[Federal Register Volume 88, Number 212 (Friday, November 3, 2023)]
[Proposed Rules]
[Pages 75523-75528]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-24084]


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

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: Proposed rule.

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

SUMMARY: The Food and Drug Administration (FDA or we) is proposing to 
amend 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 proposed rule would 
revoke 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: Either electronic or written comments on the proposed rule must 
be submitted by January 17, 2024.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of January 17, 2024. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2023-N-0937 for ``Revocation of Authorization for Use of Brominated 
Vegetable Oil in Food.'' Received comments, those filed in a timely 
manner (see ADDRESSES), will be placed in the docket and, except for 
those submitted as ``Confidential Submissions,'' publicly viewable at 
https://www.regulations.gov or at the Dockets Management Staff between 
9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review 
this copy, including the claimed confidential information, in our 
consideration of comments. The second copy, which will have the claimed 
confidential information redacted/blacked out, will be available for 
public viewing and posted on https://www.regulations.gov. Submit both 
copies to the Dockets Management Staff. If you do not wish your name 
and contact information to be made publicly available, you can provide 
this information on the cover sheet and not in the body of your 
comments and you must identify this information as ``confidential.'' 
Any information marked as ``confidential'' will not be disclosed except 
in accordance with 21 CFR 10.20 and other applicable disclosure law. 
For more information about FDA's posting of comments to public dockets, 
see 80 FR 56469, September 18, 2015, or access the information at: 
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, 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.

[[Page 75524]]


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 Proposed Rule
    B. Summary of the Major Provisions of the Proposed Rule
    C. Legal Authority
    D. Costs and Benefits
II. Table of Abbreviations/Acronyms Used in This Document
III. Background
IV. Regulation of Food Additives
V. Legal Authority
VI. Safety of Brominated Vegetable Oil Consumption
    A. 2014 Evaluation of Safety Data
    B. New Findings Do Not Support Safety of BVO Used as a Food 
Ingredient
VII. Description of the Proposed Rule
VIII. Proposed Effective/Compliance Dates
IX. Preliminary Economic Analysis of Impacts
X. Analysis of Environmental Impacts
XI. Paperwork Reduction Act of 1995
XII. Consultation and Coordination With Indian Tribal Governments
XIII. Federalism
XIV. References

I. Executive Summary

A. Purpose of the Proposed Rule

    The proposed rule would amend our regulations to revoke the 
authorization for the use of brominated vegetable oil (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 is used primarily to help emulsify citrus-flavored soft 
drinks, preventing them from separating during distribution.

B. Summary of the Major Provisions of the Proposed Rule

    The proposed rule would revoke the authorization for the use of BVO 
as an ingredient in food. Specifically, the proposed rule would remove 
Sec.  180.30 (21 CFR 180.30).

C. Legal Authority

    We are proposing this rule consistent with our authority under the 
Federal Food, Drug, and Cosmetic Act (FD&C Act). We discuss our legal 
authority in greater detail in part V.

D. Costs and Benefits

    The costs of this proposed 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 proposed rule come in the form of 
public health gains from reduced exposure to BVO. The annualized costs 
of this rulemaking (with a discount rate of 7 percent), minus the costs 
of the baseline of gradual voluntary reduction, are $0.09 million to 
$0.23 million. The first-year costs of the proposed rule are $6.4 
million to $15.9 million. We estimate the annualized reduction in BVO 
exposure under the proposed 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

    Brominated vegetable oil has been used as a flavoring oil 
stabilizer and emulsifier since the 1920s and was generally recognized 
as safe (GRAS) for this use by FDA. In 1970, FDA concluded that BVO 
could no longer be regarded as GRAS 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 (FAP 0A2532) to FDA requesting approval for use 
of BVO as a food additive in beverages at a maximum use level of 15 
ppm. FDA 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, FDA 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). FDA established an interim food additive regulation under 21 CFR 
121.1234 (now codified at Sec.  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. FDA 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 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.
    Safe and authorized substitutes for BVO are available and have long 
been in use for the same functions as BVO. For example, sucrose acetate 
isobutyrate (SAIB; 21 CFR 172.833), glycerol ester of rosin (ester gum; 
21 CFR 172.735), and locust (carob) bean gum (21 CFR 184.1343) are 
approved food additives or affirmed by FDA as GRAS when used to 
stabilize or adjust the density of flavoring oils in beverages. To 
date, FDA has not taken further regulatory action regarding BVO use in 
food because new data or information had not been available that was 
sufficient to issue a permanent food additive regulation for this use 
of BVO in food or to revoke authorization for this use of BVO.

