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Issue Number: Council I 018


Amend Food Code - Prevention of Food Allergen Cross-Contact

Issue you would like the Conference to consider

The Food Safety and Inspection Service (FSIS) recommends changing 2013 FDA Food Code Section 4-602.11 to include the use of products with food allergens as a reason for cleaning food contact surfaces and equipment. This is consistent with FSIS guidance and requirements to maintain sanitary operations in federally inspected establishments.

The 2013 FDA Food Code Section 4-602.11(A) describes five conditions when equipment food-contact surfaces and utensils shall be cleaned. While the conditions include cleaning between different types of raw animal food and a change from working with raw foods to ready-to-eat (RTE) foods, there is not a condition related to food allergens. FSIS has concerns associated with cross-contact between meat and poultry products containing differing food allergens, for example during slicing of food products containing food allergens and those not containing food allergens. Cross-contact could result without cleaning between raw or RTE foods containing differing food allergens.

Public Health Significance

Food allergens continue to be a significant issue for FSIS. From 2008 through 2013, there has been a sustained increase in the number of recalls of FSIS-regulated product that contained undeclared allergens. The proportion of recalls attributed to undeclared allergens and ingredients of public health concern has also increased, from 13% in 2008 to 35% in 2012. Furthermore, 14% of undeclared allergen recalls from 2000 through 2012 were the result of investigations following consumer complaints, 9 of which were associated with reports of allergic reactions.

In a 2001 study, of individuals with self-reported food allergies who recalled their last allergic reaction to food, approximately 50% reported it occurred after eating prepared food, most often prepared in a restaurant1. Multiple studies have shown gaps in knowledge among food service workers regarding food allergens2,3. Many of the gaps are related to cross-contact between foods in the kitchen and misunderstanding of how allergens affect sensitive individuals2,3. In a 2010 publication, Taylor and Baumert presented the food industry and restaurant practices leading to food allergen cross-contact and noted that cross-contact in a restaurant-type environment is more likely to lead to higher-dose exposures compared to typical food manufacturing4.

Jackson et al published a review of cleaning and other strategies to prevent allergen cross-contact in 20085. In one of the profiled studies involving an FDA, Minnesota, and Wisconsin partnership in 1999-20006, inadequate cleaning of equipment during product changeover and use of inadequately cleaned utensils were noted as ways that food allergens may have been introduced into food products5.


1Vierk KA, Koehler KM, Fein SB, Street DA. Prevalence of self-reported food allergy in American adults and use of food labels. J Allergy Clin Immunol 2007;119(6):1504-10.

2Ahuja R, Sicherer SH. Food-allergy management from the perspective of restaurant and food establishment personnel. Ann Allergy Asthma Immunol 2007;98(4):344-8.

3Bailey S, Albardiaz R, Frew AJ, Smith H. Restaurant staff's knowledge of anaphylaxis and dietary care of people with allergies. Clin Exp Allergy 2011;41(5):713-7.

4Taylor SL, Baumert JL. Cross-contamination of foods and implications for food allergic patients. Curr Allergy Asthma Rep 2010;10:265-70.

5Jackson SJ, Al-Taher FM, Moorman M, DeVries JW, Tippett R, Swanson KMJ, Fu T, Salter R, Dunaif G, Estes S, Albillos S, Gendel SM. Cleaning and other control and validation strategies to prevent allergen cross-contact in food-processing operations. J Food Prot 2008;71(2):445-58.

6U.S. Food and Drug Administration. Food allergen partnership. Available at (accessed 1/13/14).

Recommended Solution: The Conference recommends...

that a letter be sent to the FDA requesting the 2013 Food Code be modified by inserting a new subparagraph in Section 4-602.11(A) to avoid cross contact between raw and ready-to-eat foods with differing food allergens. Recommended language to read (new language underlined):

Section 4-602.11 Equipment Food-Contact Surfaces and Utensils

(A) Equipment food-contact surfaces and utensils shall be cleaned:

Each time there is a change from working with food containing a major food allergen to working with food containing different major food allergens or food not containing major food allergens.

Submitter Information

Name Scott Seys
Organization FSIS
Address Butler Square West, Suite 420-C, 100 North 6th Street
Minneapolis, MN 55403
Telephone (612) 659-7053
Fax (612) 370-2070
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