Revocation of Authorization for Use of Brominated Vegetable Oil in Food, 55040-55045 [2024-14300]

Download as PDF 55040 Federal Register / Vol. 89, No. 128 / Wednesday, July 3, 2024 / Rules and Regulations Country Listed person and address * * * * Federal Register citation * * Navio Shipping LLC, Suite 3801, Aspin Commercial Tower Sheikh Zayed Road, PO Box 122471 Dubai, UAE. * * * Matthew S. Borman, Deputy Assistant Secretary for Export Administration. * * 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. [FR Doc. 2024–14642 Filed 7–2–24; 8:45 am] BILLING CODE 3510–33–P DEPARTMENT OF HEALTH AND HUMAN SERVICES SUPPLEMENTARY INFORMATION: 21 CFR Part 180 [Docket No. FDA–2023–N–0937] RIN 0910–AI81 Revocation of Authorization for Use of Brominated Vegetable Oil in Food AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. 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. DATES: The rule is effective August 2, 2024. For the applicable compliance date, see section VII ‘‘Effective/ Compliance Dates’’ in the SUPPLEMENTARY INFORMATION section of this document. ADDRESSES: For access to the docket to read background documents or comments received, go to https:// www.regulations.gov 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. FOR FURTHER INFORMATION CONTACT: Jason Downey, Center for Food Safety and Applied Nutrition (HFS–255), Food and Drug Administration, 5001 Campus khammond on DSKJM1Z7X2PROD with RULES SUMMARY: VerDate Sep<11>2014 18:48 Jul 02, 2024 Jkt 262001 I. Executive Summary A. Purpose of the Final Rule B. Summary of the Major Provisions of the Final Rule C. Legal Authority D. Costs and Benefits II. Table of Abbreviations/Acronyms Used in This Document III. Background A. Need for the Regulation/History of This Rulemaking B. Summary of Comments to the Proposed Rule IV. Legal Authority V. Comments on the Proposed Rule and FDA Response VI. Description of the Final Rule VII. Effective/Compliance Dates VIII. Economic Analysis of Impacts IX. Analysis of Environmental Impact X. Paperwork Reduction Act of 1995 XI. Consultation and Coordination With Indian Tribal Governments XII. Federalism XIII. References I. Executive Summary A. Purpose of the Final Rule 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 plantderived 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 citrusflavored soft drinks, preventing them from separating during distribution. PO 00000 Frm 00020 Fmt 4700 89 FR [INSERT FEDERAL REGISTER PAGE NUMBER] 7/3/2024. * * B. Summary of the Major Provisions of the Final Rule 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.’’ C. Legal Authority Table of Contents Food and Drug Administration * Sfmt 4700 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. D. Costs and Benefits 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 firstyear 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). Abbreviation/ Acronym What it means BVO .............. CFR .............. FDA .............. Brominated vegetable oil. Code of Federal Regulations. Food and Drug Administration. Federal Food, Drug, and Cosmetic Act. Generally Recognized as Safe. National Center for Toxicological Research. parts per million. FD&C Act ..... GRAS ........... NCTR ........... ppm .............. E:\FR\FM\03JYR1.SGM 03JYR1 Federal Register / Vol. 89, No. 128 / Wednesday, July 3, 2024 / Rules and Regulations III. Background khammond on DSKJM1Z7X2PROD with RULES A. Need for the Regulation/History of This Rulemaking 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 VerDate Sep<11>2014 18:48 Jul 02, 2024 Jkt 262001 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 (NCTR), and the National Institute of Environmental Health Sciences’ Division of Translational Toxicology (formerly the Division of the National Toxicology Program), new rodent safety studies on BVO were designed and executed with the goal of addressing the potential for thyroid toxicity and bioaccumulation. The rodent safety studies conducted by NCTR were published in 2022 (Ref. 4) and confirmed previous reports that dietary exposure to BVO is toxic to the thyroid and results in bioaccumulation of lipid-bound bromine in the body at doses relevant to human exposure. To account for uncertainty in translating animal studies to humans, risk assessors evaluate the safety of food ingredients in animal studies at use levels greater than probable human dietary exposure. For example, FDA typically requires food additives to be safe in animal studies at exposures at least 100-fold higher than probable human dietary exposure (21 CFR 170.22) to account for uncertainty in applying results from animal studies to humans. Using the combined 2015– 2018 National Health and Nutrition Examination Survey and the conservative assumption that all beverages labeled as containing BVO contain the 15 ppm use level permitted by § 180.30, we estimated mean and 90th percentile dietary exposures of 5 PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 55041 and 9 milligrams (mg) BVO/person (p)/ day (d) for the U.S. population aged 2 years and older (Ref. 5), or 0.08 and 0.15 mg/kilogram (kg) body weight (bw)/d on a 60 kg bw basis. The doses of BVO used in the published studies more closely approximate levels of dietary exposure to BVO in humans than the doses used in many of the earlier studies. NCTR’s first 90-day study conducted in rats described adverse effects on the thyroids of test animals following dietary exposure to BVO. Histological changes in the thyroid, specifically follicular cell hypertrophy, were observed in males at all exposure levels and in females at the highest exposure level, suggestive of a sex-specific effect. The incidence of abnormal histopathological findings in male thyroids increased in a dose-dependent manner. This study also demonstrated alterations in hormone signaling along the hypothalamic-pituitary-thyroid axis as a result of dietary exposure to BVO (Ref. 6). Overall, these new data corroborate previous studies in rats and pigs that also reported thyroid toxicity after dietary exposure to BVO (Ref. 3). Additionally, in both studies, dietary exposure to BVO led to the accumulation of inorganic and organic bromine in test animals (Ref. 6), a finding previously related to the onset of central nervous system toxicity (i.e., lethargy, ataxia, and disorientation) in pigs exposed to BVO (Ref. 3). After 90 days of dietary exposure to BVO, accumulation had not reached steady state, but brominated fatty acids appeared to accumulate in a dosedependent manner in the heart, liver, and inguinal fat of all animals fed BVO. Based on these study results, we estimated that bioaccumulated brominated fatty acids could persist in test animals for up to 587 days after BVO was removed from the diet (Ref. 6). The observed potential for brominated fatty acids to bioaccumulate in these studies confirms previous studies in laboratory animals and humans that raised safety questions with BVO’s use as a food ingredient (Ref. 3). Importantly, the bioaccumulation of lipid-bound bromine makes it difficult to estimate cumulative dietary exposure to BVO and to interpret subchronic studies that reported no adverse effect from dietary exposure to BVO (Ref. 6). These studies demonstrate BVO consumption can result in thyroid toxicity in both male and female rats, interference with the hypothalamicpituitary-thyroid axis in male rats, and bioaccumulation of lipid-bound bromine in both sexes. These studies demonstrated adverse effects in animals at all doses tested, and the test doses E:\FR\FM\03JYR1.SGM 03JYR1 55042 Federal Register / Vol. 89, No. 128 / Wednesday, July 3, 2024 / Rules and Regulations more closely approximated levels of dietary exposure to BVO in humans than many earlier studies. We could not derive a safe level of dietary exposure to BVO from these studies. As a result of these new data, we concluded that there is no longer a reasonable certainty of no harm from the use of BVO as a stabilizer for flavoring oils in fruit-flavored