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Issue Number: Council I 017


Amend Food Code - Expanding Food Allergen Separation

Issue you would like the Conference to consider

The Food Safety and Inspection Service (FSIS) recommends changing FDA Food Code Section 3-302.11 to include identification and separation of food products containing major allergens.

Clear identification of food products containing any of the eight most common food allergens is a clear-cut mechanism that aids in the prevention of products with undeclared allergens. FSIS has seen opportunities for prevention of undeclared allergens in meat and poultry products with straightforward segregation and identification. The 2013 FDA Food Code Section 3-302.11 describes prevention of food and ingredient contamination, including a section regarding protection of food from cross contamination which details separation, packaging, and segregation. Separation, packaging, and segregation would also apply to allergen cross-contact between food products and reduce the number of undeclared allergen incidents.

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.

The trend of allergen recalls in FDA-regulated products from fiscal year 2007 through 2012 follows a similar increasing trend over time, with the exception of fiscal year 20091. Approximately 12% of the 732 allergen recalls over the six year study period resulted from the report of a consumer reaction1.

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 restaurant2. Multiple studies have shown gaps in knowledge among food service workers regarding food allergens3,4. 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 manufacturing5.

1Gendel SM, Zhu J. Analysis of U.S. Food and Drug Administration food allergen recalls after implementation of the Food Allergen Labeling and Consumer Protection Act. J Food Prot 2013;76(11):1933-8.

2Vierk 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.

3Ahuja R, Sicherer SH. Food-allergy management from the perspective of restaurant and food establishment personnel. Ann Allergy Asthma Immunol 2007;98(4):344-8.

4Bailey 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.

5Taylor SL, Baumert JL. Cross-contamination of foods and implications for food allergic patients. Curr Allergy Asthma Rep 2010;10:265-70.

Recommended Solution: The Conference recommends...

that a letter be sent to the FDA recommending that the 2013 Food Code be amended to include a new subparagraph under Section 3-302.11(A) in order to prevent undeclared allergens. Recommended language to read (new language underlined):

Section 3-302.11 Packaged and Unpackaged Food - Separation, Packaging, and Segregation

(A) Food shall be protected from cross contamination by:

Separating and clearly identifying stored food products and ingredients containing a major food allergen.

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