Revocation of Authorization for Use of Brominated Vegetable Oil in Food

<RULE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <CFR>21 CFR Part 180</CFR> <DEPDOC>[Docket No. FDA-2023-N-0937]</DEPDOC> <RIN>RIN 0910-AI81</RIN> <SUBJECT>Revocation of Authorization for Use of Brominated Vegetable Oil in Food</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 amending our regulations to revoke the authorization for the use of brominated vegetable oil (BVO) in food. This action is being taken because there is no longer a reasonable certainty of no harm from the continued use of BVO in food. Specifically, the final rule revokes the authorization for the use of BVO as a food ingredient intended to stabilize flavoring oils in fruit-flavored beverages. There are no authorizations for other uses of BVO in food. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> The rule is effective August 2, 2024. For the applicable compliance date, see section VII “Effective/Compliance Dates” in the <E T="02">SUPPLEMENTARY INFORMATION</E> section of this document. </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> Jason Downey, Center for Food Safety and Applied Nutrition (HFS-255), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-9241; or Philip L. Chao, Center for Food Safety and Applied Nutrition, Office of Regulations and Policy (HFS-024), 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> <EXTRACT> <FP SOURCE="FP-1">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-1">II. Table of Abbreviations/Acronyms Used in This Document</FP> <FP SOURCE="FP-1">III. 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">IV. Legal Authority</FP> <FP SOURCE="FP-1">V. Comments on the Proposed Rule and FDA Response</FP> <FP SOURCE="FP-1">VI. Description of the Final Rule</FP> <FP SOURCE="FP-1">VII. Effective/Compliance Dates</FP> <FP SOURCE="FP-1">VIII. Economic Analysis of Impacts</FP> <FP SOURCE="FP-1">IX. Analysis of Environmental Impact</FP> <FP SOURCE="FP-1">X. Paperwork Reduction Act of 1995</FP> <FP SOURCE="FP-1">XI. Consultation and Coordination With Indian Tribal Governments</FP> <FP SOURCE="FP-1">XII. Federalism</FP> <FP SOURCE="FP-1">XIII. References</FP> </EXTRACT> <HD SOURCE="HD1">I. Executive Summary</HD> <HD SOURCE="HD2">A. Purpose of the Final Rule</HD> The final rule amends our regulations to revoke the authorization for the only authorized use of BVO in food. We are taking this action because there is no longer a basis to conclude that this use is safe. BVO is a complex mixture of plant-derived triglycerides that have been reacted to contain atoms of the element bromine bonded to the molecules. BVO has historically been prepared from a variety of vegetable oils, including corn, cottonseed, and olive. More recently, BVO is often prepared from soybean oil and declared on food labels as “brominated soybean oil.” BVO is used primarily to help emulsify citrus-flavored soft drinks, preventing them from separating during distribution. <HD SOURCE="HD2">B. Summary of the Major Provisions of the Final Rule</HD> The final rule revokes the only authorization for the use of BVO as an ingredient in food. Specifically, the final rule removes 21 CFR 180.30, “Brominated vegetable oil.” <HD SOURCE="HD2">C. Legal Authority</HD> We are issuing this final rule consistent with our authority under sections 409(i) and 701(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 348(i) and 371(a)). We discuss our legal authority in greater detail in section IV of this rule. <HD SOURCE="HD2">D. Costs and Benefits</HD> The costs of this final rule come from reformulating products currently manufactured with BVO, relabeling products currently manufactured with BVO, ingredient substitutes for BVO, and possible changes to sensory product properties (which could lead to decreased consumption). The benefits of this final rule come in the form of public health gains from reduced exposure to BVO. The annualized costs of this rule (with a discount rate of 2 percent), minus the costs of the baseline of gradual voluntary reduction, are $0.02 million to $0.06 million. The first-year costs of the final rule are $6.6 million to $16.6 million. We estimate the annualized reduction in BVO exposure under the final rule relative to the baseline of gradual voluntary reduction to be roughly 0.02 million ounces (oz). <GPOTABLE COLS="2" OPTS="L2,tp0,i1" CDEF="xs50,r100"> <TTITLE>II—Table of Abbreviations/Acronyms Used in This Document</TTITLE> <CHED H="1">Abbreviation/Acronym</CHED> <CHED H="1">What it means</CHED> <ROW> <ENT I="01">BVO</ENT> <ENT>Brominated vegetable oil.