Issue View | Council I | 2023 Biennial Meeting

This is a brand new Issue.

Add cross contact definition & codified/Annex language within the Food Code

Unintended allergen presence due to allergen cross-contact at food establishments presents a risk to consumers with food allergies. Currently, the FDA Food Code does not define allergen cross-contact nor does it address management of allergen cross-contact within food establishments. This issue recommends that "allergen cross-contact" be defined within the Food Code as well as the addition of codified language addressing control of unintended allergen presence.

Labeling of major food allergens (MFAs) within a food establishment is a major step towards protecting consumers with food allergies by helping them make informed choices based on the labeling information about the intentional addition of MFAs in foods. However, MFA labeling alone does not address all the needed protections. Another source of MFAs within food establishments is unintended allergen presence due to cross-contact that may occur because of the very nature of the small spaces and the high throughput of orders with different allergen profiles being prepared using shared cooking utensils and common food contact surfaces. Addressing allergen cross-contact to reduce the incidences of unintended allergen presence can help achieve the overall goal of safe food for consumers with food allergies.

Food allergies and other types of food hypersensitivities affect millions of Americans and their families with estimates of food allergies in US consumers reported to be as high as 8% in children and 10.8% in adults (Gupta et al., 2011; Gupta et al., 2019). National consumer survey data from the Food Allergy Research & Education (FARE), found that 50% or more of consumers report one or more allergic reactions per year and, of unintentional exposures resulting in reactions, 24% were reported to occur due to cross-contact. Cross-contact also appeared as the most common reason for unintentional exposure to food allergens (Fierstein et al., 2021). A survey conducted by FARE in 2021, found that restaurants are the second most common location, following home, for food allergy reactions. Another study found similar data where after one's home, restaurants are the second most common location for food allergic reactions (Oriel et al., 2021).

Analysis of food product recall data has shown that allergen cross-contact presents an opportunity for allergens to be present in food products if proper controls are not instituted (Gendel et al., 2013; Sharma et al., 2022). While research has shown that certain model Food Code cleaning procedures are effective at removing allergenic compounds (Bedford et al., 2020) it remains important that the risk of cross-contact be addressed to employ effective cleaning procedures for allergen management within the food establishment.

It has been acknowledged that requirements to control allergen cross-contact in food establishments is a gap in the existing Food Code. Unintentional allergens being present in foods can be mitigated through control measures (Boyd et al., 2018). For the retail industry, taking steps to control allergen cross-contact can be challenging, but taking these steps are important in reducing the risk of allergenic proteins being present unintentionally. Allergen cross-contact control measures should be risk-based and implemented using scientific principles. To reduce the risk to the consumer from unintended allergen presence due to cross contact, special consideration should be placed on the following: (1) the storage and preparation areas provide adequate space and flow, (2) appropriate food preparation and service procedures are followed when foods are prepared for a consumer with a food allergy, and (3) employees are properly trained on food allergen management within the food establishment including employee hygiene and the impact of allergen cross-contact on the risk to a consumer that has a food allergy.

A plethora of information exists to educate stakeholders on allergen cross-contact. Refer to Supporting Document entitled, "Attachment 1 - Summary of FDA Allergen Cross Contact References" to obtain list of resources. Although this information exists, the FDA Food Code lacks explicit recognition of allergen cross-contact to minimize the potential risks associated with allergen cross-contact within a food establishment. The FDA Food Code currently requires labeling of MFAs for packaged food and written consumer notification for unpackaged foods. By addressing allergen cross-contact in the FDA Food Code, regulatory authorities, industry partners, and consumers will formally recognize the risks from allergen cross-contact and take steps to actively manage allergen cross-contact within the food establishment. Labeling of MFAs in packaged food, providing written consumer notification of MFAs in unpackaged food coupled with a plan to address allergen cross-contact provide greater assurance to consumers that MFAs are being addressed within the food establishment.

A letter be sent to FDA requesting that:

1. FDA define the term 'allergen cross-contact' in the Food Code to address the unintentional incorporation of major food allergens into food.
2. FDA incorporate codified language in the Food Code addressing a Food Establishment having a plan in place to address unintended allergen presence in food due to allergen cross-contact.