By now, we all know that the focus of food safety for the U.S. food supply chain has evolved from that of reaction to prevention. (Anyone who doesn’t can simply read the key words of the first rule of the Food Safety Modernization Act—Preventive Controls—to see this.) But it’s not just the U.S.—or the supply chain itself—that is seeing this evolution. Rather, as discussed by the Food and Agriculture Organization (FAO) of the United Nations in its webpage on laboratory services (http://bit.ly/1n5ZxML): while lab services “continue to play the essential role within the overall food control system of finally proving that practices by food producers, suppliers, and processors result in safe products for the consumers,” labs also should be evolving to “provide the necessary scientific evidence to better understand the food safety/quality issues affecting public health and trade and help solve these problems.”
Heather Jordan, director of food operations for the American Proficiency Institutes, agrees with FAO’s position. “No matter how you are viewing the food system, laboratory testing is essential, she said. “Laboratory test results provide needed scientific evidence at various points in the process whether through environmental monitoring, finished product testing, epidemiological surveillance, or trade policies.”
FILLING THE THIRD LEG. It’s an evolution of which all food labs should be a part, said Roger Brauninger, biosafety program manager for American Association for Laboratory Accreditation (A2LA), “While government and academic laboratories may be better positioned to do basic research-based investigations, captive laboratories [those associated with the manufacturer or organization] will have greater familiarity and, thus, expertise with their own particular food products and food matrices, and independent laboratories are more likely to see a broader cross-section of products. Together they both ‘fill the third leg’ of this tripartite stool of food safety investigation.”
It’s not as though labs are not already working to fulfill this role; food laboratories do provide important scientific support to the food system, Jordan said, “Yet we do not always know if the testing is conducted using appropriate standards. Food test results must be accurate to be useful.”
In addition to routine testing, food laboratories provide support to the public’s health, the international economy, and even national security, added Robin Stombler, president of Auburn Health Strategies and director of the Food Laboratory Alliance. “Without a secure, healthy food supply, population health, trade, and defense are at risk,” she said. “Accurate, reliable food laboratory testing is a foundation to this security, but more remains to achieve quality testing.”
Whether or not labs are currently leading a charge in providing scientific evidence to better understand the food safety/quality issues also depends on whether we are speaking domestically or globally, Brauninger said. “Locally, in this economy, labs expend some of their budgets on development and improvement of methods.” However, he added “from what I have heard in developing economies, not so much.”
EVOLVING CHALLENGES. That said, both captive and contract labs could be playing a greater role in outbreak analysis and mediation, which is currently conducted by federal and, to some extent, state laboratories, he said. “Many third-party and captive laboratories are better equipped than government labs, and if arrangements were in place to contract out some of the work, this would be a benefit to the communities.”
Stombler sees the role of food labs as continuing to evolve, with more accountability being required as food producers seek the services of laboratories that follow quality standards. “Frankly, there will be a greater demand for those food laboratories that are accredited, use quality controls, and participate in proficiency testing,” she said.
Jordan also is seeing an evolution taking place as more laboratories are voluntarily enrolling in proficiency testing to help assess their test accuracy, and then making necessary adjustments in their protocols. Additionally, she said, “As food safety regulations are implemented, we anticipate laboratory standards will become a requirement, not merely a voluntary action.”
Because of this, “Food laboratories that do not adhere to recognized standards may find themselves at an increasing disadvantage in the marketplace,” she added. “Becoming an accredited laboratory and following international standards may be an initial challenge for some food laboratories to mount, but the results are worth it.”
THE IMPACT OF FSMA. FSMA requires that certain food testing be carried out by accredited laboratories and directs FDA to establish a program for laboratory accreditation. Although the original due date for the establishment of a program for the testing of food by accredited laboratories was two years after the date of enactment of FSMA, this deadline is long past. In FDA’s FSMA FAQs publications (updated December 22, 2015), the agency states that it supports laboratories’ interests in pursuing accreditation, but it “has not yet fully developed its thinking or rulemaking with regard to FSMA implementation so any interpretations of requirements are premature at this time.” That said, any required accreditation will bring closer scrutiny of and more accountability by food labs.
However, Brauninger feels that international trade and competition may be an even stronger driving force toward accreditation than FSMA. This is, in part, to enable trust through verification of today’s industrialized food production that comes from around the globe, and, in part, because FDA could decide to “go narrow” and stick to the letter of the legislation as it did for the recent Third-Party Accreditation rule. That rule states, “For a regulatory audit, (when) sampling and analysis is conducted, the accredited third-party certification body must use a laboratory accredited in accordance with ISO/IEC 17025:2005 or another laboratory accreditation standard that provides at least a similar level of assurance in the validity and reliability of sampling methodologies, analytical methodologies, and analytical results.”But, even as we wait for FDA to finalize its thinking and publish a rule on accreditation, “the importance of laboratory accuracy is more critical than ever,” Jordan said.
In today’s world of prevention and increased attention on food safety by government, media, and consumers, there are many challenges that food labs must navigate, including emerging pathogens, toxins and antimicrobial resistance, new technologies, and globalization. “These complexities, among others, will require food laboratories to stay educated and current on scientific knowledge, policies and regulations,” Stombler said. “Above all, food laboratories must produce accurate and reliable test results, which will require adoption of recognized standards and accreditation.”
The author is Editor of QA magazine. She can be reached at firstname.lastname@example.org.