Frozen Cherry Pie; Revocation of a Standard of Identity and a Standard of Quality

<RULE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <CFR>21 CFR Part 152</CFR> <DEPDOC>[Docket No. FDA-2020-N-1690]</DEPDOC> <RIN>RIN 0910-AI17</RIN> <SUBJECT>Frozen Cherry Pie; Revocation of a Standard of Identity and a Standard of Quality</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Final rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA or we) is revoking the standard of identity and the standard of quality for frozen cherry pie. This action, in part, responds to a citizen petition submitted by the American Bakers Association (ABA). We conclude that these standards are no longer necessary to promote honesty and fair dealing in the interest of consumers. Revocation of the standards of identity and quality for frozen cherry pie will provide greater flexibility in the product's manufacture, consistent with comparable, nonstandardized foods available in the marketplace. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> This rule is effective April 15, 2024. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> For access to the docket to read background documents or comments received, go to <E T="03">https://www.regulations.gov</E> and insert the docket number found in brackets in the heading of this final rule into the “Search” box and follow the prompts, and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Rumana Yasmeen, Office of Nutrition and Food Labeling (HFS-820), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2371; or Alexandra Beliveau, Office of Regulations and Policy (HFS-024), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">Table of Contents</HD> <FP SOURCE="FP-2">I. Executive Summary</FP> <FP SOURCE="FP1-2">A. Purpose of the Final Rule</FP> <FP SOURCE="FP1-2">B. Summary of the Major Provisions of the Final Rule</FP> <FP SOURCE="FP1-2">C. Legal Authority</FP> <FP SOURCE="FP1-2">D. Costs and Benefits</FP> <FP SOURCE="FP-2">II. Background</FP> <FP SOURCE="FP1-2">A. Need for the Regulation/History of This Rulemaking</FP> <FP SOURCE="FP1-2">B. Summary of Comments to the Proposed Rule</FP> <FP SOURCE="FP-2">III. Legal Authority</FP> <FP SOURCE="FP-2">IV. Comments on the Proposed Rule and FDA Response</FP> <FP SOURCE="FP1-2">A. Introduction</FP> <FP SOURCE="FP1-2">B. Description of General Comments</FP> <FP SOURCE="FP1-2">C. Comments Related to Labeling of Frozen Cherry Pie</FP> <FP SOURCE="FP1-2">D. Comments Related to Quality of Frozen Cherry Pie</FP> <FP SOURCE="FP1-2">E. Comments Related to Safety of Frozen Cherry Pie</FP> <FP SOURCE="FP1-2">F. Miscellaneous Comments</FP> <FP SOURCE="FP-2">V. Effective Date</FP> <FP SOURCE="FP-2">VI. Economic Analysis of Impacts</FP> <FP SOURCE="FP-2">VII. Analysis of Environmental Impact</FP> <FP SOURCE="FP-2">VIII. Paperwork Reduction Act of 1995</FP> <FP SOURCE="FP-2">IX. Federalism</FP> <FP SOURCE="FP-2">X. Consultation and Coordination with Indian Tribal Governments</FP> <FP SOURCE="FP-2">XI. Reference</FP> <HD SOURCE="HD1">I. Executive Summary</HD> <HD SOURCE="HD2">A. Purpose of the Final Rule</HD> The final rule revokes the standards of identity and quality for frozen cherry pie. This action, in part, responds to a citizen petition submitted by the ABA. We conclude that the standards of identity and quality for frozen cherry pie are no longer necessary to promote honesty and fair dealing in the interest of consumers. Revoking these standards will provide greater flexibility in the product's manufacture, consistent with comparable, nonstandardized foods available in the marketplace. <HD SOURCE="HD2">B. Summary of the Major Provisions of the Final Rule</HD> The final rule revokes the standards of identity and quality for frozen cherry pie. <HD SOURCE="HD2">C. Legal Authority</HD> We are issuing the final rule to revoke the standards of identity and quality for frozen cherry pie consistent with our authority under the Federal Food, Drug, and Cosmetic Act (FD&C Act), which directs the Secretary of Health and Human Services (Secretary) to issue regulations fixing and establishing for any food a reasonable definition and standard of identity, quality, or fill of container whenever, in the Secretary's judgment, such action will promote honesty and fair dealing in the interest of consumers. <HD SOURCE="HD2">D. Costs and Benefits</HD> The final rule affects manufacturers of frozen cherry pie and does not require firms within the frozen cherry pie industry to change their manufacturing practices. Our analyses of current food manufacturing practices and the petition to revoke the standards indicate that revoking the standards of identity and quality could provide benefits in terms of additional flexibility and the opportunity for innovation to