Federal Register / Vol. 88, No. 212 / Friday, November 3, 2023 / Proposed Rules 75523 

as RC may be deviated from using accepted 

methods in accordance with the operator’s 

maintenance or inspection program without 

obtaining approval of an AMOC, provided 

the procedures and tests identified as RC can 

be done and the airplane can be put back in 

an airworthy condition. Any substitutions or 

changes to procedures or tests identified as 

RC require approval of an AMOC. 

(k) Additional Information 

For more information about this AD, 

contact Dat Le, Aviation Safety Engineer, 

FAA, 1600 Stewart Avenue, Suite 410, 

Westbury, NY 11590; phone: (516) 228–7300; 

email: 9-avs-nyaco-cos@faa.gov. 

(l) Material Incorporated by Reference 

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paragraph under 5 U.S.C. 552(a) and 1 CFR 

part 51. 

(2) You must use this service information 

as applicable to do the actions required by 

this AD, unless this AD specifies otherwise. 

(i) European Union Aviation Safety Agency 

(EASA) AD 2023–0102, dated May 17, 2023. 

(ii) [Reserved] 

(3) For EASA AD 2023–0102, contact 

EASA, Konrad-Adenauer-Ufer 3, 50668 

Cologne, Germany; telephone +49 221 8999 

000; email ADs@easa.europa.eu; website 

easa.europa.eu. You may find this EASA AD 

on the EASA website at ad.easa.europa.eu. 

(4) You may view this material at the FAA, 

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Issued on October 27, 2023. 

Caitlin Locke, 

Director, Compliance & Airworthiness 

Division, Aircraft Certification Service. 

[FR Doc. 2023–24166 Filed 11–2–23; 8:45 am] 

BILLING CODE 4910–13–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: 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. 


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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 plantderived 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 § 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, longerterm safety studies with BVO were 

conducted (Ref. 1). FDA established an 

interim food additive regulation under 

21 CFR 121.1234 (now codified at 

§ 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 


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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 § 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 

§ 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 § 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 dosedependent manner in the heart, liver, 

and inguinal fat of all animals fed BVO. 

Based on these study results, we 

estimated that bioaccumulated 

brominated fatty acids could persist in 

test animals for up to 587 days after 

BVO was removed from the diet (Ref. 6). 

The observed potential for brominated 

fatty acids to bioaccumulate in these 

studies confirms previous studies in 

laboratory animals and humans that 

raised safety questions with 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 hypothalamicpituitary-thyroid axis in male rats, and 


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75526 Federal Register / Vol. 88, No. 212 / Friday, November 3, 2023 / Proposed Rules 

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 § 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 § 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. 


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TABLE 1—SUMMARY OF BENEFITS, COSTS AND DISTRIBUTIONAL EFFECTS OF PROPOSED RULE

Category Primary 

estimate 

Low 

estimate 

High 

estimate 

Units 

Notes Year 

dollars 

Discount 

rate 

(%) 

Period 

covered 

Benefits: 

Annualized Monetized 

$millions/year.

........................... ........................... ........................... .................... 7 

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 

$millions/year.

$0.15 ................. $0.09 ................. $0.23 ................. 2022 7 2026–2045 The first-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 Monetized $millions/year............................ ........................... ........................... .................... 7 

........................... ........................... ........................... .................... 3 

From/To ........................... From: To: 

Other Annualized Monetized $millions/year............................ ........................... ........................... .................... 7 

........................... ........................... ........................... .................... 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-fdaregulations. 

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 


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75528 Federal Register / Vol. 88, No. 212 / Friday, November 3, 2023 / Proposed Rules 

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-analysesfda-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 

■ 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: 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 

DEPARTMENT OF THE INTERIOR 

Office of Surface Mining Reclamation 

and Enforcement 

30 CFR Part 950 

[SATS WY–051–FOR; Docket ID: OSM– 

2023–0004; S1D1S SS08011000 SX064A000 

223S180110; S2D2S SS08011000 

SX064A000 22XS501520] 

Wyoming Regulatory Program 

AGENCY: Office of Surface Mining 

Reclamation and Enforcement, Interior. 

