We establish critical limits of what we will and will not accept, and then we monitor and verify them. We take corrective actions when something we monitor is not within that critical limit. Verification involves verifying that what we’re monitoring is indeed being monitored, and finally, there is record keeping.

The crisis management team wants to prevent a recall, which is a crisis to the business, to the brand, and to the health and welfare to the public. No one wants to have a recall. When putting together this plan, you need to make sure you have a multidisciplinary team. It cannot consist of all sales people, nor can it be solely quality control people. You have to bring in people with certain expertise: Include people that are from legal, media/communications, and the business group.

FST: In preparing for a crisis, where does business continuity planning fit into the picture?

Baumfalk: Crisis management has two additional components—the business continuity plan and the food defense plan. They are not exactly the same, and they are not necessarily interchangeable. The business continuity plan is related to how you are going to continue your business if you have a situation that occurs. It can be a crisis that involves a buyer, an environmental hazard, or a physical hazard, for example.

Sometimes people will consider what is happening in the media right now. What happens if there’s an incidence at the local school and your employees have children there. What are you going to do and how will you respond? How will you continue to do business in a safe way?

When putting together a business continuity plan, you need to ask yourself, how are you going to cope with the business crisis and continue doing business.

  • Designate a senior manager who is in control of handling the organization and making the necessary decisions.
  • Identify a multidisciplinary crisis management team. Each person should have a specific responsibility (i.e., medical, regulatory services, contacting customers, suppliers and internal/external communications). Each team member should be prepared to respond to food safety issues.
  • Develop a contact list that includes legal and various experts in the industry.
  • Train employees.
  • Devise a worst-case scenario and practice, practice, practice. The plan should be tested rigorously and on an annual basis.

When we talk about a mock recall, one of the biggest deficiencies is that people don’t rigorously test it. The number one priority should be to have the plans in place and test them, and identify the weaknesses that you can correct. One of the biggest problems that may eventually cause a recall is complacency. The employees think they got it all covered. It’s important to note that an ounce of prevention is worth a pound of cure.

In Part II of this series, Baumfalk will make the connection between crisis management planning and food defense.

hemp-infused tea

Hemp-Infused Beverages: FDA Compliance and the Cannabis Industry

By Aaron G. Biros
1 Comment
hemp-infused tea

With cannabis-infused edibles gaining a bigger market share in 2014 (See the marijuana edibles regulatory update here), it comes as no surprise that cannabis-infused beverages are growing in popularity. Some of these beverage manufacturers operate in a very interesting legal environment because of the differentiation between compounds found in hemp and marijuana, two different varieties of cannabis.

“Under federal legislation, there is an exemption for hemp and as long as we process our CBD (Cannabidiol) molecules from the hemp plant, we are allowed to sell our products federally,” says Chris Bunka, CEO of Lexaria, a company that makes a hemp-infused tea.

hemp-infused tea
Lexaria’s ViPova black tea infused with CBD oil made from industrial hemp

A number of scientific research studies have suggested that the compound CBD has medical properties that can help mitigate symptoms like inflammation, anxiety, chronic pain, and much more.

Because of the federal exemption for hemp, Lexaria can enjoy interstate commerce and other freedoms that manufacturers using marijuana flowers do not, such as access to banking services. Dried marijuana flowers contain the psychoactive compound, Tetrahydrocannabinol (THC). This compound is responsible for the regulatory and legal schism between the states that have legalized marijuana and the federal government, which still considers it to be a Schedule I narcotic.

Much unlike a number of marijuana edibles manufacturers operating in states where marijuana is currently legal, hemp-infused beverage manufacturers operate in full FDA compliance.

Michael Christopher, founder of Loft Tea, is working with a laboratory and bottler that are both 100% FDA compliant. “We definitely operate up to and abide by all FDA best practices with our laboratory and as far as producing and handling material we use best manufacturing practices and processes,” says Christopher.