manufacturers. Therefore, we conclude that the final rule to revoke the standards for frozen cherry pie will provide social benefits at no cost to the respective industries. <HD SOURCE="HD1">II. Background</HD> <HD SOURCE="HD2">A. Need for the Regulation/History of This Rulemaking</HD> Section 401 of the FD&C Act (21 U.S.C. 341) directs the Secretary to issue regulations fixing and establishing for any food a reasonable definition and standard of identity, quality, or fill of container whenever, in the Secretary's judgment, such action will promote honesty and fair dealing in the interest of consumers. The purpose of these standards is to protect consumers against economic adulteration and reflect consumers' expectations about food. We proposed the standards of identity and quality for frozen cherry pie in the <E T="04">Federal Register</E> of November 1, 1967 (32 FR 15116) and finalized them in the <E T="04">Federal Register</E> of February 23, 1971 (36 FR 3364); the requirements were codified at 21 CFR 28.1 (“Frozen cherry pie; identity; label statement of optional ingredients”) and 21 CFR 28.2 (“Frozen cherry pie; quality; label statement of substandard quality”). We later amended the standards of identity and quality in the <E T="04">Federal Register</E> of June 13, 1973 (38 FR 15504), by removing minimum frozen cherry pie weight requirements, aligning the definition of blemished cherries with that in the U.S. Department of Agriculture's (USDA's) U.S. Standards for Grades of Frozen Red Tart Pitted Cherries, and adding clarifying language. We renumbered the two sections in the <E T="04">Federal Register</E> of March 15, 1977 (42 FR 14302 at 14449) and combined them into § 152.126 (21 CFR 152.126), with the new section covering both the standards of identity and quality. We received a citizen petition from ABA asking us, in part, to revoke the frozen cherry pie standards of identity and quality (Citizen Petition from the American Bakers Association, dated August 18, 2005, Docket No. FDA-2005-P-0435 (“petition”)). Among other things, the petition stated that there is no basis for singling out frozen cherry pie for the imposition of standards of identity and quality (petition at page 10). The petition observed that there are no standards of identity and quality for any other types of frozen fruit pies, or for any non-frozen fruit pies, including those filled with cherries (id.). The petition further asserted that nonstandardized fruit pies have been sold throughout the country for many years without any evidence of public confusion (id.). In the <E T="04">Federal Register</E> of December 18, 2020 (85 FR 82395), we issued a proposed rule to revoke the standards of identity and quality for frozen cherry pie, which, in part, responded to the petitioner's request. We tentatively concluded that the frozen cherry pie standards of identity and quality were no longer needed to promote honesty and fair dealing in the interest of consumers consistent with section 401 of the FD&C Act (85 FR 82395 at 82396). The preamble to the proposed rule also noted that the proposed revocation is consistent with section 6 of Executive Order 13563, “Improving Regulation and Regulatory Review” (January 18, 2011), which requires Agencies to periodically conduct retrospective analyses of existing regulations to identify those “that might be outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand, or repeal them” accordingly (85 FR 82395 at 82397). Consequently, we proposed to revoke part 152 (21 CFR part 152) (“Fruit pies”) in its entirety because the standards for frozen cherry pie are the only standards in part 152. We stated that we were unaware of any evidence suggesting that consumers have different expectations for unbaked, frozen cherry pies than for other cherry pies (85 FR 82395 at 82396). At the same time, no other cherry pies are subject to a standard of identity or a standard of quality, and we stated that we were unaware of any evidence indicating that such standards are necessary to promote honesty and fair dealing in the interest of consumers or to ensure that those cherry pies meet consumer expectations (id.). Similarly, other fruit pies are not subject to standards of identity or quality, and we stated that we were unaware of any evidence indicating that such standards are necessary to promote honesty and fair dealing in the interest of consumers or to ensure that the pies meet consumer expectations (id.). We also tentatively concluded that the prohibition of artificial sweeteners in § 152.126(a)(2) (21 CFR 152.126(a)(2)) does not promote honesty and fair dealing in the interest of consumers (85 FR 8239 ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 54k characters. 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