ACTION: Proposed rule; public comment 

period and opportunity for public 

hearing on proposed amendment. 

SUMMARY: We, the Office of Surface 

Mining Reclamation and Enforcement 

(OSMRE), are announcing receipt of a 

proposed regulatory and statutory 

amendment to the Wyoming coal 

program (Wyoming program) under the 

Surface Mining Control and 

Reclamation Act of 1977 (SMCRA or the 

Act). On September 25, 2018 the 

Wyoming Environmental Quality 

Council approved a number of revisions 

to rules governing permitting, operation, 

and abandonment of Class III 

underground injection and recovery 

wells associated with in situ mining of 

coal. Specifically, the proposed 

revisions update regulations to be 

consistent with Environmental 

Protection Agency Underground 

Injection Control regulations for class III 

wells, reorganize the chapter to better 

correlate with other key Land Quality 

Division (LQD) regulations and to 

reference existing LQD regulations and 

definitions, update regulations to be 

consistent with other Wyoming 

regulations pertaining to well 

construction, well abandonment, and 

aquifer exemptions, and update 

regulations to include current best 

management practices specific to in situ 

coal mining. 

This document gives the times and 

locations that the Wyoming program 

and this proposed amendment to that 

program are available for your 

inspection, the comment period during 

which you may submit written 

comments on the amendment, and the 

procedures that we will follow for the 

public hearing, if one is requested. 

DATES: We will accept written 

comments on this amendment until 4 

p.m., M.D.T., December 4, 2023. If 

requested, we may hold a public hearing 

or meeting on the amendment on 

November 28, 2023. We will accept 

requests to speak at a hearing until 4 

p.m., M.D.T., on November 20, 2023. 

ADDRESSES: You may submit comments, 

identified by SATS No. WY–051–FOR, 

by any of the following methods: 

• Mail/Hand Delivery: OSMRE, Attn: 

Jeffrey Fleischman, P.O. Box 11018, 100 

East B Street, Room 4100, Casper, 

Wyoming 82602. 

• Fax: (307) 261–6552. 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Instructions: All submissions received 

must include the agency name and 

docket number for this rulemaking. For 

detailed instructions on submitting 

comments and additional information 

on the rulemaking process, see the 

‘‘Public Comment Procedures’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

review copies of the Wyoming program, 

this amendment, a listing of any 

scheduled public hearings or meetings, 

and all written comments received in 

response to this document, you must go 

to the address listed below during 

normal business hours, Monday through 

Friday, excluding holidays. You may 

receive one free copy of the amendment 

by contacting OSMRE’s Casper Field 

Office or the full text of the program 

amendment is available for you to read 

at www.regulations.gov. 

Attn: Jeffrey Fleischman, Field Office 

Director, Office of Surface Mining 

Reclamation and Enforcement, 100 

East B Street, Casper, Wyoming 

82602, Telephone: (307) 261–6550, 

Email: jfleischman@osmre.gov 

In addition, you may review a copy of 

the amendment during regular business 

hours at the following location: 

Attn: Kyle Wendtland, Administrator, 

Wyoming Department of 

Environmental Quality, Land Quality 

Division, 200 West 17th Street, Suite 

10, Cheyenne, Wyoming 82002, 

Telephone: (307) 777–7046, Email: 

kyle.wendtland@wyo.gov 

FOR FURTHER INFORMATION CONTACT: 

Jeffrey Fleischman, Field Office 

Director, Office of Surface Mining 

Reclamation and Enforcement, 100 

East B Street, Casper, Wyoming 

82602, Telephone: (307) 261–6550, 

Email: jfleischman@osmre.gov 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Background on the Wyoming Program 

II. Description of the Proposed Amendment 

III. Public Comment Procedures 

IV. Procedural Determinations 

I. Background on the Wyoming 

Program 

Subject to OSMRE’s oversight, section 

503(a) of the Act permits a State to 


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