beverages. Therefore, in the Federal Register of November 3, 2023 (88 FR 75523), we issued a proposed rule to revoke the authorization of BVO as a food additive. B. Summary of Comments to the Proposed Rule We received over 40 comments to the proposed rule. All comments supported revoking authorization for the use of BVO as an ingredient in food, although some comments asked that we take action against other substances, such as color additives, preservatives, and ‘‘harmful’’ chemicals. We discuss the comments later in this final rule. khammond on DSKJM1Z7X2PROD with RULES IV. Legal Authority We are issuing this final rule under sections 409(i) and 701(a) of the FD&C Act. The FD&C Act defines ‘‘food additive,’’ in relevant part, as any substance, the intended use of which results or may reasonably be expected to result, directly or indirectly, in it becoming a component of food, if such substance is not generally recognized by qualified experts as safe under the conditions of its intended use (section 201(s) of the FD&C Act (21 U.S.C. 321(s))). Section 409(i) of the FD&C Act provides that the procedure by which food additive regulations may be amended or repealed are to be prescribed by FDA regulation and that such procedure must conform to the procedure specified in the statute for promulgating these regulations. Under 21 CFR 171.130(a), FDA may propose repealing a regulation pertaining to a food additive. Section 701(a) of the FD&C Act provides the authority to issue regulations for the efficient enforcement of the FD&C Act. V. Comments on the Proposed Rule and FDA Response We received over 40 comments on our proposal to revoke the authorization for use of BVO as an ingredient in food and are finalizing it without change. The comments came from individuals, a grocery chain, a consumer advocacy group, and an environmental group. We describe and respond to the comments in this section. To make it easier to identify comments and our responses, the word ‘‘Comment,’’ in parentheses, will appear before the VerDate Sep<11>2014 18:48 Jul 02, 2024 Jkt 262001 comment’s description, and the word ‘‘Response,’’ in parentheses, will appear before our response. We have also numbered each comment to help distinguish between different comments. The number assigned to each comment is purely for organizational purposes and does not signify the comment’s value or importance or the order in which it was received. (Comment 1) The proposed rule would revoke § 180.30, which authorizes on an interim basis the use of BVO as a stabilizer for flavoring oils used in fruit-flavored beverages, for which any applicable standards of identity do not preclude such use, in an amount not to exceed 15 ppm in the finished beverage. All comments supported revoking BVO’s authorization for use as a stabilizer for flavoring oils used in fruitflavored beverages, and some comments stated that BVO should not be present in foods generally. Most comments supported revocation without offering any additional evidence or summarized the evidence that we gave in the proposed rule. Some comments cited other published articles or made additional arguments to support revocation. (Response 1) We appreciate interest in and support of the proposed rule. We are finalizing the rule as proposed. We note that, while some comments said BVO should not be present in food generally, § 180.30 did not authorize BVO’s use in all foods. The authorization was specific to BVO’s use, on an interim basis, as a stabilizer for flavoring oils used in fruit-flavored beverages. We previously determined that the use of BVO in food is not GRAS (35 FR 1049). Therefore, BVO cannot be used in food without an authorizing food additive regulation or an applicable exception from regulation as a food additive (e.g., section 201(s)(1) through (6) of the FD&C Act). (Comment 2) Several comments sought actions in addition to revoking § 180.30. In general, the comments asked us to ‘‘ban’’ other food and color additives and unspecified ‘‘poisons and toxins.’’ (Response 2) The rulemaking, as well as the administrative record supporting the rule, are specific to BVO. Consequently, requests that we take action against other substances are outside the scope of this rulemaking. We do note, however, that reassessing the safety of substances used in food is an important part of our food safety mission, especially as new information becomes available. See https:// www.fda.gov/news-events/fda-voices/ how-fdas-new-approach-reviewing- PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 chemicals-added-food-will-strengthenfood-safety. (Comment 3) One comment said that our conclusions regarding BVO’s safety probably would extend to other brominated food additives and asked that we evaluate brominated food additives as a group and ensure that consumers are not exposed to brominerelated health risks through other means once BVO is no longer permitted as a food additive. The comment also asked that we revoke the authorization for all brominated vegetable oils, including brominated soybean oil. (Response 3) With respect to brominated soybean oil, within § 180.30, the term ‘‘brominated vegetable oil’’ includes any vegetable oil subjected to bromination, as described in section I.A. of this document. Because this rulemaking revokes § 180.30, a vegetable oil subjected to bromination (including brominated soybean, corn, cottonseed, olive, and sesame oil) is no longer authorized for use as a stabilizer for flavoring oils used in fruit-flavored beverages. With respect to other brominated food additives, this request is outside the scope of this rulemaking. (Comment 4) Two comments stated that while some manufacturers already have discontinued use of BVO, products containing BVO are available on the market and found in store-brand products and ‘‘lesser-known regional brand’’ products or ‘‘value products’’ sold in low-budget stores. The comments said that people with limited income are more likely to buy such products and, therefore, will be more likely to suffer adverse health effects. (Response 4) We agree with the comments. In addition, as noted in the economic analysis accompanying the rule, BVO-containing beverages are often sugar-sweetened beverages, and some studies show that low-income consumers may consume more sugarsweetened beverages and thus may be disproportionately exposed to BVO. Also, as noted in the economic analysis accompanying the proposed rule, news about manufacturers committing to removing BVO has been prevalent in the past decade, which may lead to consumers spending less time reading food product labels to determine whether food contains BVO. This would potentially create an information asymmetry where consumers incorrectly believe that their food no longer contains BVO. Thus, intervention is needed to avoid potential adverse health impacts in the shorter term. E:\FR\FM\03JYR1.SGM 03JYR1 Federal Register / Vol. 89, No. 128 / Wednesday, July 3, 2024 / Rules and Regulations VI. Description of the Final Rule The final rule revokes § 180.30, which authorizes on an interim basis the use of BVO as a stabilizer for flavoring oils generally used in fruit-flavored beverages, for which any applicable standards of identity do not preclude such use, in an amount not to exceed 15 ppm in the finished beverage. We previously determined that the use of BVO in food is not GRAS (35 FR 1049). Therefore, the use of BVO in food is no longer be authorized. VII. Effective/Compliance Dates The final rule’s effective date is August 2, 2024. We also recognize that the food industry would need sufficient time to reformulate products and for these products to work their way through distribution. Therefore, the compliance date for this rule is 1 year after the effective date, to provide the opportunity for companies to reformulate, relabel, and deplete the inventory of BVO-containing products before we begin enforcing the final rule. VIII. Economic Analysis of Impacts We have examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, Executive Order 14094, the Regulatory Flexibility Act (5 U.S.C. 601–612), the Congressional Review Act/Small Business Regulatory Enforcement Fairness Act (5 U.S.C. 801, Pub. L. 104–121), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104–4). Executive Orders 12866, 13563, and 14094 direct us to assess all benefits, costs, and transfers of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Rules are ‘‘significant’’ under Executive Order 12866 Section 3(f)(1) (as amended by Executive Order 14094) if they ‘‘have an annual effect on the economy of $200 million or more (adjusted every 3 years by the Administrator of [the Office of Information and Regulatory Affairs (OIRA)] for changes in gross domestic product); or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, territorial, or tribal governments or communities.’’ OIRA has determined that this final rule is not a significant regulatory action under Executive Order 12866 Section 3(f)(1). Because this rule is not likely to result in an annual effect on the economy of $100 million or more or meets other criteria specified in the Congressional Review Act/Small Business Regulatory Enforcement Fairness Act, OIRA has determined that this rule does not fall within the scope of 5 U.S.C. 804(2). The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because we estimate that this final rule will impact at most 2.5 percent of small businesses within the beverage manufacturing industry, and because we believe that costly disruptions to small entities are likely to be small due to replacement formulas for BVO having been in place and widely used for decades, we certify that the final rule will not have a significant economic impact on a substantial number of small entities. The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes estimates of anticipated impacts, before issuing ‘‘any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 55043 or more (adjusted annually for inflation) in any one year.’’ The current threshold after adjustment for inflation is $183 million, using the most current (2023) Implicit Price Deflator for the Gross Domestic Product. This final rule will not result in an expenditure in any year that meets or exceeds this amount. Food producers would not be permitted to use BVO as a food additive under the final rule. For the purposes of this analysis, we assume that all products currently using BVO will be reformulated to use some other kind of stabilizer. 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 changes to sensory product properties. The benefits of this final rule come in the form of public health gains from reduced exposure to BVO. The annualized costs (with a discount rate of 2 percent) of this rule, 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 $16.4 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 oz. It is possible that the cost of reformulation and relabeling could be passed on to consumers in the form of higher prices. We do not know what percentage of the costs will be passed on to consumers. However, replacement formulas have been in place for decades and are widely used in beverage products throughout the United States and the world. The time between the publication of our final rule and the rule’s compliance period should minimize costly disruptions to manufacturers still using BVO. TABLE 1—SUMMARY OF BENEFITS, COSTS, AND DISTRIBUTIONAL EFFECTS OF THE FINAL RULE [Millions of 2023 dollars] khammond on DSKJM1Z7X2PROD with RULES Category Benefits: Annualized monetized benefits. Annualized quantified, but non-monetized, benefits. Unquantified benefits ..... Discount rate (%) Primary estimate Low estimate High estimate Dollar year Time horizon ............................... ............................... ............................... ................ 2 .................... 0.02 million oz ...... 0.01 million oz ...... 0.03 million oz ...... ................ ................ 2026–2045 ............................... ............................... ............................... ................ ................ .................... Costs: VerDate Sep<11>2014 18:48 Jul 02, 2024 Jkt 262001 PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 E:\FR\FM\03JYR1.SGM 03JYR1 Notes (e.g., risk assumptions; source citations; whether inclusion of capital effects differs across low, primary, high estimates; etc.) The benefits of the final rule come in the form of reduction in exposure to BVO. For the rule to be cost effective, it would have to prevent over $2 worth of illness annually per oz of reduced BVO exposure. 55044 Federal Register / Vol. 89, No. 128 / Wednesday, July 3, 2024 / Rules and Regulations TABLE 1—SUMMARY OF BENEFITS, COSTS, AND DISTRIBUTIONAL EFFECTS OF THE FINAL RULE—Continued [Millions of 2023 dollars] Dollar year Discount rate (%) Time horizon Category Primary estimate Low estimate High estimate Annualized monetized costs. $0.04 million/yr ..... $0.02 million/yr ..... $0.06 million/yr ..... 2023 2 2026–2045 Annualized quantified, but non-monetized, costs. Unquantified costs .......... Transfers: Annualized monetized Federal budgetary transfers. Bearers of transfer gain and loss?. Other annualized monetized transfers. Bearers of transfer gain and loss?. ............................... ............................... ............................... ................ ................ .................... ............................... ............................... ............................... ................ ................ .................... ............................... ............................... ............................... ................ 2 .................... ............................... ............................... ............................... ................ ................ .................... ............................... ............................... ............................... ................ 2 .................... Consumers ........... ............................... ............................... ................ ................ .................... ............................... ............................... ............................... ................ 2 .................... Net Benefits: Annualized monetized net benefits. Category Notes (e.g., risk assumptions; source citations; whether inclusion of capital effects differs across low, primary, high estimates; etc.) The first-year costs are roughly $6.6 million to $16.4 million. We do not know what percentage of producer costs will be passed on to consumers. Effects Notes No significant impact on substantial number of small businesses. In the Small Entity Analysis, we estimate that this final rule does not have a significant economic impact on a substantial number of small businesses. Effects on State, local, or Tribal governments. Effects on small businesses .. khammond on DSKJM1Z7X2PROD with RULES Effects on wages ................... Effects on growth .................. We have developed a comprehensive Economic Analysis of Impacts that assesses the impacts of the final rule. The full analysis of economic impacts is available in the docket for this final rule (Ref. 7) and at https://www.fda.gov/ about-fda/economics-staff/regulatoryimpact-analyses-ria. We received comments on our preliminary regulatory impact analysis of the proposed rule. The number assigned to each comment is purely for organizational purposes and does not signify the comment’s value or the order in which it was received. (Comment 5) One comment said that banning of BVO is supported economically, socially, and scientifically in both the USA as well as many other countries in the world, and that the economic impact of such a ban would be minor especially with the ease of access to safer substitutes. (Response 5) We appreciate interest in and support of the proposed rule. The preliminary regulatory impact analysis supports the comment’s conclusion that