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US Food and Drug Administration to Provide Methodological Approach to Identifying High-Risk Foods

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On 04 February 2014 the United States Food and Drug Administration (US FDA) published their draft procedure to designate what are high-risk foods that require specific tracing requirements as defined per section 204 of the Food Safety Moderation Act (FSMA) (1). 2014-03-17 11:31:43
Draft Approach for High-Risk Foods Identification

The US FDA has designated seven different criteria and a score rating for each individual criterion in determining whether a product is high risk food or not. FSMA requires that both microbial and chemical hazards be considered as part of the high-risk foods designation.

- Frequency of outbreak and occurrences of illnesses
- Severity of illnesses – duration, hospitalization and mortality
- Likelihood of contamination
- Growth potential / shelf life
- Manufacturing process contamination probability / intervention
- Consumption
- Economic Impact

Score Rating for High-Risk Foods Identification

Every criteria section would be score from a low of 0 to a high of 9.

Example for Criteria 1: For hazards that have been involved in an outbreak and illnesses, the US FDA would use the information on outbreak and illness data from their database and that of the US Center for Disease Control dating back to 1998. For those items such as allergens and chemicals where there is no existing database information, the following criteria would be used:

For undeclared allergens:
0 = no occurrence of illnesses
1 = fewer than 10 illnesses per year
3 = 10 to 100 illnesses per year
9 = more than 100 illnesses per year

For chemical hazards:
0 = No evidence that the chemical occurs in the food commodity
1 = Little evidence of illnesses in the US
3 = Some evidence that this chemical may cause illnesses in the US
9 = Compelling evidence that this chemical causes illnesses in the US

Each criteria score would be added to determine whether or not the product is a high risk food or not.

For more information on FSMA and how to comment on the proposed regulations visit the FDA website (


(1) US FDA - Designation of High-Risk Foods for Tracing ( .. )
(2) FDA’s Draft Approach for Designating High-Risk Foods ( )
(3) Outbreak Alert! Database (

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Press Information
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