IV. Regulation of Food Additives

    Food additives are regulated under section 409 of the FD&C Act (21 
U.S.C. 348). A food additive is deemed unsafe under section 
402(a)(2)(C) of the FD&C Act (21 U.S.C. 342(a)(2)(C)), unless, in 
relevant part, the use of the food additive is authorized under a food 
additive regulation. FDA may not issue such an authorization unless the 
use of the food additive is safe. FDA defines ``safe,'' in relevant 
part, to mean that

[[Page 75525]]

there is a reasonable certainty in the minds of competent scientists 
that the substance is not harmful under the conditions of its intended 
use (see 21 CFR 170.3(i)). Certain food additives are authorized on an 
interim basis as provided under 21 CFR 180.1. 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 Sec.  171.130(a) (21 
CFR 171.130(a)), FDA may propose the issuance of a regulation amending 
or repealing a regulation pertaining to a food additive or granting or 
repealing an exception for such additive.

V. Legal Authority

    We are issuing this proposed 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 Sec.  171.130(a), FDA may propose repealing a 
regulation pertaining to a food additive. Section 701(a) of the FD&C 
Act (21 U.S.C. 371(a)) provides the authority to issue regulations for 
the efficient enforcement of the FD&C Act.

VI. Safety of Brominated Vegetable Oil Consumption

A. 2014 Evaluation of Safety Data

    In 2014, as part of our work to reevaluate food and color additives 
when, for example, new safety information becomes available about an 
authorized substance, we reviewed all available data and information 
that were relevant to the safety of BVO used as a food ingredient. For 
this reevaluation, we also reviewed the memoranda and safety studies in 
our files regarding BVO and considered current scientific principles 
and study design practices (Ref. 3).
    In our 2014 review, we identified four unresolved safety questions 
with respect to the use of BVO in food: the potential for thyroid 
toxicity, bioaccumulation, developmental neurotoxicity, and 
reproductive toxicity. 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 two of the 
unresolved safety questions: the potential for thyroid toxicity and 
bioaccumulation. We selected these two safety questions to study first 
because if these studies indicated safety concerns, we would not need 
to conduct more complex studies on the additional outcomes to take 
regulatory action.

B. New Findings Do Not Support Safety of BVO Used as a Food Ingredient

    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 recently 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 the use of BVO 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 provide important new data on two of the previously 
mentioned unresolved safety questions for BVO use in foods. In total, 
they 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

[[Page 75526]]

bioaccumulation of lipid-bound bromine in both sexes. As a result of 
these new data, we can no longer conclude that there is a reasonable 
certainty of no harm from the use of BVO as a stabilizer for flavoring 
oils in fruit-flavored beverages. While safety questions remain 
regarding the potential for developmental and reproductive toxicity 
resulting from dietary exposure to BVO, we do not believe that 
addressing these remaining unresolved safety questions is needed to 
conclude that there is no longer a reasonable certainty of no harm from 
this use. Therefore, we propose to revoke the interim authorization of 
BVO as a food additive.

VII. Description of the Proposed Rule

    The proposed rule, if finalized, would revoke 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. As we have 
previously determined that this use of BVO is not GRAS, the use of BVO 
in food will no longer be authorized. Our proposal to remove Sec.  
180.30 is supported by animal and human data, including those 
summarized in Ref. 3 and the new safety studies described above, which 
demonstrate that there is no longer a reasonable certainty of no harm 
from the authorized use of BVO in food.

VIII. Proposed Effective/Compliance Dates

    We propose that any final rule resulting from this rulemaking be 
effective 30 days after the final rule's 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, if finalized, will be 1 year after the effective date, to provide 
the opportunity for companies to reformulate, relabel, and deplete the 
inventory of BVO-containing products prior to enforcing the 
requirements of the final rule.