the economic impact of banning BVO would be minor, and this is also VerDate Sep<11>2014 18:48 Jul 02, 2024 Jkt 262001 supported in our final regulatory impact analysis. (Comment 6) One comment said that products containing BVO are available on the market and disproportionately expose low-income consumers to health risks. (Response 6) The distributional analysis section of the preliminary regulatory impact analysis and of the final regulatory impact analysis presents recent statistics and studies showing differential consumption of sugarsweetened beverages. Some of these statistics and studies concur with the comment’s conclusion that low-income consumers are disproportionately exposed to BVO. (Comment 7) One comment said that, even if the cost to transition to BVO alternatives had been determined to be untenable, BVO should still be banned. (Response 7) Given that no comments opposed revoking § 180.30 or argued for any other action (such as amending the rule), and given FDA’s determination that there is no longer a basis to conclude that this use of BVO is safe, we have finalized the rule by revoking § 180.30. PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 IX. Analysis of Environmental Impacts We previously considered the environmental effects of this rule, as stated in the proposed rule (88 FR 75523 at 75527). We stated that we had determined, under 21 CFR 25.32(m), that this action ‘‘is of a type that does not individually or cumulatively have a significant effect on the human environment’’ such that neither an environmental assessment nor an environmental impact statement is required. We did not receive any new information or comments that would affect our previous determination. X. Paperwork Reduction Act of 1995 This final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. XI. Consultation and Coordination With Indian Tribal Governments We have analyzed this final rule in accordance with the principles set forth in Executive Order 13175. We have determined that the rule does not contain policies that would have a E:\FR\FM\03JYR1.SGM 03JYR1 Federal Register / Vol. 89, No. 128 / Wednesday, July 3, 2024 / Rules and Regulations substantial direct effect on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. Accordingly, we conclude that the rule does not contain policies that have tribal implications as defined in the Executive Order and, consequently, a tribal summary impact statement is not required. XII. Federalism We have analyzed this final rule in accordance with the principles set forth in Executive Order 13132. We have determined that the final rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we conclude that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required. khammond on DSKJM1Z7X2PROD with RULES XIII. References The following references marked with an asterisk (*) are on display at 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 also are available electronically at https:// www.regulations.gov. References without asterisks are not on public display at https://www.regulations.gov because they have copyright restriction. Some may be available at the website address, if listed. References without asterisks are available for viewing only at the Dockets Management Staff. Although FDA verified the website addresses in this document, please note that websites are subject to change over time. *1. FDA Memorandum from S. Shibko to Division of Regulations and Petitions Control, May 25, 1970. *2. FDA Memorandum from L. Friedman to L. Buckley, Division of Regulations and Petitions Control, October 21, 1970. *3. FDA Memorandum from Y. Zang to T. Croce, Division of Petition Review, September 2, 2014. 4. Woodling K.A., P. Chitranshi, C.C. Jacob, et al., ‘‘Toxicological Evaluation of Brominated Vegetable Oil in Sprague Dawley Rats.’’ Food and Chemical Toxicology, 165:113137, 2022. *5. FDA Memorandum from D. Doell to J. Downey, Regulatory Review Branch— Team 1, March 1, 2023. VerDate Sep<11>2014 18:48 Jul 02, 2024 Jkt 262001 *6. FDA Memorandum from J. Gingrich to J. Downey, Regulatory Review Branch— Team 1, March 1, 2023. *7. FDA Final Rule to Revoke Uses of Brominated Vegetable Oil in Foods (https://www.fda.gov/about-fda/reports/ economic-impact-analyses-fdaregulations). 55045 58.6091–1(d), 58.6107–1(b), 58.6109– 1(b), 58.6151–1(b), 58.6694–1(e), 58.6695–1(b), and 58.6696–1(b). SUPPLEMENTARY INFORMATION: Background Internal Revenue Service (IRS), Treasury. ACTION: Final regulations. I. The Proposed Regulations On April 12, 2024, the Department of the Treasury (Treasury Department) and the IRS published proposed regulations (REG–118499–23) in the Federal Register (89 FR 25829) that would provide rules on procedure and administration applicable to the reporting and payment of the excise tax on repurchases of corporate stock (stock repurchase excise tax) imposed by section 4501 of the Internal Revenue Code (Code) for repurchases made after December 31, 2022 (proposed procedural regulations). This Treasury decision finalizes the proposed procedural regulations (other than proposed § 58.6011–1(c)) after taking into account comments received, as described in the Summary of Comments and Explanation of Revisions section of this preamble. The final regulations are added as subpart B of new 26 CFR part 58 (Stock Repurchase Excise Tax Regulations), which is added to subchapter D of 26 CFR chapter I (Miscellaneous Excise Taxes). On April 12, 2024, the Treasury Department and the IRS also published a separate notice of proposed rulemaking (REG–115710–22) in the same issue of the Federal Register (89 FR 25980) that would provide operating rules in proposed subpart A of part 58 relating to the computation of the stock repurchase excise tax (proposed computational regulations). This Treasury decision does not finalize the proposed computational regulations. The Treasury Department and the IRS intend to finalize the proposed computational regulations in a separate Treasury decision after considering comments received with respect to those proposed regulations. This document contains final regulations that provide guidance regarding the reporting and payment of the excise tax on repurchases of corporate stock made after December 31, 2022. The regulations affect certain publicly traded corporations that repurchase their stock or whose stock is acquired by certain specified affiliates. DATES: Effective date: These final regulations are effective on June 28, 2024. Applicability dates: For dates of applicability, see §§ 58.6001-(d), 58.6011–1(d), 58.6060–1(b), 58.6061– 1(b), 58.6065–1(b), 58.6071–1(e), II. Section 4501; Notice 2023–2 Section 4501 was added to a new chapter 37 of the Code by the enactment of section 10201 of Public Law 117–169, 136 Stat. 1818 (August 16, 2022), commonly referred to as the Inflation Reduction Act of 2022 (IRA). In general, section 4501 imposes the stock repurchase excise tax on each covered corporation (as defined in section 4501(b)) for repurchases made after December 31, 2022. See section 10201(d) of the IRA. The stock repurchase excise tax is equal to 1 percent of the fair market value of any stock of the covered corporation that is List of Subjects in 21 CFR Part 180 Food additives. Therefore, under the Federal Food, Drug, and Cosmetic Act and under the authority delegated to the Commissioner of Food and Drugs, 21 CFR part 180 is amended as follows: PART 180—FOOD ADDITIVES PERMITTED IN FOOD OR IN CONTACT WITH FOOD ON AN INTERIM BASIS PENDING ADDITIONAL STUDY 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321, 342, 343, 348, 371; 42 U.S.C. 241. § 180.30 ■ [Removed] 2. Remove § 180.30. Dated: June 18, 2024. Robert M. Califf, Commissioner of Food and Drugs. [FR Doc. 2024–14300 Filed 7–2–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 58 [TD 10002] RIN 1545–BQ60 Excise Tax on Repurchase of Corporate Stock—Procedure and Administration AGENCY: SUMMARY: PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 E:\FR\FM\03JYR1.SGM 03JYR1