“We have to partner with a bottler and laboratory who have the reputation to build trust with our brand as an industry leader in safety and quality,” says Christopher. “Until the FDA gives us complete guidelines on cannabis-infused products, we will continue to operate above and beyond best manufacturing practices with our infusions.”

Because these manufacturers view their hemp tea as a health and wellness product, it is only a matter of time before we see these types of products lining the shelves of health-food stores nationally. However, before this happens, an FDA regulatory framework specific to hemp-infused products is needed to address this growing industry.

“The hemp infusion industry has a lot of opportunity when presented in the right framework,” Christopher says. “There is still education needed in the marketplace to get it to the point where it will be on the shelves in stores like Whole Foods.”

Until that time comes, expect to see a steady growth of interest and inquiry from consumers, manufacturers, and regulators alike in the cannabis industry, whether federally legal or not.

RFID tags on drying marijuana flowers

Marijuana Edibles: Update on a Rapidly Developing Market

By Aaron G. Biros
No Comments
RFID tags on drying marijuana flowers

A lot has changed since last year’s article, “Marijuana Edibles: A Regulatory Nightmare.” Marijuana has since catapulted into mainstream thinking via activism, state decriminalization, and medical reforms while investors and banks are beginning to trust the market more, further legitimizing the nascent industry. According to an article from the Washington Post, Colorado’s legal marijuana industry reached $700 million in 2014 and is expected to grow to $1 billion by 2016.

Innovators are beginning to analyze trends on a national level, looking toward federal rescheduling of the drug as a catalyst for more state reforms and wider legalization measures. Federal legalization is in the back of many minds, as the introduction of pivotal state and federal legislative reforms promises more access to banking services, medical research, and more state independence.

While a black market mentality remains prevalent, widespread state reforms, increased venture capital investment, and further legitimization of an industry with less barriers of entry have fostered a perceived reduction in risk. States like Oregon, Washington, and Colorado that have already legalized marijuana for recreational and medical sales are beginning to implement strict packaging rules, requirements for traceability, QA programs, testing and laboratory monitoring requirements, and other regulations that would suggest FDA oversight down the road.

marijuana buds drying in racks biotrackthc
Dried marijuana buds curing with RFID tags as part of the traceability system of BiotrackTHC

State regulatory bodies such as the Colorado Marijuana Enforcement Division (MED) have matured and expanded their oversight to include certifications and requirements for lab testing and analysis. Marijuana testing facilities can now be certified by the MED to test for residual solvents, poisons or toxins, harmful chemicals, dangerous molds, mildew or filth, harmful microbials such as E. coli or Salmonella, pesticides, and THC levels and Cannabinoid potency.

According to an article from theCannabist.com, edible marijuana took 45% of the market share in 2014 and continues to grow, proving that food manufacturers and processors will gain a bigger share of the market.

BioTrackTHC develops a seed-to-sale traceability system that is the state-mandated reporting system used by any business that touches the plant in compliance with Washington’s i502 regulations (The company also won the contract bid for New Mexico’s and New York’s state-run traceability systems). “From day one, all retail products under i502, including infused edibles, must have laboratory-submitted passing test results and data in the traceability system before it can be unlocked for shipment to retailers,” says Patrick Vo, CEO of BioTrackTHC.

RFID tags on drying marijuana flowers
RFID tags on drying marijuana flowers, from BioTrackTHC

Regulations, especially those addressing traceability, are crucial for advancing the industry and fighting the black market, performing recalls, and improving product quality and safety. Vo adds, “As more states adopt a centralized traceability system, food safety will improve as we see the industry grow.”

“Most of the marijuana edibles producers we advise are working comfortably within their state health department regulations versus a year ago when they were struggling to implement routine compliance,” says Stephen Goldner, CEO of Regulatory Affairs Associates.  “But there is a long way to go to make this new marketplace meet the standards routinely met by US food producers in other markets such as nutritional supplements and medical foods.”

