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From: Food Quality & Safety magazine, December/January 2013

Despite Delays in Implementation of FSMA, the Food Industry Moves Forward

by Gina Shaw

The year started out with so much promise. President Obama had signed the Food Safety Modernization Act into law a year earlier, setting up rules for the FSMA’s foreign supplier verification program and safety requirements for high-risk produce, to be implemented the following January. The FDA was slated to roll out regulations for preventive controls shortly after.

But a year later, those rules have yet to be released. Although some industry observers predicted that action will finally be taken following the presidential election, others noted that additional barriers may hamper implementation. For example, with a government divided over federal spending, finding the funds to implement the new rules may be difficult. In other words, for many food safety experts, the biggest story about food safety in 2012 was what didn’t happen.

“FSMA has turned out to be yet another unfunded mandate to the FDA,” said Will Hueston, DVM, PhD, executive director of the Global Initiative for Food Systems Leadership at the University of Minnesota in St. Paul. “It passed with broad bipartisan support, but implementation has been slowed by lack of action on regulations and will continue to be slowed by simple lack of funding. It’s unfortunate, and there’s widespread frustration because we thought this was going to be the big year for compliance.”

Still Preparing for FSMA

The good news for manufacturers and distributors is that the delays and frustration haven’t stopped vendors who will help industry comply with the FSMA when it’s fully enacted. Colin Thurston, director of product strategy for process industries at Thermo Fisher Scientific, said his company has been developing laboratory information management systems focused on sample and data control and compliance based on the EU’s requirement for food safety labs. Those rules require adhering to the International Organization for Standardization’s 17025 standard for calibration and testing laboratories as a comparison point.

“Our LIMS for the food industry is focused, in addition to laboratory workflow and data management, on ISO 17025 requirements such as training records for users, calibration, and maintenance records for instrumentation in the lab; authorization of results before they are issued, even HACCP requirements; and all of those kinds of control aspects on top of the normal lab record-keeping,” Thurston said. “The goal is integrating lab data not just within its own process but throughout the manufacturing space, with connectivity tools like our CONNECTS platform, so that management has a view to risk management processes and is prepared with data in the event of any out-of-spec production, thus preventing contaminated product from reaching the consumer.”

Thurston said integrated data flow is an important tool for organizations as they prepare for FSMA, reinforcing their existing hazard plans. Storing all sample data electronically in a centralized database available to management at any critical point enables decision makers to stop production quickly if needed and to keep out-of-spec products out of the marketplace.

Even though much of the act has yet to be implemented, the FSMA has been a tipping point for the industry, according to Scott Scdoris, director of food and beverage for Celsis.

“The days of keeping paper records and not being able to readily access information from testing that you’ve completed are done,” he said, noting that just a few years ago, companies still kept records in notebooks. “Now and then the USDA or FDA would come in and look to see if we were keeping them, but not much more than that. If anyone asked us to go back six months and look at this lot of products run on this machine, it would have been almost impossible.”

Despite the FSMA’s setbacks, Scdoris said, most companies have already put in place formal policies and plans related to the law. “They’re focusing on the questions of how the data is maintained and how it is accessed if they are using electronic records.”

FSMA’s Little Siblings

Apart from the FSMA, a number of other food safety regulations were enacted in 2012, including the final phase of the FDA’s egg safety rule. The mandate, which first went into effect in 2010, required shell egg producers with more than 50,000 laying hens to implement Salmonella prevention measures. This year saw the FDA impose the same requirements on all producers with more than 3,000 hens; those with fewer are exempt.

Another regulation that went into effect this year was the USDA’s mandate to ban beef containing a broader group of E. coli strains known as the “Big Six.” These include E. coli O26, O45, O103, O111, O121, and O145—all of which are found much less frequently in beef than the O157 strain, which has been responsible for most cases of E. coli-related illness. Despite objections from industry, the U.S. Agriculture Department called for banning the sale of all products found to have any of these additional strains.

The new regulation has led industry to develop not only preventive measures but also new ways of testing to ensure compliance. These include enhancements to existing assays.

“We’ve heard a lot from the USDA about enriching for multiple pathogens,” said Wendy Lauer, senior sales product manager with the food science division at Bio-Rad Laboratories. “Ideally, they would like to test one sample for E. coli O157:H7, other STECs, and Salmonella. Our scientists have formulated a special supernutritive enrichment broth for STECs, including O157, that is being used internally to enrich for Salmonella as well. This year, we’ll be adding our STEC assay to the scope of validation, which already includes our Salmonella and O157 tests.”

At least one food safety expert doesn’t see the addition of the Big Six testing requirement as a step in the right direction. “It’s a flawed policy that needs to be revisited, and probably will be,” said Mike Doyle, PhD, director of the Center for Food Safety at the University of Georgia in Griffin. “We need to focus more on the virulence factor STEC 2a, which is largely associated with the hemolytic uremic syndrome that leads to kidney failure, particularly in children. That’s not serotype-dependent, and it’s not just associated with the Big Six. In the interest of a more effective approach to public health, we’re better off revisiting that regulation.”

Dr. Doyle noted that a large study that is now underway at the CDC is focused on identifying the virulence factors most important in disease production, which will likely lead to more effective FDA and USDA rules.

With a government divided over federal spending, finding the funds to implement the new rules may be difficult. In other words, for many food safety experts, the biggest story about food safety in 2012 was what didn’t happen.

A Few Breakthroughs

Even while the FSMA’s delay has been the food industry’s key focus this year, a few breakthroughs in food safety testing and compliance have taken place. Three of the highlights, according to Fernando Sampedro, PhD, assistant professor for risk assessment at the Center for Animal Health and Food Safety at the University of Minnesota in St. Paul, were:

  • The agreement between the U.S. Environmental Protection Agency and the USDA’s Food Safety Information Service to use the same terminology as it relates to microbial risk assessment.
    “Before, it was as if you had one document in English and another in Chinese,” Dr. Sampedro said. “Officials on one side would be hesitant to affirm or incorporate something coming out of the other agency because ‘It’s not our definition.’ It’s one of those boring yet very meaningful breakthroughs,” he said.
  • iRISK , the FDA’s new risk assessment tool developed in collaboration with a private company, became available in October.
    “It’s a simplified approach to risk assessment that they feel they can pass on to the food community, one that allows for the simultaneous consideration of microbial and chemical hazards,” said Dr. Sampedro. “Heretofore, the risk analysis tendency was to look at just one potential hazard at a time. iRISK is a type of software that is much more robust, and it’s very exciting that it’s publicly available.”
  • An agreement among the FDA, the University of California-Davis, and Agilent Technologies was reached to sequence the genomes of 100,000 microorganisms.
    “This is a real testing breakthrough,” said Dr. Sampedro. “We’ll have a new and faster way to identify pathogens associated with an outbreak using this repository of fingerprints for the most common organisms.”

So, while the much-anticipated FSMA implementation did not occur this year, efforts to improve food safety continued onward in 2012. Still, with the election now behind us, all eyes will again be on Washington as the Obama administration and Congress haggle over funding and the fate of the FSMA and similar regulations.

Gina Shaw is a freelance writer based in Montclair, NJ. She can be reached at



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