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Dairy Facts 2016

IDFA, NMPF Want Changes to Proposed FDA Model for High-Risk Foods

May 29, 2014

The Food and Drug Administration published in February a proposed risk-ranking model to identify high-risk foods that would be subject to additional recordkeeping requirements for traceability under the Food Safety Modernization Act. In joint comments submitted last week, IDFA and the National Milk Producers Federation said the proposed model needs significant revisions because it groups wholesome dairy products with negligible risk in the same category as potentially high-risk foods, such as raw milk.

FDA proposes to rank products based on the 28 categories of food included in the Reportable Food Registry. That means all dairy products would fall into one category for dairy, and “representative foods” would be selected and used in the model.

“We believe the model used to designate high-risk foods [should] be weighted such that when a company applies a validated kill step to its finished food product – such as pasteurization – that food should not be considered high-risk and in need of additional tracing-related recordkeeping requirements,” the comments said. “Such foods would not present a high-risk of contamination and would not likely result in a foodborne illness

One-Up, One-Back Traceability

IDFA and NMPF also urged FDA to consider existing recordkeeping requirements when designating any food as high-risk for tracing purposes. The “one-up, one-back” traceability requirements already used by most dairy foods companies is sufficient to cover products that have been processed in a way that greatly reduces the risk of foodborne illness, the comments said.

For the selection of representative foods, IDFA and NMPF said FDA should choose dairy products from a number of categories, not just one dairy category, to reflect the diversity in the industry. This process also would ensure that the risks presented by raw milk and raw milk products would not affect the risk scores of all other dairy products.

“For example, yogurt has never caused a single illness outbreak in the United States. In stark contrast, according to the Centers for Disease Control and Prevention (CDC), from 1998 through 2011, raw milk and raw milk products were responsible for 148 outbreaks,” the comments said. “We would urge FDA to list raw milk in its own category, ‘Raw Milk for Consumption and Raw Milk Products,’ which would include raw milk cheeses.”

Pilot Test Cross-Section of Foods

FDA also requested comments on the proposed methodology for determining which foods are high risk. IDFA and NMPF expressed concern about the scoring and weighting for product risk and recommended a pilot test on a cross-section of foods. “It is essential for stakeholders to understand how the model would be applied in practice, and to have an opportunity to provide comment on it,” they said.

For more information, contact Clay Detlefsen, IDFA vice president of regulatory affairs, at

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