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

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.

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.