Agencies

[Federal Register Volume 89, Number 128 (Wednesday, July 3, 2024)]
[Rules and Regulations]
[Pages 55040-55045]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-14300]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 180

[Docket No. FDA-2023-N-0937]
RIN 0910-AI81

Revocation of Authorization for Use of Brominated Vegetable Oil
in Food

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: 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.

DATES: The rule is effective August 2, 2024. For the applicable
compliance date, see section VII ``Effective/Compliance Dates'' in the
SUPPLEMENTARY INFORMATION section of this document.

ADDRESSES: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov 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.

FOR FURTHER INFORMATION CONTACT: 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.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
A. Purpose of the Final Rule
B. Summary of the Major Provisions of the Final Rule
C. Legal Authority
D. Costs and Benefits
II. Table of Abbreviations/Acronyms Used in This Document
III. Background
A. Need for the Regulation/History of This Rulemaking
B. Summary of Comments to the Proposed Rule
IV. Legal Authority
V. Comments on the Proposed Rule and FDA Response
VI. Description of the Final Rule
VII. Effective/Compliance Dates
VIII. Economic Analysis of Impacts
IX. Analysis of Environmental Impact
X. Paperwork Reduction Act of 1995
XI. Consultation and Coordination With Indian Tribal Governments
XII. Federalism
XIII. References

I. Executive Summary

A. Purpose of the Final Rule

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.

B. Summary of the Major Provisions of the Final Rule

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.''

C. Legal Authority

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.

D. Costs and Benefits

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).

------------------------------------------------------------------------
Abbreviation/Acronym What it means
------------------------------------------------------------------------
BVO.............................. Brominated vegetable oil.
CFR.............................. Code of Federal Regulations.
FDA.............................. Food and Drug Administration.
FD&C Act......................... Federal Food, Drug, and Cosmetic Act.
GRAS............................. Generally Recognized as Safe.
NCTR............................. National Center for Toxicological
Research.
ppm.............................. parts per million.
------------------------------------------------------------------------

[[Page 55041]]

