SUPPLEMENTARY INFORMATION:

Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Food Allergen Labeling and Reporting

OMB Control Number 0910-0792—Extension

This information collection supports the reporting associated with the submission of petitions and notifications seeking exemptions from the labeling requirements for ingredients derived from major food allergens, and the Agency's associated guidance document.

I. Background

The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) (Title II, Pub. L. 108-282) amended the FD&C Act by defining the term “major food allergen” and stating that foods regulated under the FD&C Act are misbranded unless they declare the presence of each major food allergen on the product label using the name of the food source from which the major food allergen is derived. Section 403(w)(1) of the FD&C Act (21 U.S.C. 343(w)(1)) sets forth the requirements for declaring the presence of each major food allergen on the product label. Section 201(qq) of the FD&C Act (21 U.S.C. 321(qq)) defines a major food allergen as “[m]ilk, egg, fish ( e.g., bass, flounder, or cod), Crustacean shellfish ( e.g., crab, lobster, or shrimp), tree nuts ( e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans” and also as a food ingredient that contains protein derived from such foods. The definition excludes any highly refined oil derived from a major food allergen and any ingredient derived from such highly refined oil.

In some cases, the production of an ingredient derived from a major food allergen may alter or eliminate the allergenic proteins in that derived ingredient to such an extent that it does not contain allergenic protein. In addition, a major food allergen may be used as an ingredient or as a component of an ingredient such that the level of allergenic protein in finished food products does not cause an allergic response that poses a risk to human health. Therefore, FALCPA provides two mechanisms through which such ingredients may become exempt from the labeling requirement of section 403(w)(1) of the FD&C Act. An ingredient may obtain an exemption through submission and approval of a petition containing scientific evidence that demonstrates that the ingredient “does not cause an allergic response that poses a risk to human health” (section 403(w)(6) of the FD&C Act). Alternately, an ingredient may become exempt through submission of a notification containing scientific evidence showing that the ingredient “does not contain allergenic protein” or that there has been a previous determination through a premarket approval process under section 409 of the FD&C Act (21 U.S.C. 348) that the ingredient “does not cause an allergic response that poses a risk to human health” (section 403(w)(7) of the FD&C Act).

A. Third-Party Disclosure

The labeling requirements of section 403(w)(1) of the FD&C Act apply to all packaged foods sold in the United States that are regulated under the FD&C Act, including both domestically manufactured and imported foods. As noted, section 403(w)(1) of the FD&C Act requires that the label of a food product declare the presence of each major food allergen. We estimate the information collection burden of the third-party disclosure associated with food allergen labeling under section 403(w)(1) of the FD&C Act as the time needed for a manufacturer to review the labels of new or reformulated products for compliance with the requirements of section 403(w)(1) of the FD&C Act and the time needed to make any needed modifications to the labels of those products. The allergen information disclosed on the label or labeling of a food product benefits consumers who purchases that food product. Because even small exposure to a food allergen can potentially cause an adverse reaction, consumers use food labeling information to help determine their product choices.

FDA estimates the third-party disclosure burden of the collection of information as follows:

We have retained the currently approved burden estimate associated with the information collection. Based on our experience with the information collection since it was established 3 years ago, we estimate that there are approximately 690,000 Universal Product Codes (UPCs) of FDA-regulated foods and approximately 85,000 UPCs of FDA-regulated dietary supplements for a total of 775,000 UPCs (Ref. 1). Using the labeling cost model, we estimate the entry rate of new UPCs to be 8 percent per year. Based on the entry rate of new UPCs, we estimate the rate of new or reformulated UPCs to be approximately 10 percent per year, or 77,500 products (775,000 × 10 percent). Thus, we estimate that, annually, 77,500 new or reformulated products are sold in the United States. Assuming an association of one respondent to each of the 77,500 new or reformulated products, we estimate that 77,500 respondents will each review the label of one of the 77,500 new or reformulated products. We estimate an average of 1 hour for the review of labels for compliance with the food allergen labeling requirements under section 403(w)(1) of the FD&C Act, for a total of 77,500 hours annually, as reflected in table 1, row 1.

We have no data on how many label reviews would identify the need to redesign the label. For purposes of this analysis, therefore, we estimate 5 percent, or 3,875 labels (77,500 × 5 percent) will be redesigned to comply with the requirements of section 403(w)(1) of the FD&C Act. Assuming an association of one respondent to each of the 3,875 redesigned labels and averaging 16 hours to complete the label redesign, we estimate a total of 62,000 hours annually for this activity, as reflected in table 1, row 2.

