Back in 1987 The Wall Street Journal shocked health care consumers and awakened the U.S. clinical community with these headlines:
- “Lax Laboratories: The Pap test misses much cervical cancer through labs’ errors” (Walt Bogdanich, November 2, 1987)
- “Physician’s carelessness with Pap tests is cited in procedure’s high failure rate” (Walt Bogdanich, December 29, 1987)
- “Medical labs, trusted as largely error-free, are far from infallible” (Walt Bogdanich, February 2, 1987)
- “Risk Factor: inaccuracy in testing cholesterol hampers war on heart disease” (Walt Bogdanich, February 3, 1987)
It took this Pulitzer Prize winning reporting to usher in comprehensive regulatory oversight of clinical laboratory testing performed on patients. Even though quality standards now exist for clinical laboratories, today’s food laboratories remain largely free of regulatory oversight. That needs to change long before we read disturbing headlines related to food testing.
“Our food is literally our lifeline,” pointed out the Chairman of the House Energy and Commerce Committee, Fred Upton, in June 2015. Recognizing such, a food safety system, which relies on the accuracy and quality of testing results, should require the use of laboratory standards and encourage appropriate oversight. While recognized quality standards and accreditation for food testing laboratories exist, their use is voluntary and not widely employed.
The 2011 Food Safety Modernization Act (FSMA) recognized this need. Section 202 of the law calls for the establishment of a program for the testing of food by accredited laboratories, and for a registry of accreditation bodies recognized by the Secretary of the Department of Health and Human Services (HHS). It also calls for the HHS Secretary to develop model standards that laboratories must meet in order to be accredited.
Yet, these provisions, which were due to be enacted no later than 2013, were not part of the seven already released FSMA proposed rules. In fact, the majority of those seven proposed rules make reference to food laboratory testing in some capacity, but the provision stating how testing should be performed has not yet been proposed. Most concerning, a provision within one of those proposed rules suggested, “… we tentatively conclude that it is not appropriate to specify standards of testing in the regulation…” due to the “diversity of hazards and foods that could potentially be tested.”
The Food and Drug Administration (FDA) held numerous public meetings on FSMA and its proposed rules, but except for a couple of intrepid organizations, commentary on the laboratory provisions was largely silent. With the recognition that a modern food safety system would rely on laboratory results for product testing, environmental monitoring, and verification activities, some in the laboratory community were dismayed by the lack of action to ensure that testing is performed accurately and reliably. A louder voice was needed.
To provide that voice, the Food Laboratory Alliance was created in 2013 to address the quality of food laboratory testing through information, education, regulation, and guidance. The Alliance is supported by food laboratories, providers of food laboratory products and services, and consumers — all pledging a strong commitment to laboratory testing quality and accuracy.
In addition, food laboratory leaders have been speaking out. In the Green Bay Press Gazette, Debra Cherney, Founder and CEO of Cherney Microbiological Services, a food testing laboratory and a member of the Alliance, noted: “Without these testing standards, we don’t know if all food laboratories are accurately detecting pathogens that cause foodborne illnesses. While some food laboratories, like mine, are accredited and follow recognized standards, there are many that are not. This is a problem with an easy solution.”
The President of Eurofins, Mary Kay Krogull, stated in The Des Moines Register, “By performing more than 100 million tests each year, we help to establish the safety, composition, authenticity, origin, traceability, and purity of food. Yet, our role in food safety is often unseen. This ostensible anonymity provides all the more reason that the food industry demand strong standards and accreditation for all food testing laboratories.”
The Alliance has attracted these, and other leaders in the laboratory and consumer communities who feel an urgency to speak out now before a new food safety system is built without the proper foundation for laboratory testing.
What Is Needed
At this point in time, no one accurately knows the total number of laboratories in the United States performing testing. There is no basis for the public accounting for these facilities, whether located inside a food facility or as an outside contract laboratory. FSMA rightly requires HHS to establish a registry of recognized accreditation bodies and those laboratories they accredit. This information is to include names and contact information, and should be publicly available, to the extent that national security allows.
While some food laboratory accreditation agencies self-report their accredited clients on public websites, there is no central accounting. Section 202 of FSMA would remedy that problem, assist in the provision of tracking, and provide food facilities and the public with valuable information.
The Alliance wants to see all food laboratories accredited to the international standard, International Organization for Standardization (ISO) 17025, which provides general requirements for the competence of testing and calibration laboratories. To aid in understanding the essential requirements for food testing analyses, guidance documents are offered through organizations such as the AOAC International and its “Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food and Pharmaceuticals.”
Model laboratory standards should include elements essential to accurate testing analytics, such as quality control, proficiency testing, and education and training for laboratory personnel. The FSMA calls for model laboratory standards to ensure a level playing field of expectation for all accreditation bodies and laboratories.
Applying Model Laboratory Standards
Microbiologics, a global provider of biological reference materials and a member of the Alliance, commissioned a survey in 2015 to ascertain the level of laboratory standards currently employed by food laboratories. In terms of proficiency testing, respondents stated that 52 percent of contract laboratories participated in proficiency testing, and 48 percent stated that they did not know if their contract laboratory participated in proficiency testing. Fifteen percent of respondents stated that their onsite laboratories did not participate in proficiency testing.
Proficiency testing is an objective method used to assess analytical performance and verifies that performance against broad practice trends. It is used to improve practices by identifying problem areas sooner than if proficiency testing results were not applied. By using proficiency testing for verification of testing accuracy, it is possible to detect areas of failed performance sooner. All food laboratories should utilize proficiency testing, but the survey indicates that this is not occurring.
TIME Magazine noted a 14-year study by the American Proficiency Institute, another Alliance member, which determined, on average, food laboratories had a false negative result rate of 9.1 percent for Campylobacter and 4.9 percent for Salmonella. False positive rates were reported on average as 3.9 percent for Salmonella and 2.5 percent for E. coli. This data was compiled from food laboratories that voluntarily participate in proficiency testing.
False negative test results, which may lead to a contaminated product entering the market, may expose consumers to foodborne illness or death. When a contaminant-free product is incorrectly rejected due to a false positive test result, economic losses and loss of trust in the food brand or commodity may be a consequence.
Labs Integral To Safety
The FSMA mentions “laboratory (ies)” 57 times and “laboratory test” 29 times. In a nutshell, food laboratories are integral to food safety. Yet, without regulatory oversight, we do not know which food laboratories are performing testing and if recognized standards are applied to the performance of that testing.
The results of these laboratory tests can mean the difference between food going to market or being recalled from the grocery shelves. It can mean the difference between sickness or health. Accuracy is key. To get there, section 202 of FSMA should be promulgated now, in conjunction with other elements of the law that require food testing.