Increased Testing Brings the Question: To Test In-House or Outsource

With increased globalization, regulation, and consumer demand changing the face of the food industry, food laboratories—both in-house and third party—are having to change along with it, or get left behind. This change is not only impacting the dynamics of food laboratories and the services that are performed, but also the decision by food businesses on whether to use in-house or third-party labs for testing.

Pending final rules of the Food Safety Modernization Act (FSMA), the increase in imported and exported foods, and new consumer trends have all led to an increase in testing, most significantly in pathogen and allergen testing. While the advent of rapid tests has increased in-house testing, mandates for validation and accreditation are increasing manufacturers’ decisions to outsource more. Additionally, the choice of in-house or outsourced is often decided by company size and resources.

Food manufacturers have to decide whether to invest in in-house technology and systems to increase quality while maintaining efficiencies or if it is easier and more cost effective to outsource the testing, said Roka Director for Government and Scientific Affairs Erin Dreyling.

Not only will compliance with the FSMA Preventive Controls rule require this increased testing, but the industry is also seeing an increase in the need to test products that had not previously required it. This has impacted segments such as pet foods and produce, because of both increased recalls and the new FSMA rules focused on produce safety and animal foods.

But it’s not just FDA-regulated businesses that are seeing this, Dreyling added. With the goal of reducing Salmonella contamination, “FSIS is also driving poultry to want to do increased numbers of pathogen testing,” she said.

Increasing regulation is particularly impacting the decision of smaller businesses to move away from in-house testing. “The fear of and true nature of FSMA will require more small and medium-size companies to outsource because they don’t have the in-house resources,” said BioMerieux Senior Director, Scientific Affairs Stan Bailey. While this has led to more testing by third-party labs, Bailey also has seen some large, multi-site companies pulling testing in-house and forming their own regional commercial labs.

Bailey sees two key deciding factors in the choice of in-house or third-party testing as being those of cost control and prioritization. Small companies don’t always have the volume, knowledge, or staff microbiologists to perform pathogen testing in-house. Or, he said, “they may send out testing so that they can focus on what they do well—produce food; not on what they don’t do as well.”

Or they may simply want to keep out of litigious situations, he said. “Historically, the industry wants to do what’s right, but they don’t want to spend any more than they have to. So they’ll do what they need to do, but in the most cost-effective way.”

While smaller companies are outsourcing their testing, the receiving third-party labs are seeing an increase in requests for allergen as well as pathogen testing. “We’re seeing the third-party lab space growing faster than the market as a whole,” Bailey said.

Dreyling expressed similar sentiments, saying, “We’re seeing a greater focus on outsourcing of testing,” which she said is being driven not only by FSMA, but also by upstream customer purchasing specifications, increased recalls, and consumer trends. “Larger companies want assurance that the ingredient or food is safe,” she said.

With the heightened attention on recalls, “there’s no such thing as a small recall,” she said. So when a company purchases a food supply that gets recalled, it brings into question the brands of both companies. Thus, the purchasers are requiring more supply testing, verified by certificates of analysis.

But even with all this, she said, “the biggest driver for testing that we’re seeing is consumer desire for allergen- and gluten-free foods.” This is further driven by the focus that FDA and FSIS are putting on allergens and allergen labeling, and the fact that mislabeling of allergens is the greatest cause of recalls.

Bailey expects that the increase in testing will continue, as will the decisions by small- to medium-size companies to outsource their testing. From this, he said, “The model of localized testing in the environment by third parties is a trend I see growing.” The localized model is that of a third-party laboratory bringing its lab services to local companies or regions (e.g., through a lab in a trailer), and, essentially, becoming those companies’ in-house lab. In addition to testing, these labs provide interpretation of test results and recommendations on what to do, he said, adding, “I see that as a trend that will continue.”
 

Allergens.

In addition to the third-party testing, Bia Diagnostics/Elution Technologies CEO Thomas Grace has seen a push to do just-in-time allergen testing in in-house labs. “Down time is very important. Most can’t wait a day, or even four to five hours, to make sure the equipment is clean and to restart production,” he said. So, rather than having a full in-house lab, some plants are choosing to use lateral flow device (LFD) tests for sampling. He has seen a shift from ELISA to LFD because there is no preparation required, results can be obtained quickly, and anyone can run the test—which is similar to a home pregnancy test.

Grace attributes the increase of rapid testing to both a push toward greater productivity and the change in labeling regulations to require clear, specific labeling of allergens (e.g., milk not casein), and the continuing drive to zero in detection and tolerance. The globalization of foods has added another challenge in allergen testing due to the variance in national definitions of allergens and what constitutes an allergen.

Gluten testing is a prime example of the impact that consumer trends can have on testing. With many consumers feeling that gluten-free products provide healthier alternatives, many food companies are jumping on the bandwagon and producing gluten-free products—which means increased testing to ensure the products truly have no gluten. “I’m not sure when the bubble will break,” Grace said. “Gluten has impacted testing significantly; we test up to 250 samples per day for gluten.”
 

Lab accreditation.

Another area in which the laboratory segment is seeing an increase is the request for ISO17025 accreditation. Dreyling sees this as being driven by downstream customers, standards, and regulations. Often customer specifications call for specific methods or that the testing be done in an ISO-certified lab, she said. Additionally, while international standards, such as GFSI, are not requiring the certification, there is a strong reinforcement of their use for ensuring the quality of the food system and integrity of test results.

While the FSMA rules on import testing in accredited labs have not yet been specified, implications are that this is likely to follow ISO 17025, and that, as well as the general knowledge that some form of requirement will be included, has heightened the interest in accreditation, Dreyling said.
 

The Challenges.

With increased testing being seen across the industry in both in-house and third-party labs, a key challenge is ensuring they have the ability to meet the demand while maintaining quality of results. Companies need to think about how they can best produce high-quality test results with minimum resources and bring in new automated technologies to not only increase throughput and quality, but also reduce touchpoints—thereby reducing risk, Dreyling said. “When considering automation and talking about where the industry needs to go, we need to think about the lab as a business and how it can produce quality with limited resources.”

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