III. Background

A. Need for the Regulation/History of This Rulemaking

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 Sec. 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 (NCTR), and the National Institute of Environmental Health
Sciences' Division of Translational Toxicology (formerly the Division
of the National Toxicology Program), new rodent safety studies on BVO
were designed and executed with the goal of addressing the potential
for thyroid toxicity and bioaccumulation.
The rodent safety studies conducted by NCTR were published in 2022
(Ref. 4) and confirmed previous reports that dietary exposure to BVO is
toxic to the thyroid and results in bioaccumulation of lipid-bound
bromine in the body at doses relevant to human exposure. To account for
uncertainty in translating animal studies to humans, risk assessors
evaluate the safety of food ingredients in animal studies at use levels
greater than probable human dietary exposure. For example, FDA
typically requires food additives to be safe in animal studies at
exposures at least 100-fold higher than probable human dietary exposure
(21 CFR 170.22) to account for uncertainty in applying results from
animal studies to humans. Using the combined 2015-2018 National Health
and Nutrition Examination Survey and the conservative assumption that
all beverages labeled as containing BVO contain the 15 ppm use level
permitted by Sec. 180.30, we estimated mean and 90th percentile
dietary exposures of 5 and 9 milligrams (mg) BVO/person (p)/day (d) for
the U.S. population aged 2 years and older (Ref. 5), or 0.08 and 0.15
mg/kilogram (kg) body weight (bw)/d on a 60 kg bw basis. The doses of
BVO used in the published studies more closely approximate levels of
dietary exposure to BVO in humans than the doses used in many of the
earlier studies.
NCTR's first 90-day study conducted in rats described adverse
effects on the thyroids of test animals following dietary exposure to
BVO. Histological changes in the thyroid, specifically follicular cell
hypertrophy, were observed in males at all exposure levels and in
females at the highest exposure level, suggestive of a sex-specific
effect. The incidence of abnormal histopathological findings in male
thyroids increased in a dose-dependent manner. This study also
demonstrated alterations in hormone signaling along the hypothalamic-
pituitary-thyroid axis as a result of dietary exposure to BVO (Ref. 6).
Overall, these new data corroborate previous studies in rats and pigs
that also reported thyroid toxicity after dietary exposure to BVO (Ref.
3). Additionally, in both studies, dietary exposure to BVO led to the
accumulation of inorganic and organic bromine in test animals (Ref. 6),
a finding previously related to the onset of central nervous system
toxicity (i.e., lethargy, ataxia, and disorientation) in pigs exposed
to BVO (Ref. 3). After 90 days of dietary exposure to BVO, accumulation
had not reached steady state, but brominated fatty acids appeared to
accumulate in a dose-dependent manner in the heart, liver, and inguinal
fat of all animals fed BVO.
Based on these study results, we estimated that bioaccumulated
brominated fatty acids could persist in test animals for up to 587 days
after BVO was removed from the diet (Ref. 6). The observed potential
for brominated fatty acids to bioaccumulate in these studies confirms
previous studies in laboratory animals and humans that raised safety
questions with BVO's use as a food ingredient (Ref. 3). Importantly,
the bioaccumulation of lipid-bound bromine makes it difficult to
estimate cumulative dietary exposure to BVO and to interpret subchronic
studies that reported no adverse effect from dietary exposure to BVO
(Ref. 6). These studies demonstrate BVO consumption can result in
thyroid toxicity in both male and female rats, interference with the
hypothalamic-pituitary-thyroid axis in male rats, and bioaccumulation
of lipid-bound bromine in both sexes. These studies demonstrated
adverse effects in animals at all doses tested, and the test doses

[[Page 55042]]

more closely approximated levels of dietary exposure to BVO in humans
than many earlier studies. We could not derive a safe level of dietary
exposure to BVO from these studies. As a result of these new data, we
concluded that there is no longer a reasonable certainty of no harm
from the use of BVO as a stabilizer for flavoring oils in fruit-
flavored beverages. Therefore, in the Federal Register of November 3,
2023 (88 FR 75523), we issued a proposed rule to revoke the
authorization of BVO as a food additive.

B. Summary of Comments to the Proposed Rule

We received over 40 comments to the proposed rule. All comments
supported revoking authorization for the use of BVO as an ingredient in
food, although some comments asked that we take action against other
substances, such as color additives, preservatives, and ``harmful''
chemicals. We discuss the comments later in this final rule.

IV. Legal Authority

We are issuing this final rule under sections 409(i) and 701(a) of
the FD&C Act. The FD&C Act defines ``food additive,'' in relevant part,
as any substance, the intended use of which results or may reasonably
be expected to result, directly or indirectly, in it becoming a
component of food, if such substance is not generally recognized by
qualified experts as safe under the conditions of its intended use
(section 201(s) of the FD&C Act (21 U.S.C. 321(s))). Section 409(i) of
the FD&C Act provides that the procedure by which food additive
regulations may be amended or repealed are to be prescribed by FDA
regulation and that such procedure must conform to the procedure
specified in the statute for promulgating these regulations. Under 21
CFR 171.130(a), FDA may propose repealing a regulation pertaining to a
food additive. Section 701(a) of the FD&C Act provides the authority to
issue regulations for the efficient enforcement of the FD&C Act.

V. Comments on the Proposed Rule and FDA Response

We received over 40 comments on our proposal to revoke the
authorization for use of BVO as an ingredient in food and are
finalizing it without change. The comments came from individuals, a
grocery chain, a consumer advocacy group, and an environmental group.
We describe and respond to the comments in this section. To make it
easier to identify comments and our responses, the word ``Comment,'' in
parentheses, will appear before the comment's description, and the word
``Response,'' in parentheses, will appear before our response. We have
also numbered each comment to help distinguish between different
comments. The number assigned to each comment is purely for
organizational purposes and does not signify the comment's value or
importance or the order in which it was received.
(Comment 1) The proposed rule would revoke Sec. 180.30, which
authorizes on an interim basis the use of BVO as a stabilizer for
flavoring oils used in fruit-flavored beverages, for which any
applicable standards of identity do not preclude such use, in an amount
not to exceed 15 ppm in the finished beverage.
All comments supported revoking BVO's authorization for use as a
stabilizer for flavoring oils used in fruit-flavored beverages, and
some comments stated that BVO should not be present in foods generally.
Most comments supported revocation without offering any additional
evidence or summarized the evidence that we gave in the proposed rule.
Some comments cited other published articles or made additional
arguments to support revocation.
(Response 1) We appreciate interest in and support of the proposed
rule. We are finalizing the rule as proposed.
We note that, while some comments said BVO should not be present in
food generally, Sec. 180.30 did not authorize BVO's use in all foods.
The authorization was specific to BVO's use, on an interim basis, as a
stabilizer for flavoring oils used in fruit-flavored beverages. We
previously determined that the use of BVO in food is not GRAS (35 FR
1049). Therefore, BVO cannot be used in food without an authorizing
food additive regulation or an applicable exception from regulation as
a food additive (e.g., section 201(s)(1) through (6) of the FD&C Act).
(Comment 2) Several comments sought actions in addition to revoking
Sec. 180.30. In general, the comments asked us to ``ban'' other food
and color additives and unspecified ``poisons and toxins.''
(Response 2) The rulemaking, as well as the administrative record
supporting the rule, are specific to BVO. Consequently, requests that
we take action against other substances are outside the scope of this
rulemaking.
We do note, however, that reassessing the safety of substances used
in food is an important part of our food safety mission, especially as
new information becomes available. See https://www.fda.gov/news-events/fda-voices/how-fdas-new-approach-reviewing-chemicals-added-food-will-strengthen-food-safety.
(Comment 3) One comment said that our conclusions regarding BVO's
safety probably would extend to other brominated food additives and
asked that we evaluate brominated food additives as a group and ensure
that consumers are not exposed to bromine-related health risks through
other means once BVO is no longer permitted as a food additive. The
comment also asked that we revoke the authorization for all brominated
vegetable oils, including brominated soybean oil.
(Response 3) With respect to brominated soybean oil, within Sec.
180.30, the term ``brominated vegetable oil'' includes any vegetable
oil subjected to bromination, as described in section I.A. of this
document. Because this rulemaking revokes Sec. 180.30, a vegetable oil
subjected to bromination (including brominated soybean, corn,
cottonseed, olive, and sesame oil) is no longer authorized for use as a
stabilizer for flavoring oils used in fruit-flavored beverages.
With respect to other brominated food additives, this request is
outside the scope of this rulemaking.
(Comment 4) Two comments stated that while some manufacturers
already have discontinued use of BVO, products containing BVO are
available on the market and found in store-brand products and ``lesser-
known regional brand'' products or ``value products'' sold in low-
budget stores. The comments said that people with limited income are
more likely to buy such products and, therefore, will be more likely to
suffer adverse health effects.
(Response 4) We agree with the comments. In addition, as noted in
the economic analysis accompanying the rule, BVO-containing beverages
are often sugar-sweetened beverages, and some studies show that low-
income consumers may consume more sugar-sweetened beverages and thus
may be disproportionately exposed to BVO. Also, as noted in the
economic analysis accompanying the proposed rule, news about
manufacturers committing to removing BVO has been prevalent in the past
decade, which may lead to consumers spending less time reading food
product labels to determine whether food contains BVO. This would
potentially create an information asymmetry where consumers incorrectly
believe that their food no longer contains BVO. Thus, intervention is
needed to avoid potential adverse health impacts in the shorter term.

