[Lab Management] Industry Regulations

Editor’s note: This article attempts to open the topic of industry regulation to discussion. Send your insights to llupo@giemedia.com.

In June, U.S. lawmakers voted to subpoena nine food testing laboratories, as part of an ongoing investigation of imported foods. Citing confidentiality agreements with the food import companies for which they had conducted the tests, nine of 10 laboratories had declined to voluntarily submit their records.  

Investigators were told that retesting to a negative is routine industry practice for private labs. If true, the practice may have allowed potentially dangerous food to be imported into U.S. commerce.

The legal wrangling raises a number of questions regarding quality and ethics in the lab, a laboratory’s responsibility when positive test results are attained and accountability in a recall situation and, on a much larger scale, the ability and viability of not only laboratories, but the industry as a whole, to continue the tradition of voluntary disclosure and self-policing vs. ever-increasing government regulation and oversight.

It is a question that is no longer left to the discretion of the industry. With the food supply chain in the news on a virtually daily basis, it is a subject that is gaining ever-increasing attention and pressure from regulatory agencies, retailers and consumers. 

As noted by Paul Roberts in The End of Food, “As a culture we probably haven’t paid this much attention to the food system and its flaws since the turn of the last century.”

Flaws that — because of the global nature of food production and the resistance of the food economy to sudden change — critics argue are not fixable from within.  “That change must be driven from outside the system, and that the objectives must be to replace some or all of that system with something entirely new.”

THE ISSUE. “It’s a complex issue,” said Roger Brauninger, senior accreditation officer for the American Association for Laboratory Accreditation (A2LA). “It’s an interesting issue because the laboratory does not work for FDA or USDA, but  for whoever is paying them, so in a sense it is up to the customer whether they want to reveal the results.”

In fact, some processors may “shop” labs, Brauninger added, giving their business to the one it expects to provide the most favorable results. There are, of course, regulations that prevent a processor from knowingly putting out an unsafe product, and very few would do so because of the potential monetary and brand reputation repercussions — not to mention the health impacts on those who would consume the product. But as tests become more sensitive, they may produce positive results below legally established threshold limits that were set using older techniques. This could, in essence, force a discretionary decision on the part of the processor which they would often prefer to not have to make.

Because food is a product that has long been generally regarded as safe, the testing, while required, is in effect a quality assurance, thus FDA regulations governing food are more flexible and discretionary than are those for pharmaceuticals, for which adverse data identifying a product as unsafe cannot be “hidden.”

Should testing for food be more like that for pharmaceuticals — with regulations requiring third-party laboratories to report test results to authorities? Or would that raise even more issues with processors turning to internal testing with, perhaps, inadequate resources or training for certain tests?

Brauninger suggested that a possible means to rebut the argument that adverse data are hidden from authorities might involve private sector laboratories being required to track the food testing data in a manner analogous to those private sector laboratories that test pharmaceutical products by making use of a “master schedule” approach. By doing so,  he explained, all testing results would be available for review by the government at any time.

“While it is the responsibility of the processor and importer to be ethical and follow HACCP approaches and other quality management system tools,” Brauninger said, “perhaps increasing the relationship between the private sector laboratory and the agencies responsible for review could increase confidence in the technical ability and professionalism of the private laboratory.”

SELF-POLICING IS VIABLE. Charles Deibel, president of Deibel Laboratories, Lincolnwood, Ill., said that there has, in fact, been some movement toward more laboratory regulation, such as that required of pharmaceutical testing labs. “We’ve seen a shift maybe 10 years ago with people moving forward with (various standardized) quality management systems,” Deibel said. But he does not necessarily feel that such standardization is good for the food industry in which each plant and product has unique, individual attributes which need to be considered and which currently has a greater degree of freedom to adapt FDA methods to the unique aspects of each customer.

At Deibel, the focus is on “hybrid vigor,” which describes the increased superior results arising from the integration of various experts, expertise or experience.

It is a concept that is applicable to achieving the best lab results, Deibel said, because it integrates training and education with research and actual experience, “allowing your experience to shape a study, shape an assay,” with validation of results. In addition, he said, hybrid vigor is a scientific, integrated approach that requires flexibility that conformance to rigid standards or regulations does not allow for.

The need for flexibility in a lab is similar to that required in a hospital emergency room, which must deal with very diverse types of treatments at any one time, Deibel said. “We have to be able to handle multiple client emergencies concurrently and not let any of our clients down.” For this reason, he said, “I would rather train my people and spend as much money on training as on ISO.  I would rather have problem solvers than automation.”