</ENT> </ROW> <ROW> <ENT I="01">CFR</ENT> <ENT>Code of Federal Regulations.</ENT> </ROW> <ROW> <ENT I="01">FDA</ENT> <ENT>Food and Drug Administration.</ENT> </ROW> <ROW> <ENT I="01">FD&C Act</ENT> <ENT>Federal Food, Drug, and Cosmetic Act.</ENT> </ROW> <ROW> <ENT I="01">GRAS</ENT> <ENT>Generally Recognized as Safe.</ENT> </ROW> <ROW> <ENT I="01">NCTR</ENT> <ENT>National Center for Toxicological Research.</ENT> </ROW> <ROW> <ENT I="01">ppm</ENT> <ENT>parts per million.</ENT> </ROW> </GPOTABLE> <HD SOURCE="HD1">III. Background</HD> <HD SOURCE="HD2">A. Need for the Regulation/History of This Rulemaking</HD> BVO has been used as a flavoring oil stabilizer and emulsifier since the 1920s and was listed as generally recognized as safe (GRAS) for this use by FDA. In 1970, FDA concluded that BVO could no longer be regarded as GRAS for use in food because of toxicity concerns under the conditions of use at the time, at a level of approximately 150 parts per million (ppm) in beverages (Ref. 1). FDA removed BVO from the list of “Substances generally recognized as safe” in 21 CFR part 121 (now codified under 21 CFR part 182) (35 FR 1049, January 27, 1970). In response, the Flavor and Extract Manufacturers Association submitted a food additive petition requesting FDA approval for use of BVO as a food additive in beverages at a maximum use level of 15 ppm. We reviewed the petition, including results from unpublished BVO studies, and while the available information did not indicate an immediate threat to health from the use of BVO in beverages at 15 ppm, we concluded in our petition response that additional long-term studies were needed to support the 15 ppm limit (Ref. 2). Based on the data available at the time and the history of use of BVO in food without apparent harm, we determined, in October 1970, that there would be an adequate margin of safety from the use of BVO in beverages at the reduced use level of 15 ppm on an interim basis while additional, longer term safety studies with BVO were conducted (Ref. 1). We established an interim food additive regulation under 21 CFR 121.1234 (later codified at § 180.30 (21 CFR 180.30)) authorizing the use of BVO as a stabilizer for flavoring oils used in fruit-flavored beverages in an amount not to exceed 15 ppm in the finished beverage. We initially authorized this use of BVO on a 3-year interim basis pending the receipt of additional data (35 FR 12062, July 28, 1970), and then for an indefinite period to allow for completion of subsequent safety studies (39 FR 36113, October 8, 1974). BVO is not approved for any other use in food in the United States. BVO is not permitted for use in beverages in some jurisdictions, including Australia, the European Union, Japan, and New Zealand. Some BVO-containing products have been reformulated to replace BVO to market the products in jurisdictions that do not permit the use of BVO in those products, and safe and authorized substitutes for BVO are available and have long been in use for the same functions as BVO. In 2014, as part of our work to reevaluate food and color additives, we reviewed all available data and information that were relevant to the safety of BVO used as a food ingredient. We also reviewed the memoranda and safety studies in our files regarding BVO and considered current scientific principles and study design practices. We determined that the safety data and information available did not provide evidence of a health threat resulting from the limited permitted use of BVO as a flavoring stabilizer in fruit-flavored beverages, but many studies that we reviewed did not clearly establish safe levels of chronic use (Ref. 3). We identified deficiencies in the existing studies, including poor study design by modern standards, equivocal results, inconsistencies in measured parameters between studies, and suboptimal dose selection (Ref. 3). We concluded that high-quality data from contemporary studies, performed under current guideline standards, were needed to address the knowledge gaps regarding the safety of BVO (Ref. 3). Therefore, through a collaboration between FDA's Center for Food Safety and Applied Nutrition, the National Center for Toxicological Research ( ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 36k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━