4164-01-P
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 [INSERT DATE 30 DAYS AFTER DATE OF PUBLICATION
IN THE FEDERAL REGISTER]. 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).

II. Table of Abbreviations/Acronyms Used in This Document
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
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 § 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 § 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-pituitarythyroid 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 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 § 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,
§ 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-chemicalsadded-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 § 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.
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 [INSERT DATE 30 DAYS AFTER DATE OF
PUBLICATION IN THE FEDERAL REGISTER].
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.

Category

Table 1.--Summary of Benefits, Costs, and Distributional Effects of the Final Rule (millions of 2023 dollars)
Notes (e.g., Risk Assumptions;
Source Citations; Whether
Primary
Low
High
Discount
Time
Dollar Year
Inclusion of Capital Effects
Estimate
Estimate
Estimate
Rate
Horizon
Differs Across Low, Primary,
High Estimates; etc.)

BENEFITS
Annualized monetized benefits
Annualized quantified, but
non-monetized, benefits

2%
0.02 million
oz

0.01 million
oz

0.03 million
oz

$0.04
million/yr

$0.02
million/yr

$0.06
million/yr

2026 2045

Unquantified benefits

COSTS
Annualized monetized costs
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?
NET BENEFITS
Annualized monetized net
benefits
Category
Effects on State, local, or
Tribal governments
Effects on small businesses
Effects on wages
Effects on growth

2%

2026 2045

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.
The first-year costs are roughly
$6.6 million to $16.4 million

2%

2%
We do not know what
percentage of producer costs
will be passed on to consumers

Consumers
2%
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

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-impactanalyses-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 § 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.

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
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
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: 7/2/2024 8:45 am; Publication Date: 7/3/2024]