Many edible producers are sadly mistaken to ignore FDA labeling and production regulations just because the producer only ships within their own state, according to Goldner. “Whenever FDA has found label or food safety violations of products, whether they are food, drugs or any other product, it has always acted quickly to seize the product, inspect the producer and insist that violative labeling or production practices be remedied,” he says, adding that it won’t be surprising to see FDA start to “seize marijuana-infused food products that make drug claims, especially from the leading current producers” as a way for the agency to insert itself into the inspection and compliance process. “These companies need to have FDA food GMP’s solidly in place and properly documented,” says Goldner.

“Those who have experienced the most consistent and long term success in this industry are those who play above board, those who take the extra effort and make the investment in effort, time, and money to treat their business as if it was already federally legal and had to adhere to standards that other industries must follow,” says Vo. He agrees with the view held by many that long term planning is vital in this industry. “Those who have implemented best practices, QA programs, and traceability software will succeed in the long run, and the bad actors will eventually, by their own poor practices, be filtered out by regulatory and market forces.”

In the near future, the industry will look to other states in regulatory experiments on opposite sides of the spectrum. “New York, which legalized medical marijuana in 2014, is handing out 5 licenses to operate 4 dispensaries each, and allowing licensees to have a grow facility to supply their respective dispensaries. The Commissioner of the New York State Department of Health will have authority on licensing, testing, and medical requirements for patients seeking treatment with medical marijuana,” says R. David Marquez, who operates a Long Island law firm focusing on the cannabis industry.

New York is implementing very strict rules regarding cultivating and processing the plant. California, on the other side of the spectrum, already operates a somewhat loosely regulated medical marijuana market and has been doing so since 1996. The bill to legalize marijuana recreationally in the state is widely expected to pass vote and be implemented in 2016. This would open up an enormous market potential and contribute to the growth of the industry on a national level.

Because marijuana edibles are theoretically both a food and a drug, it is only appropriate that the FDA should look to regulate the industry in the future. In the meantime “Those who have invested the time and money in staying compliant now will be far ahead of the game tomorrow,” says Patrick Vo, who is looking toward federal legalization.

It seems that manufacturers and processors at the forefront of quality and safety testing will succeed in the long run.

Footnote: This is a regulatory update on the cannabis industry with an emphasis on edible marijuana. CannabisIndustryJournal.com, the newest publication, will be launched in September of this year. CannabisIndustryJournal.com will educate the marketplace covering news, technology, business trends, safety, quality, and the regulatory environment, aiding in the advancement of an informed and safe market for the global cannabis industry. Stay tuned for more!

Rapid and Robust Technologies Improve Sample Preparation for Analyzing Mycotoxins

By Olga I. Shimelis
No Comments

Mycotoxins are produced as secondary metabolites by various mold species during the growth and harvest of grains, fruits, nuts and condiments. Their production is directly related to the dry/wet weather conditions during the growing season. Mycotoxins are very stable compounds and are not easily removed during storage, processing and preparation of raw agricultural commodities.

Mycotoxins & Grains
Mycotoxins can be found in a variety of grains.

Different classes of mycotoxins are distinguished on the basis of the structural similarity and originating mold species. For example, more than a dozen different aflatoxin compounds exist but only five of them are routinely tested (aflatoxins B1, B2, G1, G2, and M1). Aflatoxin B1 is of particular interest because it is listed as a Group 1 Carcinogen by the International Agency for Research on Cancer (IARC). Aflatoxin M1 is a metabolic product that can be present in milk upon ingestion of aflatoxin B1 by an animal. Aflatoxins are ubiquitous in important agricultural commodities including maize and peanuts, and are among the most studied mycotoxins.

Deoxynivalenol (DON) is produced by a different fungi species. It is prevalent in cereal crops grown under wet conditions and temperatures above 15o C (60o F). Chronic exposure of livestock to DON may result in slowed growth, impaired immune function and reduced rates of reproduction, particularly in non-ruminants.