The application of experience also is beneficial in test selection. Although a test may have AOAC approval, it may not be the best test for the product, he said. And while experience can provide this knowledge to a technician, a procedurally driven process or strict regulation may not.

With such processes in place, Deibel said the industry can indeed continue to self-police and that increased regulation could even negatively impact food safety. “I think that if there are government  standards that come up to circumvent the client and give (test) results right to the government, that plants will circumvent contract laboratories and go straight to an internal lab to get the work done.”

This could impact food safety because lab personnel learn something new on a daily basis, resulting from the diverse experiences of serving a multitude of clients; attention to ever-evolving research, tests and processes; and scientific understanding for proper testing, adequate sample size, interpretation of results and validation. “That’s why a lot of people use contract labs. We don’t want to destroy that as an industry.”

In addition, he said, a good laboratory which is trusted by its clients will follow ethical standards, which for Deibel includes advice against retesting. “You cannot test away a positive result,” Deibel said. “Once you get a positive, you do something about it.” 

Deibel also believes that self-policing is appropriate because most processors understand the need to protect their brand and realize that testing is one form of insurance for brand protection. “Companies that don’t put enough priority into protecting their brand over time will not have a brand to protect.”

It is this same focus that provides argument for keeping the final decision to act in the hands of the processor rather than the lab or regulatory body. “The lab should provide the appropriate guidance to interpret results, and a good lab will advise a plant when to pitch product or not,” but the rest, Deibel said, “rests with the ethics of the plant.”

MORE TRANSPARENCY IS NEEDED. Increased auditing, regulation and transparency for contract and in-plant laboratories and test manufacturers would benefit the industry, said Wendy Warren-Serna, vice president of technical services for Food Safety Net Services, San Antonio.

“There’s really not a function that polices that per se, particularly in non-regulated functionality,” she said, adding that she is particularly concerned on an international level where there is no policing at all.

This means, she said, “It is up to the processor to choose the lab as to criteria they set forth or their customer sets forth.” This sometimes means that the processor ends up choosing the cheapest bidder. “You get what you pay for, which could be a lack of a quality structure or lack of an ethical structure.”

Labs also need to understand that ethical decisions they make can affect the entire industry, she said, as a recall can provoke consumers to avoid an entire product type. “You have to set ground rules, and it’s up to the principals of the company to say that these are the protocols we follow,” she said.

Some laboratories may feel it ethical to retest product based on customer requests, Warren-Serna said, but “retesting can be like playing statistical roulette.” Because a contaminant generally is not homogeneous across a sample, you can almost always find a sample that will retest with opposing results, she explained.

Rather than leave the safety of food open to such discretion, Warren-Serna sees accreditation, proficiency testing, third-party auditing and government regulation as a safer, more consistent option than self-policing. “I think there are labs with management structures in place to (self-police) effectively, but across the board, I would say no.

“I’m the type of person that welcomes audits and another set of eyes,” Warren-Serna added, explaining that regulation usually involves more auditing. Following such standards as published testing protocols is another way of ensuring consistent, scientific results, she said. “A lab needs to perform tests according to published protocols or have approval from the customer on any deviation, and the deviation would have to be scientifically valid.”

When there are multiple labs conducting testing without any policing, you will get multiple interpretations, she said.

Warren-Serna said quality management standards, such as ISO, are good auditing tools for ensuring quality in the lab, although she realizes that these do not always go as deep as ascertaining technician skills and ability to recommend statistically valid sampling or determine the best test for a product or situation. “It’s a very dynamic decision tree that has to be followed,” she said.

Warren-Serna also feels that test manufacturers should be held to higher accountabilities, particularly when the laboratory which manufactures the kit is also running the tests. “It’s controversial, but there almost needs to be a sort of a shooting match between test kits,” she said. “I would really like to see shooting matches happen more frequently, where you have vendor A, B and C going toe to toe.”  This type of activity seems less controversial when you consider the consequence of using sub-optimal test protocols that may allow contaminated products into commerce, Warren-Serna explained.

Currently, tests are compared to a Gold Standard that typically is a peer-reviewed, validated method recognized by regulatory agencies. A test is considered to be good if it is equal to or better than the standard. “But sometimes the Gold Standard is not the best available method.” Instead, she said, tests should be assessed according to well-defined performance criteria and compared to one another to determine the best performing test for a given situation.

Warren-Serna said the industry does have some natural self-policing, particularly by key players who continually push for improvements. “But you really only see it if there is a visionary in the right spot or a company has the resources to think about such things.”

“It is irritating to see competitors doing shady science,” she added, and increased regulation will not only help level that playing field but make the entire process more visible. “I hope to see more transparency in the laboratory arena.”

The author is staff editor of QA magazine.