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From: Food Quality & Safety magazine, June/July 2012

Contract Labs Eye FSMA's Impact

by Samara Kuehne

Current consumer concerns about food safety, coupled with recent legislation—specifically, the FSMA—have made an impact on the food industry. Food product manufacturers are in need of reliable and accurate sample analyses, and many will outsource their testing to contract food laboratories.

These contract analytical laboratories are already seeing increases in sample volumes, but the new regulations and manufacturer demands are calling for more complex tests and procedures. The contract lab industry is poised for steady growth in the coming years, but some labs may need to revise current procedures and processes to ensure they’re at the top of their game.

The passage of the FSMA is bound to affect the business of independent testing labs, but many labs remain in a holding pattern while waiting for test requirements to be implemented.

“In theory, this could cause an increase in lab business,” said Harvey Klein, laboratory director of Garden State Laboratories in Hillside, N.J. “We have to wait and see, and it might be months, or even a year or two, before we see an impact.”

Mansour Samadpour, PhD, president and CEO of IEH Laboratories in Seattle, is apprehensive about the FSMA’s impact on the business of contract labs, and is concerned that the legislation will create a culture of “testing for the sake of testing.”

“My view has always been that food companies—or anyone who is doing testing—should be testing for a purpose to answer specific questions,” Dr. Samadpour continued. “Testing really has to help manufacturers in controlling their production process by assessing the risk of the raw material and ensuring the safety and quality of the product. There are places where you can do this, and places where you’re just wasting resources.”

Customer-Driven Growth

As the food industry waits for new requirements to take effect, some food manufacturers are taking a proactive approach by requesting more testing now. “We’re seeing an impact from our existing customers and have new customers coming on board as well,” said Keith Klemm, director of food and microbiology at Sherry Laboratories in Warsaw, Ind. Business at Sherry Laboratories has been building steadily for the past two years, so much so that he’s added three employees in the past six months and will likely fill two more positions by the end of the year.

Pressure on food manufacturers from their own clients continues to increase, driven in part by consumer concerns over food safety. This, in turn, drives up sample volume.

“Bad press in the news can hurt an entire industry, so food manufacturers are looking to stay ahead of the curve,” said Carolyn J. Otten, PhD, senior manager of analytical services for Chemir in Maryland Heights, Mo. Manufacturers want to beat out their competition by being able to tell customers they have certain types of testing done, she said. To combat the “hysteria” associated with food scares, she added, they’ll try to develop the best quality checks and mechanisms they can to keep their customers safe.

Additionally, manufacturers often want testing to be done immediately. Sometimes this is complicated and may require method development, said Dr. Otten. “This takes time and money, and a lot of times these analytical tests can be quite costly.” Manufacturers also want the data faster. “The days of turning around pathogen testing in five days are over,” said Dr. Samadpour. “You’re now talking about 12 hours.”

These types of customer requests can make the business of food analysis more complex. Another relatively recent trend is an increased need for more sophisticated instrumentation and a more sophisticated knowledge base from operators and staff. Over the past year, Chemir has seen in increase in the number of requests regarding analyses adhering to specific components of California Proposition 65, the Safe Drinking Water and Toxic Enforcement Act that was passed in 1986 and now extends to food safety. The legislation applies to all manufacturers who sell products in the state of California, requiring them to notify consumers if their products contain chemicals that may cause cancer or reproductive harm. “With a lot of these analyses, they’re not necessarily established methods for detecting in food—maybe for waste water, but not necessarily for food,” Dr. Otten said. “Food matrices can be complex, and it’s tough to achieve the levels put forth by Prop 65.”

Future of the Industry

The FSMA will allow the FDA to create a food testing certification process, and the FDA will recognize these accreditations.

“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

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.



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