Mycotoxins were discovered as the cause of poisoning outbreaks in both humans and farm animals in the mid-20th century. Since then, multiple government regulations were established to control the presence of these toxic compounds in food and feeds. For example, harvested grains are checked for mycotoxin contamination using rapid field screening methods prior to grain deposition into silos. If contamination is found, the crops are sent to an analytical laboratory to perform the confirmation analysis. Liquid chromatographic methods were often used for such analysis with both fluorescence and UV detection. In recent years, mass spectrometry has been employed as a detection method.

Sample Preparation for Laboratory Mycotoxin Analysis

When performing analysis, it is important to choose the right sample preparation method to ensure accuracy, sensitivity of detection, repeatability and robustness, as well as fast sample preparation for high throughput. During laboratory analysis of mycotoxins, the sample preparation procedure typically includes extraction, purification and concentration steps.

Extraction of mycotoxins from samples is conducted by mixing the ground sample with the mixture of organic solvent and water, such as acetonitrile:water (80:20). Using methanol is not recommended, because it does not provide complete extraction. Prior to cleanup, the sample is filtered. Historically, mycotoxin analysis required extensive extract cleanup to minimize interference by matrix components. This holds true as new regulations continue to require lower detection limits.

Cleanup methodologies often include the use of phase extraction (SPE). Of the different types of SPE, one of the most common is the use of immunoaffinity sorbents that result in the selective retention and cleanup of mycotoxins. The drawback to using the immunoaffinity sorbents in the lab is that they are not compatible with the mycotoxin extraction solvent. In order to load the extract into the immunoaffinity SPE tube, the extract must be diluted with water, sometimes 20-fold, to prevent precipitation or folding of the protein-based antibodies by exposure to organic solvent. This presents an additional sample preparation challenge, as the grain extracts tend to form precipitates upon the addition of water and can clog the SPE columns. Thus, apart from the high cost of immunoaffinity SPE columns, the methods tend to be labor and timeintensive.

Super Tox SPE cartridges
Super Tox is a line of SPE cartridges for mycotoxin families that eliminates extra sample prep steps.

It would be beneficial to a laboratory to eliminate these extra sample preparation steps required by immunoaffinity SPE. Such cleanup SPE procedures are available and can be applied directly to the mycotoxin extracts without the need for further dilution, filtration and evaporation. A line of SPE cartridges for different mycotoxin families was recently introduced to the market. These SPE cartridges are compatible with the extracts generated during mycotoxin extractions and can be stored at room temperature. The tubes can also be used for cleanup of multiple classes of mycotoxins.

Analysis of Aflatoxins and Zearalenone

SPE cartridges are available for aflatoxins and zearalenone.
SPE cartridges are available for aflatoxins and zearalenone.

The following results employed SPE cartridges for mycotoxins that can be used for two aflatoxin classes, aflatoxins and zearalenone, and were applied to the cleanup of grain and peanut extracts. Results were compared to cleanup using immunoaffinity columns.

AflaZea SPE cartridges are based on the “interference removal” strategy that requires fewer processing steps compared to the “bind-and-elute” strategy of the other SPE. Peanut extracts contain not only co-extracted protein and complex carbohydrates but also fat. This extract was successfully cleaned using AflaZea SPE. When the SPE tube and a leading IAC column were applied to the peanut extract, both methods demonstrated good recoveries for spiked aflatoxins B1, B2, G1, G2 with AflaZea recovery values of 101–108% and immunoaffinity recovery values of 79–100%. However, the AflaZea provided better reproducibility for detection with a relative standard deviation (RSD) of 2–4% RSD versus 10–25% RSD with immunoaffinity SPE. This is likely because sample preparation using AflaZea is less tedious and takes one tenth of the time compared to immunoaffinity SPE.

Analysis of Deoxynivalenol

Wheat samples can be analyzed for deoxynivalenol using a new SPE cartridge.
Wheat samples can be analyzed for deoxynivalenol using a new SPE cartridge.