B. Reporting

Under sections 403(w)(6) and (7) of the FD&C Act, respondents may request from us a determination that an ingredient is exempt from the labeling requirement of section 403(w)(1) of the FD&C Act. An ingredient may obtain an exemption through submission and approval of a petition containing scientific evidence that demonstrates that the ingredient “does not cause an allergic response that poses a risk to human health” (section 403(w)(6) of the FD&C Act). This section also states that “the burden shall be on the petitioner to provide scientific evidence (including the analytical method used to produce the evidence) that demonstrates that such food ingredient, as derived by the method specified in the petition, does not cause an allergic response that poses a risk to human health.” Alternately, an ingredient may become exempt through submission of a notification containing scientific evidence showing that the ingredient “does not contain allergenic protein” or that there has been a previous determination through a premarket approval process under section 409 of the FD&C Act that the ingredient “does not cause an allergic response that poses a risk to human health” (section 403(w)(7) of the FD&C Act).

The guidance document entitled, “Food Allergen Labeling Exemption Petitions and Notifications: Guidance for Industry,” sets forth our recommendations with regard to the information that respondents should submit in such a petition or notification. The guidance states that to evaluate these petitions and notifications, we will consider scientific evidence that describes: (1) The identity or composition of the ingredient; (2) the methods used to produce the ingredient; (3) the methods used to characterize the ingredient; (4) the intended use of the ingredient in food; and (5) either (a) for a petition—data and information, including the expected level of consumer exposure to the ingredient, that demonstrate that the ingredient, when manufactured and used as described, does not cause an allergic response that poses a risk to human health; or (b) for a notification, data and information that demonstrate that the ingredient, when manufactured as described, does not contain allergenic protein, or documentation of a previous determination under a process under section 409 of the FD&C Act that the ingredient does not cause an allergic response that poses a risk to human health. We use the information submitted in the petition or notification to determine whether the ingredient satisfies the criteria of section 403(w)(6) and (7) of the FD&C Act for granting the exemption.

We estimate the reporting burden associated with the collection of information as follows:

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Based on our experience with the collection thus far, we retain the currently approved burden estimate. Accordingly, we estimate that we will receive an average of five petitions and five notifications annually over the next 3 years. Assuming an association of one respondent to each petition or notification, we estimate that five respondents will each submit one petition and five respondents will each submit one notification. We estimate a petition takes, on average, 100 hours to develop and submit (Ref. 2). Therefore, we estimate the total burden associated with petitions will be 500 hours annually (5 petitions × 100 hours per petition).

The burden of a notification involves collecting documentation that a food ingredient does not pose an allergen risk. Either we can make a determination that the ingredient does not cause an allergic response that poses a risk to human health under a premarket approval or notification program under section 409 of the FD&C Act, or the respondent submits scientific evidence demonstrating that the ingredient when manufactured as described does not contain allergenic protein. We estimate it takes a respondent 20 hours to prepare and submit a notification based on our determination under a process under section 409 of the FD&C Act that the ingredient does not cause an allergic response. We estimate respondents may spend 100 hours to prepare a notification submitting scientific evidence (including the analytical method used) that demonstrates that the food ingredient (as derived by the method specified in the notification, where applicable) does not contain allergenic protein. We have no data on how many notifications would be based on our determination that the ingredient does not cause an allergic response or based on scientific evidence that demonstrates that the food ingredient does not contain allergenic protein. Therefore, we estimate that three of the five notifications would be based on scientific evidence, and two of the five notifications would be based on our determination. The average time per notification is then estimated to be 68 hours (2 × 20 hours + 3 × 100 hours)/5). Therefore, we estimate that the burden associated with notifications will be 340 hours annually (5 notifications × 68 hours per notification), as reflected in table 2.

II. References

The following references are on display in the Dockets Management Staff (see ADDRESSES ) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov. FDA has verified the website addresses, as of the date this document publishes in the Federal Register , but websites are subject to change over time.

1. RTI International, “Model to Estimate Costs of Using Labeling as a Risk Reduction Strategy for Consumer Products Regulated by the Food and Drug Administration, Final Report.” Prepared for Andrew Stivers, FDA/CFSAN. Prepared by Muth, M., M. Ball, M. Coglaiti, and S. Karns. RTI Project Number 0211460.005. March 2011.

2. Gendel, S.M., “Food Allergen Petitions and Notifications.” Memorandum to File. August 8, 2011.