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FSMA and Labs
Laboratory information management systems make it easy to monitor safety procedures
by Vincent Paez
FSMA’s effect on food production facilities and testing laboratories bears considerable analysis. The key technologies that can facilitate compliance with the new legislation, along with the subsequent need for the development of new analytical methods, are, in a sense, under the microscope.
A primary goal of the FSMA is to provide the FDA with more power and control over safety procedures implemented in food production facilities. The increased frequency of inspection of food production facilities by the FDA is probably the most pronounced and remarkable mandate of the FSMA. Until recently, the FDA had been severely understaffed; however, in order to enable enforcement of the new regulation, a significant part of the funding appropriated to the act will be invested in staffing inspections.
To enforce safety procedures, the legislation also empowers the FDA with expanded record access, meaning that the agency is now legally entitled to review the safety records of food production facilities. These records may contain important data regarding facility cleanliness, hazard control procedures, and food safety testing. In general, FDA inspectors can request access to any records that they deem necessary, especially in cases when the food supply is considered to be at risk.
Under FSMA, the FDA’s import certification authority has increased considerably. As a result, imported food products must carry safety certification, which should be issued by authorized and certified bodies recognized by the U.S. government. Certification can be issued by a foreign government itself or by a third party such as an auditing and/or certification body.
An additional, important part of the new legislation is that the FDA now has the authority for mandatory product recalls. In the past, the agency was only able to recommend that a food producer recall a particular product.
The Need for LIMS
The unrestricted access to records granted to the FDA under FSMA is effective immediately, with all food producers legally obliged to register for mandatory inspections. Registration will identify every person involved in the production process so that a food tracing system can be established.
As a result, food producers must work quickly to ensure that they have in place automated systems for monitoring their processes and methodologies in order to verify batch content or origin of raw materials. Manual collection of paper-based data is increasingly recognized as a time-consuming, error-prone, and costly method of monitoring operations and processes in a food production facility.
State-of-the-art laboratory information management systems (LIMS) enable efficient data tracking and management, making it easy to map and monitor safety procedures implemented in food production facilities. A LIMS provides the producer with the knowledge that the quality of the product meets the standards set by the regulator, while recording all 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.
A common thread throughout the FSMA is traceability. LIMS play a critical role in the traceability of quality in the production process. These systems can store and monitor any type of food safety data, from information about seed quality at the time that a crop is planted to results of contaminant analysis performed on raw material and records of certificates of analysis. Cleaning schedules and their outcomes can be also archived in a LIMS, enabling food production facilities to easily prove that they are free from contamination when validation takes place. In addition, many food production companies perform shelf-life tests on their products and store the resulting data on a LIMS. Overall, competent LIMS solutions enable food production facilities to comprehensively and efficiently record and store all data, ensuring compliance with FSMA regulations.
Another important requirement of the new act is for food production facilities to implement a HACCP plan. There are many stages in the food production process where contamination can occur. In order to avoid contamination and ensure the safety of final food products, companies must identify the critical control points in the process and perform a thorough hazard analysis. A critical control point may exist in the containers used to transport raw materials or in a storage area where chemicals are kept in proximity to food products. Critical control points can also be identified on the production line. There have been cases in which maintenance on air conditioners positioned above the conveyor belt resulted in metal shavings falling into food products. In general, machines with moving parts operating in food production facilities constitute critical control points.
Critical control points can trigger three different types of contamination—microbiological, chemical, and physical—all of which drive a need for instrumentation that can provide rapid, accurate analysis with efficient sample preparation. Microbiological contamination testing kits enable fast and accurate identification of bacteria and other microbiological contaminants, thereby facilitating timely and efficient response. Using the kits, microbiological contamination testing is completed in a few simple steps. The sample is first collected, then transported into an environment where enrichment takes place to trigger growth of microbiological contaminants. Finally, the sample is tested, either with a microscope or more typically by color, in order to confirm the presence or absence of microbiological contaminants. The kits can be also used for proficiency testing in cases when food safety laboratories wish to be validated.
Chemical contaminants such as pesticides, melamine, fertilizers, and mycotoxins can be effectively identified using chromatography, mass spectrometry and inductively coupled plasma (ICP) for elemental analysis. Physical contaminants, including bones in meat and glass in food contained in glass jars, can be successfully detected using X-ray inspection and metal detectors as the product goes through or comes off the production line.
Nuclear contamination, though not as common as the other types of contamination, may also occur, particularly in food production facilities located near a nuclear plant. Those facilities should be equipped with radiation detectors to be used in case of an unfortunate event, such as the recent destruction of the cooling systems of a nuclear plant in Japan following a massive earthquake and tsunami.
As stipulated by the FSMA, the FDA must ensure that only standardized methods conducted by accredited laboratories are used for food testing. Unfortunately, the FDA does not have the necessary resources to deal with the analytical requirements of a sudden influx of food samples collected upon inspection of food production facilities. As a solution to this limitation, regulators introduced section 202, according to which the FDA must outsource food safety testing to third parties, such as contract testing laboratories and state laboratories, using standardized, commercially available analytical methods. The stipulation for rapid technologies refers to the need for immediate crisis response, when a sudden influx of contaminated samples occurs. Technology must be commercially available to ensure all methods of analysis are conducted using instrumentation from reliable, recognized instrument providers.
Food safety testing is a challenging task due to the complex chemical nature of foodstuffs. When chemically analyzing a food sample, specific contaminants must be extracted and analyzed using powerful instrumentation such as an ICP elemental analyzer or a mass spectrometer. This procedure can require significant sample preparation, from chopping up the sample and mixing it with solvents to putting the resulting material through a filter and extracting the contaminant under investigation. The extract, which is normally in a liquid form, is then analyzed using the appropriate instrumentation.
Food safety testing laboratories such as Thermo Fisher’s Scientific Food Safety Response Center (FSRC) in Dreieich, Germany, are dedicated to developing new methods to respond to new food safety crises using the latest cutting edge technologies such as Thermo Scientific TurboFlow and Orbitrap. New, advanced methods must be designed to perform food safety analyses in a rapid manner with limited sample preparation, in compliance with section 202 of the FSMA. The methods produced by the FSRC are often developed in close collaboration with other entities, such as private companies and/or government laboratories and are offered free of charge to the scientific community.
Under the FSMA, the FDA will be using new, comprehensive, and prevention-focused tools across the food supply chain, including increased inspection frequency, enhanced record access and mandatory product recalls. The new law also significantly enhances the FDA’s ability to achieve greater oversight of the millions of food products produced domestically or coming into the U.S. from other countries each year. All these key aspects of the FSMA have a direct impact on food production facilities and food testing laboratories, necessitating the use of specific technologies to facilitate compliance with the new act. LIMS solutions, mass spectrometers, chromatography, ICP elemental analyzers, microbiological contamination testing kits, metal detectors, X-ray inspection, and radiation detectors are considered essential tools, helping food safety laboratories adhere to the FSMA requirements.
Along with the requirement for innovative technology, new or improved methods of sample analysis will increasingly be needed as more and more contaminants are revealed and speed and efficiency of detection are demanded. As a result, dedicated research centers that are staffed with experienced scientists of broad and varying specializations will become vital tools in the development of new testing methods in order to ensure FSMA compliance.
Vincent Paez is director of business development for food safety at Thermo Fisher Scientific.