[[Page 55043]]

VI. Description of the Final Rule

The final rule revokes Sec. 180.30, which authorizes on an interim
basis the use of BVO as a stabilizer for flavoring oils generally used
in fruit-flavored beverages, for which any applicable standards of
identity do not preclude such use, in an amount not to exceed 15 ppm in
the finished beverage. We previously determined that the use of BVO in
food is not GRAS (35 FR 1049). Therefore, the use of BVO in food is no
longer be authorized.

VII. Effective/Compliance Dates

The final rule's effective date is August 2, 2024.
We also recognize that the food industry would need sufficient time
to reformulate products and for these products to work their way
through distribution. Therefore, the compliance date for this rule is 1
year after the effective date, to provide the opportunity for companies
to reformulate, relabel, and deplete the inventory of BVO-containing
products before we begin enforcing the final rule.

VIII. Economic Analysis of Impacts

We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, Executive Order 14094, the
Regulatory Flexibility Act (5 U.S.C. 601-612), the Congressional Review
Act/Small Business Regulatory Enforcement Fairness Act (5 U.S.C. 801,
Pub. L. 104-121), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4).
Executive Orders 12866, 13563, and 14094 direct us to assess all
benefits, costs, and transfers of available regulatory alternatives
and, when regulation is necessary, to select regulatory approaches that
maximize net benefits (including potential economic, environmental,
public health and safety, and other advantages; distributive impacts;
and equity). Rules are ``significant'' under Executive Order 12866
Section 3(f)(1) (as amended by Executive Order 14094) if they ``have an
annual effect on the economy of $200 million or more (adjusted every 3
years by the Administrator of [the Office of Information and Regulatory
Affairs (OIRA)] for changes in gross domestic product); or adversely
affect in a material way the economy, a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or State, local, territorial, or tribal governments or
communities.'' OIRA has determined that this final rule is not a
significant regulatory action under Executive Order 12866 Section
3(f)(1).
Because this rule is not likely to result in an annual effect on
the economy of $100 million or more or meets other criteria specified
in the Congressional Review Act/Small Business Regulatory Enforcement
Fairness Act, OIRA has determined that this rule does not fall within
the scope of 5 U.S.C. 804(2).
The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because we estimate that this final rule will impact at most
2.5 percent of small businesses within the beverage manufacturing
industry, and because we believe that costly disruptions to small
entities are likely to be small due to replacement formulas for BVO
having been in place and widely used for decades, we certify that the
final rule will not have a significant economic impact on a substantial
number of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes estimates of
anticipated impacts, before issuing ``any rule that includes any
Federal mandate that may result in the expenditure by State, local, and
tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one
year.'' The current threshold after adjustment for inflation is $183
million, using the most current (2023) Implicit Price Deflator for the
Gross Domestic Product. This final rule will not result in an
expenditure in any year that meets or exceeds this amount.
Food producers would not be permitted to use BVO as a food additive
under the final rule. For the purposes of this analysis, we assume that
all products currently using BVO will be reformulated to use some other
kind of stabilizer.
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 changes to
sensory product properties. The benefits of this final rule come in the
form of public health gains from reduced exposure to BVO. The
annualized costs (with a discount rate of 2 percent) of this rule,
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 $16.4 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 oz.
It is possible that the cost of reformulation and relabeling could
be passed on to consumers in the form of higher prices. We do not know
what percentage of the costs will be passed on to consumers. However,
replacement formulas have been in place for decades and are widely used
in beverage products throughout the United States and the world. The
time between the publication of our final rule and the rule's
compliance period should minimize costly disruptions to manufacturers
still using BVO.

