Proposed Rule2023-24084
Revocation of Authorization for Use of Brominated Vegetable Oil in Food
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 3, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 212 (Friday, November 3, 2023)</title>
</head>
<body><pre>
[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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
<a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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:
<a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations">https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations</a>.
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. References without asterisks are not on public
display at <a href="https://www.regulations.gov">https://www.regulations.gov</a>
[[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 (<a href="https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations">https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations</a>).
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
</pre></body>
</html>Indexed from Federal Register on November 3, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.