[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]


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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.

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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.
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[[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