Tag Archives: laboratories

Food Safety is Key Initiative as FDA Develops Lab Testing Standards

When President Barack Obama in 2011 signed the Food Safety Modernization Act, the most sweeping reform of American food safety laws in more than 70 years, the Food and Drug Administration’s job got a lot tougher.

As the FDA’s Palmer Orlandi explained at Pittcon [on March 9], they might need your help to get that job done. Orlandi, who spoke as part of the two-day Food Safety Tech Food Labs Conference at Pittcon, is the agency’s  acting chief science officer in the office of food and veterinary medicine. The FDA traditionally has been very good at reacting to safety issues in our food supply as they arise and finding the source of the problem, Orlandi said. But, now the agency is charged with more of a preventive role, which means identifying the biggest risks before they become a threat to the public. That’s a big job, and the FDA can’t do it alone. “We’re looking for burden-sharing,” Orlandi said.

Partnerships with other federal agencies such as the Department of Agriculture and the Department of Homeland Security are part of the solution. They’re also working with state-level laboratories and even the private sector, he said. As an example, he cites the Food Emergency Response Network, which includes food-testing laboratories at the local, state, and federal levels. Initially formed to deal with bioterrorism threats, Orlandi said it has become a useful food safety network as well. FERN-affiliated labs recently tested 1,600 samples of avocados for salmonella and listeria, he said.

Much of the burden of this new preventive approach will fall on food producers. Orlandi said FDA is willing to work with private labs to develop standards. This can be tricky, however, because the agency doesn’t want to create the impression that it is somehow favoring one private sector entity over another. Meanwhile, private companies have their own trade secrets to protect. “Where is the middle ground where we can cooperate?” Orlandi asked rhetorically.

FDA has developed validation standards that field labs can use, he said. But, he concedes, the agency hasn’t done a good job compiling and publishing those standards into an accessible document or reaching out to stakeholders to make sure they’re up to speed. “That’s another thing on our to-do list,” he said.

Funding for these efforts is scarce. Joe Konschnik, a market research manager for Restek Chromatography Products who attended Orlandi’s presentation, helps to supply scientists working in College Park, MD to develop new procedures to analyze pesticides. Traditionally, once the research is published, the researchers’ jobs are over. Konschnik says now they’re trying to send the information out to other labs in the U.S. and overseas. That way, everyone can work from the same page to validate the work and create consistent standards.

One of the problems is that, for example, aerating seeds to run multilevel validation studies can cost $35,000, he said. But the FDA only has about $75,000 to fund such studies, which obviously would run out very quickly. “There’s no money to fund the back-end stuff,” Konschnik said. He said he works with the American Council of Independent Laboratories, which is willing to do the testing for free. But it still costs money for the FDA to make samples, send them to the labs, gather the data, and validate the data.

In short, the partnerships FDA is building remain a work in progress. But it has a new tool: the America Competes Act, which gives federal agencies the authority to award prizes for solving significant problems. The FDA has issued a “food safety challenge,” Orlandi said, looking for ways to reduce turnaround times on food safety tests, checking for salmonella, for example, from a few weeks to a day or two. The agency has a $500,000 prize pool, with $400,000 potentially going to the winner.

This article originally appeared in CEN media group’s Pittcon Today on Tuesday, March 10 and has been republished with permission. 

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

The Value of Effective LIMS

By Sangita Viswanathan
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Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

With the announcement of proposed rules under the Food Safety Modernization Act (or FSMA), the burden of food safety testing and record keeping placed on smaller and medium size food companies and use of contract testing labs is growing tremendously. So how do these labs manage growing requests for testing, and increasing volumes of data and demand for records? 

Here is where Laboratory Information Management Systems or LIMS play an important role, in helping labs manage the testing requests, handle all the data and records, be better prepared for audits, and comply with changing regulations, says Anthony Uzzo, President & Co-Founder of Core Informatics.

Uzzo has extensive experience in software engineering, informatics, laboratory automation, project management and science. He co-founded Core Informatics in 2006, along with Jim Gregory (Executive VP of Customer Solutions). A biomedical engineer, Uzzo started his career as a pharmaceutical lab scientist, and in that role, realized that most LIMS solutions were rigid in their scope. 

“This exposed me to different labs having different data management requirements, and gave me a profound appreciation of the impact of data management and having effective LIMS in labs. When starting Core Informatics, my goal was to provide labs with the opportunity to tailor their data management system to their needs without having to change their workflow, systems, personnel etc.,” he describes. 

We present below some excerpts from an interview with Food Safety Tech (FST).

FST: Why are LIMS so important for food and beverage companies in the current environment?

Uzzo:The food and beverage industry faces increasing regulatory scrutiny, pressures to control costs, and the challenge of maintaining quality throughout a global supply chain. A LIMS solution needs to be a solution to aid companies in the delivery and discovery of products, while complying with industry and government regulations.

The LIMS need to identify hazards, determine and monitor critical control points, and establish corrective actions and verification procedures to ensure that standards are met and the system is functioning properly. Our HACCP compliant system helps companies in the F&B industry to monitor products and make sure they do not become contaminated with chemicals or food pathogens. 

FST: How can food companies and labs choose the ideal LIMS solution?

Uzzo: According to me, the top criteria for choosing a LIMS solution would be flexibility; being web-based (able to use the LIMS with smart devices for data entry and access and no antiquated client server technology); and total cost of ownership.

There are now all sorts of novel testing methodologies being applied for food safety, and as a result, the data management requirements are constantly changing. Solutions would need to facilitate administrators to use the LIMS without writing a new code, and easily and quickly enable multi-site collaboration. For instance, there are new rapid detection technologies, such as PCR technologies for Salmonella detection, now in the market. An ideal LIMS should be able to rapidly process these results and use that data analysis, come up with efficient reports and enable lab scientists to do their job in a cost-effective manner. 

Cloud-based solutions offer great advantages in providing the ability to auto-scale, handle any amount of data, send out samples to other labs, support multi-site collaboration etc. Core Informatics, for instance, is fully embracing the power of the cloud. 

An ideal LIMS solution should address chain of custody from registration to report. The final report needs to be mentioned and be able to track who had handled that sample and every derivative of it, how it has been handled, under which condition it has been stored and for how long, and if appropriate procedures have been followed for storage and handling. Downstream, if there’s any problem, we need to be able to go back upstream and identify the correct source material.

LIMS solutions need to be prepared as new laws come into play in the next few years. Industry trends are accelerating the use of contract food testing labs. How effectively companies are able to process their data management requirements such as automatically receiving and recording test requests, preparing for their audits and complying with their food safety management programs, will all become critical.