Table 1--Summary of Benefits, Costs, and Distributional Effects of the Final Rule
[Millions of 2023 dollars]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notes (e.g.,
risk
assumptions;
source
citations;
Dollar Discount Time whether
Category Primary estimate Low estimate High estimate year rate (%) horizon inclusion of
capital effects
differs across
low, primary,
high estimates;
etc.)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
Annualized monetized ..................... ..................... ..................... ......... 2 ........... ................
benefits.
Annualized quantified, but 0.02 million oz...... 0.01 million oz...... 0.03 million oz...... ......... ......... 2026-2045 The benefits of
non-monetized, benefits. the final rule
come in the
form of
reduction in
exposure to
BVO.
Unquantified benefits..... ..................... ..................... ..................... ......... ......... ........... For the rule to
be cost
effective, it
would have to
prevent over $2
worth of
illness
annually per oz
of reduced BVO
exposure.
Costs:

[[Page 55044]]

Annualized monetized costs $0.04 million/yr..... $0.02 million/yr..... $0.06 million/yr..... 2023 2 2026-2045 The first-year
costs are
roughly $6.6
million to
$16.4 million.
Annualized quantified, but ..................... ..................... ..................... ......... ......... ........... ................
non-monetized, costs.
Unquantified costs........ ..................... ..................... ..................... ......... ......... ........... ................
Transfers:
Annualized monetized ..................... ..................... ..................... ......... 2 ........... ................
Federal budgetary
transfers.
Bearers of transfer gain ..................... ..................... ..................... ......... ......... ........... ................
and loss?.
Other annualized monetized ..................... ..................... ..................... ......... 2 ........... ................
transfers.
Bearers of transfer gain Consumers............ ..................... ..................... ......... ......... ........... We do not know
and loss?. what percentage
of producer
costs will be
passed on to
consumers.
Net Benefits:
Annualized monetized net ..................... ..................... ..................... ......... 2 ........... ................
benefits.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Category Effects
Notes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects on State, local, or
Tribal governments.

--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects on small businesses... No significant impact on substantial number of small businesses.
In the Small Entity Analysis, we estimate that this final rule does not have a
significant economic impact on a substantial number of small businesses.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects on wages..............

Effects on growth.............

--------------------------------------------------------------------------------------------------------------------------------------------------------

We have developed a comprehensive Economic Analysis of Impacts that
assesses the impacts of the final rule. The full analysis of economic
impacts is available in the docket for this final rule (Ref. 7) and at
https://www.fda.gov/about-fda/economics-staff/regulatory-impact-analyses-ria.
We received comments on our preliminary regulatory impact analysis
of the proposed rule. The number assigned to each comment is purely for
organizational purposes and does not signify the comment's value or the
order in which it was received.
(Comment 5) One comment said that banning of BVO is supported
economically, socially, and scientifically in both the USA as well as
many other countries in the world, and that the economic impact of such
a ban would be minor especially with the ease of access to safer
substitutes.
(Response 5) We appreciate interest in and support of the proposed
rule. The preliminary regulatory impact analysis supports the comment's
conclusion that the economic impact of banning BVO would be minor, and
this is also supported in our final regulatory impact analysis.
(Comment 6) One comment said that products containing BVO are
available on the market and disproportionately expose low-income
consumers to health risks.
(Response 6) The distributional analysis section of the preliminary
regulatory impact analysis and of the final regulatory impact analysis
presents recent statistics and studies showing differential consumption
of sugar-sweetened beverages. Some of these statistics and studies
concur with the comment's conclusion that low-income consumers are
disproportionately exposed to BVO.
(Comment 7) One comment said that, even if the cost to transition
to BVO alternatives had been determined to be untenable, BVO should
still be banned.
(Response 7) Given that no comments opposed revoking Sec. 180.30
or argued for any other action (such as amending the rule), and given
FDA's determination that there is no longer a basis to conclude that
this use of BVO is safe, we have finalized the rule by revoking Sec.
180.30.

IX. Analysis of Environmental Impacts

We previously considered the environmental effects of this rule, as
stated in the proposed rule (88 FR 75523 at 75527). We stated that we
had determined, under 21 CFR 25.32(m), that this action ``is of a type
that does not individually or cumulatively have a significant effect on
the human environment'' such that neither an environmental assessment
nor an environmental impact statement is required. We did not receive
any new information or comments that would affect our previous
determination.

X. Paperwork Reduction Act of 1995

This final rule contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.

XI. Consultation and Coordination With Indian Tribal Governments

We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13175. We have determined that the rule
does not contain policies that would have a

[[Page 55045]]

substantial direct effect on one or more Indian Tribes, on the
relationship between the Federal Government and Indian Tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian Tribes. Accordingly, we conclude that the rule
does not contain policies that have tribal implications as defined in
the Executive Order and, consequently, a tribal summary impact
statement is not required.

XII. Federalism

We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. We have determined that the final
rule does not contain policies that have substantial direct effects on
the States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, we conclude that the rule
does not contain policies that have federalism implications as defined
in the Executive order and, consequently, a federalism summary impact
statement is not required.

XIII. References

The following references marked with an asterisk (*) are on display
at 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 also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. Although FDA verified the website addresses
in this document, please note that websites are subject to change over
time.

*1. FDA Memorandum from S. Shibko to Division of Regulations and
Petitions Control, May 25, 1970.
*2. FDA Memorandum from L. Friedman to L. Buckley, Division of
Regulations and Petitions Control, October 21, 1970.
*3. FDA Memorandum from Y. Zang to T. Croce, Division of Petition
Review, September 2, 2014.
4. Woodling K.A., P. Chitranshi, C.C. Jacob, et al., ``Toxicological
Evaluation of Brominated Vegetable Oil in Sprague Dawley Rats.''
Food and Chemical Toxicology, 165:113137, 2022.
*5. FDA Memorandum from D. Doell to J. Downey, Regulatory Review
Branch--Team 1, March 1, 2023.
*6. FDA Memorandum from J. Gingrich to J. Downey, Regulatory Review
Branch--Team 1, March 1, 2023.
*7. FDA Final Rule to Revoke Uses of Brominated Vegetable Oil in
Foods (https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations).

List of Subjects in 21 CFR Part 180

Food additives.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under
the authority delegated to the Commissioner of Food and Drugs, 21 CFR
part 180 is amended as follows:

PART 180--FOOD ADDITIVES PERMITTED IN FOOD OR IN CONTACT WITH FOOD
ON AN INTERIM BASIS PENDING ADDITIONAL STUDY

0
1. The authority citation for part 180 continues to read as follows:

Authority: 21 U.S.C. 321, 342, 343, 348, 371; 42 U.S.C. 241.

Sec. 180.30 [Removed]

0
2. Remove Sec. 180.30.

Dated: June 18, 2024.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2024-14300 Filed 7-2-24; 8:45 am]
BILLING CODE 4164-01-P

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