The following compares a new SPE cartridge for the analysis of DON, one of the Fusarium mycotoxins, with immunoaffinity SPE. Analysis of DON often is conducted using liquid chromatography (LC) with UV detection, so sample cleanliness is important to permit the separation of the DON peak from background interferences. The new SPE DON cartridge was compared to the immunoaffinity SPE for the cleanup and analysis of wheat samples. Clean chromatography and good recovery of spiked DON was obtained by both methods (86–97% RSD). However, clogging of the filters by the immunoaffinity SPE sample was observed during cleanup and complicated the sample preparation procedure. The SPE DON cartridge provided faster sample preparation.

Analysis of Patulin

Patulin is a mycotoxin commonly found in rotting apples.
Patulin is a mycotoxin commonly found in rotting apples.

Another SPE technology for mycotoxin analysis is based on molecularly imprinted polymers (MIPs), which are sometimes called “chemical antibodies” and mimic the performance of immunoaffinity sorbents. MIPs have binding sites that conform to the shape and functionality of specific compounds or compound classes. Strong binding of the analyte to the MIP makes it possible to perform intensive SPE washes that lead to very clean samples. Unlike immunoaffinity sorbents, MIPs are compatible with organic solvents and strong acids and bases.

Foods containing apples and similar fruits are required to be tested for patulin toxin, as they are the most common source for patulin exposure in humans. The MIP SPE procedure for patulin is faster than other SPE or liquid-liquid extraction methods and provides selective retention and superior cleanup. It is a robust method for analyzing apple juice and apple puree with HPLC-UV detection. After cleanup, patulin is quantified in apple puree at 10 ppb levels, which meet most regulatory requirements. The MIP SPE cleanup method eliminated 5-(hydroxymethyl)furfural (HMF) from the matrix, which sometimes appears as an interfering chromatographic peak when other sample prep methods are used. An SPE wash using sodium bicarbonate removed the interfering organic acids, while patulin was stabilized during elution at the end of the SPE procedure by using acidified solvent. Thus, most problems encountered during patulin analysis were resolved during this single SPE procedure.

Conclusion

As government regulations and consumer demand warrant cleaner, non-contaminated products, mycotoxin analysis will continue to be performed around the world. Careful selection of sample preparation methods is required for such analysis to achieve accurate testing results, best method performance and high laboratory throughput. Although many sample preparation methods exist, laboratories should choose the methods that not only provide adequately prepared samples, but also result in time and cost savings. The SPE technologies discussed in this article are sample preparation techniques that provide the required analytical sensitivity without capital expenditure into higher-end LC-MS equipment; the LC-UV and LC-FL methods can still be used. In addition, these SPE methods are simple, more robust, and less-time consuming compared to other SPE methods or liquid-liquid extraction.

All images courtesy of Sigma Aldrich

Food Safety Culture: Measure What You Treasure

By Lone Jespersen, Brian Bedard
1 Comment

A culture of food safety is built on a set of shared assumptions, behaviors and values that organizations and their employees embrace to produce and provide safe food. Employees must know the risks and hazards associated with their specific products, and know why managing these hazards and risks in a proactive and effective manner is important. In an organization with a strong food safety culture, individuals and peers behave in a way that represents these shared assumptions and value systems, and point out where leaders, peers, inspectors, visitors and others may fail to protect the safety of both the consumers and their organizations.

A number of factors influence these organizations, such as changing consumer demographics, emerging manufacturing hazards, and the regulatory environment. The United Nations predicts that the number of people over 60 years will double by 2035, the number of diabetes patients will increase by 35% (International Diabetes Federation), and the number of individuals living with dementia will increase by 69% (Alzheimer’s Disease International). This poses an increased urgency for food manufacturers, as these population cohorts are more susceptible to foodborne infections or may have challenges with food preparation instructions.

Much has been published on food safety culture, and we owe it to the front-runners to use their work to go deep into practical, everyday challenges and to continuously strengthen organizational and food safety culture.1 An element common to most of these publications is a reference to the importance of behaviors.2-8

There is a renewed recognition of the importance of individual behaviors specific to food safety and personal self-discipline in food processing and manufacturing organizations. Employees throughout the organization must be aware of their role and the expected food safety behaviors, and held accountable for practicing these behaviors. Embedding food safety culture in an organization can be very challenging given the need to carefully define appropriate behaviors, the difficulty in changing learned behaviors, and the complexity of objectively evaluating the level of food safety culture in a company. This article is an attempt to define useful food safety behaviors and to describe a behavior-based method that you can use to measure the maturity of your organization’s food safety culture.