IX. Preliminary Economic Analysis of Impacts

    We have examined the impacts of the proposed rule under Executive 
Order 12866, Executive Order 13563, Executive Order 14094, the 
Regulatory Flexibility Act (5 U.S.C. 601-612), 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 proposed rule is not a 
significant regulatory action under Executive Order 12866 Section 
3(f)(1).
    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 proposed 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 propose to certify 
that the proposed 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 proposing ``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 $177 
million, using the most current (2022) Implicit Price Deflator for the 
Gross Domestic Product. This proposed rule would 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 
if the rule is finalized. 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 proposed 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 proposed rule come in 
the form of public health gains from reduced exposure to BVO. The 
annualized costs (with a discount rate of 7 percent) of this 
rulemaking, minus the costs of the baseline of gradual voluntary 
reduction, are $0.09 million to $0.23 million. The first-year costs of 
the proposed rule are $6.4 million to $15.9 million. We estimate the 
annualized reduction in BVO exposure under the proposed rule relative 
to the baseline of gradual voluntary reduction to be roughly 0.02 
million ounces (oz). For the proposed rule to be cost effective, it 
would have to prevent $0.15 million worth of illness (with a discount 
rate of 7 percent) on an annual basis to cover the domestic costs to 
industry. This amounts to almost $9 worth of public health benefits per 
oz of reduced BVO exposure.
    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 proposal and any subsequent final 
rule as well as that rule's compliance period should minimize costly 
disruptions to manufacturers still using BVO.

[[Page 75527]]



                                     Table 1--Summary of Benefits, Costs and Distributional Effects of Proposed Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                 Units
                                                                                                ---------------------------------------
           Category               Primary estimate        Low estimate         High estimate         Year       Discount      Period          Notes
                                                                                                   dollars      rate (%)     covered
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized        ....................  ....................  ...................  ...........            7
     $millions/year.                                                                                                    3
    Annualized Quantified.....  0.02 million oz.....  0.01 million oz.....  0.03 million oz....  ...........  ...........    2026-2045  The benefits of
                                                                                                                                         the proposed
                                                                                                                                         rule come in
                                                                                                                                         the form of
                                                                                                                                         reduction in
                                                                                                                                         exposure to
                                                                                                                                         BVO.
                               -------------------------------------------------------------------------------------------------------------------------
    Qualitative...............  For the rule to be cost effective, it would have to prevent
                                 almost $9 worth of illness annually per oz of reduced BVO
                                 exposure.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized        $0.15...............  $0.09...............  $0.23..............         2022            7    2026-2045  The first-year
     $millions/year.                                                                                                                     costs are
                                                                                                                                         roughly $6.4
                                                                                                                                         million to
                                                                                                                                         $15.9 million.
                                $0.06...............  $0.03...............  $0.08..............         2022            3    2026-2045
    Annualized Quantified.....  ....................  ....................  ...................  ...........            7
    Qualitative...............  ....................  ....................  ...................  ...........            3
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
    Federal Annualized          ....................  ....................  ...................  ...........            7
     Monetized $millions/year.
                                ....................  ....................  ...................  ...........            3
                               -------------------------------------------------------------------------------------------------------------------------
    From/To...................  From:
                                To:
                               -------------------------------------------------------------------------------------------------------------------------
    Other Annualized Monetized  ....................  ....................  ...................  ...........            7
     $millions/year.
                               -------------------------------------------------------------------------------------------------------------------------
                                ....................  ....................  ...................  ...........            3
                               -------------------------------------------------------------------------------------------------------------------------
    From/To...................  From: Producers
                                To: Consumers                                                      We do not
                                                                                                   know what
                                                                                                  percentage
                                                                                                 of producer
                                                                                                  costs will
                                                                                                   be passed
                                                                                                       on to
                                                                                                  consumers.
                               -------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local or Tribal Government:
    Small Business:
    Wages:
    Growth:
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We have developed a comprehensive Preliminary Economic Analysis of 
Impacts that assesses the impacts of the proposed rule. We request 
comment on our estimates of benefits, costs, and transfers of this 
proposed rule. The full preliminary analysis of economic impacts is 
available in the docket for this proposed rule (Ref. 7) and at https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

X. Analysis of Environmental Impacts

    We have 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. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

XI. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed 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.

XII. Consultation and Coordination with Indian Tribal Governments

    We have analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13175. We have tentatively 
determined that the rulemaking 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. We invite comments from tribal officials 
on any potential impact on Indian tribes from this proposed action.

XIII. Federalism

    We have analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. We have determined that 
the proposed 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.

XIV. 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

[[Page 75528]]

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. FDA has verified the 
website addresses, as of the date this document publishes in the 
Federal Register, but 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 Preliminary Economic Analysis of 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, it is 
proposed that 21 CFR part 180 be 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: October 25, 2023.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2023-24084 Filed 11-2-23; 8:45 am]
BILLING CODE 4164-01-P