Back in the 1980s, the pharmaceutical industry grappled with the prospect of requiring testing laboratories to receive accreditation, a certification of credibility according to a qualifying body. Some labs were following international standards, while others set their own standards, and, as a result, there was no minimum level of quality which any of them were legally required to achieve.
Ultimately, pharmaceutical testing labs were required to adopt accreditation standards. Today, many other industries require accreditation for their labs, including those that test for harmful chemicals in everything from drinking water to children’s toys.
But, when it comes to testing our food, experts estimate that less than five percent of the food testing laboratories in the U.S. are accredited according to international standards. With implementation of the 2011 Food Safety Modernization Act (FSMA), however, that number may see a sharp rise as more food laboratories may be required to seek accreditation depending on how the final details of the law are written.
FSMA Rules on Lab Accreditation Still Shaky
When it comes to lab accreditation requirements in FSMA, the U.S. Food and Drug Administration has still kept the industry largely in the dark. While the agency has released draft rules for a number of other portions of the FSMA, such as new rules for produce growers and foreign importers, draft rules pertaining to lab accreditation have still not been released.
Some believe that FDA will begin requiring accreditation for at least some significant segment of the food testing industry, of which the U.S. has roughly 25,000 laboratories. Whether that’s restricted to third-party labs – numbering roughly 5,000 – or will also include all food manufacturers’ internal labs is yet to be seen.
Whatever FDA comes up with, requiring accreditation for at least some food testing laboratories will be a step toward catching up with other food industries around the world, many of which already require accreditation, said Keith Greenaway, vice president of ACLASS at ANSI-ASQ National Accreditation Board.
ANSI is one of eight laboratory accrediting bodies in the U.S., which accredit labs according to standards set by the International Laboratory Accreditation Cooperation (ILAC). ILAC gives recognition to accreditation bodies around the world via multilateral recognition arrangements (MRA), which strives to provide one test and/or calibration accepted everywhere. With the MRA, exporters or importers don’t have to retest product when it arrives in the destination country.
Greenaway added that it would be a “grave mistake” on FDA’s part to not require accreditation for all food testing laboratories.
“You want to be able to demonstrate that your results meet a minimum standard,” Greenaway said. “Accreditation is a stamp of approval that you’re producing competent testing results.”
It isn’t just the accreditation bodies themselves pushing for baseline standards. Representatives within the food testing industry see accreditation requirements as a logical development, said Robin Stombler, president of Auburn Health Strategies, LLC, and director of the Food Laboratory Alliance, a coalition of organizations focused on improving the quality of food lab testing.
“It’s not sufficient to allow for individual laboratories or companies to determine individual standards,” Stombler said. “We need to have standards that are the minimum rules everyone should follow. That way there’s more of an opportunity to say we know how everyone’s operating across the system to assure better quality.”
So far, the FSMA lab rules that do exist discuss elements of laboratory testing and how testing might be conducted. It’s important for the food testing laboratories to have a voice in terms of how that should look, Stombler said.
The most common argument against requiring accreditation is the added cost, said ANSI’s Greenaway. But, from his perspective, it should be looked at as one additional cost of following “good business practices.”
Accrediting bodies typically charge labs anywhere from $7,000 to $15,000 to assess and accredit their firm. Reassessments, which occur at least every two years, cost about that much over again.
However, the assessment itself may only account for part of the true cost. Firms may also spend a considerable chunk of change just preparing for the assessment, said Roger Brauninger, program manager for biosafety at the American Association of Laboratory Accreditation (A2LA), another U.S. accreditation body.
“In order to get accredited, it can also take a lot of hours internally to develop a system that meets the standards,” Brauninger said. “Even if you hire a consultant, it can be expensive to have them develop it for you. Having a consultant develop it for you can be a mixed blessing. They don’t really know your business, and they’re writing their policies for you.”
Accreditation is a Growing Trend
Both Brauninger and Greenaway agreed there were likely economic advantages to gaining accreditation. For one, going through the process of accreditation means that labs have documented all of their processes, which will likely translate into systems correcting themselves before small problems become bigger issues, Brauninger said.
“Having a scientifically controlled system means you’re monitoring the testing in a way that allows you to intervene and institute corrective actions,” he added.
Accreditation may also add appeal from clients in the food industry, Greenaway said.
“From a monetary standpoint, it gives someone who’s buying a lab test a bit more confidence that they’re going to get a reliable result,” he added.
Mansour Samadpour, CEO of IEH Laboratories, one of a minority of food testing laboratory networks to have accreditation, said he doesn’t see accreditation as an economic advantage but as a necessity.
“Quality systems should be independently assessed,” Samadpour said. “Without that, it’s really hard to determine the accuracy or veracity of your results.”
In an effort to build stronger trust between laboratories and the food industry, more laboratories will likely be looking to gain accreditation in the future regardless of FDA mandates, said Reinaldo Figueiredo, program director for product certification accreditation at ANSI.
“The industry sector is becoming more and more demanding and specific on what’s expected from labs,” Figueiredo said.
Accreditation Does Not Guarantee Safety
Both ANSI’s Greenaway and A2LA’s Brauninger were careful to point out that the accreditation of food laboratories can only better guarantee that their results are reliable and accurate. Nothing more, nothing less.
“As a consumer of food, I think the key is product quality in the first place,” Brauninger said. “Testing is never going to make a food safe. It’s going to ensure that safe food is safe. It doesn’t make the food safer, but it’s going to help ensure the practices that help make safe food are up there.”© Food Safety News