THE ROLE OF MYCOTOXIN TESTING IN FSMA COMPLIANCE
As the FDA’s new approach to food safety continues to unfold, rigorous mycotoxin testing promises to become a cornerstone of a solid FSMA compliance strategy. To ensure this strategy doesn’t impose an undue burden on businesses, FSMA rules allow food and feed facilities the flexibility to design testing programs that are appropriate for their needs. The test format, the frequency of testing, and the question of whether the program will employ in-house personnel or a third-party laboratory are left up to the facility’s discretion. These decisions should take into account a variety of company-specific factors:
- The FDA and business requirements that must be met
- The test data’s intended use
- The likelihood of contamination
- The commodity to be tested
- The facility’s budget and technical resources
At processing and manufacturing facilities, routine end-to-end monitoring promises to play an important part in documenting FSMA compliance and maintaining the quality and value of products. Testing at regular intervals before shipping, processing, and packing can reveal an upward trend in contamination levels before the problem leads to a failed inspection, substantial product losses, or rejected shipments. Equally important, a complete record of test results from critical control points enables midstream and downstream companies to not only verify the effectiveness of their hazard prevention plan and the reliability of their suppliers, but also trace contamination back to its source. By comparing test results across different growing regions, suppliers, in-house storage areas, and weather conditions, the processor or manufacturer can identify where and when potential food problems originate and how to prevent their recurrence. Based on these data, a company can make proactive changes like sourcing ingredients from another location, cleaning storage bins and rotating stock more often or increasing the frequency of testing during hot, dry spells and rainy springs. Timely interventions like these expand the role of traceability in food safety and brand protection, enabling it to serve as not only critical preparation for a recall, but also a cost-effective preventive strategy.
Even facilities that are exempt from the FSMA’s preventive control and CGMP rules, such as grain elevators, will increasingly depend on accurate, reliable mycotoxin test data to sustain the confidence of their customers and confirm the merchantability of their products. Given that the receiver of a shipment will bear responsibility for any safety problems associated with that shipment, it’s in the best interest of buyers to require their suppliers to thoroughly test every commodity load and verify its safety before delivery. In the event that an FDA audit of the buyer leads back to the supplier, that supplier will need comprehensive test data to demonstrate that the contaminant levels in its products met contractual requirements.
FSMA-READY MYCOTOXIN DETECTION AND CONTROL
While many upstream providers already test for mycotoxins, their test systems will have to address tougher regulatory demands and increasingly urgent bottom-line concerns in the wake of FSMA. The viability of frequent monitoring programs for these businesses ultimately hinges on the availability of practical, cost-effective screening tools, according to Patricia Jackson, a market development manager at the Massachusetts-based test developer VICAM. “While the best opportunity for mycotoxin prevention is just after raw commodities are harvested and before grain or feed processing, many growers, handlers, and grain elevators lack access to laboratory facilities. With advanced rapid quantitative methods like lateral-flow strip tests, onsite personnel can confidently and efficiently handle the challenges of accurately measuring mycotoxins.” Those challenges are both technical and practical. Mycotoxins tend to occur in pockets, or “hotspots” in widely scattered locations in large loads of commodities. The percentage of mycotoxins in a load is typically minute, yet the concentration in a few grains or kernels could exceed the FDA limit. To get a statistically valid measurement, multiple subsamples have to be collected from randomly selected locations throughout the load and then thoroughly ground and mixed together to create a test sample. “A fast, easy-to-use test method minimizes the additional time needed to get the test data in the hands of the person waiting to decide whether or not to accept the load,” said Jackson.
A line of lateral flow strip tests made by VICAM adapts the company’s advanced immunoaffinity technology to a simplified format that accurately measures mycotoxins at ppm or ppb levels in as little time as 5 minutes.Unlike strip tests that require users to evaluate color changes, the VICAM line delivers results that require no interpretation. Numerical readings are displayed on the digital screen of a handheld optical reader. Jackson noted another important advantage. “The VICAM line include strip tests that require no organic solvents,” she said. This helps reduce the financial burden and environmental impact of routine monitoring in the field and in storage and packing facilities, transport vehicles, and processing plants. Laboratories that need a fast, economical way to pre-screen samples also appreciate the combined benefits of this method.”
To confirm test results obtained with screening methods, VICAM recommends using its line of AOAC and USDA-GIPSA approved immunoaffinity (IA) columns to prepare samples for instrumental analysis. By removing components of food that can interfere with accurate detection while efficiently extracting mycotoxins from samples, IA column cleanup minimizes the risk of false positives and false negatives.The simplicity of this method also greatly reduces the chances of procedural missteps. Test methods that incorporate IA sample cleanup detect lower concentrations of mycotoxins and measure them more precisely than strip tests. Their cost varies according to their technical sophistication and performance level. The most economical option uses a fluorescence detection device that can be easily operated by onsite users in grain elevators and processing plants and at buying points, as well as by laboratory technicians. Accurate ppb results are available in less than 15 minutes. The VICAM Series-4EX® fluorometric reader offers processors and manufacturers the additional advantage of storing as many as 200 test results, streamlining the FSMA-mandated task of documenting their monitoring efforts. IA methods that require more specialized analytical skills provide the greatest degree of accuracy and precision for a tradeoff in price.
VICAM recommends combining IA column cleanup with high or ultra performance liquid chromatography (HPLC/UPLC®) or liquid chromatography – mass spectrometry (LC-MS) for exacting applications like documenting the geographical source of raw materials, verifying that foreign suppliers meet acceptable safety standards, and certifying products for export. The exceptional sensitivity of these sophisticated instrumental techniques enables laboratory analysts to precisely measure the very low levels of mycotoxins required to comply with mycotoxin limits in strictly regulated foreign markets. The IA column line includes a variety of multi-analyte methods that measure two or more mycotoxins in a single test run. Companies that deal with commodities such as grain and spices that are susceptible to multiple mycotoxins will find these columns particularly useful for determining which mycotoxins should be the focus of their preventive control efforts. Food and feed testing laboratories whose customers require exceptionally detailed and authoritative mycotoxin profiles should consider Myco6in1+ for LC-MS/MS, a powerful validated method that simultaneously determines aflatoxins, ochratoxin A, fumonisins, deoxynivalenol, zearalenone, the T-2 and HT-2 toxins, and nivalenol at or below EU guidance levels.
ESTABLISHING TRUST IN AN INCREASINGLY RISK-CONSCIOUS WORLD
With all its challenges, the advent of FSMA offers the food and feed industry an important opportunity to reaffirm its commitment to serving as responsible stewards of the world’s food supply. In recent decades, consumers’ awareness of the risks of food-borne contaminants has grown steadily, prompting a rising call for greater transparency and stronger assurances of quality and safety from the businesses that grow, process, and distribute their daily sustenance. The knowledge that these providers are striving to not just meet but consistently exceed the new FDA requirements promises to strengthen the public’s loyalty to brands that achieve this goal and deepen their belief in an industry that embraces openness and accountability.