Contract Labs Eye FSMA’s Impact

“Laboratory accreditation will be critical in years to come,” said Klemm. “We’re creating legally defensible data, so everything that touches that sample has to be traceable. This is critical to a food company.” Labs that do not have in place a good quality system or validation process may not fare as well in the coming years, he added. “In terms of the food business, you really don’t get second chances. The brand name is so critical that [manufacturers] are not going to take a gamble on lab results that are substandard.”

Generally, independent labs have very strong growth potential over the next few years, said Klemm. The business edge may go to larger operations, though, said Dr. Samadpour. The higher demand for more sophisticated testing and the consolidation of food manufacturers may mean that smaller laboratories, which are already seeing more consolidation themselves, will lose out in the years to come, he said. “A company that has 15 manufacturing sites doesn’t want to work with 15 different labs; they want to work with a single lab that can accommodate the totality of their testing needs,” said Dr. Samadpour.

In the meantime, labs will continue to wait for FSMA regulations to go into effect. “Whether there will be significantly more testing, only time will tell,” said Klein. However, in an industry primarily driven by regulation of one kind or another—internationally or domestically—the FSMA and similar regulations are likely to have some impact, said Dr. Otten.

“As more stringent regulations around the world come, that puts constraints on the business,” she said. “The analytic services industry will need to bend to meet the needs of the clients.”

Samara Kuehne is an editor and writer for Wiley-Blackwell.

Toxicology A Growth Area

For the past two years, contract analytic laboratory Chemir has seen an increase in the number of clients who ask, simply, if their product is safe to eat. In the past, the company has maintained that it can’t make that determination—lab analysts are chemists and not toxicologists. But, they’ve recently started to partner with licensed toxicologists to expand their client services, said Dr. Otten. Chemir provides the product sample analysis to the toxicologist, who will then use a toxicity risk assessment to determine whether the product represents a health hazard or is toxically insignificant.

While larger manufacturers often have internal labs and their own toxicologists, midsize and smaller companies don’t always have the same resources and don’t have a long list of people they can turn to who can perform the assessment. “This way, the client gets information they ultimately need,” said Dr. Otten.