Defining measurable behaviors

Behaviors is the element that, when combined with results, creates performance.9 Behaviors, if used to measure and strengthen food safety culture, must be defined carefully in a consistent, specific, and observable manner. Martin Fishbein and Icek Ajzen, authors of multiple publications on the Reasoned Action Approach, teach us how these three factors can be used to predict and explain human behavior, attitude, perceived norms and perceived control.10 They also teach us that behaviors can be defined consistently by including four elements (Figure 1).

Figure 1: Four components to a consistently defined behavior
Figure 1: Four components to a consistently defined behavior

Case: CCP operator on a baked chicken line. I work in a chicken processing company and am responsible for monitoring the internal cook temperature of chicken breasts after the product has gone through the oven. One of the important behaviors for my role could be defined as “Measure temperature of chicken after oven at predetermined time intervals”. This behavior is consistent, as it includes all four elements of the behavior definition (Table 1). The content of the behavior is defined in a way that makes it relevant for me, the CCP operator, and I am clear on the assumptions made by others on the processing line about my behavior. The behavior is observable and most people would be able to enter the processing area, observe the behavior and assess if it is performed as needed, YES or NO.

Leaving out any of the four elements of a behavior definition or becoming too general in your statements leads to poorly defined behaviors that are difficult to use as an assessment of behaviors, and ultimately as a measure of the sites for food safety culture (Table 1).

 Scenario  Behavior  Action Context Target Timing
Consistent, relevant, and observable  Measure and record temperature of three chicken pieces every hour at end of oven  Measure and record temperature  End of oven  Three chicken pieces  Every hour
Missing definition elements  Measure temperature at pre-determined intervals  Measure temperature  Not defined  Not defined  Pre-determined time intervals
Not specific  The product is cooked and checked every hour  Not defined  Not defined  The product  Every hour
Not observable  The product is cooked and check to see if it meets standard  Checked  Not defined  The product  Not defined
Table 1: Scenarios of defining behaviors

Behaviors are observable events and for this to be true, a behavior must be defined objectively in a language clear to everyone involved. It can be helpful to target a grade-six readability level, as it forces everybody writing the behavior to avoid words that are not understood in plain language.

Using behaviors to measure food safety culture

Assuming that behaviors are defined in a consistent, specific, and observable format, how do we decide the critical few behaviors that get measured? A suggested method is the use of the food safety maturity model (Table 2). The model outlines five capability areas that a processor or manufacturing company can use to measure its current state and to set priorities and direction. One capability area is Perceived Value that describes how an organization might see the value of food safety. The maturity level ranges from a low level of maturity of “Checking the box because regulators make us” to a high level of maturity for “food safety is an enabler for ongoing business growth and improvement”. Consistent, specific, and observable behaviors can be defined for each of these stages of maturity. By assessing the performance of these behaviors we can aggregate these assessment scores into a site or organization measure of the maturity of the site or organizational food safety culture. It is important to note that the maturity score does not measure “good or bad” culture. The measure is one of progression along the food safety maturity model scale, and can therefore be used to highlight areas of strength and help prioritize areas of improvement for the individual organization.

 

Table 2: Food Safety Maturity Model. The Food Safety Maturity Model was developed by Lone Jespersen in collaboration with Dr. John Butts, Raul Fajardo, Martha Gonzalez, Holly Mockus, Sara Mortimore, Dr. Payton Pruett, John Weisgerber, Dr. Mansel Griffiths, Dr. Tanya Maclaurin, Dr. Ben Chapman, Dr. Carol Wallace, and Deirdre Conway.

For more details on the food safety maturity model, visit www.cultivatefoodsafety.com.

