Stricter FSMA rules for process water advocated by some

The public comment period for proposed rules in current GMPs and risk-assessment requirements under the Food Safety Modernization Act continues until Sept. 16, after which FDA officials will sift through the many comments and suggestions submitted in writing and at public hearings. Among them is the testimony of an equipment supplier who questions the safety and efficacy of municipal water used as process water.

The testimony came from Phyllis Posy, vice president-regulatory affairs for Atlantium Technologies, an Israeli firm that manufactures UV sterilization equipment for water. The equipment has been validated for use in U.S. dairies under the Pasteurized Milk Ordinance. Under the proposed FSMA rules, the requirement for a risk-based hazard analysis is satisfied when a food processor's "water is supplied by a municipal water authority that monitors the water and alerts its customers of any safety problems," according to Posy, quoting from FDA's FSMA guidance issued in January.

Three months later, EPA published revisions to the Total Coliform Rule for municipal drinking water that will simplify the public notification protocol and require an assessment and corrective action when E. coli contamination is detected. But the changes, which go into effect April 1, 2016, also eliminate public notification when positive results for generic coliform occur, increasing the possibility that a food plant could "unknowingly incorporate contaminated water into their product," she testified.

"EPA views water quality very differently than food processors do," Posy tells Food Processing. Only 95 percent of public water samples need to be in spec for microbial contaminants, and one illness per 10,000 exposures is considered tolerable, she says. Based on 300 gallons of daily use by a family of four, that translates to a single upset stomach every 3.5 years. "But for a food manufacturer, 300 gallons isn't even one hour's consumption," she points out. "If you're company takes in 500,000 gallons a day, you're risk factor can be very high."

There's a self-serving subtext to a supplier of water-sterilization equipment advocating stricter FSMA hazard analysis of process water, but her point about assuming municipal water is the same as process water has merit. After all, much of family's consumption involves a shower or toilet bowl. A food company's water, on the other hand, either contacts products directly or the surfaces that touch them. Some measure of brand protection, be it filtration, UV or thermal, might be advisable.

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