Lab Standards & Accreditation

Development of laboratory accreditation for the analyses of foods is a key component of the Food Safety Modernization Act (FSMA) as enacted in January 2011. It is, however, a component for which FDA has not yet proposed a rule, but one which the U.S. network of food laboratories is both eagerly and anxiously awaiting.

“In part because of the absence of such a rule, a number of organizations are moving off in their own directions, without the prime mover of FDA,” said American Association for Laboratory Accreditation (A2LA) BioSafety Program Manager Roger Brauninger. The Association of American Feed Control Officials (AAFCO) has come up with a set of quality and food safety requirements for feed; the U.S./Canada Regulatory Cooperation Council (RCC) just completed a GAP analysis identifying the similarities and differences between U.S. and Canadian standards; the International Congress on Harmonization is developing an international agreement; and a variety of international organizations are working to create documentation and procedures.

Discussion and controversy centers around some basic questions of applicability, such as: What is an appropriate battery of tests? Is there a most appropriate test to run, or are there various acceptable methodologies that arrive at the same outcome?

“We’re waiting to see what FDA will do,” said Director of the Alliance and President of Auburn Health Strategies Robin Stombler. “But overall the needle has moved from food laboratory testing being an area of little regulation to one of more oversight.” Stombler sees the development of model standards through the FSMA rule as being a positive development. “Through this, quality standards may be set by which laboratories must adhere. These standards would provide a feeling of assurance of testing results for food manufacturers and the public.”

Both Stombler and Brauninger have been involved with The Food Laboratory Alliance since it was established in 2013. The Alliance is a coalition of organizations devoted to food safety and the quality of food laboratory testing. (See Food Laboratory Alliance Update, page 66.) Current members of the Alliance include the American Proficiency Institute (API), Cherney Microbiological Services, Eurofins, Microbiologics, and Roka Bioscience and A2LA.

“Model standards were included in FSMA because they are important, necessary, and missing from the U.S. food science industry. We, and the rest of the quality-conscious industry, are eager for the FDA to address this mandate in the rule making process,” said API Director of Food Operations Heather Jordan. “The release of these model standards is an important step in raising the food safety bar, not only to the labs, but to the rest of the industry who relies on the quality of the results the labs provide. The cost of inaccuracy is significant, both in dollars and in avoidable potential illnesses.”
 

International Standards.

At this point, it seems that FDA is leaning toward the use of ISO 17025 and taking a global approach for the FSMA regulation. “But we don’t know if they will require the use of FDA BAM [Biological Analytical Methods] for microbiological analyses or if they are willing to accept substantially equivalent methods,” Brauninger said. Although ISO/IEC 17025 is the quality control testing standard recognized internationally by most countries and is appearing in more and more governmental regulations, it simply sets up the quality management system framework, he added. “It’s too soon to know whether the regulation will accept one method over another.”

Additionally, although the rule will apply to foreign laboratories testing food to be imported into the U.S. as well as domestic labs, it is unclear how whatever specified methodologies that are in the final FSMA rule will be accepted internationally.

The key is getting agreement on the appropriate test method, so that equivalent outcomes are acceptable. “You would think that there would be a gold standard of methods,” Brauninger said. “As one would suspect, the difficulty is that regulators in different countries have different methods they see as most applicable.” Additionally, even if methods are similar, regulators in some countries may take action based on a positive screening method that shows any presence of an organism —live or dead, while others want to be certain that the organism is recoverable before regulatory action is taken.

“A lot of the methods are so sensitive that they can detect the shadow of an organism that was there but is no longer viable,” he said, adding, “We don’t know if all will agree on which method and which test for which product matrix.

“My own sense is that we need to come up with an equivalent method and approach in a harmonized manner and then be able to have the regulators comfortable enough with it to be able to accept it as good enough.”

This also could be important because some countries may have difficulty getting, or affording, the reference materials, equipment, training, and other resources that will be required for a specific methodology.

That said, Land O’ Lakes Analytical Laboratory Manager Julie Honsa said she hopes that FSMA does use the network that is already in place for ISO 17025 accreditation, which includes:

• Eight ISO 17025 accrediting bodies in the U.S. standard as part of the Mutual Recognition Arrangement (MRA) with the International Laboratory Accreditation Cooperation (ILAC).
• 84 worldwide signatories in a global network of accredited testing and calibration laboratories and inspection bodies that are assessed and recognized as being competent by ILAC arrangement signatory accreditation bodies.
• The signatories, in turn, peer reviewing each other to show ILAC’s criteria for competence have been met.

“ISO 17025 is a rigorous technical and quality standard,” Honsa said. “By tapping into the current 17025 accreditation system, either by establishing a national ISO 17025 accrediting body that is a primary control for the other accreditation bodies in the U.S. or by simply accepting current ISO 17025 accreditation, they can ensure quality food safety testing. I don’t believe that an additional inspection or accreditation is necessary for FSMA if ISO 17025 has already been achieved for the testing in question.”

In attending related meetings and speaking with FDA, Brauninger said, he gets a sense that the FSMA rule on accredited laboratories could be fairly similar to what is laid out in their 2011 draft guidance document on submittal of laboratory results. This document describes a scenario in which ILAC recognized accreditation bodies, operating in accordance with ISO/IEC 17011 and accrediting labs to ISO/IEC 17025 and the AOAC supplemental Guidance for Food and Pharmaceutical Laboratories, in addition to supplemental FDA criteria on reporting results and product sampling, is recognized for the accrediting of laboratories for FDA compliance and enforcement.

The author is Editor of QA magazine. She can be reached at llupo@gie.net.