Call to Action

The organization’s culture will influence how individuals throughout the group think about safety, their attitudes towards safety, their willingness to openly discuss safety concerns and share differing opinions with peers and supervisors, and, in general, the emphasis that they place on safety. However, to successfully create, strengthen, or sustain a food safety culture within an organization, the leaders must truly own it and promote it throughout the organization.8

The call-to-action for food industry leaders and regulators is to embrace a standardized measure of food safety culture to allow for comparison and sharing within an organization and between companies. “Food safety is everybody’s responsibility” was the theme of the recent GFSI Global Food Safety Conference in Kuala Lumpur, but to act on this with food safety culture as the ultimate outcome, we must adopt standardized measure. The GFSI benchmarking technical working group is an ideal forum to continue this dialogue.

During the upcoming GMA Science Forum April 12-15, 2015 join the conversation at a practical and detailed level. The preconference Food Safety Culture workshop takes place April 12, with facilitators from leading organizations;  the Food Safety Culture Signature Session on April 13 will discuss what our industry requires to enable this level of standardization and collaboration. For more information and to sign-up, visit http://www.gmaonline.org/forms/meeting/Microsite/scienceforum15.

References

  1. Schein, E. H. (2010). Organizational culture and leadership. San Francisco: Jossey-Bass.
  2. Ball, B., Wilcock, A., & Aung, M. (2009). Factors influencing workers to follow food safety management systems in meat plants in Ontario, Canada. International Journal of Environmental Health Research, 19(3), 201-218. doi:10.1080/09603120802527646.
  3. Hanacek, A. (2010). SCIENCE + CULTURE = SAFETY. National Provisioner, 224(4), 20-22,24,26,28-31.
  4. Hinsz, V. B., Nickell, G. S., & Park, E. S. (2007). The role of work habits in the motivation of food safety behaviors. Journal of Experimental Psychology: Applied, 13(2), 105-114. doi:10.1037/1076-898X.13.2.105.
  5. Nickell, G. S., & Hinsz, V. B. (2011). Having a conscientious personality helps an organizational climate of food safety predict food safety behavior. Food Supplies and Food Safety,189-198.
  6. Jespersen, L., & Huffman, R. (2014). Building food safety into the company culture: A look at maple leaf foods. Perspectives in Public Health, (May 8, 2014) doi:DOI: 10.1177/1757913914532620.
  7. Seward, S. (2012). Assessing the food safety culture of a manufacturing facility. Food Technology, 66(1), 44.
  8. Yiannas, F. (2009). In Frank Yiannas. (Ed.), Food safety culture creating a behavior-based food safety management system. New York: Springer, c2009.
  9. Braksick, L. W. (2007). Unlock behavior, unleash profits (Second ed.) McGraw-Hill.
  10. Fishbein, M., & Ajzen, I. (2009). Predicting and changing behavior: The reasoned action approach. London, GBR: Psychology Press.

Why Everyone Should Care About Food Safety

By Matt Shipman
No Comments

Food safety poses a global health problem. According to the World Health Organization, contaminated food can cause more than 200 diseases – and food- and water-borne diseases that cause diarrhea are estimated to kill two million people each year worldwide.

And food safety is not just someone else’s problem.

“Foodborne illnesses are a significant problem in the United States, with massive impacts on public health and the economy,” says Ben Chapman, a food safety expert and researcher at NC State. And the numbers back Chapman up.

According to a 2012 report from researchers at the Emerging Pathogens Institute, Resources For the Future, and the U.S. Department of Agriculture’s Economic Research Service, foodborne illness is estimated to cost the U.S. more than $14 billion annually. (The estimate takes into account factors such as medical costs and productivity losses.)

And a 2011 report from the U.S. Centers for Disease Control and Prevention (CDC) reported an estimated 9.4 million episodes of foodborne illness each year in the U.S. from known pathogens. An additional 38.4 million cases are estimated to come from unspecified or unknown pathogens. In total, foodborne illnesses are thought to contribute to 48 million illnesses annually – resulting in more than 128,000 hospitalizations and 3,000 deaths. It is, in short, a big deal.

So what are these foodborne illnesses? And how much damage does each of them cause? In advance of World Health Day, we wanted to explain a handful of the relevant pathogens implicated in foodborne illness.

Campylobacter fetus bacteria Image credit: CDC. Obtained via Wikimedia Commons. Click for more information.
Campylobacter fetus bacteria
Image credit: CDC.
Obtained via Wikimedia Commons.

Campylobacter

Campylobacter is a genus of bacteria, many of which can cause an illness called campylobacteriosis in humans, with symptoms including diarrhea and abdominal pain. People can contract campylobacteriosis from undercooked chicken, from cross-contamination via raw chicken, or from drinking unpasteurized milk.

According to the 2012 paper, campylobacteriosis affects 845,000 people annually in the U.S., costing the nation an estimated $1.747 billion every year and leading to 8,463 hospitalizations.

Listeria monocytogenes

This is a bacterium that causes listeriosis, which is characterized by fever, muscle aches, and sometimes by gastrointestinal problems, such as diarrhea. Listeriosis can be contracted from an incredibly broad range of foods.

According to the 2012 study, listeriosis costs the U.S. $2.577 billion annually, despite the fact that there are only 1,591 illnesses per year. But 1,455 of those illnesses require hospitalization – and 255 result in death.

Norovirus

Noroviruses are the most common cause of foodborne illness in the U.S., affecting an estimated 19-21 million people each year. Symptoms range from vomiting and diarrhea to fever and headache. Transmission comes from ingesting infected feces or vomit particles – for example, by touching a contaminated surface and then touching food or touching your mouth.

According to the 2012 study, noroviruses cost the U.S. $2 billion per year, with more than 14,000 hospitalizations and approximately 150 deaths annually. NC State is a leader in norovirus research, and home to NoroCORE – the Norovirus Collaborative for Outreach, Research, and Education. NoroCORE pulls together norovirus research from 18 institutions, with funding from the U.S. Department of Agriculture.

Salmonella enteritidis Image credit: U.S. Department of Agriculture. Obtained via Wikimedia Commons.
Salmonella enteritidis
Image credit: U.S. Department of Agriculture.
Obtained via Wikimedia Commons.

Salmonella enterica

This is one species of the pathogen that has myriad of subspecies and types – more than 1,400 of which are known to cause human illness. Infection with Salmonella species causes salmonellosis, with symptoms including diarrhea, fever, and cramping. Salmonellosis can be contracted from a variety of sources, ranging from poultry to peanut butter to mangoes.

According to the 2012 study, the subspecies within S. enterica alone costs the U.S. $3.3 billion each year, causing more than one million hospitalizations and almost 400 deaths annually.

What are researchers doing about this?

The four pathogens listed above are just a few of the rogue’s gallery of bacteria and viruses that can cause foodborne illness. But researchers are constantly learning more about these health risks.

“New technology and new research on pathogens, practices and prevention are improving our ability to identify and address foodborne illness,” Chapman says. “The field is really opening up. It’s an exciting time to be involved in food safety research.”

Between now and April 7, we’re planning to publish a series of posts on various aspects of food safety – what we know, what we don’t know, and what we’re working on. We also hope to offer insights to help folks lower the risk of contracting foodborne illnesses. We hope you’ll learn something new.

Note: This article originally appeared on NC State News, and has been published here with permission. You can find all of NCSU’s posts related to food safety here.

Citations:

  1. Batz, Michael B., Sandra Hoffmann, and J. Glenn Morris, Jr. “Ranking the Disease Burden of 14 Pathogens in Food Sources in the United States Using Attribution Data from Outbreak Investigations and Expert Elicitation” Journal of Food Protection, Vol. 75, No. 7, 2012, Pages 1278–1291. doi:10.4315/0362-028X.JFP-11-418
  2. Scallan, Elaine, et al. “Foodborne Illness Acquired in the United States—Major Pathogens” Emerg Infect Dis, Vol. 17, No. 1, 2011. doi:10.3201/eid1701.P11101